NEW REQUIREMENT - WATER TESTING - PWS.pdf

DHA PWS Template V13 November 16, 2021

Department of Defense Defense Health Agency

Performance Work Statement

Water Analysis Testing

Hemodialysis

David Grant Medical Center, Travis AFB, California

Solicitation Number:

Version: 1

Date: 10 April 2025

November 16, 2021

PART 1

1.0 GENERAL INFORMATION

1.1 This is a non-personal services contract to provide: annual, monthly, and acute water analysis testing.

1.2 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 analysis testing as defined in this Performance Work Statement (PWS) except for those items specified as government furnished property and services. The contractor shall perform to the standards in this PWS.

1.3 Background: David Grant Medical Center (bldg. 777) located at 101 Bodin Circle, Travis AFB CA 94535 is requesting a 2-year contract for Hemodialysis Environmental Water Analysis Testing. The Central Water Processing (CWP) Unit, the Portable Reverse Osmosis Units and dialysis machines must produce the quality of water defined in © ISO 2020, ® American National Standard Institute (ANSI)/Association for the Advancement of Medical Instrumentation (AAMI) ISO 23500-3:2019 as incorporated by reference Guidance for the Preparation and Quality Management of fluids for Hemodialysis and Related Therapies-Part 3, 4.1-5.3.

Monitoring of each dialysis delivery device must include monthly microbiological and endotoxin testing and annual testing of chemical quality (AAMI Dialysis Analysis) of the product water on each water treatment device (CWP, Portable RO and HD Machines). Testing schedule can be found in © ISO 2020, ® American National Standard Institute (ANSI)/Association for the Advancement of Medical Instrumentation (AAMI) ISO 23500-1:2019 Annex C, C.1, pages 54- 56.

1.4 Objectives: Contracting laboratory will provide all necessary supplies for the collection and shipment of samples. Detailed instructions will be included to ensure the preservation of samples from the time of collection to accession at vendors facility. Contracted vendor must provide pre-paid shipping and accommodate priority and weekend overnight shipping. Contracting laboratory will update Korus Web Application upon receipt of received specimens within 24 hours of initial delivery (see example #Section 6-Received Date). A verbal report (by phone) will be given by Spectra Lab personnel for any abnormal result (s) to Lead Dialysis Technician, assigned Alternate or Charge Nurse on duty). Furthermore, final results will be available through Kours NLT four (4) days (routine testing) and seven (7) days (AAMI testing) after initial report.

Spectra Laboratories, Korus Web Application must provide copies of all analytical data performed on behalf of the David Grant Medical Center that includes minimum/maximum detection limits for the contaminants being analyzed and that the laboratory is reporting the data using AAMI guidelines and meeting all established standards.

1.5 Scope: Water analysis testing. Services include AAMI water analysis (tests included- Aluminum, Antimony, Arsenci, Barium, Beryllium, Cadmium, Calcium, Chromium, Copper, Lead, Magnesium, Mercury, Potassium, Selenium, Silver, Sodium, Thallium, Zinc, Fluoride, Nirate and Sulfates), Environmental Culture (Water and/or Dialysate), Colony Count (Water and/or Dialysate), Endotoxin (Water and/or Dialysate), and Organism ID (Water and/or

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Dialysate). The contractor shall accomplish testing of dialysis water to AAMI standards, deliver supplies at no extra charge with a unique and easy-to-tray packaging system that is specifically designed to protect the integrity of the specimens during transit. The contractor additionally supplies all specimen collection cups, specimen tubes, ice packs, and sealing bags to ensure leakage is contained. All testing materials can be ordered through Spectra Lab at www.spectra-labs.com/supply-order-form using customer login and account number.

1.6 Period of Performance (PoP):

Base Year: 7 Jul 2025 – 6 Jul 2026 Option Year 1: 7 Jul 2026 – 6 Jul 2027 Option Year 2: 7 Jul 2027 – 6 Jul 2028 Option Year 3: 7 Jul 2028 – 6 Jul 2029 Option Year 4: 7 Jul 2029 – 6 Jul 2030 6 Month Ext: 7 Jul 2030 – 6 Jan 2031

1.7 Administrative specifications

1.7.1 Place of performance: The work shall be performed at Specimen Handling, Spectra Laboratories, 1280 Stateline Road East, Southaven MS 38600.

