Water filters for legionella mitigation

Added: May 31, 2013 10:19 am
The Department of Veterans Affairs, Salem, Virginia has a need for point of use shower and faucet filters to protect against legionella that meets or exceeds the following Scope of Work:

Scope of Work- Point-of-use (POU) filters for potable water protection

The tasks to be performed under this Statement of Work are described below.

1. Point of Use filtration products with required minimum validated service life of at least 31 Days per ASTM F838-051 and Health Industry Manufacturers Association (HIMA) guidance for validating 0.2 ?m sterilizing grade filters. The Point of Use filter will have a bacteriostatic additive in the housing to reduce the risk of retrograde contamination from gram positive and gram negative organisms.

2. Validation documentation must be provided outlining the following:
a) Minimum sterility level of 10-6 validated and routinely controlled based on the standards of BS EN 552 (1994) 'Sterilization of Medical Devices Validation and Routine Control of Sterilization by Irradiation' and ISO 11137-1, ISO 11137-2, ISO 11137-3 (2006) 'Sterilization of Healthcare Products - Radiation - Part 1 -Requirements for development, validation and routine control of a sterilization process for medical devices. Part 2 -Establishing the sterilization dose. Part 3 - Guidance on dosimetric aspects'.
b) Verification of 0.2 ?m sterilizing grade filter performance-POU filters retain Brevundimonas diminuta, the validating bacterium specified in healthcare industry standard laboratory liquid microbial challenge tests used for validating 0.2 ?m sterilizing grade filters, to > 107 CFU/cm2. A summary of the methods used for microbial challenges for retention of bacteria and bacteriostatic properties must be specified along with the microbial challenge rig diagram, microbial challenge test result data for retention, intermittent use, and evaluation of bacteriostatic properties.
c) Validation of physical characteristics-Show testing that illustrates typical water flow rates that might be expected using the POU filter
at different inlet water pressures. Show testing that confirms that the
POU filter is capable of continuously operating at a maximum water temperature of 140°F (60 °C) combined with a maximum inlet pressure of 75 PSI (5 bar). A summary of the methods used for testing must be specified along with the hot water test rig diagram, flow, temperature, and pressure data.
d) Biological reactivity testing- Show testing that verifies the biological
suitability of the materials of construction of the POU filter. The
summary of the method must show biological reactivity tests (in vivo) were independently performed as described in United States Pharmacopoeia (USP) (in vivo).

3. Studies performed at customer sites or under controlled or semi-controlled
conditions without the validation specifications listed above will not be
accepted.

4. The POU supplier will have a unique serial number identification with a bar-code
to validate and verify the installation and change out of the product. The supplier change-out representative will have the capability of scanning the barcodes on the POU filters for use with reporting tool.

5. The POU filter supplier will provide all connectors and fittings at no additional
charge.

6. The POU filter supplier will remove all used product and dispose off site so customer does not incur disposal costs associated with the POU filters.

7. The POU filter supplier will document change outs and provide a report following the change out of the POU filters.

8. The POU filter supplier shall change out, according to manufacturer specifications,
the point of use filters in all departments designated by the customer and adhere
to all customer visitation procedures including on-site safety and PPE
requirements.
9. All documentation will be sent via email to the customer point of contact.
10. The contractor shall invoice the customer on a monthly or quarterly basis for payment.
11. The customer will provide access to the departments for the appropriate personnel (i.e. management, technical, etc.) necessary to fulfill the Statement of Work requirements.
12. Sensitive or proprietary information shall NOT be removed, copied, or otherwise replicated from the customer site without the approval of the customer.

The NAICS code for this requirement is 333999 and the size standard is 500 employees. This is not a request for bids, quotes, or proposals. This is a SOURCES SOUGHT announcement only. The purpose of this notice is to conduct market research and obtain information from qualified businesses. The responses to this announcement will assist in determining the socio-economic set aside if feasible.
The Veterans Administration is required by Public Law 109-461 to give first priority to SDVOSB and VOSB concerns if there should be sufficient firms available to compete under a set aside. If insufficient veteran owned and small business response is received to establish the basis for setting this action aside for other than large business participation then the action will be advertised as full and open competition, in which case, all interested parties responding shall be eligible to bid.
This notice shall not be construed as a commitment by the Government to ultimately award a contract, nor does it restrict the Government to a particular acquisition approach. All information submitted in response to this announcement is voluntary; the Government will not pay for information requested nor will it compensate any respondent for any cost incurred in developing information provided to the Government.
Interested parties should submit their response to this notice should include the following: name and address of company; business size (large or small); identify whether or not firm falls into any of the socioeconomic categories and any pertinent information which demonstrates firms ability to meet the above requirement. All responses shall be submitted in writing no later than June 6, 2013, 12:00 PM, EST to the attention of: John J. Summers, VA Medical Center, 27 Averill Avenue, Hampton, VA 23667. E-mail address: john.summers2@va.gov