Practice Tips

Office-based surgical practices must have systems in place to identify and manage inherent risks and implement a risk management plan that ensures patient safety. Below is an outline of risk management strategies to consider.

Primary Areas of Risk

The following areas of risk act as internal guidelines to provide optimum patient safety and protect the practitioner against liability. Ongoing monitoring of these areas ensures patient safety and quality of patient care.

1. Patient Screening and Selection
   • Develop written guidelines to ensure patient selection is appropriate for the procedure completed in the ambulatory surgery center.
   • Ensure procedures are of a duration and complexity that will permit patients to recover and be discharged home from the office.
   • Assess risk indicators, including a complicated medical history that may include obesity, cardiac disease, chronic respiratory condition, epilepsy, or previous reactions to anesthesia. The needs and limitations of pediatric and elderly patients also should be considered.
   • Ensure pre-operative evaluations consist of reviewing the patient's health and social history, conducting a physical exam, providing diagnostic testing and specialist consultation, developing a plan of anesthesia care, and developing a safe plan for discharge to home from the practice after recovery from the procedure.
   • Evaluate for expected blood loss to only be 500 ml or less for each procedure, following the Ambulatory Surgery Center Association guidelines.
2. Plan of Anesthesia Care
   • Ensure the following American Society of Anesthesiologists’ publications are considered when developing the office-based surgical practice's anesthesia policies and procedures:
     • Guidelines for Office-Based Anesthesia
     • Practice Guidelines for Sedation and Analgesia by Non-Anesthesiologists (if administered by the surgeon, or surgeon supervises administration by non-anesthesiologists)
     • Guidelines for Preoperative Fasting
     • Standards of Basic Anesthetic Monitoring
   • Ensure the necessary monitoring equipment, medications, and resuscitative capabilities are present, including the correct size for special populations like pediatrics and bariatric patients.
   • Ensure in practice settings where a practitioner is required to supervise the administration of anesthesia by a CRNA, the supervising physician:
     • Completes an appropriate pre-anesthetic examination.
     • Prescribes anesthesia to be administered.
     • Is available for diagnosis, treatment, and management of anesthesia-related complications or emergencies.
     • Prescribes post-anesthesia medications.
     • Ensures post-anesthesia care is completed including:
       1. Documented post-anesthesia evaluation includes respiratory function (rate, airway patency, oxygen saturation), cardiovascular function (pulse rate, blood pressure), mental status, temperature, pain, nausea and vomiting, and postoperative hydration.
       2. Written discharge instructions address both the procedure performed and the anesthesia received.
3. Credentialing and Staff Competencies
   • Office practice provider credentialing includes:
     • Credentials, including the delineation of privileges of all health care practitioners, are established by written policy, periodically verified, and maintained on file. These files should be available for staff to access if there are any concerns or questions.
     • Documentation of accredited training to perform the procedures offered.
     • Proof of board certification or board eligibility.
     • Documented privileges to perform equivalent or greater procedures at a local hospital or ambulatory care facility.
   • Individuals administering anesthesia are:
     • Licensed, qualified, competent, and working within their scope of practice. In cases where a non-physician administers the anesthesia, the individual is supervised by an anesthesiologist or the operating physician.
4. Competency
   • Health care practitioners who administer anesthesia or supervise the administration of anesthesia maintain current training in advanced resuscitation techniques (ACLS or PALS). Practitioners intending to produce a given level of sedation should be competent to reverse patients when that level becomes deeper than expected.
   • All clinical staff maintain competency in basic cardiopulmonary resuscitation.
   • All staff members involved in surgical procedures need proven, ongoing competencies, not only in the procedure but in managing any emergency.
   • Training in communication and teamwork, which promotes communication and encourages “speaking up.”
   • A written job description outlining the required competencies for each staff member.
   • Physicians and staff members have annual documented continuing education in their field.
5. Informed Consent Process
   • The physician performing the procedure obtains the patient's consent.
   • A comprehensive informed consent discussion with the patient, or legal surrogate, which covers the necessity, appropriateness, and risks of the proposed surgery, treatment alternatives, including no treatment, probability of success, name of other practitioners and significant tasks performed, and the patient or legal surrogate, a recount of what they have been told, including acknowledgment that their questions, if any, were answered. An acknowledgment of patient understanding.
