SOW - FY25 Zoll Defibrillator Procurement.pdf

Phoenix Area IHS – Zoll Defibrillators

Statement of Work

Project Title: Zoll Medical Corp Defibrillator FY25 Procurement

1. Introduction and Background

The Indian Health Service (IHS), Phoenix Area Office (PAO) Department of Acquisition Management (DAM), is procuring for a Contractor to provide equipment and technical services necessary to install new Zoll Mecial Corp defirbilaltors at Phoenix Indian Medical Center, Parker Indian Health Center, Hopi Health Care Center, Peach Springs Health Center, Irene Benn Health Clinic (Moapa), and Chemehuevi Clinic. This purchase includes procurement, delivery, assembly, installation, and inspection of new Zoll defibrillators by an Original Equipment Manufacturer (OEM) certified installer and authorized dealer. All requested equipment is the same brand and quality found in other Phoenix Area IHS service units in order to keep all defibrillators universal. Procurement of the Zoll equipment and accessories aids the local Biomedical Engineering department’s ability to fulfill maintenance requirements and reduces the clinician burden of new training requirements. The current Zoll defibrilaltors have reached the end of use lifecycle and new equipment is required to provide patient care in the most current standard of care settings as recommended by the American Heart Association (AHA) and The Joint Commission (TJC).

2. Service and Equipment Requirements

The Contractor shall provide Zoll Medical Corp certified personnel to perform comprehensive on-site visits to the service units in order to install new defibrillators. The Contractor installation team shall possess active Zoll Medical Corp training certification indicating the installers have received authorized dealer/partner technical training. The Contractor shall provide all test equipment, tools, labor, supervision, parts, travel, and any other items deemed necessary to fulfill the requirements of this statement of work. All equipment shall be installed without unapproved modifications to the existing structure or utilities. Specific tasks and requirements include the following:

2.1 – Zoll Defibrillator Equipment Procurement, Delivery, and Installation:

The Contractor shall procure, install, and configure all new Zoll defibrillators. The Contractor shall deliver, install, and certify all defibrillators and accessories to fully comply with all relevant Zoll installation criteria and technical standards. All equipment and accessories shall be new condition, Zoll Medical Corp factory assembled/configured, and include a factory warranty. Remanufactured items or items procured through non-authorized channels (gray market) will not be accepted. The Contractor shall warrant all workmanship with standard industry warranty. It is the Contractor’s responsibility to unload, unpack, and uncrate all equipment/cabinetry and properly remove and dispose of packing material. The Contractor shall ensure no packing materials remains on the premises. The Contractor shall remove the wrapping, transport, and physically install the defibrillators at the requested location. The Contractor shall assemble, install/adjust, and test the Zoll defibrillators to ensure proper operation and electrical safety. The Contractor is responsible for the repair and/or replacement of any damaged, defective, broken, or missing item/part/accessory. A complete list of all Zoll defibrillator equipment and services (including options/accessories/configurations) required in this procurement is listed in Section 14 – Zoll Defibrillators and Services. The Contractor shall provide and install the following Zoll defibrillators and services:

2.2.1 Zoll R Series Plus Defibrillator – Quantity 21

2.2.2 Zoll SurePower Rechargeable Lithium lon Battery Pack– Quantity 21

2.2.3 Zoll R WiFi Card with Clock Sync and FIPS - Quantity 21

2.2.4 Zoll AED 3 BLS – Quantity 36

2.2.5 Zoll AED 3 Fully Recessed Wall Cabinet – Quantity 28

2.2.6 Zoll CPR Uni-padz Universal (Adult/Pediatric) Electrodes – Quantity 39

2.2.7 Zoll AED 3 BLS Trainer – Quantity 2

2.2.8 Zoll AED Simulator – Quantity 1

2.2.9 Zoll Training/Demonstration CPR Uni-Padz – QTY 2

2.2.10 Customer Site Biomed Technical Training (2 Day), R Series

2.3 – Zoll Defibrillator Inspection and Performance Testing:

The Contractor shall test all Zoll defibrillator equipment after installation to confirm proper operation in accordance with OEM requirements. Zoll Medical Corp certified installers shall perform calibrations and function testing of the defibrillators. Phoenix Area Indian Health service will accept the equipment once installation and successful verification testing has been completed and approved.

2.4 – Zoll Defibrillator Clinical Training:

The Contractor shall provide on-site orientation and end-user training to the clinical department staff upon final installation.

