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Operating Room Medication Safety Checklist©
(Version 2)

The Operating Room Medication Safety Checklist was developed by the Institute for Safe Medication Practices Canada (ISMP Canada) in collaboration with the Canadian Anesthesiologists' Society, the Operating Room Nurses Association of Canada, and the Institute for Safe Medication Practices (US) with support from the Ontario Ministry of Health and Long-Term Care. It is based on findings from focused safety reviews, medication incident analyses, the patient safety literature, and pilot testing.

A hospital operating room (OR) is a unique environment where high-alert medications and procedures requiring sterile fields are used. This checklist is designed to assess this unique environment and the medication-related practices used therein.

The Operating Room Medication Safety Checklist© represents a standardized approach to identifying goals and opportunities for medication safety enhancements in the OR. The checklist and findings are intended for internal use by facilities and become more useful as repeat assessments are performed to see where improvements have been achieved over time.

If you would like additional information, or are at a facility that would like to participate, please contact ISMP Canada at:

  Telephone: 416-733-3131 or toll free 1-866-544-7672 (1-866-54-ISMPC)
  Email: OperatingRoomChecklist@ismp-canada.org

Please allow up to 1 week for delivery of the Operating Room Medication Safety Checklist© booklet.

Changes in the 2009 version of the Operating Room Medication Safety Checklist©:
Deleted Items - Several items have been deleted. In order to maintain continuity of numbering and scoring with the previous checklist, the inactive items are displayed in grey type and provide no scoring options. New Items - New items have been added and are distinguished by being captioned as "NEW" and numbered in red type. They are grouped with like items.

 


September 2009:  FDA Alerts the Healthcare Community About Patient Deaths from Injection of Topical Epinephrine

  FDV WMV video   Full FDA Safety Alert:
www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=90#10

Watch the two-minute FDA video: (Size : 4.5 MB)
www.ismp-canada.org/download/FDA_Topical_Epinephrine_200909.wmv

Full ISMP Canada Safety Bulletin developed through the Canadian Medication Incident Reporting and Prevention System (CMIRPS)


 

Failure Mode and Effects Analysis (FMEA) Report Available

Given the high risk of harm or death associated with the inadvertent injection of epinephrine 1 mg/mL, further study of the management of this medication was deemed necessary. An Ontario hospital volunteered to assist ISMP Canada with a prospective analysis of processes related to the use of concentrated epinephrine intended for topical use in the operating room. The hospital had already implemented enhancements to its operating room processes to reduce the potential for error and welcomed the opportunity to assess these enhancements and to share learning with others upon completion of the FMEA.

ISMP Canada gratefully acknowledges the Ontario hospital and team members who participated in this analysis, as well as the Ontario Ministry of Health and Long-Term Care, which provided funding support for the FMEA project.

A Collaborative FMEA with an Ontario Hospital: Reducing the Risk of Inadvertent Injection of Concentrated Epinephrine Intended for Topical Use

Once you have received a copy of the Operating Room Medication Safety Checklist©, please refer to the steps below. These steps are also listed on pages 6 and 7 of the document.
Instructions for Completing the Checklist
1.
Establish a multidisciplinary team and consider including the following individuals (listed here in alphabetical order):  
– Anesthesiologist
– Nurse(s)
– OR Manager or Director
– Perfusionist
– Pharmacist
– Pharmacy Technician
– Physician Assistant
– Registered Respiratory Care Practitioner
– Risk Manager or Director and/or quality improvement professional
– Surgeon
2.
Before beginning the process, have everyone read and review the checklist in its entirety. The estimated amount of time to complete the checklist is about 3 hours. We suggest you schedule a series of three meetings of about one hour to complete the self-assessment. Although the document is copyrighted, ISMP Canada authorizes facilities to make copies of the Operating Room Medication Safety Checklist©, for internal use only, for ongoing quality improvement and risk reduction activities.
3.
Complete the section entitled "Demographic Information".
4.

For each of the Checklist sections (1 through 10), discuss each item and evaluate the facilitys current success in implementing it.

A glossary of terms is provided as a reference after section 10. Prompts alert users to any terms that are defined in the glossary.

5.
When the team reaches a consensus on the level of implementation for a checklist item, mark one of the following choices next to the item:
  A – No activity to implement this strategy
B – Strategy is developed but is not utilized or is only partially implemented
C – Strategy fully implemented
 

For items with multiple components, a score of C is appropriate only if ALL components have been fully implemented. Some items contain multiple components that are closely linked. If just one or some of the components have been fully or partially implemented, score B.

If an item does not apply to services offered in your hospital then an answer of C may be appropriate since your hospital would not be prone to errors in medication dosing for certain patient populations

6.
A notes area is provided at the end of each section. Here you can briefly record barriers or challenges that limit implementation of item concepts and to record comments that may be helpful to your team when reviewing the checklist at a future date. (In the web-based program, notes can be added for each item and are retained with your results. Access them by clicking on the small notepad icon under the number for an item.)
Web-Based Program:
7.
Take advantage of the web-based program, which allows comparison of your facility's results over time, as well as to the grouped results of other respondents on both a national and regional basis. When all the items in the checklist have been completed, send an email message to OperatingRoomChecklist@ismp-canada.org to request a username and password.
8.
Once you receive your username and password and the link to the ISMP Canada secure web page for data input, you will be ready to enter your findings from the completed checklist.
9.

