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36C26121Q0082

PAGE 1 OF

1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a. PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

DUNS:

DUNS+4:

PHONE:

FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19.

20.

21.

22.

23.

24.

ITEM NO.

SCHEDULE OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA

26. TOTAL AWARD AMOUNT (For Govt. Use Only) 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________

29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. 2/2012)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

36C26121Q0082 Jared Dawson 808-433-0594 03-08-2021 15:00

PST

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 X X 532283 $35 Million N/A X See Delivery Schedule

00261 Department of Veterans Affairs Network Contracting Office 21 Southern Nevada Healthcare System 6900 N. Pecos Road, Building 6 North Las Vegas

NV

89086

Financial Services Center P.O. Box 149971 Austin

TX

78714-9971 See CONTINUATION Page $0.00 See CONTINUATION Page X Jared Dawson Contracting Officer Table of Contents

SECTION A1
A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS1
SECTION B - CONTINUATION OF SF 1449 BLOCKS5
B.1 CONTRACT ADMINISTRATION DATA5
B.2 PRICE/COST SCHEDULE6
ITEM INFORMATION6
B.3 DELIVERY SCHEDULE7
1SCOPE8
2EQUIPMENT15
3EQUIPMENT SERVICE23
4EQUIPMENT MONITORING, MAINTENANCE AND REPAIR23
5STORAGE27
6.CONTRACTOR VISITS29
7PERIODIC EVALUATION32
8PATIENT EDUCATION REQUIRMENTS33
9HOME RESPIRATORY SET-UPS37
10EMERGENCY PROTOCOL44
11.DISCONTINUATION OF OXYGEN SERVICES47
12SERVICE TRANSITION47
13VA BENEFICIARY RECORDS48
14PLANS OF SERVICE49
15TRAVELING BENEFICIARIES50
16INFECTION CONTROL53
17VEHICLES54
18EVIDENCE OF COVERAGE54
19PAYMENTS AND INVOICING55
20REPORTS56
21QUALITY ASSURANCE59
22QUALITY ASSURANCE SURVEILLANCE PLAN FOR HOME OXYGEN SERVICES59
23.QUALITY ASSURANCE SURVEILLANCE PLAN65
Home Oxygen RRT/CRT Concentrator Compliance Visit (180 day)78
Home Oxygen Maintenance Inspection for equipment in patient’s home (Manufacturer’s recommendation)79
CPAP/BIPAP79
Home Oxygen RRT/CRT Ventilator Maintenance/Compliance visit (30 day)79
Service Call80
SECTION C - CONTRACT CLAUSES84
C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (OCT 2018)84
C.2 52.216-18 ORDERING (AUG 2020)90
C.3 52.216-19 ORDER LIMITATIONS (OCT 1995)90
C.4 52.216-22 INDEFINITE QUANTITY (OCT 1995)91
C.5 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)91
C.6 VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA ACQUISITION OF COMMERCIAL ITEMS (APR 2020)91
C.7 VAAR 852.215-70 SERVICE-DISABLED VETERAN-OWNED AND VETERAN-OWNED SMALL BUSINESS EVALUATION FACTORS (OCT 2019)93
C.8 VAAR 852.212-72 GRAY MARKET AND COUNTERFEIT ITEMS (MAR 2020)94
C.9 VAAR 852.215-71 EVALUATION FACTOR COMMITMENTS (OCT 2019)94
C.10 VAAR 852.219-74 LIMITATIONS ON SUBCONTRACTING—MONITORING AND COMPLIANCE (JUL 2018)94
C.11 VAAR 852.219-75 SUBCONTRACTING COMMITMENTS MONITORING AND COMPLIANCE (JUL 2018)95
C.12 52.225-8 DUTY-FREE ENTRY (OCT 2010)96
C.13 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)98
C.14 52.232-37 MULTIPLE PAYMENT ARRANGEMENTS (MAY 1999)98
C.15 52.237-3 CONTINUITY OF SERVICES (JAN 1991)98
C.16 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (NOV 2020)99
SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS108
SECTION E - SOLICITATION PROVISIONS109
E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS (JUN 2020)109
E.2 52.212-2 EVALUATION—COMMERCIAL ITEMS (OCT 2014)116
E.3 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL ITEMS (NOV 2020)117
E.4 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (OCT 2020)135
E.5 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)138
E.6 52.216-1 TYPE OF CONTRACT (APR 1984)139
E.7 52.233-2 SERVICE OF PROTEST (SEP 2006)139
E.8 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)140
E.9 52.229-11 TAX ON CERTAIN FOREIGN PROCUREMENTS—NOTICE AND REPRESENTATION (JUN 2020)140
E.10 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018)141
E.11 VAAR 852.247-71 DELIVERY LOCATION (OCT 2018)143
E.12 VAAR 852.252-70 SOLICITATION PROVISIONS OR CLAUSES INCORPORATED BY REFERENCE (JAN 2008)143

