PWS Water Quality Testing_Final.pdf

DHA PWS, FEB 2024

Department of Defense

Defense Health Agency

Performance Work Statement

Sterile Processing Department Monthly and Emergency Water Quality Testing

Naval Medical Center Camp Lejeune

Directorate for Surgical Services

Solicitation Number:

Version: 1

Date: 10 November 2025

PART 1

1.0 GENERAL INFORMATION

1.1. Description of Service/Introduction: The contractor shall provide monthly and emergency water quality testing for Sterile Processing Department (SPD) located at Naval

Medical Center (NMCCL), 100 Brewster Blvd, Camp Lejeune, NC, 28547. The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services necessary to perform monthly and emergency water quality testing as defined in this Performance Work Statement (PWS) except for those items specified as government furnished property and services.

1.2. Background: Water quality is an important consideration in all stages of medical device reprocessing. The Association for the Advancement of Medical Instrumentation (AAMI) ST 108 establishes minimum requirements for water quality and monitoring for water used in medical device reprocessing. The minimum water quality requirements and monitoring established in the

AAMI ST108 are set to prolong the useful life and effective functioning of medical instrumentation and minimize the risk of adverse patient outcomes. Per the AAMI ST 108 and local policy water quality testing must be performed at a minimum monthly and asset pH, Alkalinity, Heterotrophic Bacteria Plate Count, Endotoxin, Total Organic Carbon, Color and

Turbidity, Conductivity, Total Hardness, and Ionic Contaminants to include Aluminum, Chloride, Copper, Iron, Manganese, Nitrate, Phosphate, Sulfate, Silicate, and Zinc. In addition to monthly testing, emergency situations that can’t be planned for arise where we must be able to retest water quality throughout each period of performance to ensure water quality standards are returned to or maintained in a safe range.

1.3. Period of Performance (PoP):

Base: 10 November 2025 – 09 November 2026

Option 1: 10 November 2026 – 09 November 2027

Option 2: 10 November 2027 – 09 November 2028

Option 3: 10 November 2028 – 09 November 2029

Option 4: 10 November 2029 – 09 November 2030

FAR 52.217-8: 10 November 2030 – 09 May 2031

1.4. Objectives: To provide monthly and emergency water quality testing at Naval Medical

Center Camp Lejeune, NC in accordance with AAMI ST 108 standards and local policy.

1.5. Scope: The contractor shall provide Water Quality Collection and Testing. Services include collection, shipping and pick up of water samples at seven (7) locations within the Sterile

Processing Department at Naval Medical Center Camp Lejeune. Either on-site or after pick-up samples are to be tested for pH, Alkalinity, Heterotrophic Bacteria Plate Count, Endotoxin, Total

Organic Carbon, Color and Turbidity, Conductivity, Total Hardness, Ionic Contaminants to include Aluminum, Chloride, Copper, Iron, Manganese, Nitrate, Phosphate, Sulfate, Silicate, and

Zinc at either a company owned or sources laboratory. The contractor shall accomplish Water quality testing in accordance with all Federal, State, and Local laws and regulations. As well as any DHA regulations, instructions, and Joint Commission requirements, which are specified in the Comprehensive Accreditation Manual for Hospitals (CAMH) available at www.jointcommision.org. Any required Defense Health Agency (DHA) regulations and instructions will be made available upon request. The American National Standards Institute

(ANSI) and the Association for the Advancement of Medical Instrumentation (AAMI) is readily available at www.aami.org.

1.6. Federal Regulations: Not Applicable

1.7. Geographical Location: Not Applicable

1.7.1 Place of performance: The work shall be performed at Naval Medical Center Camp

Lejeune, 100 Brewster Blvd, Camp Lejeune, NC 28547 in the Sterile Processing Department.

1.7.2 Recognized Federal holidays: The contractor is not required to perform services on recognized Federal holidays.

New Year’s Day Labor Day

Martin Luther King Jr.’s Birthday Columbus Day

President’s Day Veteran’s Day

Memorial Day Thanksgiving Day

Juneteenth Day Christmas Day

Independence Day

1.7.3 Hours of operation: The contractor is responsible for conducting business Monday thru

Friday 7:00am to 4:00pm 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 contractor must always 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. Samples shall not be collected on Fridays due to risk of shipping delays and subsequent erroneous results.

1.7.4 Emergency Services: On occasion, services may be required to support an activation or exercise of contingency plans outside the normal duty hours.

1.8 Contractor travel: Contractor shall be required to travel to and from Camp Lejeune, NC to collect water samples.

1.9. Quality Control (QC): The contractor shall develop and maintain an effective QC program to ensure services are performed in accordance with this PWS. The contractor shall develop and implement procedures to identify, prevent, and ensure nonrecurrence of defective services. The contractor’s QC program is the means by which the work complies with stated requirements.

