Statement of Work DSSWater13.pdf

15 Apr 2021

Statement of Work

DI Water Sample service

1. Scope: The Contractor shall provide all services, labor, parts, materials, and equipment necessary for the water samples in Decontamination area of Sterile Processing at Naval Medical Center San Diego (NMCSD).

Contractor shall service and maintain the equipment within the original equipment manufacturer’s specifications, and in accordance with the US, State, and Local laws and regulations, US Navy regulations, American Association for Medical Instrumentation (AAMI) guidelines, and Joint Commission recommendations.

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

2.1. Service and maintenance: (a) any modification, adjustment, or replacement of the equipment that corrects a malfunction and effectively brings the equipment into material conformity with the technical specification for that equipment as designated by the original equipment manufacturer (OEM), (b) a procedure or routine that, when observed in the regular, proper operation of the equipment, avoids the material adverse effect of the applicable nonconformity, (c) any measures performed that assure the continued operation of the equipment or returns the equipment to its designed efficiency and capacity, (d) replacement of a piece of equipment on a one-for-one basis in order to provide a substitute of equal or greater value in lieu of a damaged or defective device for compensation, return, or refund of equipment.

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:

Naval Medical Center San Diego 34800 Bob Wilson Drive San Diego, CA 92134-5000

4. Requirements:

4.1. General Performance Requirements:

4.1.1. The Contractor shall provide on-site services to include all periodic planned maintenance and unscheduled repairs in accordance with manufacturer specifications and in compliance with ISO 9001 standards, to include repairs necessitated by operator error.

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 provide 51% of the services provided in the contract. 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 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 collection of water samples for bacteriological testing. Upon request, Contractor shall provide written assurance of the competency their personnel as well as a list of credentials for personnel (including any personnel that are subcontracted by contractor). 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 NMCSD 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 NMCSD Sterile Processing Department. All FSR's shall be submitted within 72 hours of completion of service and shall be sent to the following personnel:

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

1. Contractor Name

2. Service personnel printed name, telephone number, and signature

3. Date and Time of Arrival

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

5. 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 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 order to expedite invoicing process.

4.2. End-User Requirements:

4.2.1. Testing Requirements

4.2.1.1. Monthly, Quarterly, and Annual Testing

The Contractor shall perform testing on a fixed schedule at the following intervals:

monthly, quarterly, and annually. The quarterly and monthly sample will be taken in conjunction with the monthly water samples as each characteristic is due. Quarterly samples will be taken in January, April, July, and October. The annual sample will be taken in conjunction with the October water sample. Water samples will be taken from designated sample ports identified by the department. Water testing results will be compared to the American Association for Medical Instrumentation (AAMI) recommended levels for critical water. An electronic copy of the lab results must be delivered to all listed POCs identified in 4.1.5. within seven (7) days of testing.

- Deionized (DI) Water System: Testing of water quality to include the following results:

Monthly:

Chlorides pH

Bioburden

Endotoxin

Conductivity Quarterly

Total Organic Carbon (TOC)

Total Dissolved Solids (TDS) Annually

Hardness

Anions/Cations/Divalents

- Monthly water samples will be taken from sample port DI-4 above WD290

Washer #3 and documented on the corresponding lab report.

4.2.2. Delivery Requirements

The vendor will supply qualified personnel to come to the Sterile Processing Department and collect the water sample for the Deionized Water.

4.3.1. Other Services

4.3.3.1. The Contractor may be requested to provide Ad Hoc services in the event of an emergency requirement and/or failed result. The Ad Hoc services are covered within the contract. The Contractor is expected to be onsite to complete re-testing within 24 hours if the test results do not pass IAW AAMI TIR34 standard.

4.3.3.2. The Contractor will provide the following materials necessary for testing of the tasks covered under this Statement of Work. The cost for these is included in the contract.

