HINES TCA Q-A - IARxV2.docx

HINES TCA

QUESTION & ANSWERS

Questions

1. The proposal Requirements & Evaluation Factors (page 67 of the solicitation and page 3 of Amendment 1) calls out a minimum throughput requirement of 80,000 prescriptions per 7.5-hour work shift. Page 7 of Attachment 1 further defines the Statement of Need, detailing 7,948 bottles per hour through automated packaging and 1,000 bottles per hour through semi-automated packaging for a total of 8,948 bottles per hour for a total of 67,110 bottles per hour processed through the proposed solution. Page 23 of the Functional System Description also details 8,947 bottles per hour through automated packaging with a total conveyor capacity of 80,000* prescriptions per 7.5-hour shift).

a. Please clarify throughput requirements of the system if the detail in the Statement of Need includes all work to be processed by the proposed solution and that the throughput acceptance criteria are 67,110 bottles per 7.5-hour work shift.

Answer: Yes that throughput criteria is acceptable. Use 8,948 bottles per hour equating to 67,110 bottles per 7.5-hour shift. The 7,948 bottles per hour is a typo in Attachment 1 (PWS), updated to 8948.

Answer: The 80,000 prescriptions per shift equates to 97,600 bottles per shift (1.22 bottles per prescription) and is the combined future capacity representing an APFS (Automated Pharmacy Fulfillment System) that includes the TCA as a subsystem in the future.

b. If additional capacity is required to meet the 80,000 prescriptions per 7.5-hour shift, please provide the completion method (packaged and ready for induction to the delivery system) to be considered.

Answer: No additional capacity is required. The 80,000 prescriptions per 7.5 hour shift is regarding future growth when the TCA is included in a larger overall APFS system down the road and in the future. Use 8,948 bottles per hour. The 8.948 bottles per hour are to be completed with a package ID on the bag and ready for induction to the delivery system (FedEx Supply Chain later prints a shipping label to apply to the bag based on this barcode data from the package ID printed on the bag).

c. Please note if the * on page 23 of the Functional System Description requires further detail, or if it can be ignored.

Answer: The * on page 23 of the PWS (with the 80,000*) can be ignored.

d. Page 24 of Attachment 1 references a requirement of "Minimum of 500 bags/hr. per input conveyor with four input conveyors per bagger," equating to a total bagging output capacity of 10,000 bags/hr. On page 32, the summary table indicates an average of 1.22 bottles per Rx. Is a total system capacity of 10,000 bags per hour and 12,200 bottles per hour required? How does this align with the 67,110 bottles processed per 7.5-hour shift listed above?

Answer: The statement on page 24, “Minimum of 500 bags/hr. per input conveyor with four input conveyors per bagger” does not align and has been removed as a requirement. The vendor is expected to propose enough (automated with the existing semi-automatic packers) packing capacity to sustain processing of 8,948 bottles per hour without creating any TCA system backup or production flow stoppages.

e. Page 33 of Attachment 1 references growth projection tables that contractors are to base their designs upon, however the table appears to be missing. Are there projected volumes beyond 2025 that must be part of the submitted design? If so, please provide the throughput details to be considered and measured.

Answer: Yes, as stated in Attachment 1 (PWS), 2025 is considered the ground zero year and through 2033 on pages 32 and 33. Volumes from the data on the tables on those pages are projected to grow at a rate of 3% each year and are not in a separate table.

f. For TCA-only orders, can you provide the percentage of orders that are made up of 1, 2, 3, 4, 5, or 5+ bottles?

Answer: Three-month data range expressing percentage of orders is as follows:

g. For the scope of this bid, please clarify expectations for Combination orders (TCA and unit-of-use items).

Answer: No unit of use items are to be included in the scope of this TCA.

2. Will vendors be required to feed TCA items into an existing system to complete the unit-of-use items of the prescription orders, or will vendors be required to collate and pack unit-of-use items coming into the TCA area with the TCA portions of the order? If so, please clarify the throughput required above and beyond the above-stated fill/pack throughput requirement that must be supported by TCA and transported externally.

Answer: Yes and no. There are four semi-automatic packers (QMSI Qpak system) that are being installed in September of 2024 that are expected to be integrated into this TCA. No additional increase to throughput is calculated in this requirement. Additionally, the TCA is not intended to feed into any other existing systems at this time.

No, all unit-of-use will be filled and packed separately from this TCA within this requirement. No collation is planned until after unit-of-use system is replaced in the future, which is not part of this requirement but is projected as a future requirement.

3. Regarding the QMSI Qpak system:

a. Does the proposer need to include space for the QMSI Qpak system? If so, please provide the unit and access dimensions for the layout.

