First Amended Bid Protest Complaint

Date: 2024-06-12

Full text

IN THE UNITED STATES COURT OF FEDERAL CLAIMS
BID PROTEST
AIRBOSS DEFENSE GROUP, LLC,
Plaintiff,
and
STRING KING LACROSSE LLC,
Plaintiff-Intervenor,
v.
THE UNITED STATES,
Defendant.
Case No. 24-365
Judge Charles F. Lettow

FIRST AMENDED BID PROTEST COMPLAINT
Plaintiff-Intervenor String King Lacrosse LLC (“StringKing” or “Plaintiff-Intervenor”), by
and through undersigned counsel, submits this amended bid protest Complaint against the United
States of America, acting through the U.S. Department of Health and Human Services,
Administration for Strategic Preparedness and Response (“HHS” or the “Agency”). StringKing
seeks permanent declaratory and injunctive relief to remedy the Agency’s arbitrary and capricious
issuance of Amendments 0008 and 0009, which unlawfully modified Request for Proposals No.
75A50322R00008 (the “RPF” or the “Solicitation”). StringKing alleges as follows:
SUMMARY OF THE CASE
1.
The Agency’s actions in issuing Amendments 0008 and 0009 have materially
changed the procurement and reflect that the Agency is attempting to unlawfully utilize the current
procurement to solicit what is, at bottom, a new requirement. These unlawful changes reflect
nothing more than a Hail Mary attempt by the Agency to redirect award to the Agency’s preferred
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vendor (and current awardee) New York Embroidery Studio, Inc. (“NYES”). It appears to be a
blatant attempt by the Agency to rewrite the Solicitation’s requirements in a manner that favors
NYES by emphasizing NYES’s strengths
in comparison to
StringKing’s product, which has
. Notably, the
record is devoid of any rational explanation to support the Agency’s arbitrary and capricious
actions.
2.
Amendment 0008 and Amendment 0009 come on the heels of StringKing’s
Government Accountability Office (“GAO”) protest in October 2023 (and the Agency’s
subsequent corrective action) and an agency-level protest in November 2023.
3.
StringKing challenged the Agency’s issuance of Amendment 0008 in a pre-award
protest before GAO in February 2024. The Agency took corrective action for a second time and
appears again to attempt to redirect the award to NYES. In taking corrective action in response to
StringKing’s February 2024 protest, the Agency first issued a notice of corrective action on March
26, 2024, that stated (among other things) an intent to terminate award to NYES and cancel the
procurement overall. Less than two weeks later, on April 9, 2024, the Agency issued a revised
notice of corrective action that reflected an inherently different planned course of action, including
not cancelling the award to NYES and not cancelling the procurement.
4.
On May 31, 2024, the Agency issued Amendment 0009 during pendency of this
bid protest action before the Court as a supposed corrective action that purported to, among other
things, add a three-year shelf-life in the procurement as an evaluation factor under Factor 2
(Technical Capability). As will be demonstrated below, the actual result of this change is a de
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facto elimination of shelf-life as an evaluation factor as well as the competitive elimination of any
offeror with a longer shelf life,
given the material changes in the Solicitation.1
5.
It is unclear what the Agency actually plans to do with this procurement and its
conduct and the record before the Court reflects internal agency disagreement and unsupported
arbitrary decisions. The Agency now apparently seeks a completely new requirement and is
unlawfully attempting to utilize the current procurement instead of properly cancelling the
procurement given its material changes to the Solicitation’s purpose and elimination of shelf life
and life cycle costs from the evaluation criteria overall.
6.
Regardless, offerors—including StringKing—have expended and invested
enormous resources to develop a product in response to the Solicitation’s stated requirements as
initially solicited for the purpose of awarding multiple awards to create a national stockpile of
disposable medical gowns for future national emergencies. The Solicitation, as originally issued,
included evaluation criteria that prioritized an offeror’s ability to provide the Agency a product
with long shelf life as part of the best value evaluation criteria. The Agency’s Amendments 0008
and 0009 show that the Agency now seeks to instead simply procure “disposable medical Isolation
Gowns used in healthcare settings” rather than “attempting to increase the availability of
domestically produced compliant PPE . . . to ensure sufficient domestic availability of such items
during national emergencies and/or pandemic events.” (Compare AR 277 (Amend. 0005) with
Exhibit A (Amend. 0009) at 11.)

1 The Agency subsequently issued Amendment 0010 clarifying that this procurement is not
partially being set-aside for small businesses after errantly checking a box indicating that it
would be. StringKing is not protesting Amendment 0010.
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7.
Specifically, Amendments 0008 and 0009: (a) materially change the stated purpose
of the Solicitation; (b) materially change the shelf life evaluation requirements under Factor 2
(Technical Capability); (c) remove shelf life from the evaluation criteria for Factor 4 (Price); and
(d) remove shelf life from the evaluation criteria for the best value determination for the
procurement. Further, the Agency’s actions reflect disparate treatment, have unduly restricted
competition in this procurement, and have unlawfully converted this from a best value
procurement to a lowest price technically acceptable (“LPTA”) procurement.
8.
The Agency cannot arbitrarily and capriciously at this late hour change the
evaluation criteria and/or Solicitation requirements in such a fundamental, material way to the
prejudice of StringKing and other offerors with longer shelf life.
9.
StringKing, accordingly, requests that the Court, inter alia: (1) declare (a) HHS’s
issuance of Amendments 0008 and 0009 to be arbitrary and capricious, an abuse of its discretion,
and contrary to law, or (b) alternatively declare HHS’s issuance of Amendment 0008 and
Amendment 0009 to reflect material changes to the Solicitation’s requirements that mandates
cancellation of the procurement overall; (2) permanently enjoin HHS from removing shelf life and
life cycle costs from the Solicitation’s evaluation criteria because shelf life is fundamental to the
evaluation of products that will be kept for a period of time in a national stockpile; (3) permanently
enjoin HHS from proceeding with the award of NYES without first evaluating StringKing’s
proposal in a manner consistent with the Solicitation and applicable law; (4) direct the Agency to
re-evaluate proposals in accordance with the terms of the Solicitation evaluation criteria to include
consideration of shelf life as originally contemplated; and (5) grant StringKing such other relief as
the Court may deem just and proper including its attorneys’ fees and costs.
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PARTIES
10.
Plaintiff-Intervenor, StringKing, is a U.S. company based in California that
qualifies as a small business under the Solicitation’s applicable North American Industry
Classification System (“NAICS”) Code No. 339113. StringKing is an experienced, well-
performing supplier of personal protective equipment (“PPE”) to the federal government, such as
the disposable medical isolation gowns being solicited in the procurement at issue.
11.
Defendant is the United States of America, acting through HHS.
JURISDICTION &VENUE
12.
The Court has jurisdiction over this bid protest under the Tucker Act, 28 U.S.C. §
1491(b).
13.
Venue is appropriate in this Court pursuant to 28 U.S.C. § 1491(b).
STANDING
14.
StringKing is an interested party and has standing in this matter as “an actual or
prospective bidder or offeror whose direct economic interest would be affected by the award of
the contract or by failure to award the contract.” Myers Investigative and Sec. Servs., Inc. v. United
States, 275 F.3d 1366, 1370 (Fed. Cir. 2002) (citations omitted). StringKing timely submitted its
proposal in response to the Solicitation and the Agency determined

. StringKing also
submitted a revised proposal

. Finally, StringKing intends to file a revised proposal in response
to Amendment 0009.
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15.
The Agency’s actions have prejudiced StringKing and but for the Agency’s errors,
StringKing has a substantial chance to receive award of a contract resulting from the Solicitation.
See Banknote Corp. of Am. v. United States, 365 F.3d 1345, 1352 (Fed. Cir. 2004) (finding that an
“interested party” is “an actual or prospective bidder or offeror whose direct economic interest
would be affected by the award of the contract or by failure to award the contract”).
STATEMENT OF FACTS
A.
The Solicitation
16.
On June 28, 2022, the Agency issued the RFP for “ANSI [American National
Standards Institute]/AAMI [Association for the Advancement of Medical Instrumentation] Level
2 Disposable Isolation Gowns Manufactured in the U.S. or its Outlying Areas.” (AR 277.) The
Solicitation provided that the products procured would be utilized in the Strategic National
Stockpile (“SNS”), which is managed by HHS, and is a national repository of pharmaceuticals,
vaccines, medical supplies, and medical equipment stored in strategic locations around the United
States. (Id.)
17.
The Agency issued the Solicitation as a best value acquisition for the stated purpose
of creating a stockpile of disposable medical isolation gowns to be used in healthcare settings in
preparation for future national emergencies, including pandemic events. Specifically, the
Solicitation stated its purpose as follows:
The U.S. Government is interested in establishing multiple awards
for the purchase of domestically manufactured ANSI/AAMI PB70
Level 2 disposable medical Isolation Gowns used in healthcare
settings. In establishing multiple awards for such medical isolation
gowns, the Government is attempting to increase the availability
of domestically produced compliant PPE. This will enable the
United States to ensure sufficient domestic availability of such
items during national emergencies and/or pandemic events.
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(AR 277.2) Inherent in the Agency’s procurement of these disposable medical isolation gowns is
evaluation of the products’ shelf-life and consideration of related life cycle costs given the stated
intent and purpose of the procurement is to stockpile the gowns in preparation for future national
emergencies.
18.
The Agency conducted the best value procurement in accordance with Federal
Acquisition Regulation (“FAR”) 12.602 in conjunction with FAR Part 15 procedures. (AR 318.)
The RFP informed offerors that the Agency intended to establish multiple awards “to increase the
availability of domestically produced compliant PPE” to “enable the United States to ensure
sufficient domestic availability of such items during national emergencies and/or pandemic
events.” (AR 277; see also AR 270 (providing the Agency intended “award of more than one firm
fixed price contract resulting from this solicitation”); AR 318, § M.2 (Notice of Intent to . . . Make
Multiple Awards); AR 306, § L.3 (“The Government intends to award multiple contracts.”).) The
RFP provided that the Agency contemplated that each award would have a 24-month base period
of performance with one additional 12-month option period. (AR 270, 306.)
1.
Proposal Instructions
19.
The Solicitation provided the Agency will evaluate offerors’ proposals based on
four factors and eight subfactors:
Factor 1: Technically [sic] Compliance Go/No-Go
Factor 2: Technical Capability
Subfactor 1: Manufacturer/Producer

