36C25725Q0427 0001.pdf

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1 26

0001 05-02-2025

36C257

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

To all Offerors/Bidders

36C25725Q0427

04-07-2025

X

X X

** HOUR & DATE for Receipt of Offers is EXTENDED to: 05-14-2025 0900 CDT

X 1

The purpose of this amendment is to:

a. Extend the closing date from 9 May 2025 to 14 May 2025.

b. Provide answers to questions posed and include pictures.

c. Provide an updated Statement of Work based upon responses to questions. (SOW changes are in red)

///SEE CONTINUATION PAGES///

Shawn R. Reinhart Contracting Officer

36C25725Q0427-0001 CONTINUATION PAGES

QUESTIONS WITH ANSWERS

QUESTION 1: DI and Carbon Tank Inventory & RO/DI System Capacity: Per Sections 3.1.4.1 through 3.1.4.4, can you confirm for each of the four facilities:

• The number of Deionization (DI) tanks and carbon tanks

• The size (gallons or cubic feet) and capacity (GPD or flow rate) of the Reverse Osmosis

(RO) and DI systems This information is critical to accurately price the system maintenance, DI and Carbon Tanks, RO Membrane replacement, and sanitization manpower/time.

ANSWER:

• The number of Deionization (DI) tanks and carbon tanks o ALM-Audie Murphy-2 DI Tanks, 1 Carbon Tanks o NW HCC-151 – 2 DI Tanks, 2 Carbon Tanks o Data Point - 2 DI Tanks, 1 Carbon Tank o Kerrville - (No RO System in Kerrville) 2 DI Tanks, 1 carbon tank

• The size (gallons or cubic feet) and capacity (GPD or flow rate) of the Reverse Osmosis (RO) and DI systems o ALM – DI Tanks are14”, 2.1 c.f. and flow rate is: Min 1.5 gpm, max 6 gpm o NWHCC-151 DI Tanks are14”, 2.1 c.f. and flow rate is: Min 1.5 gpm, max 6 gpm o Data Point – DI Tanks are 1.33 c.f. and flow rate min .25 gpm, max .8 gpm o Kerrville- NO RO System (Small DI Tanks, Carbon tank)

QUESTION 2: Site Photos of Critical Water Equipment: As no survey date or site visit had been provided:

• Are current photos of the critical water system equipment (RO/DI, pre-treatment, loops, etc.) at each location available or can they be provided?

ANSWER: Please see equipment photos included at bottom of this document.

QUESTION 3: Interpretation of Bid Item 0007 – Test Port and Monitoring Equipment:

Regarding VA Bid Item Number 0007, does the scope include:

• The installation of 10 test ports at all 4 locations for manual physical checks when onsite to record pH, hardness, conductivity?

• OR

• The installation of 10 test ports, along with the installation of 10 continuous monitoring devices to record pH, hardness, and conductivity at all 4 locations.

To Clarify: Will the potential of 10 new test points at 4 locations result in a total of 40 new test points, or a total of 10 new test points between the 4 locations?

This distinction significantly impacts installation costs.

ANSWER: Total of 10 total potential new test points between the 4 locations/sites. Continuous monitoring sought for all 4 locations to record pH, hardness and conductivity.

QUESTION 4: Scope of Water Quality Testing – Utility vs. Critical Water: Under Section 3.2, only Critical Water points are specified, while Section 3.3 and Section 6.1 reference general water quality categories and utility water sampling.

Please clarify:

• Are only Critical Water points to be sampled monthly?

• Or should Utility-Cold, Utility-Hot, and Steam Condensate also be sampled from each applicable location (e.g., sink, cart washer, loop, sterilizer) to align with full ST108 testing scope?

For example, should a single sink have all three water types sampled monthly: Utility-Cold, Utility-Hot, and Critical Water?

ANSWER: The contract will require vendor to test Utility Water, Critical Water and Steam. Per the ST-108, Table 6, and Critical Water must be tested monthly. As applicable in Table 6, Steam and Utility Water are only tested quarterly. Table 2 indicates the water qualification minimum levels required when tested. Test schedule will need to be established for dates to be earliest possible during the month to enable potential re-testing.

QUESTION 5: Monthly Testing Scope – Table 2 vs. Table 4 from ST108:

ST108 outlines:

• Table 2 for Performance Qualification (PQ) testing, which includes TOC and Ionic

Contaminants

• Table 4 for Routine Monitoring, which excludes those analyses The Bid does not specify which table to follow or the testing frequency.

Please confirm:

• Should the monthly testing follow Table 2 or Table 4?

• Should only the first month of each contract year follow Table 2, with the remaining 11 months following Table 4?

This clarification is essential for determining testing scope and cost.

ANSWER: Table 2 applies to performance qualification. Table 2 of the standard should be utilized when establishing performance qualification testing.

Once the performance qualification testing is complete and results are maintained within the standard, your water program can move to quality monitoring. Quality monitoring ensures us that the system is functioning properly and is within standards noted at Table 4.

Thus, a baseline could be set by testing first month per Table 2 and then following for quality monitoring the remaining months.

QUESTION 6: Can a site visit be scheduled to view equipment, layout, and access at each service location?

ANSWER: Please see equipment photos included at bottom of this document.

QUESTION 7: Can the VA provide a list of the brand/model of all water treatment equipment at each service location?