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C261

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

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

[X]
52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or
[X]
52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly[]
b. Semi-Annually[]
c. Other[x] MONTHLY

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

Department of Veterans Affairs Financial Services Center P.O. Box 149971

Austin TX 78714-9971 ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

AMENDMENT NO
DATE

The guaranteed minimum award amount for this contract is $1,000.000. The maximum aggregate value of orders that can be placed under this contract is $5,000.000.00. The Government does not guarantee it will place any orders under this contract in excess of the guaranteed minimum award amount.

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM NUMBER
DESCRIPTION OF SUPPLIES/SERVICES
QUANTITY
UNIT
UNIT PRICE
AMOUNT
1.00
YR
__________________
__________________

Ordering Period 1 (1 Year) HOME OXYGEN SERVICES FOR GUAM & AMERICAN SAMOA IN ACCORDANCE WITH THE PERFORMANCE WORK STATEMENT AT THE ESTIMATED QUANTITIES IDENTIFIED IN ATTACHMENT 0001

1.00
YR
__________________
__________________

Ordering Period 2 (1 Year) HOME OXYGEN SERVICES FOR GUAM & AMERICAN SAMOA IN ACCORDANCE WITH THE PERFORMANCE WORK STATEMENT AT THE ESTIMATED QUANTITIES IDENTIFIED IN ATTACHMENT 0001

1.00
YR
__________________
__________________

Ordering Period 3 (1 Year) HOME OXYGEN SERVICES FOR GUAM & AMERICAN SAMOA IN ACCORDANCE WITH THE PERFORMANCE WORK STATEMENT AT THE ESTIMATED QUANTITIES IDENTIFIED IN ATTACHMENT 0001

1.00
YR
__________________
__________________

Ordering Period 4 (1 Year) HOME OXYGEN SERVICES FOR GUAM & AMERICAN SAMOA IN ACCORDANCE WITH THE PERFORMANCE WORK STATEMENT AT THE ESTIMATED QUANTITIES IDENTIFIED IN ATTACHMENT 0001

1.00
YR
__________________
__________________

Ordering Period 5 (1 Year) HOME OXYGEN SERVICES FOR GUAM & AMERICAN SAMOA IN ACCORDANCE WITH THE PERFORMANCE WORK STATEMENT AT THE ESTIMATED QUANTITIES IDENTIFIED IN ATTACHMENT 0001

GRAND TOTAL
__________________

B.3 DELIVERY SCHEDULE

ITEM NUMBER
QUANTITY
DELIVERY DATE
0001
SHIP TO:
VA Pacific Islands Health Care System (VAPIHCS)

1.00

0002
SHIP TO:
VA Pacific Islands Health Care System (VAPIHCS)

1.00

0003
SHIP TO:
VA Pacific Islands Health Care System (VAPIHCS)

1.00

0004
SHIP TO:
VA Pacific Islands Health Care System (VAPIHCS)

1.00

0005
SHIP TO:
VA Pacific Islands Health Care System (VAPIHCS)

1.00

36C26121Q0082

Page 1 of Page 1 of

HOME RESPIRATORY CARE SERVICES PERFORMANCE WORKSTATEMENT 2/5/2021

1 SCOPE

1.1 Scope

This Performance Work Statement (PWS) defines the effort required for the setup, installation, and management of Home Respiratory Care Services in accordance with The Joint Commission (TJC) or equivalent standards, to Veteran Beneficiaries serviced by VA Pacific Islands Health Care System (VAPIHCS). The use of the terms “Beneficiary”, “Veterans”, “Patients”, and “Patient” are used interchangeably and refer to the recipient of required supplies, equipment, and incidental services required under the contract.

