Performance Work Statement Final 6.6.24.docx

Performance Work Statement (6.6.24)

Personnel and Environmental Monitoring Certifications for VISN 8 Pharmacies

1.0. Introduction

1.1. The Government requires personnel certification testing of gloved fingertip and thumb testing, media fill testing, facility compounding area surface monitoring, and air viable and non-viable testing in accordance with USP <797>, USP <800>, CETA and FDA guidelines in support of the VISN 8 Sunshine Healthcare Network pharmacies that compound sterile preparations (CSP).

2.0. Description / Scope / Objective

2.1. The Contractor must provide all labor, equipment, tools, materials including sampling supplies, supervision and other items and services necessary to perform the work as defined in this Performance Work Statement.

3.0. Applicable Documents

3.1. The following laws, regulations, policies, and procedures in effect on date of contract issuance and all subsequent changes or updates apply:

http://www.usp.org/

CETA

Controlled Environment Testing Association https://www.cetainternational.org/

FDA

VA

U.S. Food and Drug Administration https://www.fda.gov/

Office of Construction & Facilities Management Design Manuals https://www.cfm.va.gov/til/dManual.asp

4.0. Performance Requirements

4.1: The vendor shall refer to the most current versions of standards including but not limited to USP, FDA, VA and CETA when conducting the requested monitoring and reporting. The frequencies of testing and specific procedure shall be determined by the most updated version of CETA, USP <797> and <800>, VA Design Guides (including Pharmacy Service and HVAC Design Manuals, and per specific facility requirements and/or requests. The vendor shall be responsible for complying with the most updated versions of this guidance and shall conduct all sampling per the procedures outlined within the official chapters.

4.1.1 Gowning and Garbing Evaluation: The Vendor shall perform a gowning and garbing evaluation for each employee in conjunction with the gloved fingertip and thumb sampling and media-fill test. The vendor shall use the facility’s standard operating procedure as guidance for their evaluation.

4.1.2. Gloved fingertip and thumb sampling: The Vendor shall perform the gloved fingertip and thumb sampling for employees from each facility as requested. This should be done in conjunction with media-fill testing. The results should be reported by number of colony-forming units (CFU) per hand (left hand, right hand). If any agar plates demonstrate growth, the preliminary results shall be reported to the Chief, Pharmacy Service and corresponding Pharmacy Service point of contact (contracting officer representative {COR}, etc.) as soon as the initial result is known. Final results shall be expeditiously reported after further antimicrobial testing is complete.

4.1.3. Media-Fill Testing: The Vendor shall perform media-fill testing for employees from each facility as requested. This should be done in conjunction with gloved fingertip and thumb sampling. The results shall include the name of the employee evaluated, the evaluation date/time, media and components used to include the expiration date and lot number, the results, and the signatures of the person evaluated and the observer. Failure of the test in indicated by visible turbidity or other visual manifestations of growth in the medium in one or more container-closer units on or before the end of the incubation period. If any container-closer units demonstrate growth, the preliminary results shall be reported to the Chief, Pharmacy Service and corresponding Pharmacy Service point of contact (COR, etc.) as soon as the initial result is known and final results shall be expeditiously reported after further antimicrobial testing is complete.

4.1.4 Compounding area certification: The vendor shall provide certification of classified areas using procedures in the current Controlled Environment Testing Association (CETA) application guides. Certification must be performed at least every 6 months and as needed depending on facility requirements or requests. Certification must include the following:

4.1.4.1 Airflow testing: The air changes per hour (ACPH) from the HVAC, ACPH contributed from the PEC, and the total ACPH must be documented on the certification report.

4.1.4.2 HEPA filter integrity testing: HEPA filters must be leak tested at the factory and then leak tested again after installation and as part of recertification.

4.1.4.3 Total particle count testing: Must be performed under dynamic operating conditions using current, state-of-the-art electronic equipment. Air sampling sites must be selected in all classified areas. Measurements must be taken in each PEC at locations where there is greatest risk to the exposed CSPs, containers, and closures. Measurements of nonviable airborne particles in other classified areas including the buffer room(s) and ante-room(s), shall be taken at representative locations that reflect the quality of air in the room(s).

