36C26123Q0225.docx

Presolicitation Notice Presolicitation Notice

GENERAL INFORMATION

SET-ASIDE

Jarrett White Road

Honolulu HI

CONTACT INFORMATION

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

POINT OF CONTACT*

Contracting Specialist James Postell James.Postell@va.gov

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

PRESOLICITATION NOTICE: The Department of Veterans Affairs intends to solicit proposals for Hemodialysis Equipment Preventive Maintenance services from qualified quoters.

The Veterans Health Administration (VHA) VA Pacific Islands Healthcare System (VAPIHS) requires the contractor to complete inspections, testing, preventive maintenance and repairs for Hemodialysis Unit at Tripler Army Medical Center, Honolulu, HI 96859.

The Period of Performance will be for a Base year and four (4) one-year options. The anticipated start date will be on or near February 01, 2023. The Solicitation will be issued on an unrestricted basis and will be open to all qualified quoters. To be eligible for award the business shall be relevant under the NAICS code and must be registered. Potential offerors are advised that failure to register in the SAM database will render your firm ineligible for award.

The VA anticipates issuing a solicitation for this requirement on or about January 05, 2023. Quotes will be accepted commencing with the issuance date of the solicitation. Interested contractors will be responsible for downloading copies of the solicitation (and any subsequent amendments) from the www.sam.gov website, as no hard copies will be made available. The solicitation will provide instructions to contractors about the quote submission process. Prospective contractors are encouraged to register their interest in the solicitation on the www.sam.gov website so that they are notified of the issuance of the solicitation and any amendments. In accordance with FAR 52.204-7, System for Award Management (SAM) prospective contractors must be registered in SAM to be eligible for award. SAM registration is required under the applicable NAICS Code.

PSC: F103- Environmental System Protection-Water Quality Support NAICS: 811210 – Electronic and Precision Equipment Repair and Maintenance Size Standard: $30 Million The Request for Quotes (RFQ) solicitation will be posted on Contracting Opportunities.

This Pre-Solicitation Notice is NOT a request for submittals of any kind. The VA plans to issue the RFQ.

Statement of Work:

Full-service Maintenance & Repair for the Fresenius 2008T Dialysis machines and associated portable Marcor Reverse Osmosis units:

Contractor shall provide all labor, material, and equipment to perform the following services:

a) Complete inspection, testing, preventive maintenance (PM) and repairs for the following Fresenius Hemodialysis machines and portable reverse osmosis (RO) units listed in the table below. This equipment is at the Department of Veterans Affairs Dialysis Clinic in room 4G-109 at the Tripler Army Medical Center (TAMC) Honolulu, Hawaii.

b) Maintenance, inspection, testing, and repair services shall be performed by a manufacturer’s representative with at least four (4) years’ experience with a certification in the inspection, testing, maintenance, and repair of the subject dialysis equipment. Maintenance, inspection, and testing of subject equipment and system will be required for a base year of February 1, 2023, thru January 31, 2024, and four (4) one-year options. The contractor shall furnish all tools, equipment, test instruments, cleaning materials and parts required. All work shall be performed to meet requirements of the Department of Veterans Affairs (VA), clinical dialysis standards, The Joint Commission Accreditation (JC) and other applicable code standards.

c) Work is to be performed year-round Monday through Saturday between the hours of 6:00 AM and 5:00 PM, exclusive of Federal holidays (New Year’s Day, Martin Luther King Day, Washington’s Birthday, Memorial Day, Juneteenth, 4th of July, Labor Day, Columbus Day, Veteran’s Day, Thanksgiving Day, and Christmas Day). Where equipment use schedule does not permit preventive maintenance inspections during such times, the inspections will be scheduled during other mutually acceptable hours. The Contractor shall respond to service calls at the VA facilities no later than the following schedule:

Emergency/Urgent Repairs: An emergency repair shall be defined as one in which any portion of equipment is shutdown or is inoperable due to breakdown, malfunction, or any other condition determined by the COR or authorized Government inspector that presents an immediate danger to personnel or threatens to impair the mission of the facility. A technician shall be on the site ready to service the equipment within two (2) hours of receiving a request for emergency service call, 24 hours a day, 7 days a week. After receiving a request for emergency service, the work shall be prosecuted continuously until the emergency situation is arrested. In some cases, overtime rate will apply and will be billed separately.

Routine Repair: Service at the site within the next normal workday after the Contractor has been contacted for service. Examples of routine repairs includes Minor leaking seeping or weeping, power fluctuation affecting the system, and/or clogged filters. The work is done during regular working hours at no additional cost to the Government. Shutdown of any portion of any system regardless of duration shall be coordinated through and approved by the VA Dialysis clinical staff and/or VA Facilities Management/Engineering staff.

Contractor shall respond only to calls for service placed by the following VA personnel:

1. VA Dialysis Lead Technician

2. VA Facilities Biomedical Section, telephone 808-433-0553 / 0584, or

3. VA Contracting Officer Contractor shall provide all resources required in performing these maintenance services and inspections, including, but not limited to, parts, materials, cleaning fluids, equipment, tools, shipping, travel, and labor. Contractor is responsible to determine the nature and extent of any work required to restore equipment to satisfactory condition and operation, replacing parts if conditions warrant. All service, maintenance, inspections and testing will be in accordance with manufacture requirements. The Contractor shall submit a detailed description of the procedure to be followed in performing preventive maintenance. The Contractor shall provide completed documents of all preventive maintenance, testing, inspection, and repairs to the Department of Veterans Affairs.

