36C25719R0027-001.pdf

Home Oxygen PWS Page 1

SCOPE OF CONTRACT AND PERFORMANCE WORK STATEMENT

1. VISN 17 desires to establish a five-year ordering period plus one three-year optional ordering period Home Oxygen contract. This contract will cover VISN 17 only as outlined below.

504 Amarillo VAHCS

6010 Amarillo Boulevard, West

Amarillo, TX 79106

519 West Texas VA HCS - Big Spring, TX 300 Veterans Blvd.

Big Spring, TX 79720

549 North Texas VHCS - Dallas, TX 4500 South Lancaster Road

Dallas, TX 75216

671 South Texas VHCS - San Antonio, TX 7400 Merton Minter Blvd.

San Antonio, TX 78229

674 Central Texas Veterans Health Care System - Temple, TX 1901 Veterans Memorial Drive

Temple, TX 76504-7451

740 Texas Valley Coastal Bend HCS 2601 Veterans Drive

Harlingen, TX 78550

756 El Paso, TX 5001 North Piedras Street

El Paso, TX 79930-4211

Station ID Facility (Ordering Activity) Address

The current VHA structure has the Houston VAMC organizational aligned under VISN 16. There are current discussions regarding the transfer of the Houston VAMC to VISN 17. If this occurs, the VHA reserves the option to add the Houston VAMC and appropriate satellite locations to this contract when the current contract that the Houston VAMC is working under expires. Note: This will only occur if the Houston VAMC becomes organizational aligned under VISN 17.

From time-to-time, the number of Veterans served by this contract will change. VISN 17 currently serves an estimated 6868 oxygen-using patients, an estimated 55 ventilator patients and estimated 8 non-sleep related CPAP/BiPAP/NIV/Ventilator/Oxygen patients. The volumes or amounts shown in the solicitation are estimates only. The Government is not obligated to any specified number of products and/or services but shall be obligated to provide payments for all items/services requested in accordance with the contract. The task orders will be for the actual requirements of the VA as ordered by the VA during the life of the contract. The Contracting Officers Representative (COR) or designated ordering officers will provide the Contractor with notification to initiate individual beneficiary service requirements, including the beneficiary’s oxygen prescription, ventilator prescription, equipment, supplies, and services to be provided including date and place of delivery. The Contractor will confirm receipt of the request (prescription) within two working hours of notification; the COR or designated ordering officers will also provide notification of VA initiated discontinuance of service. The notification may be made orally but will be confirmed in writing within two (2) working days. The prescription will include the authorizing physician’s signature.

2. Veterans with Computerized Patient Record System (CPRS) prescription for an oxygen concentrator (not the transfill system) shall be provided with an appropriate non-electrical backup system consisting of a compressed gas source and regulator with stand, humidifiers, cannulas/mask for use during the event of a power failure or mechanical problem and necessitating the use of the backup cylinder. The cost for the above-mentioned backup system shall be borne by the Contractor. The cost of replacement equipment damaged, lost, or misplaced not through beneficiary’s negligence shall be borne by the Contractor. Signed

Home Oxygen PWS Page 2 documentation by the patient/caregiver is required if the patient declines the oxygen back-up system. Documentation of refusal is submitted to the clinical home oxygen coordinator same day and a copy included as part of monthly billing.

3. In accordance with the home oxygen prescription received from the VA Medical facility, the Contractor shall provide the beneficiary with the following supplies:

a. Humidifiers and water traps when deemed necessary. The number of humidifiers must be sufficient to ensure that they are not depleted between re-supply visits. The number of traps will be based on the patient’s flow rate.

b. Disposable oxygen cannulas on hand for a change once weekly in 4-foot and 7-foot lengths for concentrator and portable cylinders with a one change supply in reserve at all times until the Contractors next scheduled visit based upon prescription and equipment type.

c. Disposable masks for change weekly with a one change supply in reserve at all times (when masks are prescribed in lieu of nasal cannulas).

d. 25 ft.,50 ft. and 100 ft. of oxygen connecting tubing with swivel connectors shall be replaced every two weeks with an equivalent section of tubing in reserve at all times (to be included in initial setup) until the Contractors next scheduled visit. All tubing must be colored and contrast with environmental surroundings/flooring to prevent falls/trips.

e. Trach Collar and accessories (e.g. tubing) with a supply on hand allowing for change daily or more frequently if indicated by patient needs and a supply in reserve at all times until the Contractors next scheduled visit.

f. Safety holders (plastic or metal) shall be provided at no charge for all Veterans with a prescription for four (4) or more cylinders.

g. FireSafe/FailSafe valves to decrease likelihood of fire if Veteran or family members are smoking around oxygen. Two valves should be provided per oxygen source (concentrator and mobile conserving device) when Veteran is initially set up with home oxygen. Veteran is to be advised how to remove and reapply the valves when changing their tubing. Replacement valves are to be provided if patient inadvertently disposes of the valves when changing tubing. Re-education shall occur on proper reapplication of the valves when tubing is replaced. This replacement cost will be extended to the VA at CLIN pricing. Valves should last once a year per manufacturer’s literature.

h. Veteran/family and/or caregiver educational materials to include use of equipment, contractor service number, and emergency numbers in the event of equipment malfunction will be provided. All equipment will be labelled with contractor’s name and emergency contact information.

