iFactor Readies Kaiser Pharmacies for New USP 797|800 Compliance

Pharmacies are facing strict new United States Pharmacopeia (USP) regulations requiring facilities to provide critical upgrades to remain licensed with the Board of Pharmacy. With full compliance required by the beginning of December 2019, USP 797|800 are a set of regulations developed to address the handling of hazardous drugs (HD) and non-hazardous drugs (nHD) in compounding pharmacies. USP 797 ensures patients receive quality preparations that are free from contaminants and are consistent in intended identity, strength and potency. USP 800 sets standards for proper handling of HD to minimize risk of exposure to patients, personnel and the environment.

Under the new requirements, pharmacies are required to design|redesign facilities to achieve quality standards. The key objectives are to improve standards and protect sterility of hazardous drugs in healthcare settings and help promote patient safety, worker safety, and environmental protection. Changes in regulatory requirements target general cleanliness, safety in handling as well as requirements for how to store compounding drugs. At a minimum, the new requirements must attend to the following:

  • Climate controls;
  • Personnel knowledge;
  • Work place safety;
  • Proper use of personal protective equipment (PPE); and
  • Policies for HD waste sterilization and disposal.

iFactor, in partnership with HMC Architects, is providing MEP engineering and design services in support of the remodel of eight (8) Kaiser Permanente (Kaiser) pharmacies in Fontana, CA, Ontario, CA, Lancaster, CA and Panorama City, CA. As part of the USP compliance, HVAC upgrades will bring the existing pharmacies to full ISO 7 compliance. Systems are being designed to meet new USP requirements and must address|provide:

  • Appropriate room pressurization;
  • Minimum 30 ACH supply air change;
  • Minimum 15 ACH OSA;
  • High Efficiency Particulate Air (HEPA) filter at ceiling;
  • Solution to provide adequate exhaust for all air in HD rooms;
  • Maintain room temperature below 68°
  • Room relative humidity < 60%;
  • Negative pressure receiving area for pharmacies with HD Rooms; and
  • Provide e-power to all equipment.

In addition to the requirements set forth by USP, Kaiser mandated its own set of mandatory requirements including:

  • Adapting constrained existing pharmacy spaces for remodels to accommodate new requirements;
  • 35-45 ACH supply air change;
  • Low exhaust intake at opposite corners of HD Room, nhd Room and anteroom;
  • 20% < Room RH < 60%;
  • Provide remote port for semi-annual certification;
  • Venturi type valve on return and exhaust for active pressure control; and
  • Provide redundancy supply on all fans.

With many of the projects currently entering the Construction Administration phase, iFactor is diligently working alongside Kaiser staff to ensure project completion by the December 2019 deadline. Due to constrained spaces, short design and permitting timeframes, limited availability of temporary pharmacies, and the Board of Pharmacy’s hard deadline to complete construction and certification, iFactor’s design team has been performing enhanced Construction Administration services to ensure smooth project delivery. Additionally, other project challenges included:

  • Coordination between pharmacy director, regional director (room layout), NFS team (technical) and contractors;
  • Conform to OSHPD regulations (where applicable);
  • Working in live 7×24 facilities;
  • Providing temporary pharmacy locations (as needed);
  • Surveying during office hours in a “clean” environment;
  • Providing support to assist in expediting construction schedule;
  • Coordinating with Commissioning Agents for testing of installed MEP systems to meet design criteria; and
  • Coordinating with CEPA certifiers to meet ISO-7 room requirements.

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