2 There are ten amendments to the Solicitation, which are briefly summarized infra. Amendments
0001 to 0007 were issued by the Agency prior to receipt of initial proposals. Amendment 5, issued
October 31, 2022, amended the RFP “in its entirety.” (AR 269.) All references to the RFP are to
Amendment 5, unless stated otherwise.
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Subfactor 2: Production Schedule/Manufacturing Capability
Subfactor 3: Labeling and Packaging
Subfactor 4: Natural Rubber Latex
Subfactor 5: Catalog and Literature
Subfactor 6: Shelf Life
Subfactor 7: Test Reports
Subfactor 7 [sic]: Biocompatibility Report Plan
Factor 3: Similar Experience
Factor 4: Price Evaluation
(AR 313 (emphasis in original.)
20.
The Solicitation required offerors to “provide documentation that support[ed]” the
requirements for each subfactor. (AR 308.)
2.
Evaluation and Award Criteria
21.
The Solicitation, as originally issued, advised offerors that in conducting the best
value procurement:
The Government will award a contract resulting from this
solicitation to the responsible offeror whose offer demonstrates that
it can meet the mandatory criteria and will be most advantageous to
the Government considering both price and the other evaluation
factors. The Government may award any resulting contract to other
than the lowest priced offerors, or other than the offeror with the
highest non-price rating. Price is the least important of the four (4)
evaluation factors with Factor 1-[3] [sic] being significantly more
important than price. However, as proposals become more equal in
their non-price factors, the price factor will become more important.
(AR 313 (emphasis added).)
a.
Factor 2: Technical Capability
22.
Under Factor 2 (Technical Capability), the Government was required to “evaluate
whether an offeror’s proposal demonstrates its understanding of the isolation gowns requirement
and the objectives set forth in Section C of this Solicitation.” (Id.)
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23.
In conducting its evaluation, the Solicitation required the Agency to utilize the
following adjectival ratings in assessing a subfactor rating for each offeror under Factor 2:
(AR 314.)
24.
Under Factor 2 (Technical Capability), the Solicitation required the Agency to
evaluate proposals under Subfactors 6 and 7 as follows:
Factor 2, Subfactor
Solicitation Evaluation Requirements
Subfactor 6:
Shelf Life
“If the Offeror is making a shelf-life claim (a statement in the proposal, on the technical
specification sheet, an expiration date listed on the isolation gown packaging, etc.) then
the product, when delivered to the SNS, shall have no more than 20% of total shelf-life
expended. Offerors will be evaluated based on providing the appropriate data and
documentation, such as accelerated aging and real-time testing reports and other
validating documentation, to support their shelf-life claims.” (AR 331.)

“Offerors will be evaluated based on providing a statement verifying that the Isolation
Gowns will have no more than 20% of total shelf-life expended upon delivery to the SNS.
If the Offeror is not making a shelf-life claim (no statements made or expiration date
listed on the isolation gown packaging), the product, when delivered to the SNS, shall
have no more than 3 months expended since the date of manufacture, as listed on the
gown packaging. Offerors will be evaluated based on no shelf-life claims being made and
a statement provided verifying that at time of delivery to the SNS the Isolation Gowns
will have no more than 3 months expended since the date of manufacture.” (Id.)

Subfactor 7:
Test Reports
“Offerors’ proposals will be evaluated to determine whether their proposed products
have the appropriate test reports that meet the testing criteria, gowns sampling size,
and passing result requirements. Test reports must be in English and include a
description of the test device and components tested (including the manufacturer
part/model and lot numbers), sample preparation, test procedure and/or the standard
followed result values, averages, and appropriate sampling size to meet the specific
standard.” (AR 316 (emphasis added.))

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“Test reports shall include:
A. Barrier Protection (AATCC 42 and AATCC 127)
B. Flammability (CPSC Standard 16 CFR Part 1610)
C. Seam Strength (ASTMD1683/D1683M)
D. Tensile Strength (ASTMD5034)
E. Tear Strength (ASTM D5587 or D5733).” (Id.)
“Offerors’ proposals will be evaluated to determine whether the gowns were tested at an
independent ISO 17025 laboratory and documentation provided supporting the
laboratory’s ISO 17025 accreditation and illustrating that each test performed at the
laboratory is within their scope of accreditation.” (Id. (emphasis added).)

“Offerors’ proposals will be evaluated based upon their ability to comply with
ANSI/AAMI PB70 4% AQL.” (Id.)

(AR 316.)
b.
Factor 3: Similar Experience
25.
Under Factor 3 (Similar Experience), the Solicitation required the Agency to
evaluate whether offerors met the proposal instruction requirements. (AR 317 (stating the
“Government will evaluate . . . .” and then copying and pasting the Instructions to offerors for
Factor 3).)
c.
Factor 4: Price
26.
Under Factor 4 (Price), the Solicitation required the Government to “evaluate each
Offeror’s prices to determine that those prices are fair and reasonable and to determine which
Offerors’ proposals offer the best value to the agency.” (AR 317.) The Solicitation stated that
“[r]isk of excessive pricing is a major concern and Offerors are advised to pay special attention to
the instructions related to pricing” and advised offerors that the Agency reserved “the right to reject
any proposals that, in its opinion, does not offer fair and reasonable prices.” (Id.)
27.
The Solicitation also provided the Agency would “evaluate offers for award
purposes by adding the total price for all options to the total price for the basic requirement” and
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cautioned that the Agency may determine “determine that an offer is unacceptable if the option
prices are significantly unbalanced.” (Id.)
28.
As will be discussed further below, the Agency also stated it would consider the
cost of sustaining a product with “a lesser shelf-life.” (Id.)
29.
Finally, the Solicitation also required the Agency to utilize FAR 15.401-1 in
evaluating price and required the Agency to specifically evaluate whether offerors’ proposals had
“unbalanced pricing when performing the price evaluation.” (Id.)
d.
Best Value Evaluation
30.
The Solicitation specifically required the Agency to utilize, in its best value
determination, the cost of offerors’ products as it related to shelf-life of the product in two ways.
Specifically, the Solicitation provided that:
The Government’s overall best value determination will consider
the cost of the product as it relates to the shelf-life at time of delivery
and the best value determination will also consider the time, effort,
and cost to sustain product with lesser shelf-life.
(AR 317 (emphasis added).) That is, the Solicitation required the Agency to specifically evaluate
offerors’ price by analyzing (a) the cost of the product relating to shelf-life at the time of delivery;
and (b) the cost to sustain an offerors’ product that offered the Agency lesser shelf-life than
products offered by other offerors. (See id.)
31.
The Solicitation provided the Agency would make a best value award determination
and make award to the “best overall offer, based upon an integrated assessment of Technical
and Business Proposals.” (AR 318 (emphasis added).)
32.
The Solicitation required the Agency to award to offeror(s) who were deemed:
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[R]esponsible in accordance with the FAR, whose proposal
conforms to the solicitation’s requirements (to include all stated
terms, conditions, representations, certifications, and all other
information required by Section L of this solicitation); and is judged
by an overall assessment of the evaluation factors and sub factors
to be most advantageous to the Government. As part of making the
assessment, an analysis to determine whether or not exceeding the
minimum requirements at an associated price premium provides
the best value to the Government will be performed if necessary.
Technical
proposals
determined
to
be
“Technically
Unacceptable” will not be considered for award.
(Id. (emphasis added).)
3.
Amendments 0001 to 0007 to the Solicitation
33.
During the course of the procurement, the Agency issued eight amendments to the
Solicitation. The first seven amendments were issued prior to the receipt of initial proposals and
the eighth amendment was issued as a corrective action taken in response to StringKing’s GAO
protest in October 2023 (which are both discussed below). The first seven amendments are briefly
summarized below.
a.
Amendment 00001: extended the offer date of proposals to July 29, 2022.
(AR 171.)
b.
Amendment 00002: revised various terms of the Solicitation and issued a
set of Questions and Answers. (AR 172-242.)
c.
Amendment 00003: extended the offer due date to August 3, 2022, revised
various terms of the Solicitation and issued a revised set of Questions and Answers. (AR 243-265.)
d.
Amendment 00004: changed the due date of the Biocompatibility Report to
be due within 30 days of award and prior to first delivery. (AR 266-268.)
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e.
Amendment 00005: revised various terms of the Solicitation to ensure its
compliance with the Infrastructure Investment and Jobs Act (“IIJA”)/Make PPE In America. (AR
269-318.)
f.
Amendment 00006: extended the offer due date for proposals to November
22, 2022. (AR 319.)
g.
Finally, Amendment 00007 revised line items 2001, 2002, and 2003, and
notations B.2, B.2.1, B.5, B.5.A. (AR 320-340.) Notably, Amendment 00007 also updated the
Statement of Work as it related to Shelf-Life as follows:
If the Offeror is making a shelf-life claim (a statement in the
proposal, on the technical specification sheet, an expiration date
listed on the isolation gown packaging, etc.) then the product, at time
of delivery to the SNS, shall have no more than 20% of total shelf-
life expended. Offerors shall provide data and documentation, such
as accelerated aging and real-time testing reports and other
validating documentation, to support their shelf-life claims.
Offerors shall provide a statement verifying that the Isolation
Gowns will have no more than 20% of total shelf-life expended upon
delivery to the SNS.
* * *
If the Offeror is not making a shelf-life claim (no statements made
or expiration date listed on the isolation gown packaging, etc.), the
product, at the time of delivery to the SNS, shall have no more than
3 months expended since the date of manufacture, as listed on the
gown packaging. Offerors shall provide a statement verifying that
the Isolation Gowns will have no more than 3 months expended
since the date of manufacture.
(AR 326.)
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B.
Agency’s Questions and Answers
34.
During the procurement’s question and answer (“Q&A”) period, HHS engaged in
two rounds of Q&A with offerors.
C.
StringKing’s Offer and Agency’s Initial Award Decision
35.
In accordance with the Solicitation, StringKing invested substantial resources both
in money and time to create a product responsive to the Agency’s specific Solicitation
requirements, which emphasized the need for the selected awardee to provide a best value product
that would have sufficient shelf life for stockpiling in preparation for future national emergencies
including pandemics.
36.
On November 22, 2022, StringKing timely submitted its initial proposal including
price. The Agency did not engage in discussions with StringKing or allow StringKing to revise
its business/price proposal during the procurement.
37.
On September 18, 2023, the Technical Evaluation Panel (“TEP”) issued its report.
(AR 1162.)
38.
In the TEP Report, the TEP found that
out of
were
acceptable:
(AR 1163-64.)
39.