1.7.2 Recognized Federal holidays: The contractor will perform testing on all federal holidays and support the DGMC Dialysis Hours of operation 24/7, weekends and 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 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 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.

1.8 Quality

1.8.1 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 Contractor’s QCP must be delivered to the CO within 30 days after contract is awarded.

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 6, Attachment 4 -

CDRL A001

November 16, 2021

1.8.2 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).

1.8.3 The Contractor's standard quality control practices are expected to ensure services are performed in accordance with commonly accepted commercial practices, and include procedures to identify, prevent, and ensure nonperformance and continual repeat of defective service does not occur.

1.8.4 The Quality Assurance Personnel will ensure that standards of delivery and quality of services are maintained in accordance with the PWS.

1.9 Reporting

1.9.1 Government’s 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 CO 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 contract.

1.9.2 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 FAR Subpart 42.5. The CO, COR, and other Government personnel, as appropriate, may meet periodically with the contractor to review the contractor's performance.

At these meetings the CO 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.

1.10 Contractor Identification

1.10.1 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. All contractor personnel shall identify themselves as contractor support personnel in all forms of communication with all entities with whom DHA/Deputy Assistant Director for Acquisition (DAD-A)/Head of the Contracting Activity (HCA) has business dealings. The contractor shall: Answer all telephone calls and have a personalized

November 16, 2021 voice message with an introductory statement that includes the fact that the person is contractor support personnel. Ensure all those with whom the person interacts in any face-to-face dealings while supporting the DAD-A understands that the person is contractor support personnel.

Include a title block in all emails that states the fact that the person is contractor support personnel. Ensure all those with whom the person interacts in any face-to-face dealings while supporting DHA/DAD-A/HCA understands that the person is contractor support personnel.

1.10.2 Contractor personnel will be required to attend meetings or otherwise communicate with Government and/or other contract representatives to meet the requirements of this order.

Contractor personnel shall make their contractor status known during introductions.

1.10.3 Contractor personnel, while performing in a contractor capacity, are prohibited from using their retired or reserve component military rank or title in any written or verbal communications associated with the contracts in which they provide services.

1.11 Mission Essential

1.10.1 In accordance with DFARs 252.237-7023 Continuation of Essential Contractor Services, David Grant Medical Center has confirmed the services outlined in this PWS are considered mission/emergency essential. Inability to secure services in a timely manner can cause compliance violations and impair the provision of patient care. These services are in direct support of mission essential functions for DGMC, Travis AFB.

1.10.2 Continuity of Services: Contractor will promptly notify DGMC if Contractor is unable provide an ordered product or service. The DGMC retains the right to seek these services elsewhere should services not be provided by the Contractor.

November 16, 2021

Part 2

2.0 GENERAL INFORMATION

2.1 Contracting Authority:

2.1.1 The contractor shall only accept instructions from the Contracting Officer (CO). The CO is the only authorized individual with the authority to modify or make changes to performance under this contract.

2.2 Exclusions:

2.2.1 No Preventive Maintenance or Repairs: Preventive maintenance and repair services are not included with the subscription.

2.2.2 Replacement parts are not covered under this agreement.

PART 2

2.0 DEFINITIONS, ACRONYMS, AND APPLICABLE

PUBLICATIONS/INSTRUCTIONS

2.1 Definitions:

2.1.1 Contracting Officer (CO): A person with the authority to enter into, administer, and/or terminate contracts and make related determinations and findings.

2.1.2 Contracting Officer’s Representative (COR): An individual, including a contracting officer’s technical representative (COTR), designated and authorized in writing by the CO to perform specific technical or administrative functions. This individual does NOT have authority to change the terms and conditions of the contract.

2.1.3 Dialysate: a balanced solution used during hemodialysis that contains various electrolytes and a buffer, such as bicarbonate, to help maintain the body's electrolyte balance.

2.1.4 Nonpersonal services contract: a contract under which the personnel rendering the services are not subject, either by the contract’s terms or by the manner of its administration, to the supervision and control usually prevailing in relationships between the Government and its employees.

