Combine Solicitation – Blanket Purchase Agreement for Allografts
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Notice Type: Combine Solicitation
Posted Date:
Office Address:
Subject: Blanket Purchase Agreement for Allografts
Classification Code: 65 - Medical, dental & veterinary equipment & supplies
Solicitation Number: 122013-Trahan-BPA
Contact:
Setaside: N/AN/A
Place of Performance Country: US
Description:
Air Mobility Command
60th CONS
Duration: The intended duration of the resulting Agreement(s) are anticipated to be up to five (5) years; however, either party may cancel the Agreement(s) with 30 days written notice.
Product Line: It is the Government's intent that each resulting BPA will include a manufacturer product line for processed human bone and soft tissue allografts. All items within a product line must be included in the quote(s). The intended scope of the resulting Agreement(s) includes all current and future product line items. The vendor shall submit offers that include pricing for both product lines. The Government recognizes that the market is not static and that it will need to have access to state-of-the-art technology. Therefore, in addition to the items initially agreed upon, the scope of the Agreement(s) includes all items which become available during the course of the performance. New or modified items within the awarded product line may be added to or deleted from the Agreement(s) at a later date by a Contracting Officer in accordance with the paragraph entitled, "Technology Refresh."
Description of agreement: The contractor will provide the following under the scope of this BPA: Processed human bone and soft tissue have been used in a variety of surgical applications and in combination with prosthetic devices. The amount and size of allograft necessary for a surgical procedure is based upon an individual surgeon's preference and the size and type of defect. Specifications: 1. All tissues must arrive with packaging intact and maintain sterile integrity. 2. Freeze-dried bone, freeze-dried demineralized bone and freeze-dried soft tissue have been preserved using lyophilization (freeze-drying) to lower the total water content to 6% or less. 3. Bone and soft tissues preserved by freezing have been stored at -40ºC to -90ºC until time of shipping, and are shipped on dry ice. 4. All acellular dermal matrix derived from donated human allograft skin (FlexHD) must have a thickness range of .8 mm - 1.2 mm to ensure the viability of the graft.
Donor/Processing Standards: 1. All tissue should be sorted as it is aseptically processed without using harsh chemicals or terminal irradiation. 2. All tissue must be processed in Class 10 Clean Rooms (ISO Class 4). 3. All incoming donor tissue should be evaluated for any bio burden and assessed by Qualitative and Quantitative measures. 4. Donor criteria must be strictly assessed for the methods utilized in processing the donors. There should be no donors with a history of illicit drug use, cancer, end-stage renal disease, or steroid usage. 5. Additionally, the vendor must have the Right of First Refusal for all donor tissue with their suppliers which mean that the company will take no deferred donors. 6. The company must use the Advanced Tissue Processing (ATP) which was established based on this published data. Using this process employs a series of chemical disinfectants that penetrate the tissue completely to remove endogenous materials, while minimizing exposure to hydrogen peroxide and heat. This maximizes tissue efficacy and minimizes over processing and poor graft incorporation.
Purchase limitation: The dollar limit for each call shall be
Technology Refresh: A. All implants, instruments, and accessories offered shall be state-of-the-art technology. "State-of-the-art" is defined as the most recently designed components which are announced for marketing purposes, available, maintained and supported in accordance with requirements specified in the solicitation. Components and products with a manufacturer's planned obsolescence within the first year of contract award are not acceptable. B. If upgrades of instruments, implants, or supplies become available after establishment of this Agreement, the contractor will substitute them for the initial items per Item C below. C. The contractor will provide to the contracting officer the following information: (1) A list of specific initial items which shall be updated. (2) Product literature for the new items and a detailed description of the differences between the initial items and the new items, and a specific analysis of the comparative advantages/ disadvantages of the items involved. D. The Contracting Officer will provide the information to 60TH MDG for approval. Upon approval, this Agreement will be modified to acknowledge the updated items.
