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Storage and Maintenance of Clinic Pharmaceuticals (121.001)

Storage and Maintenance of Clinic Pharmaceuticals (121.001) - Policies, Administrative, UWMF, UWMF-wide, Safety, Medication Safety

121.001


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UW Medical Foundation
SAFETY POLICIES AND PROCEDURES

Subject: Storage & Maintenance of Clinic Pharmaceuticals
Effective Date: Approved: See Authorization Section
Supersedes Policy Date: 11/17/14 Revision # 8
Distribution: Uconnect

Reviewed


Purpose: To maintain quality control and consistent storage and maintenance of clinic
pharmaceuticals. NOTE: this policy also applies to antigens, but does not apply to controlled
substances – see the Controlled Substances Distribution Policy for storage requirements.

Policy Statement: It is the policy of the UW Medical Foundation to follow current Centers for
Disease Control & Prevention recommendations and recognized best practices to ensure
the safe disposition of all clinic pharmaceuticals. Clinic managers will be the administrator of
this policy and will make certain staff complies with all applicable parts. The Safety & Security
Manager will provide initial training on the applicable parts of this policy to new clinical staff
during Clinical Orientation and annually thereafter to ensure competency and compliance.
Additionally, this person will ensure annual calibrations of temperature thermometers, will
conduct periodic audits, review this policy annually and provide resource support as
needed to help clinic sites with safely storing and maintaining their clinic pharmaceuticals.

I. Handling Procedures:
1. All temperature-sensitive clinic pharmaceuticals will be prepared and
transported in a timely manner to ensure the cold chain requirements per
manufacturer recommendations.
2. Couriers delivering such pharmaceuticals will make contact with clinical staff at
the receiving site upon arrival. In this way, clinical staff can ensure the
pharmaceuticals are immediately placed inside the appropriate refrigerating
unit(s).
3. If the courier suspects that such pharmaceuticals may have been exposed to
unsafe temperatures during transport, the following will occur:
a. Upon arrival, the courier will notify the receiving clinician immediately
b. The clinician will label the affected pharmaceuticals as “POTENTIALLY
COMPROMISED MEDS. DO NOT USE” and placed in the appropriate
refrigerator or freezer.
c. The clinician will immediately call the clinic manager and pharmacy (608-
287-2406) to report the event.
d. If advised by pharmacy, the clinician will complete and fax the
Medication Storage Investigation Form (see Attachment A) to pharmacy
to determine the safety of affected pharmaceuticals. If a temporary



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supply of same pharmaceuticals is needed; the clinician will make
immediate arrangements with pharmacy.
e. The clinic manager or designee will notify all affected staff/ providers of
the event to prevent inadvertent use of affected pharmaceuticals.

II. Ordering Procedures:
1. A PeopleSoft Requisition should be completed in PeopleSoft for each order.
III. Storage Procedures:
1. Store in a medication refrigerator or freezer that is plugged directly into a
dedicated outlet. Make sure the outlet and affected circuit breaker are labeled
as “DO NOT UNPLUG” and “DO NOT TURN OFF” respectively.
2. Do not store pharmaceuticals in door or near cold air exhaust in refrigerator. In
household-grade refrigerators, managers should store containers of water under
or near cold air exhaust to prevent pharmaceuticals from being stored too
closely to exhaust. If possible, tape shut lettuce crispers or lower bins to avoid
accidental storage of pharmaceuticals or antigens.
3. Rotate stock. Use old pharmaceuticals prior to new.
4. Multiple pharmaceuticals should be organized and labeled inside cabinet or
refrigerating/freezing unit.
5. Do not store laboratory specimens, employee food or beverages with
refrigerated or frozen pharmaceuticals.

Non-Refrigerated
Pharmaceuticals
Refrigerated
Pharmaceuticals Frozen Pharmaceuticals
Where to Store
Pharmaceuticals?
Locked cabinet or
drawer.



In the main
compartments of the
refrigerator,
sufficiently away from
walls to allow air to
circulate and away from
cold air exhaust (to
protect against cooler
temps).

In a refrigerator - freezer
with separate doors.

Place frozen meds in the
center of the freezer.
Use ice packs around
medication to maintain
temperature in freezers
that have a defrost
cycle.
Required
Temperature

60 – 70 degrees
Fahrenheit
36 – 46 degrees
Fahrenheit



5 Degrees Fahrenheit or
below (especially with
varicella
pharmaceuticals)



II. Monitoring Refrigerator / Freezer Temperature Procedure:

Requirements
Thermometers

ξ Checkpoint wireless temperature sensors will be used for
freezer and refrigerator monitoring 24/7. Additionally, one


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back-up thermometer will be on-hand in case primary
sensor fails.

