36C25725Q0427.pdf

PAGE 1 OF 1. REQUISITION NO.

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NO. 5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

a. NAME b. TELEPHONE NO. (No Collect Calls) 8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY CODE 10. THIS ACQUISITION IS UNRESTRICTED OR SET ASIDE: % FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ IFB RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE

17a. CONTRACTOR/OFFEROR CODE FACILITY CODE 18a. PAYMENT WILL BE MADE BY CODE

TELEPHONE NO. UEI: EFT:

PHONE: FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19. 20. 21. 22. 23. 24.

ITEM NO. SCHEDULE OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA 26. TOTAL AWARD AMOUNT (For Govt. Use Only)

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA ARE ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________ 29. AWARD OF CONTRACT: REF. ___________________________________ OFFER COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DATED ________________________________. YOUR OFFER ON SOLICITATION DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY (BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION (REV. NOV 2021)

PREVIOUS EDITION IS NOT USABLE Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

36C25725Q0427 04-07-2025

Mr. Shawn R. Reinhart 254-421-6661 05-09-2025

09:00 CDT

36C257

Department of Veterans Affairs Central Texas Veterans HCS 1901 Veterans Memorial Dr. Building #171 Temple TX 76504

X 100

X

221310

$41 Million

N/A

X

36C671

Department of Veterans Affairs South Texas Veterans HCS 7400 Merton Minter St.

San Antonio TX 78229

Department of Veterans Affairs Central Texas Veterans HCS 1901 Veterans Memorial Dr. Building 171

This is accomplished through the Tungsten Network located at:

http://www.fsc.va.gov/einvoice.asp This is mandatory and the sole method for submitting invoices.

(877) 353-9791 (512) 460-5540

See CONTINUATION Page

The Contractor shall provide Sterile Processing Systems testing, maintenance, and repair of sterile processing water systems testing IAW the Statement of Work (SOW).

This acquisition is being conducted IAW FAR Parts 12 and 13.

Period of Performance Base Year: 30 June 2025 – 29 June 2026 1st Option Year: 30 June 2026 – 29 June 2027 2nd Option Year: 30 June 2027 – 29 June 2028 3rd Option Year: 30 June 2028 – 29 June 2029 4th Option Year: 30 June 2029 – 29 June 2030

Refer to Addendum to FAR 52.212-1, Instructions to Offerors on pages 34 to 35.

Refer to Addendum to FAR 52.212-2, Evaluation on pages 39 to 41.

See CONTINUATION Page

X X

X 1

Mr. Shawn R. Reinhart Contracting Officer

36C25725Q0427

Table of Contents

SECTION A

A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

B.3 DELIVERY SCHEDULE

B.4 STATEMENT OF WORK

SECTION C - CONTRACT CLAUSES

C.1 ADDENDUM TO 52.212-4 CONTRACT TERMS AND CONDITIONS –

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

C.2 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.3 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.4 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

C.5 SUPPLEMENTAL INSURANCE REQUIREMENTS

C.6 VAAR 852.219-73 VA NOTICE OF TOTAL SET-ASIDE FOR CERTIFIED

SERVICE-DISABLED VETERAN-OWNED SMALL BUSINESSES (JAN 2023)

(DEVIATION)

C.7 VAAR 852.219-75 VA NOTICE OF LIMITATIONS ON SUBCONTRACTING—

CERTIFICATE OF COMPLIANCE FOR SERVICES AND CONSTRUCTION (JAN

2023) (DEVIATION)

C.8 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020)

C.9 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO

IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES (JAN 2025)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 ADDENDUM to 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

E.2 52.201-1 ACQUISITION 360: VOLUNTARY SURVEY (SEP 2023)

E.3 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT

2018)

E.4 52.216-1 TYPE OF CONTRACT (APR 1984)

E.5 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.6 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE

RESOLUTION (OCT 2018)

E.7 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

E.8 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE

(FEB 1998)

E.9 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2021)

E.10 ADDENDUM to 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES

E.11 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (MAY 2024)

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C257

Department of Veterans Affairs Central Texas Veterans HCS 1901 Veterans Memorial Dr. Building #171

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

[X] 52.232-33, Payment by Electronic Funds Transfer—System For Award

Management

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] Monthly

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

AMENDMENT NO DATE

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT

UNIT

PRICE AMOUNT

12.00 MO _________ _________

Audie Murphy SPS - 7400 Merton Minter Blvd, San Antonio, TX.

Contract Period: Base POP Begin: 06-30-2025 POP End: 06-29-2026

12.00 MO ________ _________

Dental SPS - 8410 Data Point Rm 110, San Antonio, TX

Contract Period: Base

Kerrville SPS - 3600 Memorial Blvd., Kerrville, TX

Northwest Healthcare Center SPS - 9939 State Hwy 151, San

Antonio, TX

Contract Period: Base

1.00 YR _________ _________

Emergency Services - Repairs - Additional Testing

This Line Item MUST be approved by the CO/COR prior to any work being performed.

This is a not to exceed amount per year of $20,000.00.

Contract Period: Base

Retained Services of Certified Water Treatment Specialist

10.00 EA _________ _________

Base Year Only. The installation and continuous monitoring of up to 10 new point of use test ports for potential points-of-use testing at all 4 sites (Audie Murphy, Data Point, NWHCC and

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT

UNIT

PRICE AMOUNT

Kerrville) for pH, hardness, conductivity readings.

