ATTACHMENT 02 36C261-21-Q-0700 HOME OXYGEN RENO STATEMENT OF WORK.pdf

ATTACHMENT 02

36C261-21-Q-0700

STATEMENT OF WORK

SECTION 1 – GENERAL REQUIREMENTS

1.1 Background

The Department of Veterans Affairs, Sierra Nevada Health Care System (VASNHCS) in Reno NV requires home oxygen supplies for its beneficiaries. VASNHCS currently serves an estimated 1,200 oxygen-using patients. The volumes or amounts shown in the schedule are estimates only. The contractor shall provide all required supplies, materials, labor, supervision, transportation, patient education, safety management and infection control.

1.2 Roles and Responsibilities

1.2.1 Clinician orders for providing Home Oxygen Healthcare Services, which includes the use of home oxygen, home based life support systems (i.e. ventilators) and related respiratory equipment (C-PAP/BiLevel nebulizers, compressors, etc.) are processed through the Prosthetic and Sensory Aid Services (P&SAS). 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 Technical Representative (COTR) in VASNHCS.

1.2.2 VA Clinicians will determine eligibility and necessity for admission to the Home Oxygen Program and for providing orders for admission. The contractor shall provide 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 shall coordinate, supervise, monitor, and evaluate the care and service provided in accordance with the terms of the contract. Contractor personnel shall meet the requirements of the contract and be competent to do the jobs assigned them. The VA will 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 JC standards.

1.2.5 The VA sets timelines for the provision of services and the contractor shall meet those timelines. The contractor shall 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. (See Section 5 of the Statement of Work)

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 COTR, in writing, describing the damage and/or theft. Facility COTR will notify the contracting officer to discuss a resolution to the issue.

1.3 Accreditation

The contractor shall meet or exceed all Joint Commission (JC) standards for all services provided herein.

Contractor shall submit proof of meeting or exceeding all JC standards as part of its technical proposal.

The JC standards may be accessed at www.JointCommission.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 COTR 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 shall make available all records and documentation necessary during such visits.

1.4.2 Any accrediting body (or other Government representative) accompanied by the Contracting Officer, COTR or designee necessary to review the contract services may visit contractor facilities. The contractor shall allow these visits at no additional cost to the Government.

1.5 Ordering

1.5.1 Orders will be issued under the contract by the Department of Veterans Affairs Sierra Nevada Health Care System (VASNHCS). An authorized representative of Prosthetic and Sensory Aids Service (P&SAS), or the appointed Contracting Officer’s Technical Representative (COTR) 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, Public Key Infrastructure (PKI) secured email, 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 an 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 orders placed against this contract are to be paid by the VA Medical Center (VASNHCS) placing the order. Proper invoices shall be sent to the ordering facility (VASNCHS). Contract line item delivery shall be made to the appropriate VA facility, nursing home, or patient's residence specified in the order.

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 back up 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 COTR at the time of award.

This submittal shall be the same as the solicitation submittal. If the procedure is updated a copy shall be sent to the COTR within 3 business days. (See Statement of Work paragraph 5.6)

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 COTR.

1.8 Solicitation of Beneficiaries

Contractor shall deal directly with the Contracting Officer, the facility COTR, 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 COTR.

SECTION 2 – DEFINITIONS/ACRONYMS

BiLevel – A device used for the treatment of obstructive sleep apnea/hypoventilation syndrome while sleeping. Has two pressure settings.

CBOC – VA Community Based Outpatient Clinic

CPAP – Continuous Positive Airway Pressure. A device primarily used for the treatment of obstructive sleep apnea. Has single pressure setting.

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 Technical Representative (COTR) – 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, used for airway clearance therapy.

Joint Commission (JC) – A national organization dedicated to improving the care, safety and treatment of patients in a health care 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 – Prosthetic & 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:

All CPAP Devices which may include masks, Non-heated humidifiers & heated humidifiers All BIPAP Devices Nebulizers (to include battery powered) Suction Pumps Air Compressors Intrapulmonary Percussive Ventilation System (IPV) Ventilators

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

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 Statement of Work paragraph 5.2.

Orders placed by the VA and received by the Contractor before 9:00 P.M local time shall be delivered the same day. Orders placed by VA and received by the Contractor after 9:00 P.M. local time shall be delivered the next day before 10:00 A.M. local time, unless the COTR or P&SAS personnel have approved other arrangements.

After Hours Setup. To be completed at the VA Facility. Orders placed by the VA after hours (9:01 P.M to 9:59 A.M following day) during the workweek and 24 hours during the weekend shall have a 1 hour response to the VA Emergency Department (or other area designated by VA) to conduct an initial Home Oxygen Set up. This will include enough oxygen to last until the in home set up.