4. Contractor shall provide the beneficiary with all necessary ventilator supplies as established by the Clinical Ventilator Coordinator to fill the prescription.

5. Home visits are required when a new patient is enrolled into the VISN 17 Home

Respiratory Care Program. This first visit is referred to as an Initial Set up which should be accomplished immediately but no longer than 24 hours (unless mutually agreed upon by Contractor/COR/Veteran/Caregiver/Clinical Home Oxygen Coordinator) after time of notification by the Clinical Home Oxygen Coordinator/COR with provision of complete patient information by the VA. The VA reserves the right to obtain the service from another source and to charge the Contractor with any excess cost that may result there from, if the Contractor is unable to meet the

Home Oxygen PWS Page 3

24-hour response time. New Set-Up will include a monthly visit for the first three (3) months to ensure patient is compliant with equipment and equipment is working properly.

6. Home visits are required by a Respiratory Therapist when a new ventilator and/or CPAP/BiPAP/NIV/Ventilator/Oxygen patient is identified. The first visit is referred to as Initial Set up which should be accomplished immediately but no longer than 4 hours (unless mutually agreed upon by Contractor/COR/Veteran/Caregiver/Ventilator Clinical Coordinator) after time of notification by the Clinical Ventilator Coordinator/COR with provision of complete patient information by the VA. The VA reserves the right to obtain the service from another source and to charge the Contractor with any excess cost that may result there from, if the Contractor is unable to meet the 4-hour response time. Contractor will perform the initial ventilator/CPAP/BiPAP setup in the hospital and/or home as directed by the VA. Follow up will occur between Contractor and patient or caregiver 24 hours after set-up, 72 hours after set-up and one (1) week after initial set up. All follow up documentation will be provided to the Clinical Ventilator Coordinator. Local power company will be notified by the Contractor of the patient being home with a life support system. This is verified on the setup documentation as to time/date, power company name, number of the power company and the power company employee notified.

7. The Contractor shall provide switch-outs during the transition period of a new contract award in accordance with FAR 52.237-3, Continuity of Services, by staff with documented competency training on the manufacturers recommended assembly, use, and maintenance of the equipment used under this contract. All beneficiary switch-outs will be accomplished within the time frame established (as soon as possible after award, but not to exceed 90 days). Failure to perform the switch-outs as specified will result in a forfeit of payment to the provider currently used for every day thereafter until switch-out is complete. Payments will be assessed based on that providers established rate and prorated from setup date.

8. POLICIES AND PROCEDURES

The Contractor shall conform to all issues addressed in the VA Medical Staff By-laws and the current versions of:

• VHA Handbook 1173.13, Home Oxygen Respiratory Care Program

(http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=349)

• VHA Directive 2006-021 Reducing The Fire Hazard Of Smoking When Oxygen

Treatment Is Expected (https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=1407)

• Joint Commission Home Care Standards regarding equipment management within the patient’s home environment National Patient Safety Goals ref. NPSG.15.02.01

(https://www.jointcommission.org/assets/1/18/S1_NPSG.15.02.01.pdf).

9. WORK HOURS

The services covered by the contract shall be furnished by the Contractor as defined herein:

At a minimum, Contractor will provide services for Initial Set ups and scheduled visits, Monday through Friday from 8:00 a.m. through 6:00 p.m. Patient visits are required as indicated per clinical prescription and equipment type, unless the Clinical Home Oxygen Coordinator/COR determines a different time is required by their healthcare system.

VA observes the ten (10) Federal holidays listed below. Scheduled clinic appointments will not http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=349 https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=1407 https://www.jointcommission.org/assets/1/18/S1_NPSG.15.02.01.pdf

Home Oxygen PWS Page 4 be available at VA during these holidays. Those holidays are:

New Year’s Day Labor Day Martin Luther King’s Birthday Columbus Day President’s Day Veteran’s Day Memorial Day Thanksgiving Day July 4th Christmas Day

It should be noted that if a holiday falls on Saturday, it is observed on Friday. If a holiday falls on Sunday, it is observed on Monday. There may be occasion that a new set up will be necessary on a weekend or holiday. CLIN 19 or CLIN 20 will be used on these occasions and only if approved by the Clinical Home Oxygen Coordinator, COR and/or designee.

