SOW Environmental and Personnel Sampling.docx

STATEMENT OF WORK (SOW)

as of 05/12/2026

1. Contracting Officer’s Representative (COR).

Cleveland, OH 44106-1702

2. Contract Title.

VANEOHS Compounded Sterile Preparations Program – Environmental and Personnel Sampling

3. Background.

Pharmacy staff must undergo regular assessments, and sterile compounding areas must be sampled to ensure compliance with regulatory standards, including U.S. Pharmacopeia (USP) General Chapters <797> and <800>. These assessments are integral to a comprehensive quality assurance program that prioritizes patient safety, staff competency, and the maintenance of a controlled environment within sterile compounding spaces. Although trained pharmacy staff are responsible for conducting these tests, it is crucial that viable samples are incubated and analyzed by an independent third party to guarantee unbiased results. Consequently, it is essential to identify an appropriately accredited microbiological laboratory contractor that specializes in USP General Chapter <797> environmental and personnel sampling.

4. Scope.

VA Northeast Ohio Healthcare System (VANEOHS) is looking to identify an appropriately accredited microbiological laboratory contractor that specializes in USP General Chapter <797> environmental and personnel sampling. The contractor shall be capable of supplying necessary testing and competency materials, performing the required analyses, and delivering results that comply with USP standards and the specific requirements of VANEOHS.

5. Specific Tasks.

5.1 Task 1 – Supply Testing Materials and Equipment

The contractor must provide the following testing materials and equipment as requested by the facility. Materials and equipment must be orderable through an online portal.

a) Microbial Growth Media Plates

1) Must include Certificates of Analysis from the manufacturer verifying that the sampling media meet expected growth promotion, pH, and sterilization requirements consistent with USP General Chapter <797>.

2) Must contain TSA general microbial growth media supplemented with neutralizing additives (e.g., lecithin and polysorbate 80) to neutralize the effects of any residual disinfecting agents.

3) Plates used for surface sampling must have a raised convex surface.

4) Must support both bacterial and fungal growth on the same plate.

5) Microbial growth media plates used for monthly surface sampling must be provided as a monthly surface sampling kit to include materials, analysis, positive and negative controls, and shipping.

6) Plates are overnight mailed the same day if ordered prior to a contractor specified time except in extenuating circumstances.

b) Enverify™ Surface Sampling Competency Kits or the equivalent

c) SAS Air Sampler or equivalent available

d) Media Fill Materials

1) Components must be available to demonstrate low, medium, or high complexity compounding.

2) Components must be available to purchase as kits or individually.

3) Chain of Custody forms to be completed by pharmacy personnel and sent to the contractor along with samples for testing.

5.2 Task 2 – Sample Incubation and Analysis

The contractor must provide sample incubation and analysis as requested by the facility.

a) Incubation must start within 48 hours of sample receipt.

b) Samples sent to the laboratory must be incubated and tested in accordance with the current official USP General Chapter <797>.

c) Surface sample, gloved fingertip sample, and viable air sample analysis must include counts of discrete colony forming units.

d) Surface sample, gloved fingertip sample, and viable air sample analysis must include identification of recovered organisms to at least the genus level when required by USP General Chapter <797>.

e) Monthly surface sampling must be provided as a monthly surface sampling kit to include materials, analysis, positive and negative controls, and shipping. Cost of microbial identification does not need to be included in this kit.

f) Media Fill Sample analysis must include visual appearance of the media product, including any indications of microbial growth including but not limited to turbidity.

5.3 Task 3 – Reporting.

The contractor must provide a final report electronically (via e-mail to facility specified e-mail address and be available on an online portal with individual user access) within 48 hours of completion of their assessment of results and no later than 72 hours after the incubation periods have completed. Preliminary failing results should be reported to the facility as soon as identified. The final report must include:

Signature indicating testing and reporting was completed accurately and in compliance with USP and applicable accreditation standards.

a) Contractor name and contact information.

b) Accreditation and testing methodology.

c) Facility name, contact information, and project name as specified by facility personnel on chain of custody form.

d) Documentation of the media received and tested, to include the type of media, manufacturer, lot number, and expiration date.

e) Date of collection, as specified by facility personnel on chain of custody form, and the date samples were received by contractor.

f) Incubation parameters including incubation temperatures, dates and times of incubation, and incubation procedures.

g) Must indicate a statement of compliance or non-compliance with USP General Chapter <797> based on results of testing (e.g., Pass or Fail). Action levels used to determine a pass or fail result must be defined in the final report.

h) For Surface Samples, Viable Air Samples, and Gloved Fingertip Samples:

1) Sample ID, description, and ISO classification (if applicable) as specified by facility personnel on chain of custody form.

2) Total number of discrete colonies of microorganisms for each sample (as CFU per sample) including a bacterial and fungal raw count.

3) Any recovered organisms (bacterial and fungal) must be identified to at least the genus level when action limits are exceeded per USP General Chapter <797>.

i) For Media Fill Tests

1) Sample ID and description as specified by facility personnel on the chain of custody form.