1.2 The Government intends to award a one (1) Indefinite Delivery, Indefinite Quantity contract (IDIQ) contract (refer to FAR Clause 52.216.22) pursuant to this solicitation. The period for which orders can be placed against this IDIQ contract will be 5 years from the date of award. Contractors desiring to submit an offer on this IDIQ must offer services to the VA Pacific Islands excluding the Hawaiian Islands. These locations are identified in paragraph 1.4.

1.3 This contract is for non-personal services. It does not create employment rights with the U.S. Government whether actual, inherent, or implied. By agreeing to perform the services described in these specifications, the Contractor acknowledges that he/she is not, and shall not become, an employee of the U.S. Government. The Contractor further agrees that he/she shall not bring any cause of action in any forum claiming that he/she has become an employee of the U.S. Government.

This contract is a “non-personal services contract” as defined in FAR 37.101. It is, therefore, understood and agreed that the Contractor and/or the Contractor’s employees or subcontractor:

A. Shall perform the services specified herein as Independent Contractors, not as employees of the government.

B. Shall manage and administer the work required and bear sole responsibility for complying with all technical, schedule, or financial requirements or constraints attendant to the performance of this contract.

C. Shall be free from supervision or control by any government employee with respect to the manner or method of performance of the services specified; but D. Shall, pursuant to the government’s right and obligation to inspect, accept, or reject the work, comply with such general direction of the Contracting Officer, or the duly authorized representative of the Contracting Officer as is necessary to ensure accomplishment of the contract objectives.

1.3 Background

The Department of Veterans Affairs, VA Pacific Islands Health Care System (VAPIHCS) in Honolulu, HI requires home oxygen supplies for its beneficiaries residing on the Island of Guam and American Samoa. VAPIHCS currently serves an estimated 50 oxygen-using beneficiaries in Guam and 7 oxygen using beneficiaries in American Samoa. The volumes or amounts shown in the Contract Line Item Number (Appendix A) are estimates only and impose no obligation on the VA. The equipment needs are subject to change as determined by the prescribing physician. The contractor shall provide all required supplies, materials, labor, supervision, transportation, patient education, safety management and infection control.

Additional clinics for the Pacific Healthcare System excluding the Hawaiian Islands may be added during the life of this agreement.

1.4 Locations

Contractors shall have a facility or resources physically located in the geographic area in which they shall provide service. The geographical boundaries described herein have been determined as the areas of responsibility/jurisdiction for the following VA Medical Clinics:

Guam VA Clinic 498 Chalan Palasyo Agana, Heights, GU 96910-6427

Faleomavaega Eni Fa’aua’a Hunkin VA Clinic Fiatele Teo Army Reserve Building Pago Pago, AS 96799

Saipan VA Clinic Marina Heights Business Park – Garapan Medical Associates of the Pacific MH-II Building Suite 100 and 206 Saipan, MP 96950-9998

1.5 Roles and Responsibilities

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/BiPAP 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 the Contracting Officer’s Representative (COR) in VAPIHCS.

A. 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/Bi-Level nebulizers, compressors, etc.) are processed through the Prosthetic and Sensory Aid Services (P&SAS) of the VA Healthcare Systems. Initiation of treatment, delivery and pick-up of equipment and, resolutions of problems related to equipment or Patients care are under the direction of P&SAS and/or the Contracting Officer's Technical Representative (COR).

B. VA Clinicians will exclusive responsibility for determining 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.

C. VA Clinicians will complete initial and ongoing patient assessments.

D. 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 may, but is not limited to, monitoring 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 or equivalent standards.

E. 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.

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

G. Contractor shall notify Contracting Officer’s Representative (COR) for review and approval of any changes to the treatment plan and/or prescription that is sent to Contractor by VA medical provider. COR shall contact VA medical provider for his or her review and approval or disapproval.

H. 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.

I. Contractor shall provide all labor, parts, equipment, transportation, fuel, and supervision necessary to provide storage, delivery set up, in-house instruction, and/or pick-up of equipment for VA beneficiaries, in accordance with the terms, conditions, special provisions, and schedule contained herein.

1.6 Accreditation

A. The Contractor shall meet or exceed all Joint Commission (JC) standards or equivalent accrediting standards for all services provided herein. The JC standards may be accessed at www.JointCommission.org. Contractor shall submit proof of meeting or exceeding all JC standards as part of its technical proposal Contractor shall be accredited by a nationally recognized organization and shall maintain that accreditation throughout the term of the contract.

