1. SOW - Water Filtration Contract - PWS.docx

Performance Work Statement (PWS)

Part 1 General Information

1. GENERAL: This is a non-personnel services contract to provide water purification through service deionization. The Government shall not exercise any supervision or control over the contract service providers performing the services herein. Such contract service providers shall be accountable solely to the Contractor who, in turn is responsible to the Government.

1.1 Description of Services/Introduction: The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services necessary to perform water purification through service deionization as defined in this Performance Work Statement except for those items specified as government furnished property and services. The contractor shall perform to the standards in this contract.

1.2 Background: Water filtration, maintenance and testing of water and steam used for sterile processing is necessary for sterilizer equipment and washers located in Central Hospital Supply (CHS), rooms B1C267, B1C279 and B1N287 (full details on supported equipment in Attachment A). Local water supply contains an abundance of mineral deposits and sediment such as Calcium, Magnesium, and Sodium, which if left unfiltered can leave trace amounts on instruments being washed. Service deionization has proven to be an excellent filtration system in order to eliminate mineral deposits as well as chlorine, chloramines and dissolved organic contaminants.

1.3 Objectives: Basic Service Object is the Following

· Water purification, via filtration, utilizing service deionization system.

· Provide ability for users to monitor filtration equipment status.

· Quality control services including testing of steam, utility and critical water in sterile processing rooms.

· Maintenance and Emergency Services.

1.4 Scope: The contractor shall supply all labor, personnel, equipment, materials, supplies, testing instruments, transportation, tools, materials, supervision, and other items and non-personal services necessary to perform the functions and tasks required in this contract, unless specified otherwise;

1. Water purification, via filtration, utilizing service deionization system:

· Vender shall set up/install and maintain a deionization system that consists of filters (pre-/post), and/or microfiltration, carbon, cation, anion and/or mixed bed tanks (as necessary), recirculation, UV treatment, and any other components such as pressure regulators, water meters, etc. in order to provide a system that meets or exceeds filtration standards for water used during sterile service processing operations. Filtration system and design must follow ANSI/AAMI ST108 standards.

2. Provide ability for users to monitor filtration equipment status

· As part of filtration system, vendor shall provide audible and/or visual systems alerting users to the following issues –

· When the system is operating on reserve tanks and an alarm alerting when the reserve tank has reached critical levels and needs to be replaced.

· If/when provided tanks are leaking and need to be replaced.

· A means to measure and display conductivity of filtered water (to be used in conjunction with testing as required by the objection below)

3. Quality control services including testing of the steam, utility and critical water in sterile processing rooms.

· Vender shall provide quality control services including water testing as part of the contract.

· Quality control plan must be submitted as part of contract proposal and/or at the beginning of each contract year. At a minimum this plan must include water quality testing as described below and in Attachment B.

· Testing must follow ANSI/AAMI ST108 Standards.

· Information on point of use fixtures and equipment that needs to be included in testing and testing reports is included in Attachment A.

· Water testing and reports must follow type of testing and frequency as described in tables #5 (testing at water generation system) and #6 (at point of use fixtures) in Attachment B.

· Reports are to be submitted to COR and designated user at a minimum, quarterly. A quarterly report must capture data collected from all testing within a quarter. Vendors may also produce monthly reports if they prefer. Frequency of reporting must be provided as part of Quality control plan.

· Reports must include performance qualification levels of water quality for medical device processing as shown in table #2 in Attachment B.

· Reports must highlight whenever tested water of water generating system or point of use fixtures fall outside of performance qualifications range/levels.

4. Maintenance and Emergency Services:

· Maintenance Services

· Vendor shall provide preventative maintenance services.

· Vendor to provide schedule of preventative maintenance as part of contract proposal and/or at the beginning of each contract year.

· Maintenance schedule and visit frequency shall be determined by contractor and shall include details on frequency of filter and/or component change outs as well as regularly scheduled preventative maintenance on system.

· The specific dates for scheduling the PM will be coordinated between the Contractor, the designated department contact and the Contracting Officer's Representative (COR) of Hospital Engineering and Facility Services (HEFS).

· Preventive maintenance inspections will be performed during the hours of 7:00 a.m. until 5:00 p.m., Monday through Friday, excluding holidays and any day declared an official Federal Holiday.

· The repair or replacement of components of provided system, which would result in additional cost, shall not proceed until approved by the Contracting Officer.

· Provided maintenance services must follow ANSI/AAMI ST108 standards.

· Emergency Services

· This contract shall provide emergency services.