Answer: Yes, there are 4 stations being installed in September of 2024 that will be standalone and manually fed. Overall System Dimensions: 112” W x 128” D x 96” H (final dimensions dependent on finalized configuration).

b. Can you provide the physical handshake specifications from the proposed system to the QMSI Qpak system (heights, loads, orientation, etc...).

Answer: The stations are flexible and typically fed by puck or bottle conveyance parallel to the operator with sufficient queueing to allow for print ahead. Then the bagged bottle(s) is removed from the individual workstation via conveyance to a consolidated package takeaway conveyor. For each packing station:

· Compressed Air: 80PSI @ 5CFM for the bagger

· Electrical Requirement: 120V, 60Hz, 2 x 20A Circuits

· Data: One ethernet drop for the PC

· Physical IT handshake specifications will be provided to vendor’s before submission of final plans.

c. Can you provide images and/or videos of the QMSI Qpak system? Can a site visit be arranged to further understand the intricacies of the proposed system integration?"

Answer: Images provided are above. The stations are to be installed in September of 2024 and no site visit is possible at this time. A site visit can be arranged after TCA plans are accepted and then to be finalized.

4. Please specify any expected software system integrations outside QMSI Qpak and the latest published OneCMOP interface specification.

Answer: Software will need to communicate with the VA’s SQL and interface with the CMOP’s order allocator. A high-level depiction of the CMOP’s IT interfaces are depicted below. There is no longer an existing interface called OneCMOP.

5. Page 31 of Attachment 1 references requirements for shipper types based on order type; "Orders must be capable of packing into mailers, bubblers, small boxes, large boxes, or cold chain boxes. The profile for package type and containers per package by order type is shown below." This information is not listed under this statement - can you clarify what the requirements will be for packaging based on order type?

Answer: The order type in the TCA refers to either multiple bottles (vials) or singles that are packed into mylar bags with the contractor determining the bag size based upon the order size to be packed. Replace with mylar bags on page 31.

6. What are the specifications of the compressor and dryer systems shown during the tour? What % of capacity is currently being used by the compressor, and can additional capacity available be used for the proposed system?

Answer: The CMOP has two compressors, two dryers, and two storage tanks (one in the compressor room and one remote next to the walk-in refrigerator/freezer). The compressors are PneuTech, RK-60VSD-115B. One compressor and one dryer are in standby mode. Each air dryer has a 10.2 Liter capacity with a normal flow rate of 375 scfm. If the proposer requires additional capacity for the TCA system, then they are responsible for providing and installing. Also, while the new TCA is being tested, the old system is required to be in operation.

7. What are the ceiling clearances?

Answer: 9’ 8” is the clearance to the HVAC Sock ducting, which is the lowest hanging portion from the lower ceiling.

8. What is the floor rating/thickness?

Answer: There is no know rating, but the slab is 6”, non-reinforced, concrete.

9. Is space available in the IT Servers and data rooms for the required TCA servers? If so, please specify the available rack utilization for TCA.

Answer: Based on the site visit and what was shown to all the vendors, VA believes there is plenty of space in the IT server room for all contractor provided servers, racks, and computer equipment. The server room that is planned for use is empty except for the AC/Environment control unit.

10. Who is responsible for providing network equipment and installation?

Answer: The network equipment and installation is required by the vendor who also runs the cabling. The vendor needs to also include PCs and monitors.

11. Will the current space proposed for the new TCA be reconditioned by the VA prior to installation? Rehab of floors, new lighting or other updates that may impact system design or implementation?

Answer: There are no plans to recondition the TCA space by the VA.

12. Will a separate area be allocated for remote PV, or will remote PV be required to be installed inside the indicated TCA production space? If physical space is required, please provide the rate (items/ hour cycle rate) that can be achieved per physical verification station. Please expand and clarify “Offline PV capable with easy access for easy modification," as referenced on page 21 of Attachment 1.

Answer: A separate area for remote pharmacy verification will be provided on the CMOP’s premises.

Answer: Contractor is to provide portable computer hardware (with monitors) and software (computers must be capable of supporting the VA’s Operating System image) supporting the pharmacy verification software program. These portable computers must connect to the TCA and shall provide a mechanism for pharmacist review and verification from a remote location. The pharmacist verification process shall be accomplished using scanning technology to minimize keystrokes for routine order processing and allow pharmacist intervention in the case of an exception. The TCA shall display all information required for pharmacist verification including a visual (as dispensed image of the correct product) compared with a VA pharmaceutical visual reference image standard, patient name, directions, drug name, quantity requested, quantity dispensed and other information necessary to determine the correct product and quantity are dispensed.

