Attachment 1 - PWS.pdf

PERFORMANCE WORK STATEMENT

for

Air Force Medical Agency (AFMED)

NEXT GENERATION THERAPEUTIC LIQUID OXYGEN

(NPTLOX)

SCHEDULED AND UN-SCHEDULED MAINTENANCE

Solicitation/Contract Number TBD

06 MARCH 2025

(Version Control Date: 22 Jun 22)

Table of Contents Section Page Number

1. DESCRIPTION OF SERVICES

1.1. Background

1.2. Scope

2. GENERAL INFORMATION

2.1. Contractor Identification

2.2. Contractor Training

2.3. Contractor/Government Communication

2.4. Monthly Status/Financial Report

2.5. Place of Performance

2.6. Travel Requirements

2.7. Mission/Emergency Essential

2.8. Duty Hours

2.9. Telecommuting

2.10. Federal Holidays

3. CONTRACT REQUIREMENTS

3.1. Support Services

3.2. Minimum Qualifications:

3.3. Security Requirements. (For Unclassified Contracts)

3.4. Service Contract Reporting (SCR)

3.5. Quality Control Plan (QCP):

3.6. Post-Award and Initial Contract Performance Meeting

3.7 Applicable Publications……………………………………………………………….11

4. PERFORMANCE OBJECTIVES

4.1. Services Summary (SS)

5. GOVERNMENT FURNISHED PROPERTY (GFP)

6. DELIVERABLES

APPENDIX A

ACRONYMS

7. ADDITIONAL SECTION HEADER………………………………………………………15

ATTACHMENT A - Serial Managed GFP Attachment……….………………………….…..…16 ATTACHMENT B - Contract Data Requirements List CDRLS)...…………………………

PERFORMANCE WORK STATEMENT (PWS)

Next Generation Therapeutic Liquid Oxygen (NPTLOX) Scheduled and Un-Scheduled Maintenance

1. DESCRIPTION OF SERVICES

1.1. Background.

The Air Force Medical Agency (AFMS) has over 750 Next-Generation Portable Therapeutic Liquid Oxygen (NPTLOX) systems currently in inventory for the supply of supplemental oxygen to patients during transport as well as for use at deployed medical facilities. The units are part of the AFMS’s War Reserve Materiel (WRM) medical capability assembly sets positioned throughout the world for rapid response deployments. The AFMS fielded NPTLOX are also embedded globally in Aeromedical Evacuation (AE) operational inventories which support on-going peacetime and theater AE operations. The NPTLOX replaced older generation Portable Therapeutic Liquid Oxygen (PTLOX) systems which were over 20 years old. The PTLOX inventory was phased out as the AFMS fielded the NPTLOX.

1.2. Scope.

This is a performance based non-personal service requirement to provide both unscheduled major and minor repairs and Original Equipment Manufacturer (OEM) level 36 month scheduled preventive maintenance, herein referred to as scheduled preventive maintenance, of NPTLOX units in AFMS inventories that is outside the scope of Air Force (AF) Bio-Medical Equipment Technician (BMET) capabilities. Major repairs are those that require replacement of the Dewars Container Assembly, LOX Quantity Indicator, or the Heat Exchanger Assembly which are significant components of the NPTLOX. Minor repairs are all other adjunct repairs. The contractor shall also provide customer service support (both telephone and email) during the contractor’s routine business hours. This Performance Work Statement (PWS) provides for a comprehensive method for maintenance and repair of NPTLOX systems to maintain their operational status.

2. GENERAL INFORMATION

2.1. Contractor Identification.

All Contractor/Subcontractor personnel shall identify themselves as Government Contractor personnel during all forms of communications such as business meetings, telephone conversations, electronic mail, attendance sheets, coordination documentations, reports, and the signature blocks utilized in all correspondence.

2.2. Contractor/Government Communication.

The Contractor shall designate a Focal Point to be the single point of contact for all Contractor and Government correspondence. The Focal Point shall provide clear and consistent written and verbal response to Government within 24 hours of Government initiated communication (e.g., return phone calls, emails, or other communication).

2.3. Monthly Status/Financial Report.

The Contractor shall provide a CLIN Balance Monthly Status Report of all NPTLOX in accordance with (IAW) Contract Data Requirements List (CDRL) A001 and associated DID.