4.1.4.4. Smoke visualization studies: Must be performed for each PEC during dynamic operating conditions to demonstrate unidirectional airflow and sweeping action over and away from the preparation (s). Additional smoke tests shall need to be performed in rooms without low air returns. A video of the smoke test must accompany the report. Any media files must be provided in a format to comply with VHA guidance for media. No .zip files, usb storage, flash drives, or downloadable files from vendor web sites.

4.1.4.5. Primary engineering control (PEC) certification (laminar flow hoods, biological safety cabinets, compounding aseptic isolators, compounding aseptic containment isolators, pass through chambers etc.). The PEC must be certified to meet ISO class 5 at 0.5 μm and larger particles during dynamic operating conditions. PEC certification must include all specifications as outlined per CETA application guides and pertinent USP chapters. This must be performed at least every 6 months and as needed depending on facility requirements.

4.1.4.6. Differential pressure certification: Must be performed at least every 6 months and as needed depending on facility requirements for ante rooms and buffer rooms. Cleanrooms used for non-hazardous compounding must be positive pressure relative to the adjacent spaces. USP chapter <797> requires a minimum pressure differential of 0.020” w.c. relative to adjacent spaces. Cleanrooms used for hazardous applications shall be negative pressure between 0.01 and 0.03 inches of water column relative to all adjacent areas.

4.1.5 Viable Air Sampling: Each classified area and pass through shall have volumetric active air sampling using an impaction device during dynamic operating conditions at least every 6 months and as needed depending on facility requirements. At least 1 cubic meter or 1000 liters of air must be sampled at each designated location. A general microbiological growth media that supports the growth of bacteria and fungi must be used (e.g., TSA). COAs from the manufacturer must verify that the sampling media devices meet the expected growth promotion, pH, and sterilization requirements. The media shall be examined and the report shall detail the total number of discrete colonies of microorganisms on each plate as CFU per cubic meter of air based on the sample type, sample location and sample date. The genus of any microorganism recovered must be identified with the assistance of a microbiologist if the CFU count exceeds the following: greater than 1 for ISO Class 5, greater than 10 for ISO class 7, and greater than 100 for ISO class 8. If any container demonstrates the presence of CFU that exceed the actionable levels, the preliminary results shall be reported to the Chief, Pharmacy Service and corresponding Pharmacy Service point of contact as soon as the initial result is known and final results shall be expeditiously reported after further antimicrobial testing is complete. The results of viable air sampling shall be trended over time. The trended result shall be included as part of the final report to the facility.

4.1.6. Viable Surface Monitoring: Each classified area including the interior of the PEC (including equipment contained in it), staging or work areas near the PEC, frequently touched surfaces and pass through chambers must be sampled at least monthly. Sampling shall be performed at the end of the compounding activities, but before the area has been cleaned and disinfected. The media shall be examined and the report shall detail the total number of discrete colonies of microorganisms on each device as CFU per sample based on the sample type, sample location and sample date. The genus of any microorganism recovered must be identified with the assistance of a microbiologist if the CFU count exceeds the following: greater than 3 for ISO Class 5, greater than 5 for ISO class 7, and greater than 50 for ISO class 8. If any device demonstrates the presence of CFU that exceed the actionable levels, the preliminary results shall be reported to the Chief, Pharmacy Service and corresponding Pharmacy Service point of contact (COR, etc.) as soon as the initial result is known and final results shall be expeditiously reported after further antimicrobial testing is complete. The results of viable surface sampling shall be trended over time. The trended result shall be included as part of the final report to the facility.

