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FBO DAILY ISSUE OF FEBRUARY 23, 2012 FBO #3743
DOCUMENT

65 -- Cardioplegia Solutions 4-1-2012 through 3-31-2017 - Attachment

Notice Date

2/21/2012
 

Notice Type

Attachment
 

NAICS

325412 — Pharmaceutical Preparation Manufacturing
 

Contracting Office

Department of Veterans Affairs;VA Pittsburgh Healthcare System;Acquisitions (90C-A);1010 Delafield Rd;Pittsburgh PA 15215-1802
 

ZIP Code

15215-1802
 

Solicitation Number

VA24412Q0321
 

Response Due

2/24/2012
 

Archive Date

2/24/2012
 

Point of Contact

Theresa A Pietrowski
 

E-Mail Address

822-3741<br
 

Small Business Set-Aside

N/A
 

Description

The VA Pittsburgh Healthcare System (VAPHS) intends to negotiate on a sole source basis with Central Admixture Pharmacy Services, Inc. (CAPS), Corporate Office, 2525 McGaw Avenue, Irvine, CA, 92614 for amino acid enriched Cardioplegia solutions utilized for open heart surgery (Amino Acid Enriched Cardioplegia Solution which contains Sodium Bicarbonate (1mEq/ml) 20 ml, CPD 12 ml, Isolyte-S 15 ml and MSA/MSG (0.92M) 20.79 ml in a 250ml Viaflex or Compatible IV Bag.) The vendor must be a licensed compounding pharmacy or manufacturer. Products and services will be provided directly by the vendor and not a subcontracted vendor. The vendor must formulate specialty compound IV mixtures per VAPHS specifications on a per order basis. These compound solutions are only available through CAPS. VAPHS requires a 0% tolerance error rate for the compounded IV admixtures. The VAPHS has a requirement for a vendor who is fully compliant with United States Pharmacopeia (USP) Chapter 797 regulations for compounding 'high risk' sterile products, and one that must be FDA-approved to produce glutamate/aspartate solution for Cardioplegia. The vendor must meet or exceed all applicable Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) guidelines. The vendor will provide regular quality assurance reports; employ highly-experienced, customer-oriented admixture licensed pharmacists; will provide proof of staff competency and certification of pharmacy at time of award; will have monitored and controlled clean-room conditions; will possess detailed protocols for each admixture process; will provide validation for pyrogen assay; microbial growth, stability, and aseptic fill technique; release tests and finish inspection protocols; will provide environmental particulate and boiburden monitoring, will provide a copy of the biannual (every 6 months) IV room certification documenting compliance with USP 797 standards. Vendor staff participates in continuous quality assessment and improvement program, which meets requirements developed by the Joint Commission, the FDA, ISO 9000, and USP 797. Vendor will meet all Federal, State and Joint Commission requirements for quality assurance. Vendor hours of operation shall be seven (7) days per week between 8:00 am - 10:00 pm with a contact number for 'after -hours' inquiries. Orders will be same day delivery or delivered Federal Express for AM priority next business day Monday - Friday. Estimated usage is 21 bags per month. Vendor shall provide a packing list with each/all deliveries. Vendor fax number will be required. This notice of intent is not a request for proposal. Vendors who wish to identify their interest and capability to formulate and distribute amino acid enriched Cardioplegia solutions for open heart surgery as described above must notify this Contract Specialist at Theresa.Pietrowski@va.gov or by telephone at 412-822-3741 no later than 1:00PM EST Friday, February 24, 2012. Upon receipt of interested parties' notification, the Contract Specialist will determine whether to conduct a competitive procurement or proceed with sole source negotiations. Technical questions can be directed to Lucy Speerhas at Lucy.Speerhas@va.gov or telephone 412-360-3360.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/PiVAMC646/PiVAMC646/VA24412Q0321/listing.html)
 

Document(s)

Attachment
 

File Name: VA244-12-Q-0321 VA244-12-Q-0321.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=298731&FileName=VA244-12-Q-0321-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=298731&FileName=VA244-12-Q-0321-000.docx

 

File Name: VA244-12-Q-0321 FEDBIZOPPS INTENT TO SS CARDIOPLEGIA FV_02.DOCX (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=298732&FileName=VA244-12-Q-0321-001.DOCX)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=298732&FileName=VA244-12-Q-0321-001.DOCX

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Place of Performance

Address: VA Medical Center;30 University Drive C;Pittsburgh, PA

Zip Code: 15240
 

Record

SN02679753-W 20120223/120221235100-e58fffde9b235690267b509c2bcf2b91 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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