Endorsed by the Joint Commission on Accreditation of
Healthcare Organizations (JCAHO) with an aggressive
compliance schedule, USP 797 has received great attention
from hospital administrative, clinical and pharmacy staff.
However, its requirements also extend to architectural
and environmental areas. Consequently, hospital design,
construction and operations professionals should also
become familiar with it.
Far-reaching regulation
USP 797 is a far-reaching regulation that governs a
wide range of pharmacy policies and procedures. It is
designed both to cut down on infections transmitted to
patients through pharmaceutical products and to better
protect staff working in pharmacies in the course of their
exposure to pharmaceuticals.
Issued by U.S. Pharmacopeia (USP), the regulation
governs any pharmacy that prepares "compounded sterile
preparations" (CSPs). Many pharmacies fit this
description. Moreover, many large hospitals have several
pharmacies--a main one and several satellite
pharmacies--that will be affected.
The schedule for compliance with USP 797 per JCAHO is
as follows:
- JCAHO began surveying for compliance with USP 797 on
July 1, 2004;
- JCAHO's deadline for an "Approved Facility
Renovation Plan" (AFRP) is January 31, 2005; and
- JCAHO's deadline for completion of construction
called for in the AFRP is January 31, 2008.
First step in compliance
The first step in the process of compliance is to
categorize a pharmacy into one of the following
classifications: "Low-Risk Level CSP," "Medium-Risk Level
CSP" or "High-Risk Level CSP."
A complete description of each level is outside the
scope of this article. However, a general idea can be
derived from examples excerpted from the USP 797 document,
which can be purchased directly from USP through their Web
site at www.usp.org.
These examples of low-risk compounding include the
following:
- "Single transfers of sterile dosage forms from
ampuls, bottles, bags and vials using sterile syringes
with sterile needles, other administration devices and
other sterile containers ... "; and
- "Manually measuring and mixing no more than three
manufactured products to compound drug admixtures ... ."
Examples of medium-risk compounding include the
following:
- "Compounding of total parenteral nutrition fluids
using manual or automated devices ... ";
- "Filling of reservoirs of injection and infusion
devices with multiple sterile drug products ... ";
- "Filling of reservoirs of injection and infusion
devices with volumes of sterile drug solutions ... ";
and
- "Transfer of volumes from multiple ampuls or vials
into a single final sterile container or product."
Examples of high-risk compounding include the
following:
- "Dissolving nonsterile bulk drug and nutrient
powders to make solutions which will be terminally
sterilized.";
- "Sterile ingredients, components, devices and
mixtures are exposed to air quality inferior to ISO
Class 5 ... ";
- "Measuring and mixing sterile ingredients in
nonsterile devices before sterilization is performed.";
and
- "Assuming, without appropriate evidence or direct
determination, that packages of bulk ingredients contain
at least 95 percent by weight of their active chemical
moiety and have not been contaminated or adulterated
between uses."
Overriding physical requirement
The overriding physical requirement of USP 797 is the
creation of two zones: a "buffer room" (in general, where
the sterile compounding is done) as well as an "anteroom"
(in general, where nonsterile compounding activities
occur, such as hand washing, storage and
measuring/weighing/mixing of nonsterile substances).
There is a critical difference, however, between the
configuration of the buffer room and anteroom in a low-,
medium- or high-risk environment. In a low- or medium-risk
environment, the buffer room and anteroom can be in one
shared room. In a high-risk environment, the buffer room
and anteroom must be separated by a wall with a door.
USP 797 provides specific direction on the cleanliness
or purity of the air in the buffer room. For a start,
compounding of sterile substances must be done in a
"Laminar Airflow Workbench" (LAFW), which must provide an
air purity micro-environment of the International
Organization for Standardization's ISO-5 (equivalent to a
"Class 10" cleanroom). The ISO-5 LAFW, in turn, must be
located in the buffer room, which must itself provide air
quality equal to ISO-8 (equivalent to a "Class 100,000"
cleanroom). To complicate matters, there is current
discussion that the buffer room air purity level
requirement may be raised to ISO-7 in the next version of
the regulations.
USP 797 also provides detailed guidelines for
architectural finishes in the buffer room. Only the
minimum amount of furniture, equipment and supplies should
be brought into the buffer room. All surfaces--ceiling,
walls, floors, fixtures, shelving, counters and
cabinets--should be "smooth, impervious, free from cracks
and crevices, and nonshedding ... ." Junctures of ceilings
to walls should be coved. Wall construction should be
either a locked panel system or epoxy-coated gypsum board.
Floors should be sheet vinyl with heat-welded seams and
coved base. Exterior surfaces of lighting fixtures should
be smooth, mounted flush and sealed. There should be no
sinks or floor drains in this area, and work surfaces
should ideally be stainless steel.
Cleaning and sanitizing
Another section of the guidelines concerns the cleaning
and sanitizing of critical pharmacy areas, and refers to
all compounding areas (low-, medium- and high-risk).
Prescribed as the domain of trained pharmacists and
technicians, cleaning and sanitizing should be done
according to written procedures, and should be performed
at the beginning of every shift.
The guidelines address the LAFW, buffer and anteroom
separately. Within the LAFW, all items are to be removed,
all surfaces cleaned of loose materials and residue from
spills, and a residue-free sanitizing agent must be
applied and left on for the time required to be effective.
In the buffer room, work surfaces are cleaned in a
similar manner, storage shelving is to be emptied and
sanitized weekly, and floors should be mopped daily when
no aseptic operations are being performed.
In the anteroom, supplies and equipment removed from
boxes should be wiped with a sanitizing agent. However, if
the supplies arrive in pouches, they can be moved into the
buffer room without sanitizing. External cartons must
remain in the anteroom because they are prohibited from
the buffer room.
In general, the anteroom is to be cleaned and sanitized
by trained personnel at least once a week; however, floors
must be cleaned and sanitized daily. Storage shelving must
be emptied and cleaned and sanitized at regular intervals,
but at least once a month.
Monitoring requirements
A final topic worth noting is a section on
environmental monitoring. This monitoring entails the
measurement of both the total number of particles and the
number of viable microorganisms in the air of the
compounding area.
To begin with, the LAFW must be tested at least once
every six months (and/or every time the LAFW is relocated)
to verify that the equipment meets the requirements of ISO
Class 5 (or cleanroom "Class 10"). Beyond this, the air
quality of the buffer room itself (the room containing the
LAFW) must also be tested at least every six months
(and/or whenever renovations occur) to confirm compliance
with ISO Class 7 or ISO Class 8 (cleanroom "Class 10,000"
or "Class 100,000").
On a fast track
The quick endorsement by JCAHO and equally quick
implementation by JCAHO of a mandatory compliance schedule
has forced hospitals to fast-track their evaluation and
action plans.
Because of the complexity of the regulation, most
administrators are opting to have an overall understanding
of it, then setting up a team composed of themselves, an
architect versed in USP 797, the chief pharmacist and the
facility engineer. This team, in turn, is charged with
coming up with a plan to meet JCAHO's looming compliance
deadlines.
William N. Bernstein, AIA, ACHA, is a principal
of the firm Bernstein & Associates Architects, New York
City. Bernstein is currently involved in a number of USP
797 projects. He can be contacted at
wb@bernarch.com.
