Attachment 1_Biomed_SOW.pdf

Solicitation Number: 75A50223R00002

ATTACHMENT 1

NDMS Biomedical Maintenance

Statement of Work

BACKGROUND

The mission of the U.S. Department of Health and Human Services (HHS) Administration for Strategic Preparedness and Response (ASPR) is to ensure the availability and rapid deployment of life-saving pharmaceuticals, antidotes, other medical supplies, equipment, and support infrastructure of the National Disaster Medical System (NDMS) to counter the effects of a medical disaster. When state, local, tribal, and territorial responders request federal assistance to support their response efforts, NDMS ensures that the right medicines, supplies, and support resources get to those who need them most during an emergency.

ASPR 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/Division of Logistics is the lead element for maintaining all caches, equipment and logistics systems and capabilities.

PURPOSE

U.S. Department of Health and Human Services, Administration for Strategic Preparedness and Response has a need for a comprehensive preventative maintenance (PM) program of NDMS medical equipment and non-medical equipment.

The purpose of this contract is to establish an Indefinite Delivery/Indefinite Quantity (IDIQ) that allows for a robust preventative maintenance program. ASPR requires a wide variety of equipment that is purchased then subsequently housed in caches/kits that are maintained by ASPR in preparation for a disaster. During a disaster, ASPR may require the use of this house equipment. Therefore, the purpose of this contract is to ensure this equipment is operational. This contract ensures preparedness for use when an event occurs.

REQUIREMENTS – SCOPE OF WORK

Contractor shall provide preventive maintenance capabilities, (such as but not limited to: expertise, labor, material, equipment, and certified technician). This equipment is contained within kits, caches, sets, and in general inventory. The type and quantity vary yearly due to such things as funding availability, mission change, change to cache components, lease vs. purchasing. Because of such, the IDIQ contract award shall reference the maximum number of items that could be serviced while each preventive service activity shall be task order issued for the inventory needing service. The Contractor shall allow for flexibility to accommodate for slight changes to the equipment and equipment list such as manufacturer, model, serial number, quantity needed, etc. Items of a different model that are of similar type, functionality, and complexity may be added to the contract and serviced under established Contract Line Item Numbers (CLINs) and LOT numbers.

Written confirmation shall be provided to the Government upon completion of maintenance activities for each ASPR facility.

Equipment devices requiring services are listed below.

Equipment Manufacturer Total

Unit Price

Total

Propaq MD (all models) Zoll 232

Ventilator, EMV+ 731 Zoll 160

Aspirator, 330 Multifunctional Zoll 52

Multi-Therapy Single Channel IV Pump

Sapphire 432

GlideScope Go Video Laryngoscope Verathon 142

Buddy Lite Fluid Warmer Belmont Medical 42

Fabius Tiro M Anesthesia Machine Draeger 8

Vamos 2 Draeger 8

Vapor 2000 Sevoflurane Draeger 8

Gomco G-180 Optivac Aspirator Allied Healthcare Products 206

Vscan Extend Handheld Ultrasound GE 160

Sonosite Edge II Ultrasound System Fujif ilm 8

M-11 UltraClave Midmark 8

Cautery, Electrosurge Unit Midmark 8

Intra-Compartmental Pressure Monitor System, Stryker

Midmark 4

Complete Portable Medical X-ray System Package HF120/60HPPWV PowerPlus

MXRSLW 6

Full Body X-Ray unit Beam limiting device, R-72/32D

Ralco 6

Portable MinXray Apparatus HF120/60HPPWV PowerPlus w/ Tube

SXR-130-15-1.2

MXRSLW 1

Portable Collimator, CPL125MX01-C Collimare 1

Cocoon, gun type light weight portable x-ray unit, DX7017

Dexcowin 6

Aribex X-Ray Gun, NOMAD DENTAL Nomad 9

Refrigerator, Portable (45 Liter) FridgeFreeze 3

Refrigerator, Portable (60 Liter) FridgeFreeze 53

Refrigerator, Portable (100 Liter) FridgeFreeze 4

PortaCount, 8048 TSI 12

Microscopes MicroMaster, Motic B series, Olympia

Most equipment will be assigned to specific sets or caches for inventory and tracking purposes. Some devices may require an Alternative Maintenance Program to meet the ASPR storage, readiness, and operational requirements.

TECHNICAL REQUIREMENTS

A. The contractor shall provide preventive maintenance (PM) (such as but not limited to cleaning, periodic inspections, testing, calibrations, charging, repackaging, and necessary part replacements) in accordance with the latest version of the original equipment manufacturer (OEM) service manual. The contractor shall perform required function checks and maintenance to ensure the readiness of equipment for rapid deployment. Government logistics personnel shall make efforts to ensure equipment is readily accessible to the contractor, as each location varies in its size and layout. The contractor shall initiate and complete any required corrective actions according to this statement of work and the terms of the contract. Tasks include, but may not be limited to, the following: replace defective batteries or as required (battery replacement annually or biennially for GlideScope video laryngoscope, Gomco G-180 aspirator, and Sapphire IV pump), check device power access (AC/wall power and connect battery power), visually inspect equipment for damage, check equipment light indicators and message/data indicators on equipment to ensure proper operation, turn devices on/off, press buttons, and turn knobs to verify proper operation, and verify that refrigerators/freezers are operating at the proper temperature.