10. Emergency Communication System

a. Contractor shall provide a toll-free emergency response system to patient or caregiver that accepts initiated calls 24 hours a day, seven days a week concerning respiratory equipment failures or other problems. Patient must be provided with an emergency contact telephone that is answered by a human being versus an answering machine. The Contractor shall use reasonable, sound judgment in determining whether a true emergency exists that requires immediate attention or whether the problem can be resolved by telephone trouble-shooting with the patient or caregiver. When it is determined that an emergency response is indicated, the Contractor shall take all reasonable actions to meet the patient’s need. Contractor shall respond and provide services in the beneficiaries’ home within two (2) hours. Remote areas could require a longer response time but never more than six (6) hours. If Contractor is unable to respond to an emergency service call within six (6) hours, the Contractor is responsible for arranging with another supplier to provide services at the Contractor’s expense. A written explanation of why the Contractor was unable to respond to the emergency must be provided to the COR or designee within two (2) business days.

b. The Contractor shall ensure all patients have at minimum, a non-electrical oxygen supply to last three (3) times the Contractors’ response time to a call. The minimum supply will take into account each patient’s prescription flow-rate and distance from the Contractors location, and so actual supply levels may differ from patient to patient, as long as each patient has oxygen supply to last a minimum of three (3) times the Contractors’ response time. The cost of backup systems including backup oxygen, and backup equipment shall be borne by the Contractor (with the exception of Ventilators). The Contractor shall furnish an appropriate tank stand for each backup tank/system as indicated at no cost to the government. Liquid oxygen supply may be considered backup oxygen; however, the oxygen supply must be maintained at the minimum three (3) times the Contractor’s response time, and the cost of any additional equipment such as extra stationary units used solely to maintain the minimum level of backup oxygen shall be borne by the Contractor.

The cost of liquid oxygen used solely for backup purposes shall be borne by the Contractor.

c. The Contractor must notify the COR/designated ordering officers and the Clinical Home Oxygen Coordinator and/or Clinical Ventilator Coordinator immediately when emergency preparedness plan is activated in the event of a disaster, natural or otherwise, that may affect the services covered under this contract. Contact with VA officials may be accomplished electronically or via telephone. Contractor will notify/contact all patients regarding the emergency situation and provide instructions regarding emergency services.

Contractor will provide a written report to the appropriate VA staff of the emergency actions taken and all patients contacted and/or not contacted within two (2) working days.

11. The Contractor shall provide and post on all entrances into the residence, a sign stating "Warning Oxygen in Use, No Smoking" or other verbiage that NO Smoking is allowed due to

Home Oxygen PWS Page 5 oxygen being present and document that the beneficiary/care giver is instructed in the safe use of oxygen and equipment per OSHA. Throughout the life of the contract, the Contractor will monitor and document whether the No Smoking Warning signs are displayed and/or readable.

12. Reports

The Contractor will provide a monthly (5th day after the end of the month) and quarterly summary report (10th day after end of each quarter) meeting all of The Joint Commission’s (TJC) Standards for improving organizational performance (TJC standards may be accessed at http://www.jointcommission.org/). Reports, documentation and billing are submitted in accordance with COR policy at each healthcare system.

i. Incident Report – 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. Usually includes not switching out supplies as instructed, not using equipment as prescribed, not following no smoking policy, smoke alarms not being present or tested, failure to keep scheduled appointments-two (2) consecutive missed or any other unsafe situation or circumstances counter-productive to the Veteran’s home treatment goals.

ii. Customer Satisfaction - In accordance with TJC standards, the Contractor will collect data on service satisfaction from contracted patients and their families from each facility on a quarterly basis. A copy of survey results will be submitted to COR’s or designated ordering officers in Quarterly reports. These reports should report satisfaction of all clients as well as the sub-set of VA contracted clients.

iii. Infection Control/Communicable Diseases – Quarterly report will include data related to the Contractor’s ongoing Infection Control Program, which include recent hospitalizations where a patient was discharged with infectious disease.

iv. Performance improvement – The Contractor will collect data on important processes and outcomes related to patient care and organizational functions and other patient-related data as directed for performance improvement and quality purposes. The Contractor will present data in the required format as requested by the VA.

v. Contractor representative participates as a member (in person or via telephone) of the Respiratory Home Care Team at each of the healthcare systems. Team meetings are usually quarterly or at the call of the Team Chair or COR.

vi. Dashboard will be submitted electronically per HCS with a summary of all HCS reports sent to the VISN Prosthetic Representative.

