BWH
Alaris Infusion Pump
Policies and Procedures
The following policy is located within the policy
and procedure manuals of Biomedical Engineering, Nursing, and Pharmacy.
A.
Overview of the Alaris drug library
B. Maintaining the drug library
C. Handling of requests for changes in
the drug library
D. Procedures for the coordination of uploading
E. Documentation
F. Authorization
A.
Overview of the Alaris drug library
The
Alaris drug library contains the data set of all drugs infused at
BWH. The data set is divided into a limited number of profiles.
Each profile may contain up to 100 medications with a larger number
of medications available in future versions of the software. The
instructions manual on the use of the software is located with the
Alaris drug library “owner”, a pharmacy representative.When
programming IV medications for infusion, nurses are required to
utilize the drug library whenever possible.
B.
Maintaining the drug library Pharmacy
services will maintain the drug library. This includes updating
the data set with changes to any of the existing profiles within
the library as well as the addition, updating, or removal of drugs
(or other parameters) from the library. These changes may only occur
following approval from a nursing representative from Clinical Practice
and the drug library owner, the pharmacy representative. Issues
that cannot be resolved by these persons must be resolved by Drug
Safety Committee (nursing and pharmacy representation). Issues that
need immediate action and approval must be approved by both the
Director of Nursing and Director of Pharmacy. Only the drug library
owner will input the changes into the drug library. Another pharmacy
representative will be assigned as a backup.
Biomedical
Engineering will perform the initial and subsequent uploads to the
pumps.
A
list of drug library contents, will be available online at the BWH
Pharmacy web page.
C.
Handling of requests for changes in the drug library
Requests
for changes to the drug library will flow through the following
matrix:
Note: Requests directly from staff personnel will not be approved.
They will be directed to their supervisor if they wish to pursue
the change.
1.
Staff Nurses must receive approval from their Nurse Manager and
Medical Director of their service. A Request
Form must then be filled out.
2.
The Nurse Manager or representative must submit the request to the
drug library owner. The drug library owner will facilitate the approval
process (described above).
3. Once
approved, the drug library owner will update the drug library and
alert biomedical engineering that an update has occurred. Biomedical
engineering will update the pump on the next major pump upload per
normal procedure (see below).
4.
The approved form will be kept on file for a minimum of one year.
The drug library owner will have Pharmacy IS update the web page.
Note:
Any requests within 3 months of pump implementation will be allowed
fast-track approval. It will not be necessary for the request form
to be filled out. Verbal approval from the nursing representative
from Clinical Practice, the drug library owner from pharmacy, and
the staff educator or nurse manager from the service can be approved
if deemed appropriate.
D. Procedures for the coordination of uploading
1. Preparation before the day of upload
Drug library uploads will occur every six months. The pump needs to be
off-line when updating the pump library (the update cannot occur
while the pump is running). The pump is switched from "pump"
mode to "maintenance" mode.
When the uploads occur, the following groups will be given two months to properly plan for the uploading:
a. Biomedical Engineering: to ensure the proper resources and personnel
are available to complete the upload of each individual pump. Pharmacy
will provide the new validated data set two weeks prior to the upload
date.
During these two weeks Biomedical Engineering will load the new
dataset to a pump, perform a function check on that pump (only brain
and one module is needed), download the logs and send those logs
to Pharmacy. The results should show that the data set uploads correctly
and functions with the pump. These downloaded logs are part of the
validation documentation.
b. Nursing Services: to ensure that staff is aware and there is
adequate personnel to prepare the necessary drugs and/or IV tubing
necessary for the upload. Based on recommendations from Alaris,
Biomedical Engineering and Nursing it will be determined before
the upload based on the particular nursing unit whether individual
pumps are changed over to a new pump or the update can be done between
intermittent infusions. If additional medication is required, nurses
must alert the additional pharmacy personnel on the unit, if present,
or enter a “Please Send” into the system. If drugs are
needed immediately, the nurse should page the pharmacist covering
their area to coordinate drug delivery.
c. Equipment Pool: to ensure adequate resources and personnel are
available to assist with the transfer of pumps to areas where the
uploading is going to occur. This will facilitate for the orderly
uploading of the library.
d. Pharmacy Services:
1. to provide the new data set to Biomedical Engineering two weeks
prior to the upload date. The new data set will be validated by
two nursing representatives from Clinical Practice and checked
by two pharmacists – neither of which shall be the drug
library owner who is responsible for entering the drug data. This
shall be completed three weeks prior to the upload date.
2. to ensure adequate supply of drug. Two extra technicians will
be available (one to assist with SureMed restocking and its timing
and one to assist with extra IV preparation in the IV Room). These
two technicians will operate under the direction of the Pharmacist-In-Charge
and the 7am IV Room Pharmacist who will be briefed beforehand.
