36C26124Q0072 0004 SNVHCS Las Vegas Home Oxygen Supplies and Services.pdf

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Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

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is extended,

(a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY is not extended.

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15C. DATE SIGNED

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

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Contractor

16C. DATE SIGNED

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16B. UNITED STATES OF AMERICA

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

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AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

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1 24

0004 None

00261

Department of Veterans Affairs Network Contracting Office 21 VA Southern Nevada Healthcare System 6900 N. Pecos Road, Building 6 North Las Vegas NV 89086

00261

Department of Veterans Affairs Network Contracting Office 21 Southern Nevada Healthcare System 6900 N. Pecos Road, Building 6 North Las Vegas NV 89086

To all Offerors/Bidders

36C26124Q0072

01-26-2024

X

The purpose of amendment 0004 is the following:

A. Provide Updated Statement of Work reflecting revision of a 90 day transition period.

B. Provide responses to follow up questions.

STATEMENT OF WORK

For

Home Oxygen Supplies and Services

SECTION 1 - GENERAL REQUIREMENTS

1.1 Intent

The Intent of this solicitation is to establish one contract with one (1) supplier to provide all supplies, materials, labor, supervision, transportation, patient education, safety management and infection control for home oxygen services as described in this contract to beneficiaries of the VA Facilities listed in the pricing pages. Successful contractors shall provide service for all beneficiaries covered by the facilities they are awarded, at the contract rates, regardless of the physical location of the beneficiary.

1.2 Roles and Responsibilities

1.2.1 Clinician orders for providing Home Oxygen Healthcare Services, which includes the use home oxygen, home based life support systems (i.e., ventilators) and related respiratory equipment (Nebulizers, Compressors, etc.) are processed through the Prosthetic and Sensory Aid Services (P&SAS) at the Southern Nevada Healthcare System. Initiation of treatment, delivery and pick up of equipment and, resolutions of problems related to equipment or patient care are under the direction of P&SAS and/or the Contracting Officer’s Representative (COR).

1.2.2 VA Clinicians have the exclusive responsibility for determining eligibility and necessity for admission to the Home Oxygen Program and for providing orders for admission. The Contractor has responsibility for providing the services, supplies and equipment as ordered, under the timelines specified.

1.2.3 VA Clinicians will complete initial and ongoing patient assessments.

1.2.4 The contractor Is responsible for coordinating, supervising, monitoring, and evaluating the care and service provided and must assure that the contracted services are performed according to the terms of the contract. The contractor must also assure that its personnel meet the requirements of the contract and are competent to do the jobs assigned them. The VA shall monitor the contractor's performance through contractor site visits, patient home visits, record checks, patient satisfaction/complaints, monthly review of invoices for accuracy. Monitors will focus on timeliness of equipment delivery; timeliness of maintenance visits; accuracy of required paperwork, and adherence to Joint Commission on Accreditation of Healthcare Organizations (JCAHO) standards.

1.2.5 VA sets timelines for the provision of services and the contractor must meet those timelines. It is the contractor’s responsibility to schedule the times and dates for the delivery of services within the timelines established. Deliveries shall not be left unattended at the beneficiary's home unless prior arrangements are made with the beneficiary.

SOW: Home Oxygen Supplies and Services VA Southern Nevada Healthcare System

1.2.6 VA providers determine the discharge plan from the Home Oxygen Program based on clinical assessment that may also include data submitted by the contractor.

1.2.7 In the event of damage to and/or theft of contractor's equipment due to patient negligence, contractor shall, within 10 calendar days of having knowledge of damage and/or theft of any contractor issued equipment under this contract, notify the respective facility COR, in writing, describing the damage and/or theft. Facility COR will notify the contracting officer to discuss a resolution to the issue.

1.3 Accreditation

The contractor shall meet or exceed all Joint Commission on Accreditation of Healthcare Organizations (JCAHO) standards for all services provided herein. Contractor shall submit proof of meeting or exceeding all JCAHO standards as part of its technical proposal. The JCAHO standards may be accessed at www.jcaho.org. Contractor shall be accredited by a nationally recognized organization and shall maintain that accreditation throughout the term of the contract.

1.4 Site Visits

1.4.1 On-site Contractor and VA beneficiary visits will be made on a scheduled and unscheduled basis. The Contracting Officer and/or the COR and, other VA employees as necessary, will conduct contractor site visits. The purpose of these visits is to monitor the Contractor's performance as it relates to the contract and commercial practices. The Contractor agrees to make available all records and documentation necessary during such visits.

1.4.2 In addition the Contractor agrees to visits by any accrediting body or other Government representative accompanied by the Contracting Officer, COR or designee necessary to review the contract services. These visits shall be allowed at no additional cost to the Government.

