36C26221Q0280_2 0001.pdf

5. PROJECT NUMBER (if applicable)

CODE7. ADMINISTERED BY

2. AMENDMENT/MODIFICATION NUMBER

CODE

6. ISSUED BY

8. NAME AND ADDRESS OF CONTRACTOR

4. REQUISITION/PURCHASE REQ. NUMBER3. EFFECTIVE DATE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED

PAGE OF PAGES

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED

BPA NO. 1. CONTRACT ID CODE

FACILITY CODECODE

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

E. IMPORTANT:

is extended,

(a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY is not extended.

12. ACCOUNTING AND APPROPRIATION DATA

(REV. 11/2016)

is required to sign this document and return ___________ copies to the issuing office.is not, A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

15C. DATE SIGNED

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER

Contractor

16C. DATE SIGNED

14. DESCRIPTION OF AMENDMENT/MODIFICATION

16B. UNITED STATES OF AMERICA

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER 16A. NAME AND TITLE OF CONTRACTING OFFICER

15B. CONTRACTOR/OFFEROR

STANDARD FORM 30 PREVIOUS EDITION NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.243

(Type or print) (Type or print)

(Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

(Number, street, county, State and ZIP Code)

(If other than Item 6)

(Specify type of modification and authority)

(such as changes in paying office, appropriation date, etc.)

(If required)

(SEE ITEM 11)

(SEE ITEM 13)

(X)

CHECK

ONE

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

(Signature of person authorized to sign) (Signature of Contracting Officer)

1 4

0001 02-12-2021

00262

Department of Veterans Affairs Network Contracting Office 22 4811 Airport Plaza Drive Suite 600 Long Beach CA 90815

00262

Department of Veterans Affairs Network Contracting Office 22 4811 Airport Plaza Drive Suite 600 Long Beach CA 90815

To all Offerors/Bidders

36C26221Q0280

02-12-2021

X x x

8:00AM 2/24/21

x 1

The following changes shall be made to the solicitation:

1. See updated Attachment A Schedule Urology 1.1

2. See updated Attachment B Statement of Work and Salient Characteristics Urology 1.1

3. Closing date of the solicitation shall now be 8:00AM 2/24/21

4. No extension shall be provided for additional questions.

In addition, see page 2 for questions asked by all contractors within the accepted timeframe and answers to those questions.

Deeptichandra Chakka Contracting Officer

Urology Medical Scopes Lease Solicitation Questions and Answers

1. Will the offerors be reviewed by technical committee comprised of a representative from each VISN 22 VAMC? If so, will it be a Clinician/Surgeon or BioMed?

a. This is not information we normally release in the solicitation. Evaluators will all have the commensurate skill to evaluate all offers.

2. The Solicitation includes both a Lithotripsy Unit and a Laser both of which are not endoscopes, nor required to utilize them. There are many units available from other companies such as Boston Scientific, Cook, etc. Though we offer both and in the light of trying to be consultative I would suggest you consider looking at other vendors. Since the salient characteristics are Olympus lock-out specs would you consider removing those as a requirement to provide a fair and open competitive solicitation for just the endoscopes and corresponding video?

a. We have updated the section, please see the updated attachment B.

b. This is now optional and may be added as an item within the first tab of the schedule as an optional item.

3. Is the Currently Owned Inventory for each facility listed in Attachment A inventory that each facility will be retaining? Further, is the Total Quantity Needed the only inventory that will be priced? For example under San Diego Lease Req are they reducing their inventory of HD Flexible Cystoscopes from 20 to 10 or, increasing it from 20 to 30?

a. The quantity listed in column G illustrates the total amount needed. The quantity in column H indicates the current amount of owned equipment and is eligible for trade ins. Please provide pricing based upon column G and any trade in pricing on Column H. This list serves as a benchmark for price evaluation as a close to accurate representation of what the facilities require. However, some changes will be made to individual leases after award of the IDIQ to better reflect the changing environment of facilities.

4. The Service Agreement calls for a 24-48 hour turnaround time. Shipping to a repair facility takes a day and the return shipping to the facility takes a day. Epoxies used for repairs take conservatively 24 hours to cure. Is the VISN’s experience that the facilities always receive loaners since the typical turnaround time is far from that time frame?

a. We typically receive a replacement loaner within 24-48 hours of notifying the vendor.

5. Under 2.1.3.2 do any of the included facilities have actual trade-in’s that the facility owns which could be included in the solicitation?

a. Yes, they’re listed as the items currently owned. Trade-ins will be necessary to ensure equipment uniformity to maintain consistent cleaning standards. Offerors typically provide a list of all acceptable trade in items with established pricing.

The price evaluation will take into consideration all trade in pricing offered.