4.1.7 Environmental wipe sampling for hazardous drug (HD) surface residue shall be performed routinely as outlined by USP <800> for facilities that request such services. Samples should be obtained and be analyzed at the minimum for cyclophosphamide, fluorouracil, ifosfamide, methotrexate and platinum containing compounds. Additional hazardous drug assays may be requested by the facility pending availability of the specific assay in the hazardous wipe sampling kit utilized by the contractor. Facilities shall provide the contractor the number of samples requested and the desired analysis for each sample. Results shall be reported to the Chief, Pharmacy Service and corresponding Pharmacy Service point of contact (COR, etc.) as soon as results are available. Reference Appendix A for sample by location details.

4.1.8 The contractor shall complete additional repairs associated with clean room certification and operations, and within contractor ability to resolve which may include, but are not limited to: PEC Chemo Decontamination. LAFW filter or blower replacement, BSC filter or blower replacement, test and balancing. Repairs may include parts if agreed upon by facility prior to installation. Fees related to repairs shall be agreed upon by the facility prior to beginning work.

4.1.9. The contracting officer representative or designee shall schedule testing with the vendor. Routine requests for scheduling should be made at least one month in advance of the desired date. The vendor must be able to provide requested services within 7 calendar days of the requested date. Emergent requests should be handled on a case by case request with the vendor. The vendor shall provide the corresponding Pharmacy Service with all service reports and certification of the job performed. After completion of work, the vendor shall notify the contracting officer representative for signature and verification of work performed.

4.1.10. All equipment shall be maintained in proper operating condition as specified by the Manufacturer, USP, CETA and FDA standards. The vendor is to have required supplies, manuals, and schematics, which must be available on site to perform the services. All work is to be performed in accordance with the guidelines established by state and local ordinances with manufacturer’s manual and quality control manual, and with all terms, conditions, provisions, schedules and specifications provided herein.

4.2. In the event that the facility or personnel require recertification or testing due to actionable results, the vendor must be able to provide retesting within 7 calendar days of the request..

4.3. In the event that the samples obtained during testing are damaged during transport or processing, the vendor shall annotate the damage in the report and provide retesting within 7 calendar days of the request at no additional cost to the facility. If the vendor is not able to provide services within the required timeframe, the vendor shall propose a reasonable alternative response time.

5.0. Performance Location and Hours

5.1. Please see appendix A which outlines each facility’s location and anticipated testing needs. Additional compounding locations, equipment or personnel may be added or removed depending on fluctuations in compounding production. Facilities shall discuss needed changes with the vendor and contracting officer. Comment by LaPlant, Kourtney D.: Ask Paul-completed by modification to the contract?

5.2 Anticipated locations are as follows:

Miami VA HealthCare System

1201 NW 16 ST MIAMI, FL 33125

9800 W Commercial Blvd, Sunrise, FL 33351

West Palm Beach

7305 North Military Trail West Palm Beach, FL 33410

Port St. Lucie/Vero Beach

10 Casia St (119) San Juan, Puerto Rico 00921-3201

#175 Algarrobo Ave., Mayaguez, Puerto Rico 00680

James A. Haley VA Hospital

13000 Bruce B. Down Blvd Tampa Fl 33612

7900 Little Road New Port Richey, FL 34654

2080 Meadowland Park Blvd Lakeland, FL 33803

Orlando

13800 Veterans Way Orlando, FL 32827

2900 Veterans Way Viera, FL 32940

5201 Raymond Street Orlando, FL 32803

North Florida/South Georgia VAMC

619 S Marion Ave. Lake City, FL 32025

1601 SW Archer Rd. Gainesville, FL 32608

1536 North Jefferon St. Jacksonville, FL 32209

5.3. Hours are from 0730-1600, Monday through Friday, excluding Federal holidays.

6.0. Deliverables.

6.1. Report shall include all components specified in 4.1.1 through 4.1.9. The structure of the report shall follow specifications outlined in the CETA application guides.

6.2. Report of all testing results shall be sent via e-mail to the Chief, Pharmacy Service and contracting officer representative.