1.5 Delivery Orders

1.5.1 Delivery orders will be issued under the contract by the Southern Nevada Healthcare System facilities. An authorized representative of P&SAS or the appointed COR will place orders for supplies or services. Each order will contain the beneficiaries' name, social. security number, and home address as well as the type of supplies, services or oxygen system prescribed.

1.5.2 Orders may be placed by telephone, fax, PKI secured E-mail, or through a contractor owned and maintained secure website and as necessary, will be confirmed in writing and accompanied by the Home Oxygen Prescription. If a delivery order is placed verbally a written copy of the verbal delivery order will be transmitted to the Contractor within 48 hours of placing the order. Confirmations shall be required for any order placed.

NOTE: All delivery orders placed against this contract are to be paid by the VA Medical Center placing the order. Proper invoices shall be sent to the ordering facility. Delivery shall be made to the appropriate VA facility, nursing home, or patient's residence specified in the order.

1.5.3 Contractor shall provide a single source entry system/office for VA facilities to submit delivery orders, request discontinuation of service and, request travel arrangements for beneficiaries traveling or temporary relocating.

1.6 Emergency Service

The Contractor shall have twenty-four (24) hour, seven (7) day a week, 365 days per year emergency service capability. At a minimum, the Contractor shall have a company employee on duty or a twenty-four-hour answering service or, an employee within paging range to respond to emergency calls. Contractor shall respond within 30 minutes by telephone upon receipt of an emergency call and advise patient of the specific emergency procedure to be implemented.

Contractor shall have a backup procedure in the event they are unable to reach the patient by phone. This back-up procedure shall be specific to the geography and conditions of the area being serviced with a copy provided to the appropriate COR at the time of award. If the procedure Is updated a copy shall be sent to the COR within 3 business days. If contractor cannot reach a Veteran by their telephone number Inform VA unable to reach Veteran within 24 hours to initial set up or 4 hours of discharged patients.

1. 7 Documentation

The Contractor shall maintain documentation of all orientation programs and background checks for all employees involved in delivery/recovery of home oxygen equipment. As a minimum, topics should include safety and equipment management such as electrical requirement, back-up systems, equipment safety checks, troubleshooting, equipment set-up, infection control procedures, patient confidentiality and handling procedures. Annual competencies are required. Documentation shall be made available upon written request of the Contracting Officer or facility COR.

1.8 Solicitation of Beneficiaries

Contractor shall deal directly with the Contracting Officer, the facility COR, or the appropriate facility P&SAS representative relative to any aspect of the contract. Contractor agrees he/she shall not directly or through his/her dealers solicit the beneficiaries of the Department of Veterans Affairs. Contractor is to contact the patient or caregiver only to make arrangements for rendering services or supplies authorized by VA.

1.9 Demurrage Charges

Contractor agrees to provide cylinders without assessing demurrage charges to the Government. The Contractors further agrees that the free loan period of cylinders is indefinite but shall not exceed the term of the contract.

1.10 Product Substitutions

No product substitutions shall be made without prior approval of the treating facilities COR.

SECTION 2 -DEFINITIONS/ACRONYMS

CBOC -A VA Community Based Outpatient Clinic.

Concentrator - An electrical device used to deliver oxygen therapy in the home.

Contracting Officer -VA official with the authority to enter into, administer, and/or terminate contracts.

Contracting Officer’s Representative (COR) - VA official responsible for providing contract oversight and technical guidance to the Contracting Officer. Responsibilities Include certification of invoices, placing orders for services, and technical guidance.

FAR-Federal Acquisition Regulations

HCPCS-Health Care Procedure Coding System

IPV-Intrapulmonary Percussive Ventilation use for airway clearance therapy.

Joint Commission on Accreditation of Healthcare Organizations (JCAHO) – A national organization dedicated to improving the care, safety, and treatment of patients in a healthcare facility and environment.

Liquid Stationary System -A device used to store and dispense liquid oxygen.

Liquid Oxygen. -Oxygen in a liquefied state.

Nebulizer - A device used to dispense inhaled medication

Oxygen Tanks -Cylinders made of steel, light steel, and aluminum used to store oxygen in a compressed state.

P&SAS - Prosthetics & Sensory Aids Service.

Suction Machine - A device used to remove secretions from a patient's mouth or airways.

VA - Department of Veterans Affairs Medical Center, or Healthcare System.

VISN - Veterans Integrated Service Network.

Plan of Care - Medical care plan is a patient assessment initiated on each patient by VA clinician.

Plan of Service - Form initiated by Contractor that depicts patient's home environment, problems/needs, goals, and action.

SECTION 3 -GOVERNMENT FURNISHED PROPERTY

The following equipment will be issued or authorized by the VA in the performance of this contract, all of which remain the property of the VA:

Nebulizers (to include battery powered) Suction Pumps Air Compressors Intrapulmonary Percussive Ventilation System (IPV) Ventilators

The government may from time to time, not furnish the above equipment. If equipment listed above is required, the Contracting Officer Representative (COR) will request a pricing for that required equipment and will coordinate procurement of that required equipment. If this equipment is required to be added to the Indefinite Delivery Indefinite Quantity (IDIQ) Contract, due to a repeated requirement of contractor provided equipment, the government will then update and modify the SOW and price schedule.