Annually Contractor will submit to the COR their Periodic Performance Review for contracted services within 90 days of the end of the annual ordering period. Contractor will assess and score each TJC standards and elements of performance that is applicable to the contracted services by entering a self-assessed score. Any noncompliant findings or gaps in service identified on the self-assessment will require a plan of action to correct as part of the Periodic Performance Review submitted to the COR. The Periodic Performance Review for home care is based upon TJC home care standards and may be accessed at http://www.jointcommission.org/

13. The Contractor shall provide the following emergent patient safety notifications immediately by telephone and then followed up with written documentation throughout the contract period.

http://www.jointcommission.org/ http://www.jointcommission.org/

Home Oxygen PWS Page 6

i. Sentinel Events - The Contractor is required to inform the Clinical Home Oxygen Coordinator/Designee immediately (day of event) of a sentinel event (as defined by TJC) that occurs during the performance of this contract that involves VA beneficiaries.

ii. 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 Clinical Home Oxygen Coordinator by telephone within one (1) hour. If the refusal occurs during a home visit, the Contractor’s staff shall attempt to notify the Clinical Home Oxygen Coordinator of the refusal during the home visit.

iii. The Contractor’s delivery personnel shall report suspected incidents of abuse or neglect of the patient by family members or caregivers to their company officials. If substantiated, suspected incidents shall be reported immediately (within 24 hours) to Adult Protective Services (APS). The Contractor will follow all state and local laws in reporting suspected incidents of abuse or neglect. Contractor will inform the Clinical Home Oxygen Coordinator if APS has been contacted.

iv. The Contractor shall immediately notify the Clinical Home Oxygen Coordinator of patients who are non-compliant with smoking.

14. The Contractor shall be responsible for notifying the COR or designated ordering officers by telephone at time of set-up, if any alteration to the beneficiary's home is necessary to accommodate the oxygen equipment, including electrical work.

The Contractor is responsible for making every effort to establish appointments with VA beneficiaries when initiating set ups and deliveries. Deliveries will not be left unattended at the beneficiary’s home. If the VA beneficiary chronically fails to meet appointments the Contractor is to notify the COR or designated ordering officers. The COR or designated ordering officers will contact the VA beneficiary and a corrective action plan will be implemented. COR will notify the Contractor of any changes. If the Contractor has not made valid and documented attempts to contact the VA beneficiaries for set ups and or deliveries, the Government reserves the right to call in a third party and bill the Contractor if the Contractor fails to perform for any due month.

15. Infection Control/Communicable Diseases Requirements

a. Contractor must have a current plan for surveillance, prevention and control of infection. The plan must meet current TJC standards.

b. Contractor will provide a list of names to the Clinical Home Oxygen Coordinator of all Veteran patients exposed to communicable diseases by contracted staff during an identified incubation period. The type of exposure will also be identified.

c. The Clinical Home Oxygen Coordinator will consult with VA infection control staff regarding the need to contact exposed patients and/or complete any needed medical follow-up.

16. Assessment Requirements

The Contractor shall perform an assessment of the beneficiary’s home and environment in accordance with TJC standards and maintain documentation of assessments in the individual patient file or folder. An oxygen safety risk assessment should be conducted before starting any

Home Oxygen PWS Page 7 home oxygen and/or CPAP/BiPAP/NIV/Ventilator/Oxygen therapy in the home. Such assessment documentation for each patient shall accompany the quarterly invoice and billing.

a. The Contractor shall verbally notify the Clinical Home Oxygen Coordinator and COR during the home visit if the Contractor’s staff determines that the presence of any CPAP/BiPAP/NIV/Ventilator/Oxygen respiratory equipment in the home presents such a danger that they must be removed, or in the case of an initial set-up, not placed in the home. All verbal notification will be documented in the patient folder and faxed to the appropriate VA facility by the end of the same business day as well as being included within the billing package.

b. The Contractor shall verbally notify the Clinical Home Oxygen Coordinator and COR during the home visit of any unsafe conditions observed in the VA beneficiary’s home that precludes the installation or continuance of any CPAP/BiPAP/NIV/Ventilator/Oxygen respiratory equipment. Unsafe conditions may include, but are not limited to, 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 furnish verbal and written documentation of the safety hazard or the incident. All verbal notification will be documented in the patient folder and faxed to the appropriate VA facility by the end of the same business day as well as being included within the billing cycle.

c. The Contractor will check the adequacy of the electrical outlets in the patient’s home and immediately report unsafe conditions to the Clinical Home Oxygen Coordinator and COR. VA shall not be responsible or liable for any unsafe electrical conditions caused by the Contractor. Any alterations to the Veteran’s residence will be the responsibility of the Veteran. If ordered equipment cannot be safely installed, the Clinical Home Oxygen Coordinator may provide an alternative oxygen delivery system, after documented approval, until a new prescription can be obtained. If no alternative is available, the Clinical Home Oxygen Coordinator and/or the prescribing VA physician will be notified in writing within 24 hours of discovery.

d. The Contractor shall verify the presence of a working smoke detector and the presence of functional fire extinguisher with a full gauge. The Contractor shall document this verification in the patient file and submit documentation with the billing cycle. If the patient does not have a working smoke detector, Contractor will provide per CLIN 21. If there is no functional fire extinguisher the Contractor will strongly advise the patient to obtain one at his or her own expense.