B. If awardee is non-Joint Commission Accredited, the Contractor shall provide a quarterly comprehensive report to COR documenting in detail how each standard is met and certifying that the contractor meets the Joint Commission standards for respiratory and home care. This report will be at no cost to VA. This report will be included in the Quality Assurance Quarterly Report.

1.7 Site Visits

A. 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 shall make available all records and documentation necessary during such visits.

B. Any accrediting body (or other Government representative) accompanied by the Contracting Officer, COR 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.

1.8 Ordering

A. Authorized VA representatives of Prosthetics and Sensory Aids Service (P&SAS) or appointed CORs at VAPIHCS will issue orders for home oxygen services. Such individuals will be identified at time of award.

B. Home Respiratory Care prescriptions will be submitted to the Contractor and include the beneficiary’s name, social security number (last 4 digits only), and home address as well as the type of supplies, services or oxygen system prescribed.

C. COR or designee will submit order 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 24 hours of placing the order.

D. The Contractor will provide a daily update via PKI encrypted email on orders received from the previous day to ensure all orders are tracked and accounted for. At minimum, the daily summary will include the following information: patient’s name and last four SSN; date and time received; type of service requested; date and place of delivery. Contractor shall have a direct local number with an employee on duty for after-hours orders and not be referred to a call center.

E. The Contractor should provide VA equipment unless otherwise specified by the COR or designee on the order.

1.9 Employee Orientation and Competency Requirements

A. 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. The Contractor will educate, evaluate and document employee education in strict accordance with current Joint Commission accreditation standards. Annual competencies are required. Documentation shall be made available upon written request of the Contracting Officer or facility COR.

B. Copies of the orientation/training programs attendance sheets (with employee signatures) will be reviewed by the COR during site visits.

C. VA HIPAA and VA Privacy training is required for all Contractor employees and subcontracted employees that handle VA patient-specific information – at the minimum on an annual basis. All contractor and subcontractor employees performing work under this contract and having access to patient records and other privacy act information are required to complete the Veterans Health Administration (VHA)’s mandatory “VHA Privacy Policy” training course(s). The course(s) is/are available on-line at the VA Talent Management System 2.0 (TMS) website: https://www.va.gov/oaa/mandatory.asp Instructions: Complete the below required training:

1. Completion of VA Privacy and Information Security Awareness and Rules of Behavior (VA 10176) will satisfy the annual information security and general privacy FISMA requirement for VA Health Care System.

2. Employees who have access to Protected Health Information (PHI) for administrative and clinical purposes have an additional requirement that will be met by completing the Privacy and HIPAA Focused Training (VA 10203).

D. The Contractor shall establish a written policy detailing how employees are to approach and deal with bereaved family members when picking up equipment for a deceased beneficiary. This plan shall include provision of training to all employees who work with veterans and/or their families. The Contracting Officer and facility COR shall review and approve the policy and training plan prior to implementation by the Contractor.

1.10 Solicitation of Beneficiaries

Contractor shall deal directly with the Contracting Officer and ,facility COR 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.

1.11 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.

1.12 Product Substitutions

No product substitutions shall be made without prior approval of the treating facility’s COR.

2 EQUIPMENT

2.1 Government Furnished Equipment

A. 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:

i. Concentrator (stationary)

ii. Oxygen Cylinder Refill Station

iii. All CPAP Devices which may include masks, Non-heated humidifiers & heated humidifiers

iv. All BIPAP Devices

v. All APAP Devices

vi. Suction pump

vii. Nebulizer (to include battery powered)

viii. Air Compressors

ix. Intrapulmonary Percussive Ventilation System (IPV)

x. Portable Oxygen Concentrator Inogen or equivalent including batteries

B. 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 by contract modification executed by the Contracting Officer.

C. Contractor will need to provide storage for government furnished equipment (GFE) drop shipped to the contractor.

D. Government-owned equipment shall be returned to the VA in cleaned condition for repairs, replacement, or disposal as appropriate. Government furnished equipment shall be handled in accordance with FAR 52.245-1 Government Property.