SECTION 4 - CONTRACTOR FURNISHED PROPERTY

The contractor shall furnish the following list of equipment:

Concentrator Systems Liquid Oxygen Systems Portable Gaseous Systems Portable Gaseous Oxygen Systems Portable Liquid Oxygen Systems Ventilators and all appropriate prescribed equipment Air Compressors Aluminum Oxygen Tanks Steel Oxygen Tanks (Optional) Supplies (e.g., tubing, cannulas, masks)

In addition to the above list the contractor shall furnish all equipment necessary to comply with the requirements of the contract. Equipment furnished by the contractor shall remain property of the contractor unless purchased by the VA.

SECTION 5 - SPECIFIC TASKS

5.1 New Patient Set-ups – Oxygen Systems

5.1.1 Upon receipt of a VA prescription, the Contractor shall deliver and set up in the veteran's residence all equipment and supplies ordered. New set-ups shall be performed as described in Section 5.2.

Orders placed by VA and received by the Contractor two (2) hours prior to the ordering VA facility close of business shall be delivered the same day. Orders placed by VA and received by the Contractor less than two hours prior to ordering VA facility close of business shall be delivered the next day before 10:00am local time, unless the COR or P&SAS personnel have approved other arrangements.

5.1.2 In the event Contractor is unable to meet these delivery times, VA reserves the right to obtain the service from another source and to charge the Contractor with any excess cost which may result there from.

5.1.3 Contractor shall notify the ordering facility COR or P&SAS if the contractor is unable to contact the patient or caregiver, no later than 12 hours after receipt of the delivery order.

5.2 See addendum to Statement of Work, at the end of this document.

5.2.1 Initial Oxygen Follow Up Visit - Required when initial set-up is performed by a contractor qualified technician.

Performed by an RRT, CRT, or RN only, within 72 hours after initial set-up by a qualified technician.

Proof of initial set up, patient Plan of Service and Education Documentation sent to facility COR with the next monthly invoice.

If the initial home oxygen visit is performed by a contractor technician, an ART, CRT, or RN shall follow up within seventy-two (72) hours to perform the required patient education and develop a plan of service. Documentation of patient education, plan of service, and all visits shall be in compliance with the current JCAHO Home Medical Equipment (HME) Standards and shall be provided to the respective facility COR or designee with the next monthly invoice.

Failure to provide the required documentation by the 10th calendar day of each month will result in a 2% reduction for each day the documentation is late, applied to the monthly Invoice.

5.2.3 The initial oxygen equipment set-up in the home, shall address at a minimum, the following:

Name of the contractor's branch/division servicing the patient.

Date of Visit.

Recommendations and/or problems relating to the beneficiaries use of the oxygen equipment.

Proper name, social security number and phone number.

Review of prescription, verify percent of oxygen concentration.

Manufacturer's model, serial number, for Government Owned Equipment.

Review of safety and beneficiary education issued, and interventions taken and/or recommendations for equipment maintenance and safety.

Monitoring of all equipment for proper functioning (i.e., internal/external batteries, settings, humidifiers, suction machines temperature probes, and nebulizers).

Assessment of infection control procedures and the general home environment.

Evidence of smoking in the home.

Cleanliness of equipment/filters and home.

Check of function of smoke detectors in the patient's home.

Colored tubing that will contrast with home environment.

Providing a cylinder stand capable of holding a minimum of 12 cylinders, sizes E, D, C &

M-6 as appropriate.

In addition to the above list the contractor shall also provide review of on-site environmental conditions that includes a check of electrical sockets if powered equipment is provided, and make all appropriate site preparations (e.g., uncluttered area for free storage of standing tanks, fire safety notation of observable safety hazards, etc.) before placing oxygen equipment in the home.

5.3 Initial Set-Up - Ventilators

• Performed by an RRT, CRT, or RN only

• Delivery and aet up within 24 hours of receipt of VA Prescription

• Proof of initial set up, patient Plan of Service and Education Document sent to facility COR or designee with the next monthly invoice.

Set-up may consist of contractor and/or Government owned equipment with proper backup systems, and shall include pressure setting(s), mask fitting, safety, maintenance, and any other instructions necessary.

5.3.1 Contractor shall provide and install, at no extra charge, a three-prong adaptor when the patient's home outlets are not grounded.

5.3.2 Contractor shall notify the local VA COR or designee, verbally and in writing, if they are unable to set-up the prescribed oxygen system because of environmental or other safety issues immediately upon discovery of any of these issues. VA will work with the patient to abate the condition preventing set up of the originally prescribed oxygen system.

