Questions and Answers REVISED 4.1.2020.pdf

Solicitation: 246-Q-20-0038: Pharmacy IV Hoods and Room Testing and Certification

Revised Q&A

As of 04/01/20 Question 1 - The Air Viable sample locations have been included in the Q&A dated 3/26/2020, but not the Surface Viable locations. Is it to be assumed that the Surface Viable test locations are the same as the Air Viable locations?

Question 1 ANSWER: Per 797 guidelines: Surface sampling of all classified areas and pass-through chambers connecting to classified areas for microbialcontamination must be conducted at least monthly (the facility will do the monthly testing).

. Each classified area must be sampled, including the following:

• The interior of the PEC and the equipment contained in it

• Staging or work area(s) near the PEC

• Frequently touched surfaces

When conducted, surface sampling must be performed at the end of compounding activity or shift, but before the area has been cleaned and disinfected.

Question 2 - The Terms and Conditions does not indicate what is being tested for with the microbial sampling, ie. Bacteria/Fungus. If both are to be tested for, are we to use TSA agar for Bacteria and SDA for Fungus (requiring 2 samples at each location), or TSA agar for both (1 sample at each location)?

Question 2 ANSWER: Surface sampling devices must contain general microbial growth media (e.g., TSA) supplemented with neutralizing additives (e.g., lecithin and polysorbate80) to neutralize the effects of any residual disinfecting agents. Surface sampling devices must have a raised convex surface. Sterile swabs wetted with sterile water or a sterile neutralizing buffer may be used when sampling irregular surfaces and difficult-to-reach locations, such as crevices, corners, and spaces between surfaces. After sampling, the sampled area must be thoroughly cleaned and disinfected (see

7. Cleaning, Disinfecting, and Applying Sporicidal Agents in Compounding Areas) Samples must be incubated in a calibrated incubator at temperatures that will promote growth of bacteria and fungi.

The incubator temperature must be monitored during incubation, either manually or by a continuous recording device, and the results must be reviewed and documented. The incubator must be placed in a location outside of the sterile compounding area.

Question 3 - The Terms and Conditions has the following statement:

4.3 The contractor shall contact Claremore Indian Hospital to arrange date and time with Inpatient Pharmacy staff to perform testing at least 30 days prior to the certificates expiration date.

Does this mean that the certification has to be performed no less than 30 days prior to the expiration of the previous date, or just that the scheduling must be made prior to the 30 days, with the certification being performed at some point after that, but prior to the expiration?

Question 3. This means a date and time would need to be scheduled 30 prior to the certificates expiration date. Since this is April now when the award is made we will need to have someone here before the end of the month.

REVISED Q&A

As of 03/31/20 We received a couple question, they are:

1. Follow-on Question to # 5 below in reference to section 4.3 of the BPA Terms and Conditions:

4.3 The contractor shall contact Claremore Indian Hospital to arrange date and time with Inpatient Pharmacy staff to perform testing at least 30 days prior to the certificates expiration date.

Question: Does this mean that the certification has to be performed no less than 30 days prior to the expiration of the previous date, or just that the scheduling must be made prior to the 30 days, with the certification being performed at some point after that, but prior to the expiration?

Answer: The scheduling would need to be made prior to last day of the month of the expiration on the certificates. Our months of recertification are April and October. Surface sampling can be taken from anywhere. We would like at least one sampling to come from the pass-thru.

2. Question: Do we do the quote on the attached document or do we go to the website BETA.Gov and look up the solicitation to do the bid on?

Answer: The notice states: “A single award BPA is anticipated as a result of this solicitation.

Interested parties who will accept the attached terms and conditions shall submit a complete no later than April 3, 2020 at 3:00 pm CST to Eileen Soban at email: eileen.soban@ihs.gov.

mailto:eileen.soban@ihs.gov

Responses will be evaluated on price alone. Additionally, please provide your DUNS’s number and point of contact for the local area for placing service orders.”

Questions & Answers

3/26/2020

Below are the questions asked and the answers.

1. Is this a new requirement or follow-on requirement? If a follow-on, who is the incumbent and what is the incumbent contract number?

ANSWER: New

2. Can the USG provide a reflected ceiling diagram / Schematic of the Cleanroom environment?

ANSWER: See attached.

3. Is it possible to share the report from the previous Certification?

ANSWER: N/A

4. 4. Given the timeframe and 30 day advance notice requirement, is the APRIL 2020 certification able to be performed in MAY 2020?

ANSWER: We will need the recertification completed by the end of April.

5. Can the requirement to complete 30 days (Section 4.3) before the prior certificate's expiration date will cause CIH to continuously lose one month of the certification period - recommend APR & OCT as indicated by Section 8.1. Please advise.

ANSWER: We can wave off the 30 days prior this time seeing that it is the end of March, but the recertification will need to complete by the end of April.

6. It says unit cost, however, there is no qty. There is not a place to put the semi-annual total, when the testing is done semi-annually. Do you only want a grand total for each item, per year? Air and Contact viables have a qty of more than 1 associated with them. Air Viables for example, there is Qty of 10, twice per year, total of 20 annual.

ANSWER: Yes. Note: This is a Blanket Purchase Agreement (BPA). You are only required to submit your individual unit cost for each line per year (Base plus option years). Individual call outs will be placed against the BPA for each year for what the department may require during the year. You may submit your company quote with the BPA Terms and Conditions, showing the individual pricing per year.

EXAMPLE (pricing is only an example):

BASE

YEAR

OPTION

YEAR 1

OPTION

YEAR 2

OPTION

YEAR 3

OPTION

YEAR 4

POP:

4/15/20 - 4 /14/21

4/15/21 - 4/14/22

4/15/22 - 4/14/23

4/15/23 - 4/14/24

4/15/24 - 4/14/25

CLIN DESCRIPTION U/I

UNIT

COST UNIT COST UNIT COST UNIT COST

UNIT

COST

Service Call Travel Fees (from within 100 miles of Claremore) EA $100 $125 $150 $150 $150

Testing Price Off-Schedule Clean Bench

EA

Place your individual cost here for the base year.

Same for option year

Same for option year

Same for option year

Same for option year 4 and then start with the next line.