2020 Patient Safety and Risk Management Education
The Patient Safety and Quality Management Plan and Risk Management Program are both designed to protect the life and welfare of patients, visitors, employees and healthcare providers. Additionally, the Risk Management Program provides a framework to prevent adverse incidents by providing an environment in which potential risks to safety can be identified and managed.
Teamwork and participation among leadership, providers, and employees is essential. Improvement processes are based on the belief that risk reduction, patient safety, and process improvement can be achieved when everyone strives to improve their personal performance and the performance of the surgery center.
Employees, allied health professionals and physicians are responsible for actively participating in the functions of the Risk Management Program, working safely according to applicable standards of care within his/her licensure and position, reporting incidents and near misses, and identifying, recommending, and implementing corrective action(s) if needed.
In this course, we will review key components of the Patient Safety and Quality Management Plan and the Risk Management Program that is designed to meet AAAHC, CMS, and OSHA requirements.
- Define a Culture of Safety
- Review OISC visitor, observer and sales representative/vendor guidelines
- Define an Incident and Adverse Incident
- Know what incidents need to be reported and how to complete an incident report
- Review the OISC Emergency Operations Plan including Fire Safety, Severe Weather, and Loss of Electrical Power and HVAC
- Outline procedures for handling medical emergencies including Code Blue and Malignant Hyperthermia
- Review electrical equipment safety and how to manage equipment that is malfunctioning or requires repair
- Review medication safety practices including Sound-Alike-Look-Alike medications, High-Alert medications, Do Not Use abbreviations, and labeling and administration.
Culture of Safety
Orthopaedic Institute Surgery Center (OISC) is committed to establishing a culture of safety.
A culture of safety encompasses these key features:
- Acknowledgement of the high-risk nature of our activities and the determination to achieve consistently safe operations
- A blame-free environment where individuals are able to report errors or near misses without fear of reprimand or punishment
- Encouragement of collaboration across ranks and disciplines to seek solutions to patient safety problems
- An organizational commitment to resources to address safety concerns.
Improving the culture of safety is an essential component of preventing or reducing errors and improving overall quality of care provided.
Visitors and Observers
OISC has guidelines for all visitors in an effort to provide a safe and secure environment for our patients, employees, and healthcare providers.
- Patients have the right to choose who may visit them and withdraw consent to visitation at any time.
- The number of visitors may be restricted in patient bays as requested by OISC staff.
- Visiting may be temporarily restricted for clinical care reasons (i.e., for a procedure or during the immediate post-operative recovery period). The patient and their visitors will be informed of the restriction.
- Visitors less than 18 years of age must be accompanied by an adult, other than the patient, at all times
Observers in the OR (excluding Sales/Vendor Representative)
Approval is required for all shadow observation or tour experiences and clinical training programs in patient care areas for where participants may access personal health information.
- Before any observer is allowed in the OR the following criteria must be met:
- Observation request must be received and approved prior to experience
- The patient agrees that students and other may watch the procedure as indicated on the Informed Consent
- Any visiting physician that is assisting in a procedure may so do only upon invitation and supervision of the primary physician and must have appropriate privileges for participating granted by the Board.
- No family members or friends of patients will be permitted in the OR, except in extenuating circumstances
- Observers should check in at the registration desk. They will be escorted to the appropriate locker room to don OR attire.
- The names of all observers should be recorded in the OR record.
Sales Representatives/Vendors in the OR
- Sales representatives/vendors must obtain approval from at least one of the following persons prior to entering the OR:
- Surgeon has the authority to determine necessity of vendor presence in their procedures
- Surgeon may request their preference during scheduling of the procedure
- Surgeon may inform the facility of their overall preference for vendor presence unless communciated otherwise
- Medical Director
- Surgeon has the authority to determine necessity of vendor presence in their procedures
- Sales/vendor representative should check-in with surgical services staff on arrival to the facility. A company identification badge should be worn.
- The patient must agree that students and others may watch the procedur as indicated on the Informed Consent. The circulating RN will confirm this prior to entry to the OR.
- Sales/Vendor representatives are prohibited from providing services as an active participant in patient care. They may provide consultative services for the use, care, demonstration, handling, and maintenance of their products or their services. Reps are not allowed to scrub or be involved in the sterile field, such as opening sterile supplies.