1. The Contractor shall ensure that all test equipment and/or calibration standards, which are to be used in the performance of this contract, are traceable and certified in accordance with National Institute of Standards and Technology (NIST). Upon request by the Contracting Officer Representative (COR), the Contractor and/or service vendors shall provide a copy of the current calibration certification of all test equipment to be used, or which has been used.

2. Laboratory equipment must be serviced and have documentation required for Clinical Laboratory Improvement Amendments (CLIA) certification or accreditation.

3. Sterilization and repackaging should be completed at Occupational Safety and Health Administration (OSHA) or other governmental health specifications.

4. Medical Grade Oxygen and tank testing/replacement shall follow all appropriate guidelines.

B. The contractor shall clearly define all proposed activities in response to this solicitation.

1. The contractor shall provide a proposed approach for each item for routine preventative maintenance and corrective maintenance for normal wear and tear and component part failures and perform function checks as described in operator manuals. All labor and parts shall be included. The contractor may group similar or like items. The contractor should consider the differences between a storage environment and an active environment when evaluating risk factors.

2. The contractor shall provide a separate proposed approach for emergency preventative maintenance and corrective maintenance for normal (or above) wear and tear and component part failures in the field.

3. Corrective maintenance for unintentional damage, operator error, operator abuse, environmental issues, missing parts or accessories, or similar circumstances shall be performed under a Time & Materials CLIN using contract pricing. The contractor shall provide detailed documentation of findings and include photographs or other information upon request. The contractor shall provide an estimate for review and approval by the Government before any services are conducted.

C. The personnel employed by the Contractor shall be trained and certified to do all work covered by the SOW.

1. Medical maintenance technicians shall perform function checks and maintenance that shall comply with applicable regulatory compliance pertaining to each piece of equipment to include but not limited to Code of Federal Regulations (CFR) Title 10 Part 20, CFR Title 21 Parts 800-1299.

2. Technicians for support equipment such as generators and environmental control units shall be trained and shall comply with applicable regulatory standards pertaining to each piece of equipment to include but not limited to National Fire Protection Association (NFPA), OSHA, and Environmental Protection Agency (EPA).

3. Specific to Zoll manufactured equipment, the Contractor shall complete all prescribed services either under subcontract to Zoll Medical Corporation or its subsidiary, for any proprietary equipment and associated components. Zoll has no authorized/certified third-party licensed to perform maintenance on Zoll proprietary equipment.

4. Contractor shall be licensed / authorized by product manufacturer to perform maintenance and preventative maintenance services on the items associated with this contract.

D. The place of performance by the contractor shall be at ASPR facilities, response sites, and/or the contractor’s facility depending on level of service and effort required. The contractor shall perform all work at ASPR facilities to reduce additional inventory transfer activities and issues. If the contractor determines that performing work at contractor facility is more advantageous to contract objectives, the contractor may submit a written request to the COR requesting off-site performance.

1. Major sites and Regional Field sites in the Continental United States

(CONUS)

▪ Frederick, Maryland

▪ Rancho Cordova, California

▪ Other regional as needed locations

2. Outside Continental United States (OCONUS)

▪ Hawaii

▪ Alaska

▪ Puerto Rico

GENERAL REQUIREMENTS

A. Kickoff Meeting

B. The Contract including product prices and other terms and conditions, may be deemed public information and may be releasable under the Freedom of Information Act (FOIA); however, due to the sensitivity of this procurement and the program it supports, it shall be treated as confidential and shall not be disclosed except as required by applicable laws and regulations. In addition, procurement related information, including negotiations, shall be treated as confidential and shall not be disclosed except as required by applicable laws and regulations.

C. If the contractor falls out of good standing with the government (i.e., System for Award Management (SAM) registration) and/or no longer has applicable registrations and licenses, the contractor must notify the Contracting Officer of this within five (5) calendar days. This includes all Federal, State, and local inspection that result in any findings (i.e., Food and Drug Administration).

OTHER REQUIREMENTS

Due to the nature and security of the customer and program, areas of ASPR pertaining to national security issues may be determined as non-releasable. The Contractor is required to classify all information under and/or pertaining to this solicitation and any resultant contract(s) as "Confident ial" and shall not release any information pertaining to this solicitation and any resultant contract(s) to unauthorized individuals. Should the contractor be contacted about their partnership with the government regarding this solicitation and its resulting contract(s), the contractor shall notify the Contracting Officer immediately.

The Contractor shall agree to sign a non-disclosure agreement (applicable and enforceable to all employees of the contractor), agree to not disclose any details relating to the contract, and hold all employees and/or subcontractors involved in the performance of this requirement to the same. At any time, the Government may request employees and/or subcontractors related to this performance to sign a non-disclosure. HHS Non-Disclosure forms shall be released to the awardees as part of their award package. The Contractor shall be responsible to adhere to the sensitivity concerns of the national security issues of this program and shall not share the programs information or its association with the government.

COMPLETION

Upon conclusion of the contract, the Contractor shall provide a final all maintenance history report. All Contractor records are to be retained for a maximum period of five (5) years from the date of the conclusion of this award and these records are to be destroyed upon the five-year anniversary date.