ξ Designated staff will access the Checkpoint database to
ensure temperatures are within acceptable ranges (see
Attachment B). Additionally, Vaccine for Children sites will
document temperatures on a hard copy log and retain
documentation for at least three years (see Attachment D).

ξ Temperature checks must be done when the clinic opens
and closes at the end of the day.

ξ Managers will access database at least monthly to verify
temperatures, corrective action and user login activity (see
Attachment B).

Temperature Reports ξ As required, managers will create temperature reports for
auditing purposes. If reports need to be printed, contact
the Safety & Security Manager (608.826.6724), EHIC/ Safety
Assistant (608.826.6732) or Pharmacy Manager
(608.203.4895).

Troubleshooting (see Attachment C for checklist)
Temperatures
deviate from
accepted range
during or after clinic
hours
1. The Checkpoint software will initiate an email alert to
UW Paging.

2. UW Paging (608.262.2122) will call the appropriate
contact and share the temperature deviation or
equipment failure for the affected clinic and
refrigerating unit.

3. The responding staff must assess the alert cause onsite
and initiate corrective action in the Checkpoint
database for the affected equipment to prevent future
email alerts to UW Paging. (If a power outage has
occurred, see Power Outage Policy.)

4. Keep affected pharmaceuticals refrigerated per
manufacturer recommendations.

5. Affected pharmaceuticals must be labeled as
“Potentially compromised meds. Do not use.”

6. Notify your Clinic Manager or designee as soon as
possible.

7. The Clinic Manager or designee will call the Pharmacy,
Safety and their Director to start the investigation and
determine the stability of affected pharmaceuticals.



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8. Complete and fax the Medication Storage Investigation
Form (see Attachment A) to pharmacy to determine
the safety of affected pharmaceuticals. If a temporary
supply of same pharmaceuticals are needed; make
immediate arrangements with pharmacy.

9. All affected employees and providers will be informed
of investigation process and outcome.
Outcome of Investigation

Report findings of
Investigation




1. If the findings prove the affected pharmaceuticals
have not been compromised, such
pharmaceuticals may be returned to inventory
stream – only if approved by Clinic Operations.
2. If the findings prove the affected pharmaceuticals
have been compromised, the Clinic Manager (or
designee) must submit a PSN and report the loss
and related costs.
New medication
refrigerators/
freezers
1. If the findings support purchasing a new
medication refrigerator/ freezer, the Clinic
Manager must make arrangements through
storeroom. Upon arrival, the unit must sit for a day
unplugged. Thereafter, the unit must be monitored
for at least 2 days to ensure temperatures are
steady and adequate. The Clinic Manager is
responsible for retaining all warranties/
documentation that comes with the new unit.


III. Expiration Dating Procedures:
1. All medications are viable until the expiration date printed on the
container, including samples. EXCEPTIONS are:

ξ Nitroglycerin tablets expire one month after the date of opening.
ξ Injections with preservatives (e.g. methylparaben, benzyl alcohol,
chlorobutanol) expire 28 days after the first date of use. These are
generally multiple dose vials.
ξ Injectables without preservatives expire 24 hours after first use.

2. Vaccines can be used until the expiration date on the vial unless
otherwise noted, e.g. varicella pharmaceuticals stable for 30 minutes after
reconstitution.
3. Date and initial multidose vials when opened.
4. Expiration dates of all pharmaceuticals kept in stock should be checked
monthly


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NOTE: See the Hazardous Material & Waste Management Plan for information on the disposal
of clinic pharmaceuticals and credit for unopened, expired pharmaceuticals/other
pharmaceuticals.

AUTHORIZATION (must include signature, name and title of preparer):

Dr. Richard Welnick, Medical Director 11/16/2015
Date


Michael Holman, Safety & Security Manager 11/16/2015
Date


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MEDICATION STORAGE INVESTIGATION FORM ATTACHMENT A

Clinic Location: Date:

Clinic Contact: Highest/ lowest Temperature Outside of Range:
Phone #: ____________________
Total Time Unit Was Out of Range:_____________________
Fax #: _____________________

Unit Affected: __________________________

Medication # of
doses
Lot # Exp.
Date
Vial Type Open/ unopened Stability
(Pharmacy use
only)
Cost
(Pharmacy
use only)


















Fax to 1 S. Park Pharmacy (608) 287-2987




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Checking Temperatures Attachment B
STEP ONE: Access Checkpoint on Uconnect through the Quick Links header. Then select
Checkpoint under Clinical Links (note: you may have to use the Internet Explorer Browser to
see data).



