DRAFT PERFORMANCE WORK STATEMENT.docx

DRAFT PERFORMANCE WORK STATEMENT

Sterile Compounding Training and Competency Scope of Work: The Overton Brooks VA Medical Center (OBVAMC) is seeking a contractor with specialized expertise in sterile compounding and aseptic technique training, performing viable fingertip sampling and media-fill testing, strictly adherent to the USP <797> and <800> Standards. The Contractor shall provide on-site educational presentations, didactic tests, and assessments of staff cleaning and aseptic competencies which are tailored specifically to OBVAMC compounding equipment, practices, and policies. The Contractor shall provide annual pharmacy staff training and semi-annual (every 6 months) pharmacy staff competency assessments.

This Contract has a five-year ordering period, the periods of performance will be specified in each order issued under this Contract.

General Requirements:

· Service Hours: Services are expected to be available from 0600 to 2200, Monday through Friday, with flexibility for additional hours on Saturdays and Sundays.

· Objective: Evaluate and enhance hand hygiene, garbing, and aseptic techniques through systematic testing, alongside improving operational efficiency with recommendations from vendor’s experience with OBVAMC compounding equipment, spaces, and policies.

· Documentation:

· All test results shall be provided and along with the chain of command document. Documentation shall be in accordance with USP <797> requirements and require the following:

· Name of the individual being evaluated.

· Date and time of evaluation.

· Media and components used to include manufacturer, expiration date, and lot number.

· The starting temperature of each interval of incubation

· Dates of incubation

· Results of media-fill, fingertip samples, and surface sample to include but not limited to CFU counts, pass/fail designation, and turbidity in media fill.

· Name of the individual observing and the individual reading and documenting the results

· Documentation shall be provided to the pharmacy for all training sessions, test results, and competencies.

· Education & Training:

· Training sessions shall include practical demonstrations, hands-on practice, and theoretical knowledge assessments, including specific details on OBVAMC compounding equipment and policies, as well as hazardous drug handling.

· Staff Credentials:

· Contractor staff shall hold current, relevant certifications and licenses, to include USP <797> certification of pharmaceutical compounding of sterile preparations and USP<800> Hazardous Drug Handling.

· All personnel are subject to VA background checks for security clearance.

· Insurance:

· Contractor shall maintain Workmen's Compensation and general liability insurance, providing proof of coverage annually or upon request.

· Pricing Structure:

· The contract will operate on a fixed, all-inclusive rate, with no additional charges for materials, travel, insurance, or any other incidental costs.

· Work Environment:

· Maintain compliance with OSHA and VA environmental regulations, ensuring a sterile and safe testing area.

· Compliance with Federal Regulations:

· Verify that no contractor personnel are listed on the HHS OIG Excluded Parties List before and during contract execution.

· Location:

· All services will be performed at Overton Brooks VA Medical Center, located at 510 East Stoner Ave, Shreveport, LA 71101.

· Procurement Authority:

· Governed by the regulations of FAR Part 12 of Simplified Acquisitions, ensuring a straightforward procurement process.

The Contractor shall perform the following Tasks:

TASK 1: The Contractor shall provide Viable Fingertip Sampling services as required below.

· Frequency: Shall be conducted semi-annual testing every 6 months (April and October) for a minimum of 25 pharmacy personnel.

· Shall include initial testing when applicable: Each employee new to compounding at OBVAMC shall undergo at least three separate viable fingertip samplings to ensure proper hand hygiene and personal protective equipment (PPE) garbing practices are being followed. Each sampling is done after separate instances of PPE garbing required for compounding in accordance with OBVAMC policies.

· Shall include subsequent testing: One sample per employee per session after PPE garbing and hand hygiene for ongoing monitoring and compliance, once the initial testing is successfully completed.

· Supplies: The contractor is responsible for providing all consumables, media, and equipment necessary for the tests.

· Media: Sampling plates shall be tryptic soy agar (TSA) supplemented with neutralizing additives (e.g., lecithin and polysorbate 80). Plates shall be incubated at 30-35C for no less than 48 hours then at 20-25C for no less than 5 additional days.

TASK 2: The Contractor shall provide Media-Fill Testing services as required below.

· Frequency: Shall be conducted semi-annually every 6 months (April and October) in conjunction with fingertip sampling.

· Scope: Shall include a Category 2 media fill test with both fingertip and surface samples for 25 pharmacy staff over a period of 10-15 consecutive days. Aseptic technique of each staff member shall be assessed for competency.

· Compliance: All procedures shall strictly adhere to the current USP <797> standards.

· Supplies: The contractor is responsible for providing all consumables, media, and equipment necessary for the tests.

· Media: Sterile growth media shall be used for the media fill test. A certificate of analysis (COA) shall be provided. Final containers shall be incubated at 20-25C and 30-35C for a minimum of 7 days at each temperature.

TASK 3: The Contractor shall provide reports as described below.

· Delivery: Detailed reports shall be submitted within 20 days following the completion of each testing session.

· Content: Reports for media fill tests and glove fingertip samples shall include:

· Name of the individual being evaluated.

· Date and time of evaluation.

· Media and components used to include manufacturer, expiration date, and lot number.

· The starting temperature of each interval of incubation

· Dates of incubation

· Results of media-fill, fingertip samples, and surface sample to include but not limited to CFU counts, pass/fail designation, and turbidity in media fill.

· Name of the individual observing and the individual reading and documenting the results

· Format: Reports shall be structured for clarity, including an executive summary, chain of command, methodology, results, and recommendations for action if contamination is found.

TASK 4: The Contractor shall provide staff competency evaluation and training services as required below.

· Contractor Personnel Requirements: Contractor personnel shall provide a certificate of completion of a USP <797> Pharmaceutical Compounding Sterile Preparations course and USP<800> Hazardous Drug Handling course prior to conducting this training and assessing the competency of VA personnel.

· Training shall include but is not limited to:

· Annual cleanroom training sessions which shall include:

· Aseptic sterile compounding techniques for Category 1 and Category 2 preparations as defined by USP <797>.

· Handling of hazardous drugs in accordance with USP <800>.

· Proper deactivation, decontamination, cleaning, and disinfection in accordance with USP <797> and <800>.

· Environmental requirements of OBVAMC’s compounding areas as described in USP <797>and <800> which includes segregated compounding areas, cleanroom suite, gloveboxes, laminar flow workbench, and biological safety cabinet.

· Each training session will conclude with a didactic test where at least 25% of the questions are refreshed from the previous year to ensure up-to-date knowledge. There will be 80% passing grade required. Approximately 25 OBVAMC staff shall be trained.

· Additional Training: The Contactor shall train and confirm the competency of at least two OBVAMC staff members to independently perform media-fill tests and fingertip sampling. The Contractor shall provide a certificate to staff members receiving this additional training.

Facility Pharmacy Contacts:

Dakota Harrell, IV Program Manager (Dakota.harrell@va.gov) Darlene Cook, Inpatient Pharmacy Supervisor (Darlene.Cook@va.gov) Daniel Brignac, Associate Chief of Pharmacy Operations (Daniel.Brignac@va.gov) Facility address:

Overton Brooks VA Medical Center, 510 E. Stoner Avenue, Shreveport, LA 71101.

Please contact the facility for unscheduled closures due to weather or other designation for closure. Please see list of federal holiday closures below:

U.S. federal holidays for 2025 are as follows: