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USP 800 compliance is fast approaching. The original implementation deadline of July 2018 has since been pushed back to December 1, 2019 by USP in order to coordinate with the release of the updated USP 797 requirements anticipated for release the same date.

The Impact of the USP 800 requirements will most affect the HVAC needs within the Compounding, Unpack and Storage areas. The main components affected are: Unpacking, Compounding, Storage of hazardous drugs. Currently, under USP 797, Hazardous Drugs are allowed to be unpacked in the same room with non-hazardous drugs which will no longer be allowed in USP 800. The unpacking of Hazardous drugs will now be required to occur in a non-positive (neutral or negative) room. Also Hazardous drugs will no longer be allowed to be processed/compounded in the same buffer room with non-hazardous drugs, requiring a negative pressure buffer room for non-sterile hazardous drug compounding and positive pressure buffer room for sterile non-hazardous drug compounding.

Sterile processing of hazardous drugs will now require an ISO Class 7 room that provides 30 ACPH with HEPA filtration.  Storage of hazardous drugs, per USP 800, will now be required to be stored in a negatively pressurized room with 12 ACPH.  With USP 800, there are more requirements, with those listed here seen as the Prominent items which will most likely affect  current pharmacy space provisions and operations of the existing HVAC system’s capacity.

Keep in mind, appropriate re-design takes time to reconfigure these spaces as they are currently functioning well as their actual construction, testing, balancing/calibration and certification by your local Board of Pharmacy as well as Compounding Environment Certifier.

Pharmacy Renovation – USP 797,800 Compliance Southside Virginia Regional Medical Center – Emporia, VA

Pharmacy Renovation - USP 797,800 Compliance Southside Virginia Regional Medical Center - Emporia, VA

Pharmacy Renovation – USP 797,800 Compliance Southside Virginia Regional Medical Center – Emporia, VA

Project Scope: 1,000 SF existing pharmacy compounding suites. The scope was to review regulatory requirements for High Risk-Hazardous drug compounding and determine renovation required for the existing pharmacy compounding spaces (hazardous and non-hazardous) to meet current regulatory compliance requirements. Dedicated exhaust, power, HEPA filtration supplied air, room air flow/quality/pressurization, secured/refrigerated hazardous compounding stock and monolithic finishes were also key elements in the compliance and renovation scope determination process. The pharmacy is a 24/7 operation and not feasible to be interrupted. The challenge for this project was to assess the Infection Control Risk & Mitigation, Interim Life Safety Planning, construction phasing and allowable activity near the areas under construction in terms of security, introduction of debris, noise and vibration and material movement through the area (waste & construction supplies).

Architect: Currin Design Consulting, LLC

Owner: Southside Virginia Regional Medical Center – CHS

Project Cost: $200,000 (Estimated)

Project Completion: TBD

Pharmacy Consolidation and USP 797,800 Compliance Virginia Center for Behavioral Rehabilitation – Piedmont Geriatric Hospital (VCBR – PGH) Facility Consolidation – Burkeville, VA

Pharmacy Consolidation and USP 797,800 Compliance Virginia Center for Behavioral Rehabilitation - Piedmont Geriatric Hospital (VCBR - PGH) Facility Consolidation - Burkeville, VA

Pharmacy Consolidation and USP 797,800 Compliance Virginia Center for Behavioral Rehabilitation – Piedmont Geriatric Hospital (VCBR – PGH) Facility Consolidation – Burkeville, VA

Project Scope: 3,500 SF new consolidated pharmacy for staff and pharmaceutical processing efficiency. The scope was to assess the existing PGH (Piedmont Geriatric Hospital) facility inpatient pharmacy and also the existing VCBR (Virginia Center for Behavioral Rehabilitation) inpatient pharmacy facility in terms of operations, equipment, functionality as well as future growth/consolidation projections and determine how to increase efficiency by consolidation of key components.

Currin Design Consulting, LLC provided programming, planning, design, existing program assessment services and medical equipment coordination for the pharmacy portion of the new consolidated behavioral health facility, VCBR-PGH.

