Contact Us |  MGH Clinical Site |  BWH Clinical Site |  MGH Timesheet |  MGH SET Request |  TMS Reference Guides |  Site Map |  Search     

BWH Alaris Policies and Procedures

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

Send comments regarding the website to:

This page was last updated on 3/7/2007