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Risk Management Strategies for the Outpatient Setting: Clinical and Patient Safety Risks

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Creating and maintaining a culture of patient safety can be challenging and should be a high priority for healthcare organizations. Leadership, clinical and nonclinical staff, providers, patients and visitors have a role in patient safety. Key responsibilities include patient identification, handoff communication, infection control, medication management, test results management, medical device safety as well as responding to clinical emergencies.
 

Patient Identification

Identifying the correct patient for the correct medication, procedure/treatment represents the first step in all patient safety measures. Avoiding misidentification is more critical in the electronic healthcare environment due to the multitude of linked internal and external databases such as laboratory, radiology and health information networks. Patient misidentification and associated incorrect documentation in the patient healthcare information record or other linked systems may have a cascade effect that can be difficult to overcome. Studies have demonstrated that patient misidentification occurs in all healthcare settings. These errors cost healthcare providers and facilities millions of dollars annually in professional malpractice claims and denied insurance claims.

Because correct patient identification is integral to patient safety, outpatient healthcare facilities should establish acceptable and reliable patient identifiers which match the correct service(s) or treatment(s) with the correct person. A patient identifier is “information directly associated with an individual that reliably identifies the individual as the person for whom the service or treatment is intended.” To prevent instances of misidentification and near-misses, two identifiers must be standardized within each healthcare setting, and used by all staff at every patient encounter. The patient and/or the patient’s representative should be actively engaged in the identification process. The following do’s and don’ts may be used to define appropriate and inappropriate identifiers:

Do:
  • Verify patient’s full name
  • Confirm patient’s date of birth
  • Use medical identification (ID) number
  • Verify patient’s telephone numbers
  • Use patient’s Social Security number
  • Review patient’s photo Identification

Don't:
  • Use a patient’s room number
  • Assume a patient is the individual whom you think
  • Select a patient’s name from a list of names
  • State the patient’s name rather than asking the patient to state their name
  • Rely on the patient to correct staff if the patient is called the incorrect name.
  • Match a patient with a diagnosis/procedure
 

Patient Identification Resources

  • The Joint Commission (TJC). While an outpatient organization may not be accredited, the TJC offers examples of what would or would not be acceptable patient identifiers.
  • Through the ECRI Institute, the Partnership for Health IT Patient Safety was established to support the ongoing work on patient identification in order to gain a better understanding of the problems and prevalence of patient identification errors in clinical settings.
  • Patient Safety Network. Patient Identification Errors: A Systems Challenge.
 

Hand-off Communication

Communication and teamwork are critical elements of patient safety. Ineffective communication, both with patients and other members of the healthcare team, has been linked to medical errors, patient harm and professional liability claims.

Miscommunications between providers during transitions of care (i.e. hand-offs) create special risks, as gaps or omissions in the transfer of vital clinical information may result in potential delays in diagnosis, misdiagnosis, or treatment errors. Time constraints, lack of standardized processes, distractions and interruptions are among the contributing factors that can lead to communication breakdowns. Effective provider-patient communication processes are also important in ensuring safe and effective transfers of clinical information. Providers and staff should be cognizant of their communication style with patients and engage in active listening while patients present their health concerns.

Potential areas of risk specific to the outpatient healthcare setting include, but are not limited to, lapses in reporting test results or treatment plans to patients, omissions of critical information in handoffs involving on-call coverage, and incomplete exchange of clinical information from the outpatient setting through hospital admissions and discharges. Specialty-specific risks, for example, include hand-offs between radiologists and ordering physicians, hand-offs from hospitalists to primary care providers and communications involving referrals to specialists.