(AR 1172-200.)
40.
In its evaluation of NYES’s proposal, the

(AR 1181.)
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41.
Further, the TEP Report found that

(Id.)
42.
Additionally, according to the TEP Report, NYES’s proposed gowns had a shelf-
life of
. (Id.)
43.
Comparatively, StringKing had a recognized shelf life of
, with the TEP
also observing that StringKing’s shelf life could
. (AR 1190.)
44.
However, in contravention of the solicitation’s stated evaluation criteria, the TEP
Report said, in reference to StringKing’s proposal, “

.” (Id.)
45.
On September 22, 2023, the Agency issued its Award Decision Memo. (AR 1308.)
46.
In its Memo, the Agency largely copied the TEP’s findings, beginning by noting
that only
were found acceptable
and then
repeating the TEP’s conclusions about the offerors’ proposals. (AR 1313-28.)
47.
Importantly, the Memo also noted that

(AR 1319.)
48.
The Memo also noted the same domestic manufacturing concern as the TEP Report,
parroting, “

.” (AR 1342.)
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merits of this conclusion, “

.” (Id.) Such a decision is clearly in conflict with the Solicitation’s terms
that “[t]he Government’s overall best value determination will consider the cost of the product as
it relates to the shelf-life at time of delivery and the best value determination will also consider the
time, effort, and cost to sustain product with lesser shelf-life.” (AR 317.)
54.
Because
did not consider
in her decision, the Agency held that
.” (AR
1344.)
, therefore, determined that NYES,
, would be
awarded the contract. (AR 1345.)
55.
, however, made no mention of

(See id.)
56.
On September 27, 2023, the Agency issued a notice of unsuccessful offer to
StringKing and informed StringKing that the Contract had been awarded to NYES. StringKing
timely requested a debriefing by e-mail the same day.
57.
On September 29, 2023, the Agency conducted an oral debriefing for StringKing
via video conference during which counsel for StringKing was present. During the oral debriefing,
the Agency stated that because it determined that the awardee, NYES, and StringKing were
the Agency had made award to NYES because

(Compl. Ex. B, Decl. of
.) The CO also stated that the Agency did
not review StringKing’s
during its evaluation of StringKing’s proposal because the
Agency evaluators were not “experts on shelf life.” (Id. at ¶ 14.)
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D.
StringKing’s First GAO Protest and the Agency’s Corrective Action
58.
On October 4, 2023, StringKing filed a protest with GAO alleging the Agency
improperly evaluated offerors by improperly: (a) utilizing a de facto lowest-price, technically
acceptable scheme; (b) failing to evaluate proposals equally and fairly under Factors 2, 3, and 4;
(c) engaging in unequal and improper discussions with NYES, allowing NYES to amend its
proposal, and not engaging in discussions with StringKing or allowing StringKing to amend its
proposal; (d) failing to consider StringKing’s product’s shelf life in evaluating price; (e) failing to
adequately document its award decision; and (f) failing to consider StringKing’s product’s shelf
life in making its award determination. (See generally AR 1438.)
59.
On October 27, 2023, the Agency issued its Notice of Corrective Action, which
StringKing objected to on October 31, 2023, as failing to remedy the concerns in StringKing’s
protest.
60.
On November 3, 2023, GAO dismissed the protest and issued a Public Decision,
which read the Agency’s Notice of Corrective Action as encompassing StringKing’s protest
allegations.
E.
StringKing’s November 2023 Agency-Level Protest
61.
On November 13, 2023, StringKing filed an agency-level protest with the CO,
which requested review above the contracting officer level. StringKing’s agency-level protest
sought an acknowledgment from the Agency that proposals would be evaluated in alignment with
the criteria outlined in the Solicitation and that the Agency’s corrective action would resolve
StringKing’s previous protest grounds at GAO in an equitable manner, including its concerns with
the Agency’s evaluation of offerors’ products’ shelf life.
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62.
StringKing never received a decision on the merits from the Agency on its agency-
level protest despite the FAR’s mandate for agencies to “make their best efforts to resolve agency
protests within 35 days after the protest is filed[,]” FAR 33.103(g), and despite StringKing’s
counsel following up with the Agency eight times. (See Compl. Ex. C, Agency Protest E-mails to
CO at 1-7 (showing requests for a decision or status of the Agency’s review on December 20,
2023; December 22, 2023; December 29, 2023; January 11, 2024; January 18, 2024; January 22,
2024; January 29, 2024; and February 9, 2024).) The CO acknowledged receipt of StringKing’s
agency-level protest and its counsel’s follow-up emails on several occasions. (See id.) The
CO also indicated StringKing would receive a decision on January 16, 2024, which it never did.
63.
After the Agency issued Amendment 0008, on February 20, 2024, the Agency
dismissed StringKing’s agency-level protest as being moot. (AR 2308.) In its notification of
dismissal, the Agency mischaracterized StringKing’s agency-level protest and ignored several
elements of the protest, failed to confirm whether the protest was received or reviewed a level
above the CO as StringKing reasonably requested, and provided that the protest was moot due
to the Agency’s issuance of Amendment 0008. (See id.)
F.
The Agency’s Corrective Action Reevaluation
64.
On January 3, 2024, the TEP issued a new report. (AR 1680.)
65.
The TEP Report, again, found that only

submitted acceptable proposals and that each offeror was rated as

(AR 1682, 1693-721.)
66.
Largely, the newest TEP Report, with minimal changes, repeated the findings and
conclusions of the previous TEP Report and Award Decision Memo. (Compare Tab 42 with Tabs
25-26.) In fact, the TEP Report reiterated that

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.
(AR 1703.) Then, on February 16, 2024, the Agency issued a Competitive Range Memo,
determining a competitive range for the procurement. (AR 1835.)
67.
The Competitive Range Memo, again, largely followed the newest TEP Report’s
and the previous Award Decision Memo’s findings, resulting in

being found as the only acceptable proposals and being rated as

(AR 1840-52.)
68.
The Agency then performed a price assessment and found that all
acceptable
offerors had a
, resulting in the Agency establishing a competitive range
of those
offerors. (AR 1900-03.)
69.
The Agency would then issue Amendment 0008 for the submission of revised
proposals and stated that “[d]iscussions will be conducted with
offerors that have been
determined to be in the competitive range for this solicitation” (AR 1903.)
G.
The Agency Issues Amendment 0008 to the Solicitation
70.
On February 16, 2024,3 at 10:27 p.m. EDT,4 the Agency e-mailed “offerors in the
competitive range” to issue Amendment 0008, which extended the discussion period until 1 p.m.
EDT on Wednesday, February 28, 2024; invited offerors to submit a revised proposal based on

3 We note that while the Amendment is dated February 14, 2024, and the CO’s text says February
15, 2024, offerors did not receive Amendment 0008 until the Agency issued the Amendment post-
business hours on a Friday before a holiday weekend. (See AR 1916-18, AR 2305-06.) Offerors
therefore did not receive the amendment for business purposes until Tuesday, February 20, 2024
because Monday, February 19, 2024, was a federal holiday.
4 Please note that while the e-mail says 7:27 p.m., this time was PST as StringKing is located in
California and so the e-mail was received by StringKing at 10:27 p.m. EST.
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Amendment 0008; and informed offerors that questions regarding Amendment 0008 should be
submitted to the Agency by 1 p.m. EDT on February 21, 2024. (AR 1916-18, AR 2305-06.)
71.
Amendment 0008 drastically changed the requirements of the Solicitation by
removing shelf-life from the Agency’s evaluation criteria for Factor 4 (Price) and the Agency’s
best value determination. Specifically, Amendment 0008 stated:
4. Factor 4: Price Evaluation is hereby revised to remove
paragraph (a), and to read as follows:
REMOVED: a) The Government’s overall best value
determination will consider the cost of the product as it relates
to the shelf-life at time of delivery and the best value
determination will also consider the time, effort, and cost to
sustain product with lesser shelf-life.
Factor 4: Price Evaluation
The government will evaluate each Offeror’s prices to determine
that those prices are fair and reasonable and to determine which
Offerors’ proposals offer the best value to the agency. Risk of
excessive pricing is a concern and Offerors are advised to pay
special attention to the instructions related to pricing. The
government reserves the right to reject any proposal that, in its
opinion, does not offer fair and reasonable prices.
a) Options. The Government will evaluate offers for award purposes
by adding the total price for all options to the total price for the basic
requirement. The Government may determine that an offer is
unacceptable if the option prices are significantly unbalanced.
Evaluation of options shall not obligate the Government to exercise
the option(s).
b) In accordance with FAR 15.401-1 Proposal Analysis techniques,
the Government will consider unbalanced pricing when performing
the price evaluation.
c) A written notice of award or acceptance of an offer, mailed or
otherwise furnished to the successful offeror within the time for
acceptance specified in the offer, shall result in a binding contract
without further action by either party. Before the offer’s specified
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expiration time, the Government may accept an offer (or part of an
offer), whether or not there are negotiations after its receipt, unless
a written notice of withdrawal is received before award.
(End of provision)
(AR 1917-18 (emphasis added).)
72.
Amendment 0008 also allowed offerors to submit revised Technical Proposals and
Business Proposals. (AR 1917.) However, offerors’ Technical Proposal revisions were limited to
a maximum of five (5) pages as an addendum to the Technical Proposal (i.e., proposals cannot be
revised in their entirety in their prior full length). (Id.)
73.
Pursuant to Amendment 0008, offerors were given only seven business days to
submit revised proposals in response to these objectively large changes to the Agency’s evaluation
criteria (and product requirements) by removing shelf life from the evaluation for Factor 4 and the
best value determination. (AR 1916-18.)
H.
Agency’s Questions and Answers Post-Amendment 00008
74.
On February 21, 2024, StringKing timely filed questions in response to the
Agency’s Amendment 0008. (AR 2309-10.)
75.
On February 23, 2024, the Agency issued a compilation of questions the Agency
received from offerors within the competitive range and the Agency’s responses. (AR 1919-21.)
76.
StringKing’s questions and the Agency’s answers are below.
No.
Question
Answer
7
Has there been a change to the general
needs of the agency found in sections “C.1.
Background” and “C.2 Purpose”? (If yes,
then how?)
Examples of the solicitation’s stated needs:
• “[T]o
ensure
sufficient
domestic
availability of [Level 2 Isolation Gowns]
There have been no alterations to the government's
requirements in Section “C.1 Background” and “C.2
Purpose”

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during national emergencies and/or
pandemic events.”
• “[T]he
SNS
ensures
medical
countermeasures are available and can
be rapidly deployed to counter the
effects
of
chemical,
biological,
radiological, nuclear and explosive
threats as well as pandemics, emerging
infectious
diseases
and
natural
disasters.”
8
Are life-cycle costs (sustainment costs) still
being considered? If not, then why?
The Government intends to evaluate and make award(s) in
accordance with the terms of the Solicitation and all
applicable statutes and regulations.
9
If life-cycle costs (sustainment costs) are
being considered, then please provide
details on how they will be evaluated, and
the cost model used.
The Government intends to evaluate and make award(s) in
accordance with the terms of the Solicitation and all
applicable statutes and regulations.
10
If life-cycle costs (sustainment costs) are
not being considered, is this an SNS wide
change to procurements or just specific to
this solicitation?
The Government intends to evaluate and make award(s) in
accordance with the terms of the Solicitation and all
applicable statutes and regulations. The Government is not
making any determination as to an SNS wide change to its
future procurements.
11
Is there any preference for longer shelf-life
gowns? If yes, where is this evaluation
factor located and how is the shelf life
valued? If not, can the agency explain why?
The Government intends to evaluate and make award(s) in
accordance with the terms of the Solicitation and all
applicable statutes and regulations. There is no evaluation
factor providing a preference for longer or shorter shelf-
life gowns.
12
Is there any preference for a 100-year shelf-
life gown vs. a 3-month shelf life gown? If
not, can the agency explain why?
See Response on #11
13
Are contractors liable for gowns meeting
performance requirements after shelf life is
expired?
No contractors are not held liable once gowns are expired.
14
What does SNS plan to do with expired/and
or otherwise defective gowns that no longer
meet technical requirements?
SNS will dispose any expired or defective gowns.
15
Is the agency willing to accept recently
expired gowns if the price is compelling
enough?
For
example,
would
the
government be willingly to purchase gowns
for $0.10 which expired the day before
delivery?
No
16
Is the agency willingly to accept gowns that
don’t meet the stated seam strength
requirements if the price is compelling
enough?
For
example,
would
the
government be willing to purchase gowns
for $0.10 which had a seam strength 5%
below the technical requirement?
No.
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17
Does the agency see any value in these
gowns lasting until the next pandemic? If
yes, then how is this reflected in changing
the
price
evaluation
from
cost
of
sustainment to lowest unit price? If not,
then
what
is
the
purpose
of
this
procurement?

