Amendment 1 - RFQ IHS1453261.pdf

Amendment One (1) RFQ: IHS1453261 PPE

The combined synopsis/solicitation for commercial items, RFQ IHS1453261 PPE, is amended to:

A. Respond to the questions submitted during the question time period.

B. Update the description of CLINS 1, 2 and 3 in Section C of the Solicitation.

C. Extend the due date for quotes and samples.

A. Response to questions:

1. I have a question about IHS1453261 PPE samples. Does the NSSC need 2 samples of each size of item requested? Example: 2 each Medium, Large, Xl, and XXL hazmat suit?

For the hazmat suit, you only need to provide two samples of any size. For the other CLINS, two samples are required for each size.

2. Can you please confirm if this is an all or none Indian set-aside solicitation?

Per the Buy Indian Act, this is a 100% ISBEE set-aside. Any requirements that cannot be met by an ISBEE vendor will be re-evaluated and could be put out in a new solicitation.

3. We are requesting clarification on the MTR's and description for CLIN 3. Just looking to confirm the requirement (both FYA and FYC are class 2 devices as listed with the FDA).

The CLIN 3 description has been updated to reflect OEA and Class I as the product code and device listing. Please see section B below for details.

4. Can we submit a bid for some of the items not all of them?

Vendors are encouraged to quote on any or all CLINs in the amounts they are able to provide.

5. Can we supply the requested items with multiple brand names?

To maintain consistency and assure quality control, only one manufacturer for a single CLIN will be accepted. In order to meet the quantities, a CLIN cannot be broken into various quantities by different vendors.

6. Does the product need to be made in USA?

All products must meet the minimum technical and Buy American requirements.

7. Can you please confirm if we have to submit a response for all line items? (Clin’s 1 through 9).

See answer to Question #4.

8. Does the solicitation require that the Prime be registered with the FDA or is it sufficient that the manufacturer and their products be registered on the FDA site?

The products need to be FDA registered.

9. Does the packaging have to be exactly as specified in the RFQ? i.e. 10 gowns per pack. Our packaging might be 20 gowns per pack for example. Would this be acceptable as long as we meet the total requirement?

The government will consider alternative package quantities.

10. REGARDING: 52.225-1 Buy American-Supplies (Nov 2021): CLINS (1) through (3) specifically say

“made in the USA”. On the other CLINS, are there exceptions (such as insufficient availability, prohibitive cost, etc.), such that imported products are being considered?

See answer to Question #6.

11. Must all CLINs be offered for the response to be satisfactory?

12. Excel Quote Schedule Question: On CLINs (1) through (7) does “Price per Unit” (Column N) equal Price per Case -OR- Price per each?

Case price is preferred, but you can do it either way as long as you specify which way you do it.

13. Excel Quote Schedule Question: It appears offeror can use columns L and M if the Package and/or Case quantity is other than defined in the specifications. Please confirm or clarify.

Yes, those would be the appropriate columns.

14. Is it possible IHS will make an award on a particular CLIN for a quantity less than the quantity requested/offered?

15. In addition to the quote schedule for the full quantity, can offeror submit volume-based, tiered pricing?

Yes, all pricing information must be included in your quote.

16. Is there a minimum quantity IHS will award per CLIN?

17. Do you need (2) samples of each size of item or just (2) samples per CLIN?

See answer to Question #1.

18. On the yellow hazmat suit: Will colors other than yellow be considered?

Yes, the government will accept alternative colors.

19. On the yellow hazmat suit: Will styles with attached booties/foot covers be considered?

Yes, the government will consider styles with attached booties/foot covers.

20. Can the pulse oximeters be medical (prescription) oximeters or must they be over the counter (no-script)?

The government will only accept OTC pulse oximeters.

21. Will Indian Health consider non-USA made, however TAA compliant commodities if US made are not available in the quantities/delivery time specified on the bid?

22. Will non-TAA or US products be considered?

23. Will Indian Health consider a teaming arrangement for this opportunity with a large business distributor?

IHS is required to comply with the Buy Indian Act and first fill requirements with ISBEE vendors. Opportunities outside of this set-aside will be evaluated if necessary.

