Attachment 01 -PWS Ophthalmic Laser Maintenance.pdf

LETTER REQUEST FOR QUOTATION

Ophthalmic Refractive Laser Equipment Preventative and Corrective Maintenance

RFQ # HT9407-24-Q-0003

Attachment 01

RFQ# HT9407-24-Q-0003 Attachment 01

PERFORMANCE WORK STATEMENT

08 Aug 2024

Ophthalmic Refractive Laser Equipment Maintenance

Naval Medical Treatment Facilities across DHA

1.0. GENERAL INFORMATION

1.1. General. Naval Refractive Surgery Centers (NRSC), NH Bremerton, NH Camp Pendleton, and NH Jacksonville, Naval Medical Center (NMC) Portsmouth, NMC Camp Lejeune, and pengovernment-owned ophthalmic refractive laser medical equipment, manufactured by AMO Sales and Services Inc.

1.2. Scope. The contractor shall provide preventive and corrective maintenance services for ophthalmic refractive laser medical equipment at the locations listed in the PWS. The contractor shall maintain the equipment within the original equipment manufacturers (OEM) specifications, in accordance with all US, State, and Local law and regulations, instructions, and Joint Commission requirements (specified in the Joint Commission’s Comprehensive Accreditation Manual for Hospitals, readily found on jointcommission.org (CAMH). When product recalls or upgrades are necessary to maintain the equipment in service within the original manufacturer’s specifications, the contractor shall obtain and install same.

1.2.1. The Firm Fixed Price (FFP) Maintenance includes regularly scheduled preventive maintenance (PM) and inspections, corrective maintenance tasks, and unlimited emergency responses as described in the coverage section for ophthalmic refractive laser medical equipment. The ophthalmic refractive laser medical equipment shall fluctuate over time as equipment items reach their useful life and are replaced and as new equipment comes off warranty, however, the aggregate requirement and level of effort will remain relatively constant over the life of the contract.

1.2.2. This contract shall provide support coverage 7:30 am – 5:00 pm, Monday –Friday (local time at each medical treatment facility (MTF), unless otherwise specified. The contractor shall provide all parts, labor, materials, travel, personnel, supervision, and freight for the scheduled (preventive) and unscheduled (corrective) maintenance for all ophthalmic refractive laser medical equipment.

1.3. Compliance with Applicable Laws: contractor shall be knowledgeable of and comply with all applicable Federal, State, and local laws, regulations, and requirements regarding the conduct of their business.

1.4. Physical Security. The contractor shall use commercially reasonable efforts to safeguard all government property provided for contractor use. The contractor shall designate an individual and alternate(s) to receive and account for government-furnished facilities and equipment.

1.5. Government Right to Change Standard Operating Procedures. The government reserves the right to establish and/or change Standard Operating Procedures which shall be binding on the contractor, i.e., work order procedures, emergency and fire procedures, security procedures and power failures, upon reasonable advance notice to contractor.

2.0. DEFINITIONS. As used throughout this work statement, the following terms shall have the meaning set forth below:

2.1. Contracting Officer (KO). A warranted representative of the federal government who has the express authority to enter into, administer, and/or terminate contracts and make related determinations and findings. The KO is the only person authorized to approve changes to any terms, conditions, or requirements of the contract.

2.2. Contracting Officer’s Representative (COR). A government employee appointed by the KO and responsible for the inspection, evaluation, and acceptance of products and services provided in accordance with the terms and conditions of the contract.

2.3. Alternate Contracting Officer’s Representative (ACOR). A government employee appointed by the KO and responsible in the event the COR is absent due to leave, illness or official business, all the responsibilities and functions assigned to the COR.

2.4. Corrective Maintenance: Repair, adjustment, calibration, software manipulation and upgrades or other action taken to return a piece of equipment to original manufacturers specifications following a failure, damage, or other incident that causes the product to no longer perform within the original specifications.

2.5. Defense Medical Logistics Standard Support (DMLSS). The automated procurement, maintenance, and supply system utilized to document various material management functions within the command, and throughout the Department of Defense.

2.6. ISO 9001. The ISO 9000 series is a set of five individual, but related, international standards on quality management and assurance. These standards were developed to effectively document the quality system elements to be implemented in order to maintain an efficient quality system in a company. ISO 9001 is the most comprehensive, standard covering design, manufacturing, installation, and servicing systems.

2.7. Medical Treatment Facility (MTF) or Patient Care Facility. All gross square footage for building with a primary function of delivering government health care services. (i.e. hospital or clinic, including all activities providing outpatient and/or inpatient health services for authorized patient care)

2.8. Non-Patient Care Facility - All gross square footage for buildings with a primary focus of non-patient care activities (i.e. storage, warehouse, etc.).

