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SOP Power Failure Natural Disasters 09FEB21

This 3 sentence summary provides the key details about the document: This standard operating procedure outlines the steps the [CRS name] takes in the event of a power failure or natural disaster. It describes maintaining backup power for critical equipment, assessing damage, and documentation and reporting requirements. Staff are trained on applicable SOPs and documentation of training is maintained.

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Dyrom Aquino Torio
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172 views

SOP Power Failure Natural Disasters 09FEB21

This 3 sentence summary provides the key details about the document: This standard operating procedure outlines the steps the [CRS name] takes in the event of a power failure or natural disaster. It describes maintaining backup power for critical equipment, assessing damage, and documentation and reporting requirements. Staff are trained on applicable SOPs and documentation of training is maintained.

Uploaded by

Dyrom Aquino Torio
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOC, PDF, TXT or read online on Scribd
You are on page 1/ 3

[insert CRS name]

Standard Operating Procedure for


Power Failure and Natural Disasters
SOP #: [0.0] Place DO NOT COPY
label here.
Version: 1.0
Author(s): [Name], [Title]
[Name], [Title]
Approval: Approved By Date

[Name], Principal Investigator

[Insert name and title, if applicable]

Revision Version Effective Date Description


History: 1.0 [dd-MMM-yy] First Approval

Purpose
This document describes how the [site name] CRS deals with power failure and natural
disasters.

References
 [insert site name] CRS DAIDS Pharmacy Establishment Plan
 Power Failure Log
Scope
This SOP applies to the following [site name] CRS staff: [insert titles of appropriate
staff members]

Allowable Exceptions
This SOP is meant to be followed without deviation. However, it is an allowable
exception to follow procedures specified in a protocol or Study Specific Procedure
Manual (SSP) that may deviate from this SOP.

Procedures
A. Power Failure
1. Clinical Facilities
a. For power outages occurring during work hours:
 Clinic visits can continue if they are being carried out in a space with
sufficient lighting and the participant’s safety is not compromised.
 Clinic visits are cancelled and rescheduled if the power outage is severe.
 [insert title of appropriate staff member] verifies the status of critical

SOP [0.0], Version 1.0 Page 1 of 3


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SOP for Power Failure and Natural Disasters

equipment.
b. If the power failure occurs during off hours:
 [insert title of appropriate staff member] makes a general round to assess
the functioning of the emergency power supply and checks specific
alarms located throughout the clinic.
c. If temperature logs show a deviation from acceptable levels, [insert
appropriate plan of action or reference the plan].
2. Laboratory (Remove this section if the information is documented in the
Laboratory SOPs)
a. The power source for laboratory equipment is backed-up [describe backup
power].
b. If the power failure occurs during off hours, [insert title of appropriate staff
member] makes a general round to assess the functioning of the emergency
power supply and checks specific alarms located throughout the laboratory.
c. If the power outage occurs during working hours, [insert title of appropriate
staff member] verifies the status of critical equipment.
d. If temperature logs show a deviation from acceptable levels, [insert
appropriate plan of action or reference the plan].
3. Pharmacy (Remove this section if the information is documented in the
Pharmacy Plan or SOPs)
a. The power source for pharmacy equipment is backed-up [describe backup
power and all equipment connected to it].
b. If the power failure occurs during off hours, [insert title of appropriate staff
member] makes a general round to assess the functioning of the emergency
power supply.
c. If the power outage occurs during working hours, [insert title of appropriate
staff member] verifies the status of critical equipment.
d. If there is a temperature deviation from acceptable levels, [insert appropriate
plan of action or reference the CRS's Pharmacy Plan].
B. Natural Disasters [remove if not applicable]
1. [insert type of natural disaster]
a. [insert description of natural disaster, including likely time of year, if
applicable]
b. If a [insert type of natural disaster] occurs, [insert title of appropriate staff
member] assesses the status of the freezers and other critical equipment as
noted in Sections A.2. and A.3.
C. Reporting

SOP [0.0], Version 1.0 Page 2 of 3


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SOP for Power Failure and Natural Disasters

1. Documentation
a. A log is maintained for all power outages.
b. Incident reports are generated for all significant power failures and natural
disasters that interrupt clinic operations for more than one day, and/or impact
the integrity of products or specimens. These reports are kept on file in the
[insert location], including any associated correspondence. Documentation is
not required when power is restored or back-up power is established such
that there is no impact on clinic, product and specimens.
c. [insert title of person responsible] notifies the study Sponsor, Laboratory
Center, SDMC, Leadership Operations Center, and Pharmaceutical Affairs
Branch (PAB) by telephone, email or fax should there be an emerging [insert
type of natural disaster] or a significant power failure.
d. As soon as clinic activities are resumed, [insert title of person
responsible]updates the study sponsor, Laboratory Center, SDMC,
Leadership Operations Center, and PAB with any significant outcomes or
occurrences.

Training
1. Each staff member receives or has direct access to applicable Standard Operating
Procedures (SOPs).
2. Each staff member reviews the applicable SOPs [Insert frequency of review].
3. All SOP training is documented and tracked [Insert where the documentation is
kept].
4. New staff is trained on applicable SOPs within [Insert #] days of employment.
5. Staff members whose duties fall within this SOP scope are retrained within [Insert
#] days of the approval of each SOP revision.

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