The CLIN Balance Monthly Status Report is funds based and tracks total dollars on the contract.

2.4. Place of Performance.

The work to be performed under this contract will be performed at the Contractor’s facility.

2.5. Travel Requirements.

No travel requirements under this Contract.

2.6. Mission/Emergency Essential.

None of the services listed in this PWS are mission/emergency essential.

2.7. Duty Hours.

The contractor shall be available during routine duty hours, Monday – Friday (excluding Federal Holiday), 7:30AM to 4:30PM, except Federal Holidays and any other holiday declared by executive order. Scheduling of work outside of these times is permitted provided it is agreed upon by the government and contractor on a case by case basis. The contractor is required to make accommodations at no additional expense if the inability to comply with previous arrangements is due to factors attributable to the contractor (e.g. the contractor arrived late.).

2.8. Federal Holidays.

Federal offices are closed on federal holidays as established by Federal law (5 U.S.C. 6103) and any other holidays declared by executive order. Holidays are documented by year on the Office of Personnel Management website for Federal employees located at:

https://www.opm.gov/policy-data-oversight/pay-leave/federal-holidays/#url=Overview.

2.9. Facility Closures.

Not Applicable.

2.10. Conduct of Contractor Personnel.

Not Applicable.

https://www.opm.gov/policy-data-oversight/pay-leave/federal-holidays/#url=Overview

3. CONTRACT REQUIREMENTS

3.1. Support Services.

The contractor shall provide a service for the maintenance and repair of the NPTLOX system.

The contractor shall perform both unscheduled (major or minor repair service) and planned scheduled preventive maintenance, herein referred to as scheduled preventive maintenance, on NPTLOX units. All depot level repaired or reconditioned NPTLOX units will be fully operational per Technical Order (TO) 15X2-5-21-2. All parts used shall be Original Equipment Manufacturer (OEM) to maintain the unit’s safe-to-fly (STF) certification in accordance with Air Force Manual (AFMAN) 10-2909, Aeromedical Evacuation Equipment Standards. OEM parts must be used for AE certified equipment because of the testing criteria and limitations imposed by AE certification. The process flow for NPTLOX maintenance shall be:

3.1.1. The COR notifies the contractor of NPTLOX units that need to be sent into the contractor’s repair facility for either unscheduled or scheduled preventive maintenance;

the COR will request a Return Material Authorization (RMA) for each unit identified in the notification.

3.1.2. Contractor provides the RMA to the COR for each serial number to be shipped to the contractor’s repair facility.

3.1.3. COR adds shipment doc in SMT by selecting applicable Serial Number from GFP Attachment of serial managed NPTLOX for Contractor identify inbound GFP to receipt against and coordinates shipment of NPTLOX to contractor’s repair facility.

3.1.4. Contractor confirms delivery receipt of NPTLOX in GFP module.

3.1.5. Contractor completes a technical evaluation and inspection of NPTLOX shipped into their repair facility for service/maintenance.

3.1.6. Contractor provides a written technical inspection and evaluation quote to COR outlining required service needed to return unit(s) to full operational status. The technical inspection and evaluation quote will include total labor hours needed to accomplish any major or minor unscheduled maintenance and a list of parts (part number, description, quantity, per unit cost and total cost) that need to be replaced to accomplish the un-scheduled maintenance. Shall also include what issue(s) or discrepancies were found with the lox unit during the initial inspection. Will also include complete corrective action including maintenance actions taken to correct issue/discrepancy and any diagnostic evaluations performed.

3.1.7. COR provides written authorization via email notification to the contractor to proceed with any unscheduled and scheduled maintenance identified in the technical inspection and evaluation.

3.1.8. Contractor performs all approved maintenance (unscheduled and scheduled) services authorized under the RMA by the COR.

3.1.9. After approved repairs are accomplished the Contractor coordinates return shipment to the end-use customer; shipment tracking information is created and provided to the COR via GFP Module.

3.1.10. Unit is delivered to End Use Customer notifies COR to receive in GFP Module. The End Use Customer will then who completes a limited acceptance inspection and reports results to the COR. Upon receipt of the limited acceptance inspection, the COR will post the receipt in Wide Area Workflow (WAWF).