Invoicing will be based on actuals.

Contract Period: Base POP Begin: 06-30-2025

TX.

Contract Period: Option 1 POP Begin: 06-30-2026 POP End: 06-29-2027

Contract Period: Option 1

Antonio, TX

Contract Period: Option 1

This Line Item MUST be approved by the CO/COR prior to any work being performed.

This is a not to exceed amount per year of $20,00.00.

Contract Period: Option 1

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT

UNIT

PRICE AMOUNT

TX.

Contract Period: Option 2 POP Begin: 06-30-2027 POP End: 06-29-2028

Contract Period: Option 2

Antonio, TX

Contract Period: Option 2

This Line Item MUST be approved by the CO/COR prior to any work being performed.

This is a not to exceed amount per year of $20,00.00.

Contract Period: Option 2

TX.

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT

UNIT

PRICE AMOUNT

Contract Period: Option 3 POP Begin: 06-30-2028 POP End: 06-29-2029

Contract Period: Option 3 POP Begin: 06-30-2028 POP End: 06-29-2029\

Antonio, TX

Contract Period: Option 3

This Line Item MUST be approved by the CO/COR prior to any work being performed.

This is a not to exceed amount per year of $20,00.00.

Contract Period: Option 3

12.00 MO _________ ________

TX.

Contract Period: Option 4 POP Begin: 06-30-2029 POP End: 06-29-2030

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT

UNIT

PRICE AMOUNT

Contract Period: Option 4 POP Begin: 06-30-2029

Contract Period: Option 4

Antonio, TX

Contract Period: Option 4

1.00 YR ________ _________

This Line Item MUST be approved by the CO/COR prior to any work being performed.

This is a not to exceed amount per year of $20,00.00.

Contract Period: Option 4

12.00 MO ________ __________

Contract Period: Option 4

GRAND

TOTAL

B.3 DELIVERY SCHEDULE

ITEM

NUMBER SHIPPING INFORMATION QUANTITY

DELIVERY

DATE

0001-

SEE SOW SEE

SCHEDULE

B.2

SEE

SCHEDULE

B.2

B.4 STATEMENT OF WORK

Sterile Processing Services (SPS) Water Testing

1. BACKGROUND. South Texas Veterans Healthcare System facilities have Sterile Processing Systems requirement for testing, maintenance, and repair of sterile processing water systems.

SPS is a critical part of any Hospital as it ensures all clinical departments have a readily available supply of sterile equipment. One of the key pieces of equipment supporting any SPS is the direct critical water supply to SPS personnel and equipment.

1.1 The updated AAMI ST108:2023 Standard, which governs the processes and requirements for Sterile Processing, added requirements to the roster of locations needing monthly critical water sampling. Per the standard, the requirement to test critical water at “every point of use” has significantly raised the quantity of water samples needed each month. Current water sampling contracts only cover the bare minimum of testing locations at the source of Critical Water systems. ALL TABLE NUMBERS IN THE SOW ARE THE APPROPRIATE TABLE

FROM ANSI/AAMI ST108:2023.

2. SCOPE OF WORK. The purpose of this service is to provide for the testing of water, maintenance, and repair of water systems to ensure effective water quality for processing medical devices. The testing shall include testing of utility water, critical water and steam per guidance published in ANSI/AAMI ST108:2023, Water for the Processing of Medical Devices. In the event that ST108 is updated during the life of the contract the Contractor shall use the most recent version unless informed differently.

2.1 ST108:2023 (ST108) covers the minimum requirements for the quality of water and steam purity necessary to effectively process medical devices. The VHA may require more stringent requirements or more frequent testing and maintenance of water systems for processing medical devices in addition to the minimum requirements called out in ST108; however, the ST108 is the current guidance used by the VHA.

2.2 PERIOD OF PERFORMANCE.

Base Year: 30 June 2025 – 29 June 2026 1st Option Year: 30 June 2026 – 29 June 2027 2nd Option Year: 30 June 2027 – 29 June 2028 3rd Option Year: 30 June 2028 – 29 June 2029 4th Option Year: 30 June 2029 – 29 June 2030

3. CONTRACTOR RESPONSIBILITY. The Contractor shall maintain and repair the sterile processing equipment related to critical water production and the steam supported sterilization system equipment. The work shall include required maintenance, change of Deionized (DI) Tanks, system filters and Reverse Osmosis (RO) membrane changes and water testing per the frequencies noted in ST108. The Contractor shall perform quarterly RO system sanitization, Distribution Loop sanitization and replace RO membrane on quarterly basis. The locations for these services are listed below in paragraphs 3.1.4 through 3.2.4.

3.1 The Contractor shall provide all labor, materials, tools, equipment, applicable state licenses and permits to accomplish the requirements.

3.1.1 The Contractor shall provide all testing requirements as outlined by ST108 for testing quantity guides.

3.1.2 The Contractor shall provide a fully qualified Laboratory for processing of water samples to meet all metrics of ST108-2023. The Contractor shall ensure all laboratory certificates, credentials and capabilities are provided to the Contracting Officers Representative (COR).

3.1.3 The Contractor shall follow testing frequencies as described in ST108. For any testing completed, provide the results/reports back to the VHA as soon as possible after completion.