· Emergency services are those services required when the equipment is not in a usable condition and timely response during normal business hours by the Contractor is required. The Contractor will provide emergency support service by phone 24 x 7 x 365, with a telephone response time the next business day. A qualified service technician must call back within four (4) hours and be on site (if needed) by the next business day after initial notification of a problem by the department’s point of contact. The term "response time" will result in the physical presence of a fully qualified technician arriving on the CC campus within the specified time. The contractor shall provide a response time for unscheduled service calls placed through the call center.

· Equipment is to be fully operational within a maximum of 8 hours of the on-station response time. If the Contractor requires additional parts/time to complete required repair/service, the Contractor should contact the COR to coordinate completion of work within an agreed upon completion time/date, as these units support mission critical operations.

· Any work/repair that is determined to be outside the scope of the contract/results in an additional charge, shall not proceed until approved by Contracting Officer.

1.5 Period of Performance: The period of performance shall be for one (1) Base Year of 12 months and four (4) 12-month option years. The Period of Performance reads as follows:

· Base Year – September 24,2025 thru September 23, 2026

· Option Year I – September 24,2026 thru September 23, 2027

· Option Year II – September 24, 2026, thru September23, 2027

· Option Year III – September 24, 2027, thru September 23, 2028

· Option Year IV – September 24, 2028, thru September 23, 2029

1.6 General Information

1.6.1 Quality Control: The contractor shall develop and maintain an effective quality control program to ensure services are performed in accordance with this PWS. The contractor shall develop and implement procedures to identify, prevent, and ensure non- recurrence of defective services. The contractor’s quality control program is the means by which he assures himself that his work complies with the requirement of the contract. Contractor shall furnish a quality control plan as part of the proposal, this quality control plan shall detail how the contractor will implement, and maintain an effective service deionization filtration system monitoring and maintenance program. After acceptance of the quality control plan the contractor shall receive the contracting officer’s acceptance in writing of any proposed change to his QC system.

1.6.2 Quality Assurance: The government shall evaluate the contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan. This plan is primarily focused on what the Government must do to ensure that the contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rate(s).

1.6.3 Recognized Holidays: Contractor may be required to perform maintenance in the event of an Emergency during federally recognized holidays listed below:

· New Year’s Day

· Martin Luther King Jr.’s Birthday

· Inauguration Day*

* Federal employees in the Washington, DC area are entitled to a holiday on the day a President is inaugurated, January 20 for each fourth year after 1965

· President’s Day

· Memorial Day

· Juneteenth Independence Day

· Independence Day

· Labor Day

· Columbus Day

· Veterans Day

· Thanksgiving Day

· Christmas Day

1.6.4 Hours of Operation: Under normal circumstances the contractor is responsible for conducting business, between the hours of 7 AM and 5 PM, Monday thru Friday except Federal holidays or when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings. The only exception to these hours and dates is in the event of an Emergency if contractor services are needed, contractor may need to work outside of normal business hours and days. For other than firm fixed price contracts, the contractor will not be reimbursed when the government facility is closed for the above reasons. The Contractor must at all times maintain an adequate workforce for the uninterrupted performance of all tasks defined within this PWS when the Government facility is not closed for the above reasons. When hiring personnel, the Contractor shall keep in mind that the stability and continuity of the workforce are essential.

1.6.5 Place of Performance: The work to be performed under this contract will be performed at NIH Clinical Center Building 10, Sterile Processing services location. Attachment #1 specifies locations of equipment that utilizes DI water.

1.6.6 Type of Contract: The government will award a firm fixed price contract.

1.6.7 Security Requirements: NA

1.6.7.1 PHYSICAL Security: The contractor shall be responsible for safeguarding all government equipment, information and property provided for contractor use. At the close of each work period, government facilities, equipment, and materials shall be secured.

1.6.7.2 Key Control. The Contractor shall establish and implement methods of making sure all keys/key cards issued to the Contractor by the Government are not lost or misplaced and are not used by unauthorized persons. NOTE: All references to keys include key cards. No keys issued to the Contractor by the Government shall be duplicated. The Contractor shall develop procedures covering key control that shall be included in the Quality Control Plan. Such procedures shall include turn-in of any issued keys by personnel who no longer require access to locked areas. The Contractor shall immediately report any occurrences of lost or duplicate keys/key cards to the Contracting Officer.