Implementing the following patient safety strategies, among other actions, may help to improve communication among providers and reduce patient harm:
  • Develop a standardized process that can be leveraged for acute care transfers, referrals and on-call coverage purposes. Face-to-face communication is preferable, as it provides the opportunity for the sender and receiver to ask clarifying questions and to discuss potential issues. Alternatively, if a face-to-face meeting is not possible, consider video conferencing or a telephonic exchange and ask for critical information to be read back.
  • Consider using evidence-based communication tools such as SBAR (Situation, Background, Assessment, and Recommendation) and I-PASS (Illness severity, Patient summary, Action list, Situation awareness and contingency planning, Synthesis by receiver). 
  • Conduct handoff discussions between providers in an environment that is free of distractions, and ensure that the following information is addressed:
    • Provider contact information.
    • Details regarding the patient’s condition, including anticipated complications.
    • Severity of condition and urgency regarding plan of care.
    • Contingency plan and timeframes.
    • Allergies and current medications.
    • Significant and pending diagnostic laboratory and imaging results.
    • Opportunity for clarifying questions.
  • Engage patients and families in handoff discussions between office staff and providers. In addition to keeping patients informed, this process also promotes effective communication between providers during office visits.
  • Encourage patients to write down their questions/concerns prior to the office visit.
  • Use templates, lists or the electronic medical record in order to readily access key data such as medications, allergies, history of present illness and laboratory and imaging results during handoff discussions.
  • Provide ongoing education for providers and staff. Conduct role-playing sessions to identify opportunities for improving communications with patients and other members of the healthcare team.
Creating an awareness of the importance of effective communication during office visits, procedures and transitions of care will help to enhance patient safety in all healthcare settings.
 

Responding to Emergency Medical Situations

Emergency medical situations can involve patients, staff or visitors. If a medical emergency occurs, appropriate responses may range from calling 911 to performing CPR to attempting more complex medical interventions, depending upon staff competencies and the setting. The following steps can enable staff to respond more effectively to a medical emergency:
  • Encourage staff to achieve and maintain certification in CPR, and permit any certified staff member to initiate CPR, if indicated.
  • Instruct staff members to contact a provider in the office immediately if they believe a medical emergency is occurring, implement the internal emergency process, call 911 as directed and remain on the scene until emergency personnel arrive.
  • Inspect the automated external defibrillators (AEDs) and/or emergency crash cart on a daily basis and maintain inspection logs, if applicable.
  • Provide, and document, training for staff who are responsible for the use of emergency equipment and medications.
  • Retain inspection and preventive maintenance records for all emergency equipment.
  • Conduct emergency drills on a routine basis. These drills include situations such as cardiac arrest, anaphylaxis, choking and falls.
 

Ambulatory Surgery and Office-Based Procedures/Surgery

The expansion in the number and type of surgical services being performed in the outpatient setting has resulted in an increase in exposures. Each state defines office-based surgeries and procedures differently.

Ambulatory and office-based procedures/surgeries may require moderate or deep sedation. The Federation of State Medical Boards provides a link to each state’s statutes, regulations and policies for ambulatory and office-based surgeries. Leaders and providers of an outpatient facility must understand and comply with governing state requirements. The American College of Surgeons (ACS) provides ten core principles of patient safety that providers may utilize when considering whether to offer procedures and/or surgeries in an office or ambulatory surgery setting.

Implementing and utilizing a comprehensive checklist may be an effective tool to reduce patient safety risks associated with ambulatory surgeries and office-based procedures. The Association of periOperative Registered Nurses (AORN), and the World Health Organzation (WHO) provide checklists that can be customized to meet a facility’s needs. These checklists may be designed for use in all types of settings and offer guidance for pre-procedure/pre-surgical check in, sign in, time out, sign out and discharge. During each stage of the procedure/surgical process, clinical staff should always use open-ended questions to encourage active participation from all members of the surgical team. In addition to the suggested items on the checklists referenced above, the following items are required:
  • A formal pre-procedure/pre-surgical check-in process in the pre-operative area. This interactive process between clinical staff and the patient and/or patient’s representative includes the verification of the patient’s identity, confirmation of the procedure/surgery, as well as the provider who will perform the procedure/surgery. During this process, a clinical staff member confirms the presence of a recent history and physical, preanesthesia and nursing assessment and relevant diagnostic and radiologic test results.
  • A formal sign-in process on the day of the procedure/surgery. The sign-in process is performed prior to administering anesthesia or medications which can alter a patient’s cognitive abilities. As with the pre-procedure/pre-surgical process, the sign-in process is an interactive process between clinical staff and/or the patient or patient’s representative. During this process, the clinical staff and, as appropriate, a representative from anesthesia confirm the procedure/surgery being performed and verify the surgical site(s), any medication or latex allergies and acknowledge the completion of the informed consent process. At this time, the surgical site is marked by the provider performing the procedure/surgery.
  • A formal time-out process is performed prior to skin incision. This is a crucial patient safety step and all other activities should be suspended during the time-out process so that every person involved with the procedure/surgery can participate. Verbal confirmation of the patient’s identity, procedure, incision site and completed consent(s) is performed with active team participation.
  • A formal sign-out process is performed prior to the patient leaving the operating/procedure room. This process includes the completion of sponge, sharp and instrument counts, as well as the identification and labeling of any specimens.
Before a patient can be safely admitted to the post-anesthesia care unit (PACU), a formal hand-off communication should be performed by the operating room or anesthesia staff with the PACU staff.