5.3.3 Any VA beneficiary refusing to accept oxygen equipment or supplies prescribed by P&SAS, must sign the visit documentation form, noting their refusal. The contractor shall also sign the form and immediately report the incident to the authorized P&SAS or COR, first by telephone followed by a facsimile of the signed form, or PKI secured E-mail message if electronically sent a scanned copy of the signed form.

5.3.4 Upon delivery of oxygen refills, the Contractor shall inspect the patients existing equipment and supplies, clean and sanitize or replace same whenever necessary. Oxygen refill visits shall be made as necessary to maintain continuous oxygen services. The Contractor shall report any apparent changes noted in beneficiary status, address, changes, and/or any problems that may warrant the attention of P&SAS or the appointed COR. The contractor shall report to the COR and or P&SAS after the contractor has made three attempts to deliver over five working days.

5.3.5 The Contractor shall provide two (2) signs for each VA beneficiary stating, "NO SMOKING OXYGEN IN USE", and assure they are posted in the patients home according to JCAHO standards. Contactor shall provide educational and/or warning information for patients and families on the hazards of smoking while oxygen is in use. The educational materials shall be provided upon initial delivery and every six (6) months thereafter. Non-compliant or at-risk patients are to be reported to the COR as soon as possible, but no later than the next business day. In the event patient is not using the oxygen as prescribed the COR or designee shall be notified as soon as possible, but no later than the next business day.

5.3.6 Contractor shall provide only aluminum/composite oxygen tanks for all patients using compressed gas for portability. Contractor may use aluminum or composite tanks for backup systems in the home. Safety holders/cylinder racks shall be provided for all veterans with a prescription for four (4) or more cylinders of multiple sizes.

5.3.7 Prior to entering a VA beneficiary's residence for monitoring visits, equipment checks, or any other required Contractor visits called for in the contract. Contractor personnel will present a photo identification badge to the beneficiary/primary care giver and verbally identify themselves.

5.4 Equipment Monitoring/Maintenance Visit Requirements and Time Frames

As part of the equipment monitoring visit the contractor shall assure the patient has adequate supplies (e.g., mask supplies, colored tubing, filters, water for humidification, etc.) to last between visits. Costs for supplies and the delivery of those supplies that are needed by the patient between visits shall be borne by the contractor.

5.4.1 Concentrators

Performed Quarterly not to exceed 90 calendar days after the initial visit or the previous maintenance visit.

Performed by a qualified technician.

Completed Maintenance visit form due to facility COR or designee with the next monthly invoice.

5.4.2 Ventilators

Performed every 30 calendar days after initial setup or the previous maintenance visit.

Performed by an RRT, CRT or RN only.

Completed Maintenance visit form due to facility COR or designee with the next monthly invoice.

5.4.3 Failure to provide the required documentation for any of the above equipment monitoring or maintenance visits by the 10th calendar day of each month will result in a 2 % reduction for each day the documentation is late, applied to the monthly invoice.

5.4.4 By use of the maintenance form the contractor shall at a minimum, cover the following items:

No Smoking signs are provided and/or posted.

Smoke alarm is present and alarms when tested.

Veteran has been instructed to remove the cannula, shut-off the oxygen supply, and wait for oxygen to dissipate prior to smoking.

Verification that the veteran has been Instructed to test all smoke alarms monthly.

Veteran and family or cohabitants are given educational materials regarding the hazards of smoking and using an open flame near oxygen.

Number of days since last equipment monitoring visit.

Average usage per day.

Assessment of equipment filters.

Evidence of compliance with physician orders (prescription) for equipment maintenance.

5.4.5 Contractor shall check each veteran's home regarding appropriately working smoke alarms. The presence of the smoke alarms must be verified, and the patient must be instructed by the Contractor to test all smoke alarms monthly. Contractor shall document and notify the veteran in the event smoke alarm(s) is not in working order. In any home where smoke alarms are not present, the Contractor shall notify the COR or designee for further review and potential action on the part of the VA.

5.4.6 The contractor shall report to the COR and or P&SAS after the contractor has made three attempts over five working days that they have been unsuccessful in performing a maintenance visit.

5.5 Emergency Protocol

5.5.1 Emergency calls made to the Contractor shall be considered life threatening with an immediate response to the site of the veteran beneficiary’s domicile, no matter the distance from the Contractor's place of business. An emergency exists if the appropriate P&SAS staff or COR informs the Contractor that he/she considers the situation an emergency, or if the VA beneficiary states in a telephone call to the Contractor that an emergency exists in regard to the function or use of the respiratory related equipment or use of the equipment.

For all patients with medical equipment providing partial or full ventilator support, a backup ventilator system shall be provided at no charge, which includes self-inflating resuscitation bag and a spare breathing circuit. As a minimum, the backup system shall provide continuing equipment function for forty-eight (48) hours. In addition to the ventilators, the contractor shall provide a twenty-four (24) hour backup system for all other Primary Oxygen Systems, including Government owned equipment.