Delivery Requirements: Delivery for all items should be accomplished within 72 hours of receipt in order to be ready for short notice surgical cases unless shipping requirements mandate more immediate delivery. All product deliveries shall go through the Medical Logistics office at 101 Bodin Cr. Bldg 777,
Interested offerors should also note the Health Insurance Portability and Accountability Act (HIPAA) of 1996, Privacy and Security of Protected Health Information applies to resulting BPAs. The following provisions and clauses are incorporated in this notice and are those in effect through Federal Acquisition Circular 2005-71 effective
52.204-9 Personal Identity Verification of Contractor Personnel 52.204-10 Reporting Executive Compensation & First Tier Subcontract Awards 52.209-6 Protecting the Government Interest 52.212-1 Instructions to Offerors 52.212-3 Alternate 1 Offeror Representations and Certifications - Commercial Items 52.222-3 Convict Labor 52.233-3 Protest After Award 52.233-4 Applicable Law for Breach of Contracts 52.212-4 Contract Terms and Conditions-Commercial Items 52.212-5 Contract Terms and Conditions (Deviation) 52.219-28 Post Award Small Business Program 52.222-19 Child Labor Cooperation with Authorities and Remedies 52.222-21 Prohibition of Segregated Facilities 52.222-26 Equal Opportunity 52.222-36 Affirmative Action for Workers with Disabilities 52.222-50 Combating Trafficking in Persons 52.223-11 Ozone-Depleting Substances 52.223-18 No Texting While Driving 252.204-7003 Control of Government Personnel Work Products 252.225-7001 Buy American Act and Balance of Payment Program 252.225-7002 Qualifying Country Sources as Subcontractors 252.232-7010 Levies on Contract Payments 252.232-7003 Electronic Submission of Payment Requests 252.247-7023 (Alt III) Transportation of Supplies by Sea 252.204-7006 Billing Instructions (full text) 252.212-7001 Contract Terms and Conditions DEVIATION 5352.201-9101 OMBUDSMAN
52.212-3 Offeror Representations and Certifications -- Commercial Items
An offeror shall complete only paragraphs (b) of this provision if the offeror has completed the annual representations and certificates electronically via https://www.acquisition.gov. If an offeror has not completed the annual representations and certifications electronically at the ORCA website, the offeror shall complete only paragraphs (c) through (o) of this provision.... (b) (1) Annual Representations and Certifications. Any changes provided by the offeror in paragraph (b)(2) of this provision do not automatically change the representations and certifications posted on the Online Representations and Certifications Application (ORCA) website. (2) The offeror has completed the annual representations and certifications electronically via the ORCA website accessed through https://www.acquisition.gov. After reviewing the ORCA database information, the offeror verifies by submission of this offer that the representation and certifications currently posted electronically at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items, have been entered or updated in the last 12 months, are current, accurate, complete, and applicable to this solicitation (including the business size standard applicable to the NAICS code referenced for this solicitation), as of the date of this offer and are incorporated in this offer by reference (see FAR 4.1201), except for paragraphs ____________. [Offeror to identify the applicable paragraphs at (c) through (o) of this provision that the offeror has completed for the purposes of this solicitation only, if any. These amended representation(s) and/or certification(s) are also incorporated in this offer and are current, accurate, and complete as of the date of this offer. Any changes provided by the offeror are applicable to this solicitation only, and do not result in an update to the representations and certifications posted electronically on ORCA.] CLAUSES INCORPORATED BY FULL TEXT ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS--COMMERCIAL ITEMS The following provisions are incorporated into 52.212-1 as an addendum to this solicitation: QUOTE ORGANIZATION
Offerors shall provide information as described below. Failure to submit complete information in the manner described below for either the Business or Technical Proposal may be considered a "no response" and exclude the proposal from further consideration. The offeror shall submit its proposal in two volumes in the format and quantities described below: VOLUME VOLUME TITLE I BUSINESS II TECHNICAL
The volumes shall be emailed to the contract specialist and cc the Contracting Officer. In the alternative, the offeror may hand-deliver to the 60th Contracting Office,
Point of contact is A1C
Technical Volume Content: A. No cost or price information shall be included in the Technical Proposal. The offeror shall provide descriptive product literature (see definition below).
1. Product Line - Provide product literature that demonstrates the breadth and depth of each product line, including but not limited to: design options, size options, materiel options, etc. Offerors are highly encouraged to identify unique elements about their products that make them superior in terms of quality. 2. Patient Care - The offeror shall provide information that would demonstrate the product has a quality or element that makes it: result in a better outcome for the patient, reduce the risk to the patient, and/or reduce the recovery time for the patient. Warranty information would apply to this category as well. C. The technical volume should be no more than 25 pages, excluding product catalogs and descriptive literature.
DESCRIPTIVE LITERATURE a. "Descriptive literature," as used in this provision, means information (e.g., cuts, illustrations, drawings, and brochures) that is submitted as part of an offer. Descriptive literature is required to establish, for the purpose of evaluation and award, details of the product offered that are specified elsewhere in the solicitation and pertain to significant elements such as (1) design; (2) materials; (3) components; (4) performance characteristics; and (5) methods of manufacture, assembly, construction, or operation. The literature will be used to evaluate the depth and breadth of the offerors product line. b. Descriptive literature, required elsewhere in this solicitation, should be (1) identified to show the item(s) of the offer to which it applies and (2) received by the time specified in this solicitation for receipt of offers.