The purpose of this procurement is to purchase
domestically manufactured ANSI/AAMI PB70 Level 2
disposable medical Isolation Gowns used in healthcare
settings to ensure sufficient domestic availability of such
items during national emergencies and/or pandemic
events.

It cannot be determined when the next pandemic or natural
disaster will occur.

See SECTION C.2 – Purpose in Amendment 0005 of the
solicitation.
18
Is there stiff funding available for a new
gown award(s)? There is concern that the
funds for NYES award were appropriated
for 2023 and cannot be re appropriated.
Funding is available for this Isolation Gowns procurement.
19
Is the agency's current requirement for
75,200,000 gowns or ~132,500,000 gowns,
which is how many gowns were previously
purchased from NYES?
The quantity for this procurement is identified in Sections
B.1 and B.2 of the Solicitation, to include base quantities
of 75,200,000 gowns, optional quantities of up to
150,400,000, and surge capacity not to exceed 20% of
CLIN 2001 and 2002.
20
The solicitation states, “The Government
intends to award multiple contracts." and "
The U.S. Government is interested in
establishing multiple awards.” Does the
government still intend to make multiple
awards?
See response on question 1.
21
What are the main reasons the government
would decide to make a single award
instead of multiple awards?
See response on question 1.

(See AR 1919-21.)
I.
StringKing’s Second GAO Protest, the Agency’s Notice of Corrective Action,
and the Agency’s Amended Notice of Corrective Action
77.
On February 26, 2024, StringKing timely filed a second GAO protest challenging
the Agency’s unreasonable issuance of Amendment 0008 and improper modification of the
Solicitation in removing shelf life from the evaluation criteria for Factor 4 (Price) and in the best
value determination for the procurement.
78.
On March 26, 2024, the Agency filed a Notice of Corrective Action and Request
for Dismissal of StringKing’s protest. (AR 2253.) The Agency announced its intention to
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terminate the contract award to NYES; cancel the Solicitation in full; review and reconsider the
Agency’s requirement for isolation gowns, to include shelf-life considerations, which may include
additional or updated market research and a new or revised acquisition plan for a new solicitation;
and take other actions deemed necessary and appropriate by the Agency. (Id.)
79.
On March 28, 2024, StringKing filed an Objection to the Agency’s Notice of
Corrective Action and Request for Dismissal of StringKing’s protest. (Compl. Ex. D.)
80.
On April 9, 2024, GAO dismissed StringKing’s protest as academic.
81.
Within a few hours after GAO dismissed StringKing’s protest on April 9, 2024, the
Agency filed a Revised Notice of Corrective Action and Request for Dismissal of StringKing’s
protest. (Compl. Ex. E.) HHS’s revised corrective action completely changed the Agency’s course
of action. Specifically, HHS determined not to cancel the Solicitation and instead stated it would
review and reconsider the Agency’s requirement for isolation gowns, including shelf-life
considerations, and fully document the Agency’s conclusions; reconsider its competitive range
determination; issue an Amendment to the Solicitation to companies in the competitive range
revising the current shelf-life requirements, engaging in discussions as needed, and soliciting
complete revised final proposal revisions; withdraw the cancellation of the contract to NYES and
instead maintain the stop work order for Contract No. 75A50323C00013, the award made under
the prior award decision, which has been under a stop work order since October 2023; make a new
award decision; and take other actions, as deemed necessary and appropriate by the Agency. (Id.)
82.
StringKing then intervened into this action and filed a complaint challenging the
issuance of Amendment 0008 and the subsequent corrective action.
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J.
The Agency Issues Amendment 0009
83.
On May 31, 2024, the Agency then issued Amendment 0009 purporting to, among
other things, add shelf-life back into the requirements by requiring a three-year shelf-life. Notably,
none of the technically acceptable offerors had
This
Amendment requires a proposal date of June 17, 2024, despite the Agency significantly altering
the shelf-life requirement, materially changing the overall purpose of the Solicitation, and
removing shelf life from the evaluation criteria for Factor 2, Factor 4, and the overall best value
determination—which requires offerors to design a new product in response to the Agency’s new
requirement.
84.
Altering the shelf-life requirement means that potential bidders can use much
cheaper materials, but those cheaper materials must be procured and tested at a substantial cost;
that is not something that can realistically be accomplished within a few months, let alone a few
weeks.
85.
More specifically, procuring a new gown design includes the following steps (to be
in compliance with FDA’s required manufacturing processes):
a. Plan gown design
b. Procure raw materials (generally not off the shelf)
c. Test biocompatibility of raw materials
d. Create samples (this requires extensive research and development to
understand interactions of ultrasonic welding machines with the raw
material to optimize seam strength)
e. Send samples to an independent lab for testing
f. Make final samples including five production lots
g. Properly age gowns through an independent lab to enable certified shelf
life claims
h. Conduct pre-aging testing on gowns
i. Conduct post-aging testing on gowns which must occur once aging tests
are completed
j. Prepare final bid
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86.
In addition, Amendment 0009 continues to require companies to have an FDA-
registered facility when submitting their bids, substantially raising the bid and proposal costs for
offerors.
87.
Other changes include a change to the “Purpose” section of the Solicitation to
delete: “In establishing multiple awards for such medical isolation gowns, the Government is
attempting to increase the availability of domestically produced compliant PPE. This will enable
the United States to ensure sufficient domestic availability of such items during national
emergencies and/or pandemic events. The Government is concerned about the risks of disruption
of any manufacturing facilities or supply chains located outside of the United States. Thus,
offerors are advised to pay special attention to the requirement regarding location of
manufacturing.”
88.
Amendment 0009 also deleted information about the National Stockpile in the
“Background” section:
The Strategic National Stockpile (SNS) ─ managed by the U.S.
Department of Health and Human Services’ Administration for
Strategic Preparedness and Response ─ is a national repository of
pharmaceuticals,
vaccines,
medical
supplies, and medical
equipment stored in strategic locations around the nation. These
assets are designed to supplement state and local medical supplies
and equipment during public health emergencies. The supplies,
medicines, and devices for lifesaving care contained in the SNS can
be used as a short-term, stopgap buffer when the immediate supply
of these materials may not be available or sufficient.

***
The mission of the SNS is to ensure the availability and rapid
deployment of life-saving pharmaceuticals, antidotes, other medical
supplies, and equipment necessary to counter the effects of
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biological, chemical, radiological, natural disasters or other
emerging infectious disease agents. When state, local, tribal, and
territorial public health and medical authorities request federal
assistance to support their response efforts, the SNS ensures that the
right medicines and supplies get to those who need them most
during a public health emergency or pandemic event.

(See AR 277.)

89.
Amendment 0009 also changed the flammability requirements. While the Agency
previously allowed for Class II intermediate flammability, it now only permits Class I normal
flammability under 16 CFR 1610. Under Class II, the burn time is 4.0 to 7.0 seconds whereas the
burn time under Class I is more than 7.0 seconds.
90.
Test reports also no longer require testing for biocompatibility under ISO 10993-5
and ISO 10993-10, though it is listed in Subfactor 8.
91.
Under Section C.4, the Agency now requires a three year shelf-life: “Isolation
Gowns must have a shelf life of 3 years, and, at the time of delivery to the SNS, isolation gowns
shall have no more than 3 months expended since the date of manufacture, as listed on the gown
packaging labels.” (See Amendment 0009 at 17.)
92.
Under Section D.2, the Agency deleted a requirement in the “Markings” section:
“Product name, lot number, part number, UDI, quantity, gown size, AAMI level, date of
manufacture, and expiration dating/use by date (if applicable) included on both the outer case and
the inner gowns packaging label.” (Compare AR 286 with Amendment 0009 at 18.)
93.
The Technical Proposal is now limited to 20 pages, instead of 41 pages. (Compare
AR 307 with Amendment 0009 at 41.)
94.
Amendment 0009 also added requirements to Subfactor 5, Catalog and Literature:
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Offerors will be evaluated on their ability to provide non-sterile,
single-use, disposable Level 2 Isolation Gowns that are blue or
yellow; made of woven, non-woven or composite materials; with
elastic wrists or knitted cuffs; meets PB70 testing requirements to
claim gown as Level 2; and meets ASTM F3352-19 and other
applicable standards as identified in the solicitation.

Offeror’s proposals will be evaluated based on:
1) having included a technical drawing for each offered Isolation
Gown model and each offered size illustrating the points of
measures used for the gown length, sleeve length, and chest width;
2) having provided front and back photographs of each offered
Isolation Gown model and size being worn on an appropriate height
male (accordingly to the gown size) with arms to the side and arms
extended from sides- height of person was provided; and
3) gown dimensions for length, sleeve length, and chest width within
the minimum maximum range provided in Section C of the
solicitation; and
4) each gown model and size offered providing 360-degree
protection to the wearer, that at a minimum, ensures both arms,
front, back, and sides of the body from the knees up to but not
including the neck are fully covered during movement and use when
the correct gown size is worn (per Section C and ASTM F3352-19).

(Compare AR 316 with Amendment 0009 at 53.)

