H946--Sterile Processing Service (SPS) Testing Water/Steam for Battle Creek and Wyoming

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36C25025Q0419 0001
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Contractor Questions
Question 1: Could the NAICS code be changed to 221310 rather than 238220?
Answer 1: No, the NIACS shall remain 238220. NAICS 238220 is broadly defined as Plumbing, Heating, and Air-Conditioning Contractors, however it is narrowed to more specific parameters under its corresponding index entries. One of these index entries is water system balancing and testing contractors. As this contract is for water testing, NAICS 238220 was deemed a suitable fit.

Question 2: Can FAR 52.219-14 be removed from the solicitation?
Answer 2: This solicitation is set-aside for Small Businesses. As prescribed in 19.507(e), FAR 52.219-14(c)(1) is to be inserted in contracts that have been set aside for any of the small business concerns identified in 19.000(a)(3). This clause shall not be removed.

Question 3: Could the contractor provide a turnaround time of 7-10 business days for sterile processing samples except for bacteria (HPC) and endotoxin which could be provided in 2 business days?
Answer 3: We are happy to accept results of any samples prior to the 5 business deadline stated in the SOW

Question 4: The SOW Specific Task #7 mentions the creation of a Water management program. What Clin should we include this pricing in? Can a Clin 0005 be included to encapsulate the cost of this development? Additionally, does the VA require program facilitation post Program development.
Answer 4: Upon further review, this shall be removed from the SOW. An updated SOW has been attached.



SOW Title: Sterile Processing Service (SPS) Water and Steam Testing
Background: The Battle Creek VA Medical Center (BCVAMC) is required to complete testing on all water and steam systems utilize 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.
Scope: The BCVAMC requires a contract for SPS water and steam testing to meet the criteria of AAMI ST108 Reprocessing of Reusable Medical Equipment and Veterans Health Administration (VHA) Directive 1116(2) Sterile Processing Services at the BCVAMC and Wyoming VA Clinic, located at 5500 Armstrong Rd, Battle Creek, MI and 5838 Metro Way, Wyoming, MI, respectively. Services shall be in accordance with the terms, conditions, provisions and schedule of the contract.
Specific Tasks for Testing-Deliverable Product:
Contractor shall provide all labor, materials, equipment, transportation, lodging and supervision necessary to collect appropriate samples and deliver to a lab meeting requirement for processing of AAMI ST108.
Contractor shall provide training to SPS and Engineering personnel on AAMI ST108 requirements and responsibilities within one (1) week of contract award.
Contractor shall be escorted for all sample collection, either Chief of SPS or Water Safety Engineer shall meet with the collector before any samples are collected.
Tester shall be proficient in AAMI ST108 testing methods and procedures.
Contractor shall collect all samples utilizing aseptic technique to prevent contamination; gloves shall be worn, sample container cap shall not be laid down, sample container mouth shall not encounter anything. All sample ports shall be flushed for a minimum of 5 minutes prior to collecting any samples. Samples shall be collected before disinfection of the water treatment system. Sample ports will be treated with a general disinfectant such as alcohol and be completely dry prior to collecting sample. Do not use bleach or other disinfectant solutions on sample ports prior to sample collection. Do not contaminate sample port or sample container while collecting samples. The collection container shall not be made of polypropylene. At least 100 to 300ml of water should be collected per sample. To prevent bacterial replication samples shall be placed on ice or at 4°C until delivered to the laboratory for testing. Results should be provided in five (5) calendar days of them being received by the lab.
Contractor is to provide emergency service for retesting of out of parameter testing and testing five (5) calendar days post disinfection.
Testing shall be in alignment with VA and industry standards and guidance, including the AAMI ST108-2023 Water for the Reprocessing of Medical Devices ii. Association of periOperative Registered Nurses (AORN) Guideline for Cleaning and Care of Surgical Instruments (https://www.aami.org/standards/featured-standards/aami-st108).
Table 1: AAMI ST108 Utility Water, Critical Water, and Steam Testing
Water Quality Measurement
Water Requirements
Testing Frequency
Total Tests Required
Utility Water
AAMI ST108 Chemical Analysis1
See Table 5-6 AAMI ST108
Quarterly/As Needed*
20 Original Samples for Battle Creek/year
40 Original Samples for Wyoming/year
12 Retest/year
Critical Water
AAMI ST108 Chemical Analysis1
See Table 5-6 AAMI ST108
Monthly/As Needed*
120 Original Samples for Battle Creek/year
156 Original Samples for Wyoming/year
55 Retest/year
Steam
AAMI ST108 Chemical Analysis1
See Table 5-6 AAMI ST108
Quarterly/As Needed*
12 Original Samples for Battle Creek/year
8 Original Samples for Wyoming/year
2 Retest/year
1:pH, Alkalinity, TOC, Aluminum, Conductivity, Hardness, Copper, Iron, Manganese, Nitrate, Phosphate, Sulfate, Silicate, Chloride & Zinc (See Table 4 AAMI ST108 for required units)
Conduct one Table 2 test on the first of August each year at each location with 1 retest per location if needed.
Table 2: Table 2 Categories and performance qualification levels of water quality for medical device processing
Water Quality Measurement @ 25 °C:
Total Alkalinity, Bacteria, Endotoxin, Total Organic Carbon (TOC), Color and Turbidity, Ionic Contaminants, Aluminum, Chloride, Conductivity, Copper, Iron, Manganese, Nitrate, Phosphate, Sulfate, Silicate, Total Hardness, Zinc

