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New England Healthcare Engineers’ Society
New
Englandthe
Healthcare
Engineers’ Society
Designing
Built Environment
USP 797/800 - Designing the Built Environment
Panel
Ronald Gorham
Robert J. Falaguerra
Frank Peropat
Associate Principal
System Vice President
Facilities, Construction and
Support Services
Business Manager
Architecture
New England Healthcare Engineers’ Society
USP 797/800 - Designing the Built Environment
Northeast Division
Statistic
20
64
STATES
DEATHS
2012
753
IP/OP
CASES
HOSPITAL
Ref: http://www.cdc.gov/HAI/outbreaks/menigitis
New England Healthcare Engineers’ Society
USP 797/800 - Designing the Built Environment
Overview
 USP 797
 USP 800
 Federal/State Regulations
 Case Study
New England Healthcare Engineers’ Society
USP 797/800 - Designing the Built Environment
USP 797
"The objective of this chapter is to describe conditions and
practices to prevent harm, including death, to patients..."
 Focused on "Protecting the Patient" by
protecting compounds from contamination
 Originally Published in 2004
 Amended and Incorporated into USP in 2008
 Adopted by many regulatory agencies as a
compliance document (CMS, Joint Comm,
DPH, etc..)
 Currently under revision
Conceptual representation of the arrangement of a facility for
preparation of CSP's categorized as low-, medium-, and high
risk level. Diagram from USP 797.
New England Healthcare Engineers’ Society
USP 797/800 - Designing the Built Environment
USP 797
Box 3-1 Hand Hygiene Procedures
•
Anticipated Changes
•
•

Completely Re-Written for Clarity

"Low/Medium/High Risk" classification
replaced with Category 1 or Category 2 CSP.

All references to Hazardous Drugs defer to
USP 800.

Built environment requirements remain
unchanged
•
Remove debris from underneath fingernails, in present, using a nail cleaner
under warm running water.
Wash hands and forearms up to the elbows with unscented soap and water
for at least 30 seconds.
Immediately prior to donning sterile gloves, apply a suitable alcohol-based
hand rub with sustained antimicrobial activity, following the manufacturer’s
instructions for application times, and use a sufficient amount of product to
keep the hands wet for the duration of the application time.
Allow hands to dry thoroughly before donning sterile gloves.
Example of new "boxes"
New England Healthcare Engineers’ Society
USP 797/800 - Designing the Built Environment
USP 800
"This chapter describes practice and quality standards for
handling hazardous drugs (HDs) to promote patient safety,
worker safety, and environmental protection."
• 2014 Survey of 719 Compounding Pharmacies shows only
55% in compliance with 797 Hazardous Drug Guidelines
• Focused on "Protecting Patients/Staff"
• Incorporated into USP in 2016
• (implementation date July 1, 2018)
• NIOSH defines Hazardous Drugs:
http://www.cdc.gov/niosh/docs/2014-138/pdfs/2014-138_v3.pdf
• Being quickly implemented across the country
• Built Environment Impacts
Hazardous Compounding
New England Healthcare Engineers’ Society
USP 797/800 - Designing the Built Environment
USP 800
Makes recommended practices mandatory
Requires Dedicated Hazardous Drug storage
• Negative Pressure Space
• Dedicated Refrigerators
Mandates Separate Compounding Rooms
• Hazardous Drugs (Negative)
• Non-Hazardous (Positive)
New England Healthcare Engineers’ Society
USP 797/800 - Designing the Built Environment
USP 800
New England Healthcare Engineers’ Society
USP 797/800 - Designing the Built Environment
State Regulations
State
USP 797
USP 800
Additional Regulation
Massachusetts
●
●
MA CMR 247, CH. 17 AND 19
Connecticut
●
●
DCP Checklist, Chapter 400j
Section 20-633b
Rhode Island
●
●
R5-19.1-PHAR
http://sos.ri.gov/documents/archives/regdocs/released/pdf/DOH/8185.pdf
New Hampshire
●
●
Title XXX Chapter 318.14
http://www.gencourt.state.nh.us/rsa/html/NHTOC/NHTOC-XXX-318.htm
Maine
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02-392 Chapter 37
Vermont
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Administrative Rules of the
Board of Pharmacy Part 13
New England Healthcare Engineers’ Society
USP 797/800 - Designing the Built Environment
Resource
http://www.mass.gov/eohhs/gov/departments/dph/programs/hcq/dhpl/pharmacy/draft-regulations.html
https://www.cga.ct.gov/current/pub/chap_400j.htm
http://www.maine.gov/sos/cec/rules/02/chaps02.htm#392
https://www.sec.state.vt.us/media/702345/5-RX-Rules-2015-Final-Adopted-August-24-2015.pdf
Massachusetts Regulations
 Currently available in Draft form. Hazardous Drug Draft Regulations 247 CMR
17.00 and 19.00 recently released.