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STEP TWO: Enter your login ID and password. Remember, your password is case-sensitive. If
windows asks you to “change your password to what is already stored”, select NO (selecting
YES may prevent access to database).




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STEP THREE: Check the refrigerator temperature history by moving your cursor over the
“Graph” menu or right click over the row where the equipment is listed. Select “Graph It”
with your cursor.

























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STEP FOUR: Check temperature history by moving your cursor to the “Period” drop down and
selecting the desired interval (i.e. 24 hrs, 7 days, 1 month, etc).


























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STEP FIVE: As necessary (i.e. Vaccine for Children audits), print out temperature chart by
moving cursor over the “File” and “Print” options.


























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Taking Corrective Action
UW Paging will monitor Checkpoint alerts 24/7. If an alert occurs after hours, advise UW paging of your response intention
and respond onsite to assess alert condition/ initiate corrective action within Checkpoint.
STEP ONE: After accessing Checkpoint, move cursor over the affected equipment in the
“Current Alerts:” section. Right click over the equipment and select “Take Corrective
Action”. If you do not take corrective action same day, the alert will trigger again 15 hours
later to remind you to take corrective action.





















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STEP TWO: From the corrective actions options, select the item that best matches the
problem and click “Next”.

























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STEP THREE: Click the “Next” button again to describe the corrective action.


























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STEP FOUR: Include name of product, corrective action taken (i.e. purchasing new
refrigerator), indicate if equipment is working properly, enter your login ID and click “Save”.

























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STEP FIVE: When corrective action is initiated and equipment is not working properly, select
No and save (from Step 4). Checkpoint will change the “Current Alerts” condition to
“Corrective Action in Progress”. This will shunt alert signals to UW Paging for at least one
week. If corrective action is expected to take longer, notify Safety & Security Manager
(608.287.2190) and the sensor will be deactivated until correction action is completed.






















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STEP SIX: When corrective action is complete (i.e. new refrigerator in service), right click over
the equipment in “Corrective Action in Progress” and select “Process Further”.

























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STEP SEVEN: Include the required information, note the equipment is working properly, enter
login ID and click “Save”. This will remove the equipment from the “Corrective Action in
Progress”

























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Monthly Manager Reviews in Checkpoint
STEP ONE: From the Reports menu, select “User Login History” and/ or “Corrective Action
History” to review appropriate staff use of Checkpoint.

























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STEP TWO: Select the “Time Period” for User Login History data (i.e. 7 days, 1 month, 3 months,
etc.). The same can be done for Corrective Action History. If a printed record is needed,
contact the Safety & Security Manager 608.287.2190.
























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Lastly, contact the Safety & Security Manager (see contact information below)
with the following:
1. Trouble with Checkpoint use or access
2. Requests to add/ delete users
3. System use questions
4. Concerns or complaints with system

Mike Holman, Safety & Security Manager
Phone: 608.287.2190
Email: Mike.Holman@uwmf.wisc.edu
Back up: Casey Farnum, Safety & Security Technician
Phone: 608.287-2191
Email: Casey.Farnum@uwmf.wisc.edu












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Checkpoint Temperature Monitoring for Medication Refrigerators/ Freezers
Frequently Asked Questions (as of 10/6/15)

1. As a clinician, what is expected of me to ensure policy compliance with the new Checkpoint system?
a. As we have before, staff needs to check refrigerator/ freezer temperatures twice daily to
ensure Checkpoint is working properly and temperatures are safe. These checks need to occur
by accessing the system upon arrival at the clinic and just before closing.
b. If corrective action is needed to resolve a temperature deviation or equipment malfunction,
staff needs to work with their manager to resolve and document within the Checkpoint system
to prevent future alerts.

2. How will I know of a temperature deviation or equipment malfunction?
a. UW Messaging & Paging monitors all alert signals from the Checkpoint system 24/7. If there is
an equipment malfunction or temperature deviation that is at least 30 minutes in duration, the
following occurs:
i. An email and pager alert are transmitted to UW Messaging & Paging. Paging staff refer
to the clinic contact list and notify the contact of the alert location, affected equipment
and reason for the alert (i.e. temperature above max limit).
ii. An email alert is also transmitted to assigned clinic staff.
iii. Staff needs to consider the severity of the deviation as well. For example, if the
temperature dropped to 20F for 30 minutes, but corrected shortly thereafter,
pharmaceuticals will likely be compromised. Pharmacy will provide guidance on the final
disposition of all affected pharmaceuticals.