2.2 Acronyms:

AAMI Association for the Advancement of Medical Instrumentation AIS Automated Information System ANSI American National Standard Institute APL Approved Products List APL

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AQL Acceptable Quality Level CO Contracting Officer(s) COR Contracting Officer Representative COTR Contracting Officer’s Technical Representative CWP Central Water Processing DAD-A Deputy Assistant Director for Acquisition DGMC David Grant Medical Center DHA Defense Health Agency FAR Federal Acquisition Regulation HCA Head of Contracting Activity HCW Health Care Worker HD High Definition HIPAA Health Insurance Portability and Accountability Act ID Identification ISO International Organization for Standardization MDG Medical Group MTFs Military Treatment Facilities NLT No Later Than PoP Period of Performance PWS Performance Work Statement QA Quality Assurance QASP Quality Assurance Surveillance Plan QC Quality Control QCP Quality Control Plan RO Reverse Osmosis US United States

2.3 Applicable Publications, DHA Administrative Instructions (AI), etc.

Applicable Publications (Current Editions): The Contractor shall abide by all applicable regulations, publications, and manuals. Following is a list of basic publications applicable to the PWS. The most current version of the publication applies. Publications not on the internet or MTF policies and procedures can be obtained from the MTF. Current issues of publications and links to other service publications can be accessed at the following websites:

http://www.apd.army.mil/ http://www.defenselink.mil/pubs http://www.dtic.mil/whs/directives/ http://www.e-publishing.af.mil

Contractors are obligated to follow these codes as mandatory only to the extent that they apply to the contract.

November 16, 2021

Supplements, amendments, or changes to these mandatory publications may be issued during the life of the contract.

Advisory publications may be used for information and guidance but are not binding for compliance.

2.4 Payment Method

Government Wide Commercial Purchase Card (GCPC) is an authorized form of payment for all services invoiced against BPA. Vendors must email invoices to below CORS to ensure payment is authorized.

EMAIL INVOICE TO:

usaf.travis.60-mdg.mbx.60-mdg-sgslb-contract-management@health.mil (org box) Keshia Dornish, keshia.r.dornish.mil@health.mil (707) 423-7628 Samuel Upham, samuel.d.upham.mil@health.mil, (707) 423-5185 Courtney Stewart, courtney.l.stewart19.mil@health.mil, (707) 423-7630 Francis Ramos, franciskeil.m.ramos.mil@health.mil, (707) 423-7613

DEPARTMENT OF DEFENSE (DoD) REGULATIONS/MANUALS

INSTRUCTIONS/DIRECTIVES

PUB NO. TITLE

DoDD 5500.7 Standards of Conduct DoDI 5400.7-R Freedom of Information Act DoD 6025.18-R Health Information Privacy Regulation Jan 03 DoDD 8500.1 Information Assurance DoD 8580.02-R HIPAA Security Rule DODI 3020.37 Continuation of Essential DOD Contractor Services During Crises AFI 33-332 Air Force Privacy and Civil Liberties Program DHA-IPM 18-013 Interim Procedures 18-013, Risk Management Framework DFARS 239.7602-2 Required Storage of Data within the United States or Outlying Areas

AIR FORCE INSTRUCTIONS/MANUALS

Publications Code:

DAFI—Department of the Air Force Instruction DAFMAN- Department of the Air Force Manual AFP--Air Force Pamphlet AF Form--Air Force Form DD Form--Department of Defense Form MDGI – Medical Group Instruction

Pre-Market Approval Section 510(k) of the Food, Drug and Cosmetic Act requires In Vitro device manufacturers to register with the FDA at least 90 days in advance of their intent to market a medical device. This is known as Premarket Notification - also called PMN or 510(k).

Must be in compliance with Section 510(k) of the Federal Food, Drug, and Cosmetic Act for mailto:franciskeil.m.ramos.mil@health.mil

November 16, 2021 those medical device products intended to be delivered to the Government. Only devices that have received Premarket Notification Approval from the U.S. Food and Drug Administration (FDA) shall be considered for award under this solicitation.

November 16, 2021

PART 3

3.0 GOVERNMENT FURNISHED PROPERTY, EQUIPMENT, AND SERVICES

The Requiring Activity Authority has assessed the need for Government Furnished Property, Equipment, and Services 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.

3.2 Facilities: The Government:

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

3.3 Utilities: The Government:

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

3.4 Equipment: The Government:

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

November 16, 2021

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.