24. Is there any flexibility on packaging?

See the answer to Question #9.

25. Do all gowns need to be Sterile which would mean they need to be individually wrapped as well?

No, that is not necessary.

26. For CLIN 3, Will the government clarify CLIN 3 MTRs with respect to sterility (MTR 8), FDA product code (MTR 10), and acceptable packaging?

See answer to Question #3.

27. Will a valid premarket notification (510K) be required for CLIN 3, surgical gowns?

28. Will you clarify if IHS will require that the 510K owner be a U.S. based company?

29. Is IHS accepting products manufactured by U.S. agents using Chinese intellectual property?

30. If IHS allows foreign, Chinese- and Cambodian-owned specification developers/510K owners to offer surgical gowns on this solicitation through their agents, does IHS recognize that, according to the FDA, the safety/efficacy of the surgical gown is the legal responsibility of the Chinese- and Cambodian-owned specification developer and not their U.S. agent (contract manufacturer/distributor)? How would the government enforce liability, including for potential recalls, on the Chinese and Cambodian 510K owners?

31. Will IHS require offerors to disclose the 510K under which the surgical gowns are manufactured, along with the owner of the 510K, FDA listed specification developer and OEM of the gown (including company name, FDA registration number and registration country)?

32. Is it the intent of this IHS procurement to allow products with 510K owners, specification developers and

OEMs based in China and Cambodia to enter its stockpile via their agents at the expense of U.S. OEMs?

33. Will you please clarify if IHS will only accept products from domestic specification developers that own their own premarket notification (510K) for product code FYA?

34. Will IHS accept product contract manufactured under 510K#s K120192, K111067, K102652, and

K102692 for which there is no listed specification developer?

35. Will IHS require offerors to disclose any 510K licensing agreements between the contract manufacturer

(if applicable) and the 510K owner of the surgical gown being offered to be subject to the False Claims

Act?

36. As long as the 17025 accredited lab testing reports shows it meeting the required ANSI/AAMI PB70 level and all other MTRs, would IHS accept a non-Raglan Sleeve gown?

No, the government will not accept a non-Raglan Sleeve gown.

37. Just to confirm that IHS would like an elastic wrist on the surgical level 3 gown not a knit/tubular cuff?

The government will accept knitted cuffs or elastic cuffs on CLIN 1, 2, and 3.

38. We believe it is likely that product code FYC is the closest match to your Isolation gown requirements but again the solicitation states both FDA product codes OEA and FYA for CLIN 3 which are directly conflicting. Can you please clarify?

39. How will proposals be evaluated? Are they based on Best Price or FAR 52.212-2?

Evaluation information is located on page 40 of the solicitation.

40. Are we required to submit a proposal to supply all CLINS within the solicitation?

41. Is the Prime contractor required to have FDA registration or is it sufficient for the supplier / sub-contractor / manufacturer to be FDA registered?

See answer to Question #8.

42. Is the Prime contractor required to be a manufacturer of any of the CLIN #’s or can the Prime just be an authorized reseller?

It is not required that the prime contractor be a manufacturer.

43. Are CLINS # 1-9 required to be Berry Amendment compliant?

44. Is a 510k required for CLIN # 3?

45. Is the Hazmat suit regulated by the FDA? If so, what is the FDA product code for Device Listing?

No, the hazmat suit is not regulated by the FDA.

46. What PDM’s are required for CLIN #s 8 and 9?

One sample for CLIN 8 and CLIN 9 is required.

47. When evaluating offerors, will the government take into account the past performance of companies that have successfully performed with HHS on previous requirements of a similar nature?

See answer to Question #39.

48. Is the method of evaluation "Best Value" or "LPTA"?

49. Would IHS consider awarding a TAA version of the Hazmat suit?

50. Would the government consider modifying the RFP to allow for TAA-compliant products?

51. Will the government permit multiple products to be submitted, such that the government will have options to choose from that best fit their requirement's needs?

Yes, vendors may submit multiple products.