   • The individual responsible for administering the anesthesia obtains the patient’s, or legal surrogate’s consent for the anesthetic, discussing possible complications, alternatives of administering anesthesia, and the patient’s or legal surrogate’s recount of what he or she has been told, including an acknowledgment that their questions, if any, were answered.
   • The use of a written consent form for the procedure and the anesthetic, including a timed and dated patient signature indicating they understand the discussion and accept the risks outlined, is recommended. Physicians and anesthesia providers should also sign the form and document the consent discussion in the medical record.
   • Evidence of patient education about their care and consent to the procedure and anesthetic is documented with the use of patient "teach-back" or similar form of assurance of patient understanding of their health status and procedures to be performed.
   • Please reference our practice tip Informed Consent Guidelines.
6. Pre-op Process
   Universal Protocol is a set of guidelines for preventing wrong-site, wrong-procedure, and wrong-person surgeries. It was created by The Joint Commission (TJC) in 2004 and is based on the consensus of clinical experts. The protocol includes three main steps. Ensure these are incorporated into the pre-operative process.
   • Pre-procedure verification: Confirm the correct patient, procedure, and site at every stage of the process.
   • Marking the procedure site: Use a permanent marker to mark the surgical site in an unambiguous way. The mark should be visible after the patient is prepped and draped.
   • Time-out: A brief pause before the incision to confirm the patient, procedure, and site. This is also an opportunity to check that the patient is positioned correctly and that any necessary equipment is available. All team members should be involved in the time-out, and any concerns should be addressed. This should also be addressed during the intra-operative process as well.
7. Intra-op Process
   • The average length of time of procedures is less than 6 hours.
   • Procedures are limited to 2 hours or less and 20% of total body surface area, if warming devices (Bair hugger), forced air warmers, or IV warmers are not available.
   • Intra-operative physiologic monitoring including:
     • Continuous monitoring by an individual not participating in the procedure who has the knowledge and skill to recognize and treat airway complications.
     • Assessment of ventilation.
     • Oxygenation.
     • Cardiovascular status.
     • Body temperature.
     • Neuromuscular function and status.
     • Patient positioning.
   • Medication safety including at a minimum:
     • Medications and solutions, both on and off the sterile field, are labeled.
     • Drug concentrations are standardized.
     • Emergency medications are located in the surgical procedure area.
8. Supply Counts
   • Sponge, sharps, and miscellaneous item counts should be performed:
     • Before the procedure to establish a baseline.
     • Before the closure of a cavity within a cavity.
     • Before wound closure begins.
     • At skin closure or end of procedure.
     • At the time of permanent relief of either the scrub person or the circulating nurse.
9. Infection Control Policy
   • There should be a schedule/procedure for cleaning, disinfecting, and sterilizing equipment and patient care items, according to the manufacturer’s instructions.
   • Quality control/audit of sterilization should be performed and documented at scheduled times.
   • Staff should be trained in universal precautions, practices of infection control, and disposal of hazardous waste. The practice should ensure that they are complying with state and federal regulations/guidelines regarding infection prevention/control.
   • In addition, all surgical procedures should meet current CDC requirements for the appropriate level of sterilization.
10. Post-op Care
    • A staff member trained in post-op recovery stays with the patient at all times until fully recovered.
    • The physician is physically present during the intra-operative period and is available until the patient has been discharged home from the office.
    • At least one person with training in advanced resuscitative techniques (ACLS or PALS) is immediately available until all patients are discharged.
    • Physician-defined discharge criteria are in writing and include stable vital signs, responsiveness and orientation, voluntary movement, controlled pain, and minimal nausea and vomiting.
11. Patient Discharge Process
    • Uniform post-op patient education provided for specific procedures.
    • Written instructions provided and documented in the record, including:
      • An emergency phone number to contact for any questions.
      • Pain management plan.
      • Post-procedure diet.
      • Patient educational material.
    • A complete discharge list of medications, including current medications and changes.
      • Acceptable activities.
      • A follow-up appointment.
    • Patients are informed of the surgeon's scheduled absence in the post-op period and have been given the name of the covering surgeon.