3.1.4 The Contractor shall conduct a monthly water monitoring program as described for the following locations:

3.1.4.1 Audie Murphy SPS - 7400 Merton Minter Blvd, San Antonio, TX

• Perform all testing per the reference tables in ST108.

• Perform all tests to comply with the frequencies required and listed in the associated

ST108 tables.

• Maintain the VA’s RO system and all supplied distribution equipment.

• Provide DI and carbon tanks, scale inhibitor as required.

• Perform quarterly RO system sanitization, Distribution Loop sanitization and replace RO membrane on quarterly basis.

• Provide DI service tanks for the sanitary sinks within SPS.

• Provide monthly quality report when tanks are exchanged.

• Provide monthly testing and service report.

3.1.4.2 Dental SPS - 8410 Data Point Rm 110, San Antonio, TX

• Perform all testing per the reference tables in ST108.

• Perform all tests to comply with the frequencies required and listed in the associated

ST108 tables.

• Maintain the VA’s RO and all supplied distribution equipment.

• Provide monthly DI and carbon tanks, scale inhibitor.

• Perform quarterly RO system sanitization, Distribution Loop sanitization and replace RO membrane on quarterly basis.

• Provide monthly testing and service report.

3.1.4.3 Kerrville SPS - 3600 Memorial Blvd., Kerrville, TX

• Perform all tests to comply with the frequencies required and listed in the associated

ST108 tables.

• Perform quarterly Distribution Loop Sanitization.

• Provide monthly quality report when tanks or equipment are exchanged.

• Provide monthly testing results and service report.

3.1.4.4 Northwest Healthcare Center SPS - 9939 State Hwy 151, San Antonio, TX

• Perform all tests to comply with the frequencies required and listed in the associated

ST108 tables

• Maintain VA’s RO and all supplied distribution equipment.

• Review all logged daily readings to ensure all components are operating correctly.

• Provide DI and carbon tanks, scale inhibitor.

• Perform quarterly RO system sanitization, Distribution Loop sanitization and replace RO membrane on quarterly basis.

• Provide DI service tanks for the sanitary sinks within SPS.

• Provide monthly testing results service report.

3.2 CRITICAL WATER TEST POINTS OF USE BY LOCATION

3.2.1 Audie Murphy Location. Testing points shall be in SPS Decontamination Area:

• 4 Sinks (Final Rinse Sinks)

• Washer Location (Test port in cabinet adjacent to Washer Units)

• Cart Washer (Test port in closet adjacent to the cart washer bay)

• Distribution Loop-Out Test Point.

• Distribution Loop-In Test Point.

• Ultrasonic Test Port

3.2.2 Datapoint Location (Dental Services)

• Loop Out prior to equipment

• RO Machine port

3.2.3 Northwest Health Care Center - 151

• 2 Sinks (Final Rinse Sinks)

• Washer Location

• Loop Test Point near Ultrasonic system

• RO Machine Room (processed) tap

3.2.4 Kerrville Division

• Test port after DI System

• 2 Sinks

3.3 The Contractor shall provide a sampling of the utility or supply water at each monthly testing date.

3.4 The Contractor shall provide a rapid means of immediate shipping of all water samples to the approved laboratory.

3.5 The Contractor shall provide a consolidated monthly report of all sample locations, results, parameters on a single report.

3.6 The Contractor shall provide immediate notification of any positive samples over the bacteria and endotoxin threshold per ST108.

3.7 The Contractor shall provide an annual balance of Emergency / On-call tests for any locations that require re-testing or per direction of VA.

3.8 The Contractor shall ensure Contractor staff adhere to all PPE requirements when testing in PPE required areas.

3.9 The Contractor shall ensure Contractor staff conduct a thorough test-location wipe down with alcohol wipes and utilizes latex or vinyl gloves to avoid accidental contamination of sample.

3.10 The Contractor shall ensure contracted staff personnel conduct flushing and sampling per Annex H, paragraph H.5. of ST-108.

3.11 The Contractor shall enforce a strict chain of custody of sampling so that samples are secured and shipped by one dedicated technician.

3.12 The Contractor shall immediately notify VA of any breach in chain of custody or shipping issues that would render the samples un-usable.

3.13 The Contractor shall coordinate with VA on providing re-tests.

3.14 The Contractor shall verify all existing utility installations and take appropriate action prior to working in the vicinity of utility services (electrical, plumbing, HVAC equipment).

3.15 The Contractor’s policies and procedures shall comply with VA Privacy and Security policy, the Privacy Act and Health Insurance Portability and Accountability Act (HIPAA).

3.16 The Contractor’s personnel shall obtain a short-term identification badge issued by the VA designee.

3.16.1 The badge shall be worn by the individual and prominently displayed while on VA property.

3.16.2 No employee of the Contractor shall enter the project site without a valid identification badge issued by the VA.

3.16.3 To obtain a short-term identification badge, Contractor personnel shall present to the VA designee a valid (non-expired) photo identification issued by a US federal, State, or local government agency.

3.17 The Contractor shall deliver sufficient technical documentation with all data deliverables to permit the VA to use the data.

3.18 The Contractor shall include Certified Water Treatment Specialist for supporting integration, qualification and validation of water treatment equipment and testing.

3.19 The Contractor shall install up to 10 additional test ports for potential points-of-use testing during the period of performance.

