JA Non Bio Surgical Implants_Modification for Contract Extension - Academy.pdf

U.S. DEPARTMENT OF VETERANS AFFAIRS

Office of Procurement, Acquisition and Logistics (OPAL)

Strategic Acquisition Center (SAC)

10300 Spotsylvania Avenue, Suite 400

Fredericksburg, Virginia 22408

JUSTIFICATION AND APPROVAL

FOR OTHER THAN FULL AND OPEN COMPETITION

(1) Identification of the agency and the contracting activity, and specific identification of the document as a "Justification for Other Than Full and Open Competition."

This Justification and Approval (J&A) for Other Than Full and Open Competition is executed by the Strategic Acquisition Center (SAC), Acquisition Service 4 on behalf of the U.S. Department of Veterans Affairs (VA), Veterans Health Administration (VHA), Prosthetic & Sensory Aids Service (PSAS).

(2) Nature and/or description of the action being approved.

This activity proposes to negotiate a non-competitive contract extension via modification to Academy Medical Inc, System for Award Management (SAM) Unique Entity ID (UEID) HGEGAA2B93W9, a Service-Disabled Veteran Owned Small Business (SDVOSB), for contract VA119-16-D-0043, awarded on 09/30/2016. This national contract vehicle, currently in place, is a critical component to the infrastructure of the VA’s mission to provide VA clinicians and veterans the continued ordering access and availability of prosthetics surgical implants.

(3) A description of the supplies or services required to meet the agency’s needs (including the estimated value).

The purpose of this contract modification is to allow VA clinicians and veterans continued access to a robust supply chain for ordering and delivery of prosthetics surgical implants as the VA continues to navigate the COVID-19 pandemic emergency and the transition to new national contract vehicles. The modification to extend the ordering period on the national contract will be executed only for those supplies, at the previously agreed upon rates, that are currently available on contract for ordering.

The supplies to be acquired consist of various types of prosthetics surgical implants needed for a variety of prosthetic related surgeries and patient treatment and include only items from the surgical implants in support of prosthetics product lines.

The product line encompasses a variety of different items considered prosthetics surgical implants, to include auxiliary products (screws, anchors, plates, etc.) and instrumentation sets required for use by clinicians performing implant surgery, which may be required by a VA clinician for a Veteran patient’s treatment. The exact number and exact type of prosthetics surgical implants that are on the national contract vehicle are constantly changing based on clinicians’ requirements for veteran patient treatments and advances in technology; currently throughout the entirety of the prosthetics national

Strategic Acquisition Center (SAC)

10300 Spotsylvania Avenue, Suite 400

Fredericksburg, Virginia 22408 contract vehicle portfolio there are over 200,000+ individual prosthetics surgical implant line items.

The estimated dollar value is based on analysis of Fiscal Year (FY) 20 through FY 22 sales of the prosthetics surgical implants on the current national contract vehicle. This estimated value is most representative of the projected surgical implant market environment during the extension period covering FY22-FY23. FY22-FY23 and associated sales are likely to be impacted by the COVID- 19 national emergency in addition to Monkeypox global health emergency, which may or may not reduce surgical implant spending, as resulting restrictions affect procedures at all VA Medical Centers.

All prosthetics surgical implants to be made available during the extension of the national contract vehicle ordering period have previously been technically reviewed in a collaborative effort by the VHA PSAS and the SAC based on product usage, product form/function, and product pricing. The resulting non-competitive contract extension, to be executed via modification, will be strictly for a base ordering period of 6 months and one (6 month) option ordering period; this equates to a total maximum allowable 12 months/1 year extension to the contract ordering period,10/01/2022 – 3/31/2023 and one six-month option period 4/1/2023 – 09/30/2023.

(4) An identification of the statutory authority permitting other than full and open competition.

The statutory authority permitting other than full and open competition is Title 41 United States Code (U.S.C.) § 3304(a)(5) and 38 U.S.C. § 8123 implemented by the Federal

Acquisition Regulation (FAR) subpart 6.302-5 entitled, “Authorized or required by stature” and VA Acquisition Regulation (VAAR) 806.302-571 entitled “Authorized or Required by Statute”-VA unique authorities”.

(5) A demonstration that the proposed contractor’s unique qualifications or the nature of the acquisition requires use of the authority cited.

