PWS-Gloved Fingertip and Thumb GFT 7.28.26.docx

Statement of Work for Incubation

Speciation of Viable Samples for – Media-Fill, Gloved Fingertip and Thumb Sampling, Viable Surface Sampling

The VA Southern 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 PWS, 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 PWS and shall be considered employees of the Contractor. Contractor shall furnish all labor, materials, parts, equipment, tools, shipping, transportation, insurances, licenses, certifications, and supervision necessary to provide services in accordance with this Performance Work Statement (PWS).

1. TASKS and REQUIREMENTS:

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, Gloved Fingertip and Thumb (GFT) samples and Media-Fill Testing (MFT) samples conducted and submitted by VASNHCS Pharmacy. Samples will be processed by the laboratory immediately upon receipt according to the general requirements outlined by ISO/IEC 17025:2017 and current version of USP <797>.

The contractor shall incubate and process personnel related assessment GFT samples according to current version of USP <797> standards. 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 on the report as 0 (zero) cfu or < 1 cfu.

The contractor shall incubate and process personnel related assessment MFT samples according to current version of 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.

The contractor shall incubate and process viable surface samples according to current version of USP <797> standards. Surface sample results will be reported in number of cfu. If cfu measured during viable sampling exceed 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 on the report as 0 (zero) cfu or < 1 cfu.

Shipping the collected samples to the Contractor will be done by VASNHCS Pharmacy.

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.

The media-fill test kits will be provided by VASNHCS. The samples will be collected by qualified VASNHCS staff and will be shipped to the Contractor at the cost of the facility.

2. SCOPE:

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

Work items or services not already included in this PWS, but relevant to it, may be ordered by the CO without further competition. Only the CO has the right to obligate funding or order work not expressly detailed in this PWS. 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).

3. TASKS:

Upon request from the VA Southern Nevada Healthcare System Pharmacy:

Gloved fingertip and thumb sample incubation and sample analysis.

Media-fill testing sample incubation and sample analysis.

Bacteria and fungi surface sample incubation and sample analysis.

Microbial identification to at least the genus level of viable surface samples exceeding the cfu limits listed in current version of USP <797> standards.

4. Gloved Fingertip and Thumb Sampling:

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 current version of USP <797>. This sampling is done upon hire and then at a minimum of every 6 months thereafter. VASNHCS Pharmacy 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 facility. The samples will be shipped to the Contractor at the cost of the facilities.

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. 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 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.

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 VASNHCS Pharmacy Sterile Preparation Program Manager and COR within 1 (one) business day of any failure.

2023 (or most current version) USP <797> Standard Table 1. Action Level for Gloved Fingertip Sampling and Thumb Sampling

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

5. Media-Fill Testing Samples:

Media-fill tests will be designed and developed by VASNHCS Pharmacy Sterile Preparation Program Manager to reflect the most complicated manipulations performed by the compounder. Media-fill testing is done upon hire and at least every 6 months thereafter. The Contractor may provide media-fill test kits as well as incubate and process personnel related assessment MFT samples according to current version of USP <797>.

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.

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.

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 VASNHCS Pharmacy Sterile Preparation Program Manager and COR, within 1 (one) business day of any failure.

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.

6. Surface-Sample Plates:

Microbiological surface sampling will be performed by VASNHCS staff in the interior of the ISO Class 5 Primary Engineering Control (PEC) direct compounding area in conjunction with media-fill testing to assess aseptic manipulation competency.

One sample of TSA will be obtained per media-fill testing. 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 (five) additional days. Each media device will be labeled with the sample location, as well as personnel identifier.

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 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 current version of 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.

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.

Surface sample results will be reported in number of cfu.

Failure is if cfu of any plate is greater than the action level for the classified area. The contractor will notify the VASNHCS Pharmacy Sterile Preparation Program Manager and COR within 1 (one) business day of any failure.

2023 (or most current version) USP <797> Standard Table 8. Action Levels for Surface Sampling

(cfu/device or swab)

7. Period of Performance:

One year period of performance with 4 additional optional years

8. Contractor:

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.

9. Performance Requirement Summary:

a. 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)

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

10. Sampling Reports:

For any action levels above the current version of <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 1 (one) business day digitally via email.

The final report must be received within 3 (three) 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.

11.Security Requirements:

A. Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

B. A prohibition on unauthorized disclosure: "Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA." See VA Handbook 6500.6, Appendix C, paragraph 3.a.

C. A requirement for data breach notification: Upon discovery of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access, the contractor/subcontractor shall immediately and simultaneously notify the COR, the designated ISO, and Privacy Officer for the contract. The term 'security incident' means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. See VA Handbook 6500.6, Appendix C, paragraph 6.a.

D. A requirement to pay liquidated damages in the event of a data breach: "In the event of a data breach or privacy incident involving any SPI the contractor processes or maintains under this contract, the contractor shall be liable to VA for liquidated damages for a specified amount per affected individual to cover the cost of providing credit protection services to those individuals." See VA Handbook 6500.6, Appendix C, paragraph 7.a., 7.d.

E. A requirement for annual security/privacy awareness training: "Before being granted access to VA information or information systems, all contractor employees and subcontractor employees requiring such access shall complete on an annual basis either: (i) the VA security/privacy awareness training (contains VA's security/privacy requirements) within 1 week of the initiation of the contract, or (ii) security awareness training provided or arranged by the contractor that conforms to VA's security/privacy requirements as delineated in the hard copy of the VA security awareness training provided to the contractor. If the contractor provides their own training that conforms to VA's requirements, they will provide the COR or CO, a yearly report (due annually on the date of the contract initiation) stating that all applicable employees involved in VA's contract have received their annual security/privacy training that meets VA's requirements and the total number of employees trained. See VA Handbook 6500.6, Appendix C, paragraph 9.

F. A requirement to sign VA's Rules of Behavior: "Before being granted access to VA information or information systems, all contractor employees and subcontractor employees requiring such access shall sign on an annual basis an acknowledgment that they have read, understand, and agree to abide by VA's Contractor Rules of Behavior which is attached to this contract." See VA Handbook 6500.6, Appendix C, paragraph 9, Appendix D. Note: If a medical device vendor anticipates that the services under the contract will be performed by 10 or more individuals, the Contractor Rules of Behavior may be signed by the vendor's designated representative. The contract must reflect by signing the Rules of Behavior on behalf of the vendor that the designated representative agrees to ensure that all such individuals review and understand the Contractor Rules of Behavior when accessing VA's information and information systems.

G.Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the vendor at the end of lease, for trade-in, or other purposes." See VA Handbook 6500.6, Appendix C, paragraph 5.h., for the specific options.