- The number of reps in a single OR should be limited to two, unless otherwise requested by the surgeon.
- The name(s) of all reps in the OR should be recorded on the OR record.
An incident is any occurrence that is not consistent with the routine care or operation of the facility and includes patients, visitors, employees, allied health professionals (CRNA, PA, NP), and physicians.
An adverse incident is defined as:
- An unexpected occurrence during a health care encounter involving patient death or serious physical or psychological injury or illness, including loss of limb or function, not related to the natural course of the patient’s illness or underlying condition
- Any process variation for which a recurrence carries a significant change of a serious adverse outcome
- Events such as actual breaches in medical care, administrative procedures, or other events resulting in an outcome that is not associated with the standard of care or acceptable risks associated with the provision of care and service for a patient
- All events involving reactions to drugs and materials
- Circumstances or events that could have resulted in an adverse event (near-miss events)
All staff and credentialed practitioners are accountable for reporting incidents that cause potential (near miss) or actual harm to patients, visitors, employees, physicians and licensed independent practitioners.
OISC uses paper forms for reporting and documenting incidents. In addition to completing an incident report, serious or harmful events should be communicated to appropriate OISC Leaders (Administrator).
Incident reports are non-punitive and designed to identify opportunities for improvement in a confidential, safe, supportive, and blame-free manner.
An incident report should be completed for the following events involving a patient, visitor, employee, physician, or allied health professional. Forms can be found at the nurse’s station.
- Accidents (i.e., hand smashed in door)
- Elopement or departures AMA
- Physical or verbal assault
- Sexual aggression or behavior
- Altercations, abuse or threats
- Person without decision-making capacity discharged to the wrong person
- Confidentiality breach
- Electric shock
- Device/equipment malfunction
- Foreign object retention
- Incorrect needle/sponge count
- Wrong site/side/patient/implant/procedure
- Sterilization/sterile supply event
- Procedural complication
- Case cancellation
- Medication error
- Adverse reaction to drugs and materials
- Patient transfer or admission to acute care facility
- Pressure ulcer obtained after admission to facility
- Mislabeled specimen, unlabeled specimen, missing/lost specimen
- Significant IV infiltrate
- Inappropriate exposure to x-ray
Incidents that should be reported are not limited to the above list. These are examples. Any event that is not consistent with the routine standard of care/outcome should be reported.
**If the incident resulted in injury or potential harm it should reported immediately to a physician to develop a treatment plan and to the Administrator.
Individual Discovering the Incident
Report incidents with injury or potential harm immediately to the Administrator and the Physician (Surgeon/Proceduralist and/or Anesthesiologist)
Preserve and sequester any equipment or supplies associated with event.
DO NOT make any statements about liability or fault regarding the event.
Initiate an incident report.
Instructions for Completing the Incident Report Form
Complete the form as soon as possible following the event
Complete portions of the incident report form relevant to nature of the incident.
For incidents involving patients:
- Document the facts of the incident in the patient’s medical record.
- DO NOT document in the medical record that an incident report was completed.
- DO NOT tell patients or representative that an incident report was completed.
- DO NOT copy or distribute the incident report.
- Mandated Reporting
Certain adverse incidents must be reported to the state according to the Minnesota Adverse Healthcare Events Reporting Act.
In accordance with federal law and regulation, serious injuries, illnesses, or deaths related to a device must be reported to the medical device manufacturer, the FDA, and the Minnesota Department of Health.
**If there are other quality, safety or hazard concerns, please report them to the Administrator or complete a Quality Concern Tracking Form for follow-up and corrective action if indicated.
Emergency Operations Plan
The OISC Emergency Operations Plan (EOP) outlines the basic infrastructure and operating procedures utilized to mitigate, prepare for, respond to, and recover from emergency situations that tax the routine operating cababilities of OISC.
The EOP has been developed to manage internal and external emergency situations. This plan identifies the capabilities of OISC and establishes response procedures to care for patients, staff, and visitors who are present in the facility when an emergency incident occurs.
OISC reviews and updates the EOP and performs a hazard vulnerability assessment (risk assessment) every 2 years. The top three events identified for 2020 – 2022 are:
- Fire (Internal) – 61%
- Tornado (Severe Weather) – 56%
- HVAC Failure – 44%
Other potential emergency situations/hazards and responses are documented in the Department Specific Safety and Orange Alert Plan binder located at the nurse’s station. Emergency codes are reviewed annually online via the Learning Management System (SABA).