3.20 The Contractor shall install monitoring in-line devices for daily measuring/water monitoring of pH and conductivity.

3.21 The Contractor shall only follow guidance as provided by the Contracting Officer assigned and coordinate all work with the Contracting Officer’s Representative (COR).

4. CONTRACTOR AVAILABILITY AND RESPONSE. The Contractor shall be available for servicing equipment 24 hours a day/7 day a week. The Contractor shall promptly reply and respond within 24 hours of initial telephone call notification placed for any of the SPS facilities.

For equipment that belongs to the VA, the Contractor shall have no obligation to repair or replace parts that fail due to external causes, accidents not attributed to the Contractor, vandalism, natural disaster, power failures; abuse, misuse, or neglect of accessories; usage not in accordance with the product instructions; or servicing or repair not authorized by the Contractor.

5. MAJOR REPAIRS/DISRUPTION. Following any non-routine, major repairs/maintenance work where the distribution loop or key equipment has been disrupted, disconnected/replaced— the Contractor shall be required to thoroughly sanitize any supply lines, and perform RO sanitization service and distribution loop sanitization service (Ozone Storage and Sanitization, Set-up, and oxygen) on the sterile processing system. The Contractor shall perform three (3) consecutive validation tests after any major maintenance or disruptions of services to confirm the bacteria count is following ST108 water quality standards. The Contractor shall perform bacteria tests three (3) consecutive days, day one (1) test followed by two (2) more validation tests for day two (2), day three (3) to ensure the system is ready to use for sterile processing.

6. SAMPLING REQUIREMENTS. The Contractor shall refer to the below tables for sampling requirements required by ST108 testing for utility water, critical water, and steam.

6.1 Three (3) categories of water quality per ST 108. Three (3) categories of water quality in terms of the characteristics that are important for medical device processing and the level of treatment that may be needed.

6.1.1 Utility Water: Water as it comes from the tap that can require further treatment at the facility to achieve water quality measurement values outlined in Table 1. This water is mainly used for flushing, washing, and intermediate rinsing (e.g., rinsing between cleaning and disinfection).

6.1.2 Critical Water: Water that meets the water quality measurement values detailed in Table 1; to achieve these values, the water generally requires extensive treatment by a multi-step process that can include a pretreatment, does include primary treatment (e.g., RO and/or DI), storage, distribution, and can include final treatment to provide a level of assurance that microorganisms and inorganic and organic material are removed from the water. This water is mainly used for the final rinse after high-level disinfection, for the final rinse for critical devices prior to sterilization and feedwater for process steam production.

6.1.3 Steam: vaporized water that is produced by a centralized boiler or a generator/heat exchanger near the sterilizer. When the steam is tested as a condensate, it should meet the specified criteria as defined in Table 2 below.

Table 2 ST108 Categories and performance qualification levels of water quality for medical device processing

Water Quality Measurement

Units

Utility Water

Critical Water

Steam* pH @ 25 °C: pH 6.5 – 9.5 5.0 – 7.5 5.0 – 9.2** Total Alkalinity mg CaCO3/L <400 <8 <8 Bacteria CFU/mL <500*** <10 N/A Endotoxin EU/mL N/A*** <10 N/A Total Organic Carbon (TOC) mg/L (ppm) N/A <1.0 N/A

Color and Turbidity

Visual Colorless, clear, without sediment

Colorless, clear, without sediment

Colorless, clear, without sediment

Ionic Contaminants Aluminum mg/L <0.1 <0.1 <0.1 Chloride mg/L <250 <1 <1 Conductivity μS/cm <500 <10 <10 Copper mg/L <0.1 <0.1 <0.1 Iron mg/L <0.1 <0.1 <0.1 Manganese mg/L <0.1 <0.1 <0.1 Nitrate mg/L <10 <1 <1 Phosphate mg/L <5 <1 <1 Sulfate mg/L <150 <1 <1 Silicate mg/L <50 <1 <1 Total Hardness mg CaCO3/L <150**** <1 <1 Zinc mg/L <0.1 <0.1 <0.1

* Steam parameters are for monitoring as steam condensate ** For local steam generation, the condensate pH should be 5.0 to 7.5. For boiler-treated steam, most boilers should be treated to maintain a condensate pH of 7.5 to 9.2 *** When Utility Water is used after chemical high-level disinfection as a final rinse, the bacteria should be <10 CFU/mL and endotoxin <10 EU/mL **** If hardness is greater than 150 mg/L a water softener is recommended unless used for washing where the cleaning chemistry is capable of handling higher levels of hardness NOTE: See ST108, Annex D for additional information.

6.1.4 Utility Water is predominantly used for medical device processing, except for final rinse, where Critical Water is recommended. At the point of production, Utility Water and Critical Water shall meet the requirements as specified in Table 2. Tap water can require treatment to meet these requirements. The bacteria level for Critical Water in Table 2 (< 10 CFU/mL [< 10,000 CFU/L]) is consistent with the Clinical & Laboratory Standards Institute (CLSI) guidelines.

6.2 Water Quality and Equipment Maintenance.

6.2.1 The Contractor shall ensure water quality and equipment maintenance requirements are compliant with the guidelines and parameters established by ST108.

6.2.2 The Contractor shall provide for a monitoring and maintenance process to ensure compliance with the defined compliance parameters and associated frequencies as defined in Table 4, below from ST-108.