95.
Under Subfactor 6, Shelf Life, Amendment 0009 adds that: “A shelf life longer than
3 years will not be evaluated higher or considered to be an additional strength.” (Amendment
0009 at 54.)
96.
Under Factor 4, Price Evaluation, the Agency deleted: “The Government’s overall
best value determination will consider the cost of the product as it relates to the shelf-life at time
of delivery and the best value determination will also consider the time, effort, and cost to sustain
product with lesser shelf-life.” (Compare AR 317 with Amendment 0009 at 55.)
97.
As noted above, the Agency subsequently issued Amendment 0010 to include
clarification that there is no small business set-aside.
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98.
This Amended Complaint follows.
COUNT I5

The Agency Arbitrarily and Capriciously Issued Amendment 0008 and Amendment 0009
to the Solicitation to Remove Shelf Life From its Evaluation Criteria.
99.
StringKing incorporates by reference the allegations set forth above and in the
foregoing paragraphs as if fully stated herein.
100.
“As a general rule, offerors must be given sufficient detail in an RFP to allow them
to compete intelligently and on a relatively equal basis[,]” Glenn Def. Marine (Asia) PTE Ltd. v.
United States, 97 Fed.Cl. 568, 578 (Fed. Cl. 2011) (internal quotation omitted), and “[i]t is beyond
peradventure that a contracting agency must treat all offerors equally, evaluating proposals
evenhandedly against common requirements and evaluation criteria.” Banknote Corp. of Am. v.
United States, 56 Fed.Cl. 377, 383 (2003), aff'd, 365 F.3d 1345 (Fed. Cir. 2004).
101.
Likewise, it is “hornbook law that agencies must evaluate proposals and make
awards based on the criteria stated in the solicitation. This requirement is firmly rooted in the
Competition in Contracting Act (CICA) . . . which indicate[s] that an agency shall evaluate
competitive proposals and assess their qualities solely on the factors and subfactors specified in
the solicitation.” Banknote Corp. of Am., Inc. v. United States, 56 Fed.Cl. 377, 386 (2003); see
also, e.g., FirstLine Transp. Sec., Inc. v. United States, 100 Fed.Cl. at 388 (“It is a fundamental
principle of procurement law that an agency must conduct its best-value analysis using the

5 StringKing maintains its arguments related to Amendment 0008 to preserve the arguments in the
event the Government and/or Agency rely on or revert back to Amendment 0008.
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evaluation factors and subfactors specified in the solicitation.”) (citing 48 C.F.R. § 15.101–1(b)(1);
48 C.F.R. § 15.305(a)).
102.
Here, the Agency has unreasonably changed the Solicitation’s requirements by
issuing Amendment 0008 and Amendment 0009 to remove evaluation of shelf life from the
Agency’s evaluation criteria for Factor 2 (Technical Capability), Factor 4 (Price), and the best
value determination. This action is contrary to the fundamental requirement for offerors to compete
on an equal basis and reflects arbitrary and capricious conduct by the Agency.
103.
The Agency’s issuance of Amendment 0008 is also inconsistent with policies and
market conditions that are directly applicable to the procurement.6
104.
The Agency has conflated its discretion to determine its needs and has revised the
Solicitation in a manner that is inconsistent with the Solicitation’s actual stated requirements and
fails to meet its obligation to provide a meaningful basis to evaluate proposals. Amendment 0008
and Amendment 0009 also adopt a price evaluation method that produces a misleading result in
analyzing whether one proposal is more competitive than another.
105.
Additionally, to make such a drastic change to the Solicitation’s evaluation criteria
this late in the procurement process is fundamentally unfair and ignores the investment of time and

6 Stockpiles are prepared for national emergencies, and the only national emergency that requires
significant volumes of isolation gowns is a pandemic. (Compl. Ex. B,
Decl. ¶ 20;
AR 277 (“[T]he Government is attempting to increase the availability of domestically produced
compliant PPE. This will enable the United States to ensure sufficient domestic availability of such
items during national emergencies and/or pandemic events.”) Over the past 120 years, there have
only been five national pandemics, of which only two would require large volumes of isolation
gowns: the Spanish flu and Covid-19. (Comp. Ex. B,
Decl. ¶ 20.) This gap between
national pandemics is normally about 26.5 years, and the gap between pandemics requiring large
volumes of isolation gowns is about 100 years. (Id.) Superior shelf life, therefore, is necessary to
consider to ensure stockpiles remain viable for the next national emergency. (Id.)
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resources companies, like StringKing, have invested to create the best product to respond to the
Agency’s requirements.
106.
Finally, the Agency’s issuance of Amendment 0008 and Amendment 0009 shows
the Agency failed to take meaningful corrective action in response to StringKing’s prior protest.
107.
Each of the Agency’s actions prejudiced StringKing.
108.
StringKing’s protest should be sustained on each of these grounds. The Agency
cannot manipulate the protest process to fundamentally change evaluation requirements to
circumvent its obligation to conduct a fair and unbiased procurement.
COUNT II
The Agency’s Issuance of Amendment 0008 and Amendment 0009 Is Arbitrary and
Capricious and an Abuse of the Discretion Afforded to it Under Procurement Regulations
Because It Fails to Provide a Meaningful Basis to Evaluate Price and Make a Reasonable
Best Value Determination.

109.
StringKing incorporates by reference the allegations set forth above and in the
foregoing paragraphs as if fully stated herein.
110.
Agencies may not conflate the discretion afforded to it in crafting a solicitation by
failing to provide a meaningful basis to evaluate proposals.
111.
Here, the Agency’s issuance of Amendment 00008 and Amendment 0009 has
eliminated the consideration of shelf life in evaluating offerors’ proposed prices under Factor 2
(Technical Capability), Factor 4 (Price), and in making the Agency’s overall best value
determination. The revised evaluation methodologies fail to provide for a reasonable comparison
of the price of performance under competing quotations.
112.
The Agency cannot reasonably evaluate price without consideration of shelf life.
This is a procurement for disposable medical gowns with the express stated purpose to “ensure
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sufficient domestic availability” of these crucial personal protective equipment “during national
emergencies and/or pandemic events[.]” (AR 277.) And while the Agency changed the purpose of
the Solicitation through Amendment 0009 from “ensur[ing] sufficient domestic availability of such
items during national emergencies and/or pandemic events” to “disposable medical Isolation
Gowns used in healthcare settings[,]” this is in direct contravention from the Agency’s statement
during questions and answers that the purpose of the procurement has not changed. (AR 1920
(“There have been no alterations to the government's requirements in Section “C.1 Background”
and “C.2 Purpose”).) The Agency further confirmed that it “cannot be determined when the next
pandemic or natural disaster will occur” and that it intends to dispose of the isolation gowns once
they are expired, which comes at considerable additional cost. (AR 1919-22.)
113.
It is illogical that the Agency could evaluate price or make a best value
determination on disposable gowns being procured to stockpile for an unknown future pandemic
or natural disaster without consideration of shelf life. Any evaluation of price without considering
shelf life given the stated purpose of the procurement fails to provide for a reasonable comparison
of the price of performance under competing quotations or lifecycle costs (as the Agency is
required to consider pursuant to FAR 7.105). Without any comparative assessment of prices and
lifecycle costs, any best value determination will be made without a weighing of the true cost value
and benefits associated with an offeror’s approach against its associated cost to the government.
114.
The Agency’s elimination of shelf life from the evaluation requirements is arbitrary
and capricious and an abuse of the discretion afforded to it under procurement regulations.
115.
Each of the Agency’s actions prejudiced StringKing.
116.
StringKing’s protest on this count should be sustained.
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COUNT III
Amendment 0008 and Amendment 0009 Improperly Convert the Solicitation into an LPTA
Procurement.
117.
StringKing incorporates by reference the allegations set forth above and in the
foregoing paragraphs as if fully stated herein.
118.
Amendment 0008’s elimination of shelf life from consideration of Factor 4 (Price)
and the overall best value determination and Amendment 0009’s de facto elimination of shelf life
from Factor 2 (Technical Capability) improperly convert this procurement from a best value
procurement to a lowest price technically acceptable (“LPTA”) procurement. By eliminating shelf
life, the only difference between offerors’ proposals is price once technical acceptability is
determined by the Agency. The record confirms the Agency failed to consider whether any
proposal was more than “acceptable” in its previous evaluations (as it was required to do, see, e.g.,
AR 314). Nothing in the record shows the Agency is engaging in any different evaluation
currently.
119.
The Agency cannot maintain this is a best value procurement when it has eliminated
shelf life and life cycle costs from the evaluation criteria for the procurement. That is, the Agency
cannot claim this is a best value procurement by merely including the best value language in the
Solicitation but have price evaluation that lacks any meaningful way to compare offerors’ prices
(as discussed above). Further, this violates FAR 15.101-2(d), which specifically finds that COs
“shall avoid, to the maximum extent practicable, using the lowest price technically acceptable
source selection process in the case of a procurement that is predominantly for the acquisition of .
. . [p]ersonal protective equipment.”
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120.
Finally, the extensive revisions to the Solicitation via Amendment 0008 and
Amendment 0009 have rendered the Agency’s evaluation requirements obsolete, and the
Solicitation fails to advise offerors of the basis for award, as it is required to do pursuant to 41
U.S.C. § 3306(b)(1) and FAR 15.304(d). Each of the Agency’s actions prejudiced StringKing.
121.
StringKing’s protest on this ground should be sustained.
COUNT IV
The Agency Has Engaged in Unequal and Disparate Treatment.
122.
StringKing incorporates by reference the allegations set forth above and in the
foregoing paragraphs as if fully stated herein.
123.
The Agency’s revisions to the evaluation criteria in the Solicitation related to shelf
life under Factor 2, Factor 4, and in the overall best value determination lack a rational basis, are
arbitrary and capricious, and reflect disparate treatment as the Agency has materially changed the
requirements it is procuring and has revised the Solicitation to favor the prior awardee, NYES, and
other offerors
, which reflects disparate treatment.
124.
First, since taking its first corrective action in October 2023, the Agency has
communicated repeatedly with the other offerors that remain in the competitive range for the
procurement and has not communicated with StringKing in the same manner. Specifically, the
Agency has had phone calls and exchanged text messages with NYES

regarding the ongoing procurement and these offerors’ proposals and products but has not engaged
in the same communications with StringKing. (Comp. Ex. B, Decl. of
at ¶¶ 22-
24.) For example,
, has
stated he has had “at least fifty to sixty” phone conversations with the CO throughout the
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procurement process, including many in the last few months alone. (Id. at ¶ 22-23.) Additionally,
NYES’s CEO,
, has had several private conversations through both text message
and phone calls with the contracting officer,
, while proposals were being
previously evaluated. (Id.)
125.
These communications constitute improper exchanges and/or discussions after the
receipt of proposals, in violation of FAR 15.306(d) and/or FAR 15.306(e), and further reflect
disparate and unequal treatment by the Agency. Here, although the Solicitation did not require the
Agency to hold discussions with offerors, it is axiomatic that, in a negotiated procurement, once
an agency chooses to conduct discussions, it must do so with all offerors in the competitive range,
and that, when holding discussions, agencies may not engage in conduct that favors one offeror
over another. FAR 15.306(d)(1). Further, in conducting exchanges with offerors, agency
personnel may not “engage in conduct that . . .[f]avors one offeror over another[.]” FAR 15.306(e);
in particular, agencies may not engage in what amounts to disparate treatment of the competing
offerors.
126.
The Agency’s failure to do so here and its subsequent discussions with only NYES
and
and not with StringKing are improper and show preferential treatment
for these offerors over StringKing. Further, the Agency’s discussions with NYES and

were a motivating factor in the Agency’s decision to remove shelf life from the
Solicitation’s evaluation criteria for Factor 4 (Price) and in the overall best value determination
because the removal of shelf life favors the products offered by NYES and

(and disfavors the product offered by StringKing).
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127.
Further, the record reflects an inherent preferential treatment in favor of NYES
because the Agency is currently negotiating a request for equitable adjustment (“REA”) from
NYES at the same time it is supposedly neutrally re-evaluating proposals. This comes after it has
revised its Solicitation requirements and evaluation criteria to favor NYES’s offered product with
lesser shelf life. See FAR 3.101. The REA is related to NYES’s complaints that delays to this
procurement
that “
.”
(See, e.g., AR 2256.) StringKing has also invested
into this procurement but is
not receiving the same preferential treatment from the Agency that the Agency is extending to
NYES. StringKing also questions the Agency’s evaluation of NYES’s responsibility if NYES is
seemingly going to lose its business if it does not maintain its prior award. Regardless, the record
shows the Agency is not acting impartially and is engaging in disparate treatment (and perhaps
even bias) as it appears NYES will be maintaining its award despite the fact the Agency is
supposedly re-evaluating proposals including NYES’ (as it must, given the materially different
evaluation criteria changes the Agency has made to the Solicitation).7
128.
Each of the Agency’s actions prejudiced StringKing.
129.
StringKing’s protest should be sustained.