52. Will the government please confirm that the Surgical Isolation Gown (Product Code FYA) is not expected to be sterilized?

53. Will the government consider TAA-compliant thermometers?

54. Will the government please confirm that additional time can be provided for delivery if there are unforeseen delays in order to ensure quality products are being delivered to IHS?

See page 8 of the solicitation.

55. Will the government please confirm that the isolation gowns and surgical isolation gowns are to be newly manufactured, meaning from time of manufacture to time of delivery must be within 30 days?

The gowns do not need to be newly manufactured provided they meet all technical requirements.

56. Will the government please confirm that the requirement for this RFP is that the raw material must be sourced from the United States and the labor must be performed within the United States?

57. To clarify and confirm, the price we need to submit to the government is the delivered price?

Yes, submit the delivered price.

58. Will IHS prioritize awards to offerors who demonstrate scalability and quality assurance through technological innovations that can be broadly adopted to support the US manufacturing base?

59. Will the government consider making multiple awards?

Yes, see page 39 of the solicitation.

60. Will the government confirm that they intend to prioritize manufacturers who show lab testing from US-based labs with ISO 17025 certification and/or ANAB Accreditation?

To evaluate gowns, the government will use the AAMI level rating, FDA registration data, and physical inspection of the technical aspects of the submitted samples.

61. Does the contract officer expect to make awards to multiple small businesses?

See answer to Question #59.

62. Will the government please confirm that lab testing from outside the United States is not acceptable for submission? All lab testing must be from US-based labs with ISO 17025 accreditation and/or ANAB accreditation?

See answer to Question #60.

63. How soon after delivery will the government pay offerors?

Government payment terms is 30 days after receipt of approved product and/or valid invoice, whichever is latest.

64. Who specifically (government rep or contractor) will be conducting item inspections at the delivery location?

Inspection will be conducted by an approved NSSC designee.

65. Does the price penalty of 50% apply when evaluating BAA versus TAA compliant products on this procurement?

66. Would the government consider forehead rolling thermometers that are made in America?

No, the government will not consider forehead rolling thermometers.

67. Considering the microchip production delay for made in USA chips, will the government consider extending the delivery timeline for pulse oximeters and thermometers?

See answer to Question #54.

68. How does IHS intend on performing the technical evaluation of the gowns?

See answer to Question #62.

69. Do offerors need to submit spec sheets & 17025 accredited lab testing on the final gowns showing it meeting the required ANSI/AAMI PB70 level performance and ASTM F3352-19 for Isolation Gowns standard (as applicable)?

Vendors are encouraged to provide as much information as possible in their quotes.

70. Will there be a technical evaluation of documentation to prove that the gown components are 100% USA-

Made and gowns domestically manufactured?

See answer to Question #62.

71. Does IHS give preference to shoe covers equivalent to Halyard Health product 69254 that are 100% USA-made in line with the Buy American and Infrastructure & Jobs Act?

72. Does IHS require reports on adverse skin reactions from the Level 2 gowns?

No, that is not required.

73. Does IHS require offerors to make a shelf life claim as well for CLIN 1-3 and provide supporting documentation?

No, that is not required.

74. Do you need any specific documentation for proof for product code and USA made? Will a breakout of components and their country of origin suffice?

See answers to Questions #6 and #39.

75. Do you want the shipping cost included in the price per unit or as a separate line?

Product must be shipped FOB Destination.

76. Do you want photos of the product, the outside box, and inside soft packs? Or just photos of the product and outside boxes?

Yes, the government wants photos of the product, of all sides of the box and inside of the soft packs.

77. CLINs 1 and 2. You state gowns must tie at the neck. Is a tape or hook and loop closure acceptable for the gowns?

No, tape or hook and loop closures are not acceptable.

78. CLINs 3. Is a knitted elastic cuff acceptable?

See answer to Question #37.

79. CLIN 4-9 do not state they must be made in America. Is that a requirement for those items?

80. CLIN 1-CLIN 3: Would IHS accept an over-the-head gown for the RFQ?

No, the government will not accept an over-the-head gown.