3.1.11. Transportation. The contractor shall provide worldwide transportation capability for NPTLOX units.

3.1.11.1. The contractor shall arrange and coordinate return shipment with a commercial freight forwarder within five (5) calendar days following completion of the unscheduled or scheduled preventive maintenance or upon notification from the COR that repair service is declined.

3.1.11.2. The contractor shall provide the COR shipment notification by e-mail, to include but not limited to, the name of the freight forwarding company, shipment tracking number, freight forwarding company’s web site (if applicable), the freight forwarding company’s point of contact (name and phone number), date of shipment and estimated delivery date. This information shall be provided within one (1) calendar day after the NPTLOX has been picked up by the freight forwarder.

3.1.11.3. The contractor shall be responsible for packaging the NPTLOX for return shipment using appropriate commercial packaging and preservation techniques and standards for surface and air movement. If the NPTLOX is shipped to the contractor in the ruggedized shipping container, part number 50C-0083-0101, the contractor shall ensure that the unit is returned to the government in the ruggedized shipping container.

3.1.12. Technical Evaluation and Inspection. The contractor shall perform a technical evaluation and inspection of each NPTLOX upon receipt of a NPTLOX unit at their repair facility, whether the system is sent in for scheduled preventive maintenance or unscheduled maintenance service.

3.1.12.1. The technical evaluation and inspection shall be performed to identify any and all necessary repairs required to bring the unit back to full OEM operational status in accordance with TO 15X2-5-21-2. The Technical Evaluation shall include a description as to what was wrong with the unit and detail description of what was done to fix the unit. Inspection criteria outlined in the TO will be followed.

3.1.12.2. Container Assemblies (Dewars and Manifold Assembly) will not be replaced unless the assembly fails the inspection/test criteria outlined in paragraph 3.8.1 or 3.8.3 of the Technical Order (TO).

3.1.12.3. There will be instances in which a NPTLOX sent in for the 36 month OEM scheduled preventive maintenance may need adjunct unscheduled (corrective) maintenance above and beyond the service provided with the scheduled preventive maintenance.

3.1.12.4. The contractor shall provide a written technical evaluation and inspection quote to the COR in either PDF or MS Word format (PDF preferred) within 15 calendar days after receiving a NPTLOX at their repair facility.

3.1.12.4. The written quote will be sent to the COR as an email attachment. The report shall specify what repair services are required to return the unit to full OEM operational status, list all parts that need to be replaced or refurbished; costs parts and labor costs for the repair services. The report shall reference the NPTLOX by serial number and RMA number.

3.1.12.5. If a unit is sent into the contractor’s repair facility for scheduled preventive maintenance and no adjunct repairs are required, the report is still required indicating no additional repairs are required.

3.1.12.6. No unscheduled maintenance can be performed without the COR’s written authorization. The Contractor shall not proceed with any scheduled or un-scheduled maintenance without COR approval, in writing of service indicated on the Technical Evaluation and Inspection quote. If the Government declines the maintenance service, the contractor shall coordinate return shipment to the end use customer.

3.1.13. NPTLOX sent into Contractor for Unscheduled Maintenance Only. The contractor shall perform the service/repair for NPTLOX sent into the contractor’s repair facility for unscheduled maintenance outside of the unit’s planned 36 month scheduled preventive maintenance. For the AF, NPTLOX sent in for unscheduled maintenance are those units that failed the AF’s periodic operational check and repairs cannot be accomplished by the service career BMET. Unscheduled maintenance will be segregated into two categories;

major repairs, which constitutes replacement of the Dewars Container Assembly; LOX Quantity Indicator; or the Heat Exchanger Assembly, and minor repairs (all other unscheduled maintenance repair service).

3.1.13.1. NPTLOX sent in for unscheduled maintenance; shall have repairs accomplished within 40 calendar days following receipt of written approval from the COR to accomplish the repair service (after the COR’s review of the technical evaluation and inspection report as stated previously in the workflow process outlined in paragraph 3.1.12.).

3.1.13.2. The contractor shall notify the COR within 15 calendar days after receipt of a NPTLOX for unscheduled maintenance (as defined above) if the service required to return the unit to full OEM operational status cannot be accomplished within the 75 calendar day timeframe. The notification will identify the reason for the delay and their projected lead-time before the service can be completed and the unit is ready for return shipment.

