SOW REDACTED.pdf

Statement of Work

WITH NO LOANER OPTION

NO LOANER OPTION – MEDICAL EQUIPMENT GENERAL REQUIREMENTS:

The effort required hereunder shall be performed in accordance with this Statement of Work and in accordance with all other terms and conditions set forth herein. The Contractor shall provide all services, materials and equipment necessary for the service recertification of the IV hoods located at Navy Medicine Readiness and Training Command San Diego (NMRTCSD), San

Diego, California, to ensure equipment is functioning at an acceptable level as required by

USP797 Surface, Air Viable Sampling and Hood Testing. The scope of work performed under these specifications includes the furnishing of all labor, equipment, and materials to perform the recertification on all Pharmacy IV hoods to assure continued operation at their designed efficiency. Semi-Annual testing shall be conducted in the months of October and April and will commence at 9:00AM, unless Inpatient Division Officer requests an alternate time.

THE CONTRACTOR SHALL PERFORM THE FOLLOWING FUNCTIONS:

*Ensure that only FULLY QUALIFIED FIELD ENGINEERS & TECHNICIANS who have gone through original equipment manufacturer (OEM) or comparable third party service schools for the above mentioned equipment shall be employed in the performance of any and all work performed under this contract. Upon request, the Medical Repair Branch will provide the certificates or notarized copies for verification. All recertification services will be provided twice annually. Once in October and once in April for TSA media NMRTCSD Pharmacy requesting one laboratory control sample per media type and lab analysis. The sample will be dual-incubated to determine both bacterial and fungal colony forming units (CFUs). Collect two viable air and surface samples in the Main Chamber and one in the Anti-Chamber of each of the

Isolators to comply with USP- 797 requirements. NMRTCSD requests a formal report upon completion of the testing and receipt of laboratory results. The highest standard of professional capability and electrical/mechanical workmanship is to be maintained throughout the life of this contract.

*Equipment improvements/modifications will be conducted only after acquiring the approval from the Contracting Officer.

*Ensure that original design and functional capabilities will not be changed, modified, or altered unless the medical Repair Branch authorizes such changes.

*Provide suitable modern recommended equipment/tools required for the satisfactory execution of all tests required.

*Furnish manufacturer OEM approved lubricants and lubricate wear points if required within the equipment.

*Leak Testing of Ceiling HEPA Filter – Main Pharmacy / Chemo and Anti Room.

*Controlled Environmental Monitoring; includes room pressures, supply / exhaust airflow volume readings and room air exchange rates in Main Pharmacy/Chemo and Ante Room.

*Non-Viable Particle Counting of Buffer, Ante and Chemo Room per ISO7 at 0.5um. Includes

Temp/rH.

*Certification of Biological Safety Cabinet – Includes Leak Testing of HEPA Filters, Airflow

Velocity Measurements and Site Assessment Test. Building 3 Hem/Onc Pharmacy. Building 1

Main Pharmacy IV Room.

*Non-Viable Particle Counting of Biological Safety Cabinet per ISO 5 at 0.5um. Includes temp/rH.

*Certification of Laminar Flow Hood – Includes Leak Testing of HEPA Filter and Airflow

Velocity Measurements. Building 1 Main Pharmacy IV Room.

* Non-Viable Particle Counting of Biological Safety Cabinet per ISO 5 at 0.5um. Includes temp/rH.

*Testing of Isolator – Includes Leak Testing of HEPA, Filter, Airflow Velocity Measurements, Pressure Test and Ingress / Egress test in Building 1, Floor 3, NICU Pharmacy. Building 1, Floor

4, ICU Pharmacy. Building 1, Floor 4, MOR Pharmacy.

*Testing of Isolator – Includes Leak Testing of HEPA, Pressure Test. Building 1 – HEMOC.

Non-Viable Particle Counting of 4 Isolators per ISO 5 at 0.5um. Includes temp/rH-(main chamber and interchange).

*Airborne Viable Sampling – Includes: 2 samples in each of the hoods. Main Pharmacy. 4 samples in the buffer/chemo. 2 samples in the Ante Room. 1 Control Sample.

