This Is A Sources Sought Market Research Synopsis The Alexandria Va Health Care System Avahcs Pineville La Contracting Office Is Performing Market Research To Ascertain Whether There Are Potential Sources And Their Business Size Classification Hub Zone 8 A Small Business Small Disadvantage Business Women Owned Business Service Disabled Veteran Owned Business Sdvosb Or Veteran Owned Small Business Vosb Preferably Sdvosb Small Businesses The Naics Code Is 541380 16 5M The Overton Brook Va Medical Center Shreveport La Requires The Professional Services Of A Contractor To Perform The Necessary Testing For Compliance Of All Regulatory Requirements For The Preparation Of Sterile Compounded Products The Contractor Shall Furnish All Labor Equipment Tools Materials And Travel Necessary To Test Inspect And Certify Equipment Used For Certification Of The Containment Segregated Compounding Area C Sca And All Classified Areas Compounding Aseptic Containment Isolator Caci Compounding Aseptic Isolators Cai Laminar Air Flow Workbench Lafw Biological Safety Cabinet Bsc Three Iso Classified 7 Rooms Two Iso Classified 5 Pass Throughs Testing Will Address Certification Of Classified Areas Environmental Testing To Include Air Sampling And Surface Sampling Smoke Study Hazardous Drug Surface Wipe Sampling Contractor Shall Provide Controlled Environment Testing Association Ceta Certified Technician To Perform All Testing Inspections And Certifications In Accordance With United States Pharmacopeia Usp 797 And 800 And Ceta Cag Guidelines Testing Sampling Certification Of Classified Areas To Be Performed Under Dynamic Conditions C Sca And Classified Areas To Include Caci Cai Lafw Bsc Three Iso Classified 7 Rooms Two Iso Classified 5 Pass Throughs Certification To Include Airflow Testing Hepa Filter Integrity Testing Airflow Pattern Smoke Testing Total Particle Count Testing Site Installation Assessment Testing Certification Of Classified Areas Is Required To Be Completed Every Six Months Per Usp 797 And 800 And Ceta Cag Guidelines In The Case Of Certification Failure Contractor Will Have To Recertify After Corrective Actions Are Completed Retesting Will Be Through A Separate Purchase Order From The Facility At The Established Contract Unit Rate Due To Operational Requirements The Semi Annual Certification Of The Cai And Caci Shall Be On A Different Schedule Than The Semi Annual Certification Of The Bsc And Lafw Environmental Sampling Air Sampling Impaction Volumetric Air Sampling Under Dynamic Conditions With A Sample Size Of At Least 1000 Liters In Each Location Two 2 Sample Locations To Consist Of One 1 Fungal And One 1 Bacterial For Each Location In The Direct Compounding Area Dca Of The Four 4 Primary Engineering Controls Pec Total Of Sixteen 16 Samples One 1 Sample Location To Consist Of One 1 Fungal And One 1 Bacterial On The Cart Directly Outside Of The Two 2 Pecs In The Classified Areas Total Of Four 4 Samples One 1 Sample Location To Consist Of One 1 Fungal And One 1 Bacterial In The Two 2 Antechambers Total Of Four 4 Samples One 1 Sample Location To Consist Of One 1 Fungal And One 1 Bacterial In The Two 2 Pass Through Windows Located In The Secondary Engineering Controls Sec Total Of Four 4 Samples One 1 Sample Location To Consist Of One 1 Fungal And One 1 Bacterial In The Ante Room On The Clean Side Of The Line Of Demarcation Total Of Two 2 Samples Three 3 Sample Locations To Consist Of One 1 Fungal And One 1 Bacterial To Be Determined On Work Patterns And Approved By The Contracting Officers Representative Cor Or Their Approved Representative Total Of Six 6 Samples Total Of Thirty Six 36 Samples For Bacterial And Or Fungal Contaminates Surface Sampling Contact Plates With General Growth Media Supplemented With Neutralizing Additives Which Neutralizes Cleaning Agents And Prevents False Negative Sampling To Take Place At The End Of The Of The Compounding Activity Prior To Cleaning Two 2 Sample Locations To Consist Of One 1 Fungal And One 1 Bacterial For Each Location In The Direct Compounding Area Dca Of The Four 4 Primary Engineering Controls Pec Total Of Sixteen 16 Samples One 1 Sample Location To Consist Of One 1 Fungal And One 1 Bacterial On The Cart Directly Outside Of The Two 2 Pecs In The Classified Areas Total Of Four 4 Samples One 1 Sample Location To Consist Of One 1 Fungal And One 1 Bacterial In The Two 2 Antechambers Total Of Four 4 Samples One 1 Sample Location To Consist Of One 1 Fungal And One 1 Bacterial In The Two 2 Pass Through Windows Located In The Secondary Engineering Controls Sec Total Of Four 4 Samples One 1 Sample Location To Consist Of One 1 Fungal And One 1 Bacterial In The Ante Room On The Clean Side Of The Line Of Demarcation Total Of Two 2 Samples Three 3 Sample Locations To Consist Of One 1 Fungal And One 1 Bacterial To Be Determined On Work Patterns And Approved By The Cor Or Their Approved Representative Total Of 6 Samples Total Of Thirty Six 36 Samples For Bacterial And Or Fungal Contaminates In House Surface Sampling Monthly Contractor To Supply Fifty 50 Plates For Each Month Sampling Is Not Completed By The Contractor On Site Contractor To Provide Incubation Reading And Results From Surface Sampling Collected By The Va