The Quality Control Plan (QCP) should be emailed to the contracting officer and COR within 30 days after contract award or with the contractor’s proposal if it is an evaluation factor, a comprehensive written QCP shall be submitted to the Contracting Officer (KO) and COR within

5 working days when changes are made thereafter. After acceptance of the Quality Control Plan

(QCP) the contractor shall receive the CO’s acceptance in writing of any proposed change to his

QC system. See Part 7, Technical Exhibit 1 – Deliverables Schedule.

http://www.aami.org/

1.9.1. Quality assurance (QA): The government will evaluate the contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan (QASP). This plan provides a systematic method for the Government to evaluate performance and 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).

1.10. Contracting Officer Representative (COR): 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 KO 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 regarding 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 contract.

1.11. Contractor Identification: Contractor personnel performing services in a contractor capacity in a government facility are required to possess and wear an identification badge that displays his or her name and the name of their company.

1.11.1. The contractor shall report to Sterile Processing Department (SPD), 100 Brewster Blvd

NH100 room #C151, to SPD Division Officer who has a clear understanding of the contract requirements that will escort the contractor to required location for pick-up or service maintenance before any services are performed under this contract.

1.11.2. After services are completed, the contractor shall report to Sterile Processing Department

(SPD), 100 Brewster Blvd NH100 room #C151, to SPD Division Officer who has a clear understanding of the contract requirements that will verify the work has been completed before departure

PART 2

2.0 SPECIFIC TASK

2.1 General: The Contractor shall obtain base access and provide all materials and equipment required to collect, ship, and test all water samples collected from Sterile Processing Department located at Naval Medical Center Camp Lejeune. Upon completion of collection and testing of samples, Contractor shall provide a comprehensive Monthly Water Quality report of monthly and emergency water quality results by email.

2.1.1 In this system, we would be testing in seven (7) different locations within SPD located at

Naval Medical Center Camp Lejeune. The seven (7) samples will come from two (2) EvoTechs located in C169B, DI Tank in C152, RO Tank in C161, Eye Sink in C169, Main Sink in C169, and the Steam Generation Room.

2.2 Special Qualifications: Testing requirements must be able show readings less than 10

EU/mL.

2.2.1. Government Right of Refusal: Naval Medical Center Camp Lejeune reserves the right to reject any of the Contractor’s personnel and refuse them permission to enter the premises or work on Naval Medical Center Camp Lejeune 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 immigration status.

2.2.2. To travel freely onto and off the military installation at Naval Medical Center Camp

Lejeune, contractors may have to undergo background checks, the ‘Rapid Gate’ process, the

‘Vendor Mate’, and/or the Defense Biometric Identification System (DBIDS) process. A National

Agency Check (NAC) and/or Local Agency Check (LAC) background check or investigation may be required.

2.3. The Contractor Point of Contact (POC). The Contractor shall provide, in writing, the name and telephone number of a primary and alternate, English-speaking, individual to act as their representative for the scheduling and coordination of service calls. The Contractor shall provide, in writing, an escalation process to follow if neither the primary nor alternate representatives can be reached. This escalation process shall also be used in instances when neither the primary representative, the alternate representative, nor the contractors can effectively assist in the troubleshooting of and resolution of a corrective service instance.

2.4. Scheduling: Scheduling of work shall be coordinated via the Sterile Processing Department

Division Officer, NH-100, 1st Floor, 100 Brewster Blvd, Camp Lejeune, NC 28547; 910-449-

2841; Nicole.A.Edwards17.mil@health.mil.

2.4.1. Collection service is required on a routine basis once per month on the 3rd Monday of every month, or the 3rd Tuesday if Monday falls on Federal Holiday.

2.4.2. Emergency Response time: Within two (2) hours of notification by the Sterile Processing

Department, the Contractor shall respond by telephone. The Contractor is expected to render mailto:Nicole.A.Edwards17.mil@health.mil water collection services within 48 hours of notification if notified Monday- Thursday or Next business day if notified Friday-Sunday.

2.4.3. 100% Completion During Hours of Work: Work required in the performance of this contract shall be performed during normal working hours, unless otherwise specified.

2.4.4. Overtime: No overtime services shall be completed without the prior approval of the COR and/or TL. Accordingly, for work determined to be outside of the scope of this agreement, no overtime shall be billed to the Government without prior approval of associated services by the

COR and/or CO.

2.5 Reports: For monthly water quality testing, contractor shall email comprehensive monthly report within 1 week of water collection.

