Additional Questions Asked.docx

1. Based on the clarifications provided, please review and provide clear information on whether the system shall be capable of and measured for acceptance using a sustained throughput processing rate of 8,948 vials (bottles) per hour (HINES TCA Q-A - IARxV2.docx response 1.d) with the bottles per order breakdown provided in the three-month data range (HINES TCA Q-A - IARxV2.docx response 1.f- below), noting that the three-month data range data suggests a bottles per order calculation of 1.065, superseding the bottles per Rx of 1.22 specified on page 32 of the PWS Overall Design Summary table (since the bottles per order cannot be less than the bottles per Rx in an order). If disconfirming, please detail how the bottles per order value that calculates from the three-month data range aligns with the bottles per Rx value specified on page 32 of the PWS.

(Vials x Occurrences) % Total Vials (Vials / Total Vials)

Answer: This table has no correlation with the number of bottles to the prescription quantity; therefore, the 1.22 factor regarding 1.22 bottles per prescription is to be used in calculating total throughput.

1. Based on the answer in 1D (sustain processing of 8,948 bottles per hour) and 1F (order size and percentage of orders breakdown) of the HINES TCA Q-A - IARxV2.docx, please review and provide information on whether the requirement to sustain processing of 8,948 bottles per hour and the order percentage breakdown listed in answer 1F supersede all references to a daily prescription throughput of 55,008 with a bottles/Rx ratio of 1.22? If not, please provide the measurable daily total throughput requirement, in units produced (bottles / packages), noting that the bottles/Rx ratio is widely variable.

Answer: The Rx ration of 1.22 bottles per prescription is to be used to sustain processing 8,948 bottles per hour is what we are looking for.

1. On page 7 of the PWS, the Statement of Need states automatic printing and packaging station to handle up to 8,948 bottles per hour. Please review and provide clear information on whether this means that the fully automated packaging equipment to be provided by the contractor shall be capable of handling the full hourly throughput of bottles produced by TCA or if a portion of this should be subtracted and packed by the semi-automated packaging equipment to be provided by the VA. If the latter, please specify the total hourly quantity of bottles to be processed by the automated equipment to be provided by the contractor and the total hourly quantity of bottles to be diverted to the semi-auto pack units.

Answer: The four semi-automatic packers are included with the automatic packers to process a total of 8,948 bottles per hour. The semi-automatic packer factory testing proves to pack at a rate of no less than 200 bottles per hour per semi-automatic packing station (e.g. four stations = 800 per hour).

Please also confirm, or otherwise specify, if the order size breakdown summary provided in the HINES TCA Q-A - IARxV2.docx response question 1.f. can be used to determine the criteria for:

2. Order consolidation and group size distribution for all non-single bottle orders fed to either fully automated or semi-automated packaging

2. The % of single bottle order to be packed by fully automated packaging vs

2. The % of non-single bottle orders to be packed by fully automated packaging vs

2. The % of non-single bottle orders to be packed by semi-automated packaging

Answer: Yes, Hines TCA Q-A – IARxV2.docx can be used to guide 3a – 3d above.

1. The Semi-Automated Packing requirements state on PWS page 13 that:

3. "The integration of the semi – auto-packing components result in an ability to pack shipments of 4 or more filled bottles per shipment".

3. On page 26, it states "Semi-Auto Packer – Semi-Auto packer that can accommodate single and multi-bottle orders above 5".

1. Please review and provide clear information on the expected group sizes that the semi-automated packing equipment is required to package.

Answer: The Semi-Auto Packer is to fill multi-bottle orders above 3 (meaning orders of 4 and above). This is corrected in the PWS.

1. PWS page 7 ‘Statement of Need’ states:

4. Page 7 states "automatic printing and packing stations to handle up to 8,948 bottles an hour",

4. Page 24 states: "The automatic packing must be capable of supporting a minimum hourly rate of 8,948 bottles per hour".

1. Please review and provide clear information on the bottle per hour rate at the automated packing stations, these rate definitions influence equipment counts.

Answer: Minimum hourly rate is to be supported at 8,948 per hour. Offeror is expected to propose enough automatic packing stations needed with the four semi-automatic packing stations to support processing 8,948 bottles per hour.

1. Section E.13 52.212- on page 2 of 36C77024R0011 0001 Evaluation Factor Update.docx, states:

5. “(a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. Proposals will be evaluated based on the criteria and process outlined in this section and the remaining document. Adjectival Rating Criteria will be used for evaluating the non-price factors of all proposals. Definitions for each adjective are provided in this document. Factor 5 (Price) will be evaluated by the SSA. The four (4) non-price factors are as follows” Factors 1-4 are listed, factor 4 is defined as “PRICE”

0. Please review and clear the discrepancy on if there is an undefined 4th factor? Is factor 5 Price?

Answer: Factor 5 is now Factor 4.

1. PWS page 13 “QASP” Table (row six (6) column b) “The TCA’s integrated semi-automatic packing components must correctly pack 99.997% of the orders”

6. QMSI Semi-Auto packing solution components and performance are out of scope for solicitation #36C77024R001 where QMSI is not the awarded vendor.

0. Please review and provide notification that this is outside the scope of this contract.

Answer: Agreed. PWS page 13 “QASP Table (row six (6))” removed.

1. References required:

7. Document “36C77024R0011 Hines TCA RFP.pdf”, page 70 of 92, section 3-Past Performance (Factor 2) states “…Offerors shall furnish five (5) references for contracts occurring within five (5) years prior to the solicitation release date…”

7. PWS page 8, under Contractor Past Performance, states “…contractors are required to furnish (if possible) five (5) references for contractors occurring withing five (5) years.”

7. Page 10 of the PWS, under Attachment 5 – References and Qualifications, states “...a minimum of three such existing projects are to be listed within the last 5 years...”

2. Please review and provide directions on past performance references required.

Answer: All has been updated to provide five past performance references matching the evaluation, Factor 2.

1. Page 37 of the PWS is blank. Please review and provide directions on if this is intentional or additional data information was intended to be provided.

Answer: Page break is removed.

1. Additional Information Needed

1. Please provide the distribution of small 120cc and large 250cc bottle/vials for the TCA system (per shift and by order size).

Answer: Distribution is comprised with 120cc bottles/vials at 80%, and with 20% being 250cc bottles/vials. This ratio mix is to be used for distribution calculations.

1. On PWS page 17 the statement:

1. "Floor placement may vary but needs to fit into an approximate floor space area of 120’ x 190.” Within the illustration outlined in green, the space is not a 120'x190' rectangle.

1. Within the supplied DWG file, there is not a clearly defined space that should be used for the proposed solution footprint. For example: During the site visit there was an A-Frame within the space with no walls, but in the DWG file there is a walled room with ADU machines shown in the space.

1. Please provide the areas and shape that the concept design can place equipment into.

Answer: Refer to the PDF included with the solicitation entitled “Hines_CMOP-TCA_Layout-Oct2023". The DWG with the equipment included is too large to email. Yes, it is not rectangular, but please use the proximate floor space area of 120’x190’.

1. Please provide the salary information to be used in the Proof-of-Concept Mathematical Modeling as it relates to the requested cost to fill analysis:

2. Pharmacist, Technician, Clerk, Maintenance, General

Answer: Disregard including any labor costs in the Proof-of-Concept-Mathematical Modeling.

1. On PWS pg. 11, the statement “Quality Check System - Simultaneously Produces a mix of 4,000 120cc and 250cc Dispensed Bottles Packaged and ready for shipping manifest labels.”

3. Please provide additional information as to what the 4,000 number is and or is referring to.

Answer: Disregard the number 4,000 (Removed), the emphasis is on the quality check system being capable of handling 120cc and 250cc vial sizes at 8,948 bottles per hour.

1. Clarification Requested

1. The Automated Packing throughput requirements on PWS page 13 states:

0. "The automatic packing components are able to pack shipments of 1 to 3 filled bottles per shipment".

0. On page 24, it states "capable of packing five or fewer bottles per bag".

1. Please clarify the expected group sizes that the automated packing equipment is required to package.

Answer: The statement on page 13 is correct and the statement on page 24 has been corrected to read, “one to three bottles per bag”.

1. Please clarify / specify the plan for how the contractor is required to work around and/or with the QMSI Qpak system to be installed in September of 2024. Does the system need to continue to run during the solicitation solution implementation once awarded? If so or if not is the QMSI Qpak system mobile?

Answer: The Qpak system is not expected to continue to run during its integration in the TCA. Before the TCA integration begins, the Qpak will be running to pack production. The Qpak system is movable.

1. The statements conflict with each other, please clarify:

2. Section Automated Packing Requirements, Page 24 states: “Assumption of check weigher, pharmacist verification inspection, and cap inspection failure rate that does not exceed 2% in rejections and operates with an average of 2% rejections or less.”

2. Section Tablet Counting Assembly Process, Page 22 states: “Must include integrated automated quality check system components with a check weigher, exception stations, QA camera checks, pharmacist verification inspection, and cap inspection operating below failure rates of .05%. “

Answer: The failure rate is to be at or below .05%.

1. Please clarify if the responses presented in “HINES TCA Q-A - IARxV2.docx (responses to questions) generally supersede requirements found or still existing in version 3 of the PWS.

Answer: Yes. Information addressed and updated through an amendment would supersede information presented in a previous version.