2.5 Zoll Defibrillator Biomedical Training:

The Contractor shall provide on-site biomedical training to the biomedical engineering department staff upon final installation.

2.5 Trade-In/Removal of Existing Defibrillators

The Contractor shall coordinate with the local biomedical equipment support specialist and property technician to ensure the existing defibrillator equipment is correctly routed for removal from patient care areas. Electrical components (circuit boards, cabling, etc.) shall be recycled as electrical salvage while metal components (aluminum, brass, iron, etc.) shall be recycled as metal salvage. The Contractor shall handle all biologically contaminated materials with care and follow the necessary safety precautions. All other material types unsuitable for recycling shall be removed from the premises and disposed of appropriately.

2.5 – Documentation of services performed and supporting documents The Contractor shall provide a detailed service report indicating services performed and include pertinent information such as equipment identification (serial number and model). Printed and digital copies of all packing slips, bills of lading, and other shipping documents shall be provided to the local Property & Supply department and Contracting Officer’s Representative (COR). The Contractor shall provide all supporting documents including service manuals, user manuals, and technical data sheets.

3. Contractor Requirements

The Contractor shall provide all needed supplies, OEM parts, materials, equipment, and tools that are necessary for the performance of the contract requirements. The Contractor shall be held responsible for the cost of any necessary repairs or equipment replacements caused by negligence and/o abuse on his/her part. The Contractor shall be responsible for the cost for safeguarding all Government property that will be serviced under this contract. The Contractor shall hold active liability insurance covering faulty workmanship, negligence, and deliberate or non-deliberate acts that jeopardize the health and safety of patients and/or Government employees. The rules of law governing such incidents or actions shall prevail.

The Contractor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor, or authorized Contractor reseller for the proposed equipment/system such that the OEM warranty is supported and maintained by the OEM. The Contractor shall be OEM authorized/certified to service the required Zoll equipment/cabinetry throughout the lifecycle of the contract.

4. Reporting Requirement and Deliverables

6.1 Service Reports: The Contractor shall instruct its service representatives to obtain a signature from the COR or designee official responsible for the equipment upon completion of the installation and on-site training. A copy of the signed service report shall be left with the COR or designee official responsible for the Zoll defibrillators. The Contractor shall also forward copies of the Installation and Testing Service Reports to the COR by the 7th business day after service is performed. However, Emergency Maintenance Service Reports shall be forwarded to the COR within 10 business days after completion of the service. At a minimum, Service Reports should include the following information:

6.1.1 Device type

6.1.2 Model Number

6.1.3 Serial Number

6.1.4 Manufacturing Date

6.1.5 Configuration/settings on device

6.1.6 Serial Number, Make, Model and Last Calibration Date of all Test, Measurement, and

Diagnostic Equipment (TMDE) used. All equipment shall be NIST traceable.

6.1.7 Testing Results

6.1.8 Technician Comments.

6.2 Original Equipment Manufacturer’s Supporting Documentation

6.2.1 The Contractor shall provide hard copies and digital copies of the latest versions of the manufacturer’s manuals for operation, maintenance, inspection, and repair. Documents shall include User’s Manuals, Service Manuals, Operator’s manuals, etc.

6.3 Invoices: The Contractor shall submit an original invoice in the Invoice Processing Platform (IPP). The invoice must include the following information:

6.3.1 Name and address of the Contractor;

6.3.2 Invoice date and number;

6.3.3 Dates of service/delivery;

6.3.4 Contract number, line item number and, if applicable, the order number;

6.3.5 Description, quantity, unit of measure, unit price and extended price of the items delivered;

Device information shall include the following: Device Type, Model Name/Number, Serial Number, Manufacturing Date

6.3.6 Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading; Manufacturer make/model and serial number information is required for all equipment procured and/or serviced.

6.3.7 Terms of any discount for prompt payment offered;

6.3.8 Name and address of official to whom payment is to be sent;

6.3.9 Name, title, and phone number of person to notify in event of defective invoice; and

6.3.10 Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract.

6.3.11 Electronic funds transfer (EFT) banking information.

6.3.12 The Contractor shall include EFT banking information on the invoice only if required elsewhere in this contract. If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the Contractor shall have submitted correct EFT banking information in accordance with the applicable solicitation provision, contract clause (e.g., 52.232-33, Payment by Electronic Funds Transfer— System for Award Management, or 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management), or applicable agency procedures. EFT banking information is not required if the Government waived the requirement to pay by EFT.