3.1.13.3. Upon return of the repaired unit to the end use customer, the AF will complete an operational check and acceptance inspection on the unit and provide the results to the COR. The COR will notify the Contracting Officer (CO) of any units that fail the operational check and acceptance inspection, detailing what the operational check and acceptance inspection indicated. The CO will notify the contractor of any NPTLOX that were serviced and failed the operational check and acceptance inspection.

3.1.13.4. The Contractor shall have 10 business days to discuss, correct or identify a corrective action resolution acceptable to the government. Non-functioning units that are received after repair will be returned to the contractor for repair at no additional cost to the government and at the contractor’s expense for all transportation (to the contractor’s repair facility and back to the end use customer).

3.1.14. OEM 36 Month Scheduled Preventive Maintenance. The contractor shall perform 36 month OEM scheduled preventive maintenance on NPTLOX. This routine preventive maintenance cycle will reduce OEM level maintenance requirements; allow for maintenance data collection and analysis; and extend the useful life of the NPTLOX. This preventive maintenance is also expected to reduce the number of units that may require significant overhaul or retrofit over the planned useful life cycle of the NPTLOX. The 36 month scheduled maintenance is a requirement stipulated in Technical Order (TO) 15X2- 5-21-2.

3.1.14.1. The government will provide to the contractor a projected annual production schedule of NPTLOX to be sent into the contractor for scheduled preventive maintenance for the contract performance period. The schedule will take into account the contractor’s monthly throughput capacity. The production schedule will be provided within five (5) business days of the effective date of each performance period of the contract.

3.1.14.2. The COR will coordinate monthly shipment of NPTLOX for scheduled preventive maintenance to be delivered to the contractor’s repair facility by the 15th of each month of the contract performance period.

3.1.14.3. The contractor shall complete the scheduled preventive maintenance within 45 calendar days following receipt of the NPTLOX. This 45 day lead-time encompasses completion of the technical inspection and evaluation, completion of the preventive maintenance service and completion of any minor adjunct repair services.

3.1.14.4. The lead-time for completion of the preventive maintenance service is extended to 75 calendar days if the technical inspection and evaluation determines that the Container Assembly (Dewars and Manifold Assembly), LOX Indicator or Heat Exchanger fails the inspection/test criteria outlined in the Technical Order (TO), paragraphs 3.8.1 or 3.8.3.

3.1.14.5. The contractor shall inform the COR, via the written technical evaluation and inspection quote, of any NPTLOX that require adjunct major or minor repairs above and beyond the service provided with the 36 month OEM level preventive maintenance.

3.1.14.6. The contractor shall advise the COR at the time the written quote is provided whether the accomplishment of the adjunct repairs will delay the return shipment of the unit beyond either the 45 day or 75 day lead-times (75 days if the Container Assembly, LOX Indicator or Heat Exchanger need to be replaced).

3.1.14.7. If the return shipment is expected to be delayed beyond the 45 or 75 day lead-times, the contractor will advise the COR, in writing of the projected date that the unit will be ready to coordinate return shipment.

3.1.14.8. All adjunct repairs will only be accomplished if written approval is provided by the COR. The COR will provide the approval or disapproval for the adjunct repairs following receipt of the Technical Evaluation and Inspection report.

3.1.14.9. The scheduled preventive maintenance will consist of:

3.1.14.9.1. Removal and testing of all valves to determine whether to replace or rebuild.

3.1.14.9.2. All rebuilt valves will have new seals and O-rings installed.

3.1.14.9.3. Replacement of clamps and fasteners used to secure the valves when the replacement or rebuilt valve is installed.

3.1.14.9.4. Annotation on the NPTLOX of the month/date that the scheduled preventive maintenance was accomplished and the date of next scheduled maintenance.

3.1.14.9.5. Operational testing of the NPTLOX as a complete unit after completion of the scheduled preventive maintenance.