Performance: The Government will document performance in accordance with deliverables. Any report will become a part of the supporting documentation for any contractual action.
Security Requirements: Contractor will not have access to VA Sensitive Information, patient records, or data.
General Requirements
All on-site work shall be coordinated with COR, Chief of SPS, or Water Safety Engineer at least seven (7) days prior to performing services.
Water testing shall be done during normal business hours 0730-1600 ET Monday through Friday.
The contractor shall respond to routine communications within 24 hours on business days and 48 hours on holidays/weekends.
Situations requiring more frequent analysis and/or special testing, other than the specified requirements, may arise. The contractor shall not perform any extra cost work without written authorization from the contracting officer.
Any deficiencies or problems noted with VA test results or with the water treatment system test results are to be reported to the COR and SPS as soon as possible but no later than 4 hours after test results are received. The Contractor shall not perform any work outside of the scope of this contract unless they have been issued a separate Purchase Order to cover that work.
Deliverables
The contractor shall provide complete written reports within five (5) business days after each analysis and inspection.
The reports shall include all test results, the date of the test, testing parameters, recommendations, and a review with the COR.
Each report shall highlight the results with a green for pass and red for fail, indicating whether the results pass or fail the parameters specified in AAMI ST108.
For any products utilized in the testing process, the following shall be documented on the report: name, ingredients, control range, test procedures, physical state (liquid, powder, etc.), container size, method of delivery, compatibility with present materials being used, catalog data, Material Safety Data Sheets (MSDS) sheets.
The reports shall be emailed to the COR.
Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI): The BCVAMC will not furnish parts and/or test equipment for the performance of this contract. It is the responsibility of the contractor to bring the appropriate equipment; and/or supplies necessary to complete the work as required per this contract.
Other Pertinent Information or Special Considerations: All work shall be performed by personnel qualified to work on the specific equipment. All work performed shall be compliant with AAMI ST108 guidelines and shall be designed to assure that the BCVAMC is providing the best possible water to process reusable medical equipment.
Place of Performance: The Department of Veterans Affairs BCVAMC located at 5500 Armstrong Rd, Battle Creek, MI, and Wyoming VA Clinic located at 5838 Metro Way, Wyoming, MI. AAMI ST108 testing shall take place in Sterile Processing department, Sterile Processing Reverse Osmosis mechanical room, and GI Procedures reprocessing area.

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