7 The disparate treatment carried throughout the previous evaluation by the Agency. For
instance, NYES was a subcontractor under a DLA contract and used that as a basis for its past
performance in this procurement. (See AR 924.) NYES, however, was never listed as a place of
performance for these contracts even though it was required to be under FAR 52.215-6. If they
had
been,
NYES
would
be
listed
in
this
database:
https://www.dibbs.bsm.dla.mil//awards/awdrecs.aspx?scope=all. Either NYES did not perform
the contracts as stated or the Government was never informed that it was a manufacturer under a
government contract despite a requirement that it be listed. The Agency, in evaluating the
proposals, did not conduct basic due diligence on this prior to relying on this past performance
when awarding the contract to NYES.
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COUNT V
The Agency Has Failed to Implement Corrective Action in Response to StringKing’s Prior
Protest Allegations Concerning the Agency’s Failure to Consider Shelf Life in Its
Evaluation.
130.
StringKing incorporates by reference the allegations set forth above and in the
foregoing paragraphs as if fully stated herein.
131.
The Agency has failed to implement the corrective action it took in response to
StringKing’s GAO protest filed on October 13, 2023, and has failed to enact effective corrective
action despite a number of attempts to do so, including here. In fact, instead of implementing
corrective action, the Agency continues to try and slant the procurement in favor of its chosen
awardee.
132.
Where an agency fails to implement the promised corrective action, or implements
corrective action that fails to address a meritorious issue raised in the protest that prompted the
corrective action, such that the protester is put to the expense of subsequently protesting the very
same procurement deficiency, the agency’s action has precluded the timely, economical resolution
of the protest. See, e.g., Oak Grove Tech., LLC v. United States, 155 Fed. Cl. 84, 120-21 (2021)
(granting an injunction “where the government apparently failed to implement the corrective
action to which it had committed before the GAO.”).
133.
Here, the record indicates the Agency has not implement its proposed corrective
action and has not resolved the issues raised in StringKing’s protests. The main crux of
StringKing’s protests is that the Agency (a) failed to evaluate proposals in accordance with the
Solicitation as the Agency did not evaluate offerors’ prices by considering shelf life under Factor
4 (Price) and in the best value determination as the Solicitation required the Agency to do; and (b)
has arbitrarily and capriciously eliminated shelf life in its evaluation criteria under Factor 2, Factor
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4, and in the overall best value determination through its issuance of Amendment 0008 and
Amendment 0009.
134.
Instead of re-evaluating proposals in accordance with the express language in the
Solicitation, the Agency issued Amendment 0008 and Amendment 0009 to change the entire
evaluation landscape for the procurement and seeks to unreasonably eliminate shelf life from the
evaluation criteria for Factor 2 (Technical Capability), Factor 4 (Price), and the overall best value
determination. That is, the Agency objectively intends to not re-evaluate offerors’ prices and
technical proposals and make a best value determination that considers shelf life pursuant to
StringKing’s prior protest and instead has arbitrarily and capriciously eliminated shelf life from
the Agency’s consideration for award altogether.
135.
StringKing’s protest on this ground should be sustained and StringKing is entitled
to reimbursement of protest costs relating to this protest under the Equal Access to Justice Act and
the Court’s inherent power to award attorneys’ fees.
136.
StringKing has been put to the expense of protesting a fourth time (i.e., two GAO
protests, an agency-level protest, and now before the Court) to ensure that shelf life for offerors’
proposals (and products) are evaluated under Factor 2 (Technical Capability), Factor 4 (Price), and
in the best value determination as contemplated by the Solicitation prior to the Agency’s
unreasonable issuance of Amendment 0008 and Amendment 0009.
COUNT VI

The Agency Arbitrarily and Capriciously Issued Amendment 0009 to the
Solicitation as a Corrective Action.