Expectations for Compliance:

1. Consistently look for the presence or absence of a functional smoke detector and fire extinguisher when oxygen is delivered, as well as with subsequent encounters.

If needed:

a. Encourage the patient to have a functional smoke detector if he/she refuses VA offered smoke detector

b. Encourage the patient to have a functional fire extinguisher

c. Provide the patient with information concerning where the absent items can be obtained to include their local fire station

d. Notify the Clinical Home Oxygen Coordinator or prescribing physician in the event that any of these items are missing so they are aware of the safety hazard.

2. When smoke detectors, fire extinguishers and fire safety plans are present:

a. Ask the patient during the initial set-up if they have tested their smoke detectors and checked the condition (charge level) of their fire extinguishers in the last 30 days

b. Ask the patient during each service check visit if they have tested their smoke detectors and checked the condition (charge level) of their fire extinguishers in the

Home Oxygen PWS Page 8 last 30 days. If not, document the deficiency in the home care record, notify the Clinical Home Oxygen Coordinator within 48 hours, and re-educate the patient or caregiver of the importance of fire safety when using oxygen

c. Check all medical equipment provided to home oxygen patients on each service visit to ensure its fire safety. Document in the home care record that this check has occurred.

3. Identify all VA oxygen patients serviced by the Contractor whose homes where the patient or others use smoking materials or there is a potential for open flames such as in heating devices, cooking surfaces, or fireplaces.

a. Within these homes, verify the following:

i. That ‘no smoking’ signage is properly posted

ii. That the veteran/caregiver has been encouraged to have a functional smoke detector

iii. That the veteran/caregiver has been encouraged to have a functional extinguisher

iv. Patient and/or caregiver understand and confirm understanding verbalizing the dangers of smoking and open flames while oxygen is present

v. Patient and/or caregiver will avoid smoking or in the presence of flames anywhere near oxygen

vi. Clinical Home Oxygen Coordinator has been notified if patient/caregiver persists or continues to have open flame devices in the vicinity of oxygen

b. The Contractor shall discuss an Exit Plan with the patient. The Contractor shall ensure the Exit Plan is feasible. The Contractor shall document this discussion about the Exit Plan in the patient file as well as part of the billing cycle.

17. Discontinuation of Service

a. The government shall notify the Contractor in the event of an order to discontinue oxygen or ventilator service to any beneficiary covered under this contract. Notification shall be by telephone, secure e-mail and/or facsimile.

The Contractor shall notify the government by next business day of a patient death, or upon finding a patient has moved out of the service area.

b. The Contractor shall remove equipment from the beneficiary’s residence at the earliest possible time, but no later than five (5) business days unless approved by the Prosthetic Service. 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 beneficiary’s or beneficiary’s families’ request for pickup times. The Contractor shall honor beneficiary’s or family’s request to pick-up equipment before or after funerals or family gatherings, relative to beneficiary funerals. The Contractor shall treat such requests with the utmost courtesy and give such requests the highest priority.

c. Patients relocating out of VISN 17’s primary service area will be allowed to take all equipment, cylinders and supplies with them to their new place of residence. The patient will be provided with enough oxygen and supplies to sustain them for 30-45 days to permit enrollment into the receiving healthcare system. The Contractor will coordinate with the local Contractor in the new area for the return of Contractor owned equipment, shipping and related charges at no additional cost to the government. The Veteran may be provided with a vendor owned portable concentrator while relocating to their new primary service area. A prescription will be provided to Vendor to change equipment if appropriate.

17. Employee Certification

Home Oxygen PWS Page 9

a) The Contractor shall develop, maintain, and make available for review, personnel folders on all employees performing under this contract.

b) Contractor must provide and document employee orientation, ongoing employee education, and ongoing assessment of employee competency for all employees involved with the delivery/recovery of equipment covered under this contract according to TJC standards.

c) The Contractor will provide COR or designated ordering officers with a list of all employees currently competent to perform licensed respiratory therapy services, delivery/recovery and patient education services at the time the contract is awarded. COR or designated ordering officers will inspect employee files at the time of the inspection of Contractor premises and vehicles.

d) The Contractor will provide all required documentation of certification and/or registry from the National Board for Respiratory Care (NBRC) and a valid State license for all Respiratory Therapist personnel utilized under this contract. This documentation shall be provided for each State that is serviced under this contract.

e) The Contractor will educate, evaluate and document employee education in strict accordance with current TJC accreditation standards.

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

g) The Contractor shall be staffed and have sufficient supplies to render satisfactory and courteous service at all times to the beneficiary. The Contractor shall be responsible for the acts and omissions of his/her employees.