2.2 Contractor Furnished Equipment

A. The contractor shall furnish the following list equipment:

i. Ventilators and all appropriate prescribed equipment

ii. Liquid Oxygen Systems

iii. Portable Liquid Oxygen Systems

iv. Portable Gaseous Oxygen Systems (oxygen cylinders, regulator, oxygen conserving device)

v. Aluminum Oxygen Tanks

vi. Steel Oxygen Tanks (Optional)

vii. Supplies (e.g. green tubing, cannulas, masks)

viii. Thermal Fuses (two per device)

ix. FIRESAFE Cannula from LifeGas

x. Storage racks for 12 portable tanks

xi. Cylinder cart

xii. Safety holders

xiii. Shoulder carrying bag

xiv. Stationary and Portable Concentrators (when authorized by VA COR)

B. 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.

C. Contractor-furnished equipment shall be maintained per manufacturer's specifications. Contractor-owned equipment shall be repaired or replaced at no cost to the Government D. The VAMC shall not pay for the Contractor's lost or damaged equipment provided under this contract unless circumstances as reviewed by the Contracting Officer are concluded to be the results of willful negligence on behalf of Patients or VAMC employees. The VAMC shall not be held liable for normal wear and tear of equipment. The VA shall not pay for rental on equipment used by an unauthorized individual during the performance of this contract or for equipment that is lost. Accordingly, this is considered to be the cost of doing business, and is the requirement of the Contractor to pay for this type of equipment. See Contract Disputes Act 41 USC 602 et al.

2.3 Supplies

The Contractor shall be staffed and have sufficient supplies to render satisfactory and courteous service at all times to the Patient as listed below. The Contractor shall be responsible for the acts and omissions of his/her employees, his/her Sub-Contractors or satellite offices and their employees. Sub-Contractors shall be required to adhere to the requirements of this contract. In accordance with the prescription received from the VAMC, the Contractor shall provide the Patient with the following disposable supplies:

A. Oxygen cannula (including green colored cannula/tubing) which is indicated for change at a minimum of every two (2) weeks with a supply in reserve at all times until the Contractor’s next scheduled visit.

B. Connectors, swivel connectors, washers, wrenches, oxygen nipple adaptors (Christmas trees) provided as needed.

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

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

E. Humidifiers (both disposable and reusable) and water traps when deemed necessary. The number of humidifiers shall be sufficient to ensure that they are not depleted between re- supply visits. The number of traps shall be based on the Patient’s flow rate.

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

G. Fire safety cannula valve and tubing (Contractor shall provide two per patient per oxygen delivery system):

The Contractor shall install the FIRESAFE Cannula devices (thermal fuses) during contract startup and during any initial equipment set-ups. VHA requires that each oxygen delivery system have TWO thermal fuse devices at specific locations on the oxygen delivery tubing. One thermal fuse is located near the patient and the other thermal fuse is located near the Oxygen source. Appendix A includes a diagram of thermal fuse placement.

H. The contractor is responsible for replacing Thermal Fuses prior to expiration date, if the valve was activated or is damaged and in accordance with any other manufacturers’ guidelines for replacement. The Contractor will track the manufacturing date, set up and installation date, patient/caregiver education date, and the next exchange date on a spreadsheet. FIRESAFE Cannula device exchanges will be documented on the monthly report.

I. Contractor shall document on the Patient Home Oxygen Equipment Assessment and Patient Instruction Checklist as described in Paragraph 14.8 that the thermal fuses are being used properly and that the Veteran understands their intended use J. Contractor shall document on the Patient Home Oxygen Equipment Assessment and Patient Instruction Checklist when the thermal fuses are exchanged. Contractor shall telephone the COR and follow up with an encrypted email to the COR within 24 hours when the thermal fuse is found missing or has been activated.

2.4 Oxygen Conserving Devices

The Oxygen Conserving Device shall be battery-powered or pneumatic powered device that limits oxygen flow to inspiration only and thereby increase the duration of the supply (latest technology that meets the prescription requirements).

A. Pneumatic Powered Oxygen Conserving Devices Pneumatic units shall appropriately meet the following specifications based on Patient needs:

i. Pulse dose from .25 to 6 or higher

ii. Have easy to read content gauge

iii. Conservation ratio of 3:1 or higher

iv. Have continuous flow setting

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

B. Battery-Powered Oxygen Conserving Devices:

Battery units shall approximately meet the following specifications based on Patient needs:

i. Pulse dose from .5 to 6 or higher

ii. Have easy to read content gauge

iii. Conservation ratio of 5:1 or higher

iv. Bolus delivered per breath of at least 10cc per setting

v. Have continuous flow setting

2.5 Liquid Oxygen System:

The Liquid oxygen system consists of large reservoir and portable unit that is filled from the reservoir. Standard reservoir holds 110 pounds of liquid oxygen and portable unit holds 3-5 pounds of liquid oxygen. The standard reservoir weighs 65 pounds full and the portable unit weighs 6-8 pounds full (to include high flow systems).