137.
StringKing incorporates by reference the allegations set forth above and in the
foregoing paragraphs as if fully stated herein.
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138.
Here, the Agency has unreasonably changed the Solicitation’s requirements as part
of the Agency’s corrective action by issuing Amendment 0009, which places a ceiling on the value
the Agency may assess to the shelf life of offerors’ products under Factor 2, Technical Capability.
Specifically, Amendment 0009 states that “Isolation Gowns must have a shelf life of 3 years, and,
at the time of delivery to the SNS, isolation gowns shall have no more than 3 months expended
since the date of manufacture, as listed on the gown packaging.” (Amend. 0009 at 53 (emphasis
added).) Amendment 0009 further states that “[a] shelf life longer than 3 years will not be
evaluated higher or considered to be an additional strength.” (Id. at 53 (emphasis added).)
139.
It is well-established that “an agency has broad discretion to take necessary
corrective action” where there has been an error in the procurement process. See Sys. Application
& Techs., Inc., v. United States, 100 Fed.Cl. 687, 716 (2011). Given the broad discretion afforded
to agencies, the great weight of authority is that to survive review, an agency's corrective action
must be “‘reasonable under the circumstances and appropriate to remedy the impropriety.’”
Amazon Web Servs., Inc., v. United States, 113 Fed.Cl. 102, 115 (2013) (quoting Reema Consulting
Servs., Inc. v. United States, 107 Fed.Cl. 519, 527 (2012)); see also, e.g., Sheridan Corp. v. United
States, 95 Fed.Cl. 141, 145 (2010) (stating that “[t]o be reasonable, the agency's corrective action
must be rationally related to the defect to be corrected” and “the reason for the corrective action
must be supported by the evidence in the record”). When an agency amends a solicitation as part
of a corrective action, “in order to survive review under the arbitrary and capricious standard, ‘a
reasoned explanation is needed for disregarding facts and circumstances that underlay . . . the prior
policy[.]’” See, e.g., Prof’l Servs. Indus., Inc. v. United States, 129 Fed.Cl. 190, 206 (2016)
(internal citation omitted).
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140.
Here, the Agency’s issuance of Amendment 0009 and decision to amend the
evaluation criteria for Factor 2 to state that “[a] shelf life longer than 3 years will not be evaluated
higher or considered to be an additional strength” is not rationally related to a defect the Agency
presumably is fixing through corrective action in response to StringKing’s protest. Further, no
reasoned explanation is apparent or can be inferred on the basis of the present administrative record
and the Court should be disinclined to infer that the Agency examined its needs and engaged in
reasoned decision-making when it amended the requirements of the Solicitation in such a material
way—especially given the history of this procurement.
141.
“Presumably, the agency had good reasons for assigning” the evaluation criteria
and product requirements related to shelf life under Factor 2 in the original Solicitation. See Prof’l
Servs. Indus., 129 Fed.Cl. at 206. The record is devoid of evidence that the Agency reviewed its
needs, reasonably assessed them, and had a rational basis for deciding that the original solicitation
did not meet them. Accordingly, HHS’s decision to amend the solicitation to shorten the material
value of an offerors’ products’ shelf life under Factor 2 through Amendment 0009 is arbitrary and
capricious and must be set aside.
142.
Each of the Agency’s actions prejudiced StringKing.
143.
StringKing’s protest should be sustained.
COUNT VII
The Agency’s Issuance of Amendment 0009 is Arbitrary and Capricious and Effectively
Eliminates Product Shelf-Life as a Consideration in this Procurement.
144.
StringKing incorporates by reference the allegations set forth above and in the
foregoing paragraphs as if fully stated herein.
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145.
The Agency’s issuance of Amendment 0009 fundamentally changes the
Solicitation’s requirements by effectively eliminating the Agency’s consideration of shelf life
under Factor 2, Technical Capability. Specifically, Amendment 0009 states that “Isolation Gowns
must have a shelf life of 3 years, and, at the time of delivery to the SNS, isolation gowns shall
have no more than 3 months expended since the date of manufacture, as listed on the gown
packaging.” (Amend. 0009 at 53 (emphasis added).) Additionally, Amendment 0009 states that
“[a] shelf life longer than 3 years will not be evaluated higher or considered to be an additional
strength.” (Id. at 53 (emphasis added).) Amendment 0009, together with Amendment 0008
(which StringKing protested in its original complaint), effectively removes the evaluation of shelf
life from the Agency’s evaluation criteria. This is markedly different than the requirement
originally solicited by the Agency, which prioritized and placed emphasis and strength in an
offeror’s ability to provide a product with longer shelf life. Offerors that have products with longer
shelf life (which in turn, have a higher price)
are no longer competitive in this
procurement due to the Agency’s materially changed requirement. This action is contrary to the
fundamental requirement for offerors to compete on an equal basis and reflects arbitrary and
capricious conduct by the Agency.
146.
Further, it is unduly burdensome to expect offerors
, which
proposed a gown with a relatively long shelf-life in response to prior iterations of the Solicitation,
to prepare and submit a proposal for gowns with a relatively short shelf-life by June 17, 2024, as
offerors are required to do by Amendment 0009. The materials utilized for a short shelf-life gown
are completely different than the materials needed for a long shelf-life gown. This abrupt, material
change by the Agency requires offerors that designed products with longer shelf life to meet the
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Agency’s requirements as originally solicited,
, to procure a completely different
product. This, in turn, requires offerors to re-engage in the research and design process and to
comply with FDA’s required manufacturing process, which requires (at minimum) that an offeror:
a. Plan gown design
b. Procure raw materials (generally not off the shelf)
c. Test biocompatibility of raw materials
d. Create samples (this requires extensive research and development to
understand interactions of ultrasonic welding machines with the raw
material to optimize seam strength)
e. Send samples to an independent lab for testing
f. Make final samples including five production lots
g. Properly age gowns through an independent lab to enable certified shelf
life claims
h. Conduct pre-aging testing on gowns
i. Conduct post-aging testing on gowns which must occur once aging tests
are completed
j. Prepare final bid
147.
Further, the Agency’s removal of shelf life from the Agency’s material evaluation
requirements violates FAR 7.105, which requires the Agency to adequately consider “life-cycle
cost.” Amendment 0008 and Amendment 0009 have changed the Solicitation to eliminate any
distinction between a medical gown with three years of shelf life and a medical gown with twenty
years of shelf life—despite the concrete fact that the Agency will be required to reprocure gowns
that expire.
148.
Each of the Agency’s actions has prejudiced StringKing.
149.
StringKing’s protest should be sustained.
COUNT VIII
Amendment 0009 Unduly Restricts Competition.
150.
StringKing incorporates by reference the allegations set forth above and in the
foregoing paragraphs as if fully stated herein.
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151.
Amendment 0009 renders the Solicitation unduly restrictive because it is
unnecessary, eliminates the competitiveness of offerors whose products have longer shelf life, and
effectively allows only offerors with shorter shelf life
to compete for award.
152.
The Competition in Contracting Act (“CICA”) imposes a duty on the Agency to
“obtain full and open competition.” 41 U.S.C. § 253(a)(1)(A) (1994); 10 U.S.C. § 2304(a)(1)(A).
A consequence of this duty is that Solicitation provisions that restrict competition may be used
only “to the extent necessary to satisfy the needs of the agency or as authorized by law.” 48 C.F.R.
§ 11.002(a)(1)(ii); 41 U.S.C. § 253a(a)(2)(B); 10 U.S.C. § 2305(a)(1)(B)(ii). “Unnecessarily
restrictive specifications or requirements that might unduly limit the number of bidders are
prohibited.” 48 C.F.R. § 14.101(a).
153.
The Agency’s decision to issue Amendment 0009 is entitled to a “presumption of
regularity,” Citizens to Preserve Overton Park, Inc. v. Volpe, 401 U.S. 402, 415, 91 S.Ct. 814, 823,
28 L.Ed.2d 136 (1971), although that presumption does not shield it from a “thorough, probing,
in-depth review.” Id. (emphasis added). While courts “recognize the relevant agency’s technical
expertise and experience, and defer[s] to its analysis unless it is without substantial basis in fact,”
Fed’ Power Comm’n v. Florida Power & Light Co., 404 U.S. 453, 463, 92 S.Ct. 637, 644, 30
L.Ed.2d 600 (1972), the Court must also perform an informed review of even technical decisions
in order to meaningfully exercise its jurisdiction. Prineville Sawmill Co., Inc. v. United States, 859
F.2d 905, 910–11 (Fed. Cir. 1988). Furthermore, “[e]xpertise is a rational process and a rational
process implies expressed reasons for judgment.” Redland Genstar, Inc. v. United States, 39
Fed.Cl. 220, 231 (1997) (emphasis added) (internal citations omitted). The Court must therefore
“ensure that the agency has ‘examin[ed] the relevant data and articulat[ed] a satisfactory
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explanation for its action including a rational connection between the facts found and the
choice made.’” Id. (emphasis added) (internal citations omitted).
154. Here, the Agency has arbitrarily and capriciously changed the Solicitation’s
requirements by issuing Amendment 0009, which unduly restricts competition by materially
changing the procurement two years into the competition. Specifically, Amendment 0009 states
that “Isolation Gowns must have a shelf life of 3 years, and, at the time of delivery to the SNS,
isolation gowns shall have no more than 3 months expended since the date of manufacture, as
listed on the gown packaging.” (Amend. 0009 at 53 (emphasis added).) Amendment 0009 further
provides that “[a] shelf life longer than 3 years will not be evaluated higher or considered to be
an additional strength.” (Id. at 53 (emphasis added).) Amendment 0009 does not otherwise
reinstate shelf life as part of the evaluation criteria for Factor 4 (Price) or as a requirement for the
Agency’s overall best value determination. Moreover, Amendment 0009 changes the purpose of
the procurement from “ensur[ing] sufficient domestic availability” of gowns for future
emergencies and pandemics to merely “Isolation Gowns used in healthcare settings.”
155. The resulting impact of the Agency’s issuance of Amendment 0009 is to unduly
restrict competition. First, offerors that have products with longer shelf life (which in turn, have a
higher price)
are no longer competitive in this procurement due to the Agency’s
materially changed requirement, which places a ceiling on the value the Agency may assess to the
shelf life of offerors’ products under Factor 2. Amendment 0009’s short turnaround time for
revised proposals artificially eliminates competitors that have invested the last few years and
significant research and development dollars into developing long shelf-life gowns under the
Agency’s previous evaluation scheme that both credited gowns with a longer life-cycle and
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emphasized the Agency’s need for medical gowns with a long shelf life for the purpose of creating
a national stockpile of PPE. Second, a plain reading of Amendment 0009 shows the Agency is
irrationally requiring all gowns to have a shelf life of exactly three years or else risk being
eliminated as unacceptable. Such a requirement is arbitrary and capricious and lacks a rational
basis in restricting competition.
156.
The record shows the Agency lacks a rational basis for making these changes to the
Solicitation. For example, the Agency includes a Market Research Report in support of its
amendment but that report fails to discuss customary commercial practice for shelf life in any way
and as such does not support the Agency’s unsupported statement that the industry norm for shelf
life is five years. (See AR 11-18.) Further, the Agency’s Acquisition Plan for the procurement
arbitrarily and capriciously dismisses life-cycle costs entirely. (AR 105 (“Life-cycle cost does not
apply to this commercial medical supply acquisition.”) Gowns with a longer shelf-life inherently
have lower life-cycle costs and the Agency’s statement shows a flawed misunderstanding of both
lifecycle costs and the PPE marketplace (as shelf life is standardly considered in the commercial
marketplace and has been considered by HHS itself in other similar procurements).
157. In short, nothing in the record demonstrates a rational connection between the
Agency’s needs as originally solicited (and appropriated through federal funding) and its late hour
decision to eliminate the evaluation of shelf life in any meaningful way under Factor 2 through
Amendment 0009 and Factor 4 and the overall best value determination through Amendment 0008.
See, e.g., Redland Genstar, 39 Fed.Cl. at 234-25 (finding the agency failed to articulate the
required rational connection between its needs and its departure from previous practice, which had
a restrictive effect on competition, and that changes to bid specifications made following filing of
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the protest were arbitrary and did not retroactively rationalize the agency’s choice of bid
specifications); see also, e.g., U.S. Foodservice, Inc. v. United States, 100 Fed.Cl. 659 (2011)
(holding the MFC clause crafted by the agency exceeded the bounds of rationality and amounted
to an arbitrary and capricious requirement in granting an injunction in favor of plaintiffs).
158.
This is especially true here since the departure from prioritizing shelf life under
Factor 2 restricts competition, reflects a materially changed requirement (that likely justifies
cancellation of the procurement overall), and reflects disparate treatment and bias in favor of
certain competitors in the procurement
. Since the record does not reveal a rational
connection between the facts associated with the Agency’s decision to place a ceiling on the value
the Agency may assess to the shelf life of offerors’ products under Factor 2, the Agency’s issuance
of Amendment 0009 is invalid because it is arbitrary and capricious and an abuse of discretion.
159.
Amendment 0009 also shows the Agency failed to take meaningful corrective
action in response to StringKing’s prior protests.
160.
Each of the Agency’s actions prejudiced StringKing.
161.
StringKing’s protest should be sustained. The Agency cannot abuse the discretion
afforded to it and fundamentally change evaluation requirements to restrict competition and
circumvent its obligation to conduct a fair and unbiased procurement. StringKing is entitled to a
declaration that the Agency’s issuance of Amendment 0009 lacks a rational basis and that, as a
result, the Solicitation unduly restricts competition in violation of CICA.
COUNT IX

Alternatively, the Agency’s Issuance of Amendment 0008 and Amendment 0009 Reflects
Cardinal Changes to the Solicitation that Violate CICA and FAR 15.206(e).
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162.
StringKing incorporates by reference the allegations set forth above and in the
foregoing paragraphs as if fully stated herein.
163.
Amendment 0009 (and Amendment 0008) materially changes the Solicitation
requirements in such a substantial way that exceeds what offerors could have reasonably
anticipated.
164.
CICA requires executive agencies, when procuring property or services, to “obtain
full and open competition through the use of competitive procedures,” unless certain specified
exceptions apply. 41 U.S.C. § 3301(a)(1). This statutory imperative for full and open competition
is violated if a procuring agency makes a cardinal change to a contract requirement after accepting
bids in response to a solicitation. See AT & T Comm., Inc. v. Wiltel, Inc., 1 F.3d 1201, 1205 (Fed.
Cir. 1993) (“[M]odifications outside the scope of the original competed contract fall under the
statutory competition requirement.”). “In other words, a cardinal change to a proposed contract
during the course of a procurement, or after the contract has been awarded, disguises the essential
nature of the competed contract and frustrates full and open competition.” Golden Mfg. Co. v.
United States, 107 Fed.Cl. 264, 275 (2012).
165.
This principle is carried forth in FAR 15.206(e), which provides:
If, in the judgment of the contracting officer, based on market
research or otherwise, an amendment proposed for issuance after
offers have been received is so substantial as to exceed what
prospective offerors reasonably could have anticipated, so that
additional sources likely would have submitted offers had the
substance of the amendment been known to them, the contracting
officer shall cancel the original solicitation and issue a new one,
regardless of the stage of the acquisition.

48 C.F.R. § 15.206(e) (emphasis added). “A cardinal change to a solicitation may thus constitute
a violation of CICA and a violation of FAR 15.206(e), unless the agency takes steps to re-open the
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Original Solicitation

C.2 Purpose: The U.S. Government is interested in
establishing multiple awards for the purchase of
domestically manufactured ANSI/AAMI PB70 Level 2
disposable medical Isolation Gowns used in healthcare
settings. In establishing multiple awards for such
medical isolation gowns, the Government is attempting
to increase the availability of domestically produced
compliant PPE. This will enable the United States to
ensure sufficient domestic availability of such items
during national emergencies and/or pandemic events.
The Government is concerned about the risks of
disruption of any manufacturing facilities or supply
chains located outside of the United States. Thus,
offerors are advised to pay special attention to the
requirement regarding location of manufacturing.

Medical gowns promote infection control practices and
help protect patients and healthcare workers against
microorganisms and body fluids during routine care,
examinations, and medical procedures. The choice of
medical gown(s) is dependent on the level of risk of
contamination. The American National Standards
Institute/Association for the Advancement of Medical
Instrumentation (ANSI/AAMI) PB70 establishes a
system of classification for surgical and isolation gowns
used in healthcare facilities, based on their liquid barrier
performance. The ANSI/AAMI PB70 standard includes
four standard tests to evaluate the barrier effectiveness
of surgical gowns, isolation gowns, and surgical drapes.
Based on the results of these standardized tests, four
levels of barrier performance are defined, with Level 1
being the lowest level of protection and Level 4 being
the highest level of protection.
Via Amendment 0009

C.2 Purpose
The U.S. Government has a requirement for
domestically manufactured ANSI/AAMI PB70 Level 2
disposable medical Isolation Gowns used in healthcare
settings.