5.5.2 In emergent situations, the Contractor shall provide service at no additional cost to the Government. In the event the Contractor is unable to meet the appropriate response times, the Government has the right to obtain the services from another source and to charge the Contractor any costs incurred over and above the contract price. A mandatory written justification detailing why emergency service was not available shall be provided by the Contractor to the facility COR and the Contracting Officer within twelve (12) hours from the original time the Contractor was called to provide the service.

5.5.3 The Contractor shall provide a written Emergency Contingency Plan for natural disasters, which provides for continued uninterrupted care and support in the event of an emergency resulting in an interruption of service. As a minimum the plan shall address such items as severe weather, power outages, loss of personnel, damage to the Contractor's site and communications. A copy of this plan shall be provided to each facility COR within thirty (30) days after award.

5.6 Discontinuation of Oxygen Services

5.6.1 Upon termination of oxygen service to the beneficiary, the Contractor shall pickup all oxygen equipment and supplies no later than five (5) days after receipt of notification from the appropriate P&SAS staff or COR. Payment of services shall cease upon this notification. The final invoice shall be prorated from the date of notification. Final services shall be billed with the next scheduled invoice.

5.6.2 Upon the death of a beneficiary the appropriate P&SAS or COR will notify the Contractor as soon as the beneficiaries' death has been reported. The appropriate P&SAS authority will confirm termination of services and equipment pickups in writing. Arrangement shall be made within five (5) days to pick up all supplies and equipment. Additional billing will not be honored after the date of the cancellation notice.

5.6.3 In the event the contractor gains knowledge of the patient's death prior to the servicing VA, the contractor shall immediately notify the COR or appropriate P&SAS staff of the patient's death and the date the contractor was made aware of the death. Billing shall cease on the day the contractor becomes aware of the patient’s death. The final invoice shall be prorated from the date of notification.

5.7 Service Transition

5.7.1 In the event award(s) are made to other than the incumbent contractors, the new contractor(s) shall arrange with the incumbent Contractor for exchange of equipment ensuring that there is no disruption of supplies/services to veteran beneficiaries. Transition of services to the new contractor(s} shall be complete within (90) calendar days from the date of award of a new contract(s).

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

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

Payment to the incumbent contractor shall be made up to the day services were transferred to the successor contractor. Payment shall be pro-rated based upon the units’ prices in affect during the most recent contract year. Coordination during the transition period shall be accomplished at no additional expense to the Government.

5.8 Equipment Maintenance/Repair

5.8.1 Contractor shall provide all required service, maintenance, and repairs on all Contractor owned equipment in accordance with manufacturer standards and when required by this contract. Contractor shall also provide service and maintenance on all Government Owned equipment, as required by the Ventilator Line Items, no additional maintenance or repairs are required. Only technicians with documented training shall provide service to an of the equipment.

5.8.2 Equipment maintenance records, to include the serial number of the equipment being serviced shall be kept by the Contractor reflecting the above. Records shall be kept up to date and available for review by the facility COR and/or P&SAS staff.

5.8.3 Contractor shall send VA equipment to VA or manufacturer for repair/replacement as specified by COR.

5.8.4 The Contractor shall have an established procedure for Government Owned equipment pickup or exchanged for repairs. In the event that the equipment is no longer in use by a VA beneficiary, the cleaned, sanitized, and tagged equipment will be bagged and returned to either the VA facility that originally purchased the equipment or the contractor's facility as determined by the COR.

5.9 Reserve Supply

5.9.1 An adequate supply of aluminum/composite compressed 02 tanks, with regulator, and E-tank stands shall be provided and stored at each participating VA listed in the Schedule and their respective Outpatient Clinics as directed by the COR. Quantities, and sizes of tanks, will vary from site to site and shall be agreed upon by the Contractor and facility COR.

5.9.2 The reserve supply shall accommodate home oxygen patients who are either being discharged from the hospital or visiting (appointments, etc.) and require a supply of oxygen to enable the VA beneficiary to reach home. Adequate inventory shall be maintained by the Contractor. Reserve supply shall be provided at no additional cost to the Government.

5.10 VA Beneficiary Records

5.10.1 An individual beneficiary account record shall be maintained by the Contractor in compliance with the Privacy Act and HIPPA compliant. Copies of these beneficiary records shall be provided to the appropriate P&SAS authority or appointed COR upon request when a patient is discharged from the Home Oxygen Healthcare program or upon death. The Individual medical records shall be maintained in divided folders separated by the categories listed below and housed at Contractor's individual branch providing the Oxygen Service. As a minimum the record shall include the following:

Beneficiary identifying information (full name, SSN, home address, phone number of beneficiary care giver, and serial number and type of VA owned equipment). Emergency contact phone number at a separate residence other than the beneficiary.