81. It states that "Product must accurately measure human body temperatures to within 0.1 degree

Celsius." Is IHS referring to the reading unit of 0.1 degree Celsius or the measuring accuracy?

The government is referring to the measuring accuracy.

82. Do the thermometers and pulse oximeters need to be made in the USA?

83. On the packaging pictures, does IHS require electronic images of all sides of the packaging for each item?

See answer to Question #76.

84. CLIN 1 – CLIN 3: What is considered Light, Medium & Heavy Fabric on the gowns?

Please refer to industry standards for Light, Medium and Heavy gowns.

85. For CLIN 1 & CLIN 2: On MTR 5 for the Isolation gown the material requirement is stated as

(Spunbond/Meltblown/Spunbond)/Polyester film/SMS. Is polyethylene Isolation Gown eligible for this requirement or SMS only?

Polyethylene is not eligible. SMS only.

86. For CLIN 3: Can the requirement include Surgical Gowns made in other countries with 510(k) clearance?

B. Corrections & Updates to the Solicitation:

The following corrections are made to the Solicitation:

CLIN 1 Description is changed from:

CLIN 1. Disposable AAMI Level I Isolation Gown

Gown Minimum Technical Requirements (MTR) are listed in the table below. Coverage should fully cover the front torso, arms, and back with tie in the back. Product must be listed in FDA Establishment Registration & Device Listing database as Class 1 with

Product Code OEA made in the United States of America – Current Registration Year in

FDA Establishment Registration & Device Listing database must be either 2021 or 2022.

Quantity: 1,275,000 Each Regular size and 225,000 Each XL size. Product must be packaged in packages of 10 each and cases of 100 each (10 packages of 10 each per case).

Isolation Gown Level 1

TECHNICAL SPECIFICATIONS METHOD OF EVALUATION

MTR 1

AAMI Level 1 Liquid Barrier Protection (Minimal fluid and microbial barrier) Literature Review

MTR 2 Sizes: Regular/Large and XL Literature Review

MTR 3 Raglan Sleeves, Elastic Wrist, No Thumb Holes Literature Review

MTR 4 Weight: Light fabric Literature Review

MTR 5

Material (Spunbond/Meltblown/

Spunbond)/Polyester film/SMS Literature Review

MTR 6

Fully cover the front torso and arms and should tie in the back Literature Review

MTR 7 Disposable/Single use Literature Review

MTR 8 Non-sterile Literature Review

MTR 9 Closure - Neck Ties Literature Review

MTR 10 FDA approved – Device Product Code OEA Literature Review

MTR 11 No Hood Literature Review

MTR 12 Non-flammable Literature Review

MTR 13

Performance Requirements at 4% AQL: AATCC 42

Water Impact ≤ 4.5 g Literature Review

MTR 14

Intended Use: Minimal risk, to be used, for example, during basic care, standard isolation, cover gown for visitors, or in a standard medical unit

To:

CLIN 1. Disposable AAMI Level I Isolation Gown should fully cover the front torso, arms, and back with tie in the back. Product must be listed in FDA Establishment Registration & Device Listing database as Class 1 with

Product Code OEA made in the United States of America – Current Registration Year in

FDA Establishment Registration & Device Listing database must be either 2021 or 2022.

Quantity: 1,275,000 Each Regular size and 225,000 Each XL size. Product must be packaged in packages of 10 each and cases of 100 each (10 packages of 10 each per case).

Isolation Gown Level 1

TECHNICAL SPECIFICATIONS METHOD OF EVALUATION

MTR 1

AAMI Level 1 Liquid Barrier Protection (Minimal fluid and microbial barrier) Literature Review

MTR 2 Sizes: Regular/Large and XL Sample Review

MTR 3 Raglan Sleeves, Elastic Wrist, No Thumb Holes Sample Review

MTR 4 Weight: Light fabric Sample Review

MTR 5

Material (Spunbond/Meltblown/

Spunbond)/Polyester film/SMS Literature Review

MTR 6

Fully cover the front torso and arms and should tie in the back Sample Review

MTR 7 Disposable/Single use Literature Review

MTR 8 Non-sterile Literature Review

MTR 9 Closure - Neck Ties Sample Review

MTR 10 FDA approved – Device Product Code OEA Literature Review

MTR 11 No Hood Sample Review

MTR 12 Non-flammable Literature Review

MTR 13

Performance Requirements at 4% AQL: AATCC 42

Water Impact ≤ 4.5 g

Intended Use: Minimal risk, to be used, for example, during basic care, standard isolation, cover gown for visitors, or in a standard medical unit