(Note: The following process may not be necessary based on the
timing of the uploads and restocking may occur following normal
procedure. This will be determined by the extra SureMed technician
and the Pharmacist-in-Charge. )
On the day of upload, the automatic restock option of the Omnicell
will be turned off. Based on the actual time of the uploads, a
restocking report will be run following the completion of uploads
on that particular floor. The timing of the upload and the running
of the report will be determined by the extra SureMed technician.
The SureMed technician will be available on the units in which
the uploads are occurring. Not only will this person assist on
when to run the restock reports but will also alert the extra
IV Room Technician if additional IV meds need to be made. The
SureMed technician will also be expected to perform “as
needed” deliverires for both the SureMeds and the IV Room.
In the morning, the SureMed delivery technicians will begin their
day by filling carts instead. As more floors are completed with
their uploads, their focus will turn to filling the SureMeds.
For those drugs made in the IV Room, the extra IV Room Technician
will focus on preparing all extra doses of IV medications. This
person will prepare extra doses as indicated by the SureMed technician
and “Please Sends” entered by the nurses. This technician
will follow the direction of the pharmacist as required.
e. Materials Management: to ensure adequate stock levels of IV tubing
and other supplies exist before the upload occurs and to perform
an additional restocking following the upload.
2. Procedures on day of upload
Biomedical Engineering will begin the upload on the designated day by going
from pod to pod in an alphabetical sequence starting on the 16th
floor and working downward. When the patient care towers are completed,
the upload will continue in the CWN and ambulatory areas as well
as any biomedical engineering shops, equipment pool locations where
pumps are normally stores.
At
the time of upload, Biomedical Engineering will ensure that the
pump is properly identified and recorded on a pre-printed list of
the inventory. The IVs attached to the pumps, which are infusing
into a patient, will be changed over to previously uploaded pumps
supplied by the transport service. When the pump is given to the
biomedical engineering technician, the upload will be completed
in accordance to the prescribed technical procedure.
Before returning the pump back to service, verification that the
upload was completed must be ensured by reviewing the library version.
After this verification is completed, a highly visible sticker,
identifiable for that particular upload will be placed on the pump
to provide a quick visual reference of a pump, which has been properly
uploaded. This will ensure that if pumps are missed during the upload
day, than a quick visual inspection of the sticker is all that is
needed to identify pumps which were not previously uploaded.
An
annotation in AMM will occur at the conclusion of upload day to
ensure adequate documentation of the upload is provided for record
keeping purposes. The AMM data entry will include an edit to the
software version field. The software version field will have the
format Guardrails Version/Drug Data Set version.
Printout
of the AMM will occur to ensure that all pumps were uploaded properly
and that no pumps were missed.
3. Preventative Maintenance (PMs)
4. Performing the upload
(Procedure will be available on the Biomed network drive.)
E. Documentation
1. General
The policy and procedure will be available on-line. Approval letters
for requests for changes to the drug library will be kept on file
as indicated as above by the drug library owner.
Inventory and compliance data is available on AMM, the medical device
information database maintained by Biomedical Engineering. Reports
can be requested by contacting Biomedical Engineering at 617-732-8889.
The current data set will be available on a dedicated laptop computer
located in the pharmacy (the data set will be transferred to the
on-line system in the future) and requires a password to access
and download. The data set revision history is also available at
this location. The revision history will detail the drug data set
version number and describe all changes made. This is a dynamic
document, meaning that information for all revisions will be available
in this document. Should the document reach an unmanageable size,
the older historical data can be cut out and saved to an archived
document.
All previous versions of the drug data sets will be archived with
the current data set. These data sets will be made available by
request for any testing or verification necessary in adverse event
investigations or other as yet unforeseen reasons.
2. Problems/Issues/Errors
All problems and issues should be reported to BioMed, Nursing representatives
from Clinical Practice, Drug Safety Secretary, and the Drug Library
owner. All errors and incidents should be reported via the on-line
BICS Incident Reporting System to ensure proper documentation and
follow-up.
F. Authorization
The drug library owner and one other assigned pharmacy representative
are the only persons allowed to make changes in the drug library.
Access to make these changes the drug library is password-protected.
The drug library owner and the other pharmacy representative will
not have access to the uploading component of the drug library.
Biomedical Engineering personnel are the only persons allowed access
to perform uploads. This function is password protected. Biomedical
Engineering personnel will be authorized to access the drug library
in a “read-only” manner and will not have access to
make changes to the drug library.
All other personnel will be able to view the contents of the drug
library on-line at the pharmacy website.
DFCI has elected to do monthly updates to their drug library, in
cooperation with Alaris. As such, the BWH Biomedical Engineering Department
will not be responsible for uploading their drug libraries. The BWH
Biomedical Engineering Department will be responsible for the physical
maintaince of all DFCI Alaris pumps. This maintaince will occure
on DFCI property, and their pumps will never be transferred to a
BWH shop to prevent the possiblity of co-mingling pumps with significantly
different drug libraries.
Back to Top
Date approved: (--/--/2003)
Last Reviewed: --/--/----
Last Reviewed by: MD (5/7/03), JLJ, JS (6/25/03) JLJ: 2/24/2003 |