7.0. Contractor Personnel and Management

7.1. Contractor Personnel: The Contractor shall be responsible for employing technically qualified personnel to perform the work specified in this PWS. The Contractor shall maintain the personnel, organization and administrative control necessary to ensure that the work delivered meets the contract specifications and requirements.

7.2. Key Personnel: All work shall be completed by CETA Certified technicians in accordance with all applicable Federal, State, Local, and industry: standards, laws, policies, procedures, codes and any other applicable governing body for the proper performance of all equipment per manufactures specifications/calibrations. Personnel performing all certifications must have current CETA National Board of Testing (CNBT) accreditation and hold classification as a Registered Cleanroom Certified Professional for Sterile Compounding Facilities (RCCP-SCF). Proof of certification must be provided prior to the start of the contract. The contractor must provide written notification to the Contracting Officer & Contracting Officer Representative (COR) if RCCP-SCF certification lapses or is terminated.

7.3. Contractor Badges. Contractor personnel shall wear a laminated contractor identification badge at all times when performing services under this Contract, including when on Government directed travel. The badge shall contain a personal picture, name of employee, and Contractor's name. Badges shall be worn on the outer garment attached to the outer shirt or jacket pocket by a button or clip or worn around the neck secured by an appropriate identification card lanyard. They must also ensure that all documents or reports produced by Contractor personnel are suitably marked as Contractor products or that Contractor participation is appropriately disclosed.

7.4. Standards of conduct:

7.4.1. Conduct of Personnel. Contractor personnel shall conduct themselves in a professional manner (i.e. timeliness, communication; spoken and written etc.). The Contracting Officer may require the Contractor to remove from the job site any employee working under this contract for reasons of suspected misconduct, a suspected security breach, or suspected to be under the influence of alcohol, drugs, or any other incapacitating agent. Contractor employees shall be subject to dismissal from the premises upon determination by the Contracting Officer that such action is necessary in the interests of the Government. The hospital director or designated representative has the authority to bar individuals from the Government facility. The removal from the job site or dismissal from the premises shall not relieve the Contractor of the requirement to provide sufficient personnel to perform the services as required by this performance work statement. The Government shall not reimburse the Contractor for travel and other expenses associated with the removal of personnel.

7.4.2. Contractor personnel are not authorized to carry or possess personal weapons to include, but not limited to, firearms and knives with a blade length in excess of three inches, while assigned under this contract.

7.4.3. Working Attire and Appearance: Contractor personnel shall present a professional appearance commensurate with standards delineated for Government civilian personnel acting in similar capacities.

8. TRAVEL: N/A

9. NON-PERSONAL SERVICE STATEMENT

9.1. Contractor employees performing services under this order shall be controlled, directed, and supervised at all times by management personnel of the contractor. Contractor management shall ensure that employees properly comply with the performance work standards outlined in the PWS. Contractor employees shall perform their duties independent of, and without the supervision of any Government official. The tasks, duties, and responsibilities set forth in the contract may not be interpreted or implemented in any manner that results in any contractor employee creating or modifying Federal policy, obligating the appropriated funds of the United States Government, overseeing the work of Federal employees, providing direct personal services to any Federal employee, or otherwise violating the prohibitions set forth in Parts 7.5 and 37.1 of the Federal Acquisition Regulation (FAR). The Government shall control access to the facility and shall perform the inspection and acceptance of the completed work.

10. PERFORMANCE STANDARDS AND QUALITY MEASUREMENT

12.1. Performance standards define desired services. The Government performs surveillance to determine if the Contractor exceeds, meets, or does not meet these standards. The Government shall use these standards to determine Contractor performance and shall compare Contractor performance to the Acceptable Quality Level (AQL). PERFORMANCE STANDARDS REQUIREMENTS SUMMARY MATRIX

A contract Discrepancy Report (CDR), shall be issued. Contractor shall have 5 workdays to provide a response that includes an improvement strategy for addressing the issues. 30 days after issuing CDR, the contractor shall re-rated. If performance does not comply with PWS CO may deduct from invoice 2%, 3%, 4% progressive deduction.