Statement of Work (SOW) Biomedical services 2025 revised.docx

STATEMENT OF WORK (SOW)

FOR

Provide Annual Inspections and Calibration of Biomedical Equipment for Base Portsmouth

1.0 GENERAL

1.1 BACKGROUND

The USCG utilizes various biomedical equipment to support operational readiness and ensure the health and safety of personnel. Regular inspection and calibration are essential for optimal performance, regulatory compliance, and the safety of all users.

1.2 SCOPE

The work shall be limited to the annual maintenance inspections and calibrations in accordance with manufactures recommendations of the medical, dental, and laboratory equipment listed on attachment (1). Any major maintenance and/or repairs shall be quoted and reported to the Contracting Officer (KO) and Quality Assurance Evaluator (QAE).

1.3 OBJECTIVE

The work involves providing all labor, materials, and equipment necessesary to perform annual maintenance inspections and calibrations in accordance with manufactures recommendations of medical, dental, and laboratory equipment at USCG Base Portsmouth Medical Clinic. This ensures optimal performance, regulatory compliance, and safety for all users.

1.4 APPLICABLE DOCUMENTS

In addition to contractor provided reports, all scheduled inspections, calibration and maintenance completed will be recorded on NAVMED_6700/3CG in accordance with COMDNTINST_M6000.1(series), enclosure (2).

2.0 SPECIFIC REQUIREMENTS/TASKS

· Conditions affecting the work: All bidders should visit the site and take such other steps as may be reasonably necessary to ascertain the nature and location of the work, the general and local conditions which can affect the cost of the work thereof. Failure to do so will not relieve bidders from responsibility for estimating properly the difficulty or cost of successfully performing the work. The government will assume no responsibility for any understanding or misrepresentations concerning conditions made by any of its officers or agents prior to the execution of the contract, unless included in the request for quotes, the specification or related documents. Interested parties shall make arrangements for a site visit with HS1 Gary Zuniga at 757-483-8596, Ext: 6756.

· Permits: The contractor shall without additional expense to the government, obtain all appointments, licenses, and permits required for the prosecution of the work. The contractor shall comply with all applicable federal, state and local laws.

· Clean up: All trash and debris shall be removed from the site daily. The job site shall be left in a clean and neat manner.

· The contractor shall provide the following services:

· Inspection of Biomedical Equipment: Conduct thorough inspections of all medical, dental and laboratory biomedical devices listed in attachment (1).

· Calibration Services: Ensure that all biomedical equipment listed in attachment (1) are calibrated according to the manufacturer’s specifications and relevant safety standards.

· Documentation: Provide detailed reports for each inspection and calibration, including:

· Equipment identification

· Calibration results

· Recommendations for repairs or adjustments

· Compliance with applicable regulations (e.g., FDA, ANSI, ISO)

· Provide quote(s) for major repair(s) and/or maintenance: The contractor shall provide quotes for the hourly cost of any major service call required outside of scope of biomedical inspection and calibration services. Any additional services, including parts, will be ordered through the contractor via a separate purchase order.

· Safety requirements:

· All contractors working on CG Base Portsmouth shall abide by all federal safety regulations as published by the Occupational Health and Safety Administration, 29 CFR 1910 (series) and 29 CFR 1926 (series). Contractor written safety programs shall be reviewed by the Base Safety Officer prior to starting work.

Written notification must be provided to the Base Safety Officer, Kelvin Smith, Kelvin.K.Sith@uscg.mil in their capacity as Base Fire Marshal of any activity that could potentially cause fire or explosion or that changes or reduces the capability of fighting a fire or explosion. Some examples of qualifying activities are: a fire hydrant or fire suppression system that must be taken out of service for any reason, electrical work that affects fire alarm systems, introduction of hazardous or flammable material onto the Base, and blocking of any egress routes or emergency vehicle routes. Inclusion of this information in the contract constitutes written notification as long as the outsource review sheet is signed by Base Safety Officer.

