Attch 1 - Derm Laser PMA SOW.pdf

Statement of Work 4 Jan 2023

Dermatology VBeam Prima Laser, (Dermatology Clinic)

1.0. Scope of Work. The contractor shall provide all labor necessary to perform calibration, installation of replacement parts, other servicing of equipment, and travel time shall be included to maintain the system and ancillary equipment fully operational. Telephone and remote diagnostic and repair support 24/7, all Labor, Parts & Travel coverage Monday through Friday, 8:00 a.m. to 5:00 p.m., local time, calls received after normal business hours will be dispatched during the next business day. Includes all Hardware, Software Updates and enhancements released during term of the agreement for the products/options purchased, in addition to all Safety and Quality Updates, installation during normal business hours, Monday-Friday 8 am to 5 pm. It will include all required manufacture software (if required), parts and service technical support plan for the following equipment.

- One (1) Dermatology VBeam Prima Laser and all its components; the laser was purchased on 16 Feb 2022, total cost is $126,001.52 (Serial No. 9914-9080-0622).

- 6 MDG is requesting to proceed in establishing a Preventive Maintenance Agreement (PMA) for the Dermatology VBeam Prima Laser. The PMA shall be for one base year plus four optional years.

- The equipment is currently located in the 6th MDG, Dermatology Clinic, 3250 Zemke Avenue, Building 1078, MacDill AFB, Florida

1.1. Requests for Service. Only Medical Equipment Repair Center (BMET) personnel are authorized to place requests for service on this contract.

2. Description of Services. Warranty service shall be provided exclusively by technician and service organizations authorized by Candela. Replaceable parts and supplies shall be exclusively procured from the original manufacturer (Candela).

- During the extended service warranty period, Candela authorized and trained technicians will provide all parts, labor and travel necessary to maintain the Dermatology VBeam Prima Laser at factory specifications under normal operating condition.

- Any service required by the Customer must be telephoned in to the authorized Candela Service Department and customer must provide a verbal description of the problem they are experiencing, including error codes, if any. Candela trained specialist will coordinate a field service visit to the customer location.

- Contract shall have a complete coverage such as software (if required) parts and labor, and according to the above terms, for the Dermatology VBeam Prima Laser.

- One (1) yearly Preventive Maintenances visit, as recommended by manufacturer.

2.1. Preventive Maintenance Inspections.

2.1.1. The contractor shall provide annually PMI to ensure that the equipment performs in accordance with manufacturer’s conformance standards.

2.1.1.1. The contractor shall schedule preventive maintenance inspections (PMI) and calibrations 15 days in advance with the BMET. Preventive maintenance shall be performed during normal hours of coverage.

2.1.2. The contractor shall provide and utilize procedures and checklists with worksheet originals indicating work performed and actual values obtained (as applicable) and provide them to the BMET at the completion of the PMI.

2.1.3. PM services shall, as a minimum, include the system services at the frequencies recommended by the original equipment manufacturer (OEM).

2.1.3.1. The PM system services shall include, but are not to be limited to:

2.1.3.1.1. Clean the equipment.

2.1.3.1.2. Calibrate and lubricating the equipment.

2.1.3.1.3. Perform remedial maintenance of a non-emergency nature.

2.1.3.1.4. Test and replace faulty and worn parts and/or parts which are likely to become faulty, fail, or become worn before the next PMI. This will be at no additional cost to the government.

2.1.3.1.5. Inspect for wear and fraying, and replacing where necessary, electrical wiring, cables, high voltage cables, bushings and dielectric, as necessary.

2.1.3.1.6. Measure, adjust and calibrate as necessary for optimal image quality.

2.1.3.1.7. Inspect and replace where indicated, all mechanical components including, but not limited to, patient restraints and support devices; cables and mounting hardware; chains, belts, bearings and tracks; interlocks, clutches, motors, and keyboards for mechanical integrity, safety, and performance.

2.1.3.1.8. Inspect output devices, e.g. monitors, laser imagers, cameras and processors.

Calibrate or recommend calibration, if appropriate.

2.1.3.1.9. Consult with the equipment operator(s) regarding equipment performance.

2.1.3.1.10. Return the equipment to the operating condition defined by the original equipment manufacturer’s specifications.

2.1.3.1.11. Provide service report of services performed.

2.1.31.12. Provide any updated software required to bring the equipment up to AF regulations and standard at no extra expense to the government.

2.1.3.2. The contractor shall provide all parts, services, manuals, tools, instrumentation, or software required to successfully complete scheduled PMIs.

2.2. Calibration Services.

2.2.1. The contractor shall provide one calibration per year, which will occur at the same time as the PMI. Additional calibration of the system may be scheduled and performed more frequently in the event of a remedial service call, which requires a major component change.

2.3. Unscheduled/Corrective Maintenance.

2.3.1. The contractor shall respond to all intervening service calls between scheduled PMI's and calibrations.

2.3.2. All required parts and services shall be furnished as part of this contract without additional cost to the government.

2.3.3. The BMET has the authority to place a service call with the contractor.

2.3.4. Maintenance actions. Once a maintenance action is initiated, it shall be continuous until the task is complete. Compliance shall be manifested by continuous presence of the contractor on the job site, unless waiting for delivery of replacement parts. Under no circumstances shall maintenance actions be delayed by more than 24 hours while waiting for delivery of parts.

2.3.5. Parts. The contractor shall furnish and replace parts to meet up-time requirements. The following requirements apply to parts provided under this contract.