1.6.7.2.1. In the event keys, other than master keys, are lost or duplicated, the Contractor shall, upon direction of the Contracting Officer, re-key or replace the affected lock or locks; however, the Government, at its option, may replace the affected lock or locks or perform re-keying. When the replacement of locks or re-keying is performed by the Government, the total cost of re- keying or the replacement of the lock or locks shall be deducted from the monthly payment due the Contractor. In the event a master key is lost or duplicated, all locks and keys for that system shall be replaced by the Government and the total cost deducted from the monthly payment due the Contractor.

1.6.7.2.2. The Contractor shall prohibit the use of Government issued keys/key cards by any persons other than the Contractor’s employees. The Contractor shall prohibit the opening of locked areas by Contractor employees to permit entrance of persons other than Contractor employees engaged in the performance of assigned work in those areas, or personnel authorized entrance by the Contracting Officer.

1.6.7.3 Lock Combinations - NA

1.6.8 Special Qualifications: N/A

1.6.9 Post Award Conference/Periodic Progress Meetings: The Contractor agrees to attend any post award conference convened by the contracting activity or contract administration office in accordance with Federal Acquisition Regulation Subpart 42.5. The contracting officer, Contracting Officers Representative (COR), and other Government personnel, as appropriate, may meet periodically with the contractor to review the contractor's performance. At these meetings the contracting officer will apprise the contractor of how the government views the contractor's performance and the contractor will apprise the Government of problems, if any, being experienced. Appropriate action shall be taken to resolve outstanding issues. These meetings shall be at no additional cost to the government.

1.6.10

1.6.10 Contracting Officer Representative (COR): The (COR) will be identified by separate letter. The COR monitors all technical aspects of the contract and assists in contract administration The COR is authorized to perform the following functions: assure that the Contractor performs the technical requirements of the contract: perform inspections necessary in connection with contract performance: maintain written and oral communications with the Contractor concerning technical aspects of the contract: issue written interpretations of technical requirements, including Government drawings, designs, specifications: monitor Contractor's performance and notifies both the Contracting Officer and Contractor of any deficiencies; coordinate availability of government furnished property, and provide site entry of Contractor personnel. A letter of designation issued to the COR, a copy of which is sent to the Contractor, states the responsibilities and limitations of the COR, especially with regard to changes in cost or price, estimates or changes in delivery dates. The COR is not authorized to change any of the terms and conditions of the resulting order.

1.6.11 Key Personnel: The follow personnel are considered key personnel by the government:

· Contract Manager

· Site Supervisor

· Site Superintendent

· Systems Manager

· On-Site Technician

The contractor shall provide a contract manager who shall be responsible for the performance of the work. The name of this person and an alternate who shall act for the contractor when the manager is absent shall be designated in writing to the contracting officer. The contract manager or alternate shall have full authority to act for the contractor on all contract matters relating to daily operation of this contract. The contract manager or alternate shall be available between 7 AM and 5 PM, Monday thru Friday except Federal holidays or when the government facility is closed for administrative reasons. Qualifications for all key personnel are listed below:

· All Key Personnel listed above must show experience in their respective roles as it pertains to installation, monitoring and maintenance of installed filtration system. Experience to be shown in proposal with list of previous work done for similar equipment, setting and location.

1.6.12 Identification of Contractor Employees: All contract personnel attending meetings, answering Government telephones, and working in other situations where their contractor status is not obvious to third parties are required to identify themselves as such to avoid creating an impression in the minds of members of the public that they are Government officials. They must also ensure that all documents or reports produced by contractors are suitably marked as contractor products or that contractor participation is appropriately disclosed.

1.6.13 Contractor Travel: NA

1.6.14 Other Direct Costs: All costs (Direct and Indirect) for this contract must be listed as part of proposal. Costs need to be broken down material unit and labor hour costs.

1.6.15 Data Rights: The Government has unlimited rights to all documents/material produced under this contract. All documents and materials, to include the source codes of any software, produced under this contract shall be Government owned and are the property of the Government with all rights and privileges of ownership/copyright belonging exclusively to the Government. These documents and materials may not be used or sold by the contractor without written permission from the Contracting Officer. All materials supplied to the Government shall be the sole property of the Government and may not be used for any other purpose. This right does not abrogate any other Government rights.