Copy of physician's prescription (original or renewal).

Plan of Service as developed by Contractor.

Initial and ongoing documentation of home visits.

Initial and continuing verbal and written instructions to the beneficiary and/or care giver

(to include, but not limited to basic home safety, safe and appropriate use of equipment, handling, cleaning, precautions on smoking, and storage -universal precautions).

Patient complaints, accidents, injuries, and safety hazards identified, and corrective action taken.

Documentation of all beneficiary education to include course of action in emergency situations.

Infection control -Contractor will comply with standard precautions in the handling, storing, cleaning, and delivery of home oxygen equipment and will maintain a system for reporting, documenting, and evaluating records of infection among beneficiaries and Contractor staff.

5.11 Plan of Service

5.11.1 An initial plan of service shall be developed and implemented by RRT, CRT, or RN during the initial setup by the Contractor for each VA beneficiary and a copy shall be forwarded to the respective facility COR or designee with the monthly invoice. As a minimum the plan shall include the following:

A statement of the patients’ needs and problems.

Measurable Beneficiary goals.

Notation of the services recorded, and action taken.

The Plan of Service shall be signed by the visiting RRT, CRT, or RN and VA beneficiary or care giver. The beneficiary shall retain the original. The Contractor shall retain one (1) copy and forward a copy to the appropriate P&SAS or facility COR.

5.11.2 Revisions to the Plan of Service will not be initiated, set-in place, or changed without prior approval of the P&SAS or COR. A new plan of service will, as a minimum, be submitted when there is a change to the initial plan of service.

5.11.3 The Contractor shall maintain records of all visits for at least three (3) calendar years.

5.12 Education/Instruction

5.12.1 Education regarding all equipment, supplies, and smoking shall be provided to the beneficiary/caregiver by the contractor in accordance with JCAHO standards. As a minimum, the Contractor shall document and provide instruction to the patient/care giver on the safe and appropriate use of the medical equipment including basic home safety, storage, handling, required maintenance, electrical safety, equipment hazards and malfunctions, infection control, emergency preparedness, and the beneficiaries' responsibilities in the care and use of all equipment.

5.12.2 The Contractor shall provide as part of the technical proposal all patient education materials to be used during the course of the contract. Updates and changes to the education materials must be submitted to the COR prior to making any changes.

5.12.3 The Contractor shall provide each new Home Oxygen beneficiary with a pamphlet depicting, “Patients’ Rights and Responsibilities”.

5.12.4 At the initial Home Oxygen Healthcare Service set-up, the Contractor will provide each beneficiary a copy of the Contractor's “Patient Instruction Booklet”. This booklet will be placed in a folder/binder with any appropriate information properly annotated before the booklet is given to the beneficiary. Instructions will cover the use of all equipment delivered. The patient/care giver and the Contractor shall sign the Home Oxygen Equipment Assessment and Patient Instruction Checklist, acknowledging that written and oral instructions have been provided.

These initial Instructions shall be provided by an RRT, CRT, or RN. A copy of the signed documents shall be submitted to the appropriate P&SAS or personnel or COR with the monthly invoice.

5.13 Traveling Beneficiaries

5.13.1 The contractor shall be responsible for arranging and coordinating all oxygen services for veterans who travel both within and outside their respective contracted jurisdiction, unless otherwise indicated. The veteran and/or respective VA will be responsible for notifying the contractor where the veteran is traveling to and the mode of transportation. Arranging and coordinating travel services shall be provided at no additional cost to VA.

5.13.2 Veterans traveling within the contractors' coverage area shall be provided all oxygen services under the contract at the contract rate.

If travel takes place within the areas covered by Southern Nevada Healthcare System but to another contractors' coverage area, the contractor currently providing oxygen services shall notify and arrange for oxygen services with the contractor whose area the veteran is traveling to.

5.13.3 For veterans traveling outside the areas covered by VISN's 19 & 21 and/or temporarily relocating, the contractor shall arrange for oxygen services at no additional cost to the VA. All Maintenance requirements of Section 5.5 are applicable to this section. All set up and maintenance forms shall be sent to the respective facility COR or P&SAS. Travel outside of VISN's 19 & 21 include the remaining United States and the Philippines. Other Foreign travel is solely the responsibility of the Veteran.

5.13.4 In the event the contractor has to use a subcontractor for Oxygen services related to travel, and additional costs are incurred, the contractor shall provide copies of all subcontractor invoices with the monthly invoice. The contractor will be reimbursed the contract rate plus the additional costs for providing the appropriate oxygen service.

