Automated Medication Dispensing System - Additional Clarifying Questions.docx

1. In SOW under IV. Other Terms & Conditions, section 6, item F: The contractor shall ensure all contractor delivered applications and systems provide user authentication services compliant with VA Handbook 6500, VA Information Security Knowledge Service, IAM enterprise requirements and NIST 800-63, Digital Identity Guidelines, for direct, assertion-based authentication and/or trust-based authentication, as determined by the design and integration patterns. Direct authentication at a minimum must include Public Key Infrastructure (PKI) based authentication supportive of PIV and/or Common Access Card (CAC), as determined by the business need and compliance with VA Information Security Knowledge Service specifications.

Question: Please provide clarity - is the customer wanting PIV card authentication at the cabinet level?

Answer: If the system has a “business need” to use PIV, then the VA would need PIV at the cabinet level. However, if the “business need” does not allow for PIV capability, then the vendor shall indicate that this need is not necessary to meet the VA handbook 6500 requirements.

VA Handbook 6500 requirements:

Clarification request: Does this facility want PIV card authentication at the cabinet level included in our proposal?

Clarification response: It is not a requirement to have PIV card authentication at the cabinet level. If it is not available, then the vendor shall document that it is not necessary on the VA Handbook 6500 document. If it is available and/or required for use, the vendor shall indicate that on the 6500 document and may list it as an option within their quote.

2. Under Functional and Technical Specifications, Section 5, first bullet point: ADCs will be distributed at the Aurora main VA medical center, VA CBOC and other clinic locations and shall be a combination of both full size and half size as proposed by the contractor/offeror. Contractor’s proposed cabinets shall be able to hold all medications as specified in attachment A document and include a 25% growth annually in both the number of medications and count of each medication over the next 5 years.

Question: Does the customer intend to buy excessive device capacity today to meet 25% annual growth in med volume, or will they plan to contract for additional devices each year?

Answer: The VA does not plan on purchasing additional cabinets at this point and request that the vendor propose solutions that would allow growth within the existing space. All locations, except for ICU and Union Blvd 2nd Floor, sufficiently meet our needs and we don’t anticipate needing additional space over the next 5 years. ICU has limited to no physical space to increase ADC capacity, but VA would welcome ideas that vendors may be able to offer in the space. Union Blvd 2nd floor is at capacity with the current cabinet (Omnicell ¼ height) and cannot fit larger items (a small quantity of irrigation bottles, EpiPens, naloxone nasal spray). This location needs a larger cabinet to account for these items and potential growth.

Clarification request:

The answer is contradictory. “The VA does not plan to purchase additional cabinets” and last line “this location needs a larger cabinet”.

This contradicts what the RFQ states. Notable: Omnicell apples to apples is 20-40% more capacity than the competitor.

If intention is to increase number of meds per cabinet that is at capacity we can do two things: 1. Assist them in optimizing inventory to decrease dead/slow moving stock and 2. exchange drawers that hold fewer line items for drawers that hold more This is an Omnicell exclusive feature (reconfigurability in the field): (example single deep 18 bin for a single deep 36 bin or 15 bin double deep for a 6 bin double deep).

Clarification response: The current situation at the union blvd level 2, does not meet the VA’s requirements. Optimization (either through additional cabinet, or optimizing inventory/exchanging drawers) is required, but how best to accomplish that is up to the vendor’s discretion.

3. Additional requirements section, item 7: The multiple single-patients’ medications can be found in a single drawer with individual bins that have locking lids.

Question: Does the customer mean patient-specific medication, or multi-dose medication, like insulin? Please clarify.

Answer: If a patient requires multiple medications that are not routinely stocked in the cabinet (e.g., five inhalers), and these medications can be loaded for that specific patient into a single bin, cube, or slot equipped with a locking lid, would be considered as exceeding the minimum Government need as specified in the Statement of Work.

Clarification request:

Are you wanting a quote for the minimum government needs or exceeding the government needs?

Patient Specific Med Management (exclusive SinglePointe software) is different than “specific patients’ meds”. SinglePointe software (among other things) automatically assigns a bin or bins to patients who have many complex meds; it allows for the RN to be directed to a secure bin to issue or return meds every time, reduces hunting, manages transfers of meds from area to area, and prompts when a med/dose is discontinued. This exceeds the SOW requirement.

Clarification response: The minimum requirement is set to establish which parameters are required to be met to quote on this requirement. It is up to the vendor to determine if their solution can meet or not meet the additional requirements that exceed the minimum requirements.

4. Question: How is delivery timeline weighted in the overall evaluation criteria relative to cost and technical requirements?

Answer: Delivery timeline will be evaluated as a part of the technical evaluation.

