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FBO DAILY ISSUE OF JUNE 28, 2012 FBO #3869
DOCUMENT

B -- MICROBIOLOGICAL TESTING - Attachment

Notice Date

6/26/2012
 

Notice Type

Attachment
 

NAICS

541620 — Environmental Consulting Services
 

Contracting Office

Department of Veterans Affairs;W.J.B. Dorn VA Medical Center;6439 Garners Ferry Road;Columbia SC 29209-1639
 

ZIP Code

29209-1639
 

Solicitation Number

VA24712R0568
 

Response Due

7/2/2012
 

Archive Date

8/31/2012
 

Point of Contact

iridious.ruise@va.gov
 

Small Business Set-Aside

N/A
 

Description

Synopsis: The Department of Veterans Affairs, Dorn VAMC, and Columbia SC are seeking potential sources capable of providing Pharmacy IV Prep Area Microbiological Monitoring for USP 797 Compliance. Please see Statement of Work (SOW) for further information on the following requirement: Scope of Work Pharmacy IV Prep Area Microbiological Monitoring for USP 797 Compliance C.1 Background: WJB Dorn VA Medical Center has commissioned a new pharmacy in the main hospital which includes an ISO class 7 clean room for compounding sterile preparations. Microbiological sampling of clean rooms (ISO Class 7) and anterooms (ISO Class 8) is recommended by draft document United States Pharmacopeia, chapter 797 (USP 797) and VA information letter 10-2006-008. The sampling strategy recommended by USP 797 is to sample for fungi and bacteria using an impactor and agar plates in the anteroom, near the clean room doorway, inside the clean room twelve inches from the bio-safety cabinets, and inside the bio-safety cabinets. USP 797 recommends baseline air sampling of clean rooms and anterooms prior to their initial use, and semi-annually thereafter for low to medium risk compounding sterile preparation areas. USP 797 also recommends surface sampling and settling plate or air sampling inside ISO Class 5 bio-safety cabinets. According to USP 797, fungi and bacteria are not expected to be present in ISO Class 5 areas. The areas specified for testing are designated as low to medium risk compounding sterile preparation areas except the chemo-pharmacy on the 5th floor which is high risk. Baseline sampling has already been conducted for these areas. This information will be provided to the contractor as required. C.2 Scope: The contractor shall perform sample testing monthly for fungi and bacteria using an impactor and agar plates in the anteroom, near the clean room doorway, inside the clean room twelve inches from the bio-safety cabinets, and inside the bio-safety cabinets or as recommended by current edition of USP797. Test shall be conducted in the pharmacy in the main hospital and the satellite pharmacy located on the 5th floor (upon completion of construction). C.3 Task: The contractor shall perform the following task: a.Bacteria air sample analysis b.Fungi air sample analysis c.Bacteria and Fungi surface sample analysis d.Fungi glove dip sample analysis e.Bacteria glove dip sample analysis f.Prepare and submit laboratory test C.3.1 Performance: Perform all microbiological sampling for Dorn VA Medical Center pharmacy clean room and, upon completion of construction, the satellite pharmacy clean room in compliance with USP 797 standard, and VA information letter 10-2006-008. a.All samples shall be analyzed by a laboratory accredited by AIHA in Environmental Microbiology. b. Each sampling session will be conducted during normal business hours, Monday thru Friday 8 AM thru 4:30 PM. Each session will be scheduled at least 5 working days in advance and is subject to the workload of the pharmacy. Each session will be scheduled with Jeffrey K. Brown, Safety and Occupational Health Specialist, who will serve as the contracting officer's technical representative (COTR). c.Any laboratory results equal to or greater than the action will require notification of the COTR immediately upon receipt of laboratory results. Laboratory results of these levels or above may also require re-sampling to be performed after action deemed appropriate by the Chief of pharmacy has been taken to correct the microbiological growth. Resampling and test shall be performed within 24 hours of notification by the COTR. C.4 Reports: A repost will be issued for each sampling session and 4 hard copies an 1 electronic copy via e-mail provided to the medical center within 10 days of the receipt of laboratory results. Each session's report will include at a minimum the date, time and name of the Industrial Hygienist, narrative of work practices used, results of sampling, location where samples were collected, narrative interpretation of laboratory results, a comparison chart or table showing results of all monthly sampling by month and sample location, laboratory results and a closed chain of custody. All laboratory results shall be reported in Colony Forming units (CFU's) C.5 Personnel Qualifications: This