The purpose of this J&A is for approval of an extension of the national contract vehicle, via other than full and open competition, for a period of time to allow the ongoing clinician response to the COVID-19 national emergency to subside to ensure adequate personnel time is allocated to the completion of the Integrated Product Team (IPT) requirements for planning of the follow-on contracts and support for the technical review of proposals in response to solicitation of vendors for the follow on new national contract vehicles. The extension of the ordering period on the current national contract vehicle will ensure VA is able to maintain a successful and robust prosthetics surgical implant supply chain until such time as a new contract vehicle can be established through use

Strategic Acquisition Center (SAC)

10300 Spotsylvania Avenue, Suite 400 of technical evaluations of products that could be called upon for use in patient care as determined by a clinician on an individual patient treatment basis.

The current need for a non-competitive extension of the national contract vehicle’s current ordering period envelops prosthetics surgical implants; the use of specific surgical implants is based solely upon a patient’s need and the physician's determination of medical necessity during a medical or surgical service(s) and/or procedure(s) at any of the Veterans Affairs Medical Centers (VAMC). A physician's decision to use a particular manufacturer's surgical implant is based on the technical characteristics of the implant and that it is expected to produce a higher quality of life for the patient or achieve certain therapeutic results.

Most surgical implant products are unique and proprietary to each individual manufacturer. The use of a particular manufacturer's prosthetics surgical implant requires highly specialized training on the part of the physician. Once trained and comfortable with a manufacturer’s surgical implant, the physician will likely use that manufacturer's products for the duration of his or her career. Prosthetics surgical implants are products that are unique to each company and typically proprietary in nature. Although there are similarities amongst products, specific surgical implant(s) form and function are mostly unique to individual manufacturers. Therefore, the general nature and current market conditions for prosthetics surgical implants themselves, are a barrier to competition.

The requirement for the current national contract vehicle was based on a technical review of, and for, clinician determination of medical necessity and experience, and any effort to award a new national contract based on any individual factor, or combination of factors, not including a technical review by clinicians would be detrimental to clinician’s choice and the requirements for ensuring optimal patient care. As it relates to the follow on contract, the approval of the J&A and the subsequent extension to the current national contract, will allow for all necessary personnel to participate in identifying additional sources of supply in conjunction with those vendors who currently have a national contract. In accordance with FAR 5.301, this action will be synopsized at award on "Contract Opportunities" under beta.SAM.gov and this justification will be made publicly available. If subsequent information is received as it relates to vendors who do not currently have a national contract, that information will be included as market research for the follow-on effort and will be evaluated against the requirements respectively.

The significance of this national contract vehicle is to directly support veteran patient care, relating to and through, the ordering of prosthetics surgical implants. The national contract vehicle facilitates the prescribing clinician’s ability to provide the most optimal care by having access to an ordering vehicle for manufacturer specific prosthetics

Strategic Acquisition Center (SAC)

10300 Spotsylvania Avenue, Suite 400 surgical implant items that have been technically reviewed to ensure compliance with laws and regulations and are available for ordering at pre-determined fair and reasonable pricing. The national contract vehicle directly contributes to clinician efficiency in the veteran patient care process by saving time, money and reinforcing adequate technical safeguards.

VHA Directive 1081.01(1) dated October 29, 2018, establishes policy, procedures, and responsibilities for the use of Title 38 United States Code (U.S.C.) § 8123 authority for the procurement of prosthetics surgical implants, without regard to any other provision of law. In accordance with 38 U.S.C. § 8123, "the Secretary may procure prosthetics appliances and necessary services required in the fitting, supplying, and training and use of prosthetics appliances by purchase, manufacture, contract, or in such other manner as the Secretary may determine to be proper, without regard to any other provision of law."

Additionally, 48 CFR § 806.302-571 states that full and open competition need not be provided when authorized by a statute, and § 806.302-571(b)(1) outlines the specific products covered “[p]rosthetic appliances and necessary services required in fitting, supplying and training and use of prosthetic appliances by purchase. The prescribing clinician will provide the necessary clinical evidence to support medical need for specialized Prosthetics surgical implants and supporting equipment for the veteran who is eligible, referred, and approved for care.