SECTION 6 - EQUIPMENT SPECIFICATIONS

6.1.1 Oxygen Concentrator Systems: Systems shall include regulator/flow meter, up to 50 feet length of colored extension tubing, nasal cannula's, humidifier, distilled water, and can include, venti-masks, adult tracheostomy mask, transtracheal devices, emerging heaters for heated mist, trach T adapter with drainage bags, and a Liter Flow Restrictor and all oxygen delivery devices when prescribed by VA physician. Concentrator systems shall provide at a minimum 93% +/3% oxygen concentration at a flow of 0-10 liters per minute (lpm); allow operational simplicity and be equipped with a simple flow rate of oxygen; shall be equipped with a built-in “Alarm System” and be self-testing each time the unit is turned on. During normal operation, this alert system is to have the capability of notifying the VA beneficiary that it may be necessary to switch to an alternate source of oxygen. The size and weight of the unit shall allow the user to realize maximum mobility. The unit will be double insulated, and the compressor thermally protected.

Concentrator systems shall be in the range of 115 volts, 60 Hz, 15 amps/430 watts with household circuit current properly grounded and have UP approval. The alert system shall operate without degradable cells. Low Decibel concentrator units shall provide 95% +/-3% flow at 1-3 lpm, 92% +/-3% flow at 5 lpm and 90% +/-3% flow at 5 lpm.

The Contractor will provide a 48-hour emergency backup system in the event of a power failure or when it is necessary to shut down the concentrator. Each unit shall have an attached sticker with a correct vendor name and emergency telephone number, date with the serial number, and date including the hobb meter hours last serviced.

6.1.2 Portable 02 Cylinders: The portable cylinder system shall include: Oxygen Regulator/Flowmeter 0-8 or 0-15 lpm, Small Cylinder Yoke Connection, Carrying Bag, Electronic or Pneumatic conserver device, as requested by provider, and necessary consumables; E, D, C, and M-6 size cylinder; Mobile cart; Cylinder wrench; Cylinder stand; cart;

shoulder bag or backpack. All oxygen regulators shall use a metal-bound elastometric sealing washer to interface with cylinder valves as specified by the National Institute for Occupational Safety and Health as well as the FDA.

6.1.3 Valves: Valves shall comply with American National Standard 857.1-1965, “Compressed Gas Cylinder Valve Outlet and Inlet Connections".

6.1.4 Medical Compressed Air: Medical compressed air shall conform to compressed Gas Association Pamphlet G-7, “Standard for Compressed Air for Human Respiration, Type 1, Medical” which may be obtained from Compressed Gas Association, Inc., 1235 Jefferson Davis Highway, Arlington, VA 22202. The FDA's Compressed Medical Gases Guideline, revised February 1989, shall also be adhered to. Oxygen is to be furnished in cylinders and/or liquid dispensing systems that are in accordance with the requirements of the Interstate Commerce Commission Regulations and the specification set forth In the Code of Federal Regulations (CFR) 49. All oxygen provided shall be United States Pharmacopeia (USP) oxygen.

6.1.5 Cylinders and Containers: All cylinders and/or containers for gaseous and liquid forms of gases shall comply with Department of Transportation (DOT) specifications. They will be maintained, filed, marked, labeled, shipped, traced and/or other procedures, (e.g., recalls) to comply with current DOT regulations, (Title 49-Transportation, Code of Federal Regulations) on packaging, labeling, etc., for medical gases. Compliance is required with the Federal Food, Drug, and Cosmetic Act. All Cylinders will have a fixed flow regulator. The Contractor will maintain a log of cylinder lots and batch numbers, which will facilitate immediate location and identification for possible retrieval. In addition to marking of cylinders required by law, the marking shall comply with the American National Standard 248.1 - 1954(RI 971), Method of Marking Portable Compressed Gas containers to identify the material contained.

6.1.6 Portable Liquid Medical Oxygen Unit System includes nasal cannula, with sufficient length of nasal tubing as required, 75.1b. Reservoir including contents (when provided in the absence of a liquid stationary system rental) and one (1) lb portable container with shoulder straps and/or carrying case. Oxygen conserving devices or portable containers with built in oxygen conservation, e.g. Hellos, will be provided as requested. In the absence of a request for a container with built in oxygen conservation, the standard unit issued shall provide a regulator flow of 1 to 6 liters of oxygen per minute. Additional patient interface, as requested, can include venti-mask or trach-mask.

6.1.7 Compressor: A high volume air compressor capable of producing 1-15 liters of compressed air per minute, supplies can Include trach-collar, "T" piece or mask or reusable type aerosol corrugated home 6-inch, large volume nebulizer with adapter, reservoir for humidification.

6.1.8 Liquid Oxygen System: System includes 40-liter capacity reservoir capable of delivering 0-15 liters of oxygen with a maximum flow duration at 2 lpm continuous flow of not less than 275 hours, a flowmeter, humidifier, nasal cannula or simple mask and up to 50 feet of tubing, reservoir roller base with a JCAHO approved backup. Each unit shall have an attached sticker with an up-to-date vendor name and emergency telephone number.

