36C24420Q0460-003.docx

Environmental Microbiology Laboratory Analytical Services Draft Statement of Work

1. GENERAL REQUIREMENTS:

An ISO/TEC 17025 accredited laboratory under the Environmental Microbiology Lab Accreditation Program (EMLAP) will process (incubate, analyze, record and report results), Gloved Fingertip and Thumb samples (GFS) and Media Fill Testing (MFT) samples obtained and submitted by Erie VAMC. Samples will be processed according to the most current version of CAG-009-2011 (or its successor) and results will be compared to recommendations provided in USP <797>.

All sampling supplies, plates and media fill will be provided by the laboratory pursuant to this contract as available on as needed per order basis – (indefinite need, indefinite quantity). Certificate of analysis from the manufacturer will be provided for each lot of growth media to verify that the media meet the expected growth promotion, pH, and sterilization requirements.

The number of surface sampling, gloved fingertip testing (GFS) and media fill testing (MFT) may change throughout the contract period. This is Erie VAMC's best estimate of the number and type expected to be tested and sampled by the contract. Erie VAMC reserves the right to delete or add units as required. This requirement will represent an indefinite need and an indefinite quantity of testing supplies and analytical services.

The contractor shall process personnel related assessment testing GFS samples according to CAG-009-2011 (or its successor), and 2019 USP <797> standards. GFS results will be reported for each plate, with the amount of colony forming units (cfu) present on each plate reported. If there is no growth present that shall be indicated on the report (0 CFU or < 1 CFU).

The contractor shall process MFT testing samples according to CAG-009-2011 (or its successor) and 2019 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.

2. SCOPE:

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

If the numbers of listed items will be exceeded, no work is authorized without the prior written approval of the Contracting Officer (CO) to account for it. 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.

3. TASK:

a. Gloved Fingertip and Thumb Sample incubation and sample analysis

b. Media Fill Testing sample incubation and sample analysis Pharmacy IV personnel will conduct gloved fingertip and thumb testing, media fill testing and surface sampling according to USP <797> guidelines and pharmacy needs. The Inpatient Pharmacy/USP 797/800 program manager or their designee shall collect, label and prepare all samples for shipping pursuant to instructions provided by the contractor ensuring viability of samples during shipping. Every effort will be made to ship samples the same day as sampled and will be shipped for next day delivery to the contractor according to instructions. If samples are not able to be shipped the same day as sampled, they will be shipped no later than the day after sampling takes place. Days of sampling will be coordinated so delivery occurs according to contractor’s normal hours.

4. GLOVED FINGERTIP AND THUMB SAMPLING PLATES:

Pharmacy compounding staff must be evaluated in Gloved Fingertip and Thumb Sampling (GFS) to demonstrate competency in garbing and hand hygiene, as set forth in USP <797>. Erie VAMC will perform GFS on site, 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.

Contractor will incubate fingertip 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. 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, 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.

Failure is if total cfu for both hands is greater than the action level for the type sampling (i.e., initial or bi-annual). The contractor will notify the site specified personnel, determined post award.

All results will be transmitted the facility within one business day of final analysis.

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 SAMPLES:

Media fill tests will be designed and developed by the Pharmacy Inpatient/USP 797/800 Program Manager to reflect the most complicated manipulations performed at Erie VAMC. The contractor will be provided with the final Media Fill Testing sample (one sample) per staff member tested.

Contractor will incubate MFT samples immediately upon receipt at a temperature of 20°– 25°C for 7 (seven) days followed by 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 licensed and qualified environmental microbiologist and 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 site specified personnel, determined post award, within 1 (one) business day of any failure. All results will be transmitted the facility within one business day of final analysis.

6. PLACE OF PERFORMANCE:

Erie VAMC 135 East 38th Street Erie, PA 16504

7. PERIOD OF PERFORMANCE (POP): 5 years from date of award.

8. CONTRACTOR QUALIFICATIONS:

An ISO/TEC 17025 accredited laboratory under the Environmental Microbiology Lab Accreditation Program (EMLAP). Copies of pertinent certifications, licenses and EMLAP accreditation will be required.

9. PERFORMANCE REQUIREMENT SUMMARY:

a. Personnel related assessments include the following:

1. Gloved Fingertip and Thumb Sample incubation and sample analysis

2. Media Fill Testing incubation and sample analysis.

10. NUMBER OF SAMPLES:

Sampling services will be requested as an indefinite need, indefinite quantity basis. Services will be provided on a fee for service agreement. Baseline sampling is estimated to include (but not limited to):

a. Initial gloved fingertip and thumb sampling-6 staff for initial testing per year (36 samples annually – 6 plates per person)

b. 15 staff bi-annual fingertip and thumb samples (60 samples annually – 2 plates per sample)

c. 15 media-fill tests bi-annually (30 samples annually)

11. Sampling Reports:

Results of viable samples must be submitted to the Pharmacy Inpatient/USP 797/800 Program Manager and the Chief of Pharmacy within one (1) business days of the receipt of the results. Failure to follow these procedures may result in delay of payment or nonpayment. Pass/Fail notifications should be included where applicable. Each sampling reports shall contain, at a minimum, the following information:

a. An SOP or protocol that describes the process for the handling, incubation and analysis for each sampling plate or MFT.

b. Growth and Sterility Control Reports (where applicable)

[ End of Statement of Work ]