The national contract vehicle was originally awarded via other than full and open competition by way of the statutory authority of 38 U.S.C § 8123 which remains applicable to the products covered under the J&A. The national contract vehicle consisted of a base and options and has covered a period of performance of

10/01/2016 - 09/30/2022. The contract ordering period happened to directly coincide with the ongoing COVID-19 national emergency. This pandemic has affected the national contract, and the efforts to establish new national contracts directly and severely.

(6) A description of efforts made to ensure that offers are solicited from as many potential sources as is practicable, including whether a notice was or will be publicized as required by subpart 5.2 and, if not, which exception under 5.202 applies.

In accordance with VAAR 806.302-571, contracting activities may procure prosthetic appliances and necessary services required in the fitting, supplying, and training and use of prosthetic appliances by purchase, manufacture, contract, or in such other manner as determined to be proper, without regard to any other provision of law.

Strategic Acquisition Center (SAC)

10300 Spotsylvania Avenue, Suite 400

The determination to procure prosthetics surgical implants through contract extension is wholly with the discretion of the Contracting Officer. A notice of the proposed action will be synopsized via the Government Point of Entry (GPE) in accordance with FAR Section 5.201, and the agency will make publicly available the justification required by 6.305(a) within 14 days after contract award.

(7) A determination by the contracting officer that the anticipated cost to the

Government will be fair and reasonable.

The modification for extension of the ordering period on the national contract vehicle will utilize the products and pricing that are currently established and were previously determined fair and reasonable. No new products will be added via the refresh process until the contracting officer determines the cost to the Government to be fair and reasonable. This determination will be based on a comparison of current contract pricing, an Independent Government Cost Estimate, past proposal submissions, and other information as made available.

(8) A description of the market research conducted (see part 10) and the results or a statement of the reason market research was not conducted.

In accordance with FAR Part 10 and VA Acquisition Regulation (VAAR) Part 810, the VA is conducting market research to arrive at the most suitable approach to acquiring Prosthetics surgical implants and maintaining the necessary supply chain. This market research is conducted in a collaborative effort by PSAS and SAC contracting personnel by, but not limited to, providing results from industry through requests for information (RFI), reviewing the results of recent market research undertaken to meet similar or identical requirements, reviewing catalogs and other generally available product literature published by manufacturers, distributors, and dealers or available online, and reviewing systems such as the System for Award Management (SAM), the Federal Procurement Data System-Next Generation (FPDS-NG), and the Small Business Administration's Dynamic Small Business Search which will be completed when the current IPT completes its work process to define the follow-on requirements.

The Government has a requirement for extending the period of performance on this national contract vehicle for prosthetics surgical implants by up to a maximum of 12 months, during which the Contractor will continue to perform the services of providing prosthetics surgical implants on an as needed basis, determined by clinicians as required for veteran’s patient care.

The proposed modification to extend the ordering period of the national contract vehicle will support VA Medical Centers in performing well qualified and necessary veteran patient care nation-wide. The period of performance for this action covers a six-month

Strategic Acquisition Center (SAC)

10300 Spotsylvania Avenue, Suite 400 base period 10/01/2022 – 3/31/2023 and one six-month option period 4/1/2023 – 09/30/2023.

(9) Any other facts supporting the use of other than full and open competition.

No additional facts.

(10) A listing of the sources, if any, that expressed, in writing, an interest in the acquisition.

No additional action or data required.

(11) A statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required.

All future requirements will be handled on a case-by-case basis. Towards the expiration of this contract, consideration will be given as to whether the future acquisition should be competitive. The current national contract vehicle is a compelling part of the VA prosthetics surgical implant supply chain contributing directly to patient care. In this role, the national contract vehicle is vital to ensuring access to the most current products available in the marketplace at the best available pricing. Due to the continuing COVID-19 national emergency there has been an ongoing direct impact to the efforts and process for establishing new follow-on national contracts. As part of executing the new follow-on national contracts it is required that an IPT, comprised of clinicians and other subject matter experts from various roles across the agency, must be established and work together to define the requirements to present to industry. The clinicians support the IPT by helping define the various categories of items that consist of prosthetics surgical implants and their expertise on identifying all requirements on those items that shall make up the national contract vehicle; their role on the IPT is in addition to their roles providing direct veteran patient care. The ongoing COVID-19 national emergency has directly impacted the IPT and its work in defining the requirements for the new suite of national contract vehicles for prosthetics surgical implants as the IPT has been repeatedly delayed in it its work due to clinician’s available commitment of time to patient care due to the COVID-19 pandemic. Their ability to participate has severely impacted the process to establish the IPT and for the

IPT to complete the work required of it.