*Surface Viable Sampling – Includes: 2 samples in each of the hoods in the Main Pharmacy.

4 samples in the buffer / chemo. 2 samples in the Ante Room. 1 control sample.

*Airborne Viable Sampling – Includes: (3) Samples total in the Main Chamber & in the Pass through Chamber on each Isolator. 11 samples in the Isolators. 1 Control sample.

*Surface Viable Sampling – Includes: (3) Samples in the Main Chamber & Pass through

Chamber on each Isolator. 11 samples in the Isolators. 1 Control sample.

*Option Species ID if sample has growth. Qty TBD.

*Formal Report Documentation.

*Ensure base access prior to appointment time via Pass & Decal located at NBSD, 3101 E.

Harbor Dr. Building #3436, San Diego, CA 92113, 619‐556‐9249/50 for DBIDS access.

Contractor is required to obtain DBIDS access prior to servicing contract.

2.2. 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.

2.3. Technical Representative (TR): 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.

3. Location:

Places of performance shall be:

NAVY MEDICINE READINESS AND TRAINING COMMAND SAN DIEGO

Main Pharmacy IV Room, OR Pharmacy, ICU Pharmacy, NICU Pharmacy, HEMONC

Pharmacy

Building 1, Floor 1

34800 Bob Wilson Drive

San Diego, CA 92134-5000

4. Requirements:

4.1. General Performance Requirements:

4.1.1. The Contractor shall provide equipment maintenance services to include all periodic planned maintenance and unscheduled repairs in accordance with OEM specifications.

4.1.2. The Contractor may use third party service vendors not limited to the Original Equipment

Manufacturer (OEM), however, these vendors must be approved in advance by the KO and TR.

The Contractor must submit a list of any sub-contractors they intend to use as third party service vendors to the KO and TR for approval. Third party service vendors shall not perform any work under this contract prior to such approval.

4.1.3. Ensure that only fully-qualified field engineers and/or technicians who have gone through

OEM or equivalent third-party service schools for the equipment shall be employed in the performance of any and all work performed under this contract. Service personnel shall have sufficient experience to demonstrate proficiency in maintenance of the product. Upon request, the Contractor shall provide written assurance of the competency their personnel as well as a list of credentials for approved field service personnel. The KO and/or TR may authenticate the training requirements and request training certificates or credentials from the service vendors at any time.

4.1.4. Test equipment: Test equipment calibration shall be traceable to National Institutes of

Standards and Technology (NIST traceable). Any efforts conducted without equipment within the calibration intervals is not performance in accordance with this contract. Upon request by

TR, 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 NMRTCSD equipment.

4.1.5. Field Service Reports: Contractor shall furnish a written or electronic vendor supplied

Field Service Report (FSR) to the Duty Staff at NMRTCSD Main Pharmacy and Bio-Med. All

FSR's shall be submitted within 72 hours of completion of service and shall be sent to the following email addresses:

The contractor or their representative shall complete the FSR to include, at a minimum, the following information:

1. Contractor Name

2. Technician's printed name, telephone number, and signature

3. Date and Time of Arrival

4. ECN (to be provided by Navy) and Serial Number of Equipment

5. Time Expended Repairing/Service: Labor Hours, Rate, Materials

6. Summary of Work Performed and Accepted by End-User, with Government

Representative's Printed name and Signature)

Completed Field Service Reports are required prior to acceptance of any invoice. Failure to submit a Field Service Report to NMRTCSD Pharmacy and Biomed can result in delay of payment or rejection of invoice from Government. It is highly recommended that the Contractor attach a copy of the Field Service Report to their Wide Area Workflow Invoice in addition to the required submission to NMRTCSD in order to expedite invoicing process.

4.2. NMRTCSD Preventive Maintenance Requirements:

4.2.1. Preventive maintenance shall be performed in a manner which will minimize corrective maintenance and will include but is not limited to: calibration, adjustment, lubrication, updating software for security, safety, or system functionality issues, testing required to maintain a safe environment of care, 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).