1.6.16 Organizational Conflict of Interest: Contractor and subcontractor personnel performing work under this contract may receive, have access to or participate in the development of proprietary or source selection information (e.g., cost or pricing information, budget information or analyses, specifications or work statements, etc.) or perform evaluation services which may 1.6.17 create a current or subsequent Organizational Conflict of Interests (OCI) as defined in FAR Subpart 9.5. The Contractor shall notify the Contracting Officer immediately whenever it becomes aware that such access or participation may result in any actual or potential OCI and shall promptly submit a plan to the Contracting Officer to avoid or mitigate any such OCI. The Contractor’s mitigation plan will be determined to be acceptable solely at the discretion of the Contracting Officer and in the event the Contracting Officer unilaterally determines that any such OCI cannot be satisfactorily avoided or mitigated, the Contracting Officer may affect other remedies as he or she deems necessary, including prohibiting the Contractor from participation in subsequent contracted requirements which may be affected by the OCI.

1.6.17 PHASE IN /PHASE OUT PERIOD: To minimize any decreases in productivity and to prevent possible negative impacts on additional services, the Contractor shall have personnel on board, during the 30-Day phase in/ phase out periods. During the phase in period, the Contractor shall become familiar with performance requirements in order to commence full performance of services on the contract start date.

PART 2 DEFINITIONS & ACRONYMS

2. DEFINITIONS AND ACRONYMS:

2.1. DEFINITIONS:

2.1.1. CONTRACTOR. A supplier or vendor awarded a contract to provide specific supplies or service to the government. The term used in this contract refers to the prime.

2.1.2. CONTRACTING OFFICER. A person with authority to enter into, administer, and or terminate contracts, and make related determinations and findings on behalf of the government. Note: The only individual who can legally bind the government.

2.1.3. CONTRACTING OFFICER'S REPRESENTATIVE (COR). An employee of the U.S. Government appointed by the contracting officer to administer the contract. Such appointment shall be in writing and shall state the scope of authority and limitations. This individual has authority to provide technical direction to the Contractor as long as that direction is within the scope of the contract, does not constitute a change, and has no funding implications. This individual does NOT have authority to change the terms and conditions of the contract.

2.1.4. DELIVERABLE. Anything that can be physically delivered, but may include non- manufactured things such as meeting minutes or reports.

2.1.5.

2.1.5. KEY PERSONNEL. Contractor personnel that are evaluated in a source selection process and that may be required to be used in the performance of a contract by the Key Personnel listed in the PWS. When key personnel are used as an evaluation factor in best value procurement, an offer can be rejected if it does not have a firm commitment from the persons that are listed in the proposal.

2.1.6. PHYSICAL SECURITY. Actions that prevent the loss or damage of Government property.

2.1.7. QUALITY ASSURANCE. The government procedures to verify that services being performed by the Contractor are performed according to acceptable standards.

2.1.8. QUALITY ASSURANCE Surveillance Plan (QASP). An organized written document specifying the surveillance methodology to be used for surveillance of contractor performance.

2.1.9. QUALITY CONTROL. All necessary measures taken by the Contractor to assure that the quality of an end product or service shall meet contract requirements.

2.1.10. SUBCONTRACTOR. One that enters into a contract with a prime contractor. The Government does not have privity of contract with the subcontractor.

2.1.11. WORK DAY. The number of hours per day the Contractor provides services in accordance with the contract.

2.1.12. WORK WEEK. Monday through Friday, unless specified otherwise.

2.1.13.

2.2. ACRONYMS:

CHS - Central Hospital Supply

CO - Contracting Officer

CONUS - Continental United States (excludes Alaska and Hawaii) COR Contracting Officer Representative COTR - Contracting Officer's Technical Representative

COTS - Commercial-Off-the-Shelf

DFARS - Defense Federal Acquisition Regulation Supplement

DMDC - Defense Manpower Data Center FAR Federal Acquisition Regulation HEFS – Hospital Engineering and Facility Services HIPAA - Health Insurance Portability and Accountability Act of 1996 CO Contracting Officer OCI - Organizational Conflict of Interest

OCONUS - Outside Continental United States (includes Alaska and Hawaii) ODC Other Direct Costs PIPO - Phase In/Phase Out

POC - Point of Contact

PRS - Performance Requirements Summary

PWS - Performance Work Statement

QA - Quality Assurance

QAP - Quality Assurance Program

QASP - Quality Assurance Surveillance Plan

QC - Quality Control

QCP - Quality Control Program

TE - Technical Exhibit

PART 3 GOVERNMENT FURNISHED PROPERTY, EQUIPMENT, AND SERVICES

3. GOVERNMENT FURNISHED ITEMS AND SERVICES:

3.1. Services: The Government will make available applicable service employees (HEFS, CHS personnel, etc.) in order to assist in any information collection required by contractors.

3.2 Facilities: The Government will provide a space free of clutter and government equipment/material storage for installation of the required filtration system equipment.

