36C25726Q0448 0001.pdf

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AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

(Signature of person authorized to sign) (Signature of Contracting Officer)

1 21

0001 06-03-2026

36C257

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

To all Offerors/Bidders

36C25726Q0448

05-06-2026

X

X X

** HOUR & DATE for Receipt of Offers is EXTENDED to: 06-10-2026 10:00 AM CDT

See CONTINUATION Page

X 1

The purpose of this amendment is to:

a. Provide answers to questions that were received by the due date and time in the solicitation.

b. Update the Performance Work Statement (PWS) as a result of questions.

c. Extend the due date and time to 10:00 AM CDT 10 June 2026 as shown in Block 11.

///SEE CONTINUATION PAGES///

Shawn R. Reinhart Contracting Officer

36C25726Q0448-0001 CONTINUATION PAGES

RFI QUESTIONS – SPS WATER TESTING

QUESTION 1: Referring to the sampling locations in Tables 1–4 (starting on page 14), can you please clarify which measurements should be taken at each location?

ANSWER 1: Tables 1 to 4 in the PWS shows the locations where samples are to be collected and the frequency. Table 2 and Table 4 of ST108 shows the measurement parameters.

QUESTION 2: Table 4 of the ST108 specifies that the first point of use in the distribution loop for utility water requires testing for pH, conductivity, alkalinity, and hardness. It also states that each point of use for utility water must be tested for bacteria.

Similarly, there are multiple critical water sinks that would require endotoxin and bacteria sampling at each location, while the remaining parameters would be sampled at the first point of use in the loop.

Can you confirm whether pH, conductivity, alkalinity, and hardness should be tested only at the first point of use in the distribution loop, or at each point of use?

ANSWER 2: Testing shall be conducted at each point of use.

QUESTION 3: Ozone sanitization is specified in response to out-of-range bacteria or endotoxin tests;

will alternative disinfectants (i.e., peracetic acid/hydrogen peroxide) be accepted?

ANSWER 3: Ozone sanitization shall be performed once every quarter at all locations. Peracetic acid/hydrogen peroxide can only be substituted whenever there is continuous failure within that quarter.

QUESTION 4: 3.1.7-3.1.8 - Could you please specify the difference between "an increase in HPC, bacteria, or endotoxin" and "intensive growth of bacteria or endotoxin"?

ANSWER 4: An increase is where the count is above the limit (10 CFU/mL). Intensive growth is whenever the count is multiple orders of magnitude above the limit (50 CFU/mL). All test results need to be provided within 10 calendar days after testing. PWS updated to reflect 10 calendar days.

QUESTION 5: 6.1.1 - this section references "water quality measurement values in Table 1" but Table 1 in ST108 does not reference water quality values. Could you clarify which table this should reference?

ANSWER 5: PWS updated to reference Table 2 and Table 4 of ST108.

QUESTION 6: 6.1.2 - this section references "water quality measurement values in Table 1" but Table 1 in ST108 does not reference water quality values. Could you clarify which table this should reference?

ANSWER 6: PWS updated to reference Table 2 and Table 4 of ST108.

QUESTION 7: 6.1.3 - this section references "When the steam is tested as a condensate, it should meet the specified criteria as defined in Table 5 in ST108" , but Table 5 in ST108 does not reference steam.

Could you clarify if this should refer to Table 6 in ST108?

ANSWER 7: PWS updated to reference Table 2 and Table 4 of ST108.

QUESTION 8: 6.1.4 - at what specific frequency would you like this requirement to be tested and documented? ST108 does not define a minimum frequency for Table 2 and leaves the frequency up to the facility water management team.

ANSWER 8: Tables 1 to 4 in the PWS shows the locations where samples are to be collected and the frequency. Table 2 and Table 4 of ST108 shows the measurement parameters. Table 5 and Table 6 of ST108 defines the minimum frequency.

QUESTION 9: 6.3 - Table 7 does not exist in ST108, could you clarify the correct reference?

ANSWER 9: PWS updated to reference Tables 1 to 4 of the PWS, and Table 5 and Table 6 of ST108 for the frequency.

QUESTION 10: 6.5 - Table 8 does not exist in ST108, could you clarify the correct reference?

ANSWER 10: PWS updated to reference Tables 1 to 4 of the PWS, and Table 5 and Table 6 of ST108.

QUESTION 11: Are the endoscopy filters at Kerrville included in the SOW?

ANSWER 11: Yes. PWS paragraph 3.3.3 updated to include endoscopy filters.

QUESTION 12: Will the VA confirm whether there is a vent filter at Northwest AND Kerrville?

ANSWER 12: There are no vent filters at NWHCC and Kerrville.

QUESTION 13: Will the VA share previous monthly and quarterly test reports?

ANSWER 13: No.

QUESTION 14: What are the scheduling restrictions on sanitation for each system?

ANSWER 14: There are no scheduling restrictions, however the contractor shall submit testing schedule two weeks in advance for approval. NWHCC and Datapoint are leased sites and testing for those locations shall be scheduled for weekdays.

QUESTION 15: What is the model number for the stainless steel Shelco filter housing?

ANSWER 15: Model # for the stainless-steel filter housing is W2T940448 and does not state Shelco.

QUESTION 16: Will the VA confirm which tests and frequency (i.e. HPC, Endotoxin, pH, Conductivity, Alkalinity, Hardness) are to be conducted on which sample points and POU?

ANSWER 16: Refer to responses to Question 1 and Question 8 above. They shall be conducted at all POU’s and sample points.

QUESTION 17: Will the VA provide specified flow rate for the RO at Kerrville?

ANSWER 17: 14 gpm

QUESTION 18: Are the UV filters included in the SOW?

ANSWER 18: Yes. PWS updated to reflect UV Light/UV filter are to be replaced annually.

(END RFI'S ANSWERS)

PERFORMANCE WORK STATEMENT

Sterile Processing Services (SPS) Water Testing (Revised 3 Jun 2026)

1. BACKGROUND. South Texas Veterans Healthcare System facilities has a 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. The period of performance will be for a base year, with four

(4) option years.

Base Year: 30 June 2026 – 29 June 2027 1st Option Year: 30 June 2027 – 29 June 2028 2nd Option Year: 30 June 2028 – 29 June 2029 3rd Option Year: 30 June 2029 – 29 June 2030 4th Option Year: 30 June 2023 – 29 June 2031

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 3.2.1 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 install continuous in-line monitoring devices for pH, Conductivity and Flow Meters in the pump room for all sites at the critical water distribution loop out (Audie Murphy SPS, Dental SPS, Kerrville SPS and Northwest Healthcare Center SPS). The installed device shall be able to perform to the below table requirements.

In-Line Monitoring Device Table

Conductivity TDS Resistivity pH ORP/mV

IN

Temperature

Ranges 0 µS - 200 mS 0 ppm - 200 ppt

10 KΩ - 40 MΩ 0 - 14 pH ±2000 mV 0 - 250˚C

Accuracy ± 1% of reading ± 1% of reading

± 1% of reading ± 0.01 pH ± 2 mV ± 0.1˚C

Resolution 0.01 (<100 µS)

0.1 (<1000 µS) 1 (<10,000 µS)

0.01 (<100 mS)

0.1 (≤200 mS)

0.01 (<100 ppm)

0.1 (<1000 ppm) 1 (<10,000 ppm)

0.01 (<100 ppt)

0.1 (≤200 ppt)

0.01 (<100 kΩ)

0.1 (<1000 kΩ)

0.01 (<10

MΩ)

0.1 (≤40

MΩ)

0.01 pH 1 mV 0.1˚C/F

Auto Temperature

Compensation

0-71˚C 32-160˚F

0-71˚C 32-160˚F

0-71˚C 32-160˚F

0-71˚C 32-160˚F

Adjustable Temperature

Compensation

0 - 10%/˚C 0 - 10%/˚C 0 - 10%/˚C On/Off - -

Cond/TDS Ratios

Preprogrammed

KCl, NaCl, 442™ KCl, NaCl, 442™

Adjustable Cond/TDS Ratio Factor

0.20-7.99 0.20-7.99 - - - -

COND / RES 1 Conductivity, Resistivity, TDS, Sensor Input COND / RES 2 Conductivity, Resistivity, TDS, Sensor Input pH / ORP Myron L® Company model pH or ORP Sensor Input mV IN BNC Style mV Model Sensors FLOW SW Flow Switch Input 4-20 mA IN 4-20 mA Signal Input (<600Ω) FLOW / PULSE Flow Rate and Volume Totalizer/Pulse Counter/Frequency Counter (0.5-50,000

Hz)

RTD Temperature Sensor Input (1000 Ω RTD) 24 VAC / 12-24 VDC Power Supply Input (1A Max) RELAY #1 Normally Open or Normally Closed Relay Output (5A@30VDC, 8A@250VAC)

RELAY #2 Normally Open or Normally Closed Relay Output (5A@30VDC, 8A@250VAC)

RELAY #3 Normally Open or Normally Closed Relay Output (5A@30VDC, 8A@250VAC)

RA #1 Remote Alarm Output RA #2 Remote Alarm Output 4-20 mA OUT 4-20 mA Signal Output (20-36VDC) REC O/P 0-10 VDC Recorder Output (20mA Max) RS-485 ASCII Serial Communications Output

3.1.5 The Contractor shall install tank capacity alarms (e.g., red/green indicator lights) are required for both Carbon and DI for all site (Audie Murphy SPS, Dental SPS, Kerrville SPS and Northwest Healthcare Center SPS).

3.1.6 The contractor shall provide all submittal for material and equipment installation for VA approval prior to installation. The contractor shall ensure that all installed equipment, devices meet ST 108 requirements.

3.1.7 When there is an increase in HPC, bacteria, or endotoxin, or fail test in any Point of use (POU), the contractor shall perform a re-test of that POU only within 10 calendar days after testing. The contractor is responsible for all repeat testing, and the levels should be monitored weekly by repeat testing until two successive counts shows that baseline levels have been achieved.

3.1.8 Whenever there is intensive growth of bacteria or endotoxin in the system from pervious test that was performed, the Contractor shall perform Ozone Sanitization and three (3) days of testing within 10 calendar days after testing. The contractor is responsible for all repeat testing, and the levels should be monitored weekly by repeat testing until two successive counts shows that baseline levels have been achieved.

3.1.9 The Contractor shall install additional sample test ports at locations marked “X” on Table 1 - Audie Murphy SPS Location, Table 2 - Dental (Datapoint) SPS Location, Table 3 - Northwest Healthcare Center SPS Location and Table 4 - Kerrville SPS location.

3.1.10 Whenever there is a modification to the system, the contractor shall perform sanitization and three days of testing for all points of use (POUs).

3.1.11 The Contractor shall provide all test results for all sites within 10 calendar days after testing.

The Contractor is responsible for all repeat testing for all sites, and the levels should be monitored weekly by repeat testing at all sites until two (2) successive counts shows that baseline levels have been achieved.

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

3.2.1 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 monthly.

• 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 monthly.

• Provide monthly quality report when tanks are exchanged.

• Provide monthly testing and service report.

• Replace all filters to include endoscopy filters (pre & post) quarterly.

• Provide the filter replacement requirement information.

• Provide Endotoxin Filter as required annually.

• Provide monthly maintenance service for RO System and Distribution loop as required by

ST108.

• Replace all UV light/UV filters annually.

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

• 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 monthly.

• 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 monthly.

• Provide monthly quality report when tanks are exchanged.

• Provide monthly testing and service report.

• Replace all filters to include endoscopy filters (pre & post) quarterly.

• Provide the filter replacement requirement information.

• Provide Endotoxin Filter as required annually.

• Provide monthly maintenance service for RO System and Distribution loop as required by

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

• 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 monthly.

• 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 monthly.

• Provide monthly quality report when tanks are exchanged.

• Provide monthly testing and service report.

• Replace all filters to include endoscopy filters (pre & post) quarterly.

• Provide the filter replacement requirement information.

• Provide Endotoxin Filter as required annually.

• Provide monthly maintenance service for RO System and Distribution loop as required by

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

• Provide DI and carbon tanks, scale inhibitor monthly.

• 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 monthly.

• Provide monthly quality report when tanks are exchanged.

• Provide monthly testing and service report.

• Replace all filters to include endoscopy filters (pre & post) quarterly.

• Provide the filter replacement requirement information.

• Provide Endotoxin Filter as required annually.

• Provide monthly maintenance service for RO System and Distribution loop as required by

3.3 CRITICAL WATER TEST POINTS OF USE BY LOCATION

3.3.1 Audie Murphy Location. Rows noted with an “X” under the column “Location where Sample needs to be Collected” indicate sample location for collection requirements based off the “Frequency” column. Rows noted with an “X” under the column “Additional Sample Port Install Required to Collect Sample” indicates a sample port installation required for collection.

Table 1 – Audie Murphy SPS Location

No of Sample

Location

Type

Location where

Sample needs to be Collected

Additional Sample

Port Install Required to

Collect Sample

Critical Water System Updates

Frequency of Testing for each port

1 Sink 1 - Cold

Utility X Quarterly

2 Sink 1 - Hot Utility X Quarterly 3 Sink 1

Critical Critical X Monthly

4 Sink 2 - Cold

Utility X Quarterly

5 Sink 2 - Hot Utility X Quarterly 6 Sink 2 -

Critical Critical X Monthly

7 Sink 3 - Cold

Utility X Quarterly

8 Sink 3 - Hot Utility X Quarterly 9 Sink 3 -

Critical Critical X Monthly

10 Sink 4 - Cold

Utility X Quarterly

11 Sink 4 - Hot Utility X Quarterly 12 Sink 4 -

Critical Critical X Monthly

13 Washer 1 - Cold

Utility X X Quarterly

14 Washer 1 - Hot

Utility X X Quarterly

15 Washer 1 - Critical

Critical X Monthly

16 Washer 2 - Cold

Utility X X Quarterly

17 Washer 2 - Hot

Utility X X Quarterly

18 Washer 2 - Critical

Critical X Monthly

19 Cart Washer 1- Cold

Utility X X Quarterly

20 Cart Washer

- Hot

Utility X X Quarterly

21 Cart Washer

- Critical

Critical

X Monthly

22 Rm. K112 - Sink Cold

Utility X Quarterly

23 Rm. K112 - Sink Hot

Utility X Quarterly

24 Rm. K112.1 X Quarterly

3.3.2 Datapoint Location (Dental Services). Rows noted with an “X” under the column “Location where Sample needs to be Collected” indicate sample location for collection requirements based off

Location

Type

Location where

Sample needs to be Collected

Additional Sample

Port Install Required to

Collect Sample

Critical Water System Updates for each port

AER

(alternate the 2)

Utility

25 Rm. E120

AER

Utility X Quarterly

26 RO Dist Loop Out

Critical X Monthly

27 RO Dist Loop In

Critical X Monthly

28 Steam Condensate #1 (House)

Steam

X Quarterly

29 Sterilizer #4 (House Steam)

30 Sterilizer #5 (House Steam)

31 Sterilizer #13 (Self Made)

Quarterly

32 Sterilizer #12 (Self Made)

33 Ultra Sonic Washer #1

Critical X Monthly

34 Ultra Sonic Washer #1

Utility X Quarterly

35 Ultra Sonic Washer #2

Critical X Monthly

36 Ultra Sonic Washer #2

Utility X Quarterly

37 Ultra Sonic Washer #3

Critical X Monthly

38 Ultra Sonic Washer #3

Utility X Quarterly

39 Ultra Sonic Washer #4

Critical X Monthly

40 Ultra Sonic Washer #4

Utility X Quarterly the “Frequency” column. Rows noted with an “X” under the column “Additional Sample Port Install

Table 2 – Dental (Datapoint) SPS Location

3.3.3 Northwest Health Care Center – 151. Rows noted with an “X” under the column “Location where Sample needs to be Collected” indicate sample location for collection requirements based off the “Frequency” column. Rows noted with an “X” under the column “Additional Sample Port Install

Table 3 – Northwest Healthcare Center SPS Location

Sample

Sample Location

Sample Type

Location where

Sample needs to be Collected

Additional Sample Port

Install Required to

Collect Sample

Critical Water System

Updates?

for each port

1 Washer - Cold

Utility X X Quarterly

2 Washer - Hot

Utility X X Quarterly

3 Washer - Critical

Critical X X Monthly

4 Ultrasonic 1

- Cold

Utility X X Quarterly

5 Ultrasonic 1

- Hot

Utility X X Quarterly

6 Ultrasonic 1

- Critical

Critical X X Monthly

7 Ultrasonic 2

- Cold

Utility X X Quarterly

8 Ultrasonic 2

- Hot

Utility X X Quarterly

9 Ultrasonic - Critical

Critical X X Monthly

10 Sink - Cold Utility X X Quarterly 11 Sink - Hot Utility X X Quarterly 12 Sink -

Critical Critical X X Monthly

13 Sterilizer #1 (Stand Alone)

Steam X Quarterly

14 Sterilizer #2 (Standalone)

Steam X Quarterly

Loop Out Prior to Equipment

X X Monthly

16 RO Machine Port

Critical X X Monthly

Sample Location

Sample Type

Location where

Sample needs to be Collected

Additional Sample Port Install

Required to Collect Sample

Critical Water System Updates

Frequency of Testing for each port

1 Sink 1 - Cold

Utility X Quarterly

2 Sink 1 - Hot Utility X Quarterly 3 Sink 1

Critical Critical X Monthly

4 Sink 2 - Cold

Utility X Quarterly

5 Sink 2 - Hot Utility X Quarterly 6 Sink 2 -

Critical Critical X Monthly

7 Washer 1 - Cold

Utility X X Quarterly

8 Washer 1 - Hot

Utility X X Quarterly

9 Washer 1 - Critical

Critical X X Monthly

10 Washer 2 - Cold

Utility X X Quarterly

11 Washer 2 - Hot

Utility X X Quarterly

12 Washer 2 - Critical

Critical X X Monthly

13 Cart Washer - Cold

Utility X X Quarterly

14 Cart Washer - Hot

Utility X X Quarterly

15 Cart Washer -

16 Ultrasonic - Cold

Utility X X Quarterly

17 Ultrasonic - Hot

Utility X X Quarterly

18 Ultrasonic - Critical

Critical X Monthly

19 RO

Machine Point of Generation

20 RO Loop Sample (In Pump Rm.)

Monthly

Sample Location

Sample Type

Location where

Sample needs to be Collected

Additional Sample Port Install

Required to Collect Sample

Critical Water System Updates

Frequency of Testing for each port

21 Loop Test Point near Ultrasonic

X

Monthly

22 Sterilizer # (Processed

RO)

23 Sterilizer # (Processed

RO)

3.3.4 Kerrville Division. Rows noted with an “X” under the column “Location where Sample needs to be Collected” indicate sample location for collection requirements based off the “Frequency” column. Rows noted with an “X” under the column “Additional Sample Port Install Required to Collect Sample” indicates a sample port installation required for collection.

Table 4 – Kerrville SPS Location

Sample

Sample Location

Sample Type

Location where

Sample needs to be Collected

Additional Sample

Location Port Install Required

Critical Water System

Updates?

Frequen cy of

Testing for each port 1 Sink 1 -

Cold Utility X

2 Sink 1 - Hot Utility X Quarterly 3 Sink 1

Critical Critical X Monthly

4 Sink 2 - Cold

Utility X Quarterly

5 Sink 2 - Hot Utility X Quarterly 6 Sink 2 -

Critical Critical X Monthly

7 AER #1 Utility X X Quarterly 8 AER #2 Utility X X Quarterly 9 Ultrasonic Utility X X Quarterly 10 Washer -

Cold Utility X X Quarterly

11 Washer - Hot

Utility X X Quarterly

12 Washer -

Critical X X Monthly

Sample Location

Sample Type

Location where

Sample needs to be Collected

Additional Sample

Location Port Install Required

Critical Water System

Updates?

Frequen cy of

Testing for each port 13 Test Port

After DI SysteM

14 Sterilizer #1 Steam X Quarterly 15 Sterilizer #2 Steam X Quarterly

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

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

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

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

3.8 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.

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

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

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

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

3.13 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).

3.14 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).

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

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

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

3.18 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.

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

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

3.21 The Contractor shall install additional Sampling ports for water sample collections specified under each site location in each table under section 3.2.

3.23 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 tables above 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 2 and Table 4 of ST108. 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 2 and Table 4 of ST108; 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 and Table 4 in ST108.

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 per 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 6 in ST108.

6.3 The Contractor shall provide for water quality monitoring frequency as defined in Tables 1 to 4 of the PWS and Table 5 and Table 6 of ST108.

6.4 The Contractor shall provide for water quality monitoring frequency at point-of-water as defined in Tables 1 to 4 of the PWS and Table 5 and Table 6 of ST108.

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 contractor can also schedule to perform maintenance work on weekend at Audie Murphy and Kerrville SPS site.

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. The Contracting Officer will delegate a Contracting Officer’s Representative upon contract award.

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 Contractor 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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