A. Reservoir shall have condensation collection tray.

B. Shall have quick release valve for easy refilling.

C. Flow meter range of 0 to 6 LPM.

D. Portable must come with shoulder strap.

E. Shall have electrical or mechanical content indicators.

2.6 Liquid System with Conserving Device:

Liquid system with conserving device consists of large reservoir and portable unit that is filled from the reservoir. Standard reservoir holds 110 pounds of liquid oxygen and portable unit holds

1.9 pounds of liquid oxygen. The standard reservoir weighs 165 pounds full and the portable unit weighs 4 pounds full.

A. Reservoir shall have condensation collection tray.

B. Shall have quick release valve for easy refilling.

C. Shall have flow settings of 1-10 or as clinically indicated D. Portable shall come with shoulder strap and belt loop holder.

E. Shall have electrical or mechanical content indicators.

2.7 Backup Systems

A. Oxygen Concentrators

Veterans with a prescription for an oxygen concentrator shall be provided with a backup system consisting of a compressed gas source and regulator with stand, humidifiers, and cannulas/masks for use during the event of a power failure or mechanical problem with electrical home oxygen equipment. The Contractor will provide the back-up system. The cost of replacement for the above mentioned backup system shall be borne by the Contractor. The cost of replacement of equipment damaged, lost or misplaced not through Patient's negligence shall be borne by the Contractor.

B. All ventilated patients shall receive a backup device of the same type at no additional cost to the government.

C. The Contractor shall provide documentation (via encrypted email and fax) if the Patient declines the oxygen back-up system, to include the reason for declining backup system and the Veteran’s signature. Notification (via encrypted email and fax) shall be provided to COR or designee within five (5) business days of the Veteran declining any prescribed equipment or Contractor’s inability to deliver the prescribed equipment.

2.8 Reserve Supply

Contractor shall provide only aluminum/composite oxygen tanks for all patients using compressed gas for portability. An adequate supply of aluminum/composite compressed O2 tanks, with regulator, and E-tank stands shall be provided and stored at the VA Clinic in Guam and American Samoa. Quantities, and sizes of tanks, shall be agreed upon by the Contractor and COR. The reserve supply shall accommodate home oxygen patients who are either being discharged from the hospital or visiting (appointments, etc.) and require a supply of oxygen to enable the VA beneficiary to reach home. Adequate inventory as defined by the COR shall be maintained by the Contractor. Reserve supply shall be provided and stored at VA clinics at no additional cost to the Government. Safety holders/cylinder racks shall be provided for all veterans with a prescription for four (4) or more cylinders of multiple sizes.

2.9 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.

A. 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.

B. 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.

C. 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.

D. Portable Liquid Medical Oxygen Unit: System includes nasal cannula, with sufficient length of nasal tubing as required, 110 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.

E. 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.

F. 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.

G. Thermal Cannula Fuses: To prevent burn injuries, the Contractor shall provide and connect two (2) fire safety valves (or one bi-directional fire safety valve with fire safety tubing) to the oxygen delivery systems of all Veteran Beneficiaries, irrespective of their smoking status. The contractor shall ensure that the patients and/or their caretakers receive instructions how to maintain and replace their thermal cannula fuses per the manufacturer’s recommendations.

2.10 Equipment Labelling

All equipment shall contain an adhesive type label containing the vendor’s name and emergency 24 hour toll-free phone number. This label shall be placed on the equipment in an area that is viewable to Patients and/or Caregivers at all time. Patient shall be given a document listing toll-free phone number for routine resupply of oxygen cylinders and supplies.

3 EQUIPMENT SERVICE

3.1 The Contractor shall furnish, install and service all equipment and supplies ordered under this contract. All disposable supplies shall be new and unused. The repair/maintenance of all equipment by the Contractor shall be performed by a competent professional familiar with nature of the equipment involved and fully qualified under the laws of the State in which the services are being rendered.