3.3 Utilities: The Government will provide terminal connections for electrical and water supply as required. The Contractor shall instruct employees in utilities conservation practices. The contractor shall be responsible for operating under conditions that preclude the waste of utilities, which include turning off the water faucets or valves after using the required amount to accomplish cleaning vehicles and equipment.

3.4 Equipment: NA

3.5 Materials: The Government will provide Standard Operating Procedures, policies, equipment information and information on operations as needed to complete installation of water filtration system, and in support of maintaining that system through the life of the contract.

PART 4 CONTRACTOR FURNISHED ITEMS AND SERVICES

4. CONTRACTOR FURNISHED ITEMS AND RESPONSIBILITIES:

4.1 General: The Contractor shall furnish all labor, personnel, equipment, materials, supplies, testing instruments, transportation, tools, materials, supervision, and other items and non-personal services necessary to perform the functions and tasks required in this contract that are not listed under Section 3 of this PWS.

4.2 Secret Facility Clearance: NA

4.3. Materials: The Contractor shall provide all labor, personnel, equipment, materials, supplies, testing instruments, transportation, tools, materials, supervision, and other items and non-personal services necessary to install and maintain materials as required in order to perform water filtration through service deionization.

4.4. Equipment: The Contractor shall provide all labor, personnel, equipment, materials, supplies, testing instruments, transportation, tools, materials, supervision, and other items and non-personal services necessary in order to install and maintain equipment in order to perform water filtration through service deionization system.

4.5.

PART 5 APPLICABLE PUBLICATIONS

5. APPLICABLE PUBLICATIONS (CURRENT EDITIONS)

5.1. The Contractor must abide by all applicable regulations, publications, manuals, and local policies and procedures.

5.2. The Contractor must follow standards as provided by ANSI/AAMI ST108.

PART 7 ATTACHMENT/TECHNICAL EXHIBIT LISTING

7. Attachment/Technical Exhibit List:

7.1. Attachment 1/Technical Exhibit 1 – Performance Requirements Summary

7.2. Attachment 2/Technical Exhibit 2 – Deliverables Schedule

TECHNICAL EXHIBIT 1

Performance Requirements Summary The contractor service requirements are summarized into performance objectives that relate directly to mission essential items. The performance threshold briefly describes the minimum acceptable levels of service required for each requirement. These thresholds are critical to mission success.

Performance Objective

PRS # 1.

Water purification, via filtration, utilizing service deionization system.

- The contractor provided filtration system must provide filtered water via service deionization.

- Standard of purity to be proposed by contractor, accepted by customer, and sustained throughout life of service.

- Validation that installed system works as intended to be provided after install.

- Zero deviation from standard.

Monitoring/alarm system that insures installed equipment is running as required. Validation from contractor required after each maintenance visit and/or component replacement to include tanks.

PRS # 2

Provide ability for users to monitor filtration equipment status.

Audible and/or visual systems alerting users to the following issues

- When the system is operating on reserve tanks and an alarm alerting when the reserve tank has reached critical levels and needs to be replaced.

- If/when provided tanks are leaking and need to be replaced.

- A means to measure and display conductivity of filtered water (to be used in conjunction with testing as required by the objection below)

Zero deviation from standard.

Monitoring system must be made available to customer. Reports on water quality to be given to customer on a recurring basis.

PRS # 3

Quality control services including testing of the steam, utility and critical water in sterile processing rooms.

- QC plan to be provided as part of proposal and/or at beginning of each contract year

- Testing as described in Attachment B.

- Testing frequency as described in Attachment B, Tables # 5 & 6 - vendor must follow ANSI/AAMI ST108 Standards for testing.

- Reports to be provided either quarterly or monthly (Planned frequency of reports to be included in quality control plan)

PRS # 4

Maintenance Services

Maintenance services for equipment and all components installed as part of overall system to be included in contract.

Zero deviation from standard.

Maintenance tickets and completed service call records/logs to be provided to customer after work is completed.

TECHNICAL EXHIBIT 2

DELIVERABLES SCHEDULE

Hospital Engineering and Facility Services Rep and COR

· Gabriel Birriel-Torres Gabriel.birriel-torres@NIH.gov

NIH Bethesda Campus, Bldg. 10 SPS Operations

· BB Avila belinda.avila@Nih.gov

· Gabriel Birriel-Torres Gabriel.birriel-torres@NIH.gov

· BB Avila

Gabriel.birriel-torres@NIH.gov

Gabriel.birriel-torres@NIH.gov