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FBO DAILY - FEDBIZOPPS ISSUE OF MARCH 05, 2017 FBO #5581
DOCUMENT

R -- Pharmacy Clean Room Compliance USP797 and USP800 Site Inspections and Testing - Attachment

Notice Date

3/3/2017
 

Notice Type

Attachment
 

NAICS

541611 — Administrative Management and General Management Consulting Services
 

Contracting Office

Department of Veterans Affairs;Network Contracting Office 4;1111 East End Blvd;Wilkes Barre, PA 18711
 

ZIP Code

18711
 

Solicitation Number

VA24417Q0496
 

Response Due

3/10/2017
 

Archive Date

5/9/2017
 

Point of Contact

Robert Savage
 

E-Mail Address

4-3521
 

Small Business Set-Aside

N/A
 

Description

REQUEST FOR INFORMATION a. The Veterans Health Administration is requesting potential sources and information concerning the Compliance of the Pharmacy cleans rooms to meet the standards of USP797 and USP800 at the Wilkes Barre VA Medical center located at 1111 East End Blvd, Wilkes Barre, PA 18711.   This is a sources sought and request for information for market research purposes only and is not a solicitation. b. The following information is requested from all companies capable of performing services as stated in the below draft statement of work (SOW): Vendors Name, Duns number Contact information to include telephone number and email address Technical Capability statement Similar contracts Lessons learned from similar past contract experience Socio-economic status I.E. large business, small business, service disabled veteran owned business, veteran owned business, women owned business, 8a, Hub Zone, disadvantaged, etc. System for Award Management (SAM) Registered, yes or no STATEMENT OF WORK Pharmacy Clean Room Consultant Services for USP797 and USP800 Compliance Background: The pharmacy clean room mixing area consists of a Chemo IV prep, IV prep, and Ante room. The rooms are being controlled with a single air handler. PURPOSE: The Wilkes-Barre VA Medical Center located at 1111 East End Blvd. Wilkes Barre, PA 18711 requires a qualified contractor to perform an analysis of the facility s pharmacy mixing/compounding clean rooms. The analysis of the clean rooms shall be inspected per the United States Pharmacopeia USP797 and USP800 Standards. The analysis contractor shall provide a written report on deficiencies or gaps and guidance for achieving the certifications to the clean rooms. The service required includes providing all labor, overhead, materials, tools, equipment, supervision, in-house or third-party testing services, administrative support and travel required for performing the following work: Perform onetime air-balance testing, adjustment and certification of the existing ventilation, exhaust, monitoring system (3 rooms, single air-handler, two exhaust hoods, two pressure alarms) using the Contractor s in-house resources or a qualified third-party vendor; Perform onetime microbiological testing of surfaces and air in the anti-room and two mixing rooms. The locations of the proposed tests are to be determined jointly during the initial site visit. Contractor should budget for 40 surface and 10 air samples to be collected and analyzed by a certified laboratory; Perform an analysis of the existing clean rooms to determine compliance with USP 797 Design and Functionality Standards including the suitability and performance of existing of Primary Engineering Controls (PECs) and provide recommendations for improvement/modifications/upgrade as indicated for current compliance with UPS 797 and future compliance with UPS 800; Perform analysis/audit of compounding/preparation operations and device and provide recommendations for improvement/modifications/upgrade as indicated for current compliance with UPS 797 and future compliance with UPS 800; Review space cleaning and disinfecting procedures including types of cleaning compounds used and cleaning procedures and provide recommendations for improvement/modifications/upgrade as indicated for current compliance with UPS 797 and future compliance with UPS 800; Perform a comprehensive review of existing hygiene and garbing procedures and provide recommendations for improvements, modifications, or upgrade as indicated for current compliance with UPS 797 and future compliance with UPS 800; Perform a comprehensive audit/review of existing personnel training procedures and provide recommendations for improvement, modifications and/or upgrade as indicated for current compliance with UPS 797 and future compliance with UPS 800; Perform a comprehensive audit/review of existing facility SOPs related to compounding/mixing and provide recommendations for improvement, modifications and/or upgrade as indicated; Perform a comprehensive audit/review of the existing facility Quality Assurance Program (QAP) and provide recommendations for improvement, modifications and/or upgrade as indicated for current compliance with UPS 797 and future compliance with UPS 800; Perform a comprehensive audit/review of existing environmental monitoring procedures and provide recommendations for improvement, modifications and/or upgrade as indicated for current compliance with UPS 797 and future compliance with UPS 800; and, Perform a comprehensive audit/review of all other of related UPS compliance requirements and provide recommendations for improvement, modifications and/or upgrade as indicated for current compliance with UPS 797 and future compliance with UPS 800. DELIVERABLES: The Contractor shall provide two printed copies of the final report, tests and all exhibits tabulated in 3-ring binders and one digital copy of same on a CD ROM Disc. TRAVEL: At a minimum, the Contractor shall perform an initial site visit to review operations, documentation and infrastructure and a final site visit to present/review findings QUALIFICATIONS: The Contractor shall be an expert with at least 10-years proven experience, as an organization, in USP 797/800 compliant operation, design and certification of pharmaceutical clean rooms. Professional staff employed by the Contractor and assigned to this work may include Pharmacists, Microbiologists, Architects, Scientists and/or Engineers that are NSF, NEBB and/or CETA certified as required. Special Conditions: All work shall be completed within 120-days from award of the Contract. All work shall be performed Monday thru Friday (7:30 AM to 5:00 PM). No onsite work or testing will be conducted on Federal Holidays and/or Weekends. Responses with the requested information shall be submitted to Robert.savage@va.gov
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/PiVAMC646/PiVAMC646/VA24417Q0496/listing.html)
 

Document(s)

Attachment
 

File Name: VA244-17-Q-0496 VA244-17-Q-0496.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3313362&FileName=VA244-17-Q-0496-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3313362&FileName=VA244-17-Q-0496-000.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: Wilkes Barre VA Medical Center;1111 East End Blvd;Wilkes Barre, PA 18711

Zip Code: 18711
 

Record

SN04423120-W 20170305/170303235649-d956a9dfff461e69314349233f2b3a1d (fbodaily.com)
 

Source

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

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