Solicitation W81K00-20-Q-0084 Industry Questions_Government Responses.pdf

Hematology CPRR

Solicitation W81K00-20-Q-0084

RESPONSES TO INDUSTRY QUESTIONS

1. The instructions to Offeror’s starting on page 72 include the note – NOTE: The combined technical response for

Volume II shall not exceed 20 pages, 12pt font. Can you provide some direction regarding this since the SOW criteria themselves (starting on page 31) run for 24 pages before any responses have been added. Our responses typically are placed directly after the criteria to allow the evaluators the ease of viewing and associating the response with the criteria. Responding in this manner will run over the 20 page limit, given that the criteria already run for 24 pages.

RESPONSE: The government will accept a combined technical response for Volume II not to exceed 35 pages, 12pt font.

2. The following statement in the instructions for Volume II-Technical Capability is very limiting-:Statements that the Offeror understands, agrees, can or will comply with all specifications, or statements paraphrasing the specifications or parts thereof, or phrases such as “standard procedures will be used” or “well-known techniques will be used” will be considered unacceptable. Many if not most of the criteria in sections 1, 2, 3, 4, 6 and 7 require only a “Yes or No”, “We agree”, or “Comply” type response, with no other detail needed. Sections 5 through 5.7.1 covering the equipment specific requirements will require detailed responses however. Does the above highlighted statement apply to all the listed sections?

RESPONSE: Solicitation is unchanged.

3. The main laboratory runs body fluid samples, however there are no volumes provided for body fluid samples, nor any request for body fluid controls. Can body fluid volumes be provided, and should body fluid controls be included in the pricing response?

RESPONSE: We are currently not running body fluids cell count, but we are working on a validation. The body fluid volumes is about 500 yearly and a 10% yearly increase. Yes, body fluids controls price should be included in the cost per reportable.

4. Section 5.39 indicates the requirement for the clinic sites to run body fluids. At the current time the clinics do not run body fluids, so can it be confirmed that they do require body fluids for this solicitation. If the clinics do require body fluids, can an estimate of the projected body fluid volume (per clinic) be provided in order to estimate the quantity of body fluid control required?

RESPONSE: The clinics do not require body fluid capability. The projected volume of testing for the clinic areas doesn’t warrant that testing capability. Statement of Work paragraph 5.2.39 is deleted in its entirety.

5. Similar to above, the clinics currently do not run reticulocytes, and the solicitation is not clear if this is still the case. Can you please clarify if the two clinics need analyzers with reticulocyte capability?

RESPONSE: Yes, clinics need analyzers with reticulocyte capabilities. Refer to Statement of Work paragraphs

5.2.35 and 5.2.40.

6. The main laboratory currently utilizes a device for reagent management to reduce reagent inventory and reagent changes. There is no reference or requirement in the solicitation for a reagent management system; should this be added as a requirement and/or included an Item in the pricing document?

RESPONSE: Refer to Statement of Work paragraphs 5.2.11, 5.2.12, 5.2.15, and 5.2.16.

7. Section 5.2.15 states: The Contractor shall provide a Thin Client-type data management system that allows for remote operational control of the analyzer system, management of the quality control program, on-instrument useful life of the reagents/reagent packs, and management of patient results. If the same features are provided from middleware or a in a different manner than”a Thin Client-type data management system” will that be satisfactory? This vendor provides the same features of operational control, QC management, reagent management, and patient sample management via middleware.

RESPONSE: Yes, a middleware (DHA approved/ATO) shall satisfy the requirement.

8. In section 5.2.16 requires that “the status of automation components and communications shall be able to be monitored from a single remote interface”. Is the requirement of a single interface mandatory? Due to the high

PHI security requirements this vendor utilizes two interfaces with our middleware.

RESPONSE: If two interfaces meets or exceeds the requirement, then a DHA approved/ATO two interfaces will suffice.

9. In section 5.2.17 the requirement for analyzers from other vendors to be interfaced through the Thin Client appears to be related to a Total Automation type line. Is it intended that other instruments from other vendors be interfaced to the middleware provided by the hematology vendor?

RESPONSE: No. Other vendor/brand instruments would not interface with hematology middleware.

10. Section 5.2.19 requires “full IT support as defined below at no additional cost to the

Government…”. Can this “support” be further defined and clarified with the expectations of that support provided?

RESPONSE: Vendor should provide their most comprehensive IT support at no additional cost to the

Government.

11. Section 5.2.6 mentions the “Allows the connection of a slide maker and slide stainer and an automated digital cell morphology analyzer/software.” Then again in section 5.7.2.1 is a reference to the “digital cell morphology unit”, however in the criteria there is no specific requirements or listed features expected for a digital cell morphology unit. Can the requirement for the digital cell morphology unit be provided? In addition is software for body fluids and advanced RBC morphology requested on the digital cell morphology unit? These are optional added modules for the CellaVision digital imaging system. Also, are remote review licenses needed, and if so, how many?

RESPONSE: Cell morphology unit will be evaluated on vendor’s specifications, at least a middle to high workload laboratory, integrated automated slide maker and stainer. Yes, software for body fluids and advanced

RBC morphology is requested. Yes, at least two remote review licenses will be needed.

12. Under section 5.2.27 for the two clinics, specifically sections 5.2.42 through 5.2.51 refers to data management for the clinics similar to the main hospital. The instruments proposed for the clinics provide on-board data management sufficient for the clinic menu and volume, so therefore, is the solicitation criteria for middleware data management for the clinics a true requirement or can the on-board date management satisfy this?

RESPONSE: Yes, the middleware data manager is a true requirement.

END QUESTIONS AND ANSWERS