· Copies of the following must be provided to the Base Safety Officer prior to starting work in affected areas: Confined Space Entry Permits, Hot Work Chits, and Dig Chits. Confined space clearance must be conducted by a certified marine chemist and permit required spaces will have a copy of the permit posted on site during work. Hot work will only be conducted with permission and a fire watch must be posted during work. A facility dig chit is required in addition to a Miss Utility dig chit. The systems on Base Portsmouth are not limited to what the City of Portsmouth has on file. In order to ensure electrical safety and integrity of systems, a facility chit is required.

· Lock Out/Tag Out requires notification and coordination with facilities and will not be conducted by a contractor on Base Portsmouth. A Facilities Division representative is required for all contractor Lock Out/Tag Out needs.

· Rights: Every employee working on Base Portsmouth has the right to a safe and healthy work place. The contractor has the responsibility and right to stop unsafe work. QAE’s and the Safety Officer may also institute a work stoppage relating to unsafe practices or immediate danger to life and health situations.

· Environmental requirements:

· All contractors working on CG Base Portsmouth shall abide by all federal environmental regulations as published by the Environmental Protection Agency, 40 CFR (series). Contractor written environmental management and pollution prevention programs shall be reviewed by the Environmental Protection Specialist, Lerry Fischer, Larry.S.Fisher@usch.mil prior to starting work and must be in accordance with CG BASE PORTSVA INST M5090.1B , the Unit Environmental Guide.

· Written notification must be provided to the Environmental Protection Specialist of any activity that could potentially cause a permit violation on Base Portsmouth. Some examples of qualifying activities are: any activity that could result in a spill or discharge into a waterway or introducing a hazardous material into the environment.

· Copies of the following must be provided to the Environmental Protection Specialist prior to starting work in affected areas: Material Safety Data Sheets, permits, and notices of intent.

· Hazardous materials used by a contractor are required to be disposed of by that contractor. Disposal must be in acccordance with federal, state, and local guidelines.

· Upon completion of work: Contact the Contracting Officer QAE Representative to arrange for inspection/acceptance of work.

3.0 CONTRACTOR PERSONNEL

3.1 QUALIFIED PERSONNEL

The Contractor must provide qualified personnel to perform all requirements specified in this SOW.

3.2 CONTINUITY OF SUPPORT

The Contractor must ensure that the contractually required level of support for this requirement is maintained at all times. The Contractor must ensure that all contract support personnel are present for all hours of the workday. If for any reason the Contractor staffing levels are not maintained due to vacation, leave, appointments, etc., and replacement personnel will not be provided, the Contractor must provide e-mail notification to the Contracting Officer’s Representative (QAE) prior to employee absence. Otherwise, the Contractor must provide a fully qualified replacement.

3.3 KEY PERSONNEL

Before replacing any individual designated as KeyPersonnel by the Government, the Contractor must notify the Contracting Officer no less than 15 business days in advance, submit written justification for replacement, and provide the name and qualifications of any proposed substitute(s). All proposed substitutes must possess qualifications equal to or superior to those of the Key person being replaced, unless otherwise approved by the Contracting Officer. The Contractor must not replace Key Contractor personnel without approval from the Contracting Officer. The following Contractor personnel are designated as Key for this requirement. Note: The Government may designate additional Contractor personnel as Key Personnel at the time of award.

3.3.1 Contractor Key Personnel must not be assigned by the Contractor to more than one key position for this requirement.

3.4.1

3.5 EMPLOYEE IDENTIFICATION

3.5.1 Contractor employees visiting Government facilities must wear an identification badge that, at a minimum, displays the Contractor name, the employee’s photo, name, clearance-level and badge expiration date. Visiting Contractor employees must comply with all Government rules and requirements. All Contractor employees must identify themselves as Contractors when their status is not readily apparent and display all identification and visitor badges in plain view above the waist at all times.

3.5.2 Contractor employees working on-site at Government facilities must wear a Government issued identification badge. All Contractor employees must identify themselves as Contractors when their status is not readily apparent (in meetings, when answering Government telephones, in e-mail messages, etc.) and display the Government issued badge in plain view above the waist at all times.

3.6 EMPLOYEE CONDUCT

Contractor’s employees must comply with all applicable Government regulations, policies and procedures (e.g., fire, safety, sanitation, environmental protection, security, “off limits” areas, wearing of parts of DHS uniforms, and possession of weapons) when visiting or working at Government facilities. The Contractor must ensure Contractor employees present a professional appearance at all times and that their conduct must not reflect discredit on the United States or the Department of Homeland Security. The Project Manager must ensure Contractor employees understand and abide by Department of Homeland Security established rules, regulations and policies concerning safety and security.

