ESBD_File_192689_PCS 121 - Solicitation Addendum 2 Acknowledgement Form (08-20-19).pdf

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C:\Users\Fnesbitt01\Pictures\Saved Pictures\HHS Branding\HHS Color Logo.png Effective 07/15/2016 Revised 08/16/2019 Procurement and Contracting Services, 1100 W. 49th Street, Austin, TX 78756 Form

PCS 121

SOLICITATION ADDENDUM ACKNOWLEDGEMENT FORM

PCS Contact Information Description of Addendum

THIS ADDENDUM NOW BECOMES A PART OF THE ORIGINAL SOLICITATION

RETURN ADDENDUM ACKNOWLEDGMENT FORM AS INSTRUCTED, FAILURE TO DO SO MAY RESULT IN DISQUALIFICATION OF RESPONSE.

1.

If respondent has submitted response prior to addendum, respondent may email the signed addendum to pcsbids@hhsc.state.tx.us prior to the solicitation due date and time.

2.

Acknowledge receipt of this addendum on the face of your response, or 3.

Sign and return this addendum to HHSC-PCS with the solicitation response to Procurement and Contracting Services, 1100 W. 49th Street, Austin, TX 78756; or 9.0.0.2.20101008.1.734229 p.m.

Q: Do we need to submit an intent to bid?

A: No, not required.

Q: It is not clear to us - is it sufficient to submit the bid electronically or do we have to submit one physical copy via mail/courier?

A: You have the option to submit your proposal through online bid room, hand delivery or through your specified carrier.

Q: If a physical copy IS required, can it be delivered by a commercial carrier (like UPS or FedEx)? Yes.

In section 4 (page 3 of the solicitation), it says the physical address provided is for "hand-delivery only". Does it mean we cannot have FedEx or UPS deliver to this address?

A: It can be hand delivered by FedEx or UPS.

Q: Is a "compact disk" required or can we submit a usb stick? Is portable media required or can we submit the response by email or the online bid room?

A: USB is acceptable.

Pump Requirement:

Have adjustable or variable cycling with the ability to cycle at a range of sixty (60) to seventy-two (72) times per minute.

Q: Does the pump need to operate ONLY in the range of 60-72 cycles per minute, or up to 60 … 72 cycles per minute?

A: Cycle up to a range of 60 -72 cycle per minute. This applies to both the Multi and electric single users.

Language has been revised:

Section 10.1 Multi-User Electric Pump Change from 10.1.10. Have adjustable or variable cycling with the ability to cycle at a range of sixty (60) to seventy-two (72) times per minute. To now read: 10.1.10 Have adjustable or variable cycling with the ability to cycle up to a range of sixty (60) to seventy-two (72) times per minute.

Section 10.3 Single-User Electric Pump with Milk Collection Kit Change from 10.3.14. Have adjustable or variable cycling with the ability to cycle at a range of sixty (60) to seventy-two (72) times per minute. To now read: 10.3.14 Have adjustable or variable cycling with the ability to cycle up to a range of sixty (60) to seventy-two (72) times per minute.

Video Requirement:

Audiovisual and Media in English & Spanish; with Closed Caption Q: Is it sufficient for the bidder to AGREE to provide and comply with the requirements at the time of proposal submission without having to SUBMIT Audiovisual at the time of bid submission? In other words, is it sufficient to provide AV material within 60 days of award?

A: Yes, agreement to comply with this requirement and provide the Audiovisual media within 60 days of award is acceptable.

Warranty Requirement:

Vendor(s) shall provide up to one hundred (100) insect de-infestation treatments or repairs on Multi-User Electric Pumps per year.

Q: Is this the TOTAL number of treatments or repairs, regardless of the number of pumps? Or is it 100 treatments or repairs per pump?

A: It is 100 overall treatments per year on infested pumps.

Q: In Texas WICs previous Bid request from 2017, there was a specification that a multi-user breast pump have a mechanism to prevent user from achieving a vacuum level over 250 mm Hg for longer than two (2) seconds to prevent nipple trauma. We did NOT see this specification for this bid and wonder if the requirement was inadvertently let off? We view this safety requirement a valuable feature of our products and are inquiring as to why it was not included this time?

A: Requirements were given close consideration and stand as posted. Please review the IFB in its entirety including all related exhibits and attachments.

Q: Section 10.7.1 - 7. The bid language requires instructional videos for each pump but isn’t clear if the video is required to be included with each pump. We notice the requirement to provide a DVD Master copy as well as video files. Is providing a Master DVD copy of our instructional videos AND online with a link for all users with a cell phone to access sufficient?

