DRAFT-SOW-MFT GFT-AS OF 2-2-2026.docx

Statement of Work Pharmacy Gloved Fingertip Testing and Media -Fill Testing (GFT – MFT) services VA Sierra Nevada Health Care System

GENERAL INFORMATION:

The VA Sierra Nevada Healthcare System (VASNHCS) Pharmacy has a requirement for Environmental Microbiology Lab Accreditation Program (EMLAP) to process (incubate, analyze, record and report results) microbiological surface samples, Gloved Fingertip and Thumb (GFT) samples and Media-Fill Testing (MFT) samples conducted in accordance with this SOW, in an efficient and cost-effective manner, supporting the VA mission.

This is a non-personal services contract. The Contractor shall not be considered VA employees for any purpose of fulfilling the SOW and shall be considered employees of the Contractor. The contractor shall furnish all labor, materials, parts, equipment, tools, shipping, transportation, insurances, licenses, certifications, and supervision necessary to provide services in accordance with this Statement of Work (SOW).

TASKS and REQUIREMENTS:

1) Sampling Supplies and Preparation

a. The contractor shall supply VA medical center with its sampling kits so sampling can be performed by designated VA pharmacy personnel.

b. VA pharmacy personnel will collect and store samples in accordance with Contractor’s requirements and USP 797 standards.

c. Contractor shall provide all materials necessary to preserve and transport samples to the commercial reference laboratory for testing. These materials include those items that are dictated by and in compliance with the collection requirements of USP 797 standards.

d. Contractor shall provide its own special forms and special handling procedures to maintain a valid “chain-of-custody possession” and develop the formal documentation necessary for that purpose.

e. Contractor’s testing personnel who performed the analysis may be required to provide Court testimony. Contractor testimony shall be provided as required at no additional expense to the Government.

2) Services

a. An ISO/IEC 17025:2017 accredited laboratory under the Environmental Microbiology Lab Accreditation Program (EMLAP) will process (incubate, analyze, record and report results) microbiological surface samples from the direct compounding area (DCA) , Gloved Fingertip and Thumb (GFT) samples and Media Fill Testing (MFT) samples conducted and submitted by VA Medical Centers in Veterans Integrated Service Network (VISN) 21. Samples will be processed by the laboratory immediately upon receipt according to the general requirements outlined by ISO/IEC 17025:2017 and 2023 USP <797>.

b. The contractor shall incubate and process DCA samples and personnel related assessment GFT samples according to 2023 USP <797> standards. DCA and GFT results will be reported for each plate, with the amount of colony forming units (cfu) present on each plate reported. No growth present shall be indicated in the report as 0 (zero) cfu or < 1 cfu.

c. The contractor shall incubate and process personnel related assessment MFT samples according to 2023 USP <797> standards. MFT results will be reported as negative (pass) or positive (fail); failure is indicated by visible turbidity or other visual manifestations of growth in the media in one or more container–closure unit(s) on or before 14 days.

d. The contractor shall incubate and process DCA and GFT samples according to 2023 USP<797> standards. DCA and GFT sample results will be reported in total number of cfu per plate. If cfu measured from the samples exceeds USP <797> threshold levels, the report will at minimum identify genus and, when possible, species of any microorganism recovered on the report. No growth present shall be indicated in the report as 0 (zero) cfu or < 1 cfu.

3) Shipping

a. Shipping the collected samples to the Contractor will be done in collaboration with the VA Medical facility Pharmacy Service.

b. The Contractor shall report the receipt of samples via email within two days of receipt. This report shall include the number of samples and their condition.

c. The media-fill test kits may be provided by the contractor. The plates/paddles will be provided by the facilities in coordination with the Contractor. The samples will be collected by qualified staff of the facilities listed and will be shipped to the Contractor at the cost of the facilities.

SCOPE:

The contractor shall perform routine work detailed in this Statement of Work (SOW) on a schedule that is mutually agreed upon by the Contractor and Contracting Officer Representative (COR).

Work items or services not already included in this SOW, but relevant to it, may be ordered by the Contracting Officer (CO) without further competition. Only the CO has the right to obligate funding or order work not expressly detailed in this SOW. The Government shall not be held responsible for payment for any work performed by the Contractor that is outside the scope of this contract or without the prior approval of the CO.

Fixed pricing for microbial identification shall include all isolates identified on one sample (e.g., per sample plate, per both sides of media paddle).

TASKS:

1) Upon request from the VA Medical Center:

a. Gloved fingertip and thumb sample incubation and sample analysis.

b. Media-fill testing sample incubation and sample analysis.

c. Bacteria and fungi surface sample incubation and sample analysis.

d. Microbial identification to at least the genus level of viable samples exceeding the cfu limits listed in 2023 USP <797>.