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 COTR 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 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

If the oxygen set up is performed by a technician only, the visit shall be limited to set up and instruction solely focusing on the equipment use and safety and not providing instruction for the purpose of deriving the intended medical benefit. If the set up visit is performed by an RRT, CRT, or RN, in addition to set up and instruction in the use and safety of equipment, the patient shall receive patient education relevant to his/her medical condition, the prescription, and on the intended medical benefit of the applicable home oxygen treatment.

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 COTR with the next monthly invoice

If the initial home oxygen visit is performed by a contractor technician, an RRT, 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 JC Home Medical Equipment (HME) Standards and shall be provided to the respective facility COTR 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 total 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 Documentation of potential fall hazards in patient homes. Assessment shall be kept on file by the contractor.

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 - CPAP/BiLevel

Performed by an RRT, CRT, or RN only.

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

5.3.1 All VA issued CPAP/BiLevel’s shall be delivered and set-up by an RRT, CRT, or RN within 72 hours of receipt of the VA prescription unless otherwise notified by the ordering facility. Set-up shall include the pressure setting(s), instructions, mask fitting, safety, and any other instruction necessary. Contractor shall provide sufficient supplies to last between maintenance visits.

5.4 Initial Set-Up - Ventilators

Performed by an RRT, CRT, or RN only Delivery and set up within 24 hours of receipt of VA Prescription Proof of initial set up, patient Plan of Service and Education Documentation sent to facility COTR or designee with the next monthly invoice.

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

5.4.1 Contractor shall provide and install, at no extra charge, a concentrator that is compatible with existing household wiring and no adapters are to be used.

5.4.2 Contractor shall notify the local VA COTR 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.

5.4.3 Any VA beneficiary refusing to accept oxygen equipment or supplies prescribed, 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 COTR, 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.

5.4.4 Upon delivery of oxygen refills, the Contractor shall inspect the patient's 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 COTR. The contractor shall report to the COTR and or P&SAS after the contractor has made three attempts to deliver over five working days.

5.4.5 The Contractor shall provide two (2) signs for each VA beneficiary stating, "NO SMOKING OXYGEN IN USE", and assure they are posted in the patient’s home according to JC 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 COTR as soon as possible, but no later than the next business day. In the event patient is not using the oxygen as prescribed the COTR or designee shall be notified as soon as possible, but no later than the next business day.

5.4.6 Contractor shall provide only aluminum/composite oxygen tanks for all patients using compressed gas for portability. Contractor may use aluminum or composite tanks for back up 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.

5.4.7 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 shall be in proper uniform and present a photo identification badge to the beneficiary/primary care giver and verbally identify themselves.

5.5 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. CPAP masks are not included in cost borne by the contractor.

5.5.1. 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 COTR or designee with the next monthly invoice

5.5.2 CPAP/BiLevels

Performed every six months after the initial set up or the previous maintenance visit or, at the request of VA facility Performed by a qualified technician

5.5.3 Ventilators

Performed every 30 calendar days after initial set up or the previous maintenance visit Performed by an RRT, CRT or RN only

5.5.4 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 total monthly invoice.

5.5.5 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 alarm 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.

5.5.6 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 COTR or designee for further review and potential action on the part of the VA.

5.5.7 The contractor shall report to the COTR 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.

5.6 Emergency Protocol

5.6.1 Emergency calls made to the Contractor shall be considered life threatening with an immediate response to the site of the veteran beneficiaries domicile, no matter the distance from the Contractor's place of business. An emergency exists if the appropriate P&SAS staff or COTR 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 forty-eight (48) hour backup system for all other Primary Oxygen Systems, including Government owned equipment.

5.6.2 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 COTR and the Contracting Officer within twelve (12) hours from the original time the Contractor was called to provide the service.

5.7 Discontinuation of Oxygen Services

5.7.1 Upon termination of oxygen service to the beneficiary, the Contractor shall pickup all oxygen equipment and supplies no later than forty-eight (48) hours after receipt of notification from the appropriate P&SAS staff or COTR. 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.

5.7.2 Upon the death of a beneficiary the appropriate P&SAS or COTR 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 48 hours to pick up all supplies and equipment. Additional billing will not be honored after the date of the cancellation notice.

5.7.3 In the event the contractor gains knowledge of the patient’s death prior to the servicing VA, the contractor shall immediately notify the COTR 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 patients death. The final invoice shall be prorated from the date of notification.

5.8 Service Transition

5.8.1 In the event award is made to other than the incumbent contractor, the new contractor 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 shall be complete within (60) calendar days from the date of award of a new contract.

5.8.2 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 COTR, and P&SAS staff. Any requirement for an RRT, CRT, or RN visit will be coordinated between the Contractor and COTR. The appropriate VA facility shall provide the successful contractor(s) with an up to date prescription.