FAR 52.212-2 Evaluation - Commercial Items (
Award will be made to the offer(s) that represent(s) the best value to the Government taking the foregoing factors into consideration. 52.252-2
1. Security Requirements.
2. The primary contractor will ensure all employees possess proper credentials allowing them to work in
* United States Passport
* Permanent Registration Card/Alien Registration Receipt Card (Form I-1551)
* Foreign Passport with a temporary (
* Employment authorization document that contains a photograph (Form I-766)
* Current/valid Driver's License
* Identification card issued by Federal, State or local Government
* U.S. Coast Guard
* U.S. Coast Guard New Merchant Mariner Credential
Additional supplemental sources of identity proofing which may be requested during increased FPCONS or Random Antiterrorism Measures (RAMs) include, but are not limited to:
* School identification card with photograph
* U.S. Military or draft record
* Native American Tribal Document
* U.S. Social Security Card issued by the
* Certification of Birth Abroad issued by the
* Original or certified copy of a birth certificate issued by a state, county, municipal authority or outlying possession of
* U.S. Citizen ID Cared (Form I-197)
* ID Card for use of Resident Citizen in
* Unexpired employment authorization document issued by the
* Foreign Military or Government Identification Credentials
* Foreign passport with a current arrival-departure record (Form I-94) bearing the same name as the passport and containing an endorsement of the alien's nonimmigrant status, if that status authorizes the alien to work for the employer
* In the case of a nonimmigrant alien authorized to work for a specific employer incident to status, a foreign passport with Form I-94 or Form I-94A bearing the same name as the passport and containing an endorsement of the alien's nonimmigrant status, as long as the endorsement has not yet expired and the proposed employment is not in conflict with any restrictions or limitations identified on the form.
The contractor shall not be entitled to any compensation for delays or expenses associated with complying with the provision of this clause. Furthermore, nothing in this clause shall excuse the contractor from proceeding with the contract as required.
3. Identity Proofing and Vetting. Employees whose background reveals any of the following disqualifiers will not be allowed installation access. All employees will be vetted based on the following disqualifying base access criteria:
* The installation is unable to verify the individual's:
-- Citizenship, immigration status, or social security number or claimed identity.
* The individual is/has/has been:
-- Barred from entry/access to a federal installation or facility. -- Wanted by federal/civil law enforcement authorities, regardless of offense/violation. -- On a federal agency "watch list" or "hit list" for criminal behavior/terrorist activity. -- Knowingly/willfully engaged in acts/activities to overthrow the government by force. -- Incarcerated 12 months/longer in the past 10 years, regardless of offense/violation, unless released on proof of innocence.
* The individual has been convicted of:
-- Child molestation or pornography; any crime involving indecent acts with a minor. -- Espionage, sabotage, treason, terrorism, or murder. -- Firearms or explosive violation within the past ten years. -- Felony involving violence against a person, arson robbery or burglary. -- Drug distribution, possession, intent to sell, trafficking or use more than once. -- Sexual assault, rape, human trafficking or any felony sexual in nature requiring registration as a sex offender under applicable federal or state law.
* The individual is known to be or reasonably suspected of:
-- Being a terrorist or belongs to an organization with known terrorism links or support.
* There is reasonable basis to believe the individual:
-- Submitted fraudulent information concerning his or her identity. -- Will unlawfully or inappropriately use an access credential outside the workplace. -- Will attempt to gain unauthorized access to classified documents, information protected by the Privacy Act, information that is proprietary in nature, or other sensitive or protected information.
* There is reasonable basis to believe, that issuance of an access credential poses unacceptable risk when:
-- Criminal or dishonest history exists. -- A statutory or regulatory bar prevents the individual's contract employment; or would prevent federal employment. -- The individual's material, intentional false statement, deception or fraud in connection with federal or contract employment. -- Based on the nature or duration of the individual's alcohol abuse without evidence of substantial rehabilitation. -- Based on the nature or duration of the individual's illegal use of narcotics, drugs, or other controlled substances without evidence of substantial rehabilitation.
Employees will be identity proofed and vetted each time a pass is issued. Security Forces may conduct random screenings at any time; if, disqualifying base access information is found employees may have their passes revoked.
Employees with disqualifying base access information will be issued a denial access letter immediately revoking their base access privileges. Employees requesting to contest the adjudication, denial of installation access, or requesting a waiver/exception to policy must submit a written rebuttal/request within 10 business days of receipt of the barment letter to 60 AMW/CC, through 60 SFS/CC, Attention: 60 SFS/S5R, Bldg 381,
4. Primary Contractor Responsibilities. The primary contractor will be responsible for the conduct of all employees working under that contract. Additionally, the primary contractor will:
Coordinate base entry requirements with the
Advise employees requesting base access on requirement to complete, sign and submit a
Advise employees the base pass is only valid for the purpose, person and vehicle for which it was issued. Use of the base pass for any other purpose or by any other person will result in the pass being confiscated. Employees that misuse their pass may be subject to barment actions. If a pass is lost, notify the Pass and Registration Office immediately.
