SOW - SS 36C26125Q0373.pdf

Statement of Work

Pharmacy Gloved Fingertip Testing, (GFT – MFT) services VA Sierra Pacific Network (VISN 21)

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 and air samples, 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>.

The contractor shall incubate and process personnel related assessment GFT samples according to 2023 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 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.

The contractor shall incubate and process viable surface and air samples according to 2023 USP <797> standards. Surface and air 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 in collaboration with the VA Medical facility Pharmacy Service.

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 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.

2. 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 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).

The service will be performed at 4 different locations within VISN 21.

a. VA Southern Nevada Health Care System: 6900 Pecos Rd., North Las Vegas, NV, 89086

b. VA Palo Alto Health Care System: 3801 Miranda Ave., Palo Alto, CA, 94304- 1207

c. VA Sierra Nevada Health Care System: 975 Kirman Ave., Reno, NV, 89502

d. VA San Francisco Health Care System: 4150 Clement St., San Francisco, CA 94121

3. TASKS:

Upon request from the VA Medical Center Facility:

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. Bacteria and fungi air sample incubation and sample analysis.

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

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 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.

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 Facility 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

Gloved Fingertip & Thumb Sampling Action Level*

After garbing >0

After media-fill testing >3 *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 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>.

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 Facility Program Manager the Inpatient Pharmacy Supervisor and the Associate Chief Pharmacy services, 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 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.

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.

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.

Alternate procedure:

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)]. 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.

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 exceed 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.

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 Facility 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

ISO Class Surface Sampling Action Levels (cfu/device or swab)

5 >3

7 >5

8 >50

7. Air Sample Requirement

Air sampling may be performed by VA Medical Facility staff at least every six months 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.

Additional air 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.

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)]. 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.

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 exceed 2023 USP <797> action levels listed in Table 7 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 Facility Program Manager, Inpatient Pharmacy Supervisor, and the Associate Chief of Pharmacy services, within 1 (one) business day of any failure.

2023 USP <797> Table 7. Action Levels for Viable Airborne Air Sampling

ISO Class Air Sampling Action Levels [cfu/cubic meter (1000 liters) of air/media device]

5 >1

7 >10

8 >100

8. Period of Performance: The contractor shall be for a one-year period with option years

9. 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.

10. 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. Bi-annual and as needed viable air 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).

c. 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)

d. 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.

11. 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.