Attachment Contractor Questions.pdf

36C24423Q0164 CONTRACTOR QUESTIONS

1. Schedule B CLINS 0001, 1001, 2001, 3001, 4001 calls for quantity of 880 Legionella annually and

Statement of Work (SOW) 3.2 Testing Intervals 3.2.1 calls for quantity of 936 annually (234 quarterly). Can the government clarify the quantity and provide an updated Schedule B and or

SOW? See Section 3.2 of revised SOW and revised pricing worksheet.

2. SOW Section 3.4 calls for retests of Total Heterotrophic Aerobic Bacteria (THAB). The SOW does not include regular testing for THAB.

o Can the government clarify the need for THAB retests? See Section 3.5 of revised SOW o If the contract will require regular THAB testing, can the government provide details for routine THAB testing and add a CLIN line? See Section 3.5 of revised SOW o SOW Section 3.4 Calls for “Legionella and Aerobic Bacteria (THAB) Polymerase Chain

Reaction (PCR) test kits that do not require the shipment of water to the lab shall be used (sample holding time can result in significant variation in test results) in addition to the 11731 ISO spread plate method.” See Section 3.5 of revised SOW o Can the government remove this requirement for PCR test kits or clarify that PCR kits are allowed under VA Directive 1061? VHA Directive 1061 Amended September 26, 2022, states on page C-4 paragraph c. (1) “The PCR test is to be done by a laboratory that is accredited and deemed to be proficient to detect Legionella in water samples by

PCR. NOTE: Use of point-of-use PCR kits that do not meet the laboratory requirements in this appendix is not permitted.” See Section 3.5 of revised SOW

3. If the government requires PCR Test Kits that DO NOT require the shipment of water to the lab can the government clarify the following questions: See Section 3.5 of revised SOW o Is it the government’s intention that if there are 5 retests to run with PCR Test kits that could take 2-6 hours at the VA AFTER the collection of the samples, Vendors will be conducting this testing and staying at the VA to conduct?

o Where is the Vendor performing the PCR test? Does the VA provide a facility, space, electrical power supply to perform the PCR test?

o Is there any sensitivity requirement for the PCR test?

o Is this a positive/negative PCR test or quantitative?

o What is the threshold for detection?

o How is the outcome of the PCR test to be validated?

o When is the PCR outcome to be reported?

o For PCR test report when is the test to be delivered? How is it required to be delivered.

o What is the exact method for PCR (primers, master mix composition, filtration method, cycle times and temperatures)? A proposal cannot be submitted reasonably without sufficient information about what the government is asking for.

o What is the sample concentration method required?

4. SOW Section 5.5 “Personnel who come to the facility and physically collect the sample shall be trained by the company and have 334 certifications from the state …” o Can the government clarify what is meant by 334 certifications from the state regarding

Vendor water collector personnel? See Section 5.5 of revised SOW o If 334 certifications are needed, will the government provide a list of what they are? If these certifications are not needed, will the government remove this from the SOW and issue an amended RFP? See Section 3.5 of revised SOW

5. Do you want retested samples to be plate-cultured, amplified by PCR, or both? I want to be certain that you are looking for PCR results for HPC testing. See Section 3.5 of revised SOW

6. Additionally, it seems as though the 3.4.1 statement involves a kit comparison to ISO culture methods. Is this correct? If so, this would require that one sample be taken so it can portioned off into a commercially available kit and also analyzed using ISO culture methods. Is this correct?

One sample

7. I also wanted to confirm the bottle type. Did you want the samples collected in 250mL bottles or 250 1-Liter bottles (3.3.1)? See Section 3.4 of revised SOW