OISC activates its EOP at a minimum of four (4) times per year on a quarterly basis. The activation is either the result of an actual event or planned drill. In addition, OISC will conduct quarterly fire drills. Drills include, but are not limited to:
- One (1) Malignant Hyperthermia drill
- One (1) Cardiopulmonary Resuscitation (CPR) drill
Click on the following button to review the Emergency Operations Plan.Staff are required by CMS to complete EOP training, including reviewing policies and procedures every 2 years.
Fire Safety Plan
Fires are considered a preventable occurrence and fire prevention is the responsibility of every member of the surgical team. All employees and providers are expected to know locations of local fire pull stations, extinguishers, evacuation routes, and the location of the Orange Alert Plan binder, which includes evacuation instructions specific for OISC.
The Center for Outpatient Care is a fully sprinklered building.
A fire watch will be initiated by the Administrator or designee if required fire protection systems (fire alarm and/or sprinkler system) are out of service for ten or more hours in a 24 hour period and will continue until all patients have been discharged or evacuated from the facility or the impaired system(s) have been restored to normal working order.
No new surgical procedures will be started if a fire watch is initiated. Fire watch duties will be assigned by the Administrator or designee. The individual(s) serving as a fire watch may have no other duties assigned to them while the affected fire protection system is out of service and carry a cell phone with them for fire department notification. The individual will perform continuous tours of area(s) affected by the impairment at not less than 30 minutes intervals, watching for and promptly reporting any incidents of fire, visible smoke, or strong smell of smoke or other unwanted odor.
Alert Red Procedure
Alert Red procedures will be followed for fire or visible smoke in the facility and all employees will enact the fire safety plan, RACE and PASS, together as a team.
OISC is a Prepare to Relocate or Defend in Place facility that contains more than one smoke compartment that makes horizontal relocation/evacuation possible. If the fire alarm is activated by another suite in the building, OISC will prepare for evacuation and await orders from the Fire Department.
Preventing Surgical Fires
1. Fire Risk Assessment
- Completed by the procedural team as part of the Universal Protocol Procedure Safety Checklist prior to the start of the procedure
- Based on a three point system (one point given for each of the following):
- Open oxygen or nitrous oxide source
- Use of an ignition source or any device that generates heat
- Surgery/procedure above the xiphoid
2. Protocol to prevent surgical fires for all cases (fire risk assessment score of 0-3):
- Follow the manufacturer’s instructions for use and dry time when applying any surgical skin antiseptic solution.
- Ensure that all alcohol based prepping solutions are allowed to dry and fumes have dissipated prior to applying surgical drapes.
- Prevent pooling of prep solutions. If pooling occurs, soak up excess with a sterile towel and then remove the towel from the prep area.
- Add a separate basin or graduate of sterile water or saline to the case set-up for fire suppression purposes.
- Check all electrical equipment before use.
- Activate heat source only when tip is in sight and place in holster when not in use.
- Ensure that exposed end of light cables and heat sources are not left lying on the drapes when turned on.
- Remove unneeded foot controls from the operating area.
- Use irrigation on burrs and saws when needed.
3. Additional precautions should be taken for a fire risk assessment score of 3 and discussed during the Time Out.
Click on the following button to view a Fire Safety Video (18 min) produced by the Anesthesia Patient Safety Foundation if now viewed through the annual Fire Safety module on the Learning Management System.
Alert Red Procedure
In the event of a fire, remember the acronym RACE.
RESCUE persons in immediate danger (consider own safety and assess the situation before taking action by moving anyone in danger to a safe area). If necessary perform a horizontal evacuation to the next smoke zone or set of fire doors.
ALERT by activating the nearest fire pull station. Call 9-911 to notify the Fire Department of the fire immediately. Indicate location and type of fire. Use the code phrase: “Alert Red” to verbally communicate the need to initiate RACE to fellow employees.
CONFINE fire and smoke to the smallest possible area by closing all doors. Inform patients/visitors of situation. Keep patients and their visitors in the patient room. Clear the area of corridor clutter.
EVACUATION/EXTINGUISH. Consider own safety. Fight the fire only if you are not putting yourself in danger.