At the web page for the Operating Room Medication Safety Checklist©, under the tab entitled "Enter Survey/See Results", enter your username and password. After the username and password have been accepted, you can begin to submit data.

Use the option "Save and Exit" after completing data entry for each segment of the checklist. You can leave the site and go back later to continue entering data. Update an unfinished checklist with the "Update" button. This button is not available if the checklist is already complete and finalized. You can also make changes to your responses at this stage.

Select "Finalize Checklist" only after data for all segments have been entered. The special web-based survey tool will immediately download the information into a database maintained solely by ISMP Canada. No data will be maintained on the Internet checklist form after submission. Confidentiality is assured. The aggregate findings may be used for research and education purposes.

10.
Once you have submitted your results, you will be able to compare them against the aggregate results of participants. You will be able to see your results immediately after data submission by clicking on the appropriate menu items. No other participant will be able to access or view your facility's individual results. (Please note that you will be able to view aggregate results for comparison with other facilities only after at least 3 other facilities have entered data. In addition, a minimum of 3 other facilities must submit data applicable to the various demographic subcategories to allow comparison with demographically similar facilities.) If you have completed more than one checklist, all your results can be viewed and compared on-line.
Critical Incident An incident resulting in serious harm (loss of life, limb, or vital organ) to the patient, or the significant risk thereof. Incidents are considered critical when there is an evident need for immediate investigation and response. The investigation is designed to identify contributing factors, and the response includes actions to reduce the likelihood of recurrence.

From: Davies J, Hebert P, Hoffman C. Canadian patient safety dictionary. Ottawa (ON): Royal College of Physicians and Surgeons of Canada; 2003.

Harm Temporary or permanent impairment of body functions or structures, including mental, physical, and sensory functions and pain.

From: Definitions of terms. Toronto (ON): Institute for Safe Medication Practices Canada; ©2000-2006 [cited 2007 Dec 18]. Available from: http://www.ismp-canada.org/definitions.htm. Developed by the Institute for Safe Medication Practices Canada, the Canadian Institute for Health Information, and Health Canada (collaborating parties for the development and implementation of the Canadian Medication Incident Reporting and Prevention System [CMIRPS]).

High-Alert Medication A drug that bears a heightened risk of causing significant patient harm when used in error. Although mistakes may or may not be more common with these drugs, the consequences of an error with these medications are clearly more devastating to patients.

From: ISMP’s lists of high-alert medications. Huntington valley (PA): Institute for Safe Medication Practices; 2005 [cited 2007 December 18]. Available from: http://www.ismp.org/Tools/highalertmedications.pdf.

Key Medication-Related Junctures A crucial decision point or period during a procedure involving the planned administration (or intentional nonadministration) of one or more medications. Key medication-related junctures require communication among members of the OR team to inform each other that the plan of care is proceeding or may proceed as intended. Subsequent steps in the plan of care and the overall success of the procedure will be contingent on any key medication-related junctures. Examples of key medication-related junctures include:
  • administration of deep sedation by the anesthesiologist before a procedure may begin,
  • administration of any medication by the surgeon (such as a local anesthetic given before a procedure begins, or the application / placement of epinephrine-soaked pledgets during a procedure),
  • administration of an antibiotic at a specific time during a procedure,
  • administration of heparin and the subsequent administration of protamine (or not) during a vascular procedure in collaboration with the surgeon, and
  • administration of oxytocin after delivery of the placenta.
Maximum Dose
The dose of a medication representing the upper limit that is normally mentioned in the published literature or in manufacturers' recommendations. Maximum doses may vary according to patient's age, weight, or diagnosis.

From: Medication Safety Self-Assessment® for hospitals, Canadian version II. Toronto (ON): Institute for Safe Medication Practices Canada; 2006.

Medication Delivery Device Equipment, such as syringes, tubing, infusion pumps, implantable pumps, patient-controlled analgesia pumps, automated compounding devices, robotics, and other related devices, that is used for medication preparation, dispensing, and administration.

From: Medication Safety Self-Assessment® for hospitals, Canadian version II. Toronto (ON): Institute for Safe Medication Practices Canada; 2006.

Medication Incident Any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of a health care professional, patient, or consumer. Medication incidents may be related to professional practice, products, procedures, and systems, and they may occur at any stage of the medication-use process, including prescribing, order communication, product packaging (which encompasses labelling and nomenclature), compounding, dispensing, distribution, administration, education, monitoring, and use.

