Medical Gas Cylinder Questions n Answers FINAL.pdf

Medical Gas Cylinder Questions & Answers

1. Can the Government provide any historical usage data (e.g., prior 12–24 months) by gas type and delivery location? Historical data can be provided upon award

2. Are there any estimated annual quantities or internal projections used for planning purposes? Historical data can be provided upon award

3. What is the approximate average number of deliveries per week across all locations?

One delivery per week at Togus, Portland. All other locations as needed.

4. What percentage of deliveries are typically emergency (≤2 hours) versus routine? Less than 5 per year

5. The solicitation references both comparative evaluation and lowest-price language—can the Government clarify the intended award methodology? Award will be based upon a comparative evaluation of quotes in accordance with the Simplified Acquisition

Procedures of the FAR.

6. Will pricing be evaluated using any estimated quantities, or strictly based on unit pricing?

Unit Pricing

7. Will the contractor be required to provide all cylinders, or will Government-owned cylinders be available for use? Contractor will be required to provide all cylinders except

Dewars which are currently owned by VA.

8. Is there an incumbent contractor currently performing these services? If so, are there any transition considerations or performance insights the Government can share? Yes, Transition would take effect on start date of contract. First delivery would be large, and amounts would be provided prior to 1st delivery date.

9. Are after-hours, weekend, or holiday emergency deliveries expected, and if so, how frequently? No

10. For purposes of the limitation on subcontracting, how does the Government classify delivery, cylinder rental, and gas supply components? Limitation on Subcontracting will be removed from solicitation

11. Can the VA provide a description of "service call"? Is this a product delivery and if so, please advise if the VA is willing to extend the 2-hour and/or 24-hour window

We also need a description of what the definition is of repairs and what the requirements are.

e. The Contractor shall respond to all emergency service calls within 2 hours.

f. The Contractor shall respond to non-emergency service calls within 24 hours or the next business day. Repairs/replacement would be on leased tanks, Take precautions to prevent damage to government property. Report damages immediately and replace or repair at no cost.

The Contractor shall respond to all emergency service calls within 2 hours.

The Contractor shall respond to non-emergency service calls within 24 hours or the next business day.

12. The VA has listed only a quantity of "1" for each line item. We need to understand the number of assets required and the quantities needed per location, along with the delivery frequency for each site. The RFQ states weekly deliveries - please advise quantities per delivery and does a weekly delivery apply to all locations listed? Togus and Portland weekly deliveries, all other locations as needed.

13. TRANSITION: There is no specified timeline for a phase-in transition period. The industry standard is to allow 30-60 days for a formal “event-based” transition between contractors (often depends on if the awardee is hiring the incumbent supplier or not).

Please confirm the transition timeline for all incoming contractors, including an awarded

SDVOSB who may subcontract to the incumbent supplier. First Delivery will need to be made on the first day that the contract is effective. Quantities will be provided beforehand.

14. What are the Gases required (by CLIN) and corresponding estimated monthly or annual

QTYs required for each CBOC on this contract? This is crucial information that will affect offeror pricing.

15. Approximately how often does each of the (7) CBOCs on this contract place orders/require delivery? Togus & Portland weekly, all others as needed.

16. INTEGRATED VALVE SAFETY FEATURE:

1. Can the GOV please clarify the following safety requirement, as integrated valve oxygen cylinders are not designed to nor is it ever recommended to place the regulator flow meter “between two numbers?” While many supplier cylinders will intermittently still output oxygen when the flow meter is “between two numbers,” it is not ever recommended as this is not the design function and could put the patient potentially at high risk.

1. PG 6 of 16, under para l, “Safety features include:” Oxygen air flow that does not stop if the regulator is placed between two numbers.

