Loren Data's SAM Daily™

FBO DAILY - FEDBIZOPPS ISSUE OF JANUARY 23, 2016 FBO #5174
DOCUMENT

H -- Pharmacy Clean Room and Hood Monitoring Service Wilkes-Barre VA Medical Center - Attachment

Notice Date

1/21/2016
 

Notice Type

Attachment
 

NAICS

621511 — Medical Laboratories
 

Contracting Office

Department of Veterans Affairs;Network Contracting Office 4;1010 Delafield Road;Pittsburgh, PA;15215
 

ZIP Code

15215
 

Solicitation Number

VA24416Q0358
 

Response Due

1/26/2016
 

Archive Date

2/25/2016
 

Point of Contact

mark.murray4@va.gov
 

Small Business Set-Aside

Total Small Business
 

Description

The purpose of this Sources Sought Notice is to search for small business concerns capable to conduct testing services as listed below. This Sources Sought Notice is for market research purposes only and shall not be considered an Invitation for Bids, Request for Quotations, or a Request for Proposal. Do not submit a proposal or quote. This market research is issued for information and planning purposes only and does not constitute a solicitation nor does it restrict the Government as to the ultimate acquisition approach. In accordance with FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Additionally, there is no obligation on the part of the Government to acquire any products or services described in this sources sought. You will not be entitled to payment for direct or indirect costs that you incur in responding to this Sources Sought Notice. Any contract that might be awarded based on information received or derived from this market research will be the outcome of a competitive process. Interested parties are responsible for adequately marking proprietary, restricted or competition sensitive information contained in their response. The Government does not intend to pay for the information submitted in response to this Sources Sought Notice. The draft Statement of Work (SOW) follows: STATEMENT OF WORK FOR PHARMACY CLEAN ROOM AND HOOD MONITORING AND CERTIFICATION WILKES-BARRE VETERANS AFFAIRS MEDICAL CENTER 1. General. Wilkes Bare Veteran Affairs Medical Center (WB VAMC), has a hospital pharmacy that compounds drugs for use in the facility. The pharmacy has two (2) Medium-Risk Level (CSP) compounding rooms (CB-89B, CB-89C: both are ISO 5 rooms) and attached ante room (CB-89A: ISO 7) located within the pharmacy. The intent of this contract is to have a vendor provide the required testing identified in 2007 United States Pharmacopeial Convention Guidance 797 Pharmaceutical Compounding-Sterile Preparations. The WB VAMC has an in-house laboratory that has 6 fume hoods located that need to be inspected and certified annually. 2. Scope. The scope of work shall generally consist of, but not necessarily be limited to, providing all labor, materials, tools, equipment, permits, testing, trouble shoot and reports required to test, calibrate and certify. 2.1 The onsite hours of work are from 8:00 AM to 10:00 PM Monday through Friday; any on site work will have to be previously coordinated and approved via email at least 72 hours prior to any testing. Any work determined by the contracting officer's representative (COR) as having a significant impact on the operations of the facility shall be conducted on an after-hours schedule or limited hours schedule. The Vendor shall follow all federal, state, Veterans Affairs and local code/regulations/standards. The work shall be coordinated through the designated COR. 2.2 The contractor's field personnel shall have training on fundamental practices and precautions with in USP 797 and operation of ISO 5 clean rooms. (e.g. gowning, gloving, and hand washing procedures) The contractor shall have a current National Environmental Balancing Bureau (NEBB) certification and all final reports shall be stamped and signed with NEBB seal. 2.3 This contract is for one base year and four option years. 3.0 Performance Requirements 3.1 Semi Annual Testing Requirements, Pharmacy 3.1.1 The contractor shall preform the following environmental quality control test as prescribed in 797 Pharmaceutical Compounding-Sterile Preparations (2007 revision bulletin edition) 3.1.2 Air Changes per Hour (ACH) - Contractor shall test and validate the number of air changes per hour through the compounding room (s) HVAC equipment and the exhaust hood. 3.1.2 Laminar flow testing - Contractor shall test and validate that the hood and room exhaust provide a unidirectional/laminar air flow as required to prevent contamination. 3.1.3 Inspect HVAC filter assembly for air bypass issues that would cause contamination. 3.1.4 Pressure differential monitoring - Contractor shall test / calibrate the existing air balancing monitors on the compounding rooms and ante room. 3.1.5 Particulate air sampling - Contractor shall take at least three, 800 liter sample of air to be used to count particulate for certification of ISO class room (one sample per room). 3.1.6 Viable Air Sampling - Contractor shall take at least three air samples (one sample per room) so that microbial growth media plates can be prepared for evaluation. Both TSA and MEA agar cultures shall be used. Colony forming units (cfu) results from the cultures shall be calculated in to cfu/cubic meter of air. 3.1.7 Wipe sampling- Contractor shall take 20 wipe samples in each room so that microbial growth media plates can be prepared for evaluation. Both TSA and MEA agar cultures shall be used. Colony forming units (cfu) results. 3.2 Annual Testing Requirements, Laboratory Fume Hood. 3.2.1 The contractor shall preform the following environmental quality control test as prescribed by NEBB publications and standards. (FHT Procedural Standard specification 15990) The contractor shall provide a Testing, Adjusting, and Balancing (TAB) report for the Laboratory hoods and rooms. 3.2.2 The laboratory has a total of 6 hoods in the following rooms that require certification. 3.2.2.1 A3-038 3.2.2.2 A3-038B 3.2.2.3 N3-112 3.2.2.4 N3-111 3.2.2.5 N3-95 3.2.2.6 N3-96 3.2.3 At the completion of work, the professional shall provide a report of findings with recommendations, no less than 5 business days after the onsite visit. The report shall be provided in soft copy PDF and signed/stamped with NEBB seal. 4. References. 4.1 The United States Pharmacopeial Convention 797 Pharmaceutical Compounding-Sterile Preparations 4.2 TA Certification Guide for Sterile Compounding Facilities (CAG-003-2006) NEBB Certified Clean Room Performance Testing (CFT) http://www.nebb.org/assets/1/7/Cleanroom_Spec_1996.pdf 4.3 NEBB TAB Section 15950 http://www.nebb.org/assets/1/7/TAB_Specs_-_7th_Ed._Proced._Stands.pdf Any interested small business concern must submit a no longer that 3 page capability statement addressing its ability to meet the requirements above to Mr. Mark Murray, Contract Specialist, at mark.murray4@va.gov no later than 26 January 2016. Interested parties are also welcome to identify any ambiguities with the SOW and are welcome to suggest enhancements to the SOW and include them in their 3 page capability statement. Questions regarding this Sources Sought Notice will not be answered.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/PiVAMC646/PiVAMC646/VA24416Q0358/listing.html)
 

Document(s)

Attachment
 

File Name: VA244-16-Q-0358 VA244-16-Q-0358_1.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2518809&FileName=VA244-16-Q-0358-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2518809&FileName=VA244-16-Q-0358-000.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

Zip Code: 18711-0026
 

Record

SN03997440-W 20160123/160121234337-c97e4032c0d8ef09db493e9be822c560 (fbodaily.com)
 

Source

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

---

| FSG Index  |  This Issue's Index  |  Today's FBO Daily Index Page |