3. What are the expectations for resolving Checkpoint alerts after hours?
a. Assigned staff needs to respond onsite to assess alert condition, initiate corrective action (i.e.
adjust thermostat or relocate pharmaceuticals to another safe refrigerator) and document
corrective action in the Checkpoint system.
b. IMPORTANT: if corrective action is not documented in the Checkpoint system within the
same day of the alert notice, additional alerts may be transmitted to UW Messaging & Paging
resulting in additional after hour calls to site contacts.

4. What if I am not able to log into Checkpoint to document corrective action? What can I do to prevent
additional calls from UW Messaging & Paging same night?
a. If you cannot initiate corrective action within the Checkpoint system and pharmaceuticals have
been safely stored, call the paging staff (608.262.2122) and advise to ignore alerts on affected
equipment until next business day. Notify Mike Holman, Safety & Security Manager
(608.287.2190), so that the alert condition can be resolved in Checkpoint.

5. Will on-call Facilities be available for assistance during after hour alerts?


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a. Yes. But the on-call technician will not act alone to respond to an after hour alert event. The
assigned clinic contact must page the on-call technician (608.376.7006) to request support and
meet onsite together. Facilities cannot service medication refrigerators, but can assist with
clinic access and relocation pharmaceuticals.

6. What should we do with the thermometers we have been using all along?
a. Keep these thermometers for back up use as needed. There may be an occasion whereby we
lose sensor contact and need to use another thermometer. Sites must contact the Safety &
Security Manager (608.287.2190) to request a calibrated back-up thermometer for the
temporary monitoring of pharmaceuticals until the Checkpoint sensor issue is resolved.

7. If I need to manually defrost our freezer, how can I prevent false temperature alerts with the
Checkpoint system?
a. Notify Mike Holman, Safety & Security Manager, so that the sensor can be temporarily
deactivated. When the freezer in back in service, notify Mike again so the sensor can be re-
activated.

8. If I have problems with sensor connectivity, what can I do?
a. Verify your site’s “access point” is plugged into a network jack and has two,
solid green lights. The access point receives wireless signals from your
Checkpoint sensor and transmits the data to the network database.

b. Most access points are located in the electrical closet or IT room.


c. If your site has a “repeater”, ensure it is plugged into an outlet.
A repeater is a device the helps strengthen the wireless signal at
your site. These are sometimes located between your Checkpoint
sensor and the access point.







d. Make sure your Checkpoint sensor is on by pressing the button nearby the clear LED on the
sensor (place thumb over the “POINT” in the “CHECKPOINT” label next to the clear LED). The
LED should turn green for at least 10 seconds and then clear. If it doesn’t, press and hold down




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on the button for 4 seconds. The LED green light will blink and turn solid; indicating sensor is
on.









e. If problem persists, contact Mike Holman, Safety & Security Manager at 608.287.2190.

9. What if my employee has problems accessing Checkpoint?
a. Remember that passwords are case-sensitive. So if the first letter is capitalized and remaining
characters are lower case, then this needs to be replicated.
b. If the employee receives a windows pop up asking to change existing password to what is
already stored, select NO, as this will prevent access.
c. Contact Mike Holman, Safety & Security Manager (608.287.2190) if problem persists or you
need to add/ delete users from the system.

























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MEDICATION REFRIGERATOR/ FREEZER TROUBLESHOOTING CHECKLIST ATTACHMENT C
Troubleshooting  Initials
Temperatures deviate from
accepted range during normal
clinic hours
1. Ensure wireless thermometer is located centrally. Keep 1-2
inches of clearance on all side walls to allow for proper air
circulation

2. Adjust thermostat as necessary.
3. Check the adequacy of door seal.
4. Contact Clinic Manager IMMEDIATELY if temperature does
not return to acceptable range within one hour. If deviation
occurs at the end of the day, relocate pharmaceuticals to
another safe refrigerator and report finding to manager next
day.

5. The Clinic Manager (or designee) will relocate
pharmaceuticals to another safe refrigerator/ freezer as
necessary.

Action Steps
Temperatures are found to be
out of range overnight or for
more than an hour

1. Keep refrigerator/ freezer door closed. Do not attempt to
check pharmaceuticals.

2. Notify your clinic manager (or designee) as soon as possible.
3. The Clinic Manager will contact the Safety Manager and their
Director to start the investigation.

