MODIFICATION
65 -- 339113Allograft Tissue BPA
- Notice Date
- 12/10/2015
- Notice Type
- Modification/Amendment
- NAICS
- 339113
— Surgical Appliance and Supplies Manufacturing
- Contracting Office
- Department of the Army, U.S. Army Medical Command, MEDCOM, North Atlantic Regional Contracting Office, 8901 Rockville Pike, Bldg 54, Bethesda, Maryland, 20889, United States
- ZIP Code
- 20889
- Solicitation Number
- W91YTZ-16-T-XXX1
- Archive Date
- 12/31/2015
- Point of Contact
- Eric Jones, Phone: 703-806-0170, Yvonne T. Parson, Phone: 7038060140
- E-Mail Address
-
eric.g.jones28.civ@mail.mil, Yvonne.t.Parson.civ@mail.mil
(eric.g.jones28.civ@mail.mil, Yvonne.t.Parson.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- The Regional Health Contracting Office - Atlantic, Fort Belvoir, VA intends to solicit and negotiate a multi-award unrestricted five-year Blanket Purchase Agreement for the Operating Room of Keller Army Community Hospital (KACH), West Point, NY to provide various allograft tissues. No more than three (3) awards will be made. The awardee(s) must be capable of providing ALL of the graft types listed below in various sizes which must also meet each of the twelve (12) minimum specifications. The Government, however, reserves the right to award to only one responsible offeror. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation and quotations are being requested and a written solicitation will not be issued. This solicitation number W91YTZ-16-T-XXX1 is issued as a request for quotation (RFQ). The Federal Supply Code is 6515 and the NAICS Code is 339113. The various graft tissue types are as follows: a. Ligament Reconstruction: anterior tibialis tendon, posterior tibialis tendon, semitendinosis tendon, gracilis tendon, patella bone-tendon-bone, achilles tendon b. Meniscus and Cartilage: Graft matching services with patient-specific anatomically matched allografts to include: medial and lateral knee meniscus, distal femoral osteochondral graft, patella osteochondral graft, and trochlea osteochondral graft. c. Instrument set: For osteochondral grafts, instrument set must be provided to hospital as part of the surgical package when graft is accepted. d. Bone grafts and bone void fillers: cancellous bone chips, demineralized bone matrix, structural allografts, deformity correction allografts, biologic scaffolds The above graft types shall adhere to the following minimum specifications: 1. Regulatory: Conform or exceed the standards of tissue banking set by the Food and Drug Agency (FDA) and American Association of Tissue Banks (AATB). 2. Age Criteria: a. Soft tissue grafts - age limit of 65 years old b. Osteochondral allograft - age limit of 45 years old 3. Cancer: Does not accept donors with cancer. Limited exceptions for in-situ cancer of the cervix and basal cell carcinoma, if surgically removed and no reoccurrence in six months. 4. Graft Processing: Does not use radiation or harsh chemicals such as hydrogen peroxide. 5. Domestic Donors: All domestically distributed tissues are recovered from domestic donors only. 6. Donor Screening: Does not accept donors deferred for any medical reason by any other tissue bank. 7. Infection: Does not accept a donor with any evidence of active, systemic infection, or in which infection was the cause of death or a contributing factor in the death. 8. End Stage renal disease/chronic dialysis: Reject all musculoskeletal donors with ESRD due to the potential impact on bone and soft tissue quality. Reject all donors with a history of chronic hemodialysis or peritoneal dialysis. 9. Steroids: Since steroid use can affect tissue quality and safety, reject all potential donors treated with a dose greater than 20 mg/day for more than 30 days. 10. Illegal Drugs: No IV drug use within five years of death, reject non-IV quote mark street drugs quote mark such as cocaine or methamphetamines within 12 months of death. Also, reject potential donors with drug-seeking behaviors, such as a history of stealing drugs or purchasing narcotic drugs. 11. High-Risk Behavior: Donors are rejected for history for sex with at-risk partners, active STDs, pedophilia and other at risk behaviors. Incarceration history is reviewed for duration, cause, and by type of institution. 12. Osteoporosis: Reject all donors with a confirmed diagnosis as well as those being treated with bisphosphonates. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-83. Interested persons may identify their interest and capability to respond to the requirement and submit proposals. Provide your Company's Dunn and Bradstreet number (DUNS); CAGE code; tax ID number; number of days to deliver, along with your Published Price list, by item number, for evaluation purposes. All proposals received after the date of publication of this synopsis will NOT be considered by the Government. Submit proposals via email ONLY to Eric G. Jones at eric.g.jones28.civ@mail.mil no later than 28 November 2015 @ 5:00 PM EST. No telephonic requests will be honored. Question: We would like to know if the customer has salients for the instrument set for the osteochondral grafts for this solicitation? Answer: There are no salient characteristics for the instrument set. However, the following is a more specific description of what the set is used for and what it contains. The set is to be used for fresh osteochondral graft implantation. The set includes a graft station, graft makers, lesion reamers, forceps, tamps, and dilators. The set must contain instrumentation used for the donor site (allograft tissue) and the recipient site (patient). The instruments must cover lesions measuring 15-35 mm in diameter. The set must contain at least 5-7 different diameter reamers within the range of 15-135 mm. The set accompanies the fresh allograft to KACH so that it can be inspected and processed prior to surgery. Question: In the various graft tissue types requested, can you provide any additional information or specifics for the "deformity correction allografts" in line item "d"? Answer: Since the type of surgery performed is sports medicine surgery, the deformity grafts referred to above are HIGH TIBIAL OSTEOTOMY ALLOGRAFT WEDGES (used for high tibial osteotomies and distal femoral osteotomies). Sizes must include: 6mm, 8mm, 10mm, 12mm 14mm, 16mm, 18mm.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/MEDCOM/DADA15/W91YTZ-16-T-XXX1/listing.html)
- Place of Performance
- Address: Keller Army Community Hospital (KACH), West Point, New York, 10996, United States
- Zip Code: 10996
- Zip Code: 10996
- Record
- SN03966315-W 20151212/151210234356-0da81eeac3e9c73031ed6e7605226005 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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