Factor 2: Technical Capability
Subfactor 6: Shelf Life

Offerors’ proposals will be evaluated to determine
whether the product meets the shelf life requirements
of this solicitation. Offerors shall provide the expected
remaining shelf-life for product at time of delivery.

At time of delivery, product shall have no more than
20% of total shelf-life expended. Offerors shall provide
data and documentation to support any shelf claim.
Via Amendment 0009

Factor 2: Technical Capability
Subfactor 6: Shelf Life

Offeror’s proposals will be evaluated based on
providing the signed certified manufacturer statement in
the format provided in Section L: Subfactor 6: Shelf
Life.

A shelf life longer than 3 years will not be evaluated
higher or considered to be an additional strength.
Original Solicitation

Factor 4: Price

Via Amendment 0008

Factor 4: Price

Case 1:24-cv-00365-CFL Document 52
Filed 06/12/24 Page 50 of 56
Case 1:24-cv-00365-PSH Document 72 Filed 06/27/24 Page 50 of 56

The government will evaluate each Offeror’s prices to
determine that those prices are fair and reasonable and
to determine which Offerors’ proposals offer the best
value to the agency. Risk of excessive pricing is a major
concern and Offerors are advised to pay special attention
to the instructions related to pricing. The government
reserves the right to reject any proposals that, in its
opinion, does not offer fair and reasonable prices.

a) The Government’s overall best value determination
will consider the cost of the product as it relates to the
shelf-life at time of delivery and the best value
determination will also consider the time, effort, and
cost to sustain product with lesser shelf-life.

b) Options. The Government will evaluate offers for
award purposes by adding the total price for all options
to the total price for the basic requirement. The
Government
may
determine
that
an
offer
is
unacceptable if the option prices are significantly
unbalanced. Evaluation of options shall not obligate the
Government to exercise the option(s).

c) In accordance with FAR 15.401-1 Proposal Analysis
techniques, the Government will consider unbalanced
pricing when performing the price evaluation.
The government will evaluate each Offeror’s prices to
determine that those prices are fair and reasonable. Risk
of excessive pricing is a major concern and Offerors are
advised to pay special attention to the instructions
related to pricing. The government reserves the right to
reject any proposals that, in its opinion, does not offer
fair and reasonable prices.

a) Options. The Government will evaluate offers for
award purposes by adding the total price for all options
to the total price for the basic requirement. The
Government
may
determine
that
an
offer
is
unacceptable if the option prices are significantly
unbalanced. Evaluation of options shall not obligate the
Government to exercise the option(s).

b) In accordance with FAR 15.401-1 Proposal Analysis
techniques, the Government will consider unbalanced
pricing when performing the price evaluation.

c) A written notice of award or acceptance of an offer,
mailed or otherwise furnished to the successful offeror
within the time for acceptance specified in the offer,
shall result in a binding contract without further action
by either party. Before the offer’s specified expiration
time, the Government may accept an offer (or part of an
offer), whether or not there are negotiations after its
receipt, unless a written notice of withdrawal is received
before award

169.
By way of summary, the Agency has: (a) changed the purpose of the procurement
from creating a stockpile of medical gowns “to ensure sufficient domestic availability of such
items during national emergencies and/or pandemic events” to simply soliciting medical gowns to
be used in “healthcare settings”, (compare AR 277 with Amendment 0009 at 11); (b) eliminated
the evaluation of shelf life in any substantive way under Factor 2, Subfactor 6 (Shelf Life) to
merely requiring offerors to submit a “signed certified manufacturer statement” and expressly
stating that products with shelf life that exceeds three years “will not be evaluated higher or
considered to be an additional strength”, (compare AR 316 with Amendment 0009 at 54); (c)
eliminated the consideration of shelf life in evaluating offerors’ prices under Factor 4 (Price),
Case 1:24-cv-00365-CFL Document 52
Filed 06/12/24 Page 51 of 56
Case 1:24-cv-00365-PSH Document 72 Filed 06/27/24 Page 51 of 56

(compare AR 317 with Amendment 0009 at 55); and (d) eliminated the consideration of shelf life
in making the Agency’s best value determination by removing the requirement for the Agency to
“consider the cost of the product as it relates to the shelf-life at time of delivery” and “also consider
the time, effort, and cost to sustain product with lesser shelf-life.” (compare AR 318 with
Amendment 0009 at 55).
170. These changes to the Solicitation show the Agency now seeks to procure a new
requirement—medical gowns without a long shelf life that are cheaper for only the next three
years. Because the Agency’s needs have apparently materially changed, the Agency is required
under the law and applicable regulations to cancel the Solicitation and competitively procure its
new requirements in accordance with CICA and FAR 15.206(e).8
171.
StringKing has been prejudiced by the Agency’s failure to cancel the Solicitation
and resolicit the Agency’s new requirements in accordance with CICA and the FAR. As amended,
the Solicitation unfairly skews the competition in favor of products with lesser shelf life and
essentially eliminates StringKing from consideration for award under the Agency’s new evaluation
criteria.
172.
StringKing’s protest must be sustained.
PREJUDICE
173.
StringKing incorporates by reference the allegations set forth above.

8 If the Agency’s requirements have not materially changed, the Agency should be estopped from
eliminating shelf life from the evaluation criteria for Factors 2 and 4 and in the overall best value
determination as well as changing the stated purpose of the procurement.
Case 1:24-cv-00365-CFL Document 52
Filed 06/12/24 Page 52 of 56
Case 1:24-cv-00365-PSH Document 72 Filed 06/27/24 Page 52 of 56

174.
At bottom, the Solicitation was issued by the Agency to procure medical gowns to
create a stockpile and prepare for future national emergencies and pandemics in response to the
COVID-19 pandemic, which saw dangerous shortages of personal protective equipment for
medical personnel throughout the country and world. The Agency has completely changed the
requirement it is soliciting through a series of arbitrary and capricious amendments, to the extreme
detriment of StringKing and other offerors that have products with longer shelf life.
175.
HHS’s actions have harmed StringKing specifically. StringKing has spent millions
of dollars to prepare for this procurement, which includes creating a new product with long shelf
life to specifically meet the Agency’s requirements, securing and equipping a specialized
manufacturing facility, and undergoing lengthy and expensive shelf life testing to meet the
Agency’s requirements and emphasis on shelf life as originally stated in the Solicitation.
176.
Among other things, as an offeror with surgical gowns with a long shelf life,
StringKing has been harmed by Amendment 0008, which was specifically aimed at eliminating
shelf life as a factor for the Agency’s price evaluation and overall best value determination, and
Amendment 0009, which has resulted in an arbitrary and capricious de facto elimination of shelf
life from the evaluation criteria for the procurement overall by arbitrarily and capriciously revising
Factor 2 to state that “Isolation Gowns must have a shelf life of 3 years” and that “shelf life longer
than 3 years will not be evaluated higher or considered to be an additional strength a ceiling value
on shelf life.”
177.
These amendments, both individually and collectively, have resulted in a de facto
elimination of shelf life from the evaluation criteria for the Solicitation, which is inconsistent with
the Solicitation’s original stated purpose (as well as the purpose of SNS, which is to create a
Case 1:24-cv-00365-CFL Document 52
Filed 06/12/24 Page 53 of 56
Case 1:24-cv-00365-PSH Document 72 Filed 06/27/24 Page 53 of 56

stockpile of PPE). The entirety of StringKing’s extensive preparations over the last few years have
been focused on providing the Agency with a product that has as long a shelf life as possible in
response to the Agency’s emphasis on shelf life in the evaluation criteria under Factors 2 and 4
and in the overall best value determination. And now, at the very last minute, the Agency has
sought to change course in a material way that harms StringKing and makes StringKing’s proposal
noncompetitive (especially from a price standpoint).
PRAYER FOR RELIEF
178.
Accordingly, StringKing respectfully requests that this Court enter judgment for
Plaintiff-Intervenor and further requests that the Court:
a.
Declare HHS’s issuance of Amendment 0008 to be:
i. arbitrary and capricious, an abuse of its discretion, and contrary to
law; or
ii. alternatively, declare HHS’s issuance of Amendment 0008 to be a
material change to the Solicitation’s requirements that mandates
cancellation of the procurement overall;
b.
Declare HHS’s issuance of Amendment 0009 to be:
i.
arbitrary and capricious, an abuse of its discretion, and contrary to
law; or
ii.
alternatively declare HHS’s issuance of Amendment 0009 to be a
material change to the Solicitation’s requirements that mandates
cancellation of the procurement overall;
Case 1:24-cv-00365-CFL Document 52
Filed 06/12/24 Page 54 of 56
Case 1:24-cv-00365-PSH Document 72 Filed 06/27/24 Page 54 of 56

c.
Permanently enjoin HHS from removing shelf life from the Solicitation’s
evaluation criteria;
d.
Permanently enjoin HHS from proceeding with the award of NYES’s under
the RFP without first evaluating StringKing’s proposal in a manner
consistent with the Solicitation and applicable law;
e.
Direct the Agency to re-evaluate proposals in accordance with the terms of
the Solicitation evaluation criteria to include consideration of shelf life as
originally contemplated;
f.
Award StringKing its reasonable attorney’s fees and costs; and,
g.
Provide such other and further relief as the Court deems just and proper.

Case 1:24-cv-00365-CFL Document 52
Filed 06/12/24 Page 55 of 56
Case 1:24-cv-00365-PSH Document 72 Filed 06/27/24 Page 55 of 56

Dated: June 12, 2024

Respectfully submitted,

HOLLAND & KNIGHT LLP

/s/Eric Crusius

Eric S. Crusius, Esq. (Counsel of Record)

1650 Tysons Boulevard, Suite 1700

Tysons, Virginia 22102
Phone: (703) 720-8042
Facsimile: (703) 720-8610
E-mail: eric.crusius@hklaw.com

Counsel for String King Lacrosse LLC
Of Counsel:

Amy L. Fuentes
Holland & Knight LLP
1650 Tysons Boulevard, Suite 1700
Tysons, Virginia 22102
Email: amy.fuentes@hklaw.com

Richard Ariel
Holland & Knight LLP
800 17th Street NW, Suite 1100
Washington, District of Columbia 20006
Email: richard.ariel@hklaw.com

Case 1:24-cv-00365-CFL Document 52
Filed 06/12/24 Page 56 of 56
Case 1:24-cv-00365-PSH Document 72 Filed 06/27/24 Page 56 of 56

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First Amended Bid Protest Complaint

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