5.8.3 The successor Contractor shall provide the facility COTR 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 servcies were tansferred to the successor contractor. Payment shall be pro-rated based upon the units prices in effect during the most recent contract year.

5.9 Equipment Maintenance/Repair

5.9.1 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 CPAP, BiLevel, and Ventilator Line Items, no additional maintenance or repairs are required on Government Owned equipment. Only technicians with documented training shall provide service to all of the equipment.

5.9.2 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 COTR and/or P&SAS staff.

5.9.3 Contractor shall send VA equipment to VA or manufacturer for repair/replacement as specified by

COTR.

5.9.4 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 COTR.

5.10 Onsite set-up and discharge

5.10.1 For VA patients, the contractor shall deliver required tanks and equipment necessary for set-up to VA Reno, NV upon patient discharge or when patients are low on oxygen. In addition to delivery of 02 for discharge and refills, the contractor shall perform all patient set-ups as outlined in Section 5 of the Statement of Work. Orders for additional tanks and discharge will be placed using the contractor’s intake center.

5.10.2 The contractor shall provide a reserve supply of 6 (six) each e-tanks with rack and 1 (one) rack for empty tanks to be stored in room GD104. Contractor shall provide all set up supplies along with tanks.

Reserve supply shall be provided at no additional cost to the Government.

5.11 VA Beneficiary Records

5.11.1 An individual beneficiary account record shall be maintained by the Contractor in compliance with the Privacy Act and be Health Insurance Portability and Accountability Act (HIPAA) compliant. Copies of these beneficiary records shall be provided to the appropriate P&SAS authority or appointed COTR 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.

Patient Acknowledgment of Rights & Responsibilities.

Signed Delivery Ticket.

Patient Education Acknowledgment.

Home Safety Evaluation.

*All records will be maintained in accordance to Security Clause, part 3, and destroyed in accordance with RCS 10-1 upon completion of the contract.

5.12 Plans of Service

5.12.1 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 COTR or designee with the monthly invoice. As a minimum the plan shall include the following:

A statement of the patient's 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 COTR.

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

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

5.12.4 The Plan of Service for CPAPs and BiLevels shall be requested at the direction of the COTR. As a minimum, the assessment shall include the beneficiaries tolerance and compliance to equipment, mask fitting, etc. This assessment shall be made at the time of the visits described in 5.3

5.13 Education/Instruction

5.13.1 Education regarding all equipment, supplies, and smoking shall be provided to the beneficiary/caregiver by the contractor in accordance with JC 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.

5.13.2 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 COTR prior to making any changes.

5.13.3 The Contractor shall provide each new Home Oxygen beneficiary with a pamphlet depicting, "Patient's Rights and Responsibilities".

5.13.4 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 instuctions 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 COTR with the monthly invoice.

5.14 Traveling Beneficiaries

5.14.1 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.

5.14.2 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, 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, at no additional cost to the VA.

5.14.3 For veterans traveling outside the areas covered by VASNHCS 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 COTR or P&SAS. Travel outside of VASNHCS includes the remaining United States, its Territories (e.g., Guam, Puerto Rico, Virgin Islands, American Samoa) and the Philippines. Other Foreign travel is solely the responsibility of the Veteran.

5.14.4 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 by a purchase order at 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 tracheotomy 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 oxygen concentration at a liter flow consistent with the manufacturers specification for the unit; 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 voltz, 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 O2 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 B57.1-1965, "Compressed Gas Cylinder Valve Outlet and Inlet Connections". One-way valves between CPAP units and the deliver tubing when oxygen is entrained.

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 (http://www.cganet.com/publication.asp) . 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 shall 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 shall have a fixed flow regulator. The Contractor shall 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 Z48.1 - 1954(Rl 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 lb 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. Helios, shall 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 Ipm 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 JC 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 turn knob to set volume, rotary switch to set breathing rate, and delivery of set volume, push to turn knob to set pressure level for detecting breathing, continuous adjustable from -10 to +10 cm H20, 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.

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. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

c. Contract personnel who require access to national security programs must have a valid security clearance.

National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS).

Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness.

d. Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor.

e. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor’s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.

3. VA INFORMATION CUSTODIAL LANGUAGE

a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1).

b. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor’s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA’s information is returned to the VA or destroyed in accordance with VA’s sanitization requirements. VA reserves the right to conduct on site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

c. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract.

d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.

e. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.

f. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.

g. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.

h. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated.

i. The contractor/subcontractor’s firewall and Web services security controls, if applicable, shall meet or exceed VA’s minimum requirements. VA Configuration Guidelines are available upon request.

j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations:

(i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA’s prior written approval.