6.1.9 Ventilator: Unit is powered by 110 VAC or 220 VAC, 50/60 Hz, up to one-hour operation on internal battery. Includes volume ventilator, brushless induction, piston 100 to 2220 ml, alarm silence reset, push button battery test, rotary switch to set ventilator operating mode, high alarm/limit, push to tum knob to set volume, rotary switch to set breathing rate, and delivery of set volume, push to tum knob to set pressure level for detecting breathing, continuous adjustable from -10 to + 10 cm H2O, Port for connection to the proximal pressure line of the patient circuit, 22 mm port for connection to bacteria filter, port connection to the exhalation valve of the patient circuit. Each unit shall have an attached sticker with an up-to-date vendor name and emergency telephone number. The type of ventilator currently being used by the VA is a Lifecare Ventilator.

Addendum to Statement of Work

The following paragraphs are added to the statement of work.

5.2 Initial Set-ups - Oxygen Systems

Performed by a Contractor trained and Qualified Technician or, Registered Respiratory Therapist (RRT) or, Certified Respiratory Therapist (CRT) or, Registered Nurse (RN) Provide 12 tanks with initial set up when portable is ordered. Size of tanks to be determined upon set up For patients requiring portable oxygen concentrators for travel purposes, the Contractor shall be responsible for ensuring that an RRT or CRT performed set-up of portable oxygen concentrators within 24 hours of receiving the order from the VA

Contractor shall be responsible for all maintenance and storage of portable oxygen concentrators rented and/or purchased by VA

For oxygen set up being performed by a technician only, the visit shall be limited to set up and instruction solely focusing on equipment use and safety. The technician shall not provide any instruction related to the intended medical benefit of the applicable home oxygen treatment prescribed. If the set-up visit is performed by an RRT, CRT, or RN, in addition to set-up and instruction the RRT, CRT, or RN shall provide proper use and safety of equipment and the patient shall receive patient education relevant to his/her medical condition, the proper use of the prescription and the intended medical benefit of the applicable home oxygen treatment.

Portable Oxygen Concentrators Devices are only required to allow patients to travel by air for medical appointments and/or vacations as Airlines do not provide In-Flight Oxygen. Airlines require 1.5 times battery life for the length of a flight (i.e., a two (2) hour flight requires three-(3) Hours of battery life) and the Contractor shall be responsible to ensure that patients are provided sufficient battery life.

If VA Patients travel to a Mainland and/or Inner-Island Location where Contractor facilities are not available to support the Portable Oxygen Concentrator Device, the Contractor shall make arrangements to ensure that services are provided by a Subcontractor. The Contractor shall ensure that the selected Subcontractor provides at a minimum the following information for invoicing purposes: Name and Address of the Subcontractor, Invoice Date and Invoice Number, Contract Number or Other Authorization for supplies delivered or services performed, description, quantity, unit of measure, unit price and extended price of supplies delivered, or services performed and any shipping and payment terms.

If initial services are required after the 1st of the month, the Contractor shall invoice the Government the prorated amount from the date equipment is installed in the VA patient's residence or other installation location as designated by the consult. If initial Portable Oxygen Concentrator device rentals are required after the 1st of the month, the Contractor shall invoice the Government the prorated amount from the date equipment was rented. Any selected Subcontractor shall provide to the Contractor at a minimum the Addendum to Statement of Work following information for invoicing purposes: Name and Address of the Subcontractor, Invoice Date and Invoice Number, Contract Number or Other Authorization for supplies delivered or services performed, description, quantity, unit of measure, unit price and extended price of supplies delivered, or services performed and any shipping and payment terms.

Subcontractor information shall accompany any invoicing provided to the Government.

7. The Contractor shall stock, provide and connect for all veteran patients identified as smokers or who have family members or care takers that smoke a fire safety cannula valves to their oxygen tank as per manufacturer's instructions.

The Contractor will ensure that each veteran has clear instructions on how to change the fire safety cannula valves if it becomes necessary to do so and shall instruct veteran patients and/or their family members or care takers as to fire safety cannula valves cleaning process which includes on the outside the use an alcohol or disinfectant wipe, and that these fire safety cannula valves are not to immerse in water as there should be no fluids allow on the inside of the device.

Contractor shall instruct veteran patients and/or their family members or care takers as to the procedure of fire safety cannula valves maintenance and disposal once a fire has occurs this device cannot be reset and should be discarded. The Contractor will advise the veteran patients and/or their family members or care takers of the required disposal of the device shall be four-

(4) years after manufacturing date stamped on device label. When changing out tubing, the manufacturer specifications state that fire safety cannula valves must be removed from old tubing and placed into the new tubing.

SECURITY CLAUSE

1. GENERAL

Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

a. A contractor/subcontrator shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

b. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information.