PULL the pin located at the top of the fire extinguisher.
AIM the fire extinguisher at the base of the fire.
SQUEEZE the levers together to release the extinguishing agent.
SWEEP the fire extinguisher back and forth in a slow steady motion across the base of the fire until it has been completely extinguished.
Emergency Procedures in the OR
In the event of a fire on or near the patient:
- Verbally announce the fire
- Stop the flow of all airway gases to the patient
- Immediately remove the burning materials and have another team member extinguish them. Roll burning materials (i.e., drapes) onto themselves to smother the fire
- Smother or douse the fire using sterile water or saline, or if needed, use a CO2 fire extinguisher (located in each OR) to put out the fire
- Activate the fire alarm and call 9-911
- If the fire persists, evacuate the patient, close OR doors to contain smoke and fire, turn off gas supply to room and communicate facility Alert Red
Preserve the scene until examined by the Fire Marshal and other designated officials by leaving the room and saving involved materials and devices for later investigation. Do not discard any items.
A weather radio is monitored at the registration desk by the Office Coordinators.
The Administrator or designee will notify departments of all severe weather alerts received and will continue to monitor real-time weather information.
Severe weather conditions may indicate the need to move patients and visitors to inner rooms, hallways or lower level.
A Severe Weather Watch indicates that conditions are favorable to produce severe weather, however, no severe weather has been observed yet. This is a precautionary phase.
If a Severe Weather Watch is issued for Hennepin County, staff will:
- Notify patients and visitors of weather conditions and preparedness plan
- Close all blinds
- Close doors of unoccupied rooms
- Open doors of rooms with patients in them, if able
- Gather pillows and blankets in preparation of a Severe Weather Warning
- Review the facility Severe Weather Plan
During a Severe Weather Watch:
- Patients may be admitted to the preoperative deparment
- New procedures may begin in the OR and Procedure Room
- Patients may be discharged from the PACU
A Severe Weather Warning indicates that severe weather has been observed and is issued when a tornado, thunderstorm, funnel cloud,or other severe weather phenomenon has been sighted visually or detected by radar; the location and direction of movement, if known, are given.
- Notify patients and visitors of weather conditions and preparedness plan
- Office Coordinators will assist in moving patients and visitors in the OISC lobby to inner building hallways or lower level enclosed stairwell
- Non-patient care staff should relocate to the lower level enclosed stairwell whenever possible
- Preop/PACU staff will assist patients and visitors to inner rooms in the facility (i.e., consult room, bathrooms), building hallways, or the lower level enclosed stairwell. Patients in the Preop/PACU department that are unable to relocate, should be moved furthest away from windows to the extent possible and protected with pillows and blankets. Nursing staff will stay with patients to provide continued monitoring and care as indicated. Patients and visitors in Preop/PACU should be moved furthest away from windows to the extent possible and protected with pillows and blankets. Nursing staff will stay with patients to provide continued monitoring and care as indicated.
- Staff will prepare to initiate the evacuation plan.
During a Severe Weather Warning:
- No new patients will be admitted to the preoperative department
- OR and Procedure Room staff will continue the procedure in progress, but no new procedures may begin until an “all clear” is received.
Severe Winter Weather
The Administrator will continually monitor winter weather conditions.
He/she will make the decision when conditions warrant closing the facility. Appropriate staff will remain in the facility until the last patient is discharged.
In the event of an overnight winter storm, the Administrator will determine if the facility can safely operate (i.e., appropriate staffing, electrical power, etc.) The Administrator or designee will notify patients, staff, physicians and allied health professionals if the facility will close. Patients will be rescheduled through the surgeon’s office.
Loss of Electrical Power
OISC has emergency generators that supply the facility with power in the event the normal source of electrical power is lost.
In the event of a power outage:
- Notify building management (Welltower)
- Notify Allina Health Facilities
- Ensure that all critical patient equipment is plugged into outlets with emergency power (red outlets).
- Ensure flashlights or lanterns are available in inner room without emergency lighting and available as needed for backup lighting.
All procedures in progress at the time of the power outage will be completed but no new procedures will be started until the normal source of electrical power is restored.
The Administrator will determine if pending procedures need to be cancelled and rescheduled based on the time frame in which the electrical power is expected to be reestablished.
