FedBizOpps banner

Login to begin searching the FBO/CBD
Home Page
CBD/FBO Online
CBD/FBO Email
About Us
Contact Us
Privacy
Categories
No. Notes
Archives
Search
Help
Login
Register

Popular Searches

Popular Categories

VA263-17-N-1089 - ENVIRONMENTAL AIR, SURFACE AND EMPLOYEE SAMPLE TESTING, USP 797 STANDARDS VA Black Hills Health Care Syste , SD - Attachment

General Information

Document Type:FILE
Posted Date:Aug 25, 2017
Category: Quality Control, Testing and Inspection Services
Set Aside:N/A

Contracting Office Address

Department of Veterans Affairs;Network 23 Contracting Office (NCO 23);113 Comanche Rd.;Fort Meade SD 57741

Description

VA Network Contracting Office 23, Black Hills, is issuing this Sources Sought Synopsis to determine the suitability for a Service Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB) or other Small Business set-aside for viable and nonviable environmental sampling (ES) testing services for the Black Hills HCS, SD area (see Statement of Work below). This is not a request for quotes or proposals and any such submitted in response to this notice will not be evaluated. Vendors who are interested in this requirement should respond to this notice by providing: a. A short capability statement outlining their ability to provide the service b. A list of other contracts for similar service that they have been prime or a sub-contractor on c. Certification of their SDVOSB/VOSB status through VetBiz.gov (if applicable) d. Company DUNS number e. Company Contact information Annual workload estimate for this requirement is: Description of service Qty Annual fingertip cultures (apx.) 45 IV room environment (air and surface monitoring). 2 Respond directly via email at: Stephen.holly@va.gov Statement of Work The United States Pharmacopeial Convention Chapter 797 (USP 797) sets federal regulation regarding conditions & practices for sterile compounding. It includes minimum practice and quality standards for compounded sterile preparations (CSPs). USP 797 requires viable and nonviable environmental sampling (ES) testing. Frequency of testing is based on the type of sterile compounding the facility does. Requirements for the VA Black Hills Health Care System include annual testing of employees working in the sterile compounding area via fingertip cultures and every 6 month testing of the IV room environment (air and surface monitoring). Both types of testing involve utilization of media plates (both Tryptic Soy Aga (TSA) & Malt Extract Agar (MEA)) to identify bacterial and fungal contamination within the compounding area. The plates are supplied by the vendor, sampling is done by the facility on an ongoing basis and plates are returned to the vendor at time of sampling for incubation and identification of any organism growth. Annual testing will be completed for 45 employees (possibly more). Each new employee must pass fingertip testing of 3 plates for each hand with MEA and 3 plates with TSA (total of 12 plates). Each current employee must pass fingertip testing of 1 plate for each hand with both MEA and TSA (total of 4 plates). Failures (inappropriate growth) will need retesting. All growth must be cultured and microbes identified and communicated back to us. Services Required: -Forms for submission to be provided by vendor -MEA & TSA plates for sampling to be provided by vendor -Air Sampling: Rodac plates (special sized MEA & TSA to fit PBI Air Sampler model SAS DUO 360), incubation & enumeration of colonies for each room. 1 MEA and 1 TSA plate in each room twice a year with additional testing if growth is identified. (1 MEA plate + 1TSA plate) x (1 clean-room main(FM) + 1 anti-room main(FM) + 1 inside CAI hood (FM)+ 1 clean-room chemo(FM) + 1 anti-room chemo(FM) + 1 inside CACI hood (FM) + 1 clean-room main(HS) + 1 anti-room main(HS) + 1 inside CAI hood (HS)+) x(2 six month testings + 4 extra testings) = 2 plates x 9 rooms x 6 times/year = 108 plates -Surface Sampling: Rodac plates (MEA & TSA), incubation and enumeration of colonies for multiple sites in each room (varies depending on # of hoods, counters, etc. in each room). 1 MEA and 1 TSA plate for each area tested and testing needs to be done two times a year with additional testing if concerning growth is identified. [(1 MEA + 1 TSA) x (3 +3+3 ) x 2 times/year] + [(1 MEA + 1 TSA) for extra area retesting (4x18)] = 108 plates Main IV Room(FM) areas tested include 1 hood and up to 2 other surface areas (counter tops and pass through in both clean and anterooms). Total of 3 areas tested. Chemo Room areas tested include 1 hood and up to 2 other surface areas (carts and pass through in both clean and anterooms). Total of 3 areas tested. Main IV Room(HS) areas tested include 1 hood and up to 2 other surface areas (counter tops and pass through in both clean and anterooms). Total of 3 areas tested -Gloved Fingertip Testing: 860 plates (1st year) 380 plates (future years) MEA & TSA plates, incubation and enumeration of colonies (1st year) (3 MEA + 3 TSA) x 2 hands x 1 once/year x 45 current employees = 540 plates (3 MEA + 3 TSA) x 2 hands x 10 employees retested = 120 plates (3 MEA + 3 TSA) x 2 hands x 10 new employees = 120 plates (1 MEA + 1 TSA) x 2 hands x 20 employees retested = 80 plates MEA & TSA plates, incubation and enumeration of colonies (future years) (1 MEA + 1 TSA) x 2 hands x 1 once/year x 45 current employees = 180 plates (3 MEA + 3 TSA) x 2 hands x 10 new employees = 120 plates (1 MEA + 1 TSA) x 2 hands x 20 employees retested = 80 plates -Microbial Identification Streak Plate Sub-culturing at no additional charge. -Bacteria Identification if plates grow: estimated need of 100 per year. -Fungal Identification Morphology if plates grow: estimated need of 75 per year.

Original Point of Contact

POC Stephen Holly

Place of Performance

Address:
VA Black Hills Health Care System;Fort Meade Campus;113 Comanche Rd.;Fort Meade, SD
57741,
Link: FBO.gov Permalink
Link: FBO.gov Permalink
Bookmark This Notice
Print View