4.2.2. Make repairs to the extent necessary, as determined by inspection tests or disassembly, to ensure a functional system that will efficiently serve its intended purpose and the technical specification for that equipment as designated by the original equipment manufacturer.

4.2.3. Installation of system update changes to resolve specific product reliability problems.

Hardware and software upgrades, defined as those changes that enhance or add product features, are included.

4.2.4. Preventive Maintenance shall be performed at a minimum of 2 times per year, with these scheduled preventive maintenance actions to be coordinated with NMRTCSD Main Pharmacy after contract award.

4.2.5. Preventive Maintenance Completion: Contractor must insure 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.

4.2.6. 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, and 60 days following due date, the Contractor shall immediately notify the COR.

4.2.7. 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 TR. The TR may determine that the property has been disposed of or otherwise inactive or unavailable for use and may adjust the equipment covered under this Statement of Work accordingly.

4.2.8. 100% Preventive Maintenance: Under the circumstances of 4.2.6. and/or 4.2.7., the TR and Contractor shall arrange a means of complying with the requirements for preventive maintenance at no additional cost to the government. Equipment determined missing, lost, or stolen shall be exempt from maintenance.

4.2.9. Uptime Rate: The Contractor shall maintain an overall uptime rate of 95% or better for all equipment covered by this effort. Individual uptime rate for specific equipment, if required, will be as specified on Appendix A.

4.2.10. Uptime Calculation: Uptime is calculated on a rolling 6 month basis. Until the Contractor has at least 6 months of performance history with NMCSD, the uptime shall be calculated cumulatively for the entire duration of the contract.

4.3. NMRTCSD Corrective Maintenance Requirements:

4.3.1. Correct inoperable condition in a timely manner. Contractor shall respond no later than two (2) hours after telephone notification from BIOMED, Monday-Friday, between the hours of

0800-1600.

4.3.2. Provide only the work necessary to restore the equipment to a properly serviceable/operating condition by adjustments, replacement parts, or minor repairs when it is determined that extensive repairs and parts are not necessary.

4.3.3. Equipment improvements/modifications shall be made only upon Pharmacy Department

Head written approval and direction. This includes software updates to the device. All updates/improvements/modifications performed shall be notated on the field service report or equivalent.

4.3.4. Notify Main Pharmacy and BioMed immediately upon receipt of OEM safety recall notices or upon receipt of recall notices pertaining to any parts or materials utilized by the contractor on the equipment.

4.3.5. Ensure that the original design and functional capabilities shall not be changed, modified, or altered without express written authorization from Main Pharmacy.

4.3.6. Provide suitable OEM recommended repair equipment/tools required for the satisfactory execution of all repairs made.

4.3.7. Furnish OEM approved lubricants and lubricate wear points within the equipment in accordance with OEM guidelines.

4.3.8. Replacement parts shall be covered by the contractor for the duration of the contract.

Extend to the Government all commercial warranties on replacement parts. All replacement parts or supplies utilized shall be new parts or OEM refurbished parts. OEM refurbished parts shall only be accepted upon written request from the contractor to NMRTCSD Biomed and shall only be utilized/installed upon written approval from NMRTCSD Biomed to the Contractor.

4.4. End-User Requirements:

4.4.1. Service shall be performed on all devices included under contract, regardless of the nature of the cause warranting service/maintenance. Contractor shall not refuse any device under this contract submitted for services. Contractor will perform an official inspection of the device, make an estimate for the services/parts required and the time required for the repairs and an official determination of the cause of the issue, and will provide the required parts and labor in order to restore the equipment to function within the OEM specifications.

4.4.2. Services shall be unlimited for the devices under the contract for the term of the agreement. There shall be no cap or limit placed upon the number of repairs/replacements on any individual unit, or on the facility.

4.4.3. Contractor shall perform preventive maintenance on the Isolator IV Hoods, Laminar flow

Hoods and Chemo Hoods units at least 2 times per year, with a minimum of 6 months between preventive maintenance inspections. Contractor shall perform preventive maintenance.

4.4.4. Contractor shall keep department personnel informed as to the status/condition of equipment during PM and the repair status/condition when equipment is down or out for repair.