18. Equipment: Contractor shall install and service all CPAP/BiPAP/NIV/Ventilator/Oxygen respiratory equipment and dispense CPAP/BiPAP/NIV/Ventilator/Oxygen respiratory equipment ordered under this contract. All Contractor owned equipment is to be current state-of-art 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 will be affixed to all equipment (VA and Contractor owned). Contractor shall provide collars that will reflect the tank is specifically for back up use only. This collar will be provided by the Contractor at no expense to the VA. Contractor will not service, move, assess or be responsible for any equipment that is privately owned, owned by another vendor, or otherwise not owned by the Veterans Medical Center.

19. The installation of all machines and equipment by the Contractor shall be performed by a competent professional familiar with 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 current local Fire and Safety Codes in the respective area of the State and shall conform to NFPA 99/101 (Life Safety Codes) and NFPA (Oxygen Cylinder Requirements). The Contractor shall provide a safety/emergency checklist to be completed, then signed by the Veteran or his/her caregiver and retained in the beneficiary account folder as well as submitted as part of the billing cycle. The Contractor shall ensure that all equipment is checked at manufacturer recommended intervals. A Contractor’s staff member will conduct a check of the concentrator using a certified oxygen analyzer that is calibrated according to the manufacturer standards. Preventative maintenance on equipment shall be done by a manufacturer’s checklist. It shall include compressor inlet pre-filter changes and compressor inlet bacteria filter changes according to the manufacturer recommendations. The alarm battery shall be tested at each maintenance check, changed as indicated but at least 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. Price estimates will be submitted before any

Home Oxygen PWS Page 10 preventative maintenance is done. Records will be kept of maintenance performed showing the make, model and serial number of units, date of service, itemized list of materials, parts and labor. The Contractor shall have recall procedures for equipment and supplies.

Contractor shall insure appropriate static testing on VA owned tanks will be conducted (CLIN 0015). Each cylinder bearing a DOT specification marking (including a cylinder remarked in conformance with §173.23) must be inspected, retested and marked in conformance with this section, at the frequency specified in the Retest and Inspection of Cylinders Table. Each cylinder bearing a DOT exemption number must be inspected, retested and marked in conformance with this section and the terms of the applicable exemption, at the frequency specified in the exemption.

20. The Contractor shall not change or alter a VA beneficiary’s oxygen or ventilator prescriptions or equipment requirements without a new prescription from the beneficiary’s VA Pulmonary or specialty physician submitted by the Clinical Home Oxygen Coordinator, Clinical Specialty Coordinator (ventilators), COR or designated ordering officers. The Contractor will provide items and services as authorized by the government.

21. Transition Period: At the end of the contract period, a transition period will be required during which incumbent Contractor will continue to provide services at the contract prices while the incoming Contractor is taking over. This period will be approximately 90 days.

22. EQUIPMENT SPECIFICATIONS

Standards and guidelines are as follows:

a. The American Respiratory Care Foundations for Respiratory Equipment Used in the Home.

b. American Society for Testing Materials (ASTM) minimum standards specification for electrically powered home care portable ventilators.

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

d. The Joint Commission Standard for Home Care/CMS, current year standard.

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

• Electrically powered (115 volts).

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

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

• Hour meter and OCI indicator

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

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

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

25. Government-owned equipment shall be maintained per manufacturer’s specifications.

Contractor owned equipment shall be repaired or replaced at no cost to the Government when breakdown or malfunction is due to normal usage or due to the fault of the Contractor.

Home Oxygen PWS Page 11

Government-owned equipment will be terminally cleaned, maintained and repaired by Contractor.

COR will be notified when VA owned equipment can no longer be repaired.

26. CYLINDERS: The Contractor shall furnish cylinders (other than those associated with the trans-fill system) called for under this contract that are only in accordance with the Interstate Commerce Commission Regulations, and transport cylinders in accordance with Code of Federal Regulations (CFR) Part 49, U.S. Department of Transportation. ‘H’, ‘K’, or ‘M’ cylinders furnished by the Contractor shall have ‘H’, ‘K’ or ‘M’ safety stand at no additional charge to the Government.

This stand shall remain Contractor-owned.

27. SITE VISITS: Periodic, unscheduled on-site Contractor and patient home visits will be made by Clinical Home Oxygen Coordinator and COR to monitor the Contractor’s performance under this contract. The Contractor agrees to make available all records and documentation necessary during the monitoring visits.

28. The Contractor must have experience in successfully administering CPAP/BiPAP/NIV/Ventilator/Oxygen respiratory equipment to adult and geriatric patients. The Contractor will be responsible for coordinating, supervising and evaluating the equipment and/or services provided.

29. Contractor must provide staff with documented competency training to deliver prescribed CPAP/BiPAP/NIV/Ventilator/Oxygen respiratory equipment/supplies as required to each beneficiary as needed. All established patients will be visited quarterly for transfill oxygen units and monthly for all other patients and assigned a routine delivery/service day on the same day of the same week as determined by equipment prescribed/provided. The Contractor will schedule home visits within a two-hour window and advise the patient of either morning or afternoon delivery. This notification will be documented in the patient file as well as part of the billing cycle.

