Basic Documentation

Siemens Industry, Inc. Page 5 of 6
Document No. 149-208
details of any adjustments made or corrections
applie
d to the device. Alarms should be checked for
correction function against specified design
documents.
Qualification of Cold Equipment
Large refrigerators in excess of 6 m
2
(64.6 ft
2
) or
walk-in cold rooms should undergo thermal mapping
in their empty and full state. Afterwards the
temperature distribution should be checked annually
under normal use conditions. For walk-in units,
thermal mapping should be repeated, if the unit has
undergone significant repair, replacement of
refrigeration or changes to internal storage layout.
Walk-in units should use multiple sensors for
temperature monitoring.
Compromised Temperature
Conditions
Excursions above or below established limits require
a history leading up to and including the period out
of tolerance and a documented rational for the
excursion, including corrective actions.
Reliable Emergency Power
JCAHO Environment of Care (EC7.20.5) requires
hospitals to provide reliable emergency power
system for critical storage units serving: blood, bone
and tissue units. Blood, bone, and tissue units shall
be on the critical branch of the emergency power
circuit per NFPA99 Standard for Healthcare
Facilities.
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Design Considerations
The following list describes important design criteria
for monitoring critical storage areas:
 JCAHO recommends that a gap analysis be
done on the emergency power system that
matches the critical equipment and systems
needed in an extended emergency against the
equipment and systems actually on the
emergency power system. Use disaster scenario
planning to identify critical systems that could
potentially be lost (for example, potable water or
13. NPFA 99 Standard for Healthcare Facilities 2005, section
4.4.2.2. 2.3 Critical Branch
elevators). This kind of planning will help assure
that emergency power feeds critical systems.
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 Temperature sensors shall be NIST-certified or
guaranteed by manufacturer to meet NIST
standards. Temperature sensors should have an
accuracy of ±0.25°C (32.5°F).
 Temperature sensors should be calibrated on a
regular basis per manufacturer
recommendations.
 High/low alarms limits and alerts should be
defined for all equipment being monitored.
 Remote notification of alarms to alphanumeric
pagers, numeric pagers, e-mail, and phones via
voice or SMS (Short Message Service) is
recommended to facilitate indication of critical
storage temperature alarms to healthcare
workers and facility maintenance staff.
 Integration of controlled storage area monitoring
into the building automation system (BAS)
allows historical data, alarms and alarm
acknowledgement to be collected and archived
to document corrective action taken.
 Policy must be in place for implementing backup
equipment for refrigerators, freezers, and
incubators.
 Develop an Alarm Response Protocol for
personnel.
 Temperature alarm systems must have a
separate power source to ensure proper
monitoring during power failures.
Things to Remember
When hospital areas undergo renovation, often new
controlled environmental equipment will be
purchased. Be sure to coordinate equipment
features so that the controlled environment can be
easily integrated into the building automation
system. Some things to remember are:
 All drugs should be stored according to
conditions described on the label. When
specified on the label, controls for temperature,
humidity, and lighting should be in implemented.
14. JCAHO Sentinel Event ALERT, Issue 37, September 6,
2006