3.2 Provision of all equipment shall be consistent with local Fire and Safety Codes in the respective area of the state, and shall conform to National Fire Protection Association A. (NFPA) 99/101 (Standard for Health Care Facilities/Life Safety Code) NFPA B. (Oxygen Cylinder Requirements found at http://www.nfpa.org/assets/files/PDF/ROP/51-F2001-rop.pdf.

3.3 The Contractor shall provide a safety/emergency checklist to be completed, then signed by the Veteran or his/her Caregiver and retained in the Patient account folder. The Contractor shall service all equipment at the manufacturer recommended intervals. The Contractor shall conduct a check of the concentrator using a certified oxygen analyzer that is calibrated according to the manufacturer standards.

3.4 The Contractor shall perform maintenance on all equipment according to the equipment manufacturer's guidelines. The Contractor shall change compressor inlet pre-filters and compressor inlet bacteria filters according to the manufacturer recommendations.

A. The Contractor shall test the alarm battery at each maintenance check, changed as indicated but at least annually.

B. The Contractor shall track and document maintenance of equipment in accordance with manufacturer specifications and provide these records for review upon request. Contractor shall furnish parts and labor for routine maintenance. The Contractor shall have recall procedures for equipment and supplies.

3.5 The Contractor shall not change or alter a Patient's oxygen prescription or equipment requirements without a new prescription from the Patient's VA physician.

4 EQUIPMENT MONITORING, MAINTENANCE AND REPAIR

4.1 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.

4.2 Contractor shall also provide service and maintenance on Government Owned Stationary Oxygen Concentrators and Government Owned Portable Oxygen Concentrators. Only technicians with documented and current training shall service Government owned and Contractor owned equipment.

4.3 Contractor will contact veteran to schedule maintenance visit at a minimum of two weeks prior to when the service is due. The contractor shall report to the COR after the contractor has made three attempts over five working days that they have been unsuccessful in scheduling the maintenance visit. If the Veteran is not available at the previously scheduled time, the Contractor should reattempt to schedule within 48 hours. Notify the COR if the Veteran is not available for two consecutive agreed upon appointment times.

4.4 As part of the equipment monitoring visit the contractor shall ensure 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.

4.5 Concentrator Preventative Maintenance Inspection

A. Must be conducted in accordance with manufacturer’s recommendations.

B. Performed by a qualified technician C. Submit copy of the maintenance visit form due to facility COR or designee with the next monthly data report.

D. Document Concentrator Maintenance inspections on a spreadsheet that lists patient’s name, last four SSN, item description, part number, serial number, and date of maintenance checks provide copy quarterly to COR or designee.

E. Repairs to concentrators will be conducted only after approval by COR or designee. Repair estimates will be forwarded to the COR or designee before any work is to begin or for disposition instructions. Repairs are to be tracked on weekly and monthly activity reports.

4.6 CPAP/BiPAP/APAP

A. Patients need to contact the clinic if they have concerns about the functioning of their equipment. If the Veteran calls the Contractor regarding their CPAP/BiPAP/APAP equipment, the Contractor should have the Veteran contact the Respiratory Therapy Clinic. The Government will not pay for any unauthorized CPAP/BiPAP/APAP maintenance, repair, or adjustments.

B. For CPAP/BiPAP set ups by the Contractor, the Contractor will provide the COR with the modem code and not register the system during the initial set-up.

4.7 Ventilators

A. Home visits shall be performed by the RRT/CRT for all Patients that utilize the ventilator either continuously, for nocturnal concerns, and/or for intermittent. Home visits shall be performed every 30 calendar days after initial set up or the previous maintenance visit B. Performed by an RRT/CRT only C. The check shall address the following:

i. Ventilator settings/mode

ii. Ventilator alarms

iii. Actual high and low alarm parameters

iv. Actual tidal volume and rate

v. Compliance

vi. Patient pressure

vii. Breath rate – ventilator

viii. Breath rate – Patient

ix. Tidal volume

x. Breathing effort

xi. Inspiratory time

xii. Oxygen concentration (fractional inspired oxygen (FiO2) or LPM), if necessary

xiii. Positive End Expiratory Pressure (PEEP), if applicable

xiv. Pressure Support, if applicable D. Completed Maintenance visit form due to facility COR or designee with the next monthly invoice

4.8 Preventative Maintenance

Contractor shall provide service and preventive maintenance on home oxygen equipment as recommended by the manufacturer. Preventive maintenance shall only be performed by a certified service technician that has received the approved training. Contractor shall provide all certification and training documentation to the COR with signatures and dates on the contract inception date and upon the COR’s request.