A: A link to instructional online videos must be included in the written materials along with each pump. A DVD master copy of instructional videos shall be provided to HHSC for duplication.

Q: 10.2.6 – Sterile Kit; include a minimum of four (4) different sized breast flanges. Do you mean it must include 2 sets? 2 of one size and 2 of a different size to equal 4 flanges total? A: Include a minimum of two (2) pairs of different standard sized breast flanges, to accommodate different sized breasts and nipples. Flanges should be comfortable for most users. Vendor (s) shall list size of flanges in millimeters on bid and pricing schedule. See Exhibit A Pricing Sheet.

Q: 10.3.5 – Single-User; include a minimum of four (4) different sized breast flanges. Do you mean it must include 2 sets? 2 of one size and 2 of a different size to equal 4 flanges total? A: Include a minimum of two (2) pairs of different standard sized breast flanges, to accommodate different sized breasts and nipples. Flanges should be comfortable for most users. Vendor (s) shall list size of flanges in millimeters on bid and pricing schedule. See Exhibit A Pricing Sheet.

Q: 10.8.1 - Does Reconditioned pump require a 3-year warranty?

A: Yes

Q: 24.1 - With the current situation is it acceptable to DocuSign and email bid response?

A: Yes

Q: 24.1 – If we email response, do you need hard copy in mail?

A: No

Q: 24.1 – if email response, do we need to also need to respond in HHS Online Bid Room Portal?

A: Bids/responses for this Invitation for Bids may be submitted electronically using the HHS Online Bid Room or any other method identified in the solicitation. Use of the HHS Online Bid Room is optional and is subject to all terms and conditions, affirmations, and other requirements of the solicitation as any other method of submission.

Q: 10.1 Multi-User – 10.1.16 Include a soft carrying case; can this be a separate item?

A: No

Q: 10.7 Audiovisual and Media – every Single-User pump comes with its own DVD; instructional videos are available through website. Is this acceptable?

A: It’s acceptable with the condition that a link to the website must be provided in printed materials, see section 10.6 Printed Materials.

Scope of work page 9, section 10.

Q: On your last bid 2017 for Breast Pumps, multiple items were allowed for each of the breast pumps and accessories listed in the Scope of Work. Can we submit multiple products for each of the goods listed in section 10 Scope of Work? If so, please explain the process for submitting multiple items.

A: Only submit what is required in the solicitation, exhibits and attachments. Please review the IFB in its entirety along with all exhibits and attachments.

10.1 Multi-user Electric Pump:

Q: 10.1.1 Because of the price advantage of used (refurbished pumps) what equality process are followed when evaluating New product vs Used (refurbished)?

A: This is not a requirement. Please review the IFB in its entirety along with all exhibits and attachments.

Q: 10.1.3 UL listed is a (NRTL) Nationally Recognized Testing Laboratories however there are many companies besides UL who use the same stands of testing for certification. Please consider the following revision on 10-1.3. Be UL or equivalent listed and use 110-volt electrical outlet A: Revising this section as follow: “10.1.3 Be UL or equivalent listed and use a 100-volt electrical outlet.”

Q: 10.1.13 All of our electronic pumps have 510k market clearance confirmation letters. What other FDA requirements are needed for multi-use electric pumps? Please provide an FDA link or details.

A: The approved 510K market clearance letter is enough proof of compliance with FDA requirements.

Q: 10.1.16 We offer both hard and soft carry cases. How should we submit our pricing on Exhibit C price sheet? Are we to submit multiple Exhibit C Pricing Sheets?

A: Program response: Please provide pricing as specified. Additional pricing may be included on a separate page and/or sheet.

Q: 10.1.17 Some pump models have batteries built-in so this would meet this specification correct?

A: Yes, and pumps must include a vehicle adapter, which can be plugged into any vehicle.

Q: 10.2 Sterile Milk Collection Kit for use with Multi-user Electric Pump:

10.2.6 “include a minimum of four (4) different sized breast flanges” Please clarify, are they seeking 2 standard sizes and (1) Lg flange and (1) xlg flange? For a total of 4 flanges?

A: Program response: Revising this section as follow: “10.2.6 Include a minimum of two (2) pairs of different standard sized breast flanges, to accommodate different sized breasts and nipples. Flanges should be comfortable for most users. Vendor (s) shall list size of flanges in millimeters on bid and pricing schedule. See Exhibit A Pricing Sheet.”

Q: 10.2.8 Please explain what is meant by “tubing material that meets industry standards” We have been manufacturing our tubing for many years but I’m not familiar with the definition of “industry standards” as it relates to tubing.

