36C25618Q0210-00005001.docx

Questions:

1. 1. CLIN Format

a. CLIN 001

i. For a lease, wouldn’t there be a base year and four option year CLIN(s) (similar to language found on page six for period and place of performance)? yes

ii. Assuming a lease, does the SLVHCS want to see a monthly price? yes

iii. How does the SLVHCS want this price to account for fluctuations in “supplies” as case volumes will build over time? To be competitive, as well as good stewards of tax dollars, the industry needs some guidance on how to account for “supplies.”

Fixed price contract which SLVHCS will have on a lease

iv. If there are seven towers requested, where does the quantity eleven come from? SLVHCS will require 4 mobile units with similar capabilities.

b. There are three, clinically-specific, applications listed on page six. We suggest three separate CLINS for each of the categories (with separate awards). The assumption, represented by the current CLIN structure, is that all seven towers are the same. Does the SLVHCS want to configure all seven towers the same (which would add unnecessary equipment and cost)? SLVHCS would prefer all 7 towers to be similar; however, the SOO suggest that the Offeror propose a surgical solution to meet and service our patient care demands.

2. Statement of Objectives

a. Purpose: Laparoscopic and Endoscopic video components are very technical, preferential and customizable. Flexible scopes are less available (fewer OEM providers) on the market and more clinician-specific (very specialized, potentially lower-volume procedures). Industry would need projected procedure data and physician preferences (“case cards”) to accurately quote without over or under charging the VA. We suggest that supplies need to be separate from the price to lease the capital equipment, or needs to be a flat rate for a specific quantity that does not fluctuate.

i. “Complete” is a very subjective term, allowing for a wide range of interpretation from industry. Would the SLVHCS be able to define specific requirements from a quantity perspective? 60 cases per week

1. What equipment has SLVHCS already procured for their operating rooms? This could be proprietary information that unwittingly allows one competitor an advantage. For example, Stryker knows that the SLVHCS has already purchased tourniquets and Neptune for suction. Stryker does not know if the SLVHCS has lasers, c-arms and other essential equipment for the procedures listed. Industry needs a level-playing field to ensure that SLVHCS gets exactly what their care-givers need without purchasing redundant capacity. Lasers, C-Arms, and Neptune is not required for this procurement request.

a. During the site visit, there was discussion around installed Olympus equipment. Will this Olympus equipment remain in the SLVHCS and which Performance Objectives (pages 7-12) does it already address? Olympus equipment will not remain and serve as the primary operating system.

b. Also during the site visit, Arthrex video was installed as part of last fall’s intent to sole source to Quest Medical.

i. What are the specifics (expiration) of this lease/contract? Arthrex has a temporary contract with SLVHCS. The expiration of this lease will occur once the Offeror is capable in providing the Surgical Solution.

ii. Will any of the Quest equipment remain at the SLVCHS and which Performance Objectives does it already address? no

2. What is the definition of equipment? Industry would assume capital equipment that they are capable of sourcing as an original equipment manufacturer. Some of the procedures listed in the SOO introduce germane, yet out-of-scope (for video companies), equipment such as lasers, tourniquets, suction, power tools, surgical navigation and c-arms. Lasers, tourniquets, and surgical navigation is not required for this SOO.

3. What is the definition of accessories? Each hospital has their own opinion of component pieces to support the in-room equipment/consoles. The ratio of sterilized components (e.g. cameras, scopes, trocars) to in-room equipment will vary based on volumes, sterilization equipment available and local policies. The Offeror is expected to be an expert in the proposed field that supplies and fully surgical solution to the SLVHCS patient demands and complexity.

a. Will the SLVHCS provide their desired ratios (camera heads, scopes, etc.) for a competitive submission from industry? The Offeror is expected to be an expert in the proposed field that supplies and fully surgical solution to the SLVHCS patient demands and complexity.

b. For scopes, what are the desired quantities, sizes, make and model needed per specialty? The Offeror is expected to be an expert in the proposed field that supplies and fully surgical solution to the SLVHCS patient demands and complexity.

c. Have the SLVHCS surgeons indicated a specific type of flexible scope that they require? (Stryker is able to source any manufacturer’s flexible scopes, but we need to know specific part numbers.) SLVHCS Statement of Objective did specify a specific scope flexible or ridge; as well as, SLVHCS did not submit a Limited Source Justification.

d. Are stainless instrumentation sets to be included? The Offeror is the expert in the proposed field. The Offeror is responsible to provide SLVHCS a surgical solution; as well as, the latest technology or instrumentations to meet the Gold Standard in patient care that service multiple specialties.

If so, what would be the quantities, make, model of each instrumentation set needed per specialty? N/A

4. What is the definition of supplies? Generally this would imply consumable/disposable items (e.g. surgical drapes, blades, mesh, needles and suture) that are used per procedure. Not all procedures or physicians use the same/consistent amount of disposables per procedure. Most, not all, “supplies” are better sourced from OEM that do not manufacture capital video equipment.