2.3.5.1. The contractor shall have ready access to unique and/or high mortality replacement parts.

2.3.5.2. All parts supplied shall be compatible with existing equipment.

2.4. Service Manuals.

2.4.1. The government will not provide service manuals or service diagnostic software to the contractor. The contractor shall be responsible for providing all service manuals, operational manuals, schematics, and diagnostic software necessary to maintain the required system up-time to the contractor’s field service representative(s).

2.5. Updates. The contractor shall provide all updates, to include: installation of updated software required by the government, installing manufacturer designed and issued field modifications, safety corrections and revisions for correcting software and equipment deficiencies at no additional cost to the government.

2.6. Conformance Standards. The contractor shall keep the system in good operating condition, meeting all equipment and performance requirements published by the OEM. The contractor assumes responsibility for system conformance with the latest published edition of National Fire Protection Association (NFPA) 99, Occupational Health and Safety Administration (OSHA), and Center for Devices and Radiological Health (CDRH) standards.

3. General Information. Companies that will match our Preventive Maintenance requirements shall provide a detail written statement / timeline on how they plan to provide maintenance to above mentioned equipment.

3.1. Personnel.

3.1.1. Point of contact. The contractor shall designate in writing a single point of contact to the BMET for any maintenance service required under this contract. This information shall include name, title, address, and telephone number.

3.1.2. Contractor’s field service representative shall be able to speak and understand English.

3.1.3. Qualifications/Education/Training. Prior to award of the contract and each subsequent performance period, the contractor shall certify to the BMET that the field service representative

3.2. Telephone Assistance. The contractor shall provide telephone assistance during business hours, 365 days a year for equipment covered under this contract. Telephone assistance shall be toll free to the government. The BMET shall be able to call and receive assistance in correcting problems with equipment operation.

3.3. Hours of Coverage.

3.3.1. Normal hours of coverage are, Monday through Friday, 0730--1630 hrs, excluding Federal holidays listed in paragraph 3.4 below and additional holidays where the hospital will be closed. All service/repairs shall be performed during normal hours of coverage.

3.3.2. United States Federal holidays observed by the Department of Defense (DoD) include:

New Years Day, Martin Luther King Day, President's Day, Memorial Day, Juneteenth Day, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving Day, and Christmas Day.

3.3.3. Response Time. The contractor shall respond with a phone call to the BMET or his/her designee within two (2) working hours after telephone notification during normal hours of coverage. If the problem cannot be corrected by phone, the contractor shall commence work on-site during normal hours of coverage. Repairs shall proceed expeditiously progressively until completion. For example, if a routine call is placed during normal coverage hours and insufficient hours are remaining in the day, the contractor shall be on-site within 8 hours of the initial telephone notification. If the initial telephone notification was made at 1630 hours on Tuesday, then the contractor shall report on-site at the beginning of the following day (Wednesday).

3.4. Administrative Control.

3.4.1. Service Call Log.

3.4.1.1. The contractor shall report to the BMET and sign-in on the contractor service log with the BMET prior to reporting to the work-site.

3.4.1.2. Upon completion of each PMI, calibration, or corrective service call, the contractor shall provide a signed system maintenance record to the BMET.

3.4.1.3. The BMET will countersign the report to certify that the services were rendered. At this time, the contractor shall sign-out on the contractor service log.

3.4.1.4. The government will not recognize any maintenance actions that have not been signed by the BMET.

3.4.1.5. All maintenance documents shall be prepared and validated in triplicate. The system user, BMET, and the contractor shall each retain a copy.

3.4.1.6. Documentation and reporting shall be in compliance with the Joint Commission standards.

3.4.2. The System Maintenance Record for each PMI or service call will include at minimum:

3.4.2.1. Name of the contractor.

3.4.2.2. Name of the contractor’s field service representative.

3.4.2.3. Date, time (starting and ending), equipment downtime, and hours-on-site. The contractor’s field service representative must report to the BMET in accordance with local guidelines.

3.4.2.4. Description of the problem reported by the BMET/user and an itemized description of service performed (including labor, parts, and corrective action taken)

3.4.2.5. Identification of equipment to include index number, manufacturer, device, model number, and serial number.

3.4.3. Billing Procedures. This service contract shall be billed monthly. The contractor’s invoice shall reflect the following information:

3.4.3.1. Invoice number

3.4.3.1.1. Contract/purchase order number.

3.4.3.1.2. Billing period.

3.5. Claims of government misuse or abuse. If the contractor claims any service calls are the result of government abuse or misuse, the damage shall immediately be shown on the system maintenance record, verified by the BMET, and approved by the CO before repairs are made.

The CO will resolve disagreements as to responsibility between both parties.

3.6. Reporting. Required services beyond the scope of contract. The contractor shall immediately, but not later than 24 consecutive hours after discovery, notify the CO and QAP/BMET in writing of the existence or the development of any defects, or repairs required for8 the scheduled equipment for which the contractor considers he/she is not responsible under the terms of the contract. The contractor shall furnish the CO and BMET with a written estimate of the cost to make necessary repairs, and a full technical description.

3.7. Safety. The Contractor shall comply with American OSHA Standards, and Air Force safety standards at all times while on government property and safe working practices shall be followed at all time.

3.2. Telephone Assistance. The contractor shall provide telephone assistance during business hours, 365 days a year for equipment covered under this contract. Telephone assistance shall be toll free to the government. The BMET shall be able to cal...