The Contractor in accordance with the Department of Veterans Affairs policies and procedures shall complete documentation of all preventive maintenance and repair for The Joint Commission Environment of Care Accreditation standards. Any additional documentation required in preparation for the Joint Commission (JC) inspections shall be provided by the contractor at no additional cost to the government.

Contractor shall have a comprehensive inventory of parts and components for all equipment covered under the contract, where parts are immediately available for necessary repairs in order to limit equipment downtime.

Payment will be made for the specified monthly billing period after receipt of a properly prepared invoice, provided all required work, including preventive maintenance, has been performed in accordance with contract.

The Contractor shall take all precautions necessary to protect persons and property from injury or damage during the performance of this contract. Contractor shall be responsible for any injury to any Contractor’s representative, or others, as well as, for any damage to personal or public property that occurs during the performance of this contract that is caused by the Contractor’s fault or negligence.

Requirements related to the Joint Commission (JC) The Contractor shall meet and/or exceed the requirements set forth by JC Management of the Environment of Care standards (EC) and other related documentation required by the VA facility. The JC Ambulatory Care Manual Environment of Care Standards (EC) includes; Standard EC.6.20 - Medical Equipment is maintained, tested, and inspected.

Exclusions Repair costs due to abuse, misuse, biological, chemical, radiological contamination requiring decontamination, cleaning, mishandling, defective accessories, fire, flood, power outage, human error, environmental changes, water or moisture, war, or acts of God are not covered by this contract.

Consumables, electrodes, user serviceable parts, equipment biological testing, biological disinfection, installation/replacement of reverse osmosis filter membrane, activated carbon or inlet filter.

Government Evaluation and Monitoring The dialysis center staff will evaluate and monitor hemodialysis machine performance and conduct testing to include results during and after patient treatments. The Government will verify that each dialysis machine meets clinical requirements and conduct follow-up bacteriologic testing according to AAMI guidelines. The Government will inform the Contractor of any issues discovered for remedy by the Contractor. If the issue is deemed to be an emergency by the Government and patient safety is compromised, the Contractor shall use emergency response times defined in this SOW. The Biomed staff will assess the following throughout the life of the hemodialysis machines:

a. If changes to the equipment occur, the Contractor shall re-baseline and perform requisite testing to ensure patient safety and machine functions to meet specifications;

b. Results of government evaluation and monitoring;

c. Hemodialysis machines continue to operate according to manufacturer’s specifications and AAMI guidelines;

d. The machines are safe and continue to remain safe for patient treatment (e.g., product recalls, FDA recalls, et al);

e. The hemodialysis machines continue to support Dialysis Center operations and to meet the operating capacity;

Documentation Requirements The Contractor shall provide the documentation identified in Table 4 below. The Contractor shall deliver the documents in electronic (e.g., searchable PDF, Microsoft Office application such as Word or Excel) and/or hard copy (e.g., bound or notebook) formats as specified below.

Table 4. Hemodialysis Machines, Management Software and Maintenance Documentation Requirements

Contract Reporting

Contract Management Reports; Quarterly Reports;

Tracking and management reporting

Submit the first quarterly report on the 15th day after the first full quarter after contract award. Submit monthly on the 15th day of each quarter thereafter.

Contractor format is acceptable.

CO

(Electronic only Excel)

Delivery Order Reporting

Hemodialysis Machines; Operator and User’s Guide and Procedures

Submit hard copies for each site with the equipment delivery. Submit electronic copies and updates per machine if integrated into machine function.

Contractor format is acceptable.

COR

(Electronic only Excel)

Hemodialysis Machines;

Baseline Test Reports; and FDA 510 Certification documentation.

Certification that the hemodialysis machine meets all specifications and is safe to use for patient treatments

Submit no later than 4 hours after the successful conclusion of baseline testing for each hemodialysis machine.

Contractor format is acceptable.

Dialysis Center (One hard copy and one electronic copy)

COR (site) (Electronic only)

Hemodialysis Machines; Service Reports

Warranty and Full-Service Maintenance

Submit each time any maintenance action is performed for any hemodialysis machine.

Submit NLT four (4) hours after action is completed.

Contractor format is acceptable.

Dialysis Center (One hard copy or electronic copy)

COR

(Electronic copy only)

Hemodialysis Machines;

Complete Service manual and factory level service/repair documentation.

Contractor format is acceptable.

COR

(Electronic copy only)

Equipment Trade-in and Disposal In the event the Government requests to trade-in a previously purchased hemodialysis machine as part of a purchase transaction for a new hemodialysis machine and the Contractor agrees to take such trade, the Contractor and Government will determine fair and reasonableness of the Trade-in Value prior to the issuance of the Task Order. The Contractor shall remove and dispose of any existing hemodialysis machines identified in the Delivery/Task Order under the Contract Line-Item Number (CLIN) "Consideration for Trade-in."

Subcontracting Plan Contractor shall comply with Subcontracting Plan. If Contractor is unable to meet Subcontracting goals, the Contractor shall contact the Contracting Officer and identify reason(s) why the Contractor is unable to meet Subcontracting goals. The Contracting Officer and Contractor will reassess and establish new Subcontracting Plan if needed.

Government Furnished Property/Equipment/Information

The Contractor shall provide all equipment, tools, facilities, supplies, parts, and materials to perform the tasks in this SOW. Government furnished property, equipment or information are not required for this effort.

CONFIDENTIALITY AND SECURITY

Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

Presolicitation Notice