4.2 General: The contractor shall furnish all supplies, equipment, facilities and services required to perform work listed under Section 5 of this PWS.

November 16, 2021

PART 5

5.0 SPECIFIC TASKS

5.1 Water Analysis Testing: The contractor shall provide services to conduct testing of dialysis water to Association for the Advancement of Medical Instrumentation (AAMI) Standards. The following tests will be ordered on all testable dialysis equipment (Central Water Processing Unit, Dialysate Mixer, Hemodialysis Machines and Portable Reverse Osmosis Units-approximately 40 items):

A. Annual Testing (includes monthly testing requirements)-

a. AAMI Water Analysis (tests included- Aluminum, Antimony, Arsenic, Barium, Beryllium, Cadmium, Calcium, Chromium, Copper, Lead, Magnesium, Mercury, Potassium, Selenium, Silver, Sodium, Thallium, Zinc Fluoride, Nitrate and Sulfates)

b. Environmental Culture (Water and/or Dialysate)

c. Colony Count (Water and/or Dialysate)

d. Endotoxin (Water and/or Dialysate)

e. Organism ID (Water and/or Dialysate) - may not be applicable but must be ordered. Spectra Lab will cancel request if “no growth from colony count’ is provided as the result.

B. Monthly Testing (required tests)-

a. Endotoxin (Water and/or Dialysate)

b. Colony Count (Water and/or Dialysate)

c. Organism ID (Water and/or Dialysate)- may not be applicable but must be ordered. Spectra Lab will cancel request if “no growth from colony count’ is provided as the final result.

5.2 Tests may also be ordered out of cycle due to unexpected issues with dialysis water or centennial events with the dialysis patient or equipment (see attached list of AAMI recommended water treatment testing requirements and testing fees).

5.3 The contractor will deliver supplies, at no extra charge, a unique and easy-to tray packaging system that is specifically designed to protect the integrity of the specimens during transit. The contractor additionally supplies all specimen collection cups, specimen tubes, ice packs, and sealing bags to ensure leakage is contained. All testing materials can be ordered through Spectra Lab at www.spectra-labs.com/supply-order-form using customer login and account number.

5.4 Access to a web-based application (Korus) for detailed specimen test requisitions, specimen labels, results, summaries, and reports.

5.5 Specimens are sent with pre-paid shipping (FedEx and UPS) from the DGMC Hemodialysis Unit to the vendor within 8 hours of collection (all tests are time sensitive and must be accessioned within 24 hours of collection).

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PART 7, ATTACHMENT 1

PERFORMANCE REQUIREMENTS SUMMARY

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 deliver supplies, at no extra charge, a unique and easy-to tray packaging system that is specifically designed to protect the integrity of the specimens during transit.

PWS Part 5. Para 5.3 100% of the time Random Inspection

PRS # 2

The contractor must accession all specimens within 24 hours of collection

PWS Part 5. Para 5.5 100% of the time Random Inspection

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PART 7, ATTACHMENT 2

PRODUCTS AND SERVICES

A. Annual Testing (includes monthly testing requirements):

a. AAMI Water Analysis (tests included- Aluminum, Antimony, Arsenic, Barium, Beryllium, Cadmium, Calcium, Chromium, Copper, Lead, Magnesium, Mercury, Potassium, Selenium, Silver, Sodium, Thallium, Zinc Fluoride, Nitrate and Sulfates)

b. Environmental Culture (Water and/or Dialysate)

c. Colony Count (Water and/or Dialysate)

d. Endotoxin (Water and/or Dialysate)

e. Organism ID (Water and/or Dialysate) - may not be applicable but must be ordered. Spectra Lab will cancel request if “no growth from colony count’ is provided as the result.

B. Monthly Testing (required tests):

a. Endotoxin (Water and/or Dialysate)

b. Colony Count (Water and/or Dialysate)

c. Organism ID (Water and/or Dialysate)- may not be applicable but must be ordered. Spectra Lab will cancel request if “no growth from colony count’ is provided as the final result.

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PART 7, ATTACHMENT 6

ESTIMATED WORKLOAD DATA

ITEM NAME ESTIMATED QUANTITY

1 Tests 40 Annually

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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 1.10.1