6.3.13 Invoices will be handled in accordance with the Prompt Payment Act (31 U.S.C. 3903) and Office of Management and Budget (OMB) prompt payment regulations at 5 CFR part 1315.

6.4 Training: The Contractor shall schedule and provide operator and in-service training for the clinical staff and biomedical engineering staff. The following in-service trainings shall be provided by the Contractor:

6.4.1 Provide operational and problem identification training to clinical staff on-site

6.4.2 Provide biomedical training on maintenance and repair procedures to biomedical engineering staff

6.4.3 Available Zoll training resources such as operator’s guides and quick reference sheets shall be provided in hard copies and digital copies.

5. Conformance standards

The Contractor shall install and service the Zoll defibrillators covered by this contract in accordance with the following standards:

7.1.1 Original Equipment Manufacturer’s (OEM) specification requirements

7.1.2 American Heart Association (AHA)

7.1.3 National Fire Protection Association (NFPA) 99 (2012 Edition), 101 (2012 Edition), 70E (2012 edition)

7.1.4 The Joint Commission Standard (EC.02.04.03)

7.1.5 Association for the Advancement of Medical Instrumentation (ANSI/AAMI EQ56:2013))

7.1.6 ISO Technical Committee 106-Dentistry (ISO/TC 106) recommendations

7.1.7 Occupational Health and Safety Association

7.1.8 Federal, Tribal, and local regulatory guidance and ordinances in regards to bio hazardous waste, disposal, and applications

6. Inspection and Acceptance Criteria

The Government will monitor the Contractor’s performance under this contract and shall retain the right to perform unscheduled inspections, as it deems necessary. Furthermore, the Government retains all rights provided by the FAR (Federal Acquisition Regulations) clause entitled “Inspection of Services – Fixed Price” and any other inspection clause, which may be specified in the contract. The Government will conduct an acceptance inspection following the completion of the Zoll defibrillator equipment installation. The inspection will be performed by the Biomedical Engineering staff.

Contractor shall correct any deficiencies noted within 30 days following the inspection.

The Contractor shall investigate all deficiencies, complaints, and suspected issues involving services performed that do not conform to the expectation listed within the Statement of Work. In the event an identified issue is not remediated in a timely manner, an independent qualified consultant shall be retained at the Contractor’s expense.

The COR will monitor the Contractor’s activities and accomplishments and will indicate acceptance or non-acceptance of the deliverable. The Contractor shall correct discrepancies within 10 calendar days. The deliverables identified within this Statement of Work will be inspected and either approved or, if they are not acceptable, rejected by the COR. The Contractor shall establish an inspection system covering the equipment stated in this Statement of Work. The Contractor shall maintain a history file on all deinstallation s, installations, testing, repairs, relocations and inspections conducted. The history file shall be the property of the Government and shall be maintained by the Contractor and turned over to the COR upon completion of the contract.

7. Schedule and Notification, Government Responsibility

The contractor shall provide all services during normal operating hours Monday through Friday from 8:00 a.m. to 4:30 p.m. during the week, unless otherwise specified by the COR. Any deinstallation or installation services outside of the normal work schedule shall be arranged with the facility Point of Contact at no additional expense to the Government in the event the project is delayed at the fault of the ContractorThe Contractor personnel shall check-in with the Biomedical Engineering Department or Facilities Engineering Department before beginning any work. Contractor shall call or email Service Unit staff and coordinate with the department leads during project implementation. The Contractor shall acquire approval for all scheduled dates for services and deliveries, no less than one (1) week in advance.

Contractor shall comply with IHS visitation policy.

10.1 Before performing services the Contractor personnel shall report to the local Facilities Engineering or Biomedical Engineering Department at the beginning and end of their entire visitation at the facility, to sign-in and receive a facility “Guest” badge.

10.2 The Contractor shall report to the Facilities and/or Biomedical Department at the beginning of each visitation for a wellness screening prior to start of work due to COVID-19 response. The Contractor’s personnel shall comply with all visitation requirements prior to entering the facility.

10.3 The Contractor shall be authorized to park only in areas opened to the public.

10.4 The Contractor shall be allowed minimal use of government space to store supplies and/or equipment as required under this contract.

10.5 The Contractor shall be responsible for any repair or damage incurred to the building system as a result of contractor errors or poor workmanship.

8. Performance Period

The Period of Performance for this contract is three months from the issuance of award.