CLIN 2 Description is changed from:

CLIN 2. Disposable ASTM Level 2 Isolation Gown should fully cover the front torso, arms, and back with tie in the back. Product must be listed in FDA Establishment Registration & Device Listing database as Class 1 with

Product Code OEA made in the United States of America – Current Registration Year in

FDA Establishment Registration & Device Listing database must be either 2021 or 2022.

Quantity: 1,275,000 Each Regular size and 225,000 Each XL size. Product must be packaged in packages of 10 each and cases of 100 each (10 packages of 10 each per case).

Isolation Gown Level 2

TECHNICAL SPECIFICATIONS METHOD OF EVALUATION

MTR 1

AAMI Level 2 Liquid Barrier Protection (Minimal to low fluid and microbial barrier)

Literature Review

MTR 2 Sizes: Regular/Large and XL Literature Review

MTR 3 Raglan Sleeves, Elastic Wrist, No Thumb Holes Literature Review

MTR 4 Weight: Medium fabric Literature Review

MTR 5

Material (Spunbond/Meltblown/Spunbond)/Polyester film/SMS

Literature Review

MTR 6 Fully cover the front torso and arms and should tie in the back Literature Review

MTR 7 Disposable/Single use Literature Review

MTR 8 Non-sterile Literature Review

MTR 9 Closure - Neck Ties Literature Review

MTR 10 FDA approved – Device Product Code OEA Literature Review

MTR 11 No Hood Literature Review

MTR 12 Non-flammable Literature Review

MTR 13

Performance Requirements at 4% AQL: AATCC 42 Spray Impact

≤ 1.0 g, AATCC 127 Hydrostatic Pressure ≥ 20 cm

Intended Use: Minimal to low fluid and microbial barrier for use only for low-fluid, minimally invasive surgical procedures;

Simple orthopedic procedures during which tourniquets are used; Open hernia repair; Minimally Invasive Surgery (MIS);

Interventional radiology or catheter laboratory procedures.

CLIN 2. Disposable ASTM Level 2 Isolation Gown should fully cover the front torso, arms, and back with tie in the back. Product must be listed in FDA Establishment Registration & Device Listing database as Class 1 with

Product Code OEA made in the United States of America – Current Registration Year in

FDA Establishment Registration & Device Listing database must be either 2021 or 2022.

Quantity: 1,275,000 Each Regular size and 225,000 Each XL size. Product must be packaged in packages of 10 each and cases of 100 each (10 packages of 10 each per case).

Isolation Gown Level 2

TECHNICAL SPECIFICATIONS METHOD OF EVALUATION

MTR 1

AAMI Level 2 Liquid Barrier Protection (Minimal to low fluid and microbial barrier) Literature Review

MTR 2 Sizes: Regular/Large and XL Sample Review

MTR 3 Raglan Sleeves, Elastic Wrist, No Thumb Holes Sample Review

MTR 4 Weight: Medium fabric Sample Review

MTR 5

Material (Spunbond/Meltblown/Spunbond)/Polyester film/SMS Literature Review

MTR 6 Fully cover the front torso and arms and should tie in the back Sample Review

MTR 7 Disposable/Single use Literature Review

MTR 8 Non-sterile Literature Review

MTR 9 Closure - Neck Ties Sample Review

MTR 10 FDA approved – Device Product Code OEA Literature Review

MTR 11 No Hood Sample Review

MTR 12 Non-flammable Literature Review

MTR 13

Performance Requirements at 4% AQL: AATCC 42 Spray Impact

≤ 1.0 g, AATCC 127 Hydrostatic Pressure ≥ 20 cm Literature Review

MTR 14

Intended Use: Minimal to low fluid and microbial barrier for use only for low-fluid, minimally invasive surgical procedures;

Simple orthopedic procedures during which tourniquets are used; Open hernia repair; Minimally Invasive Surgery (MIS);

Interventional radiology or catheter laboratory procedures.