Points of contact for the department are: Biomedical Repair Contracts team at 619-532-8017.

CATASTROPHIC DAMAGE CLAUSE

4.4.5. If equipment is received and is irreparably damaged, the department requires a written report as to the extensiveness of the damage and the suspected cause or type of maltreatment necessary to cause such damage (e.g., dropped, crushed, mechanically, overloaded, etc.). The field service report may serve in this regard if comprehensive.

4.5. Response Time and Labor:

4.5.1. Contractor shall use commercially reasonable efforts to respond by telephone to any report of a malfunction requiring repair within two (2) hours of notification from NMRTCSD Main

Pharmacy or Biomed, Monday through Friday, 0800-1700, Pacific Standard Time. The

Contractor shall also provide telephone consulting services, twenty-four (24) hours per day, seven (7) days a week. This consulting service shall be provided to avoid 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.

4.5.2. Contractor shall use commercially reasonable efforts to provide on-site support within two

(2) business days from notification by NMRTCSD Main Pharmacy or Biomed, unless otherwise noted in Section 4.4.

4.5.3. Work required in the performance of this contract shall be performed between the hours of

0800 and 1700, Pacific Standard Time. All compensation for labor from the hours of 0800 to

1700 Pacific Standard Time is provided for in this contract and included in the contract price.

Contractor may be permitted to arrange for the performance outside of these hours via coordination with Main Pharmacy or NMRTCSD Biomed at no additional-cost-to-the-government.

4.5.4. Any work that would require overtime must be approved, in writing, in advance by the

Contracting Officer (KO).

5. Travel and Related Expenses: Contractor shall be responsible for its service related trip expenses, including round trip travel, mileage, and overnight living expenses.

6. Shipment: The Contractor shall not exceed two (2) business days for shipment of all equipment coming from and/or going to NMRTCSD Biomed minus exceptions or conditions as previously noted in this Statement of Work. All shipping expenses/costs are provided for in this contract and included in the contract price.

7. Liability:

7.1. The Contractor shall not be liable for any loss, damage, or delay due to any cause beyond their reasonable control, including but not limited to fire, explosion, theft, flood, riot, civil commotion, war, malicious acts of mischief, or other circumstances outside of human control.

7.2. NMRTCSD Employees will not perform maintenance or attempt repairs to equipment covered under this contract while such equipment is under the purview of this contract without express, written concurrence from the Contractor.

7.3. Insurance: Contractor shall be required to have liability insurance to cover any actions on the part of the Contractor or their sub-contractors which result in injury or death to patients, staff, visitors, or other Contractors. Coverage shall be of at least $500,000 per occurrence.

Additionally, Contractor is required to have property damage liability insurance of at least

$500,000. Liability insurance shall meet the requirements set forth in FAR 28.307-2.

8. Utilities, Facilities, and Equipment Access:

8.1. The Contractor may use Government utilities (e.g., electrical power, compressed air, water) that are available and required for any service performed under this contract while at

Government facilities. The facilities engineer however must approve of any contractor equipment which would connect to these utilities in order to ensure compatibility with

NMRTCSD utilities.

8.2. Any outages required in order to perform services must be approved by NMRTCSD

Facilities Management prior to initiation of work and shall be performed per Facilities' instruction. Contractor may request Facilities assistance in performing these outages if required.

8.3. Ensure that all use, storage, transport of any materials regulated by OSHA as "hazardous", required for the performance of this contract, is in in compliance with all federal, state, and local regulations. Contractor shall have available MSDS's for any such materials on-site.

8.4. The Contractor shall protect all facilities from damage caused by the Contractor and shall repair, at no additional cost to the Government, all damages caused by the Contractor's activities.

During performance of services, Contractor shall keep the site safe, neat, clean and orderly.

Contractor shall be responsible for all means, methods, techniques, sequences, and procedures of the services

8.5. Access to Equipment: Contractor shall be provided reasonable access to all equipment that is to be serviced and utility outlets required to do the service. The contractor shall be free to start/stop all primary equipment incidentals to the operation of the maintained equipment after permission is received from on-duty personnel responsible for such equipment.