A: Quality of tubing material should be comparable to standard tubing used for breast pumps and able to endure multiple uses.

Q: 10.3 Single-User Electric Pump with Milk Collection Kit:

10.3.2 Please reference the FDA link which explains the requirement for a milk collection kit.

A: This is a requirement in the scope of work.

Q: 10.3.5 “include a minimum of four (4) different sized breast flanges” Please clarify, are they seeking 2 standard sizes and (1) Lg flange and (1) xlg flange? For a total of 4 flanges?

A: Revising this section as follow: “10.3.5 Include a minimum of two (2) pairs of different standard sized breast flanges, to accommodate different sized breasts and nipples. Flanges should be comfortable for most users. Vendor (s) shall list size of flanges in millimeters on bid and pricing schedule. See Exhibit A Pricing Sheet.”

Q: 10.3.7 UL listed is a (NRTL) Nationally Recognized Testing Laboratories however there are many reputable companies besides UL who use the same stands of testing for certification therefore please consider the following revision on 10-1.3. Be UL or equivalent listed and use 110-volt electrical outlet A: Program response: Revising this section as follow:

“10.3.7 Be UL or equivalent listed and use a 100-volt electrical outlet.”

Q: 10.3.17 All of our electronic pumps have 510k market clearance confirmation letters. What other FDA requirements are needed for multi-use electric pumps? Please provide an FDA link or details.

A: The approved 510K market clearance letter is enough proof of compliance with FDA requirements.

Q: 10.4 Manual Pump:

10.4.13 Please provide an FDA link for manual pump class 1 device or the requirements this bid is requesting.

A: The approved 510K market clearance letter is enough proof of compliance with FDA requirements.

Q: 10.8 Warranty

10.8.2 Valves, tubing, flanges and membranes should be are cleaned/boiled multiple times daily and should be replaced on a regular basis. Therefore a 1-year warranty is not realistic. A typical manufactures warranty is 30 days for any manufacturing defects and does not cover normal wear and tear of day to day pumping and cleaning. Please consider changing to a 30-day warranty.

A: One-year warranty stands as described in criteria 10.8.3.

Q: 10-8.8 Our pumps are designed to minimize any chance of infestation and we had no reports of infestation during our current TX contract, however the chance of replacing 50-100% of the purchased multiuser pumps in any given year is a huge risk for vendors. Please consider a percentage of 5-10% of the pumps purchase during the contract.

A: Considered but not applicable for this procurement. The criteria are specific to infested pumps and requires up to 100 total disinfestation treatments per year.

Q: 10.8.9 E-recyclers are very prevalent these days, therefore asking the vendor to pay for shipping and processing returns for recycling is unnecessary in most cases and only drives up bid pricing. Please consider wording to read that if there is not a e-recycle center within 5 miles of the local agency that the vendor shall assist with recycling.

A: Considered but not applicable for this procurement.

Q: 10-14 Samples: Are samples to arrive by May 11th, 2020?

A: Yes.

Q: Are the samples bound by same packaging and shipping requirements or is okay to mix product in one box if they are clearly marked?

A: You may ship together in the same box, just be sure to label the package as “SAMPLES”.

Q: During the 2017 solicitation vendors were allowed to send non-sterile samples for sterile product specs which would be sterilized upon the award. Samples would contain the same components to meet each SOW specs but may look a bit different that the final product.

A: Please review the IFB in its entirety for all requirements along with exhibits and attachments.

Q: 24.1 Number of copies: Since email bid responses are allowed are hard copies required?

A: You may email your proposal/response to HHS online bid room, if you submit through the HHS online bid room hard copies are not required.

Q: Is it necessary to send (1) electric copy if the bid is emailed? If so, are thumb drives accepted?

A: No, please refer to Appendix D, Online Bid Room.

Also, we have revised the following sections:

“10.1.3 Be UL or equivalent listed and use a 100-volt electrical outlet.”

“10.2.6 Include a minimum of two (2) pairs of different standard sized breast flanges, to accommodate different sized breasts and nipples. Flanges should be comfortable for most users. Vendor (s) shall list size of flanges in millimeters on bid and pricing schedule. See Exhibit A Pricing Sheet.”

“10.3.5 Include a minimum of two (2) pairs of different standard sized breast flanges, to accommodate different sized breasts and nipples. Flanges should be comfortable for most users. Vendor (s) shall list size of flanges in millimeters on bid and pricing schedule. See Exhibit A Pricing Sheet.”

“10.3.7 Be UL or equivalent listed and use a 100-volt electrical outlet.”