ANSWER: The equipment used at the locations are:

ALM—Evoqua RO system Data Point—Evoqua RO system NWHCC-151- the RO System is Ameri-water (Model HRC04) Kerrville Division—No RO system in Kerrville

AAMI ST108; 9.1 General Considerations

“…a typical validation program involves intensive daily sampling and testing at post water treatment system test points and at the point-of-water-use for a defined period of time against the criteria listed in Table 2 and then testing at a reduced frequency for at least one calendar year to identify seasonal changes. Construction, water supply interruption and repair of any water treatment system components should be kept in mind when assessing potential reasons to reassess frequency.”

QUESTION 8: In reference to Table 6 of the SOW regarding daily visual inspection of processing equipment, is the prospective contractor required to perform this daily inspection and if so, which period of the day should the service be performed?

ANSWER: No, the VHA Sterile Processing Staff personnel will perform the “Visual Inspection” as noted in Table 6, of ST-108

QUESTION 9: Existing Equipment & Maintenance (Section B.4, SOW). Are we required to maintain the VA’s current RO/DI systems (e.g., specific brands/models), or may we propose our own compliant systems?

ANSWER: The intent of this water testing/maintenance/repair service contract will be to maintain the existing equipment as installed. Potentially, the vendor selected may be able to propose equipment that could improve compliance—but the existing scope and intention does not include significant replacement replacements of RO/DI system brands per se.

QUESTION 10: Existing Equipment & Maintenance (Section B.4, SOW). If existing equipment must be maintained, can the VA provide make/model details for the systems at Audie Murphy, Dental, Kerrville, and NW Healthcare locations?

ANSWER: The equipment used at the locations are:

ALM—Evoqua RO system Data Point—Evoqua RO system NWHCC-151- the RO System is Ameri-water (Model HRC04) Kerrville Division—No RO system in Kerrville, only DI Tanks, carbon filter.

QUESTION 11: Testing & Compliance (Section B.4, Table 2). For monthly bacteria/endotoxin testing, must we use VA-designated labs, or may we subcontract with any AAMI ST108-accredited laboratory?

ANSWER: The contractor may use AAMI ST-108 accredited labs; VA is not designating specific laboratories per se.

QUESTION 12: Testing & Compliance (Section B.4, Table 2). Is there a preferred chain-of-custody protocol for water samples (e.g., specific forms or digital tracking)?

ANSWER: Specific forms or specific format for digital tracking is not available. Contractor and any subcontractor must be able to confidently prove/validate that the chain of custody of samples taken are consistent with ST-108 sampling techniques and types of containers used to gather samples and to transport samples. Moreover, samples must be kept sufficiently cooled to prevent any bacteria growth in the samples collected. Samples collected should be kept on ice, kept at 4°C (39.2°F) until delivery to the laboratory for testing. See SOW discussing sampling procedures.

QUESTION 13: Emergency Repairs (CLIN 0005). For the $20,000/year emergency repair cap, does this apply per facility or across all four locations collectively?

ANSWER: The $20K/year applies as a total, across all four locations. NOT $20K per location.

QUESTION 14: Emergency Repairs (CLIN 0005). Are there any pre-approved vendors for parts (e.g., RO membranes), or may we source compliant parts independently?

ANSWER: For parts, the items must be compatible with brand/type of equipment installed. The VA is not recommending or not aware of pre-approved vendors for parts per se.

QUESTION 15: Point-of-Use Test Ports (CLIN 0007). Must the 10 new test ports match existing port specifications (e.g., brand/connection type), or is any AAMI-compliant design acceptable?

ANSWER: For any new test ports that may be requested by the VHA, the contractor is advised to provide a submittal to the VA through the Contractor Officer for the VA to review and approve.

Photos for Northwest Health Care Center-151

Storage Tank- NWHCC

DI Tanks – NWHCC

RO Machine Unit—Ameri-Water Brand- NWHCC 151

Photos for Data Point SPS Site:

DI Tanks-Data Point SPS Location

Evoqua System—Data Point SPS Location

Data Point Site

Photos: Audie Murphy SPS Site

RO Set-Up/Carbon Filter—Audie Murphy SPS Site (New equipment)

RO System - Audie Murphy Site

DI Tanks- Audie Murphy Site

DI Tanks- Audie Murphy VA Site

Holding Tank-Audie Murphy Site

Additional Equipment/Additional Views (RO System Room) Audie Murphy

Audie Murphy SPS Water System

Kerrville Site – DI Tank (2) and Carbon Tank Set-Up

(END OF QUESTIONS AND ANSWERS)

STATEMENT OF WORK (SOW)

Sterile Processing Services (SPS) Water Testing

(Revised 2 May 2025)

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.

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.

2.1.1 The VHA prefers the Contractor schedule monthly work, testing at the beginning of the month. Ideally, test within the first week of every month to enable more time during a particular month for any retesting that may be required.

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

Minimum frequency of testing*

Water Quality

Measurement

Type of Testing Routine monitoring sample site

Utility Water

Critical Water

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

Minimum frequency of testing*

Water Quality

Measurement

Type of Testing Routine monitoring sample site

Utility Water

Critical Water

Steam

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

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 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. Protective lab coveralls, head covers (Bouffant caps), shoe covers, procedure masks and gloves are available from the VA, at each of the site locations; Contractors can use these items as supplied on-site by the VA for entering the Decontamination areas of the Sterile Processing Service. These items shall always be worn by all Contractor, sub-contractor personnel at each site location. 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.

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