* To obtain a pass, personnel will need a valid state or government photo identification.
* To obtain a vehicle pass, personnel will need a driver license, registration and insurance.
Provide written notification, within 24 hrs, to the
Retrieve government issued personal and vehicle passes from employees which no longer need installation access. Passes will be turned into the
Obtaining a
* Contract number
* Work site or location
* Inclusive dates of the contract
* Work schedule (include days of the week and time periods employees are on base)
* Employee's full name, date of birth, and social security number
Only persons who have undergone identity proofing and vetting and have no disqualifying base access information can serve as a sponsor. Persons appointed as sponsors will meet employees at the
5. Employee Responsibilities. All employees requiring reoccurring and unescorted access onto the installation must:
* Carry their DoD ID card or installation pass on their person while on the installation.
* Register privately owned vehicles in accordance with installation policies.
* On request, present their DoD ID card or installation pass to security personnel. Refusal may be grounds for further administrative or punitive action.
* If issued a Command Access Card (CAC), present documentation from the local security office or CAC sponsor confirming that the CAC has been reported lost or stolen.
* Turn in access credentials to the
6. Increased Force Protection Condition (FPCON). During FPCON Normal, Alpha and Bravo; employees without a base issued pass must be sponsored onto the installation. During FPCON Charlie and Delta the base will curtail non-essential operations/functions and non-essential employees will be suspended at the direction of the installation commander. All employees attempting installation access; thereafter, will be physically escorted unless FPCON Mission-Essential designation has been approved in advance and is indicated on the base pass. 7. Restricted Area Badges. Employees may be submitted for unescorted entry into restricted areas if required for their contract. contact the security manager for the military agency responsible for the project.
8. Escort Requirements. The following escort requirements apply:
Installation. Sub-contractors must be escorted at all times.
Controlled/Restricted Areas. Employees not in possession of a restricted area badge will be escorted at all times when working within controlled, restricted or other sensitive areas. Escorts can be either the military agency responsible for the project or an employee in possession of a restricted area badge. The military agency or employee in possession of a restricted area badge will follow existing procedures and instructions for obtaining entrance to controlled, restricted and sensitive areas.
9. Lost Base Passes or Restricted Area Badges.
Base Passes. The employee's supervisor will investigate and provide written notification for a lost base pass to the
Restricted Area Badges (RAB). Employees issued a RAB must report the loss immediately to the security manager of the military agency that submitted the RAB request. The individual who lost the RAB will provide a written explanation on how, when, where and what steps have been taken to locate the missing RAB. The security manager will conduct their own inquiry and forward a report of investigation [with squadron commander endorsement]; the member's written explanation and the original AF Fm 2586 to the Pass and Registration office. A new RAB will not be issued until the investigation is complete.
10. Identification Common Access Card (CAC). Employees requiring computer access must submit a request through the security manager for the military agency responsible for the project. The security manager will facilitate registration within the Contractor Verification System. The QAP is designated as the sponsor and will assist with this process. Once issued, the CAC card must be in the employees possession at all times while on base and performing official duties. The primary contractor shall advise their employees that a favorable security clearance background investigation is needed as a condition of employment under this contract.
11. Anti-terrorism Force Protection Training. IAW AFI 10-245 and TAFB OPLAN 10-245, all employees with contracts over 90 days, will complete initial and annual Level I Anti-Terrorism Awareness training at https://atlevel1.dtic.mil/at/. All personnel will be responsible to provide proof (copy of training certificates) of training to the Anti-terrorism Advisor/Representative responsible for the unit they are contracted. DAVID GRANT MEDICAL CENTER AUTHORIZED VISITORS
1. Medical sales representatives are permitted in the operating room to observe or consult on equipment/supply item only. In no instance will the medical sales representative perform any surgical procedures. Medical sales representatives must sign into RepTrax at the front desk and have an initial orientation to the surgical suite. If medical sales representative is bringing in supplies/equipment/samples this must be coordinated w/ OR supply NCO/technicians in a timely matter (7 or more days before surgery). 1.1. Orientation will be documented on Transient Staff Orientation Checklist maintained at the Operating Room Front Desk. 1.2. All authorized contractors, product representatives, & vendors must be listed at time of case scheduling in S3 (electronic scheduling system) to gain access to ORs for particular surgeries. If rep is not on the surgery schedule, access to surgical suite will not be granted. Reps must present a picture ID to be signed into Rep Trax.
ELECTRONIC SUBMISSION OF INVOICES
Contractor must be registered with WAWF. Requests for payments must be submitted electronically via the Internet through the
Link/URL: https://www.fbo.gov/spg/USAF/AMC/60CONS/122013-Trahan-BPA/listing.html
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