9. Submission of Offer

The Contractor shall provide the following documentation with the submission of offer at the time of solicitation:

12.1 Zoll Medical Corp Authorized Distributor Letter and (Documentation confirming Contractor is OEM authorized dealer/installer)

12.2 Information detailed in submitted offer shall include clear description of equipment and services by line item (Reference Section 14):

12.2.1 Zoll defibrillator equipment information (Manufacturer Item #, Device Description, Quantity, and Cost)

12.2.2 Description of all delivery/transport, installation, clinical training, and biomedical training services

12.2.3 Warranty and support provisions: Information on all parts and labor provided by the Contractor post-installation and time period of coverage.

10. Location

The Contractor shall deliver all equipment and services to the following location:

13.1 Phoenix Indian Medical Center

4212 N 16th St Phoenix, AZ 85016

13.2 Hopi Health Care Center

Highway 264 Mile Post 388 Polacca, AZ 86042

13.3 Parker Indian Health Center

12033 W Agency Ave Parker, AZ 85344

13.4 Irene Benn Health Clinic (Moapa):

#10 Lincoln Street Moapa, NV 89025

13.5 Chemehuevi Clinic

1970 Palo Verde Drive Havasu Lake, CA 92363

13.5 Peach Springs Health Center:

943 Hualapai Way Peach Springs, AZ 86434

14. Zoll Defibrillators and Services

The Contractor shall procure, deliver, and install all Zoll defibrillators and accessories and provide all services listed in the table below. The Contractor shall reference all Zoll Medical Corp Manufacturer item numbers in the submission of offer at the time of solicitation.

Technical Specifications - Zoll Defibrillators

Item Quantity Equipment Description (Including Options/Accessories/Configurations)

Zoll R Series Plus Defibrillator 21 Zoll Medical Corporation R Series Plus Defibrillator (Part

#30520007201310013) Zoll SurePower Rechargeable Lithium lon Battery Pack

21 Zoll Medical Corporation SurePower Rechargeable Lithium lon Battery Pack (Manufacturer Part 8019-0535-01)

Zoll R WiFi Card with Clock Sync and FIPS 21 Zoll Medical Corporation R WiFi Card with Clock Sync and FIPS

(Manufacturer Part #8005-000103-01)

Zoll AED 3 BLS 36 Zoll Medical Corporation AED 3 BLS Hospital Package (Manufacturer Part #8503-001103-01)

Zoll AED 3 Fully Recessed Wall Cabinet 28 Zoll Medical Corporation AED 3 Fully Recessed Wall Cabinet

(Manufacturer Part #8000-001258) Zoll CPR Uni-padz Universal (Adult/Pediatric) Electrodes

39 Zoll Medical Corporation CPR Uni-padz Universal (Adult/Pediatric) Electrodes (5 Shelf Life) (Manufacturer Part #8900-000280-01)

Zoll AED 3 BLS Trainer 2 Zoll Medical Corporation AED 3 Trainer (Part #8028-000001-01)

Zoll AED Simulator 1 Zoll Medical Corporation AED Simulator (Part #8000-000925)

Zoll Training/Demonstration CPR Uni-Padz

2 Zoll Medical Corporation Training/Demonstration CPR Uni-Padz (Part #8900-000284)

Customer Site Biomed Technical Training (2-day), R Series

3 Zoll Medical Corporation Customer Site Biomed Technical Training (2-day), R Series (Manufacturer Part #8777-005022)

Deinstallation of Existing Equipment 1 Trade-in and removal of existing, end-of-life Zoll defibrillators.

Delivery and Installation Services 1

Delivery, transport, assembly, installation, calibration, and initial inspection testing of the new Zoll Medical Corporation defibrillators. Technician service report shall be provided upon completion of installation and testing.

Service report shall include the following required information: Model Number, Serial Number, Manufactured Date

Original Equipment Manufacturer’s Supporting Documentation

The Contractor shall provide hard copies and digital copies of the latest versions of the manufacturer’s manuals for operation, maintenance, inspection, and repair. Documents shall include User’s Manuals, Service Manuals, Operator’s manuals, etc

Post-Installation Training and Configuration

1 Onsite training provided to clinical staff after final inspection and configuration.

Equipment Condition: The Offeror shall provide certification at the time of solicitation that indicates the Offeror is a fully authorized distributor/dealer for all products/services listed. If the Offeror is not the original equipment manufacturer (OEM), the products distributed to the Offeror by the OEM shall be guaranteed to be safe, maintained in adequate storage conditions, and that any/all warranties and services and/or preventative maintenance agreements are transferred and will be honored by the OEM. No gray market, counterfeit or adulterated devices shall be accepted.