Description/Part Number* Qty Unit

AR KUSP - COMPRESSED AIR K USP 5 CY

AR 40UHP- ARGON UHP 40 CU FT 5 CY

AR 6K- ARGON 6000 PSI 5 CY

CD ANEUSP- CARBON DIOXIDE ANE USP 80 CY

CD KBD- CARBON DIOXIDE BONE DRY 15 CY

HE 6K- HELIUM 6000 PSI 3 CY

MNI L0.3CMMEOX-K - 0.3% CO / 0.3% ME / 21% O2 / N2 4 CY

NI DEWARMAXFIL- NITROGEN LIQUID DEWAR MAX FILL 65 CY

NI KNF- NITROGEN K NF 71 CY

NO ANEUSP- NITROUS OXIDE ANE USP 10 CY

NO KUSP - NITROUS OXIDE K USP 5 CY

OX ANETOTEUSP- OXYGEN ANE USP WITH OXYTOTE 600 CY

OX ANEUSP- OXYGEN ANE USP 4 CY

OX KUSP - OXYGEN K USP 9 CY

OXANDTOTE size D cylinder with valve 52 CY

2. Please confirm the model of Integrated Valve Oxygen E Cylinder the HCS is actively utilizing? Based on the CLINs, it appears to be various models of the

Western Enterprises Oxytote, however the brochure for the WE Oxytote specifically has a feature to prevent the flow meter from going between (2) flow # settings:

1. WE Oxytote Brochure Link: https://westernenterprises.com/wp-content/uploads/OxyTOTE-NG-Brochure.pdf

Any cylinder-integrated regulator used under the RFQ must match that design standard. This integrated valve regulator incorporates click-stop settings, CGA fill port, and features like the SureClick™ locking flow selector

17. CLINS/GASES:

1. GAS PURITY:

1. AR 6K, ARGONN 6000 PSI: Is there a specific purity grade required

(e.g., High Purity or Ultra High Purity), or is the requirement for standard/common industrial grade? Medical grade

2. HE 6K, HELIUM 6000 PSI: Is there a specific purity grade required (e.g., High Purity or Ultra High Purity), or is the requirement for standard/common industrial grade? Medical grade

2. CYLINDER FILL QUANTITIES: All gases listed in the Price Schedule have a quantity of (1). Will the GOV please provide more accurate quantities depicting what the estimated annual usage is for each cylinder type so that offerors may appropriately price each item? Quantities based on historical usage are especially important for the total number of annual rentals expected. Offeror pricing is heavily a function of the estimated annual quantities, so only providing a quantity of (1) for each line item will result in the highest price provided to the GOV;

estimated annual totals based on usage will allow offerors to offer the most advantageous prices, especially on the most commonly used cylinders. Our recommendation is to request a 12-month usage report from the current supplier to identify the estimated annual FILLs. The same can be done with the Rentals, however some facilities elect to take the most recent on-hand cylinder balances, then multiply these by (12) months to establish the estimated annual cylinder

RENTALs. See Table Above https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwesternenterprises.com%2Fwp-content%2Fuploads%2FOxyTOTE-NG-Brochure.pdf&data=05%7C02%7C%7C26e7eb5541c14bce6b0108deb048a72b%7Ce95f1b23abaf45ee821db7ab251ab3bf%7C0%7C0%7C639142023287741812%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=ZuMmLWPInwT%2FyMdJQZrNyZlvHHdQcJlzjwm%2Fou5G1I4%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwesternenterprises.com%2Fwp-content%2Fuploads%2FOxyTOTE-NG-Brochure.pdf&data=05%7C02%7C%7C26e7eb5541c14bce6b0108deb048a72b%7Ce95f1b23abaf45ee821db7ab251ab3bf%7C0%7C0%7C639142023287741812%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=ZuMmLWPInwT%2FyMdJQZrNyZlvHHdQcJlzjwm%2Fou5G1I4%3D&reserved=0

3. CYLINDER RENTALS CLINs & QUANTITIES: On the Price Schedule attachment, line 24 includes “Cylinder Rental” but does not specify how offerors are to price rentals for different cylinder types. Will the GOV allow offerors to structure monthly cylinder rental groupings by size, type, and functionality, which allows for more accurate cylinder tracking and consolidation of rental CLINs?