While in the post-anesthesia recovery stage following a procedure/ surgery, a patient is closely monitored to ensure hemodynamic stability and manageable pain level. A formal discharge process should be established and closely followed to assure a safe post-procedure/post-surgical discharge. The American Society of Anesthesiology and Surgery provides standards and practice parameters for the safe provision of anesthesia and sedation in an ambulatory or office based setting.
 

Resources

 

Transfer and Emergency Response

Healthcare facilities that perform outpatient procedures and/or surgeries are at higher risk for adverse events and emergencies. Therefore, staff should be capable of managing all adverse events or emergencies that may occur during or following a procedure or surgery. Such activities include providing emergency care and safe patient transfer. Implement the following safeguards to assist staff in responding to medical emergencies or complications:
  • At least one licensed healthcare provider who is currently certified in advanced resuscitative techniques, as appropriate for the patient age group (e.g., Advanced Cardiovascular Life Support [ACLS], Pediatric Advanced Life Support [PALS] or Advanced Pediatric Life Support [APLS]), is present, or immediately available, until the patient has been stabilized and met the criteria for discharge or transfer. Age and size appropriate resuscitative equipment should be available throughout the procedure and recovery.
  • All office staff are conversant with the transfer policy to ensure safe and timely patient transfers to an appropriate higher level of care.
  • A plan that includes:
    • A proven accessible route for stretcher transport of the patient out of the outpatient setting;
    • Arrangements for emergency medical services and appropriate escort of the patient to the hospital;
    • A policy requiring that resuscitative equipment be evaluated for functionality according to state and manufacturer requirements and recommendations. Records of such evaluations should be maintained by the facility as governed by state record retention requirements; and
    • Where required, a compliance process to notify the regulatory or state regulatory agency of an adverse event as specified.
AHRQ has developed a national standard for team training called TeamSTEPPS®, Team Strategies and Tools to Enhance Performance and Patient Safety. This evidence-based program focuses on communication, leadership, situational awareness and teamwork. This team training can represent a useful tool to prepare staff to effectively and efficiently respond to emergencies and strengthen hand-off communication during patient transfer.
 

Infection Control and Prevention

Transmission of viral and bacterial pathogens is an ever-present safety threat, especially in a healthcare environment. Infection prevention also represents a regulatory issue that is monitored by various governing bodies. Federal and state governing bodies, such as the Occupational Safety and Health Administration (OSHA), may conduct an inspection of an outpatient facility without advance notice. Outpatient facilities should always be prepared for an unannounced or for-cause inspection. Preparation includes current policies and procedures, staff education and training.

Outpatient practice settings should develop an infection prevention plan that is written clearly, updated annually and created with staff input. All staff should have access to review the plan during orientation, annually and as needed thereafter. In addition, staff members should receive ongoing education about how infections are transmitted and what they can do to prevent the spread.

The information that follows is excerpted from the website of the Centers for Disease Control and Prevention (CDC).
 

Modes of Transmission

Knowing and understanding the modes of transmission of infectious agents is a vital part of an infection prevention and control program. Some infectious agents spread via multiple routes, and not all infectious agents are transmitted from person to person. The most
common modes of transmission in a healthcare setting include:
  • Direct contact (e.g., contaminated hands, equipment or high touch surfaces).
  • Droplets and Airborne (e.g., cough, sneeze, droplets generated from talking).
  • Bloodborne (e.g., needlestick, contact of a mucous membrane or non-intact skin with blood, tissue or other bodily fluids).
 

Standard Precautions

Standard Precautions reflect the minimum infection prevention practices in any setting where healthcare is delivered and apply to all patient care, regardless of suspected or confirmed infection status of the patient. These practices are designed to both protect healthcare providers and prevent them from spreading infections among patients. Standard Precautions include:
  • Hand hygiene.
  • Personal protective equipment (e.g., gloves, gowns, masks).
  • Safe injection practices.
  • Safe handling of potentially contaminated equipment or surfaces in the patient environment.
  • Respiratory hygiene/cough etiquette.

Continue reading Chapter 4: Clinical and Patient Safety Risks



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