4.9 Set-up / Maintenance Form

A. Home Oxygen Equipment Assessment and Patient Instruction Checklist will be used for all set ups. The contractor shall at a minimum, cover the following items:

i. No Smoking signs are provided and/or posted.

ii. Smoke alarm is present and alarms when tested

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

iv. Verify that the veteran has been instructed to test all smoke alarms monthly and verify that the fire extinguishers are available and in working order.

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

vi. Number of days since last equipment monitoring visit.

vii. Average usage per day of equipment filters

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

B. Maintenance must be documented in the patient record. A copy of the maintenance form will be submitted electronically with the Monthly Activity Report.

4.10 Equipment maintenance records, to include the serial number and lot number of the equipment being serviced shall be kept by the Contractor. Records shall be kept up to date and available for review by the facility COR or designee.

4.11 The Contractor shall have an established procedure for Government Owned equipment pickup of stationary concentrator and portable oxygen concentrator or exchange for repairs. In the event that the Government owned equipment is no longer in use by a VA beneficiary, the equipment must be cleaned, sanitized, and tagged before returning to inventory. The equipment must be cleaned and sanitized in accordance with manufacturer standards.

4.12 Contractor must follow manufacturer’s recommendations for maintenance of items in storage.

5 STORAGE

5.1 Contractor shall provide a clean, pest/rodent free, secure, contained area, with adequate space, for the storage of government owned equipment and supplies covered under this contract. The storage area shall be climate controlled throughout the year, and proper temperature and humidity shall be maintained and documented daily. A temperature range of between 68 degrees Fahrenheit and 76 degrees Fahrenheit shall be always be maintained and documented daily. Humidity should be kept between 20-60%. Storage units or storage containers (such as PODS) will not be an acceptable means of storing government owned equipment. Respiratory supplies shall be stored on a rack 12” off the floor and 18” from the ceiling. Storage area(s) must conform to all local fire codes . The contractor must be equipped to receive deliveries of Respiratory Care equipment and supplies to their storage location during normal business hours via regular trucking companies. The storage facility shall have a monitored burglar alarm, fire alarm and fire sprinkler system throughout in accordance with all local, Federal and U.S. Territory regulations (including, but not limited to OSHA requirements). In addition, the storage area shall meet all U.S. Territory requirements for insurance. There shall be no charge for storage of VA equipment but storage costs are expected to be built into the cost of the contract.

5.2 Contractor-provided storage will be separate from other areas of storage, which may be used by the Contractor. Contractor shall store all VA owned items in an orderly arrangement to allow for ready access to any item. Items that have been cleaned, refurbished and repaired should be identified as such and stored separately from those recently recovered awaiting necessary cleaning, etc. Contractor shall separate clean and dirty equipment, using a Joint Commission approved divider and protective covering. Contractor shall, at no time intermingle VA respiratory equipment and/or supplies with equipment and/or supplies from non-VA activities. Six clearly delineated areas will be designated:

A. Staging Area, - all VA owned equipment going to the contractor's facility shall be unloaded from the delivery truck into the (IN) staging area and sorted. New items shall be unpackaged if necessary, inspected for damage, and placed into the appropriate action area. All other recovered used equipment shall be placed in the Pending Assessment area.

B. Pending Assessment Area - The equipment shall be inspected and evaluated to determine whether the equipment is worthy of reissue.

C. Repair Area -Equipment that has been cleaned, disinfected, but needs repair.

D. Junk/Scrap Area - All equipment which cannot be re-issued, based on excessive repair costs or being obsolete shall be kept in this area. During periodic site visits, the COR shall assess the equipment in this area to determine final disposition. The contractor will dispose of scrap/junk at no cost to the government.

E. Ready for Issue Area - All equipment in this area will be cleaned, disinfected, in excellent working condition and ready for issue to the Veteran F. Staging (out) area - All equipment ready for delivery to the Veteran shall be placed in this area pending loading

5.3 Contractor shall have written policies and procedures relating to cleaning and storage of all recovered/dirty/reusable equipment that meet Joint Commission standards.

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