See suggested rental groupings below:

➢ CYLINDER SIZES:

a. Will the GOV please confirm what cylinder size is represented by “ANE” in the description? We can infer that it’s likely an aluminum, size E cylinder, but it’s not clear what the “N” represents. Please confirm cylinder type/size for each of the following part numbers:

▪ CD ANEUSP – CARBON DIOXIDE ANE USP SIZE E

▪ OX ANETOTENOVALVE – OXYGEN ANE USP WITH OXYTOTE

WITHOUT VALVE SIZE E

▪ OX ANETOTEUSP – OXYGEN ANE USP WITH OXYTOTE TOTE

STYLE SIZE E

▪ OX ANETOTEVALVE – OXYGEN ANE USP WITH VALVE

SIZE E

▪ OX ANEUSP – OXYGEN ANE USP SIZE E w/out built in regulator.

b. Will the GOV please confirm what cylinder size is represented by “AND” in the description? Again, it seems possible that this naming convention represents an aluminum, size D cylinder, but it’s not clear what the “N” represents. Please confirm cylinder type/size for each of the following part numbers:

▪ OXANDTOTE – OXYGEN D SIZE CYLINDER WITH VALVE

▪ OX ANETOTEVALVE – OX ANETOTEVALVE (Please note that this line item shows a part number with “AND” and a description with

“ANE.” Please clarify.) SIZE E

▪ OX ANDUSP – OXYGEN AND USP SIZE D

c. For the NI DEWARMAXFIL item, will the GOV please confirm how many and what dewar sizes the VA owns? Does this part number need to be priced per liter of liquid nitrogen (as opposed to a total fill cost for a 30-liter dewar, for example)? The only GFE is the Dewars. Currently have 2 at Togus, 1

Bangor, 1 Portland and 1 Calais. Size of Dewar is 30 LTR and Calais is

20LTR. You can provide both.

➢ POTENTIAL DUPLICATE ITEMS: There are multiple “OX TOTE” style part numbers included in the Price Schedule, including both the “AND” and “ANE” part numbers. Will the GOV please confirm the differences between the following line items (or confirm which items are possibly duplicates and specify the part numbers that need to be priced):

a. OXANDTOTE – OXYGEN CYLINDER WITH VALVE SIZE D

b. OX ANDTOTEVALVE – OX ANETOTEVALVE SIZE D

c. OX ANETOTENOVALVE – OXYGEN ANE USP WITH OXYTOTE

WITHOUT VALVE (Please also clarify the function/need for an OxyTote integrated valve cylinder that does not have a valve.) SIZE E

d. OX ANETOTEUSP – OXYGEN ANE USP WITH OXYTOTE TOTE

STYLE SIZE E

e. OX ANETOTEVALVE – OXYGEN ANE USP WITH VALVE SIZE E

All cylinders marked with the "TOTE" portion have a built-in regulator.

The valve vs no valve is a secondary safety on the cylinder.

➢ GFE CYLINDERS: Will the GOV please confirm whether any of the line items on the Price Schedule are GFE/Customer Owned cylinders? If so, please specify how many and what types of GFE cylinders the VA has on its property books. The only

GFE is the Dewars. Currently have 2 at Togus, 1 Bangor, 1 Portland and 1 Calais.

Size of Dewar is 30 LTR and Calais is 20LTR.

➢ EMERGENCY DELIVERIES: PG 5 of 16 in the RFQ (Performance Requirements) specifies that the awardee will respond to emergency deliveries in (2) hours and deliver within (24) hours, but the Price Schedule only includes a “Delivery Fee” line item for offerors to price. Will the GOV confirm whether the delivery fee listed in the

Price Schedule is for offerors to price each standard delivery or for offerors to price the emergency delivery procedures cited in the statement of work? If it’s for standard deliveries, will the GOV add a line item for emergency deliveries? SEE ABOVE

18. CYLINDER DELIVERY PROCEDURES: PG 7 of 16 in the RFQ (Task Frequency and

Instructions) states that “Empty cylinder quantity being returned to the contractor should equal the number of cylinders being delivered by the contractor.” And PG 5 (Performance

Requirements) states that “Orders will be placed by authorized individuals to be determined after contract award. Only these authorized individuals will be permitted to place orders against this contract.” Will the GOV please clarify why PG 7 is requiring a one-for-one swap procedure on delivered cylinders per the instruction that the number of cylinders being returned “should equal the number of cylinders being delivered” when the

VA will be placing authorized orders for delivery? The total number of cylinders delivered will equal the total number of cylinders ordered by the facility, not necessarily equal to the number of cylinders being returned to the contractor. Standard procedure includes the VA placing an order, the contractor delivering the order as it was requested, and picking up any available empty cylinders during delivery. A one-for-one swap procedure for authorized orders of contractor-owned cylinders is abnormal. Please clarify this requirement. Authorized individual with provide correct information on what is to be swapped out during delivery.

