H266--USP 797 TESTING LAB SERVICE

This is a Sources Sought Notice (a) The Government does not intend to award a contract on the basis of this Sources Sought or to otherwise pay for the information solicited. (b) Although "proposal," "offeror," contractor, and "offeror" may be used in this sources sought notice, any response will be treated as information only. It shall not be used as a proposal. (c) Any information received from a contractor in response to this Sources Sought may be used in creating a solicitation. Any information received which is marked with a statement, such as "proprietary" or "confidential," intended to restrict distribution will not be distributed outside of the Government, except as required by law. (d) This Sources Sought is issued by VISN 2 Contracting Office for VISN 2, which includes of collecting information about USP 797 Testing at the New Jersey VA Medical Campus-East Orange at 385 Tremont Ave, East Orange, NJ 07018. The NAICS code identified for this requirement is 541380-Testing Laboratories. The requirement is detailed in the Statement of Work section of this document. (e) Cursory market research has identified several large businesses that may be able to provide for this requirement. Contractors that are able to meet the requirements in the attachment are encouraged to email a capability statement and full information to Megan Ross at contact@example.gov. - Part of the purpose of this sources sought is to determine the viability of set aside to a specific socio-economic category. Contractors shall identify the NAICS code for the services being offered as well as their size status under said NAICS. This information will be used to determine the viability of a set aside for this requirement. - Contractors shall also identify any Federal Supply Schedules that may carry the desired services. - Contractors shall identify pertinent point of contact for company, contractor DUNS number for size standard and socioeconomic verification in SAM and VIP. - Contractors shall include any relevant comments about the Attachment(s) if applicable. STATEMENT OF WORK Description: The contractor shall perform USP 797 testing for environmental monitoring of sterile compounding areas. The Food and Drug Administration (FDA) has the authority to inspect VA medical facilities and the Joint Commission (TJC) establishes compounding standards for sterile compounded preparations based on the United States Pharmacopeia (USP) standards. The USP establishes standards for sterile compounding room including environmental monitoring and competencies for the preparation and handling of compounded sterile products (CSPs). To meet regulatory requirements in accordance with USP and to ensure compliance with VHA Directive 1108.12, Management and Monitoring of Pharmaceutical Compounding Sterile Preparations, the VA New Jersey Healthcare System requires to perform: Microbiological surface monitoring testing of primary engineering controls (PECs) Microbiological surface monitoring testing of secondary engineering controls (SECs) Testing of compounding personnel for aseptic technique by Gloved fingertip and thumb sampling Media fill testing Place of Performance: VA New Jersey Health Care System East Orange Campus Inpatient Pharmacy on 8th floor 385 Tremont Ave East Orange, NJ 07018 General Specifications: Microbiological/viable surface sampling is performed at the end of a compounding activity or shift but before the area has been cleaned and disinfected to confirm that the required environmental quality is maintained. Vendor must perform the incubation in controlled temperature environments in accordance with USP 797 and reading of each sample collected by VA staff. Each sample report to indicate: site location, media manufacturer, lot #, expiration date, and time/day of sampling. Incubate at 30° 35° for 48 hours. Examine for growth. Record the total number of discrete colonies of microorganisms on each device as colony-forming units (CFU) per sample Incubate at 20° 25° for 5 additional days. Examine the device for growth. Record the total number of discrete colonies of microorganisms on each device as CFU per sample Identify microorganism if growth occurs regardless CFU level Vendor will perform incubation and reading for minimum fourteen (14) samplings per month. Two (2) samples from each ISO Class 5 area (PECs) One (1) sample from each ISO Class 7 area (buffer rooms, anterooms, and passthroughs) Vendor will provide soybean casein digest media. A certificate of analysis (COA) must be provided. Shipping cost may be charged as a part of the invoice and paid to the company. The facility is unable to pay for shipping to the shipper directly. Gloved fingertip and thumb sampling (GFS) test are a direct measure of the aseptic technique of compounders (for on-going GFS) and their ability to don of sterile gloves without contaminating them (for initial GFS for newly hired). Vendor will perform the incubation in controlled temperature environments in accordance with USP 797 and reading of each sample collected by VA staff. Each sample shall: be labeled with a personnel identifier, whether it was from the right or left hand, the date and time of sampling, will include the name of the person evaluated, evaluation date/time, media and components used, including manufacturer, expiration date and lot number Incubate the sampling at a temperature of 30-35°C for 48 hours. Examine for growth. Record the total number of discrete colonies of microorganisms on each device as colony-forming units (CFU) per sample. Incubate at 20-25°C for 5 additional days. Examine the device for growth. Record the total number of discrete colonies of microorganisms on each device as CFU per sample. Identify microorganism if growth occurs regardless CFU level Document dates of incubation and the person who reads and documents the number of CFU Vendor will perform incubation and reading for samples collected from approximately thirty (30) VA staff every 6 months (spread over 12 months). This is one sampling plate per hand for each staff. Vendor will incubate and read for three (3) more GFS and one (1) more MFT collected for each newly hired VA staff if any. Vendor will provide soybean casein digest media. A certificate of analysis (COA) must be provided. Shipping cost may be charged as a part of the invoice and paid to the company. The facility is unable to pay for shipping to the shipper directly. Media fill test is the second measure of the aseptic technique of compounders simulating the most difficult and challenging compounding procedures and processing conditions encountered by the person replacing all the components used in the CSPs with soybean casein digest media. Vendor will perform the incubation in controlled temperature environments in accordance with USP 797 and reading of media fill test done by VA staff. The sample will be documented with the name of the person evaluated, evaluation time & date, media manufacturer, expiration date, and lot #. Incubate for 7 days at 20-25°C and then 7 days at 30-35°C Complete clarity of the test solution indicates a negative test result (Pass). Turbidity (cloudiness) of the test medium, or non-resoluble sedimentation present at many times during the incubation period constitutes a positive test result. Document dates of incubation, the result, and the person who reads and documents the results. Vendor will perform incubation and reading for approximately thirty (30) samples from VA staff (one sample per staff) every 6 months. A certificate of analysis (COA) must be provided if commercial sterile microbial growth media is provided by vendor and used for the media fill testing. Shipping cost may be charged as a part of the invoice and paid to the company. The facility is unable to pay for shipping to the shipper directly. Period of Performance: The estimated period of performance will be for the financial year 03/01/2021 to 02/28/2021. Technical certifications: Lab must be certified to monitor microbiology as previously stated under General Specifications A. Regulatory mandates: To meet regulatory requirements in accordance with USP and to ensure compliance With VHA Directive 1108.12. Verification of Services completed: The USP Program manager within pharmacy service will evaluate the reports received from the lab.