This is accomplished by telephone contact by the Contractor with the patient prior to each visit to ascertain the needs of the patient. While every effort will be taken to insure that patients are available for their regularly schedule visits, circumstances beyond the patient’s control may result in a visit that will have to be rescheduled; the Contractor is still required to provide that service, maintenance, replenishment of cylinders and supplies even if it requires making a special or non-scheduled visit to the patient’s home. Prior telephone contact with the patient by the vendor should reduce the number and frequency of the unscheduled visits. Any patient missing two consecutive scheduled visits should be immediately reported to the Home Oxygen Coordinator/COR for follow up. VA will monitor patient compliance and missed scheduled visits.

All equipment in the home must be maintained as recommended by the manufacturer. Patient, caregiver, or adult over age 18 years must be available with no “drop off” of equipment/supplies allowed.

30. Depending on type of equipment prescribed/provided, the Contractor will visit the VA beneficiaries to reassess equipment compliance, educational needs, etc. For patients prescribed transfill equipment, the visits will be quarterly all other patients with traditional tanks and concentrators will require monthly visits. The Clinical Home Oxygen Coordinator/COR can authorize a different time frame depending on the needs of the healthcare system. Written documentation to be submitted with each patient invoice will include at a minimum the following:

a. Name and social security number (SSN) of beneficiary using the equipment.

b. Monitored compliance on prescription (LPM, settings, hours per day)

c. Type of delivery system, hours on concentrator, Serial Numbers kept on file should be for VA owned equipment only. Serial Numbers for the rented equipment shall be the Contractor’s responsibility and kept on file in Contractor’s main office.

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

e. Inspection for a smoke detector.

f. Inspection for fire extinguisher.

Home Oxygen PWS Page 12

g. Review of Exit Plan, ensure plan is feasible.

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

i. Revised plan of service as needed.

j. Notification immediately of excessive missed scheduled monthly visits (two consecutive).

k. Immediate notification of compliance with switching out supplies.

l. A report shall be developed within 2 days, by the visiting technician, signed and dated by the contract staff and the VA beneficiary/care giver and copy shall be left with the beneficiary. The material should include training material, patient education, incident reporting, etc. The reports shall be legible and attached to the invoice. All reports shall be submitted to the COR or designated ordering officers in alphabetical order, with the monthly bills by the 10th business day of the month following service.

31. The Contractor shall maintain a VA beneficiary account folder in compliance with the Privacy Act and Health Insurance Portability and Accountability Act (HIPAA). All beneficiary files are subject to review by designated VA officials and accreditation surveyors on behalf of the VA during accreditation surveys or consultation. As a minimum, the VA beneficiary folder will adhere to current TJC standards for patient record keeping. This acquisition does not require services that involve connection of one or more contractor-owned IT devices to a VA internal trusted network. The Certification and Accreditation requirements do not apply, and a Security Accreditation Package is not required.

32. Contractor must provide a written emergency management plan in compliance with TJC standards. At the time of set up, Contractor shall provide beneficiaries with a telephone number to call if there are any questions or additional information is required, and instructions for what to do in a natural disaster or other emergency.

33. Standard precautions shall be used to prevent exposure to blood borne diseases when handling all contaminated equipment/items. Gloves shall be worn when handling items soiled with blood and/or body fluids. Hands shall be washed before and after visiting each patient and when gloves are removed. Contaminated equipment shall be separated from clean equipment.

The Contractor’s warehouse shall have clear demarcation between contaminated and clean storage areas. Delivery vehicles, if dirty and clean equipment is transported in the same vehicle, will have a clearly demarcated area for clean and dirty items. Contractor’s procedure for handling the pick up of dirty equipment will meet TJC Standards.

TRAVELING PATIENTS

34. The Contractor shall be responsible for coordinating all services for Veterans who travel outside jurisdiction of this contract. Department of Veterans Affairs shall be responsible for notifying the Contractor via travel prescription, where the beneficiary is traveling, and mode of transportation. The Contractor shall be responsible for instructing the patient on how to safely travel with the oxygen and how to appropriately respond in an emergency.

35. Privately owned vehicles – The Contractor shall assist the Veteran in preparing a travel plan, identify locations, etc. (logistics) along Veteran’s route where oxygen refills can be obtained and coordinate billing for services and refills as appropriate. There shall be no fee for this logistical service.

36. Airline – The Contractor shall assist the Veteran with prior arrangements to have oxygen available at point of destination for the duration of visit and to coordinate billing for services and refills as appropriate.

Home Oxygen PWS Page 13

37. Veterans traveling within VISN 17 – The Contractor shall provide oxygen refills at the rate of the contract. For Veterans traveling outside VISN 17 the VA will reimburse on a cost basis.

When available a VA contracted company will be utilized first before non-contracted companies.