19. INSURANCE REQUIREMENTS: There is no mention of required liability insurance in the Solicitation. How is the GOV going to validate that offerors are properly insured for

NAICS 325120/221210 – the actual requirement for this work to comply with the RFQ?

How do offerors confirm to the GOV that they have the correct type of Liability

Insurance, and does this need to be affirmed at the time of bid submission (if not, an awarded firm could be turned down or not be able to afford this coverage in the amounts the GOV requires, respective to NAICS 325120)? This is important because there are very few underwriters that will insure small businesses for the distribution of compressed gases and why confirmation of the applicable NAICS is being requested, in accordance with paragraph (a) of FAR 52.228-5 – Insurance Work on a Government Installation. Offerors should presume insurance adequacy (e.g., general liability including compressed gas operations) will be a responsibility at award time and must be documented before contract performance begins. If coverage is lacking or unaffordable, contractors may be disqualified post-award.

20. LOSS OF USE FOR CONTRACTOR-OWNED CYLINDERS: What are the procedures to account for Loss of Use (LOU) costs for contractor-owned cylinders lost while in the VA’s possession? There is no provided language specifying that the GOV will pay its LOU invoice following a joint cylinder audit between the Prime Contractor and the

VA. There is also no language detailing HOW the GOV will ensure payment is provided

(e.g., paid for via separate purchase order?). Restated, how the vendor will arrive at payment procedurally and be reimbursed in a timely manner for any lost cylinders? Please note, the only way to determine Loss of Use is per a VA/Prime Contractor joint audit and compare what is physically on hand at the facility.

1. To protect Contractors who must front these charges with their suppliers in order to continue delivering medical gases, to ensure compliance with the

Prompt Payment Act, and to establish accountability procedures for the VA, we recommend including the current LOU verbiage from the VISNs 9/10

Medical Cylinders Contract that does address payment procedures

(36C77623D0910):

1. NOTE: Just-in-Time invoicing and annual audits are not included in this

RFQ for the Maine VA HCS; the above image is simply an example of the

LOU PO language previously recommended to the VA. Please also note that if the Maine VA HCS requires annual audits, there is a cost associated with providing this service.

All instances of loss of Use will be handled on a case by case basis. The identifying party will alert the contracting officer immediately. Should the Government be found to have been negligent, the contractor will be reimbursed.

21. LICENSING REQUIREMENT OF SDVOSB OFFERORS: Will the GOV please confirm that the required federal and state of Maine licenses and certifications applicable to the SDVOSB offeror must be provided in the name of the Prime Contractor at the time of bid submission (and cannot be delegated to a subcontractor), which is required of an

SDVOSB offeror in order to comply with the FDA/Code of Federal Regulations to meet the requirements of the Statement of Work in this RFQ (wholesale distribution of medical-grade oxygen/compressed gases where medical-grade oxygen is defined by the FDA as a prescription drug)? Please see the below reference information regarding compliance with the FDA, CFR, and the state of Maine.

➢ INFO ONLY - REFERENCE INFORMATION REGARDING FEDERAL

WHOLESALE DISTRIBUTION LICENSING REGULATIONS BY THE FDA

& IN THE STATE OF MAINE:

• CFR Code of Regulations, Title 21, Chapter 1, Subchapter C, Part 205 –

GUIDELINES FOR STATE LICENSING OF WHOLESALE

PRESCRIPTION DRUG DISTRIBUTOR:

o LINK: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-

C/part-205

• Per the Food and Drug Administration, Code of Federal Regulations, Title 21 – Definition of a Wholesale Distributor: Based on the SOW and requirement of the offeror to sign VAR 852.219-76 (Certificate of Compliance affirming that the offeror takes ownership/possession of the product in accordance with industry standards), the SDVOSB offeror qualifies as being a