Similar Term: Medication Error

From: Definitions of terms. Toronto (ON): Institute for Safe Medication Practices Canada; ©2000-2006 [cited 2007 Dec 18]. Available from: http://www.ismp-canada.org/definitions.htm. This definition, adapted from the National Coordinating Council for Medication Error Reporting and Prevention publication entitled "What Is Medication Error?,"was developed by the Institute for Safe Medication Practices Canada, the Canadian Institute for Health Information, and Health Canada (collaborating parties for the development and implementation of the Canadian Medication Incident Reporting and Prevention System [CMIRPS]).

Medication-Use Process "The series of steps necessary to move a drug from purchase to patient use . . . includes the identification of a need for a drug and the purchase, storage, manufacture, or preparation of the drug. It also includes the prescribing, labeling, dispensing or distribution, and administration of a drug and monitoring its effects(s)."

Similar term: drug use process

From: Hannan ZJ, Durgin JM. Pharmacy practice for technicians. 2nd ed. Clifton Park (NY): Delmar Publishers; 1999. p. 98.

Near Miss or Close Call An event that could have resulted in unwanted consequences, but did not because, either by chance or through timely intervention, the event did not reach the patient.

Similar terms: near hit, good catch

From: Definitions of terms. Toronto (ON): Institute for Safe Medication Practices Canada; ©2000-2006 [cited 2007 Dec 18]. Available from: http://www.ismp-canada.org/definitions.htm. Developed by the Institute for Safe Medication Practices Canada, the Canadian Institute for Health Information, and Health Canada (collaborating parties for the development and implementation of the Canadian Medication Incident Reporting and Prevention System [CMIRPS]).

Practitioner For the purposes of this checklist, any member of the professional staff, such as physicians (e.g., anesthesiologist, surgeon), nurses (e.g., scrub nurse, circulating nurse), pharmacists, and other licensed health care professionals, as applicable.

From: Medication Safety Self-Assessment® for hospitals, Canadian version II. Toronto (ON): Institute for Safe Medication Practices Canada; 2006.

Safety Freedom from accidental injuries.

From: Kohn LT, Corrigan JM, Donaldson MS, editors; Institute of Medicine, Committee on Quality of Health Care in America. To err is human: building a safer health system. Washington (DC): National Academy Press; 1999.

Surgical Pause or Time Out A formal process in which the operating room team actively and collaboratively reviews all critical information to ensure accuracy and a shared understanding of the plan of care immediately before the start of the procedure. The surgical procedure is not started until all questions and concerns have been resolved.

Modelled after Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery ™. Oakbrook Terrace (IL): The Joint Commission; 2003 [cited 2007 Dec 18]. Available from: http://www.jointcommission.org/up_poster

System A set of interdependent elements (people, processes, and equipment) that interact to achieve a common aim.

From: World Alliance for Patient Safety. WHO draft guidelines for adverse event reporting and learning systems. Geneva (Switzerland): World Health Organization; 2005.

TALLman Lettering Enhancement of unique letters within similar drug names by use of upper case characters; may be combined with use of italics, colour background, or a combination of these elements to improve differentiation of look-alike names.

From: Medication Safety Self-Assessment® for hospitals, Canadian version II. Toronto (ON): Institute for Safe Medication Practices Canada; 2006.

A list of TALLman lettering is available from the US Food and Drug Administration.

From: Name differentiation project [Internet]. Rockville (MD): US Food and Drug Administration, Centre for Drug Evaluation and Research; [updated 2002 May 8; cited 2008 Feb 4]. Available from: http://www.fda.gov/Drugs/DrugSafety/MedicationErrors/ucm164587.htm

Once you receive your username and password, you will be ready to submit data from the completed checklist into the secure ISMP Canada web page.

Enter your username and password below, and once accepted, you can enter and submit data.

  • Answers are saved in the database every time a new tab is entered. Use the option 'Save & Exit' to suspend data entry. You can leave the site and go back later to continue entering data.
  • Update an unfinished checklist with the "Update" button. You can also make changes to your responses at this stage. The "Update" button is not available if the checklist is already complete and finalized.
  • Select "Finalize Checklist" only after data for all segments have been entered. Once finalized, the data are locked and no more changes can be made.

When finalized, the special web-based survey tool will immediately download the information into a database maintained solely by ISMP Canada. No data will be maintained on the Internet checklist form after submission; however, you will be able to access your stored data using your username and password. Confidentiality is assured. The aggregate findings may be used for research and education purposes but will not be used in any other way.

Once you have submitted your results, take advantage of the web-based program to compare your results with the aggregate results of participants. You will be able to see your results immediately after data submission by clicking on the appropriate menu items. Individual checklist results are contrasted graphically against the entire collection of user data by clicking the "Compare Aggregate" menu button. If you have completed more than one OR Checklist, all your results can be compared on-line.

No other participant will be able to access or view your facility's results. (Please note that you will be able to view aggregate results for comparison with other facilities only after at least three other facilities have entered data. In addition, a minimum of 3 other facilities must submit data applicable to the various demographic subcategories to allow comparison with demographically similar facilities.)

Click on the "Log Out" menu button when finished.

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