The Offeror is an expert in the proposed field; as well as, the specific consumable/disposables specific to their medical technology/equipment. The Universal consumable/disposable items may be required to ensure that we have at least 90-days items. After the 90-days are used, SLVHCS is responsible to utilize the universal consumable/disposable that are on either GSA or prime vendor list.

b. Is a full-time, on-site service technician part of the request? The Offeror is responsible to provide SLVHCS a surgical solution to meet its operating room demands. If the Offeror feels it is necessary to have the on-site service technician as part of the surgical solution, they should provide the details of the service.

i. If so, what would be the expected hours of coverage? N/A

ii. What is the monthly expected scope case volume? 60 cases per week.

iii. Would the on-site technician also be responsible for full SPD responsibilities (decontamination and assembly of instrumentation sets, camera sets and scope sets)? The Offeror is the expert in the proposed field; as well as, in the surgical solution requirements. Therefore, the Offeror must determine if the on-site technician should be a requirement.

3. Scope or Mission

a. If it becomes apparent that turnkey is not measurable for award criteria, will the SLVHCS provide specific equipment needs as it relates to video (camera control unit, light source, pump, insufflator, shaver, etc.)? The Offeror is the expert in the proposed field; as well as, in the surgical solution requirements.

b. What is the definition of “High-Quality”? This terminology may be inconsistent with the “Hardware Upgrades” language found on page six. Most OEM video companies will have a range of image qualities based on their camera platforms. Certain scopes will also limit resolution. The cabling, routing and monitors selected all impact the overall video ecosystem. One manufacturer’s definition of high-quality may differ from another, creating inconsistencies in the technical volumes and pricing. The Offeror is the expert in the proposed field. The Offeror is responsible to provide SLVHCS a surgical solution; as well as, the latest technology or instrumentations to meet the Gold Standard in patient care that service multiple specialties.

c. Recent technological advancements allow for near-infrared imaging. For certain procedures, the ability to identify critical anatomy and confirm perfusion before closing the surgical site would qualify as “high quality” video. Is near-infrared imaging a requirement? The Offeror is the expert in the proposed field. The Offeror is responsible to provide SLVHCS a surgical solution; as well as, the latest technology or instrumentations to meet the Gold Standard in patient care that service multiple specialties.

d. “The systems must be able to communicate with VISTA Imaging and Computerized Patient Record System (CPRS) to allow for the transfer of data into the patient's Electronic Medical Records. It is essential that the proposed surgical system integrates into existing infrastructures and exchanges data with other systems using common standard interfaces.”

i. Is the current Image Stream Operating Room nurse’s document station touch panel able to capture images from the sterile camera now? At the moment, the clinical engineer is not aware of the sterile camera.

ii. Is the current Image Stream OR nurse’s document station touch panel able to communicate with VISTA imaging and Computerized Patient Medical Record (CPRS)? Per Clinical Engineer, there are no interface between Image Stream and Vista or CPRS.

e. What is the definition of “It is expected that all equipment…(Hardware Upgrades)” (Page six)? The Offeror is the expert in the proposed field. The Offeror is responsible to provide SLVHCS a surgical solution; as well as, the latest technology or instrumentations to meet the Gold Standard in patient care that service multiple specialties.

i. Is the SLVHCS requesting industry to factor in future costs of upgrades as part of their CLIN strategy? Yes

ii. By what process will SLVHCS determine compliance with this request? The offeror will provide a Quality Assurance Surveillance Plan.

iii. As this is a future event, how will it be accurately monitored at time of award?

The Contracting Officer Representative will monitor the performance of award.

4. Basis for award (CONTRACTING TO PROVIDE GUIDANCE FOR THE BELOW QUESTIONS)

a. With all of the subjective criteria, how will the SLVHCS determine the one best solution? (Page 28) Trade -Offs Best Value

b. As no trade off factors language is included, is this a LPTA solicitation?

Please see attached evaluation factors and criteria

c. How will past performance be evaluated?

1. Will it be judged on a pass/fail basis? Please see attached evaluation factor and criteria.

2. Will confidence ratings be assigned? Please see attached evaluation factor and criteria.

d. Does this solicitation allow for the top two best solutions for enhanced care of veterans? No, only one solution will be considered.

5. Some Additional thoughts:

a. To ensure the highest degree of efficiency and clinical efficacy. Would SLVHCS allow vendors to trial their solution before procurement? NO

b. What are the requirements to get contractor personnel into the facility? Upon award the Contracting Officer Representative will work with the awardee to obtain badging.

c. What are the hours of operation of the facility? 0800 -1630 Federal Holidays can be found on the OPM official website.

d. What are the hours the contractor personnel will be allowed to work on this facility? Normal business hours 0800 – 1630. Unless otherwise specified by the Contracting Officer Representative.

e. Does the contractor need to have a government escort with them while working in this facility? Upon award the Contracting Officer Representative will work with the awardee to obtain badging.