Wholesale Distributor (restated, medical-grade/US Pharmacopoeia Oxygen is defined as a prescription drug).

https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.ecfr.gov%2Fcurrent%2Ftitle-21%2Fchapter-I%2Fsubchapter-C%2Fpart-205&data=05%7C02%7C%7C26e7eb5541c14bce6b0108deb048a72b%7Ce95f1b23abaf45ee821db7ab251ab3bf%7C0%7C0%7C639142023287780728%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=VIln%2BT4NlMSRKGhKTz37KP1SBXyz3oJw3vydzHd%2FnCE%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.ecfr.gov%2Fcurrent%2Ftitle-21%2Fchapter-I%2Fsubchapter-C%2Fpart-205&data=05%7C02%7C%7C26e7eb5541c14bce6b0108deb048a72b%7Ce95f1b23abaf45ee821db7ab251ab3bf%7C0%7C0%7C639142023287780728%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=VIln%2BT4NlMSRKGhKTz37KP1SBXyz3oJw3vydzHd%2FnCE%3D&reserved=0 o LINK:

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.c fm?fr=203.3

• Per Section 201(g) of the FD&C Act (21 USC 321(g)) provides that the term "drug" means:

• State of Maine Board of Pharmacy Wholesaler Requirements (in accordance with CFR 21 Title 21, Chapter 1, Subchapter C, Part 205 as there is no

“federal” license):

• Per Maine Pharmacy Act: Title 32, Chapter 117, Subchapter 6

(Manufacturers and Wholesalers):

o LINK:

https://www.mainelegislature.org/legis/statutes/32/title32ch117sec0.ht ml o LINK: https://www.maine.gov/pfr/professionallicensing/laws-rules https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.accessdata.fda.gov%2Fscripts%2Fcdrh%2Fcfdocs%2Fcfcfr%2FCFRSearch.cfm%3Ffr%3D203.3&data=05%7C02%7C%7C26e7eb5541c14bce6b0108deb048a72b%7Ce95f1b23abaf45ee821db7ab251ab3bf%7C0%7C0%7C639142023287815637%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=Z45fzRjGX%2FEN1Xe00P4KuZF3Arfl5jvz0FzRVEvSiC4%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.accessdata.fda.gov%2Fscripts%2Fcdrh%2Fcfdocs%2Fcfcfr%2FCFRSearch.cfm%3Ffr%3D203.3&data=05%7C02%7C%7C26e7eb5541c14bce6b0108deb048a72b%7Ce95f1b23abaf45ee821db7ab251ab3bf%7C0%7C0%7C639142023287815637%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=Z45fzRjGX%2FEN1Xe00P4KuZF3Arfl5jvz0FzRVEvSiC4%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.mainelegislature.org%2Flegis%2Fstatutes%2F32%2Ftitle32ch117sec0.html&data=05%7C02%7C%7C26e7eb5541c14bce6b0108deb048a72b%7Ce95f1b23abaf45ee821db7ab251ab3bf%7C0%7C0%7C639142023287841217%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=04aymoFR9jcjKCH4ws3QdNv9RB3%2BzZGXT6L08%2FYYgU0%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.mainelegislature.org%2Flegis%2Fstatutes%2F32%2Ftitle32ch117sec0.html&data=05%7C02%7C%7C26e7eb5541c14bce6b0108deb048a72b%7Ce95f1b23abaf45ee821db7ab251ab3bf%7C0%7C0%7C639142023287841217%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=04aymoFR9jcjKCH4ws3QdNv9RB3%2BzZGXT6L08%2FYYgU0%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.maine.gov%2Fpfr%2Fprofessionallicensing%2Flaws-rules&data=05%7C02%7C%7C26e7eb5541c14bce6b0108deb048a72b%7Ce95f1b23abaf45ee821db7ab251ab3bf%7C0%7C0%7C639142023287862886%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=jsm7NAQrXVZOrtRMyPRxd0sKfGULBasC9EZZSZgSTlk%3D&reserved=0