CLIN 3 Description is changed from:

CLIN 3. Disposable AAMI Level 3 Surgical Isolation Gown should fully cover the front torso, arms with a tie in the back. Product must be listed in

FDA Establishment Registration & Device Listing database as Class 2 with Product Code

FYA made in the United States of America – Current Registration Year in FDA

Establishment Registration & Device Listing database must be either 2021 or 2022.

Quantity: 1,275,000 Each Regular Size and 225,000 Each XL size. Product must be packaged in packages of 10 each and cases of 100 each (10 packages of 10 each per case).

Isolation Gown Level 3

TECHNICAL SPECIFICATIONS METHOD OF EVALUATION

MTR 1

AAMI Level 3 Liquid Barrier Protection (Moderate fluid and microbial barrier) Literature Review

MTR 2 Sizes: Regular/Large and XL Literature Review

MTR 3 Raglan Sleeves, Elastic Wrist, No Thumb Holes Literature Review

MTR 4 Weight: Heavy fabric Literature Review

MTR 5

Material (Spunbond/Meltblown/Spunbond)/Polyester film/SMS Literature Review

MTR 6 Fully cover the front torso and arms and should tie in the back Literature Review

MTR 7 Disposable/Single use Literature Review

MTR 8 Non-sterile Literature Review

MTR 9 Closure - Neck Ties Literature Review

MTR 10 FDA approved – Device Product Code OEA Literature Review

MTR 11 No Hood Literature Review

MTR 13

Performance Requirements at 4% AQL: AATCC 42 Spray Impact

≤ 1.0 g, AATCC 127 Hydrostatic Pressure ≥ 50 cm Literature Review

MTR 14

Intended Use: The widest range of surgical procedures, where moderate fluid protection is indicated; Mastectomies;

Arthroscopic orthopedic procedures; Endoscopic urological procedures, Transurethral Prostate Resections (TURP), Open gastrointestinal and genitourinary procedures.

CLIN 3. Disposable AAMI Level 3 Surgical Isolation Gown should fully cover the front torso, arms with a tie in the back. Product must be listed in

FDA Establishment Registration & Device Listing database as Class 1 with Product Code

OEA made in the United States of America – Current Registration Year in FDA

Establishment Registration & Device Listing database must be either 2021 or 2022.

Quantity: 1,275,000 Each Regular Size and 225,000 Each XL size. Product must be packaged in packages of 10 each and cases of 100 each (10 packages of 10 each per case).

Isolation Gown Level 3

TECHNICAL SPECIFICATIONS METHOD OF EVALUATION

MTR 1

AAMI Level 3 Liquid Barrier Protection (Moderate fluid and microbial barrier) Literature Review

MTR 2 Sizes: Regular/Large and XL Sample Review

MTR 3 Raglan Sleeves, Elastic Wrist, No Thumb Holes Sample Review

MTR 4 Weight: Heavy fabric Sample Review

MTR 5

Material (Spunbond/Meltblown/Spunbond)/Polyester film/SMS Literature Review

MTR 6 Fully cover the front torso and arms and should tie in the back Sample Review

MTR 7 Disposable/Single use Literature Review

MTR 8 Non-sterile Literature Review

MTR 9 Closure - Neck Ties Sample Review

MTR 10 FDA approved – Device Product Code OEA Literature Review

MTR 11 No Hood Sample Review

MTR 13

Performance Requirements at 4% AQL: AATCC 42 Spray Impact

≤ 1.0 g, AATCC 127 Hydrostatic Pressure ≥ 50 cm Literature Review

MTR 14

Intended Use: The widest range of surgical procedures, where moderate fluid protection is indicated

C. Closing date:

New closing date will be NLT 4 pm CST September 7, 2022. Additionally, all samples must be received by

September 7, 2022.