6. Under 3.2.2.1 only the incumbents video processors are compatible with the noted currently owned camera heads. How many CH-S190-08-LB camera heads are currently owned?

a. Loma Linda owns 12

b. GLA owns 13

7. Under 3.2.3.1 stated must be no larger than 9.5Fr tip. All companies measure slightly different, will you allow for a range of tip diameter such as 8.0Fr to 11.0Fr as the range allows for a more generic solicitation versus a company’s specific lock out specification?

The difference in this diameter is so minimal, to put it into perspective 3Fr equals 1mm.

a. From a clinical perspective we require passage of the scope to be as atraumatic as possible. The smaller aperture significantly decreases the potential for urethral trauma and patient discomfort. This scope is inserted into the penis. A 1 mm size difference is substantial (~23% larger). This is not a lock out spec as other manufacturers are in the range. The % difference from the required maximum of

9.5 to 11 is ~14%. The actual difference for the current scope we have of 8.1 to 11 is over 27%. That is a significant size difference. We cannot accept a tip larger than 9.5 fr.

b. You are allowed to describe how your solution is equivalent but you will be required to provide information that supports your claim as per 52.211-6.

8. Under 3.2.3.1 stated must have 275 degree deflection and 120 degree field of view.

Again, will you allow for slight variations to the specific salient characteristics? Our flexible cystoscopes offer deflection standards that allow for full visualization of the entire bladder including the bladder neck though they are not identical to those referenced.

For example a flexible cystoscope that offers 210/140 versus 275/275 accomplishes the same visualization. Further, field of view varies in water versus air since light refracts in water. Thus, the 120 degree field of view should be a range versus just a spec if this solicitation is intended to be open and fair.

a. We have updated the section, please see the updated attachment B.

9. Under 3.2.3.2 stated must have distal tip no larger that 4.9Fr and insertion tube outer diameter (OD) of 7.95Fr. Would you accept a fiberoptic flexible ureteroscope that the entire OD is 7.5Fr?

a. The dimension requirements for the ureteroscope are important for access to a non-stented ureter. As normally a-traumatic access is key as a stent is inserted (to allow for distal tip insertion) whereby the size difference can be consequential.

Meaning the distal tip has to be much smaller than the shaft to aid in dilating a difficult ureter (no larger than 5 fr.). You may provide information to show that your product is equal as per the requirements of 52.211-6.

10. Under 3.2.3.3 stated must have OD of 8.4Fr, 275 degree deflection and 120 degree rotating shaft. Would you accept a 8.5Fr scope with 270 degree deflection and a torque stable shaft that allows for 120 degree rotatability however, does not have incumbent lock out spec of 120 degree rotating shaft? Also, our flexible ureteroscopes are currently in use at VAMC San Diego per their request in lieu of the incumbents scopes.

a. We have updated the section, please see the updated attachment B.

11. Under 3.2.3.5 must provide HD rigid cystoscopes. Since high definition is defined as 1080p, a 24 frame per second digital video format, etc. and glass, meaning optics in a rigid cystoscopes, are rod lenses and as long as the autoclavable rigid cystoscopes in conjunction with a HD video system will produce an HD image, will accept rigid cystoscopes that are not “marketed” as HD?

a. We have updated the section, please see the updated attachment B to indicate that the the Rigid Cystoscopes must be capable of providing imaging at an HD quality. Note that HD starts at 720P, 1280 x 720, not 1080P.

12. Further under 3.2.3.5 compatibility with current owned ESG-400 generators, you also own at VAMC San Diego and VAMC Long Beach UH400 generators. Do they have to be compatible with those as well?

a. The UH400 generator does not have to be compatible with the HD rigid cystoscope. The UH400 is not the primary generator used during procedures.

13. Under 3.2.4 the noted Medivators Endoscope Washers are used exclusively for Olympus flexible endoscopes in a hospital setting, primarily focused of GI, Pulmonology, etc. Also, Olympus does not validate other manufacturers endoscopes for them.

Further, since all of these endoscopes are used in the bladder and kidneys they should be sterile and most all of the VAMC’s are using Sterrad and other modalities for sterilization. For example, our flexible endoscopes owned and used at the VAMC San Diego are sterilized using their Sterrad unit versus only cleaning with their Medivators.

Lastly, VAMC Loma Linda does not use a Medivator, as such would you consider making this requirement optional?

a. We have updated the section, please see the updated attachment B. This is now optional.

14. How should we propose the On Site Specialist in the Urology IDIQ? Shouldn’t it be included in the excel spreadsheet with the line item pricing?

a. You can propose it as an optional line item but it is not a minimum under Attachment A Tab 1.

15. If not then should we include it in the first tab of the excel spreadsheet with the other Urology products that are applicable to this IDIQ but not specified on any of the stations quotes?

a. Yes, you can propose it as an optional line item. It is not a required minimum under the solicitation.

See attached document: Attachment A Schedule Urology 1.1.

See attached document: Attachment B Statement of Work and Salient Characteristics Urology 1.1.