Microbiological testing with possible options response to contractor questions

Added: Feb 23, 2018 2:48 pm Notice Type: Posted Date:
Responses to Contractor Questions February 23, 2018

Original Set Aside: Response Date:
Open Market Small Business February 26, 2018 @ 4:30 PM EST

Classification Code: NAICS Code:
B510 Environmental Assessments 541620 Environmental Consulting Services

Synopsis:
The Purpose of this amendment is to post questions submitted during the solicitation period of this requirement. Please find questions asked, and responses provided.
*AGENCY RESPONSES ARE IN RED

If there was a prior contract, what number of hours where expended by the contractor on a monthly basis? 1 day per month for approximately 4 hours

Please confirm that the quantities listed on the pricing sheets are annual and can be divided by 12 to estimate the number of samples to be collected on a monthly basis.

What level of analysis is required: (e.g. speciation, genus level etc) testing will include bacterial air count; fungal air count; bacterial plate count; bacterial contact plate identification; fungal contact plate count;
Per USP published guidelines: Action levels are determined on the basis of colony forming unit
(CFU) data gathered at each sampling location and trended over time. The numbers in the following tables
should be used only as guidelines. Regardless of the number of CFU identified in the pharmacy, further
corrective actions will be dictated by the identification of microorganisms recovered (at least to the genus
level) by an appropriate credentialed laboratory of any microbial bioburden captured as a CFU using an
impaction air sampler. Highly pathogenic microorganisms (e.g., Gram-negative rods, coagulase positive
Staphylococcus, molds and yeasts) can be potentially fatal to patients receiving compounded sterile
preparations and must be immediately remedied, regardless of CFU count.

What turnaround times are required for sample analysis? Reports are due back to us within 10 days of samples being taken

Can you provide further information on item 0007 Media Fill testing? Media-Fill testing will be in accordance with USP (specifically 2.3 Competency Testing in Aseptic Manipulation)

Is all sampling to be performed by an ABIH certified CIH? If so can he be assisted on site by a non CIH technician? Sampling must be performed by either a ABIH certified Certified Industrial Hygienist (CIH) and preferably certified through Controlled Environmental Testing Association (CETA), OR by a Certified Safety Professional in Comprehensive Practice (CSP) that is certified through CETA.

Can the sampling be performed by other than a CIH of the sampling protocol is developed by a CIH Sampling must be performed by either a ABIH certified Certified Industrial Hygienist (CIH) and preferably certified through Controlled Environmental Testing Association (CETA), OR by a Certified Safety Professional in Comprehensive Practice (CSP) that is certified through CETA.
P. 11-12, item 001 Quantity 9, Unit MO:  Please clarify the pricing for this item.  Are you looking for a daily rate? We re looking for a monthly rate, what the charge will be for CIH services per month x 9 months. After the initial 9 month period, the optional service periods will be in 12 month increments.


P. 11-12, items 002-007:  Is the Quantity divided equally for the 9 month period? The first performance period is for 9 months (ending in December), the quantities listed are what is expected for the total 9 month period. For each optional year of service, it will be for a 12 month period.

P. 11-12, items 002-007: Do these items include the labor or just the sample media and analysis? Yes, labor should be included.

P. 11-12, items 001-007:  Are all items to be accomplished in one (1) day on-site? Yes, testing currently takes approximately 4 hours and is accomplished in a single monthly visit.

How many facility visits and/or trips to the main hospital and pharmacy do you anticipate? How many sampling sessions do you anticipate? Is the intention that all of the sampling will be done during one hospital visit? All sampling shall be done in one visit (4 hour block of time approximately)
The sampling report cost, laboratory microbial analytical cost, hours to collect the samples, sampling equipment cost, preparation of management plans, QC Plans, etc. are all to be included in the applicable unit bid item costs correct? Yes
Can I email you our submittal or do I have to mail it to you? Yes, e-mail submittal is preferred.
Will you accept a CSP in lieu of a CIH for this project? Yes, however they must be CETA certified.