2) Visual Appearance of the media product, including any indications of microbial growth including but not limited to turbidity.

j) Chain of Custody

1) Contractor will provide completed documentation of the chain of custody and return along with sampling results.

Deliverables: Final Report

5.4 Task 4 – General Procedures.

Surface Sampling

a) Surface Sampling is required per the following:

1) Initially for sterile compounding facilities to establish a baseline level of environmental quality.

2) At least monthly.

3) In conjunction with the certification of new facilities and equipment.

4) After any servicing of facilities or equipment.

5) In response to identified problems.

6) In response to identified trends.

7) In response to changes that could impact the sterile environment.

8) In conjunction with personnel media-fill testing (see below).

b) Sample plates composed of a microbial growth media supplemented with neutralizing additives (e.g. TSA with lecithin and polysorbate 80) will be utilized by pharmacy personnel to conduct surface sampling and then appropriately labeled and sent to the contractor.

c) The contractor shall promptly incubate the sample plates upon receipt and provide a final report of assessment and results in compliance with USP General Chapter <797>.

d) Surface samples will be sent to the contractor monthly, in conjunction with media fill tests as defined below, and as needed in response to events impacting the integrity of the sterile environment.

Gloved Fingertip Sampling

a) Gloved fingertip sampling is required per the following:

1) Each compounding staff member initially in triplicate and at least every six (6) months thereafter in conjunction with media fill testing and in conjunction with assessment of garbing and hand hygiene competency.

i. Post garbing gloved fingertip testing is completed with three (3) samples per hand initially then one (1) sample per hand every six (6) months thereafter.

ii. Post media fill gloved fingertip testing is completed with one (1) sample per hand initially and every six (6) months thereafter.

2) USP <797> compliant media fill testing kits and growth media plates are required for testing.

b) Sample plates composed of a microbial growth media supplemented with neutralizing additives (e.g. TSA with lecithin and polysorbate 80) will be utilized by pharmacy personnel to conduct gloved fingertip tests and then appropriately labeled and sent to the contractor.

c) The contractor shall promptly incubate the sample plates upon receipt and provide a final report of assessment and results in compliance with USP General Chapter <797>.

d) Gloved fingertip test plates will be sent to the contractor for incubation and assessment prior to compounding for new pharmacy personnel and then on a twice annual basis for all pharmacy staff. Twice annual testing is conducted on a rolling basis with multiple staff members being tested each month.

Media Fill Testing

a) Media fill testing is required per the following:

1) Each compounding staff member initially and at least every six (6) months thereafter.

b) Each designated person or person with direct compounding oversight of compounding personnel (not a compounder themselves) initially and at least every twelve (12) months thereafter.

c) Media fill products will include items such as vials, syringes and/or IV bags filled with soybean-casein digest will be manipulated by pharmacy personnel and then appropriately labeled and sent to the contractor.

d) The contractor shall promptly incubate the samples upon receipt and provide a final report of assessment and results in compliance with USP General Chapter <797>.

e) Media fill tests will be sent to the contractor for incubation and assessment prior to compounding for new pharmacy personnel and then on a twice annual basis for all pharmacy staff. Twice annual testing is conducted on a rolling basis with multiple staff members being tested each month.

Viable Air Sampling

a) Viable air sampling is required for the following:

1) Initially for sterile compounding facilities to establish a baseline level of environmental quality.

2) At least every six (6) months

3) In conjunction with the certification of new facilities and equipment.

4) After any servicing of facilities or equipment.

5) In response to identified problems.

6) In response to identified trends.

7) In response to changes that could impact the sterile environment.

b) Sample plates composed of a microbial growth media supplemented with neutralizing additives (e.g. TSA with lecithin and polysorbate 80) will be utilized by pharmacy personnel to conduct surface sampling and then appropriately labeled and sent to the contractor.

c) The contractor shall promptly incubate the sample plates upon receipt and provide a final report of assessment and results in compliance with USP General Chapter <797>.

d) Viable air samples will be sent to the contractor every six (6) months and as needed in response to events impacting the integrity of the sterile environment.

6. Security Requirements.

Employee names will be submitted to the contractor for applicable work where final reports must contain the staff name for compliance with USP General Chapter <797>.

The C&A requirements do not apply, and a Security Accreditation Package is not required.

7. Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI).

Samples will be collected by facility personnel for the contractor to complete the requested work.

8. Other Pertinent Information or Special Considerations.

The contractor shall meet the following additional requirements:

a) The contractor must be accredited by the American Association for Laboratory Accreditation (A2LA) as an environmental microbiology laboratory and shall be expected to maintain ISO/IEC 17025 accreditation to include testing related to USP General Chapter <797> enumeration, microbial identification, and media fill. Proof of this and other applicable certifications must be provided upon request.

b) All services and testing materials provided must be compliant with USP General Chapters <797>, <800>, and other applicable chapters associated with the testing being completed.

c) Sufficient staff and hours of operation to ensure that media can be received on Saturdays, is incubated promptly on receipt, moved between temperature ranges at the appropriate time intervals, and evaluated promptly upon completion of the incubation period.

9. Place of Performance.

Requested work will be performed at the contractor’s site.

10. Period of Performance

Base year plus three (3) option years.