    • The surgeon has provided "hand-off communication" information to the covering surgeon.
    • If sedation, regional block, or general anesthesia has been used, patients must leave with a responsible adult who has been instructed with regard to the patient's care, after a post-op anesthesia evaluation has been completed by the anesthesia provider. The patient should be supervised for at least 12-24 hours, depending on the anesthesia used.
    • Discharge instructions must reference the anesthetic used and any discharge instructions specific to post-anesthesia care.
12. Emergency Equipment should at least include the following:
    • Patient monitoring equipment.
    • Emergency medications.
    • A defibrillator or AED.
    • A latex allergy cart or tray.
    • An Ambu bag for positive pressure ventilation.
    • A safe and reliable source of oxygen.
    • At least two sources of suction.
    • Pulse oximetry, capnography.
    • Warming blankets.
    • IV catheters and IV fluid warmers.
13. Process for Emergency Transport should include:
    • A written emergency plan including written protocols for the timely and safe transfer of patients to a hospital within reasonable proximity when extended care due to slow recovery, complications, or emergency services are needed.
    • A written transfer agreement with a reasonably convenient hospital(s) where all physicians performing surgery have admitting privileges or transfer of patient care may be arranged at the facility.
    • All information relevant to a patient is readily available to authorized health care practitioners, and there is a process for providing information to the receiving facility/provider.
14. Additional Policies/Procedures
    • Clinical policies for surgical procedures.
    • Procedure-specific checklist to ensure completion of tasks associated with the pre-op preparations for surgery.
    • Written policies to ensure necessary personnel, equipment, and procedures are available for emergencies, e.g., surgical and other fires, power outages, weather disasters, and cardiopulmonary arrest.
    • Maintaining accurate patient medical records, including pre-and post-operative information; a process to transfer files if requested.
    • Infection control policies and procedures are in place to prevent, identify, and manage infections and communicable diseases. Include annual training for all staff.
    • Written policies and procedures, including an identified medical director, and written policies describing organizational structure, including lines of authority, responsibilities, accountability, and supervision of personnel. A process is in place to inform the primary care provider of the patient’s status.
    • For other recommended office policies and procedures, please see our Practice Tip: Policy and Procedure Manual in Practice Management.
15. Performance Improvement/Quality Assurance
    • A written process that tracks and trends patient outcomes. This process should include patient discussions and disclosure of procedure outcomes, including adverse outcomes.
    • A plan that promotes performance improvement is essential for providers to use in monitoring the processes and safeguards of their surgical office-based practice compared to published data. Performance improvement data also provides quality and risk indicators useful for credentialing, such as patient deaths, cardiopulmonary events, anaphylaxis, adverse drug reactions, infections, post-operative complications, patient satisfaction survey results, and medication errors.
    • A medical record audit of operative procedures to include pre-procedural documentation, intra-procedural documentation, post-procedural care, and discharge instructions. Identify opportunities for improvement and implement remedial actions through the practice's performance improvement processes.
    • Gathering post-op information on patients through post-op telephone calls designed to gather specific data.
    • Creating a patient brochure or packet with information on the scope of services, who to contact, the billing process, and a list of patient rights and responsibilities.
    • Federal Licensing and Accreditation program for your practice.

Resources

American Society of Anesthesiologists, Guidelines for the Administration of Office-based Anesthesia,  https://www.asahq.org/standards-and-practice-parameters/statement-on-office-based-anesthesia

State of Massachusetts, Office-based Surgery Guidelines, www.mass.gov or www.massmed.org

Each clinical specialty is an excellent resource for practice guidelines, e.g., American Academy of Ophthalmology www.aao.org

Centers for Disease Control and Prevention. Ambulatory Surgery Centers,  https://www.cdc.gov/nhsn/ambulatory-surgery/index.html

Centers for Medicaid and Medicare Services, Ambulatory Surgical Centers (ASC)  https://www.cms.gov/medicare/enrollment-renewal/providers-suppliers/ambulatory-surgical-centers

Third Edition American College of Surgeons Guidelines for Optimal Ambulatory Surgical Care and Office-Based surgery, www.facs.org

Accrediting Organizations:

Accreditation Association for Ambulatory Health Care, Inc. (AAAHC), www.aaahc.org

QUAD A (American Association for Accreditation of Ambulatory Surgery Facilities, Inc.), https://www.quada.org/

The Joint Commission, www.jointcommission.org