3.1.14.9.6. Packaging of the NPTLOX for return shipment.

3.1.15. Valves to be inspected and tested for the 36 month OEM level scheduled preventive maintenance service are:

Table 1

Part Number Item Description 50C-0021-0007 Flow Control Valve 50C-0083-0094 Pressure Regulator 20C-0008-2 Pressure Closing Valve 20C-0050-2 Relief Valve 20C-0050-14 Relief Valve 0580560100-1 Fill, Build-up and Vent Valve

3.1.16. Contractor Surge Production Capacity. The contractor shall have the capability to increase their service capacity throughput to handle up to 40 NPTLOX per month, upon request by the government, within 60 business days following receipt of the request. The government will provide an estimated duration for the increased throughput capacity with their request.

3.1.17. NPTLOX Handle Kit (P/N 50C-0083-0239) Installation. The contractor shall install a Handle Kit, Part Number 50C-0083-0239 to NPTLOX sent in for either scheduled or un-scheduled maintenance that during the technical inspection are determined not to have had this upgrade accomplished. The AF is having this handle kit installed on all NPTLOX to address a safety issue. The government procured Handle Kits previously under a Defense Logistics Agency Troop Support contract and will provide to the Contractor as Government Furnished Property (GFP) when needed for install on a NPTLOX sent in for service. The Contractor will only charge Labor for the install because all parts required for the handle installation are contained in the Handle Kit (50C-0083-0239).

3.1.18. Support Services - Estimated Workload. The government will ship approximately 22 NPTLOX per month to the Supplier for planned/scheduled 36 month OEM level scheduled (preventive maintenance) as described in paragraph 3.1.16. Additional NPTLOX may be shipped to the Supplier for Major/Minor Un-scheduled maintenance outside of the planned/scheduled 36 month OEM level preventive maintenance. The government’s Best Estimate Quantity for NPTLOX for out of cycle un-scheduled maintenance is 1 – 3 NPTLOX a month. Upon receipt of a NPTLOX for either 36 Month OEM level preventive maintenance or out-of-cycle unscheduled maintenance, the Contractor shall accomplish a technical evaluation and inspection. For units sent in for 36 month OEM level PM the purpose of the technical inspection is to determine any adjunct un-scheduled maintenance (Major or Minor) that is needed in addition to completing the 36 month OEM level preventive maintenance For units sent in for out-of-cycle un-scheduled maintenance, the Contractor is determining the extent of corrective maintenance required to return the unit to full operational status. The Contractor shall submit the technical evaluation and inspection report to the COR. The COR will review and authorize the Contractor to complete the maintenance annotated in the technical evaluation and inspection report. If the COR does not authorize the service, if deemed not economically feasible, the Contractor shall prepare the NPTLOX for shipment and coordinate return shipment to the government’s designated delivery consignee. Upon completion of the authorized service, the Contractor shall prepare the serviced NPTLOX for shipment and coordinate return shipment to the government’s designated delivery consignees. The Contractor shall provide customer service support (both telephone and email) during the Contractor’s routine business hours, Monday – Friday. The Contractor shall respond to AF customer service support inquiries within one (1) business day.

Upon the direction of the CO or COR, the contractor shall participate via telecon/teleconference in reviews and meetings on the status and condition of NPTLOX units being repaired and/or under-going preventive maintenance.

3.2. Minimum Qualifications.

Not Applicable

3.3. Security Requirements. (For Unclassified Contracts)

3.4. Service Contract Reporting (SCR)

The Contractor shall report manpower data IAW the current Guidebook for Service Contract Reporting in the SAM. User Manuals: Additional guidance can be found in the Guidebook for Service Contract Reporting in the System for Award Management.

3.5. Quality Control Plan (QCP)

Not Applicable

3.6. Post-Award and Initial Contract Performance Meeting.

The government shall hold a post-award meeting with the Contractor within 10 business days after contract award. The CO shall contact the PM/COR and the Contractor to schedule this meeting. Telecon/teleconference is permissible for the post-award meeting. The purpose of the post-award meeting is to introduce the Contractor to the Government’s representatives (PM/COR) and go over the contract. Take-away from this meeting should be an exchange of contact information; a timeline of when direct support will start; if not yet started; and an understanding by all parties of all the requirements to performed by the Contractor and any support the Government will provide the Contractor to perform the requirements, safely and efficiently.