 Adoption dates uncertain (anticipate mid-2017)
 MADPH process.
 Specific Facility Non-Hazardous Drug Impacts to Note:
• Dedicated Air Handling Units (To be replaced with procedure)
• Minimum room size
• Buffer room size (144 sq. ft.).
• Ante Room (100 sq. ft. min)
• Min ISO 8 environment for low risk compounding.
• Interlocking Ante and Buffer room Doors
• Pass through limited to 4 sq. ft.
• Refrigerators excluded from being in ISO spaces.
• Specifically prohibits overhangs and ledges
• No open concepts, pre manufactured hoods only (currently under review)
• Bans hand dryers in ante rooms.
• Specific changing area requirements.
New England Healthcare Engineers’ Society
USP 797/800 - Designing the Built Environment
Massachusetts Regulations
 Specific Facility Hazardous Drug Impacts to Note:
• UPS power for cleanroom exhausts system. (To
be replaced with procedure)
• Limits on pressure ranges. -0.01” to -0.03”
• Prohibits ANY storage of HDs in clean room.
• Prohibits refrigerators in clean room.
• Prohibits pass through from non-classified areas
into clean room.
• Currently allows Non-Hazardous and Hazardous
in single hood for adjunct meds in a patient.
New England Healthcare Engineers’ Society
USP 797/800 - Designing the Built Environment
Connecticut Regulations
 OCHA / Department of Public Health:
• Conducts Plan Review and
Mechanical Design Review
 Department of Consumer Protection /
Drug Control Division
• Conducts Plan Reviews
• Finals Site Inspections in
coordination with DPH
• Licenses
 State Specific Review
• Checklist
• Operational Procedures
• Facility
New England Healthcare Engineers’ Society
USP 797/800 - Designing the Built Environment
CASE STUDY
SMILOW Cancer Center at Saint Francis Hospital and Medical Center, Hartford CT
Challenge
Existing pharmacy did not meet current USP 797;
space was too small and inefficient; frequent
maintenance calls for repairs; staff satisfaction is
low; needed to expand to meet projected growth.
Solution
Opportunity to utilize best practices and meet
pending USP 800. Reviewed operational workflow
and processes to provide an efficient satellite
pharmacy. Utilized premanufactured cleanroom
system for best possible installation and finish
details.
Result
Phased renovations resulting in USP 797 / 800
compliant pharmacy. Panelized clean room system
reduced construction time period, provided best
possible "fit and finish", and exceeded staff
expectations.