In addition to the IPTs work in defining the requirements the IPT must also look at how the commercial marketplace has changed, from the date of award of the original national contract vehicles to present, as it relates to supplying prosthetics surgical implants and the technology available. The commercial marketplace has been severely

Strategic Acquisition Center (SAC)

10300 Spotsylvania Avenue, Suite 400 impacted from the ongoing national emergency and it has caused delays in the IPTs work of evaluating supply chain changes and how best to address them in the follow-on national contract vehicles. The COVID-19 national emergency has directly impacted the IPTs ability to meet with industry to understand the changes of the marketplace;

engagement with industry based on clinician availability as it relates to patient care, is just now beginning to become a reality and the IPT has issued a Request for

Information (RFI) and had an industry day August 2022.

The IPT for the follow-on national contracts has been directly and severely impacted by the ongoing COVID-19 national emergency causing delay in the ability to establish new national contract vehicles as discussed above. The efforts to stand up the IPT began at the end of FY20 however due to the COVID-19 national emergency and its various impacts on the agency the IPT only began its work in earnest in January 2022. The massive undertaking of the IPT, while now on the path to success and steadily making progress, will not be complete in sufficient enough time to allow for making new awards of national contract vehicles for prosthetics surgical implants before the current suite of national contract vehicles ordering periods expire.

As is the case with the IPT establishment and ongoing requirements creation, clinician availability plays a role in the evaluation of proposals received in response to any solicitation issued based on the requirements being developed by the IPT for establishing the new national contract vehicles. As part of executing the contract award process, a technical review must be completed for each product being proposed as part of a new national contract vehicle. The technical review is to be done by a group of VA clinicians who are subject matter experts regarding prosthetics surgical implants. The clinicians support the technical review in addition to their roles providing direct veteran patient care. The ongoing COVID-19 national emergency, as we have seen, will directly impact the clinician’s ability to execute the required technical review as part of the award process for the national contract vehicles. The current national contract vehicles encompass upwards of 200,000+ products and it is anticipated that number will increase on the follow-on suite of contracts. Ongoing planning between SAC and PSAS anticipates that a natural delay in the technical review process for the new national contract vehicles will push out the timeline for awards due to clinician’s comm itment of time to patient care during the COVID-19 pandemic.

Without question VHA’s preference during the ongoing COVID-19 national emergency has been, and will continue to be, that clinician time is devoted to directing veteran patient care. Under the current COVID-19 operating procedures, other duties normally assigned to clinicians, such as the work on the IPT for new national contracts for prosthetics surgical implants and any work for technical review of proposals submitted against the future solicitation, has been and will be negatively impacted due to

Strategic Acquisition Center (SAC)

10300 Spotsylvania Avenue, Suite 400 additional time devoted to patient care and lack of additional clinician resources during the pandemic emergency.

PSAS and SAC have been working hand in hand since the implementation of the current national contract vehicle on monitoring performance and actively planning how best to execute future national contract vehicles. All planning efforts to date have identified the ongoing pandemic and other unforeseen illness outbreaks as an unusual risk and have also indicated that due to the importance of the national contract vehicle and its role in the prosthetics surgical implant supply chain that the risk to lapse in coverage would be detrimental to the Government and to VA patient care. The COVID- 19 national emergency, and the procedures in which clinicians must operate due to this unusual circumstance, will essentially not allow the required IPT to complete its work in refining the requirements to support the execution of a new national contract, in addition to performing the required technical evaluations on proposals submitted, before the expiration of the current ordering period. The extension of the ordering period sought via this J&A will ensure continuity in the current supply chain and eliminates the risk of failure to the prosthetics surgical implant supply chain on which veteran patient care relies.

Due to the noted specifics around the current ordering period for the national contract vehicle, the unacceptable risk to a lapse in available ordering vehicle, and the ongoing COVID-19 national emergency, it is incumbent upon the VA to ensure the availability of the current national contract via an extension to support a robust prosthetics surgical implant supply chain in support of veteran patient care. To maintain a robust and successful prosthetics surgical implant supply chain approval of this J&A for other than full and open competition is required.