Guidelines for Office-Based Laser Procedures
Many laser procedures are safe and appropriate to the office setting with no or very little downtime. High standards of practice, similar to those in the institutional setting, should be maintained to ensure quality of care for the surgical patient who undergoes an outpatient surgical procedure in an office-based surgical facility. (1)
The mere acquisition of a skill is not the only criterion by which to measure qualifications. The office setting should not provide an opportunity for practice of inadequately trained personnel. Office staff must meet accepted standards of training and experience and would generally qualify for and hold privileges in an institutional setting. (2) (3) As new technology is introduced into the clinical setting, it is essential that all medical staff using the technology be appropriately educated and their skills assessed. (4)
Patient and Procedure Selection
Prudent selection of both procedures and patients appropriate for office-based laser procedures is critical. Procedures that have intrinsic risk or require technology not available in the physician's office are more appropriately performed in an institutional setting.
In order to determine and apply proper indications for a procedure and to select the appropriate patients for applications of the technology, comprehensive knowledge of the disease process and experience in management of patients with the disease is essential. Prompt recognition and management of complications can only be achieved when the individual or team member is fully qualified in all aspects of treatment of the disease. (5)
The proposed laser procedure should not be compromised by lack of equipment required to perform the proposed procedure. It is essential to verify that the necessary devices and supplies are available and in proper working order prior to scheduling, or performing the procedure. Periodic preventive maintenance and testing of bio-electrical equipment, including laser devices should be done by a qualified professional. The lasers and instrumentation should be checked to verify that they are functioning prior to commencing the procedure.
Standard protocols for both personnel and patient protection from infectious disease must be rigorously observed including body fluid isolation, proper specimen handling as well as proper instrument cleaning and disinfection. (6) Personal protective equipment must be checked to verify that wavelength specific eyewear is present for the patient and staff who will be present in the treatment area. These should be checked for the presence of scratches or other defects that may reduce their effectiveness, and must be replaced if necessary. Eye shields may be required for procedures on the face and these should be readily available and be provided in sterile condition if the procedure warrants same. Appropriately trained staff should be available to assist and facilitate the procedure.
Patients should understand the nature, risks and alternatives to the proposed procedure. They should give their informed consent to proceed with the procedure.
Patients should receive clear pre-procedure instructions, that are consistent with the procedure to be performed and which takes patient co-morbidities, chronic medications, and the type and level of anesthesia that will be required into consideration.
Confirmation of important compliance issues such as NPO status, refraining from tanning, site preparation (e.g. shaving, the application of topical anesthetics or other agents prior to coming to the office) should be documented.
If topical anesthesia is required, application should be performed within the treatment facility. The quantity of anesthetic applied should be calculated to be less than the amount capable of leading to systemic toxicity.
If conscious sedation is used as an adjunct for office-based laser procedures, there must be appropriate instrumentation and expertise in managing respiratory depression and cardiac arrest. Oximetry and automated blood pressure monitoring should be routinely employed; electronic cardiographic monitoring should be available. Oxygen, drugs and equipment routinely used in cardiopulmonary resuscitation, including adequate suction, must be available. Following procedures requiring sedation vital signs should be monitored and respiratory function and mental status should be assessed in a manner similar to hospitalized patients. If sedation has been used, the patient must be accompanied by a competent adult at discharge.
The availability of emergency transport to an acute care facility willing to accept patients from the office should be guaranteed.
All office-based laser patients must be sufficiently recovered from procedures and sedation prior to discharge. Written instructions regarding common complications, directions for returning for emergency evaluation and caution as to continued functional impairment for many hours following conscious sedation are appropriate, and should be provided to the patient and the patient's caregiver.
All patients should receive written and verbal instructions regarding appropriate care of the treated area(s) and follow up appointments should be arranged prior to discharge. Directions regarding medications, diet and activity should be provided as is appropriate. The patient and caregivers should understand what common complications and anticipated events may occur and should understand conditions that require emergency evaluation and treatment.
Records and Quality Assurance
Each patient should have at minimum a brief history and physical examination by the physician. Serious cardiopulmonary or other disease should be excluded by appropriate clinical, and if necessary, laboratory evaluation.
The patient chart should contain the clinical examination and evaluation, the justification for the procedure, the description of the treatment and the patient's status on discharge. Informed consent for the procedure should be documented in the chart consistent with local professional standards and applicable state law.
Records should be maintained so that complications and problems can be identified and compliance with recommendations for clinical and laser treatment ensured. (6)
American College of Surgeons monograph Guidelines for Office Endoscopic Services (1991) and Guidelines for Optimal Office-Based Surgery.
Please note that that certain States have specific regulations and requirements for office-based surgery, particularly procedures requiring sedation or levels of anesthesia higher than "local" blocks. The clinicians and facilities should comply with all local, State and applicable Federal regulations. You should contact your State Medical Board or the Department of Health for clarification.
(1) Accreditation of the Office-Based Surgical Facility: Bulletin of the American College of Surgeons, Vol. 80 (8) 1995.
(2) Standards of Training for Physicians for the Use of Lasers in Medicine and Surgery, American Society for Laser Medicine and Surgery, Inc. 1999.
(3) American National Standards Institute (ANSI), 11 West 42nd Street, New York NY 10036.
(4) Statement on Emerging Surgical Technologies and the Evaluation of Credentials: Bulletin of the American College of Surgeons, Vol. 79 (6) 1994.
(5) Statement on Issues to be Considered Before a New Surgical Technology is Applied to the Care of Patients: Bulletin of the American College of Surgeons, Vol. 80 (9) 1995.
(6) Guidelines for Office-Based Surgery: Quality Assurance: Bulletin of the American College of Surgeons, Vol. 79 (10) 1994.