Table 4 ST108 Table for Water Quality monitoring requirements.

Water Quality Measurement

Units Utility Water Critical Water Steam* pH @ 25 °C: pH 6.5 – 9.5 5.0 – 7.5 5.0 – 9.2** Conductivity μS/cm <500 <10 <10 Total Alkalinity mg CaCO3/L <400 <8 <8 Total Hardness mg CaCO3/L <150 <1 <1 Bacteria CFU/mL <500 <10 N/A Endotoxin EU/mL N/A <10 N/A Color and Turbidity

Visual Colorless, clear, without sediment

Colorless, clear, without sediment

Colorless, clear, without sediment

*NOTE 1 Sampled as Steam condensate.

**NOTE 2 The pH range for steam is wider than for Critical Water as some steam may not be generated locally but from a centralized/facility system. The need to add chemicals to the boiler and the steam to travel distances over black iron pipe may result in higher pH requirements.

6.3 The Contractor shall provide for water quality monitoring frequency as defined in Table 5.

Table 5 ST108 Frequency for water quality monitoring.

Minimum frequency of testing*

Water Quality

Measurement

Type of Testing Routine monitoring sample site

Utility Water

Critical Water pH pH meter** of Colorimetric dipsticks (sample tested within 15 minutes)

After the last treatment step

Quarterly Monthly

Conductivity Conductivity meter (in line or by measurement of a collected sample)

After the last treatment step, Storage tanks (if used)

Quarterly Monthly

Total Alkalinity

Colorimetric dipsticks Alkalinity test kit**

After the last treatment step, Storage tanks (if used)

Quarterly Monthly

Total Hardness

Determination of PPM as CaCO3 by Colorimetric dipsticks, Titration kit**, or Handheld meter**

After the last treatment step

Quarterly Monthly

Bacteria Heterotrophic plate count (see Annex H)

Loop out and loop return points

N/A Monthly

Endotoxin LAL text (see Annex H)

Loop out and loop return points

N/A Monthly

*NOTE 1 The recommendations for frequency of testing in this table are the recommended minimum frequency. If problems or issues arise with the water quality, it may be necessary to increase the frequency until they are resolved.

**NOTE 2 When using these tests, the user should carefully follow the manufacturer’s written IFU for accurate results. When measuring Critical Water levels, the water sample must be filled to the brim of these test kits, sealed, and if the sample is hot, allowed to cool to room temperature before testing. Testing within 15 minutes of sample collection prevents carbon dioxide absorption that can result in an accurate pH.

6.4 The Contractor shall provide for water quality monitoring frequency at point-of-water use as defined in Table 6, from ST-108.

Table 6 ST108 Frequency for water quality monitoring at point-of-water use

Minimum frequency of testing*

Water Quality

Measurement

Type of Testing Routine monitoring sample site

Utility Water

Critical Water

Steam pH pH meter** of Colorimetric dipsticks (sample tested within 15 minutes)

After the point the distribution loop enters the processing area or first POU on the distribution loop

Quarterly Monthly Quarterly

Conductivity Conductivity meter (in line or by measurement of a collected sample)

After the point the distribution loop enters the processing area or first POU on the distribution loop

Quarterly Monthly Quarterly

Total Alkalinity

Colorimetric dipsticks Alkalinity test kit**

After the point the distribution loop enters the processing area or first POU on the distribution loop

Quarterly Monthly Quarterly

Total Hardness

Determination of PPM as CaCO3 by Colorimetric dipsticks, Titration kit**, or Handheld meter**

After the point the distribution loop enters the processing area or first POU on the distribution loop

Quarterly Monthly Quarterly

Bacteria Heterotrophic plate count (see Annex H)

Each location of point-of-use in department

Quarterly Monthly N/A

Minimum frequency of testing*

Water Quality

Measurement

Type of Testing Routine monitoring sample site

Utility Water

Critical Water

Steam

Endotoxin LAL text (see Annex H)

Each location of point-of-use in department

N/A Monthly N/A

Visual Inspection Visual inspection of inside of equipment - Look for residue, staining, scaling and discoloration (Annex I)

Spray Arms/Inside Chamber Walls/Inside Interior of Machine

Daily Daily Daily

*NOTE 1 The recommendations for frequency of testing in this table are the recommended minimum frequency. If problems or issues arise with the water quality, it may be necessary to increase the frequency until they are resolved.

**NOTE 2 Test type need to measure Critical Water and Steam levels. Steam condensate must be filled to the brim, sealed, and allowed to cool before testing to prevent carbon dioxide absorption.

7. SAMPLING PER ST108 GUIDANCE.

7.1 Sample Collection: Critical Water samples, or other types of water when indicated, shall be collected from several locations within the distribution system to provide a representative microbial water quality of the system. In general, samples shall be collected at the beginning and end of the water distribution loop. A point-of-use in the distribution loop is a location where water enters equipment utilized to process medical devices. Where any storage tank is used, water shall be sampled at the end of the purification process and the exit of the storage tank.

Samples shall always be collected before disinfection of the water treatment system. If repeat cultures are performed after the system has been chemically disinfected (e.g., with hydrogen peroxide, chlorine, or peracetic acid), the system shall be flushed completely before samples are collected. Before samples are collected, the storage tanks and distribution system shall be drained and flushed until residual disinfectant is no longer detected. For new systems, the water shall be cultured weekly until an established pattern has been determined. For established systems, the water shall be cultured monthly unless a greater frequency is dictated by historical data at a given institution.