2.5.1 Endotoxin: If Endotoxin result is greater than 10 EU/ml contractor shall notify SPD

Division Officer at 910-449-2841 as soon as result received but no later than 96 hours after water collection.

2.5.2 Heterotrophic Bacteria Plate Count: If Heterotrophic Plate Count is greater than 10 CFU/ml contractor shall notify SPD Division Officer at 910-449-2841 as soon as result received but no later than 48 hours after water collection.

2.5.3 Emergency Water Quality Testing Report: For Emergency Water Quality Testing contractor shall email comprehensive Emergency Water Quality Testing Report within 48 hours of water sample collection.

PART 3

3.0 GOVERNMENT FURNISHED PROPERTY, EQUIPMENT, AND SERVICES

The Requiring Activity Authority has assessed the need for Government Furnished Property, Utilities, and Materials and determined:

3.1. Services: The Government:

☒ Will NOT provide Government Furnished Services in support of this contract/task order. As a result, this paragraph is Not Applicable.

☐ WILL provide Government Furnished Services required in support of this contract/task orders. These

Services are described below:

3.2. Utilities: The Government:

☐ Will NOT provide Utilities in support of this contract/task order. As a result, this paragraph is Not

Applicable.

☒ WILL provide Utilities in support of this contract/task orders. The Government provided Utilities are described below:

The Government will ensure access to water treatment systems and water point-of-water use access points located at Naval Medical Center Camp Lejeune, NC, 28547 in Sterile Processing

Department, NH-100, 1st Floor, Rooms C152, C161, and C169.

3.3. Materials: The Government:

☒ Will NOT provide Materials in support of this contract/task order. As a result, this paragraph is Not

Applicable.

☐ IS providing Materials in support of this contract/task orders. The Government-provided Materials are described below:

PART 4

4.0 CONTRACTOR FURNISHED ITEMS AND SERVICES

4.1. Services: The Contractor:

☐ Will NOT provide Contractor Furnished Services in support of this contract/task order. As a result, this paragraph is Not Applicable.

☒ WILL provide Contractor Furnished Services required in support of this contract/task orders.

These Services are described below: provide Field Service Technician to perform water collection with sufficient experience to demonstrate proficiency in proper collection and processing of laboratory samples.

4.2. General: The contractor shall furnish all supplies, equipment, facilities and services required to perform work listed under Section 2 of this PWS.

4.3. Secret Facility Clearance: N/A

4.4. Materials: The contractor shall provide all materials and supplies that comply with

Federal, State, and municipal specifications required to perform work listed under Part 2 of this

PWS.

4.5. Equipment: The contractor shall furnish all equipment necessary to efficiently and satisfactorily perform the requirements of this contract. The use of Contractor provided two-way radios and cell phones for communication between personnel shall be approved by the Base

Communications activity and may not be used in designated areas in NMCCL. Contractor shall submit a written request to use the radios to the COR. The request shall detail proposed equipment, operating frequencies, and other particulars in writing. The Government shall not be liable for any damages as a result of not permitting the use of radios within the facility.

4.6. Facilities: The contractor shall provide or contract facilities for any sample that needs to be analyzed off-site in order to perform work listed in section of this PWS.

PART 7, ATTACHMENT 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

(The Service required—usually a shall statement from Part 5)

PWS Reference Acceptable Quality Level

(AQL) (This is the maximum error rate. It could possibly be “Zero deviation from standard”)

Method of Surveillance

Performance Requirements

Summary (PRS) # 1.

The contractor shall provide collection services of water samples from 6 Critical Water Point-of-water use access points within

Sterile Processing Department located at Naval Medical Center

Camp LEJEUNE, NC.

PWS Part 2.1.1

100 % of the time

Inspection, Service

Reports

PRS # 2

Monthly Water Quality Report received within 1 week of water collection.

PWS Part 2.5

95% of the time

PRS # 3

Immediate reporting of Endotoxin or Hetertropic Plate Count result out of specified range.

PWS Part 2.5.1 and 2.5.2

PRS # 4

Emergency Response Time:

Telephone contact within 2 hours and onsite within 48 hours.

PWS Part 2.4.2

Customer Complaints, Inspection

PART 7, TECHNICAL EXHIBIT 1

DELIVERABLES SCHEDULE

Deliverable Frequency Medium/Format Submit To Applicable to:

CDRL A001 –

Quality Control Plan

Within 30 days of task order award

Contractors discretion

CDRL A001 to CO All, See PWS 1.9

Monthly Water

Quality Report

Within 1 week of onsite water sample collection

Via Email COR See PWS 2.5

Emergency Water

Quality Testing

Report

With in 48 hours of onsite water collection

Via Email

COR

See PWS 2.5.3.