5. Question: What is 25% annual growth referring to? Number of beds or patients or Medications stored in the ADC.

Answer: The annual growth is in reference to medications stored in the ADC. The VA does not plan on purchasing additional cabinets at this point and request that the vendor propose solutions that would allow growth within the existing space. All locations, except for ICU and Union Blvd 2nd Floor, sufficiently meet our needs and we don’t anticipate needing additional space over the next 5 years. ICU has limited to no physical space to increase ADC capacity, but VA would welcome ideas that vendors may be able to offer in the space. Union Blvd 2nd floor is at capacity with the current cabinet (Omnicell ¼ height) and cannot fit larger items (a small quantity of irrigation bottles, EpiPens, naloxone nasal spray). This location needs a larger cabinet to account for these items and potential growth.

Clarification request:

This is the same answer as provided in #2. Contradictory to need of additional cabinets or whether the government wants us to quote additional cabinets in our response.

See comments above regarding expansion and Omnicell exclusive features allowing for reconfiguration of cabinet drawers and Solution Advisor assistance with optimizations. Reality: ICUs and ED may need more hardware to expand due to the nature of the patient acuity, 1st doses, emergency meds. We can assist in suggesting new location(s) if expansion of #s of meds occurs in the future

Clarification response: Please see clarification response for question #2.

6. Question: What items are to be stored in the refrigerators. How many patients will they service.

Answer: Please see attachment “Database Maintenance - Items” which includes a list of all refrigerated items the facility has tied to a cabinet or to central pharmacy storage (RMCP) at this time: Tab “Q6 Refrigerated Items.” Patients serviced is dependent on the clinic/ward; PAR of non-controlled items is 7-14 days while PAR of controlled substances is generally 5 days or less. 0 PAR/0 quantity on hand items has been filtered out from everywhere except RMCP.

7. Question: Narcotic Safe: Please provide the number of doors and Cells you require.

Answer: Please see attachment “Database Maintenance - Items” for the inpatient vault, which is currently in CSM with essentially 5 cells and a computer/printer: Tab “Q7 Narcotics.” The facility does have to store overflow propofol outside the cabinet and essentially use all space available to them. There are some items that have PAR and Quantity on Hand of 0 – these are assigned when they have patient-specific needs but are typically only stored outpatient otherwise.

Clarification request:

How many doors are needed on the narcotics safe?

Confirm 5 cells is enough plus console.

Clarification response: Narcotic vault has limited to no physical space to increase ADC capacity beyond 5 cells, but the VA would welcome ideas that vendors may be able to offer in the space to optimize the usage.

8. Question: Please verify that you require single dose dispensing for narcotics that will fit into a Controlled Substance Dispenser.

Answer: Currently we utilize CSDs but are looking for ways to optimize use of space, which could mean locking bins instead of CSDs.

Clarification request:

Do you require single dose dispensing for narcotics? Do you want a quote for locking bins and CSD’s or just one or the other?

Confirm which units they want CSDs in. Recommend conversion to drawers unless clinically applicable. Omnicell has an exclusive formula for that.

Clarification response: Whether the vendor quotes CSDs or locking bins, this is up to the vendor based on the current inventory. Below are units where Controlled Substances are stored and we would need vendor to provide recommendations on configuration:

VARXCSINF Colorado Springs Infusion Clinic

9. Question: What is the SMAK tool kit? The SMAK toolkit can be installed without voiding the support agreement or warranty. Shall allow for management of users and enable termination or initiation of users from a web-based server interface or similar.

Answer: The System Monitoring and Accountability Knowledge AntiMalware (SMAK-AM) toolset is used for real-time reporting of malware infections on Windows based MDIA devices. The toolset is also used to collect device antimalware status and configuration details which are reported to a central server. The SMAK-AM toolset consists of HTM authored Command shell batch files, PowerShell scripts and executables to assist VHA Biomedical Engineering programs in collecting necessary data to meet Continuous Readiness in Information Security Program (CRISP)/Federal Information Security Management Act (FISMA) requirements without compromising medical devices and systems as stipulated by the Food and Drug Administration (FDA).

10. Question: What do you mean by the vendor needs to provide 60 months support for the OS?

Answer: The VA is requesting a system that has a currently supported operating system. The 60 months of support (ie Windows 11) would be considered as exceeding the minimum Government need as specified in the Statement of Work.

Clarification request:

Should we quote monthly support for 60 months on the OS or the minimum requirements as outlined in the RFQ?

Clarification response: No. The requirement is annual software and hardware support for a period of 12 months. This specific requirement is for the OS itself. The minimum requirement is that the OS should be supported by Microsoft. If the OS is supported by Microsoft for 5 years, it would be considered as exceeding the minimum Government need.

11. Question: VA Denver currently uses the Omnicell System. Infrastructure has already been built and is operational. Are you requiring Omnicell to re-quote this and redo all of the infrastructure work?

Answer: Yes.

12. Question: If an ADC has recently been installed or will be installed from a past Award, do you require Omnicell to quote it again to meet the specs of this RFQ?

Answer: Yes. Due to multiple life expectancies within the ADC system at ECH, the intent is to standardize all equipment to the same age/life expectancies.

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