2) Gloved Fingertip and Thumb Sampling:

a. Pharmacy compounding staff must be evaluated in Gloved Fingertip and Thumb (GFT) sampling to demonstrate competency in garbing and hand hygiene and assess aseptic technique and related practices as set forth in 2023 USP <797>. VISN 21 Medical Facility staff will perform GFT onsite, using one sampling device per hand (e.g., plates, paddles, or slides) containing general microbial growth agar {e.g., trypticase soy agar (TSA) supplemented with neutralizing additives (e.g., lecithin and polysorbate 80) as this agar supports both bacterial and fungal growth. Each media device will be labeled with a personnel identifier, right or left hand, and the date and time of sampling. The plates/paddles will be provided by the facilities in coordination with the Contractor. The samples will be shipped to the Contractor at the cost of the facilities.

b. Contractor will incubate GFT sampling plates immediately upon receipt at a temperature of 30-35° C for no less than 48 hours and then at 20°–25° C for no less than 5 (five) additional days.

c. Samples must be incubated in an incubator. Sampling plates will be stored during incubation to prevent condensate from dropping onto the agar and affecting the accuracy of the cfu reading (e.g., invert plates). Contractor will record and report the total number of cfu per hand (left hand and right hand), as well as the starting temperature for each interval of incubation, dates of incubation, and the identification of the person who reads and documents the results. Contractor personnel who analyze sampling plates including reading of plates, counting cfu, and performing identification of recovered microorganisms will be a licensed and qualified environmental microbiologist or technician.

d. Failure is if total cfu for both hands is greater than the action level for the type of sampling (i.e., initial, or biannual) listed in Table 1. The contractor will notify the Compounded Sterile Preparations (CSP) Program Manager, Inpatient Pharmacy Supervisor and Associate Chief Pharmacy Services, within 1 (one) business day of any failure.

2023 USP <797> Table 1. Action Level for Gloved Fingertip Sampling and Thumb Sampling

*Action levels are based on the total cfu count from both hands.

3) Media-Fill Testing Samples:

a. Media-fill tests will be designed and developed by the Facility Program Manager to reflect the most complicated manipulations performed by the compounder. The Contractor may provide media-fill test kits as well as incubate and process personnel related assessment MFT samples according to 2023 USP <797>.

b. Contractor will incubate MFT samples immediately upon receipt at a temperature of 20°–25°C for a minimum of 7 (seven) days followed by a minimum of 7 (seven) days at 30°–35°C to detect a broad spectrum of microorganisms.

c. The contractor will report pass/fail results, as well as the starting temperature for each interval of incubation, dates of incubation, and the identification of the person who reads and documents the results. Contractor personnel who analyze media fill including reading results are a licensed and qualified environmental microbiologist or technician.

d. Failure is indicated by visible turbidity or other visual manifestations of growth in the media in one or more container closure unit(s) on or before 14 days. The contractor will notify the Facility Program Manager, the Inpatient Pharmacy Supervisor and the Associate Chief Pharmacy services, within 1 (one) business day of any failure.

e. If the VA Medical Facility procures the media-fill test kit from the Contractor, then the Contractor will provide the certificate of analysis (COA). If the VA Medical Facility procures the media-fill test kit from another source, then the COA for the media-fill test kit will be provided by the facility.

4) Surface-Sample Plates:

a. Microbiological surface sampling will be performed by VA Medical Facility staff at least monthly in each classified area, at minimum in each room, the interior of each ISO Class 5 Primary Engineering Control (PEC), and pass-through chambers connecting to classified areas. Surface sampling in the direct compounding area must also be conducted in conjunction with media-fill testing to assess aseptic manipulation competency.

b. Additional surface sampling may be performed during certification of new facilities and equipment, after servicing facilities or equipment, in response to identified problems, in response to identified trends, or in response to changes that could impact the sterile compounding environment.

c. One sample of TSA will be obtained per sample location. Contractor will incubate surface sampling plates immediately upon receipt at a temperature of 30-35° C for no less than 48 hours and then at 20°–25°C for no less than 5 additional days. Each media device will be labeled with the sample location, as well as personnel identifier if applicable.