If the Heating, Ventilation and Cooling (HVAC) system fails, adequate air exchanges and temperature/humidity controls cannot be maintained in the facility.
In the event of an HVAC Failure:
- Notify building management
- Notify Allina Health facilities
All procedures in progress at the time of HVAC failure will be completed, but no new procdures shall be started until the HVAC has been restored.
The Administrator will determine if pending procedures need to be cancelled and rescheduled based on the time frame in which the HVAC is expected to be reestablished.
A Dr. Blue (cardiac or respiratory arrest) will be managed per current resuscitation guidelines by medical professionals with BLs and ACLS. The anesthesiologist will manage the code and assign tasks based on staff availability, job role, and licensure/certification.
Cardiopulmonary resuscitation will be initiated as indicated.
A crash cart with emergency drugs and supplies and a defibrillator for resuscitation and other medical emergencies is located in the Phase 1/Block Area. The contents of each drawer are listed and available on the crash cart and each drawer is labeled with a general description of contents (i.e., anesthesia, medications, etc.).
A Dr. Blue will be called via the overhead paging system or activated by pressing the Staff Emergency button in the preoperative/postoperative department or the Code button in the OR. The crash cart will be brought to the appropriate location.
The Administrator and all available staff and providers will respond to a Dr. Blue in the facility.
Emergency Medical Services will be notified by calling 9-911 as directed by the anesthesiologist and the individual transferred to the nearest acute care hospital.
Malignant Hyperthermia (MH) is a potentially lethal syndrome caused by a hypermetabolic state that can be precipitated by but are not limited to the administration of volatile inhalation anesthetic agents and depolarizing muscle relaxants such as succinylcholine. MH can occur once anesthesia has been completed.
MH symptoms include:
- Sudden rise in end tidal CO2 (often the first sign) in the OR
- Cola-colored urine
- Muscle rigidity
- Hyperthermia (late sign)
If the nursing preoperative assessment indicates a patient history of, susceptibility to, or risk factors for malignant hyperthermia, it will be referred for anesthesia review.
Management of a malignant hyperthermia crisis is the responsibility of the Anesthesia team. Therapy will follow the guidelines set forth by the Malignant Hyperthermia Association of the United States (MHAUS) and the MHAUS emergency hotline will be contacted for consultation.
Members of the surgical team and available staff will follow directives given by the Anesthesiologist and assist anesthesia as needed.
The MHAUS hotline number and the Emergency Therapy for Malignant Hyperthermia Protocol is available in each OR and on the MH Cart.
The MH Cart contains the following medications:
Dantrolene: up to 36 vials
Sterile preservative-free water for reconstitution
Sodium Bicarbonate (acidosis treatment)
Lidocaine (cardiac dysrhythmia treatment)
Dextrose 50% (with regular insulin to treat hyperkalemia)
Call 9-911 when the patient is stable for transfer as directed by the Anesthesiologist.
Electrical Equipment Safety
All electrical equipment (facility owned and loaned) must be inspected for functional testing and safety prior to its initial use.
All electrical equipment will be labeled by Biomed/CES with an identification number and a tag indicating inspection completion. Some low risk devices may be labeled with an inspection sticker with no date.
Inspection and testing of all electrical equipment is performed by Allina Biomed/CES or other contracted service (i.e, Steris for sterilizers). Preventative maintenance (PM) schedules and frequencies are determined by CES.
All electrical equipment should be inspected prior to use for operational integrity and immediately removed from service if it known or suspected of being unsafe. Remove from service all equipment that is malfunctioning and/or requires repair and tag it. Tags are located in the Procedure Room. Contact CES or equipment manufacturer contractor to initiate an inspection and/or repair of the equipment.
Sound-Alike and Look-Alike (SALA) Medications
SALA medications can be confused for one another. These medications will be segregated to the extent possible/practical and a combination of capital and small letters will be used on labels in storage cabinets to reduce confusion and maximize safety.
OISC List of SALA Medications:
- epHEDrine and epINEPHrine
- hydrALAzine and hydrOXYzine
- HYDROmorphONE and morphINE
- HYDROcodone and oxycodone
This list is posted on the inside of the medication storage cabinets.
High-Risk or High-Alert Medications
High-risk or high-alert medications are those medications that carry a high risk for error and adverse drug events and outlined processes should be followed to reduce the potential for harm.