• Per Maine Pharmacy Act: Title 32, Chapter 117, Subchapter 1 (Title and

Definitions):

o LINK:

https://www.mainelegislature.org/legis/statutes/32/title32ch117sec0.ht ml

• Per the Maine Board of Pharmacy website (Licensing for

Establishments):

o LINK:

https://www.maine.gov/pfr/professionallicensing/professions/board-pharmacy/licensing/establishments#5 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.mainelegislature.org%2Flegis%2Fstatutes%2F32%2Ftitle32ch117sec0.html&data=05%7C02%7C%7C26e7eb5541c14bce6b0108deb048a72b%7Ce95f1b23abaf45ee821db7ab251ab3bf%7C0%7C0%7C639142023287884519%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=rQsjH7hcw4u2uWZ1MlJ6FfefngcMB7HRa%2B2mYxZ29Jw%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.mainelegislature.org%2Flegis%2Fstatutes%2F32%2Ftitle32ch117sec0.html&data=05%7C02%7C%7C26e7eb5541c14bce6b0108deb048a72b%7Ce95f1b23abaf45ee821db7ab251ab3bf%7C0%7C0%7C639142023287884519%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=rQsjH7hcw4u2uWZ1MlJ6FfefngcMB7HRa%2B2mYxZ29Jw%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.maine.gov%2Fpfr%2Fprofessionallicensing%2Fprofessions%2Fboard-pharmacy%2Flicensing%2Festablishments%235&data=05%7C02%7C%7C26e7eb5541c14bce6b0108deb048a72b%7Ce95f1b23abaf45ee821db7ab251ab3bf%7C0%7C0%7C639142023287907520%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=0Y0EPCOEzf823vBrBtqLhBjvlekhsU3Ad7TE2h680sY%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.maine.gov%2Fpfr%2Fprofessionallicensing%2Fprofessions%2Fboard-pharmacy%2Flicensing%2Festablishments%235&data=05%7C02%7C%7C26e7eb5541c14bce6b0108deb048a72b%7Ce95f1b23abaf45ee821db7ab251ab3bf%7C0%7C0%7C639142023287907520%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=0Y0EPCOEzf823vBrBtqLhBjvlekhsU3Ad7TE2h680sY%3D&reserved=0

*** Since medical-grade oxygen is regulated as a prescription drug, both federal and

Maine law require that the license is held by the distributing entity at the time of service.

State law explicitly disallows delegation of that license requirement to a subcontractor—it must be held and signed for by the Prime Contractor (owner/officer level) when distributing within Maine.

Federal regulation (21 CFR Part 205) aligns by insisting that the licensed party engaging in wholesale distribution must be the one listed and authorized, further supporting the principle that licenses must be in the Prime Contractor name, not subcontracted. ALL LICENSES and

Certificates MUST be in Compliance

7515(1)_D_2019-09-2

7.pdf https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-205

22. AWARD ELIGIBILITY OF SDVOSB OFFEROR:

1. To ensure uninterrupted delivery of medical-grade gases to the HCS and to avoid post-award delays that could impact patient care, will the GOV revise the

Solicitation to require SDVOSB offerors to submit, with their proposal submission, evidence that they currently hold all applicable federal, state, and local licenses required for the distribution and delivery of medical-grade gases, including gases classified as prescription drugs, as a definitive responsibility criterion?

SEE ABOVE

2. Given that medical oxygen and other medical-grade gases are life-sustaining products regulated as prescription drugs, does the GOV intend to limit competition to offerors that are already legally authorized to distribute and deliver such products at the time proposals are submitted, in order to avoid delays in commencement of performance following award?

SEE ABOVE

3. Will the status of an offerors’ license (in this case, a registered pharmaceutical wholesaler in the state of Maine) be evaluated as a definitive responsibility criterion during the consideration of offers?

SEE ABOVE

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-205

4. How will the GOV evaluate a proposal submitted by an offeror that does not possess an active and applicable medical gas distribution license at the time of proposal submission but proposes to obtain or rely upon such licensure after award?

SEE ABOVE