36C26224Q0073 - Question _ Answers.docx

Solicitation 36C26224Q0073 Question & Answers

Please verify that item 0004 includes chloride, iron, copper, and manganese together. The listed compounds are known as “Ionic contaminants” and can be found in the table below. Water used in the mechanical cleaning and disinfection of medical devices should have metal ion concentration as shown in the table below.

What is 0-phosphate? I don’t think this is a universally used term. I am unsure what the leading zero (0) is, however Phosphate can enter water as run off from agricultural uses and can contribute to scale formation, leave residues on instrumentation, and interact with cleaning chemicals and so the updated standards are asking us to test for this compound.

Sample re-testing – please elaborate. VA can order only one resample per year of any test? The re-testing amount is based on an estimated/as-needed quantity to be determined by the offeror.

Is there a specified limit of detection for your chlorides testing? Yes, this has two parts to the answer. Chloride detection for Utility(Potable or also known as City water) water is <250mg/L and <1mg/L for Critical Water.

Can you verify that all testing will occur within the Carl T. Hayden Medical Center and not at any outlying sites? Yes, service contract is to conduct monthly, quarterly, semi-annual, and annual sampling and testing at various distal sites within the Phoenix VA Medical Center and its central plant to determine water quality parameters.

The scope of work says the testing must be accomplished in a "local certified water testing laboratory". Could you explain the requirement to be local and what exactly is meant by local? This seems unnecessarily restrictive to competition as there are many labs that perform SPS testing for the VA nationwide without issues on a regular basis. While this testing does not need to be local, there are concerns with “what if” the testing is positive. This what if statement requires immediate retesting as to not inhibit patient care by not retesting quickly and shutting down SPS Sterile Processing. The first step in outlier results is to re-test. At present time it is required for a “Sampler” to be on site to do some of the pertinent testing such as pH at the time of collection. If we have to re-culture water, it is easiest to collect the samples and run them right down to the lab for culturing. Again, this is all to say a local (Phoenix metropolitan area) lab is necessary to keep the SPS unit running and the OR functioning.

On page #33 and #34, it seems to imply that:

Project Objectives: The objective of this service contract is to conduct monthly, quarterly, semi-annual, and annual sampling and testing at various distal sites within the Phoenix VA Medical Center and its central plant to determine water quality parameters. This must be accomplished from a local certified water testing laboratory that can provide onsite sample collecting and provide results of testing and demonstrate itself to be able to meet the critical demands for this effort . Does this mean the Prime has to be in Phoenix and be a certified water testing lab? If not, what is considered "local" when referring to the certified water testing laboratory (Phoenix, Arizona, West Coast)? See above for the needs of the “Sampler.” This is to say, yes the “Sampler” must be certified as an Environmental Water Sampler. Certified by Arizona Health Service, State Certified Laboratory to perform regulatory reporting.

Special & Technical Requirements • Contractor is responsible to supply all labor for all test sample collections. • Contractor will supply all parts and materials to complete the service. • Contractor is responsible for all subcontractors required to complete reports. Does this imply that the Prime must collect the water samples, or can any member of the Prime's team collect the samples as long as the limitations of subcontracting are met? As long as they are certified to test and collect samples, then a team member is allowed to do this work.

It seems this specification is written from the old AMMI TIR-34 and not the new AMMI ST-108, the biggest change between the two is Endotoxin testing is now required monthly at all Critical Water Locations. Does the RFP need to be updated to the new AMMi ST-108? Yes, it needs to be updated to reflect this change.

Are there any requirements for limits of detection in any of these tests? Please see below for detection limits.

Besides the Endotoxin test are there any required turnaround times? Turnaround times are not specified, however quick turnaround times are necessary to keep SPS functional for sterile processing and the OR performing surgeries. If we have to wait on test results, it may be necessary to stop SPS functions which will affect surgery and patient care.

Page 5 of 62 B2. PRICE/COST SCHEDULE CLIN 0001 Sample Re-testing. Can the government clarify which testing this resampling applies to? The re-testing amount is based on an estimated/as-needed quantity to be determined by the offeror.

Page 34 of 62 REPORTING (During Other than Normal Working Hours)– Will the government allow on-site collection services to begin earlier than 8:00AM? Samples can be scheduled as early as 0600 local time and dependent on patien Page 34 of 62 REPORTING (During Normal Working Hours) states “For any repairs or service that will be performed…” Can the government clarify the reference to “any repairs” as this work is for water collection and testing? This is a blanket statement for “any repairs or service”.

Page 38 of 62 File#3: Past Performance “a. No Price information shall be included in the technical proposal (File #2). Can the government clarify as File #2 is the Price/Cost Schedule? File #3 is for past performance only the file #2 in quotations in directing you to put pricing in file #2. All pricing must be included in File #2.

Page 38 of 62 File#4: Other Requirements “c. VAAR 852.219-75 and -76 certifications shall be signed and filled out at the time of bid/quote/offer submission.” The government states “and” but the solicitation does not contain VAAR 852.219-76. Can the government clarify that offers are required to only submit VAAR 852.219-75? If -76 is also required, will the government provide? -76 does not apply to this requirement, please sign on page 22 of the RFQ.

Page 39 of 62 Submittal Instructions state “The Contractor’s quotation must be labeled with the Contractor’s name and business address of the firm, the solicitation number 36C26223Q1706….” The solicitation number in Box 5 of the SF 1449 is 36C26224Q0073. Can the government clarify the Solicitation number and provide an amendment as needed? The correct solicitation number is 36C26224Q0073.

On page 34 of 62 – “A request of ten (10) Endotoxins per year. As needed basis…”. Would these 10 Endotoxins tests be at each of the 49 sample locations? Would there be a maximum of 10 tests per year under the contract? The 10 added test are for retests when required.

Regarding the monthly “Bacteria” tests – would that be Heterotrophic plate counts? What type of bacterial determination? It recovers bacteria in a water system but does not specifically identify each species. This is the same type of testing used in the Dental Clinic with their line testing.

We have a local lab that would send some or all samples to their sister lab (same company) an out of state lab for analysis. This lab is set up to perform testing per ANSI/AAMI ST108:2023 standards. Would this fall under the parameters of the contract? Unable to answer, but from a microbiology point of view; delay in water testing and further shipping to other labs puts risk into the water results and delays decision making capabilities effecting patient care.

How many different buildings are involved with the sampling? How many sample sites are within the main VA Hospital?

Bldg 2, and Bldg 1.

Item 0008 – What are the sampling locations for the 8 Ionic contaminants tests? BLDG 2 in the Boiler Plant

Item 0009 – Is this a mobilization fee to resample? Are any tests included in this price? Resampling will be required when the Endotoxins are out of limits. This is why the 10 added samples are included and a line item.

What organization certifies a “certified” local water lab? What water lab certifications are accepted? Certified by Arizona Health Service, State Certified Laboratory to perform regulatory reporting.

Can you please provide us with the exact addresses for the locations. All test locations will be conducted at 650 E Indian School Rd. Phx AZ 85012 Provide specific tests for:

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