3.7 REMOVING EMPLOYEES FOR MISCONDUCT OR SECURITY REASONS

The Government may, at its sole discretion (via the Contracting Officer*), direct the Contractor to remove any Contractor employee from DHS facilities for misconduct or security reasons. Removal does not relieve the Contractor of the responsibility to continue providing the services required under the contract. The Contracting Officer will provide the Contractor with a written explanation to support any request to remove an employee.

*Note: For some requirements, the QAE may be the more appropriate government employee to direct the Contractor to remove its employee. The matter should be discussed with your Contracting Officer.

4.1 SECURITY

Coordinate with the CSO Office and DHS Instruction Handbook 121-01-007, Department of Homeland Security Personnel Suitability and Security Program to check appropriate box.

Add any additional sections with “-or-“ if appropriate and delete the others.

Security Risk and Background Investigation Form Requirements

The requirements office anticipates the following:

-or-

Contractor access to unclassified, but Security Sensitive Information may be required under this SOW. Contractor employees must safeguard this information against unauthorized disclosure or dissemination.

4.2 PERIOD OF PERFORMANCE

The period of performance for this contract is a one-year base period with four one-year option periods as follows:

4.3 PLACE OF PERFORMANCE

The primary place of performance will be the Contractor’s facilities with semi-annual visits to the United States Coast Guard at USCG Base Portsmouth Medical Clinic, 4000 Coast Guard Blvd, Portsmouth, VA 23703.

4.4 HOURS OF OPERATION

Contractor employees must generally perform all work between the hours of 0730 and 1600 EST, Monday through Friday (except Federal holidays). However, there may be occasions when Contractor employees may require to work other than normal business hours, including weekends and holidays, to fulfill requirements under this SOW. If the contractor desires to carry on work on Saturday, Sunday, holidays or outside the clinic’s regular hours, a request shall be submitted in writing to the Contracting Officer’s QAE Representative for approval consideration. The contractor shall allow ample time to enable satisfactory arrangements to be made by the government for inspecting the work in progress.

4.5 TRAVEL

Contractor travel must not be required for this requirement.

4.6 GENERAL REPORT REQUIREMENTS

The Contractor must provide all written reports in electronic format with read/write capability using applications that are compatible with DHS workstations (Microsoft Office Applications).

4.7 PROTECTION OF INFORMATION

Contractor access to information protected under the Privacy Act is required under this SOW. Contractor employees must safeguard this information against unauthorized disclosure or dissemination in accordance with the law and Government policy and regulation.

6.0 CONTRACTOR FURNISHED PROPERTY

The Contractor must furnish all facilities, materials, equipment and services necessary to fulfill the requirements of this contract, except for the Government Furnished Resources specified in SOW 2.0.

7.0 GOVERNMENT ACCEPTANCE PERIOD

The QAE will review deliverables prior to acceptance and provide the contractor with an e-mail that provides documented reasons for non-acceptance. If the deliverable is acceptable, the QAE will send an e-mail to the Contractor notifying it that the deliverable has been accepted.

7.1 The QAE will have the right to reject or require correction of any deficiencies found in the deliverables that are contrary to the information contained in the Contractor’s accepted proposal. In the event of a rejected deliverable, the Contractor will be notified in writing by the QAE of the specific reasons for rejection. The Contractor may have an opportunity to correct the rejected deliverable and return it per delivery instructions.

7.2 All other review times and schedules for deliverables must be agreed upon by the parties based on the final approved Project Plan. The Contractor must be responsible for timely delivery to Government personnel in the agreed upon review chain, at each stage of the review. The Contractor must work with personnel reviewing the deliverables to assure that the established schedule is maintained.

8.0 DELIVERABLES

The Contractor must consider items in BOLD as having mandatory due dates. Items in italics are deliverables or events that must be reviewed and/or approved by the QAE prior to proceeding to next deliverable or event in this SOW.

DISTRIBUTION

Clinic POC/Supply supervisor