2.9. Preventive Maintenance: Preventive maintenance is used to describe those periodic and “as required” services necessary to maintain equipment in an operating condition which minimizes corrective maintenance, including but not limited to calibration, adjustment, lubrication, updating software for security, safety or system functionality issues, as well as that testing required to maintain a safe environment of care which includes electrical safety testing, output testing, replacement of batteries and other shelf life components on a scheduled basis (which becomes corrective maintenance if the component fails due to lack of preventive maintenance).

2.10. Quality Assurance (QA). Actions, including inspections, performed by the government to determine whether products and services conform to contract requirements.

2.11. Quality Assurance Evaluator (QAE). A government employee responsible for performing quality assurance functions for a contracted service.

2.12. Quality Control (QC). Actions, including inspections and preparation of inspection records, performed by the contractor to ensure that products and services conform to contract requirements.

2.13. Uptime: Uptime is defined as that time, during the clinical areas’ normal business hours, when the equipment is available for clinical use without restrictions to the quality of the results, and without safety hazards to the patient, staff, or visitors.

3.0. PERFORMANCE REQUIREMENTS:

3.1 The contractor shall provide equipment maintenance services to include all periodic planned maintenance and unscheduled repairs in accordance with OEM specifications and in compliance with ISO 9001 standards, to include repairs necessitated by operator error.

3.2. Service Vendors Qualification: All work shall be performed by service personnel with original equipment manufacturer service training on the products for they perform service.

Service personnel shall have sufficient experience to demonstrate proficiency in maintenance of the product. Occasional experience with a limited set of equipment does not meet the requirements of this contract.

3.2.1. Field Service Personnel shall be authorized by the service vendor to perform the required maintenance services. Service vendors shall provide, to the COR, written assurance of the competency of their personnel as well as list of credentials of approved field service personnel.

The KO and/or COR may authenticate the training requirements and request training certificates or credentials from the service vendors at any time.

3.2.2. Government Right of Refusal: The MTF reserves the right to reject any of the service vendor’s personnel and refuse them permission to enter the premises or work on MTF equipment. This right may be exercised at any time. The reasons for rejections may include: lack of training and experience, but may also include but not be limited to:

behavior, attire, security concerns, and employment eligibility.

3.3. Preventive Maintenance Completion: contractor must ensure that 95% or more of all periodic maintenance is performed within 30 days of due date, and that 100% of periodic maintenance is performed within 60 days of the due date.

3.3.1. Equipment in Use: If, for reasons beyond the contractor’s control, equipment is not made available for maintenance for the entire 30 days before the maintenance due date, the contractor shall immediately notify the COR.

3.3.2. Equipment Unable to Locate (UTL). If the contractor is unable to locate an item within the maintenance window specified, the contractor shall immediately notify the COR. The COR may determine that the property has been disposed of or otherwise inactive or unavailable for use.

3.3.3. 100% Preventive Maintenance: Under the circumstances of 3.3.1 or 3.3.2, the COR and contractor shall arrange a means of complying with the requirements for preventive maintenance.

Equipment determined missing, lost, or stolen shall be exempt from maintenance.

3.4. Training: The contractor shall provide one initial training session for all MTF Biomedical Repair personnel on the procedures and processes of the contractor’s maintenance program immediately upon contract award. This training will provide the Biomedical Technicians insight into the OEM specified procedures for preventative maintenance and frequently observed issues that require corrective maintenance.

3.5. 100% Completion During Hours of Work: Work required in the performance of this contract shall be performed during 7:30 am – 5:00 pm, Monday –Friday (local time at each MTF). The contractor shall also provide a telephone consulting service, twenty-four (24) hours per day, seven (7) days a week. This consulting service shall be provided to avoid undue delays in contract service coverage during after-hours and weekend/holiday periods as applicable. Under no circumstances shall the contractor assume an inquiry, via telephone or any other means, is authorization to provide services not specifically covered by the terms of the contract. No overtime shall be billed to the government.

3.6. Preventive maintenance: The contractor shall schedule service vendor preventive maintenance visits as specified for each equipment item. All preventative maintenance shall be completed based on the OEM’s recommendation. Preventive maintenance visits shall include complete inspection and testing of the equipment in accordance with DMLSS maintenance procedures identified in DMLSS and/or manufacturer’s recommended guidelines, as provided by the on-site DHA Biomedical Technicians. Preventive maintenance visits shall be scheduled at least one week (40 working hours) in advance. If the routine scheduling for the equipment items is more than 1 week in advance, then the preventive maintenance visits must be coordinated at least that far in advance, so as to not require rescheduling patients.

3.7. Corrective maintenance: The contractor shall provide for any corrective maintenance services necessary to maintain equipment within the original manufacturer’s specifications, and in accordance with any applicable FDA requirements.