7.1.1 Water samples shall be collected directly from outlet taps situated in different parts of the water distribution system. In general, the sample taps shall be opened, and the water shall run for at least 60 seconds (per ST-108) before a sample is aseptically collected in a sterile, endotoxin-free container. The South Texas VA Health Care Center recommends flushing points-of-use at least 120 seconds prior to drawing samples. The collection container shall not be made of polypropylene, as polypropylene has been shown to inhibit endotoxin detection [78]. At least 100 to 300 mL of water shall be collected. Sample taps shall be treated with a general disinfectant (e.g., alcohol) prior to sampling and shall be completely dried to prevent contamination of the collected sample disinfectant residual from the sample tap. Bleach or other disinfectant solutions shall never be used. Bacterial replication is prevented by holding the sample on ice, or at 4 °C, until it is delivered to the laboratory for testing.

7.1.2 For bacteria test samples, sample analysis shall be initiated as soon as possible after collection to minimize changes in the bacterial population. The recommended maximum elapsed time between collection and analysis is 8-hours (maximum transit time 6-hours, maximum processing time 2-hours). When analysis cannot begin within 8-hours, the Contractor shall maintain sample at a temperature below 4 °C but do not freeze. Maximum elapsed time between collection and analysis shall not exceed 24-hours.

7.2 Water sampling technique. Sampling shall be consistent in procedure and sampling locations to ensure the accurate monitoring of water quality.

7.3 Flushing. Sample points shall be flushed commensurate to the size of the water system and distribution loop. Biofilms can develop throughout the water system, including infrequently used valves or downstream connectors between the distribution loop and equipment. Flushing these areas with a high flow velocity across these surfaces can shear off fragile tops of biofilms possibility growing in these areas. A standardized flush before sampling can limit the microbial contribution from the sampling points. For consistent testing results, the Contractor shall thoroughly flush points of use test locations for at least 120 seconds.

7.4 Sampling containers. The appropriate sampling container shall be used to collect the water sample. The container shall be of the required quality not to introduce contamination into the test sample. For example, samples used in the sampling for bacterial endotoxin shall be of the appropriate quality (e.g., pyrogen-free).

7.5 Sampling technique. Valves/taps/hoses used for sampling shall be of the appropriate design to not contaminate the sample. For example, sampling locations do not provide a stagnant water environment when not in use and is accessible to the distribution loop disinfection process. Prior to sampling the sampling surfaces (e.g., valves, hoses) shall be disinfected both externally and internally to reduce microbial contamination. Aseptic technique shall be used for water collection.

7.6 Results exceeding specifications. When detecting microbial quality levels exceeding specification, the Contractor shall perform a repetition of the disinfection and sampling at the location to confirm the results. Upon confirmation of the exceedance, the Contractor shall take immediate action as required to reduce the microbial contamination.

7.6.1 The distribution loop shall be disinfected using methods described in ST108, Annex E, to ensure the microbial contamination is not being introduced through the distribution system.

Automated instrument re-processors (e.g., washer–disinfectors, washer–decontaminators, AERs) shall be flushed with 1,000 ppm of a chlorine-releasing agent after the first instance of persistent unacceptable microbial levels is detected. Other agents that could be considered for flushing include chlorine dioxide, peracetic acid, hydrogen peroxide, and super oxidized water. Before the unit is flushed with any of these agents, the Contractor shall confirm with the re-processor manufacturer that the components of the machine are compatible with the disinfectant to be used in its intended concentration. The levels shall be monitored weekly by repeat testing until two (2) successive counts show that baseline levels have been achieved.

8. HOURS OF OPERATION. Normal duty hours are 8:00 a.m. through 4:30 p.m., Monday through Friday, not including federal holidays.

The Government observes the listed days as holidays. If the holiday falls on a Saturday, the Friday before is the holiday. If the holiday falls on a Sunday, the Monday after is the holiday:

New Year's Day January 1st Martin Luther King's Birthday Third Monday in January Washington’s Birthday Third Monday in February Memorial Day Last Monday in May Juneteenth June 19th Independence Day July 4th Labor Day First Monday in September Columbus Day Second Monday in October Veterans Day November 11th Thanksgiving Day Fourth Thursday in November Christmas December 25th

In addition to the days designated as holidays, the Government observes the following days:

• Any other day designated by Federal Statute

• Any other day designated by Executive Order

• Any other day designated by the President’s Proclamation

The observance of such days by Contractor personnel shall not otherwise be a reason for an additional period of performance, or entitlement of compensation. In the event the Contractor’s personnel work during the holiday, they may be reimbursed by the Contractor, however, no form of holiday or other premium compensation will be reimbursed either as a direct or indirect cost, other than their normal compensation for the time worked.

9. CONTRACTING OFFICERS REPRESENTATIVE.

Umair Aslam Healthcare Engineer, Facilities Management Service South Texas Veterans HCS

7400 Merton Minter St.

San Antonio, TX 78229

Tele: 925-357-7557 Email: umair.aslam@va.gov

10. SAFETY PLAN. The Contractor shall be required to provide a safety plan for the work to be performed under this contract before starting physical work. The plan shall include an Activity Hazard Analysis (AHA) focused on the essential areas of work where risks must be addressed.