Medical / Hematology Oncology – Floor 2
New England Healthcare Engineers’ Society
USP 797/800 - Designing the Built Environment
CASE STUDY
SMILOW Cancer Center at Saint Francis Hospital and Medical Center, Hartford CT
Project Process
 Comprehensive Team
 Process Evaluation
 Operational Workflow
 Gap Analysis
 Plan/Design
 Regulatory Input/Review
New England Healthcare Engineers’ Society
USP 797/800 - Designing the Built Environment
Work Flow Diagram Concept 1
CASE STUDY
SMILOW Cancer Center at Saint Francis Hospital and Medical Center, Hartford CT
Pharmacy Program
 Receiving (Off Site)
 Work Room
 Ante Room
NHD
MIXING
ISO 7
(+++)
HAZARDOUS DRUG MIXING
ISO 7 (-)
HD
STOR
12 ACH
(-)
 NHD Mixing
 HD Mixing
 HD Storage
New England Healthcare Engineers’ Society
USP 797/800 - Designing the Built Environment
ANTE ROOM
ISO 7 (++)
PHARMACIST / TECH WORK ROOM
ISO 8 (+)
CASE STUDY
SMILOW Cancer Center at Saint Francis Hospital and Medical Center, Hartford CT
Work Flow Diagram
 Staff
 Product
 Standard Operating
Procedures
New England Healthcare Engineers’ Society
USP 797/800 - Designing the Built Environment
CASE STUDY
SMILOW Cancer Center at Saint Francis Hospital and Medical Center, Hartford CT
Safety Diagram
 Restricted Area
 Lighting
 Visibility
 Communication
 Minimize Medication Errors
New England Healthcare Engineers’ Society
USP 797/800 - Designing the Built Environment
CASE STUDY
SMILOW Cancer Center at Saint Francis Hospital and Medical Center, Hartford CT
Work Room - Entrance
New England Healthcare Engineers’ Society
USP 797/800 - Designing the Built Environment
Work Room – View 1
CASE STUDY
SMILOW Cancer Center at Saint Francis Hospital and Medical Center, Hartford CT
The facility design must consider policies and
procedures for PPE, Product and Staff workflow.
Example: Personal Protection Equipment
Two pairs of shoe covers must be worn in a negativepressure buffer room where hazardous drugs are
compounded,
One pair of shoe covers is removed before leaving the
hazardous drug buffer room to prevent the spread of
hazardous drug contamination from the floor of the
buffer room to spaces outside the buffer room.
Ante Room
New England Healthcare Engineers’ Society
USP 797/800 - Designing the Built Environment
CASE STUDY
SMILOW Cancer Center at Saint Francis Hospital and Medical Center, Hartford CT
Hazardous Drug Mixing Room – View 1
New England Healthcare Engineers’ Society
USP 797/800 - Designing the Built Environment
Hazardous Drug Mixing Room – View 2
CASE STUDY
SMILOW Cancer Center at Saint Francis Hospital and Medical Center, Hartford CT
Air Handling Unit - Supply Ventilation
New England Healthcare Engineers’ Society
USP 797/800 - Designing the Built Environment
Dedicated Exhaust Fans
Equipment Safety
 Biosafety Cabinets
USP 797 Update
USP 800
 Medication Dispensing
Specific for NHD compounding
Required for Non Sterile and
Sterile Handling of Hazardous
Drugs
 Robotics
 Inventory Management
 Remote Verification
Aligns with USP 800
No Changes to the Facility /
Engineering requirements
Requires separate HD
Storage with negative
pressure at 12 ACH
Requires separate
compounding rooms (HD and
NHD)
No pass thru refrigeration
units.
Temp / Humidity clarifications
Fully Exhausted Clean
Rooms
Compliance by July 1, 2018
New England Healthcare Engineers’ Society
USP 797/800 - Designing the Built Environment
Take Aways
Facility Requirements
 Design team should consist of Pharmacy, Infection
Control, and Facility Engineering Staff along with the
Architects and Engineers.
 “Form follows Function” - Design starts with
Operational Process - Put Process In Front of Space
Planning.
 Prioritization of Staff and Patient Safety
USP 797 Update
USP 800
Specific for NHD compounding
Required for Non Sterile and
Sterile Handling of Hazardous
Drugs
Aligns with USP 800
No Changes to the Facility /
Engineering requirements
Requires separate HD
Storage with negative
pressure at 12 ACH
Requires separate
compounding rooms (HD and
NHD)
 Pharmacy’s required to be USP 800 compliant by
July 1, 2018 – per USP
No pass thru refrigeration
units.
 Review with local state regulators / inspectors
Fully Exhausted Clean
Rooms
Temp / Humidity clarifications
Compliance by July 1, 2018
New England Healthcare Engineers’ Society
USP 797/800 - Designing the Built Environment
THANK YOU
New England Hospital Society of Engineers
New
Englandthe
Healthcare
Engineers’ Society
Designing
Built Environment
USP 797/800 - Designing the Built Environment