4. If needed, arranged to have a temporary supply of
pharmaceuticals available and an alternate storage location
within the clinic. DO NOT USE ANY PHARMACEUTICALS
FROM AFFECTED REFRIGERATOR/ FREEZER until
investigation is complete.

5. All affected employees and providers will be informed of
investigation process and findings.

Outcome of Investigation
Report findings of
Investigation

1. If the findings prove the affected pharmaceuticals have
not been compromised, such pharmaceuticals may be
returned to inventory stream – only if approved by Clinic
Operations.

2. If the findings prove the affected pharmaceuticals have
been compromised, the site manager (or designee) must
submit a PSN and report the loss and related costs.

TROUBLESHOOTING POINTS - If you confirmed proper location of thermometer, tried adjusting thermostat
and checked door seal, consider the following:
1. Stock your storage unit with as much bottle water/ ice packs as possible to stabilize temperature
2. If your refrigerator/freezer is under warranty, call the appropriate customer service number for technical support
3. If you have an older refrigerator, contact Facilities and ask if it would be worthwhile to have an appliance technician
evaluate the unit
4. Contact the Storeroom for information on our new standard medication refrigerator and/ or freezer.
5. If refrigerator door does not close by itself, have Facilities adjust front tilt so door swing is influenced by gravity/ closes
freely
6. Use a sharpie to identify ideal thermostat setting and/ or direction for warming/ cooling the unit




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ATTACHMENT D
Medication refrigerator/freezer temperature log
VACCINE FOR CHILDREN VERSION (see backside for instructions)

Clinic: Ref/Fzr ID:_______ Month/Year:

Vaccine Coordinator:_________________________ Back-up Vaccine Coordinator:__________________________
Appropriate Refrigerator Range: 36 θF to 46 θF Appropriate Freezer Range: -15 θF to 5 θF

Day Record Temps
Morning Check (beginning of day) Afternoon Check
(end of day)

Time Temp Initials After
Hours
MIN
After
Hours
MAX
Time Temp Initials Action taken (if temperatures
out of range)
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
ξ In the event that the refrigerator / freezer temperature is not within the accepted range, the staff member shall:
1. Notify clinic manager or designee immediately.
2. Store the vaccine under proper conditions as quickly as possible. This may include adjusting thermostat or relocating vaccine to
another safe refrigerator. Be sure to label the affected vaccines with “Potentially compromised meds. Do not use.”
3. Call pharmacy (608-287-2406) to determine whether the potency of the vaccine(s) has been affected.
4. Document the action taken on log form.

ξ If the refrigerator requires service, the clinic manager or designee will contact Safety to coordinate repairs. In the interim, medications
will be moved to a replacement refrigerator/freezer and appropriate staff will be notified.


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Medication refrigerator/freezer temperature log
VACCINE FOR CHILDREN VERSION
INSTRUCTIONS

At the start of each month, include the following on the temperature log:
o Clinic name
o Refrigerator/ freezer identification name or number (each VFC refrigerator/ freezer needs a log)
o Month and year
o Vaccine Coordinator and Back-up Vaccine Coordinator (see below)
A Vaccine Coordinator and a Back-up Vaccine Coordinator – appointed staff who are responsible for:
o Overseeing proper receipt and storage of vaccine deliveries
o Ensuring that vaccines are properly organized in the refrigerator/ freezer(s)
o Verifying that temperatures are being checked twice per day (at very beginning and very end of day)
o Monitoring expiration dates and ensuring expired vaccine is promptly removed from refrigerator/
freezer(s).
o Ensuring proper response to possible temperature deviations
o Ensuring that designated staff who have a role in vaccines safety are adequately trained
Recording Temperatures:
o Morning Check (beginning of day) – document the time the check was made, the actual temperature
at the time of the check and include person’s initials. Additionally, include the After Hours Min and
Max Temperatures from Checkpoint (see below example). In most cases, this will be min/ max temps
within “Past 24 hours”. If recording min/ max temps from the weekend, choose “Past 3 days” for the
period.















o Afternoon Check (end of day) - document the time the check was made, the actual temperature at the
time of the check and include person’s initials.
o Action taken (if temperature is out of range) – include the same corrective action language person
used in Checkpoint to address the alert.
Temperature Log Retention – maintain the log onsite for a period of at least 3 years.