13. Is the long SIG label referenced in the RFP a static-sized label? If so, are there required dimensions to be adhered to?

Answer: Long Sig Label is not a static label with dimensions is 2.5” x 5.5” (differing from the standard prescription labels) and also using a smaller font adhering to these dimensions.

14. Page 43 of Attachment 1 under the section Mechanical Requirements, item 5, "All equipment must be sized for receipt through doors 6’ wide by 80” high.” We toured a loading dock that would allow access in excess of these dimensions. Can this dock be used to unload and transport material?

a. Yes.

15. Can it be assumed that all medication and consumables inventory backstock will be held in an area outside of the allocated TCA space?

a. Yes.

16. On Page 25 of Attachment 1, the Semi-Auto Baggers are stated to be able to handle orders of over 5 bottles. What is the maximum bottle order size they can handle?

Answer: The max is dependent on the queueing capacity for print ahead and bag sizes, and for example it is projected to handle 3 to 4 250cc bottles, or 7 120cc bottles dependent on bag size.

17. Is additional space available above the cage or in other areas of the floor where the installation of the new TCA is planned?

Answer: VA cannot commit to space outside of the conceptual layout.

18. Are all patient and HIPAA data (from VA databases, bar code scanning, or transferred by RFID) to be discarded once labels are printed by the TCA?

Answer: All data is stored on the VA (SQL) database and is also retrieved from there (existing VA automation equipment), which is external to the TCA’s automated equipment. No information (e.g. patient and HIPAA data) is stored on the TCA as the prescriptions get received, allocated, and printed (or any other processes). The data is dumped once printing operations take place.

19. What measures are needed to protect the contents in the vials (120 cc & 250 cc) from either cross contamination, or from outside contamination entering into the vials?

Answer: Design shall incorporate features to protect the contents from contamination (from dust and foreign particles) to include, but not limited to all OSHA safety standard and codes. The TCA processes shall take employee protection and engineering controls into consideration by including the use of local HEPA filtered capture ventilation. Safeguards must be added to remove the risk of wrong product dispensing and mixed drug dispensing when bottles are filled at a cell and while the bottle is traveling on the conveyor without a cap. A bottle must have neither a resting stop, nor travel that is under any other cell while being moved or awaiting fill at a designated cell. Additionally, a single level of cells on the floor level is preferred over multiple levels of cells above the floor level cells. Should dispensing of hazardous drugs be integrated, then use of HEPA-filtered capture ventilation is required according to USP Compounding Compendium Chapter 800 and recommended by NIOSH Guidelines.

20. Are there any additional ergonomic integration design principles listed by OSHA that are applicable to the TCA’s engineering considerations?

Answer: Guidelines under OSHA 1910.22 and 1910.36-37 are also applicable and can be referenced at Ergonomics - Standards and Enforcement FAQs | Occupational Safety and Health Administration (osha.gov). Workstations adjustments must mee OSHA ergonomic standards including powered adjustments. Additionally, these standards do not exclude the minimum industry standard guideline where installed equipment should be capable of adjustment to a minimum clearance of about 6 inches above the floor.

21. What is meant by replenishment operations? Can more details be provided?

Answer: Replenish operations for the TCA system should include all components for a complete replenishment area (e.g. replenishment station, conveyance, computer servers and workstations with monitors and printers) to ensure fluid TCA operations. The replenishment area must be built and designed as a supplemental area to the TCA with storage containers/canisters and to prioritize replenishment workflow and ensures optimal dispensing of TCA system throughput. The container filling area may be physically separate from (but shall be in close proximity to) the TCA production area maximizing efficiency of the replenishment process. Consideration shall be given to efficient workflow and ergonomic design (meeting OSHA Pharmacy ergonomic standards) within the replenishment area to include container cleaning, staging, movement, and storage of working stock, and replenishment storage containers. TCA replenishment software must provide an error-free mechanism for replenishment actions. The TCA replenishment system shall maximize efficiency and include forcing functions ensuring 100% accuracy when placing containers in the TCA and subsequently transferring drug product into TCA containers. The system requires an independent NDC scan of each commercial bottle prior to transferring its contents into the container, and the empty commercial bottle shall be tracked through disposal prior to the system accepting the next commercial bottle. The replenishment system requires electronic verification of filled canister to include a mechanism to assign and track status for each canister (e.g. assigned, complete, verified/staged, loaded, released, and ready) and record the NDC, lot/expiration date, quantity, operator(s), and the canister fill date.

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