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Pharmacy Compliance

Remote Surface Sampling & Employee Qualification Support

HSS provides remote surface sampling programs and employee qualification assessments to help pharmacies demonstrate continued compliance with USP 797 (sterile compounding) and USP 800 (hazardous drug handling).

We help facilities maintain defensible environmental monitoring data and verify personnel competency in safe aseptic technique and hazardous drug handling. As a Service-Disabled Veteran–Owned Small Business (SDVOSB), HSS supports VA Medical Centers, DoD hospitals, academic medical systems, and independent compounding pharmacies nationwide.

Between-Visit Compliance

Remote Surface Sampling Program

This service supports continuous compliance when on-site certification is not active.

Sampling Kits & Workflow

  • Pre-assembled sampling kits shipped directly to site
  • Step-by-step collection procedures for pharmacy or EVS staff
  • ISO 17025 accredited laboratory analysis
  • Chain-of-custody documentation included

Sampling Locations

  • PEC work zone surfaces
  • High-touch cleanroom areas
  • Segregated compounding spaces (SCA)
  • HD compounding & storage areas (USP 800)

Reporting & Trending

  • Microbial CFU counts by location
  • Alert/action limit comparison
  • Corrective action recommendation guidance
  • Quarterly & annual trending summaries available
Personnel Competency

Employee Qualification & Competency Program

Initial & Ongoing Qualification

  • Aseptic technique competency demonstrations
  • Media fill (process simulation) guidance & review
  • Gloved fingertip testing protocols & frequency
  • Surface sampling tied to personnel workflows

Hazardous Drug Handling Competency (USP 800)

  • HD preparation & transfer technique validation
  • PPE selection, donning/doffing verification
  • Hazardous waste handling & decontamination practice reviews
  • Spill procedure training and assessment

Documentation Provided

  • Competency sign-offs with evaluator verification
  • Pass/fail scoring criteria
  • Written corrective coaching guidance
  • Files aligned for Joint Commission, State Board, VHA, CAP review
Regulatory Alignment

Standards & Regulatory Alignment

Our programs align directly with current pharmacy and laboratory compliance standards. All documentation is audit-ready and traceable.

USP 797 – Sterile compounding personnel competency & surface EM

USP 800 – Hazardous drug handling, PPE, and residue control

CETA CAG-003 – PEC cleanroom and operational certification practices

ISO 14644 – Cleanroom classification & particulate expectations

Joint Commission / State Board – Survey compliance and documentation readiness

Our Clients

Who We Support

Hospital & Outpatient PharmaciesVA & DoD Healthcare FacilitiesOncology & Infusion CentersAcademic Medical Centers503A Compounding PharmaciesSterile Processing & Research Facilities
The HSS Advantage

Why Partner with HSS

01

Clear, Easy-to-Follow Workflows

Staff can collect samples confidently and consistently.

02

Accredited Laboratory Partnerships

Defensible results suitable for regulatory review.

03

Practical Training & Coaching

Focused on real-world compounding workflows.

04

SDVOSB Nationwide Support

Meets federal set-aside & subcontracting requirements.

SDVOSB Certified

Service-Disabled Veteran–Owned Small Business — meets VA / DoD set-aside & subcontracting requirements

Request a Quote

Ready to Set Up a Remote Sampling Program?

Contact our team to discuss your facility's environmental monitoring needs or employee qualification program requirements.