sampling shall be performed by an Industrial Hygienist certified (CIH) by the American Board of Industrial Hygiene (ABIH). NOTE: Industrial Hygiene Technicians shall not be utilized on this project. C.6 Contractor Qualification: Contractor shall have at least 3 year of successful experience in conducting sterile environment sampling. Experience shall be verified by having at least two references complete and return the Past Performance Survey directly to this office no later than the closing date of the solicitation. C.7 Equipment: Contractor shall utilizing appropriate air sampling pumps that are capable of achieving and maintaining the required flow rate of 28.3 liters per minute (LPM), Anderson N-6 impactor or equivalent, Tryptic Soy Agar (TSA) and Malt Extract Agar (MEA) plates, and appropriate sterile sampling swabs or equivalent. C.8 Place of Performance: VA Medical Center Columbia, 6439 Garners Ferry Road, Columbia, SC 29209. C.9 Period of Performance: Base Year: 1 October 2012 - 30 September 2013 1st Option Period1 October 2013 - 30 September 2014 2nd Option Period1 October 2014- 30 September 2015 3rd Option Period1 October 2015 - 30 September 2016 4th Option Period 1 October 2016 - 30 September 2017 C.10. Contract Performance Monitoring: The government reserves the right to monitor services in accordance with Performance Based Matrix. C.11 Invoices: Payment will be made upon receipt of a properly prepared detailed invoice, prepared by the Contractor, validated by the Contracting Officer's Technical Representative (COTR), and submitted to VA FSC, P. O. BOX 149971, AUSTIN, TX 78714. A properly prepared invoice will contain: oInvoice Number and Date oContractor's Name and Address oAccurate Purchase Order Number oSupply or Service provided oTotal amount due C.12. Records Management Language for Contracts The following standard items relate to records generated in executing the contract and should be included in a typical Electronic Information Systems (EIS) procurement contract: a.Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228. b.Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. c.Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records. d.Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act. e.Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract. f.The Government Agency owns the rights to all data/records produced as part of this contract. g.The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data. h.Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.]. i.No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules. j.Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information. All work must be in accordance with federal, state, and local environmental laws and regulations. This synopsis is for planning purposes only and does not constitute a solicitation for bids/proposals. Responses will assist the Government in determining whether to set-aside/restrict competition in some way or solicit offers from all responsible sources. The Government does not intend to award a contract on the basis of this notification or otherwise pay for any information or inquiry. This synopsis does not constitute a request for proposal, and is not considered to be a commitment by the Government. All interested parties who believe that they can meet the requirements are invited to submit in writing the complete information describing their capability and qualifications to provide the aforementioned support services. Please include your company name, point of contact, address, telephone number, Duns & Bradstreet Unique Numbering System (DUNS) number, Central Contractor Registration (CCR), and Commercial and Government Entity (CAGE) code and your firms small business status. Potential offerors must be registered in CCR to be eligible for contract award or payment from. Information on registration and annual confirmation requirements may be obtained at www.ccr.gov and Online Representations and Certifications Application (ORCA) found at https://orca.bpn.gov/ All respondents that can provide any of the requested shall provide a detailed capabilities statement in writing within five (5) days of this publication. POC: Iridious T. Ruise@ iridious.ruise@va.gov /Phone: 803-776-4000x4035.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/CSCVAMC/WJBDDVAMC/VA24712R0568/listing.html)
 

Document(s)

Attachment
 

File Name: VA247-12-R-0568 VA247-12-R-0568_1.doc (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=382591&FileName=VA247-12-R-0568-000.doc)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=382591&FileName=VA247-12-R-0568-000.doc

 

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

Record

SN02786329-W 20120628/120626235019-7e697a5b30abb9935c0ebd8097732d2e (fbodaily.com)
 

Source

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

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