Preventive Maintenance for Propaqs - MD Defibrillators

Added: Aug 26, 2016 6:00 pm The U.S. Department of Health and Human Services (HHS), Office of the Assistant Secretary for Preparedness and Response (ASPR), Washington, D.C. Metropolitan Area, intends to award a firm-fixed-priced sole source requirement contract in accordance with the satatutory of 10 U.S.C. 2304(c)(1) as implemented by FAR 6.302-1, Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements to Impact/Zoll, 27 Fairfield Place, West Caldwell, NJ 07006-6206. The NAICS code for this procurement is 811219 with a size standard not to exceed 20.5 million. The requirement is for preventive maintenance services on Impact brand Ventilators, Aspirators, and Zoll Propaq-MD Defibrillators used by the Office of Emergency Management (OEM) under the Department of Health and Human Services (HHS). The OEM uses the Impact and Zoll biomedical equipment in emergency response efforts throughout the United States. These items require Preventive Maintenance to ensure they are at a constant state of readiness so they can be utilized at a moment's notice. Impact/Zoll is the only vendor providing this service as the manufacturer does not allow other parties to provide the Preventive Maintenance services to their Government and military customers and they have no authorized resellers or dealers. This proposed contract action is for services which the Government intends to solicit and negotiate with only one source under the authority of FAR 6.302-1, ‘Only One Responsible Source and No Other Supplies or Services will Satisfy Agency Requirements.'

Interested Persons may identify their interest and capability to respond to the requirement or submit proposals to be used for consideration of future requirements. THIS NOTICE IS NOT A REQUEST FOR COMPETITIVE QUOTES and no solicitation will be issued, however, all proposals received by the closing date and time will be reviewed and used for future requirements. Supporting evidence must be furnished in sufficient detail to demonstrate the ability to comply with the requirements of this notice/ Statement of Work (SOW) listed. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement for a future requirement. Any vendor who wishes to submit a proposal for future consideration should email their company's capabilities information to the attention of Ms. Minnie Wright, @ minnie.wright@hhs.gov no later than 12:00 Noon, EST, September 09, 2016. Only email responses will be accepted.

Statement of Work

Purpose:

The purpose of this contract is to maintain the preventive maintenance program for the #97 Propaq-MD defibrillators (with the ability to increase additional #60 units on the option years), #150 Impact Uni-Vent Model 754 ventilators, and #260 Impact Model 321 aspirators located in the DMAT caches and kits. These ASPR caches and kits are located in sites geographically linked to the DMAT locations and the ASPR Logistics Centers. The equipment needs an annual preventive maintenance program to keep them in a state of constant readiness for deployment.

Background:

The Department of Health and Human Services (HHS), Office of the Secretary (OS), Office of the Assistant Secretary for Preparedness and Response (ASPR), Office of Emergency Management (OEM) is responsible for ensuring HHS meets its Primary Mission Essential Functions while meeting requirements in leading US Government efforts for Emergency Support Function (ESF) 8, Public Health and Medical Services. The ASPR/OEM Division of Logistics is the lead element for maintaining all caches, equipment and logistics systems and capabilities.

Scope of Work:

There are #97 Propaq-MD defibrillators, #150 Impact Uni-Vent Model 754 ventilators, and #260 Impact Model 321 aspirators that require annual preventive maintenance, to include annual inspection and required service, recalls, software updates, or any other issue pertaining to the equipment. Fees for the annual inspections do not cover any repair costs that may be discovered on its annual inspection. The contractor will maintain documentation, listed per NDMS site, of the model #, serial numbers, and on site repairs and inspections. This will provide documentation for emergency notification if there is a recall of the affected equipment.
Propaq-MD Defibrillator Preventive Maintenance and Calibration
• Each Preventive Maintenance will include:
1. Clean all exterior surfaces of unit
2. Perform visual inspection to ensure integrity of the unit
3. Test power supply, ECG, pacer outputs and rates, defib times and output energy
4. Test of MFC functions
5. Test real time clock of the system
6. Perform operational check of all system level functions per device Service Manual
7. Perform CO2 and NIBP calibration
8. Recertify device for clinical use

Impact Uni-Vent Model 754 Ventilator Preventive Maintenance and Calibration
• Each Preventive Maintenance will include:
1. Visual inspection of all boards
2. Inspect and clean valves
3. Full hardware calibration
4. Computer calibration
5. Replace Leaf Valve Part #490-0005-00
6. Replace Pumphead Gasket Part# 340-0049-00
7. Replace Compressor Air Inlet Filter Part# 465-0012-00
8. Replace Copper Shielding Tape Part# 312-0073-00
9. Full functional/operational testing and burn in
10. Replace Battery Pack Part#704-0754-01
11. The PM in year 4 and year 5 includes all of the above plus the replacement of the ventilator(s) Lithium Ion battery and the internal real time clock battery

• This annual preventive maintenance will also satisfy the FDA's requirements for tracking of life saving/support devices. When the contractor performs the inspection it will record serial numbers and the physical address of the ventilators. This will provide documentation for emergency notification if there is a recall of the affected equipment.
• Fees for the annual inspections do not cover repair costs that may be discovered on the annual inspection. Any additional problems found in the PM visit are charged per part and per hour labor rate.
Impact Model 321 and 326 Aspirator Preventive Maintenance and Calibration
• Recharge/Replace battery pack for a period of not less than 10-hours (continuous).
1. If battery is less than 3 years old - Recharge
2. If battery is over 3 years old - Replace
• Check battery voltage (under full vacuum) after recharge or replacement.
• Perform operational, maximum vacuum and free airflow tests.
1. Operational and maximum vacuum - Turn unit on, occlude patient fining on collection canister (connect to RT-200 or equivalent). Verify presence of vacuum and record maximum vacuum reading. Pass if reading is greater than 550mmHg.
2. Free Air Flow - Connect RT-200 or equivalent to "Patient" fitting, turn unit on. Measure and record free airflow reading. Pass if reading is greater than 30 LPM.

• Fees for the annual inspections do not cover repair costs that may be discovered on the annual inspection. Any additional problems found in the PM visit are charged per part and at per hour labor rate.

Specific Requirements:

1. The Contractor shall meet with the Project Officer within one (1) week after the contract award to discuss setup, approach, and scheduling of efforts to fulfill this SOW.
2. The Contractor shall submit to the Project Officer the schedule for inspection visits.

Personnel Requirements:

The personnel employed by the Contractor shall be qualified to do all work covered by the SOW.

Place of Performance:

The Contractor shall provide the service at the MSC warehouses where the units are located or at the Contractor's service depot.

Point of Contact:

Minnie Wright, minnie.wright@hhs.gov