OISC List of High-Alert Medications
Regular insulin is the only insulin stocked at OISC.
All insulin and heparin doses must be verified by two licensed practitioners (RN, CRNA, MD) prior to administration unless there is an event in which the patient care needs are such that the practitioner is unable to leave the bedside to obtain the double check and/or a delay in therapy to obtain the double check would result in patient harm. The verification/double check should be documented on the appropriate form in the patient’s medical record.
OISC does not permit the use of certain abbreviations, acronyms, dose designations, and symbols that may be misleading, confusing, and have been prone to medication errors.
- U, u (for unit): Write “unit”
- IU (International Unit): Write “International Unit”
- Trailing zero (X.0 mg): Never use a zero after a decimal point. Write X mg
- Lack of leading zero (.X mg): Always use a zero before a decimal point when the dose is less than a whole unit. Write 0.X mg
- Q.D., QD, q.d., qd (every day): Write “daily”
- Q.O.D., QOD, q.o..d., qod (every other day): Write “every other day”
- MSO4: Write “Morphine Sulfate”
- MS: Write “Morphine Sulfate” or “Magnesium Sulfate”
- MgSO4: Write out “Magnesium Sulfate”
Medication Labeling and Administration
Always follow the Five Rights (plus one) for medication administration: Right Patient, Right Drug, Right Dose, Right Route, Right Time, and Right Reason.
All medications that are not immediately administered must be labeled with the date and time of draw, initials of the person drawing, medication name, strength, and beyond-use date and time (CMS).
Medications should not be stored or transported in pockets or clothing. This practice increases the risk of contamination, errors and adverse events.
The individual retrieving a controlled substance from locked storage is responsible for the administration of the medication, except when controlled substances are necessary in the management of a medical emergency (i.e., LAST, seizures, etc.).
A drug guide can be found at the nurse’s station. There are also drug guides available on the AKN. Education & research → Library services
The Orthopaedic Instistute Surgery Center is committed to providing patient care in a safe and caring environment.
Improvement processes are based on the belief that risk reduction, patient safety and process improvement can be achieved when everyone in our organization strives to improve their personal performance and the performance of the organization.
The safety of all patients, employees, practitioners and visitors is a leadership priority. Patient safety and Qualtiy Management as defined and practiced in our organization is:
- An organizational strategy and commitment of leaders, practitioners and employees
- A culture and environment supportive of employees and practitioners as they report errors, near miss events, and adverse incidents
- A patient safety and clinical performance monitoring process to improve patient care and safety, services, and satisfaction outcomes
Thank you for completing this education module. Please complete the following Attestation Form.
Agency for Healthcare Research and Quality. Safety Culture. https://psnet.ahrq.gov/primers/primer/5/safety-culture
Accreditation Association for Ambulatory Health Care Inc. Accreditation Handbook. 2017/2018. Quality Management and Improvement, Subchapter II – Risk Management.
APIC Position Paper: Safe Injection, Infusion, and Medication Vial Practices in Health Care (2016). http://apic.org/Resource_/TinyMceFileManager/Position_Statements/2016APICSIPPositionPaper.pdf
Minnesota Department of Health. Roadmap to Controlled Substance Diversion Prevention. http://www.health.state.mn.us/patientsafety/drugdiversion/divroadmap041812.pdf
Minnesota Department of Health. Minnesota’s 29 Reportable Adverse Health Events. http://www.health.state.mn.us/patientsafety/ae/adverse27events.html
U.S. Food and Drug Administration. Medical Device Reporting. http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm
ECRI Institute. Surgical Fire Prevention. https://www.ecri.org/Accident_Investigation/Pages/Surgical-Fire-Prevention.aspx
Malignant Hyperthermia Association of the United States. What is MH? http://www.mhaus.org/
Institute for Safe Medication Practices (ISMP). ISMP’s List of Confused Drug Names. https://www.ismp.org/tools/confuseddrugnames.pdf
Institute for Safe Medication Practices (ISMP). ISMP List of High-Alert Medications in Acute Care Settings. https://www.ismp.org/tools/highalertmedications.pdf
Occupational Health and Safety Administration. Prevention of Musculoskeletal Disorders in the Workplace. https://www.osha.gov/SLTC/ergonomics/