The Contractor shall provide Personal Protective Equipment (PPE) for the Contractor’s employees and ensure all Contractor employees to include sub-contractors have and properly use the PPE. The Contractor shall follow all OSHA (Office of Safety and Health Administration) and VHA Safety Guidelines and ensure their contracted personnel and all sub-contractors adhere to OSHA safety guidelines. The contractor shall be responsible to follow OSHA guidelines

11. TUBERCULOSIS (TB) SCREENING.

11.1 The Contractor shall provide written certification that all Contractor employees assigned to the worksite have had a pre-placement negative tuberculin screening within 90 days prior to assignment.

11.2 The Contractors shall be required to show documentation of negative TB screening for any additional workers who are added after the 90-day requirement before Contractor employees are allowed to work on the work site. NOTE: This can be the Center for Disease Control (CDC) and Prevention and two-step skin testing or a Food and Drug Administration (FDA)-approved blood test.

11.3 Contract employees manifesting positive screening reactions to the tuberculin shall be examined according to current CDC guidelines prior to working on VHA property. If a Contractors employee is found without evidence of active (infectious) pulmonary TB, a statement documenting examination by a physician shall be on file with the Contractor noting that the employee with a positive tuberculin screening test is without evidence of active (infectious) pulmonary TB. If the employee is found with evidence of active (infectious) pulmonary TB, the Contractor employee shall be required to obtain treatment with a subsequent statement to the fact on file with the employer before being allowed to return to work on VHA property.

(End Statement of Work)

(END OF SECTION B)

SECTION C - CONTRACT CLAUSES

C.1 ADDENDUM TO 52.212-4 CONTRACT TERMS AND CONDITIONS –

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

Clauses that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

The following clauses are incorporated into 52.212-4 as an addendum to this contract:

C.2 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

https://www.acquisition.gov/browse/index/far https://www.va.gov/oal/library/vaar/

(End of Clause)

FAR

Number

Title Date

52.203-17 CONTRACTOR EMPLOYEE WHISTLEBLOWER

RIGHTS

NOV 2023

52.204-9 PERSONAL IDENTITY VERIFICATION OF

CONTRACTOR PERSONNEL

JAN 2011

52.204-13 SYSTEM FOR AWARD MANAGEMENT

MAINTENANCE

OCT 2018

52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE

MAINTENANCE

AUG 2020

52.228-5 INSURANCE—WORK ON A GOVERNMENT

INSTALLATION

JAN 1997

852.201-70 CONTRACTING OFFICER'S REPRESENTATIVE DEC 2022

852.203-70 COMMERCIAL ADVERTISING MAY 2018

852.204-70 PERSONAL IDENTITY VERIFICATION OF

CONTRACTOR PERSONNEL

MAY 2020

C.3 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months.

The Contracting Officer may exercise the option by written notice to the Contractor within 15 days.

C.4 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor within 15 days; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 30 days before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed five (5) years.

C.5 SUPPLEMENTAL INSURANCE REQUIREMENTS

In accordance with FAR 28.307-2 and FAR 52.228-5, the following minimum coverage shall apply to this contract:

(a) Workers' compensation and employers liability: Contractors are required to comply with applicable Federal and State workers' compensation and occupational disease statutes. If occupational diseases are not compensable under those statutes, they shall be covered under the employer's liability section of the insurance policy, except when contract operations are so commingled with a Contractor's commercial operations that it would not be practical to require this coverage. Employer's liability coverage of at least $100,000.00 is required, except in States with exclusive or monopolistic funds that do not permit workers' compensation to be written by private carriers.

(b) General Liability: $500,000.00 per occurrences.

(c) Automobile liability: $200,000.00 per person; $500,000.00 per occurrence and $20,000.00 property damage.

(d) The successful bidder must present to the Contracting Officer, prior to award, evidence of general liability insurance without any exclusionary clauses for asbestos that would void the general liability coverage.

C.6 VAAR 852.219-73 VA NOTICE OF TOTAL SET-ASIDE FOR CERTIFIED

SERVICE-DISABLED VETERAN-OWNED SMALL BUSINESSES (JAN 2023)

(DEVIATION)

(a) Definition. for the Department of Veterans Affairs, ‘‘Service-disabled Veteran-owned small business concern or SDVOSB’’:

(1) Means a small business concern—

(i) Not less than 51 percent of which is owned by one or more service-disabled Veterans or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more service-disabled Veterans or eligible surviving spouses (see VAAR 802.201, Surviving Spouse definition);

(ii) The management and daily business operations of which are controlled by one or more service-disabled Veterans (or eligible surviving spouses) or, in the case of a service-disabled Veteran with permanent and severe disability, the spouse or permanent caregiver of such Veteran;

(iii) The business meets Federal small business size standards for the applicable North American Industry Classification System (NAICS) code identified in the solicitation document;

(iv) The business has been certified for ownership and control pursuant to 38 U.S.C. 8127, 13 CFR 128, and is listed as certified in the SBA certification database at https://veterans.certify.sba.gov/; and

(v) The business agrees to comply with VAAR subpart 819.70 and Small Business Administration (SBA) regulations regarding small business size, government contracting, and the Veteran Small Business Certification Program at 13 CFR parts 121, 125, and 128.