- Lab, Test Code – for Chlorides

- Lab, Test Code – for pH

- Lab, Test Code – for Bioburden

- Lab, Test Code – Endotoxins

- Lab, Test Code – Conductivity

- Lab, Test Code – Total Organic Carbon (TOC)

- Lab, Test Code – Total Dissolved Solids (TDS)

- Lab, Test Code – Hardness

- Lab, Test Code – Anions/cations/divalents

4.3.3.3. All laboratory test results must be forwarded to the Sterile Processing Department and Facilities Management Department within seven (7) days of sample collection. The contractor should contact SPD within one (1) business day of receiving test results if any results are outside the AAMI TIR34 standards (fail).

4.3.3.4. All laboratory test reports must state the sample port tested and all test results will be compared against the recommended AAMI water quality levels for critical water. All laboratory test results should be documented on a single lab report and submitted to the Sterile Processing Department each month. The test results should be compared to the AAMI TIR34 standard ranges with a pass/fail clearly listed for each specific test. Examples are provided below

SPECIFICATION FOR BIOBURDEN <10 CFU/mL Description/location Sample ID Results Pass/Fail Incoming port to

WD290 #3

DI-4 1 Pass

Negative control n/a No Growth

SPECIFICATION FOR pH 5-7 Description/location Sample ID Results Pass/Fail Incoming port to

WD290 #3

DI-4 7 Pass

4.4. Response Time and Labor:

4.4.1. 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.

4.4.2. The Contractor shall use commercially reasonable efforts to provide on-site support within 24 hours from notification by NMCSD, unless otherwise noted in Section 4.4.

4.4.3. All compensation for labor is provided for in this contract and included in the contract price.

4.4.4. Any work that would require overtime or additional charges must be approved, in writing, in advance by the KO. Any materials that would require additional charges above and beyond those already provided for under the contract must be approved, in writing, in advance by the KO.

4.5.1 Sample collection shall not be performed on the following Holidays: New Years, Martin Luther King, President’s Day, Memorial Day, Independence Day, Labor Day, Columbus Day, Veteran’s Day, Thanksgiving Day, and Christmas. In the case where a scheduled monthly service (per 4.5.4) would be performed on a holiday, the services will be performed on the next available business day.

4.5.2 Work required in the performance of this contract shall be performed between the hours of 0800 and 1600, Pacific Standard Time. All compensation for labor from the hours of 0800 and 1600 Pacific Standard Time is provided for in this contract and included in the contract price.

4.5.3 The contractor will collect the Deionized water samples on the first Monday of the month. If the first Monday falls on a holiday, the collection day will occur the business day following the Holiday. If the contractor has to delay sample collection, the contractor must contact SPD via email 24 hours in advance. If the contractor is unable to collect the sample due to an emergency, the contractor should make a reasonable effort to contact SPD and provide a new date for the sample.

4.5.4 The contractor will notify the SPD POC before sample collection is taken. The SPD POC (as noted in section 4.1.5) will observe the contractor in the collection of the water sample. If the contractor has not completed the sample collection correctly, the SPD POC will correct the contractor.

5. Travel and Related Expenses

5.1.1. Travel expenses for the monthly testing are listed as pickup charge. The vendor will send a representative to collect the water sample from Sterile Processing.

6. Shipment: The Contractor shall not exceed seven (7) days for delivery of all results as previously noted in this Statement of Work or as approved by the KO. 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. NMCSD 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 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 NMCSD utilities.

8.2. Any outages required in order to perform services must be approved by NMCSD 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 NMCSD. 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_prot ection/pass_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 NMCSD Biomed not later than 1400 on the day prior to a scheduled visit to submit the required information to complete the NMCSD 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 NMCSD: Field service personnel shall wear visible photo identification at all times while on the premises of NMCSD. It is the responsibility of the field service personnel to park in the appropriate designated parking areas. Information on parking is available from NMCSD Security personnel. Smoking is prohibited inside any buildings of NMCSD 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.

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

9.3. Contractor Check-In/Check-Out: Contractor is required to report to Material Management Department, Biomedical Repair Division at Building One (1), Ground Floor, Room GD-18H1 at NMCSD 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. NMCSD 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: NMCSD reserves the right to reject any of the contractor's personnel and refuse them permission to enter the premises or work on NMCSD 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.

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:

For administrative matters, the Contractor may contact the contracting officer as designated in blocks 7.a, 7.b, 8, and 9 as found on the Standard Form 1449 issued for the contract, or may contact: