SOW Sterile Processing Water Testing Service Contract.docx

STATEMENT OF WORK (SOW)

Sterile Processing Services (SPS) Water & Steam Testing

1. BACKGROUND. Texas Valley Coastal Bend Health Care System (TVCBHCS) is required to complete testing on all water and steam systems utilized in the reprocessing of reusable medical devices. Water impurities can have adverse effects on medical devices and patient outcomes. The requirements of Association for the Advancement of Medical Instrumentation (AAMI) ST108: Water for the Processing of Medical Devices are intended to mitigate the risks associated with water identified to be in improper quality. The TVCBHCS requires water quality testing to meet the standards of ANSI/AAMI ST108 for reprocessing of reusable medical equipment. This Sterile Processing Service is located at 2601 Veterans Dr., Harlingen, TX, 78559. Services shall be in accordance with the provisions listed in the contract.

1.1 ANSI/AAMI ST108 Standard (Current Edition), which governs the processes and requirements for Sterile Processing, added requirements to the roster of locations needing monthly critical water sampling and daily conductivity monitoring. Per the standard, the requirement is to test critical water at “every point of use” each month.

2. SCOPE OF WORK. The purpose of this service is to provide for the sampling and testing of water and provide a report for the analysis of the results to ensure effective water quality for processing medical devices. The testing shall include testing of critical water and steam, as condensate, per guidance published in ANSI/AAMI ST108: Water for the Processing of Medical Devices. The Contractor shall use the current edition of this standard for the life of the contract unless informed differently.

2.1 ANSI/AAMI ST108 covers the minimum requirements for the quality of water and steam condensate necessary to effectively process medical devices.

2.3 The Contractor will perform testing and verification of water and steam condensate used in the VA's sterile processing departments to ensure compliance with ANSI/AAMI ST108 standards. The services will include sampling, testing, and reporting activities to confirm that water and steam used in sterilization processes meet the required specifications. It is the responsibility of the contractor to bring all the appropriate equipment and/or supplies necessary to complete the work; the VA shall not furnish any supplies or equipment for the performance of the contract

2.2 PERIOD OF PERFORMANCE. Base Year for a period of 12 months with 4 option year period. (TBD upon contract award)

3. CONTRACTOR RESPONSIBILITY. The Contractor shall perform water and steam condensate testing in accordance with Table 5 & Table 6 at every point of use. The locations for these services are listed in subsequent section of this SOW.

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 ANSI/AAMI 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 ANSI/AAMI ST108. The Laboratories shall be accredited by the Texas Commission on Environmental Quality (TECQ) and National Environmental Laboratory Accreditation Program (NELAP). 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 in Tables 5 & 6 as described in ANSI/AAMI ST108. For any testing completed, provide the results/reports back to the VHA as soon as possible after completion but no later than seven (7) calendar days.

3.1.4 The Contractor shall perform water and steam testing & monitoring program as described for the following locations:

3.1.4.1 Harlingen Care Center (HCC) – 2601 Veterans Dr., Harlingen, TX

· Perform all testing per the reference Table 4 in ANSI/AAMI ST108.

· Perform all tests to comply with the frequencies required and listed in the associated ANSI/AAMI ST108 Tables 5 & 6.

· Provide Report of Analysis within seven (7) calendar days of sampling. Identify all results which are in compliance with ANSI/AAMI ST108 standards in green and all results which are out of tolerance in red.

· Allow for up to 10 emergency testing actions per year.

3.2 WATER TEST POINTS OF USE BY LOCATION

3.2.1 Harlingen Care Center (HCC). Testing points shall be in SPS Areas:

· Three decontamination sinks with each having hot and cold lines, and one critical

· Two washer-disinfector with hot and cold lines, and one critical water

· One cart washer with hot and cold lines, and one critical water

· Two ultrasonics with all critical water

· Two medivators with utility water

· Three Sterilizers with steam sample ports (steam as condensate).

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

3.4 The Contractor shall provide a final report of all findings (i.e. sample locations, results, parameters) and compliance status within seven calendar days of sampling.

3.6 The Contractor shall provide immediate notification of any positive samples over the bacteria and endotoxin threshold per ANSI/AAMI ST108 no later than 24 hours of the finding by both telephone and email.

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 Contractor shall submit a sampling procedure for concurrence and compliance with flushing and sampling per Annex H.

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

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

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

3.13.3 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.

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

3.15 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 COMMUNICATION. The Contractor shall be available for servicing equipment during normal hours of operations. The Contractor shall reply and respond to routine communications within 48 hours and emergency communication within four (4) hours. The Contractor shall communicate any results that are out of compliance within 24 hours of the finding by both telephone and email. The Contractor shall provide a schedule at the beginning of each option year, specifying pre-planned dates for routine monitoring and testing. This schedule must be submitted for review and acceptance by the COR. Any changes to the approved dates must be communicated no later than 48 hours in advance. Please note that communications cannot be performed over weekends, or federal holidays.

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

5.1 Three (3) categories of water quality per ANSI/AAMI 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.

5.1.1 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. This water is mainly used for flushing, washing, and intermediate rinsing (e.g., rinsing between cleaning and disinfection).

5.1.2 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.

5.1.3 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 ANSI/AAMI ST108 Categories and performance qualification levels of water quality for medical device processing

Water Quality Measurement

Units

Utility Water

Critical Water

Steam*

Ionic Contaminants

* 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 ANSI/AAMI ST108, Annex D for additional information.

5.2 Water Quality Routine Monitoring.

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

5.2.2 The Contractor shall provide for routine monitoring to ensure compliance with the defined compliance parameters as defined in Table 4.

Table 4 ANSI/AAMI ST108 Table for Water Quality monitoring requirements.

*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 piping may result in higher pH requirements. A pH <7.5 in these systems should be avoided.

5.3 The Contractor shall comply with the frequency of testing and monitoring as defined in Table 5 & Table 6.

Table 5 ANSI/AAMI ST108 Frequency for water quality monitoring.

Minimum frequency of testing*

Alkalinity test kit**

*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.

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

Minimum frequency of testing*

Alkalinity test kit**

*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.

6. SAMPLING PER ANSI/AAMI ST108 GUIDANCE.

6.1 Sample Collection: The Contractor shall perform sample collections per Annex H of ANSI/AAMI ST108.

7. 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:

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.

8. 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

9. TUBERCULOSIS (TB) SCREENING.

9.1 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.

9.2 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.

9.3 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)