3.7.1. Response time: Within one (1) hour of the notification, contract personnel shall respond by telephone. If the equipment cannot be restored to the operating condition via telephone, the contractor shall arrive onsite within twenty-four (24) hours, subject to weather conditions and other matters beyond the contractor’s reasonable control, including, without limitation, employee, and transportation availability. The onsite response time is measured from the time the contractor is originally called, not from the time the contractor returns the call. The contractor is expected to return the machine to service within 48 hours from the time the contractor was contacted.

3.7.2. Parts: The contractor shall provide coverage for all repair and replacement parts necessary to maintain the ophthalmic refractive laser medical equipment in the original manufacturer’s specifications.

3.8. Recalls and Updates: The contractor shall perform installation for all manufacturer recalls and mandatory updates within thirty (30) calendar days of the original equipment manufacturers notification for all equipment covered under this contract.

3.9. Service Events: Upon arrival on-site, prior to performing any work, field service personnel shall coordinate with the COR during normal working hours. Outside of normal working hours, the Biomedical Equipment Technician (BMET) shall be contacted. The COR or his/her designee may accompany the field service person as an observer during any work performed on-site.

3.9.1. Service Event Documentation: Upon completion of each preventive maintenance visit and each corrective maintenance visit, field service personnel must submit a signed service report to the COR or COR designee. The service report shall indicate all problems addressed, devices checked, parts replaced/repaired, parts ordered, and problem resolution or pending action. Each service report must at a minimum document the following data legibly and in complete detail:

1) Name of contractor

2) Name of field service personnel performing service

3) contractor log/control number

4) Date, time (beginning and ending), and hours on-site for service call

5) Description of problem reported by user

6) Equipment identification factors to include: Manufacturer, make, model, serial number and local MTF Equipment Control Number (ECN)

7) Description of service performed 8) Problem resolution or pending action

9) Signatures of Field service person performing services and local MTF Biomedical Equipment Technician verifying service

Deliverable: Service Event Documentation

3.10. Monthly Reports: The contractor shall submit monthly management reports on the maintenance and repair activity of all equipment under this contract to the COR via e-mail. This report shall address total preventive and corrective maintenance work orders generated, numbers completed as a percentage, and numbers outstanding at the end of each month. Report of previous month activity should be submitted no later than the fifteenth (15th) day of the following month.

Deliverable: Monthly Reports

3.11. Test equipment: The contractor’s test equipment calibration shall be traceable to National Institutes of Standards and Technology (NIST). Upon request by 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, on MTF equipment.

Deliverable: Calibration certification of test equipment

3.12. Removal of equipment from site: No equipment shall be removed from the MTF without the approval of the COR and/or duty Biomedical Equipment Technician.

3.13. Unscheduled Meetings: The government reserves the right to schedule meetings to discuss or resolve issues/problems as it deems to be critical, at no additional cost to the government. All such visits or meetings shall be scheduled at mutually agreed upon times by the parties.

4.0. SAFETY REQUIREMENTS:

The contractor shall take safety precautions as required by Occupational Safety and Health Administration (OSHA) to protect the lives and health of occupants of buildings in which work is being performed.

5.0. IDENTIFICATION, PARKING, SMOKING MTF REGULATIONS:

Field service personnel shall wear visible photo identification at all times while on the premises of the MTF. It is the responsibility of the field service personnel to park in the appropriate designated parking areas. Information on parking is available from MTF Security personnel.

Smoking is prohibited inside any buildings of the MTF. Enclosed containers, including tool kits, are subject to search. Violations of MTF regulations may result in citation answerable in the United States (Federal) District Court.

6.0. MODIFICATIONS TO CONTRACT:

Only the Contracting Officer has the authority to obligate the government, and then only in writing. No direction or instruction from any party shall be construed to authorize the contractor to perform work outside of the scope of this contract for which they expect compensation without written authorization from the Contracting Officer.

7.0. GOVERNMENT-FURNISHED PROPERTY

N/A

8.0. CONTRACTOR-FURNISHED PROPERTY

N/A

DELIVERABLES SCHEDULE

Deliverable Frequency # of Copies Medium/Format Submit To

Service Event Documentation

(PWS section: 3.9.1.)

Upon completion of each preventive maintenance visit and each corrective maintenance visit

1 Signed Hard/Digital Copy

COR and

BMET

Monthly Reports

(PWS section: 3.10.)

Monthly. Report of previous month activity should be submitted no later than the fifteenth (15th) day of the following month.

1 E-mail COR and

BMET

Deliverable Frequency # of Copies Medium/Format Submit To

Calibration certification of test equipment

(PWS section: 3.11.)

Upon Request 1 Digital/Hard Copy COR and

BMET

DELIVERABLES SCHEDULE