(2) The term ‘‘Service-disabled Veteran’’ means a Veteran, as defined in 38 U.S.C. 101(2), with a disability that is service-connected, as defined in 38 U.S.C. 101(16).

https://veterans.certify.sba.gov/

(3) The term ‘‘small business concern’’ has the meaning given that term under section 3 of the Small Business Act (15 U.S.C. 632).

(4) The term ‘‘small business concern owned and controlled by Veterans with service-connected disabilities’’ has the meaning given the term ‘‘small business concern owned and controlled by service-disabled veterans’’ under section 3(q)(2) of the Small Business Act (15 U.S.C. 632(q)(2)).

(5) The term “SDVOSB participant” or certified SDVOSB means a small business that has been certified in the SBA Veteran Small Business Certification Program and listed in the SBA certification database (see 13 CFR 128.102).

(b) General. In order for a concern to submit an offer and be eligible for the award of an SDVOSB set-aside or sole source contract, the concern must qualify as a small business concern under the size standard corresponding to the NAICS code assigned to the contract and be listed as an SDVOSB participant in the SBA certification database as set forth in 13 CFR 128.

(1) Offers received from entities that are not certified SDVOSBs and listed in the SBA certification database at the time of offer shall not be considered.

(2) Any award resulting from this solicitation shall be made to a certified SDVOSB listed in the SBA certification database who is eligible at the time of submission of offer(s) and at the time of award.

(3) The requirements in this clause apply to any contract, order or subcontract where the firm receives a benefit or preference from its designation as an SDVOSB, including set-asides, sole source awards, and evaluation preferences.

(c) Representation. Pursuant to 38 U.S.C. 8127(e), only certified SDVOSBs listed in the SBA certification database are considered eligible to receive award of a resulting contract. By submitting an offer, the prospective contractor represents that it is an eligible and certified SDVOSB as defined in this clause, 13 CFR 121, 125, and 128, and VAAR subpart 819.70.

(d) Agreement/LOS certification. When awarded a contract action, including orders under multipleaward contracts, an SDVOSB agrees that in the performance of the contract, the SDVOSB shall comply with requirements in VAAR subpart 819.70 and SBA regulations on small business size, and government contracting programs at 13 CFR part 121 and part 125, including the non-manufacturer rule and limitations on subcontracting (LOS) requirements in 13 CFR 121.406(b) and 13 CFR 125.6. For the purpose of limitations on subcontracting, only certified SDVOSBs listed in the SBA certification database (including independent contractors) shall be considered eligible and/or ‘‘similarly situated’’ (i.e., a firm that has the same small business program status as the prime contractor). An otherwise eligible firm further agrees to comply with the required LOS certification requirements in this solicitation (see 852.219–75 or 852.219–76 as applicable). These requirements are summarized as follows:

(1) Services. In the case of a contract for services (except construction), the SDVOSB prime contractor will not pay more than 50% of the amount paid by the government to the prime for contract performance to firms that are not certified SDVOSBs listed in the SBA certification database (excluding direct costs to the extent they are not the principal purpose of the acquisition and the SDVOSB/ VOSB does not provide the service, such as airline travel, cloud computing services, or mass media purchases). When a contract includes both services and supplies, the 50 percent limitation shall apply only to the service portion of the contract.

(2) Supplies/products.

(i) In the case of a contract for supplies or products (other than from a non-manufacturer of such supplies), the SDVOSB prime contractor will not pay more than 50% of the amount paid by the government to the prime for contract performance, excluding the cost of materials, to firms that are not certified SDVOSBs listed in the SBA certification database. When a contract includes both supply and services, the 50 percent limitation shall apply only to the supply portion of the contract.

(ii) In the case of a contract for supplies from a non-manufacturer, the SDVOSB prime contractor will supply the product of a domestic small business manufacturer or processor, unless a waiver as described in 13 CFR 121.406(b)(5) has been granted. Refer to 13 CFR 125.6(a)(2)(ii) for guidance pertaining to multiple item procurements.

(3) General construction. In the case of a contract for general construction, the SDVOSB prime contractor will not pay more than 85% of the amount paid by the government to the prime for contract performance, excluding the cost of materials, to firms that are not certified SDVOSBs listed in the SBA certification database.

(4) Special trade construction contractors. In the case of a contract for special trade contractors, no more than 75% of the amount paid by the government to the prime for contract performance, excluding the cost of materials, may be paid to firms that are not certified SDVOSBs listed in the SBA certification database.

(5) Subcontracting. An SDVOSB subcontractor must meet the NAICS size standard assigned by the prime contractor and be certified and listed in the SBA certification database to count as similarly situated. Any work that a first tier SDVOSB subcontractor further subcontracts will count towards the percent of subcontract amount that cannot be exceeded. For supply or construction contracts, the cost of materials is excluded and not considered to be subcontracted.

When a contract includes both services and supplies, the 50 percent limitation shall apply only to the portion of the contract with the preponderance of the expenditure upon which the assigned NAICS is based. For information and more specific requirements, refer to 13 CFR 125.6.

(e) Required limitations on subcontracting compliance measurement period. An SDVOSB shall comply with the limitations on subcontracting as follows:

[X] By the end of the base term of the contract or order, and then by the end of each subsequent option period; or [] By the end of the performance period for each order issued under the contract.

(f) Joint ventures. A joint venture may be considered…