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Surgery - Office-Based Procedures

Physicians are encouraged to scrutinize their practices to assure suitable precautions are in place to provide for patient safety and reduce unnecessary risks. Below is an outline of risk management strategies essential to consider when offering a surgical office-based practice. Surgical office-based practices must have office systems in place to identify and manage inherent risks and implement a risk management plan that ensures patient safety.

Primary Areas of Risk

Building office systems to address the following twelve primary areas of risk act as internal guidelines to provide optimum patient safety and protect the practitioner against liability. Ongoing monitoring of these office systems ensures patient safety and quality of patient care.

  1. Patient Screening and Selection
    • Develop written guidelines to ensure patient selection is appropriate for the office procedure.
    • Assure procedures are of duration and complexity that will permit patients to recover and be discharged home from the office.
    • Assess and screen patients for office-based surgery to determine risks and appropriateness for office setting.
    • Assess other risk indicators including a complicated medical history of obesity, cardiac disease, and chronic respiratory condition, or epilepsy, previous reactions to anesthesia. The needs and limitations of pediatric and elderly patients also should be considered.
    • Assure pre-operative evaluations consist of reviewing the patient's health and social history, conducting a physical exam, providing for 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.
  2. Plan of Anesthesia Care
    • Assure the following ASA 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 surgeon, or surgeon supervises administration by non-anesthesiologists), "Guidelines for Preoperative Fasting," and "Standards of Basic Anesthetic Monitoring."
    • Assure the necessary monitoring equipment, medications, and resuscitative capabilities are present, including correct size for pediatric or obese patients.
    • Assure in practice settings where a practitioner is required to supervise the administration of anesthesia by a CRNA, the supervising physician:
      • Assures 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.
      • Assures the provision of indicated post-anesthesia care 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 delineation of privileges, of all health care practitioners are established by written policy, periodically verified and maintained on file.
      • 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 and working within his/her scope of practice. In those cases in which a non-physician administers the anesthesia, the individual is under the supervision of an anesthesiologist or the operating physician.
  4. Competency includes:
    • 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 rescue 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 itself, but in managing any emergency that ensues.
    • Training in communication and teamwork which promotes communication and encourages “speaking up.”
    • A written job description outlining required competencies for each staff member.
    • Physicians and staff members have annual documented continuing education in their field.
  5. Informed Consent Process includes:
    • The physician performing the procedure obtains the patient's consent.
    • The physician conducts a comprehensive informed consent discussion with the patient, or legal surrogate, which covers the necessity, appropriateness, and risks of proposed surgery, treatment alternatives, including no treatment, probability of success, name of other practitioners and significant tasks performed, and the patient or legal surrogate, recount of what he or she has been told, including acknowledgement that their questions, if any, were answered. Also acknowledgement of patient understanding.
    • The individual responsible for administering the anesthesia obtains the patient, or legal surrogates, consent for the anesthetic, discussing possible complications and alternatives of administering anesthesia, and the patient or legal surrogates’ recount of what he or she has been told, including acknowledgement that their questions, if any, were answered.
    • The use of a written consent form for the procedure and for the anesthetic including the patient's signature indicating he or she understands the discussion and accepts the risks outlined is recommended. Physicians and anesthesia providers also should 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 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 Tips: Informed Consent: A Process for Building Patient Confidence and Health Literacy: Delivering the Message Right Improves Patient Safety and Reduces Liability.
  6. Pre-op Process includes:
    • Site marking by the surgeon while the patient is fully alert including the patient in the process.
    • Uniform pre-op patient education is provided for specific procedures.
  7. Intra-op Process includes:
    • 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 with knowledge and skill to recognize and treat airway complications.
      • Assessment of ventilation.
      • Oxygenation.
      • Cardiovascular status.
      • Body temperature.
      • Neuromuscular function and status.
      • Patient positioning.
    • "Time out" conducted with the operative team to verify correct patient, correct side and site, agreement on the procedure to be done, correct patient position, and availability of special equipment and materials.
    • Medication safety including:
      • 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 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. 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 OSHA requirements for appropriate level of sterilizations.
  10. Post-op care including:
    • 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 including:
    • 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.
    • A complete list of medications including any changes.
      • Acceptable activities.
      • A follow-up appointment.
    • Patients are informed of 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 and the patient should be supervised for at least 12-24 hours, depending on the anesthesia used.
    • Discharge instructions must reference anesthetic used and any discharge instructions specific to post anesthesia care.
  12. Emergency Equipment should at least include:
    • Patient monitoring equipment.
    • Emergency medications (atropine, epinephrine, rescue drugs: Narcan and Romazicon).
    • 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 a reasonable proximity when extended care due to slow recovery, complications or emergency services is 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. 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.
    • Clinical policies for surgical procedures.
    • Procedure-specific checklist to assure 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, cardiopulmonary arrest.
    • Maintaining accurate patient medical records including pre- and post-operative information; process to transfer files if requested.
    • A process is in place to inform the primary care provider of the patient's status.
    • Infection control policies and procedures are in place to prevent, identify and manage infections and communicable diseases. Include annual training for all staff.
    • For other recommended office policies and procedures, please see our Practice Tip: Policy and Procedure Manual in Practice Management.
  14. Performance Improvement/Quality Assurance including:
    • 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 in comparison to published data. Performance improvement data also provides quality and risk indictors useful for credentialing, such as patient deaths, cardiopulmonary events, anaphylaxis and 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 scope of services, who to contact, the billing process, and a list of patient rights and responsibilities.
    • Considering obtaining accreditation for your practice.

Resources

American Society of Anesthesiologists, Guidelines for the Administration of Office-based Anesthesia, www.asahq.org

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, www.cdc.org

Center for Medicaid and Medicare Services, www.cms.hhs.gov

ECRI Healthcare Risk, Quality, & Safety Guidance Office-Base Surgery and anesthesia Published 1/1/2013, www.ecri.org

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

https://www.infectioncontroltoday.com/guidelines/aorns-recommended-practices-sponge-sharp-and-instrument-counts-review

ACCREDITING ORGANIZATIONS:

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

American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF), www.aaaasf.org

The Joint Commission, www.jointcommission.org