38. For Veterans who temporarily relocate from VISN 17 to another VISN (i.e. cooler climates for summer months), accommodations shall be made to assist Veterans so as not to interrupt services. The Contractor shall keep on file the latest prescription for oxygen. Upon return, beneficiaries shall be responsible for contacting the Contractor to re-establish oxygen services.

The Contractor shall immediately notify the COR or designated ordering officers of the beneficiary’s return.

PATIENT EDUCATION REQUIREMENTS

39. The Contractor shall provide education to each Veteran and/or family or caregiver at the time of set-up, and reinforce patient education every visit. This information is to be presented verbally, in demonstration and material covered shall be in written form to be left with Veteran/family/beneficiary/caregiver. The written material shall be in English as well as the foreign language of the beneficiary, should the beneficiary not speak English. In the case of such an occurrence, the Contractor is to advise the VA to facilitate adequate instructions. All patient education material must be presented in written form to the COR for approval prior to the award. The Contractor as directed by COR or designated ordering officers will implement any new or revised education material. The VA will determine whether the Contractor shall use their forms or forms supplied by the VA for documentation of services provided to VA beneficiaries.

a. The Contractor will provide educational and/or warning information for patients, their families, or caregivers on the hazards of smoking while oxygen is in use. The educational materials must be provided upon initial delivery and minimally every 6 months thereafter. The checklist used by vendors for medical gas follow-up services must, at minimum include:

1. No Smoking signs provided and or posted.

2. Smoke alarm and fire extinguisher are present, Veteran instructed to test all smoke alarms monthly, and smoke alarm sounds when tested and fire extinguisher is charged and in code.

3. Veteran has been instructed to remove the cannula, shut off the oxygen supply, and leave the vicinity of the oxygen prior to smoking

4. Veteran, family or cohabitants given educational material regarding the hazards of smoking and using an open flame near oxygen.

5. Ensure fire safe/fail safe valves are in use on all oxygen devices.

40. Veterans will be provided a copy of VA Patient Rights & Responsibilities, and any advance information concerning directives. The Contractor shall document that the beneficiary/care giver is instructed in accordance with TJC Standards.

41. The Contractor shall visit beneficiaries' residences in performance of this contract by appointment only, between the hours of 8:00 a.m. and 5:00 p.m., five (5) days per week, exceptions will be made in the cases of emergencies. The Contractor is responsible for scheduling the appointments to the beneficiary’s home 24-48 hours prior to the visit. On each scheduled setup/delivery, the Contractor shall reassess the need to instruct the beneficiary on the use and care of the equipment and supplies as necessary.

42. DEMURRAGE CHARGES: The Contractor agrees to provide cylinders without assessing demurrage charges on the Government. The Contractor further agrees that the free loan period of cylinders is indefinite, but shall not exceed the term of the contract.

Home Oxygen PWS Page 14

43. The VA will 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. Accordingly, this is considered the cost of doing business, and is the requirement of the Contractor to pay for this type of equipment. Contractor may request payment by submitting a written summary of the circumstances of lost or damaged equipment to the Contracting Officer within 30 calendar days of the occurrence of the incident in question. The Contracting Officer will review the summary, and a written determination will be made to the Contractor as to the liability. The VA will not pay for rental on equipment not being used by an authorized Veteran during the performance of this contract or for equipment that cannot be found.

44. Representative of Contracting Officer: The Contracting Officer reserves the right to designate a representative to act for him/her in furnishing technical guidance and advice or generally supervise the work to be performed under this contract. Such designation will be in writing and will define the scope and limitations of the designated ordering officers’ authority. A copy of the designation will be furnished to the Contractor after notice of award.

45. The Contractor shall provide a clean, separate and secure storage space located within each healthcare system’s primary service area. The Contractor must protect the territorial integrity of the VA storage area from encroachment. All VA owned items shall be stored in an orderly arrangement to allow for ready access to any item and its components. In addition, the Contractor must, regardless of the size, weight or frequency of shipments have the capability to accept and receipt for respiratory equipment freight deliveries from all sources. Normal delivery hours shall be Monday to Friday, 8:00 a.m. to 5:00 p.m.

46. Contractor shall have a storefront (storage) facility accessible to the disabled and meeting ADA requirements with regard to wheelchair access to allow Prosthetic Staff, Clinical Home Oxygen Coordinator, VA patients, and/or beneficiaries to pick-up items from the Contractor’s facility when so authorized.

47. The Contractor will account weekly for all VA owned equipment shipped to, stored at and/or set up in the patient’s home. Inventory list shall be legible and formatted to show type of equipment by brand, model, serial/lot number, tag number, condition of the equipment; and quantity on hand as well as issued to patients. This information will be provided electronically to the COR.

48. Bills shall be submitted weekly or monthly (as designated by the COR), and each patient’s invoice shall include the appropriate TJC documentation such as: environmental assessment;

communi…