Facility Architect: HDR

Owner: Department of Behavioral Health and Disability Services – Commonwealth of Virginia (DBHDS)

Project Cost: Undetermined

Project Completion: TBD

Pharmacy Renovation – USP 797,800 Compliance Hampton Veterans Affairs Medical Center (VAMC) – Hampton, VA

Pharmacy Renovation - USP 797,800 Compliance Hampton Veterans Affairs Medical Center (VAMC) - Hampton, VA

Pharmacy Renovation – USP 797,800 Compliance Hampton Veterans Affairs Medical Center (VAMC) – Hampton, VA

Project Scope: The scope was to review regulatory requirements for High Risk – Hazardous drug compounding and renovate the existing pharmacy compounding provisions (2,000 SF) to meet current regulatory compliance requirements. The adjacent work area will be converted to the required secured enclosed dedicated hazardous drug compounding ante room to control air flow, traffic and provide a safety barrier against accidental exposure to room contents. The existing compounding room is dedicated to non-hazardous compounding activities and will have its own ante room as well to avoid cross contamination. Dedicated exhaust, power, HEPA filtration supplied air, room air flow/quality/pressurization, secured/refrigerated hazardous compounding stock and monolithic finishes were also key elements in the compliance and design process for the suite.

The pharmacy is a 24/7 operation and not feasible to be interrupted. The challenge for this project was to assess the Infection Control Risk & Mitigation, Interim Life Safety Planning, construction phasing and allowable activity near the areas under construction in terms of security, introduction of debris, noise and vibration and material movement through the area (waste & construction supplies).

Currin Design Consulting, LLC provided infection control risk assessment; interim life safety measures; regulatory compliance review; full-discipline coordination and construction phasing.

Architect-of-Record: Avetech Design Group

Owner: Department of Veterans Affairs (VAMC)

Project Cost: Undetermined

Project Completion: 2017

Pharmacy Renovation – USP 797,800 Compliance Southside Regional Medical Center – Petersburg, VA

Pharmacy Renovation - USP 797,800 USP Compliance Southside Regional Medical Center - Petersburg, VA

Pharmacy Renovation – USP 797,800 USP Compliance Southside Regional Medical Center – Petersburg, VA

Project Scope: 1,000 sf existing pharmacy compounding suite. The scope was to review regulatory requirements for High Risk- Hazardous drug compounding and renovate the existing pharmacy compounding provisions to meet current regulatory compliance requirements. The adjacent office was converted to the required secured enclosed dedicated hazardous drug compounding room and its required ante room to control air flow, traffic and provide a safety barrier against accidental exposure to room contents.

The existing compounding room is now dedicated to non-hazardous compounding activities. Dedicated exhaust, power, HEPA filtration supplied air, room air flow/quality/pressurization, secured/refrigerated hazardous compounding stock and monolithic finishes were also key elements in the compliance and design process. The pharmacy is a 24/7 operation and not feasible to be interrupted. The challenge for this project was to assess the Infection Control Risk and Mitigation, Interim Life Safety Planning, construction phasing and allowable activity near the areas under construction in terms of security, introduction of debris, noise and vibration and material movement through the area (waste and construction supplies).

Currin Design Consulting, LLC provided facility condition assessment, planning and regulatory compliance research as well as design, full-discipline coordination and medical equipment planning/selection.

Architect-of-Record: Hening-Vest-Covey-Chenault Architectural Corporation

Owner: Southside Regional Medical Center – CHS

Project Cost: $200,000 (Estimated)

Project Completion: 2016

Other Facilities include:

  • Walter Reed National Military Medical Center (Renovation and USP 797 Compliance)
  • Bon Secours Richmond Community Hospital (USP 797 Compliance)
  • Bon Secours St. Anthony Hospital (Renovation and USP 797 Compliance)
  • Camp Lejeune Hospital (USP 797 Compliance and Renovation to Full Automation)
  • Ft. Belvoir Community Hospital – Hemotology/Oncology Pharmacy, General Pharmacy, Nuclear Medicine Pharmacy (USP 797 Compliance)
  • Eastern State Mental Health Facility Pharmacy (New Pharmacy)
  • Northern Virginia Mental Health Institute (Pharmacy Efficiency Study)

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