5) Alternate procedure:

a. For participating sites, all samples will be processed as dual media single incubation as described in USP 2023 <797>. Two surface sampling devices will be collected for each sample location and incubated concurrently. Both media devices could be TSA, or one TSA and one fungal media [e.g., malt extract agar (MEA) or Sabouraud dextrose agar (SDA)]. The contractor would incubate the surface sampling plates immediately upon receipt. Incubate each media device in a separate incubator. Incubate one media device at 30°–35° for no less than 48 hours and incubate the other media device at 20°–25° for no less than 5 (five) days. If fungal media are used, incubate the fungal media device at 20°–25° for no less than 5 (five) days.

b. Sampling plates will be stored during incubation to prevent condensates from dropping onto the agar and affecting the accuracy of the cfu reading (e.g., inverted plates). Contractor will report the number of cfu per plate as well as the starting temperature for each interval of incubation, dates of incubation, and the identification of the person who reads and documents the results. In addition, if cfu measured during viable surface sampling exceeds 2023 USP <797> action levels listed in Table 8 then the report will at a minimum identify genus and, when possible, species of any microorganism identified.

c. Contractor personnel who analyze sampling plates including reading of plates, counting cfu, and performing identification of recovered microorganisms will be a licensed and qualified environmental microbiologist.

d. Surface sample results will be reported in number of cfu.

e. Failure is if cfu of any plate is greater than the action level for the classified area. The contractor will notify the CSP Program Manager, Inpatient Pharmacy Supervisor, and the Associate Chief Pharmacy services, within 1 (one) business day of any failure.

2023 USP <797> Table 8. Action Levels for Surface Sampling

PERIOD of PERFORMANCE:

Base Year: March 26, 2026 – March 25, 2027 Option Year 1: March 26, 2027 – March 25, 2028 Option Year 2: March 26, 2028 – March 25, 2029 Option Year 3: March 26, 2029 – March 25, 2030 Option Year 4: March 26, 2030 – March 25, 2031

CONTRACTOR: TBD:

An ISO/IEC 17025:2017 accredited laboratory under the Environmental Microbiology Lab Accreditation Program (EMLAP) shall perform the services without outsourcing. Copies of pertinent certifications, licenses, and EMLAP accreditation will be required.

PERFORMANCE REQUIREMENT SUMMARY:

a. Monthly and as needed surface sampling analysis of viable samples taken from the Segregated Compounding Areas (SCA), Chemo Ante Room, Chemo Buffer Room, IV Ante Room, IV Buffer, and associated Primary Engineering Controls (PECs) and pass-through chambers connecting to classified areas.

b. Personnel related sampling analysis of the following:

i. Gloved Fingertip and Thumb Sample incubation and sample analysis

ii. Media Fill Testing incubation and sample analysis

iii. Surface sample of the direct compounding area (DCA)

c. Identification of any surface and air sample to at least genus for any growth that exceed the levels in Table 8 and Table 7, and when possible, to species of the microorganism recovered.

SAMPLING REPORTS:

For any action levels above the 2023 <USP 797> or MFT failure, the results must be submitted to the Facility Program Manager, Inpatient Pharmacy Supervisor, and the Associate Chief of Pharmacy services within one (1) business day digitally via email.

The final report must be received within 3 business days of testing completion. The report must include sample identifications and results, incubation dates, incubation period, incubation order and incubation temperatures for each sample. The final report shall also contain the condition of the sample at receipt, the type of media, the lot number, and the expiration date. Failure to follow these procedures may result in delay of payment or nonpayment. Pass/Fail notifications should be included where applicable.

RECORDS MANAGEMENT OBILIGATIONS

This clause applies to all Contractors whose employees create, work with, or otherwise handle Federal records, regardless of the medium in which the record exists. All data, information, and supporting documentation created as part of this contract is owned by the Government Agency. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.

The term “Federal record” is defined in 44 U.S.C. § 3301. Federal records:

· Include all recorded information, regardless of form or characteristics.

· Are made or received by a Federal agency under Federal law or in connection with the transaction of public business.

· Are preserved or are appropriate for preservation as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them.

Contractors are responsible for complying with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to:

· The Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33)

· NARA regulations a 36 CFR Part 1222 and Part 1228

· Privacy Act of 1974 (5 U.S.C. 552a)

· Freedom of Information Act (5 U.S.C. 552a)

Contractor shall:

· Comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format, mode of transmission, or state of completion.

· Treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

· Deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

· Immediately report to the Contracting Officer any unlawful or accidental removal, defacing, alteration, or destruction of records.

· Obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, this contract.

· Incorporate the substance of this clause, its terms and requirements including this paragraph, in all subcontracts under this contract, and require written subcontractor acknowledgment of same.

· Abide by Government and Agency guidance for protecting sensitive and proprietary information.

· Immediately notify the Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records, or equipment.

· Ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected.

· Ensure employees assigned to this contract who create, work with, or otherwise handle records are required to take Veterans Health Administration provided records management training.

Contractor shall not:

· Create or maintain any records that are not specifically tied to or authorized by the contract.

· Remove records from the legal custody of the Agency.

· Create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records.

· Disposition or destroy documents without the prior written consent of the Contracting Officer.

· Retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act.