Total Of Four Hundred 400 Plates Yearly Environmental Sampling Is To Be Performed Quarterly It Is Expected That Two Samplings Will Be Performed At The Areas Identified Above As Part Of This Contract If A Positive Result Is Received Then Retesting Will Be Performed After The Va Has Taken Remedial Action Within 72 Hours Of Notification From The Va That The Remediation Has Been Completed The Contractor Will Be On Site To Perform The Retest Then Testing Will Be Performed Monthly Until Three 3 Consecutive Negatives Are Obtained With No Actionable Recommendations Per Usp 797 Guidelines Any Additional Testing Required Due To A Positive Result Will Be Covered By A Separate Purchase Order At The Approved Unit Price Per Test Smoke Study Smoke Study To Be Performed And Videoed Bi Annually One 1 In Each Of The Four 4 Pec S Each Study Of Adequate Length For Viewer To See The Directional Air Flow Completely Video To Be Provided Via Digital Versatile Disc Dvd Hazardous Drug Surface Wipe Sampling Hazardous Drug Surface Sampling To Be Performed Bi Annually Sampling To Be Performed On The Cart Outside Of The Bsc And Caci In The Bottom Of The Chemo Pass Through Ante Chamber Of The Caci And On The Floor Below The Bsc And Caci Total Of Six 6 Wipe Samples Equipment Prior To Any Testing The Following Information Must Be Provided To The Cor For All Equipment Used In The Certification And Sampling Process Manufacturer Model Serial Number Equipment Calibration Date Calibration Due Date Acceptance Criteria For Each Test Pass Fail Statement For Each Test And For The Unit Overall Pass Fail Refer To Any Appropriate Industry Standards Type Of Cabinet Name Of Certifier Signed Venting Criteria To Room To Roof Exhaust Fan Type Of Damper Type Of Agar Use In Sampling Lot And Expiration Date Of All Media Used In Sampling Certificate Of Analysis Of Media Used In Sampling To Verify That The Devices Meet The Expected Growth Promotion Ph And Sterilization Requirements Any Additional Information As Required Per Usp 797 And 800 And Ceta Cag Contractor Shall Provide Written Certification Reports Upon Completion Of Testing To Include The Ceta Certification Certificate Of The Technician Performing The Test Inspection And Certification Written Report Will Be Provided Within 15 Work Days Of Completion Of Sampling And Or Testing Written Report Must Contain Test Results Media Lots Utilized For Samples Comments Indicating When Dynamic Conditions Were Used Certificates Of Analysis Of Media Used Room Number Of Locations Tested Sketches Depicting Testing Locations All Calculations Number Of Staff Va And Contractor Present In Each Pec And Sec During Total Particle Count Test And Dynamic Air Flow Smoke Pattern Test Any Additional Information As Required Per Usp 797 And 800 And Ceta Cag The Report Should Have Guidance On Interpreting Results Possible Contamination Pathways And Proper Corrective Actions To Remediate Contamination A List Of Recommendations And Discrepancies Written Advisement Will Include Any Issues Which Will Impact Testing Certification Contractor Will Also Advise Cor Of Recommendations To Resolve Any Issues Related To Regulatory Changes The Contractor Shall Supply Every Unit That Passes Certification Specifications With A Certification Sticker Special Proposal Considerations By The Contractor None Safety Considerations Contractor S Workmen Shall Provide And Utilize Any Items Required To Ensure Safety Requirements Are In Accordance With Osha Regulations During All Phases Of The Work Period Of Performance A Base Year Of 12 Months Plus 4 One Year Option Periods Base Year 1 Oct 2020 30 Sep 2021 Option One 1 Oct 2021 30 Sep 2022 Option Two 1 Oct 2022 30 Sep 2023 Option Three 1 Oct 2023 30 Sep 2024 Option Four 1 Oct 2024 30 Sep 2025 Hours Of Performance Work Is To Be Performed During The Duty Hours Of 7 30 Am And 4 30 Pm Monday Through Friday Exclusive Of Federal Holidays Contractor To Schedule All Testing And Sample Collection With The Cor Or Their Authorized Representative Any Work Required To Be Performed Outside Of Normal Working Hours Needs To Be Scheduled And Approved By The Cor Or Their Authorized Representative This Notice Is To Assist The Va In Determining Sources Only This Is Not A Solicitation For Proposals Or Quotes A Solicitation Will Be Issued At A Later Date And Time All Information Submitted In Response To This Sources Sought Notice Is Considered Voluntary Interested And Capable Respondents Are Requested To Provide Company Name Address Point Of Contact Phone Number Duns Number Geographical Location Business Size And Number Of Employees Responses To This Notice Shall Be E Mailed To Lonest Bonton Contracting Officer At E Mail Address Lonest Bonton Va Gov Telephone Responses Will Not Be Accepted Reponses Must Be Received By No Later Than Cob 4 30Pm Cst May 12 2020
Contact Information
Other Detail
View Notice Now...
Fill Detail for Getting Instant Access
Download Tender Document / Tender Notice
Dear Sir,
Warm Greetings from TenderDetail.com !!
We have received Tender Document request for the TDR No : 31346505
Tender Notice along with it's Attachments ( Tender Document / Scan Image of News Paper)
sent to your Email Address :.
Please check your email for Tender Document.