9. Security and Safety Requirements:

9.1. The Contractor is required to submit/complete Naval Base San Diego Base access requirements for access to NMRTCSD. Contractor shall contact Naval Base San Diego Security

Department at 619-556-1653/5336 or at https://www.cnic.navy.mil/regions/cnrsw/installations/navbase_san_diego/om/force_protection/p ass_and_decal.html in order to obtain the necessary clearances to perform this contract. All costs for completing the requirements for access are the responsibility of the contractor.

While waiting for authorized access, contractor shall, at a minimum, contact NMRTCSD Main

Pharmacy no later than 1400 on the day prior to a scheduled visit to submit the required information to complete the NMRTCSD Temporary Security Pass. In case of emergent repairs or service, the contractor shall wait at the NMCSD Main Gate for escort from Biomed personnel.

9.2. Identification, Parking, and Smoking Regulations at NMRTCSD: Field service personnel shall wear visible photo identification at all times while on the premises of NMRTCSD. It is the responsibility of the field service personnel to park in the appropriate designated parking areas.

Information on parking is available from NMRTCSD Security personnel. Smoking is prohibited inside any buildings of NMRTCSD and is restricted to designated smoking locations only.

Possession of weapons, alcohol, or pharmaceuticals that are not over the counter and not prescribed to the individual/family is prohibited on the premises. Enclosed containers, including tool kits, are subject to search. Violations of regulations may result in citation answerable in the

United States (Federal) District Court. Violation of any policy which results in lost time for

Contractor or his sub-contractors is the sole responsibility of the Contractor, and shall not be charged to the government. Contractor employees shall demonstrate appropriate behavior and dress at all times.

9.3. Contractor Check-In/Check-Out: Contractor is required to report to Main Pharmacy

Department, Building One (1), Floor One, at NMRTCSD prior to and upon completion of any services or repair work performed.

9.4. General Safety Requirements: The Contractor shall exercise safety precautions as the TR may determine to be reasonably necessary to protect the lives and health of occupants of buildings in which work is being performed. NMRTCSD will notify the Contractor of any non-compliance with the foregoing conditions and the action(s) to be taken. Service vendors shall, after receipt of such notice, immediately correct the conditions to which attention has been directed. If field service engineer refuses to comply promptly, the TR may issue an order stopping all or any part of the work. Under such circumstances, the KO and hold the service vendor in contract default. Nothing in this section will be construed so as to limit the Contractor or his sub-contractors responsibilities to comply with any existing law, nor to switch jurisdictions.

9.5. Government Right of Refusal: NMRTCSD reserves the right to reject any of the contractor's personnel and refuse them permission to enter the premises or work on NMRTCSD 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, immigration status.

https://www.cnic.navy.mil/regions/cnrsw/installations/navbase_san_diego/om/force_protection/pass_and_decal.html https://www.cnic.navy.mil/regions/cnrsw/installations/navbase_san_diego/om/force_protection/pass_and_decal.html

10. 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 his business. The Contractors personnel shall comply with the DoD Information Assurance

Policies applicable. Contractors are required to maintain a Drug Free Workplace, as well as to require any sub-contractor to do the same. Contract shall require wage determinations and comply with applicable Federal and State worker's compensation and occupational disease statutes.

11. Modifications to Contract: Only the KO has the authority to obligate the government, and then only in writing. No modification or instruction from any party shall be construed to authorize the Contractor to take any action for which they expect compensation without written authorization from the KO.

12. Invoicing: All invoicing shall be done in accordance with this statement of work and in accordance with contract. Failure to do so may delay or interfere with payment for services rendered.

13. NMCSD Points of Contact: For all matters concerning performance of this contract, the primary point of contact shall be:

Navy Medicine Readiness and Training Command San Diego

Main Pharmacy

Building 1, Floor 1, Pharmacy Logistics

34800 Bob Wilson Drive

San Diego, CA 92134

TEL: 619-532-5093

Fax: 619-532-6260

14. PERIOD OF PERFORMANCE:

14.1 Contract Period: The period of performance shall include a base year plus four option years