3.7. Applicable Publications.

3.7.1. Technical Order (TO) 15X2-5-21-2.

3.7.2. Air Force Instruction (AFI) 41-201, Managing Clinical Engineering Programs, paragraph

2.31.5.

4. PERFORMANCE OBJECTIVES

4.1. Services Summary (SS).

The Contractor services requirements are summarized into performance objectives that relate directly to mission essential items. The performance threshold briefly describes the minimum https://dodprocurementtoolbox.com/cms/sites/default/files/resources/2020-10/SCR%20Guidebook%2021%20October%202020.pdf https://dodprocurementtoolbox.com/cms/sites/default/files/resources/2020-10/SCR%20Guidebook%2021%20October%202020.pdf acceptable levels of service for each requirement. These thresholds are critical to mission success.

Table 2 SS

SS# PERFORMANCE

OBJECTIVE

PWS Para PERFORMANCE THRESHOLD

1 Provide worldwide transportation of

NPTLOX

3.1.11 Coordinate return shipment, to include

shipping notification and tracking information, no later than five (5) calendar days after completion of either scheduled preventive or unscheduled maintenance or upon written notification from the COR that maintenance service identified in the technical evaluation and inspection quote is declined. 90% of the time.

2 Provide a written Technical Evaluation and Inspection Quote

3.1.12 Provide technical evaluation and

inspection quote within 15 calendar days following receipt of a NPTLOX for scheduled preventive or unscheduled maintenance. 90% of the time.

3 Perform unscheduled maintenance on

NPTLOX

3.1.13 Complete maintenance to bring unit to

full OEM operational status within 75 calendar days following receipt of written approval from COR to perform repair service for NPTLOX sent into contractor’s repair facility for unscheduled maintenance. 90% of the time.

4 Perform scheduled preventive maintenance on NPTLOX

3.1.14 Scheduled preventive maintenance is

completed on all NPTLOX sent into repair facility within 45 calendar days if no or minor adjunct repair service is required. 90% of the time.

5 Perform scheduled maintenance on

NPTLOX

3.1.14 Scheduled preventive maintenance is

completed on all NPTLOX sent into repair facility within 75 calendar days if replacement of the Container Assembly (Dewars and Manifold Assembly), LOX Indicator or Heat Exchanger are required as an adjunct repair service. 90% of the time.

5. GOVERNMENT FURNISHED PROPERTY (GFP)

6. DELIVERABLES

6.1. The Contractor shall submit all deliverables as specified in this PWS and contract

Attachment B, Contract Data Requirements List (CDRL).

6.2. All deliverables shall be submitted electronically to the COR(s) unless otherwise directed.

6.3. The Contractor shall provide informal reports by e-mail as requested by the COR.

Appendix A

ACRONYMS

ACRONYM DEFINITIONS

AE Aeromedical Evacuation AF Air Force AFI Air Force Instruction AFMS Air Force Medical Service AFMED Air Force Medical Agency AIS Automated Information System BMET Bio-Medical Equipment Technician CDRL Contract Data Requirements List CO Contracting Officer COR Contracting Officer Representative CPAR Contractor Performance Assessment Reports CPOC Contractor Point of Contract DHA Defense Health Agency DoD Department of Defense FOUO For Official Use Only IAW In Accordance With LOX Liquid Oxygen MHS Military Health System MTF Medical Treatment Facility NLT No later than NPTLOX Next-Generation Portable Therapeutic Liquid Oxygen OCONUS Outside the Continental United States OCI Organizational Conflict of Interest OEM Original Equipment Manufacturer PM Program Manager POC Point of Contact PTLOX Patient Therapeutic Liquid Oxygen PWS Performance Work Statement RMA Return Material Authorization SOP Standard Operating Procedure SS Services Summary STF Safe-to-Fly TO Technical Order WAWF Wide Area Workflow

WRM War Reserve Materiel

7. ADDITIONAL SECTION HEADER

7.1. Attachment A - Serial Managed GFP Attachment

7.2. Attachment B - Contact Data Requirement List (CDRLs)

Attachment A - Serial Managed GFP Attachment

Attachment A is a separate attachment due to the size of the document.

Attachment B

Contract Data Requirements List (CDRLS)

CDRL / DID TITLE

CDRL / DID A001 CLIN Balance Monthly Status Report