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As office-based ambulatory surgery developed into an increasingly significant aspect of a surgeon's practice, the American Association for Accreditation of Ambulatory Surgery Facilities, Inc. (AAAASF) was established in 1980, to accredit both single-specialty and multi-specialty surgery facilities and ASCs, owned and/or directed by American Board of Medical Specialties (ABMS) Surgeons. This has been expanded to include facilities ownned and/or directed by American Osteopathic Association Bureau of Osteopathic Specialists (AOA) Surgeons. The Association determined that it was crucial to ensure high standards not only for the physicians through board certification, but also set standards for the ambulatory facilities in which 70 to 80% of them practice. Thus, the American Association for Accreditation of Ambulatory Surgery Facilities, Inc. (AAAASF) designed and implemented an accreditation program for outpatient surgery centers.

The comprehensive requirements remain the same for each specialty including hospital core privileges for the same procedures being performed within the ambulatory surgery unit and adherence to the appropriate local and state laws and regulations governing ambulatory surgery units.

The Accreditation Program

The American Association for Accreditation of Ambulatory Surgery Facilities, Inc. (AAAASF) conducts an accreditation program that certifies that an accredited facility meets nationally recognized standards. The accreditation program is conducted by physicians, podiatrists and oral and maxillofacial surgeons who determine the standards under the direction of a Board of Directors. The AAAASF strives for the highest standards of excellence for its facilities by regularly revising and updating its requirements for patient safety and quality of care.

Basic Mandates

Surgical procedures should be of a duration and degree to permit safe recovery and discharge from the facility.

Patients receiving anesthetic agents other than topical or local anesthesia should be supervised in the immediate post discharge period by a responsible adult for at least 12-24 hours, depending on the operation and anesthesia used.

Changes in facility ownership must be reported to the AAAASF Office within thirty (30) days.

Any death occurring in an accredited facility, or any death occurring within thirty (30) days of a surgical procedure performed in an accredited facility, must be reported to the AAAASF office within five (5) business days after the facility is notified or otherwise becomes aware of that death. In addition to this notification, the death must also be reported as an unanticipated operative sequelae in the biannual Peer Review report. In the event of a death occurring within thirty (30) days of an operation done in an AAAASF accredited facility, an unannounced inspection will be done by a senior inspector.

All individuals using the facility must meet one of the following criteria:

1. A Doctor of Medicine certified or eligible for certification by one of the member boards of the American Board of Medical Specialties (ABMS medical or surgical specialty).
2. A Doctor of Osteopathy certified or eligible for certification by the American Osteopathic Association Bureau of Osteopathic Specialists (AOABS).
3. A podiatrist certified or eligible for certification by the American Board of Podiatric Surgery (ABPS).
4. An oral and maxillofacial surgeon certified or eligible for certification by the American Board of Oral and Maxillofacial Surgery (ABOMS).

Every physician, podiatrist, and oral and maxillofacial surgeon operating in an AAAASF accredited facility, must hold, or must demonstrate that they have held, unrestricted hospital privileges in their specialty at an accredited and/or licensed acute care hospital within thirty (30) minutes of the accredited facility for all operations that they perform within the facility. Only surgical procedures included in those hospital privileges may be performed within the AAAASF accredited facility. A physician must be present when anesthesia other than strictly local is being administered in Class B, Class C-M, and C accredited facilities.

Inspection

A facility is inspected every three years. The facility inspector will review any deficiencies with the facility director and forward the Standards and Checklist answer sheet to the AAAASF Central Office. To be accredited by AAAASF, a facility must meet every standard for its Class (A, B, C-M or C).

Self-Evaluation

A facility is evaluated by the facility director each year between inspections and the Standards and Checklist answer sheet is sent to the AAAASF Office. A facility's AAAASF accreditation remains valid if it continues to meet every standard for its Class (A, B, C-M or C). Otherwise, accreditation is revoked.

Denial or Loss of Accreditation

The AAAASF may deny or revoke accreditation of a facility if the facility fails to satisfy every standard for its Class (A, B, C-M, or C), or if any surgeon operating at the facility;

•  has had their privileges to perform surgery restricted or limited by any hospital at which the surgeon has privileges , related to lack of clinical competence, ethical issues, or professional problems other than economic competition.

•  has been found to be in violation of the Code of Ethics of any professional medical, podiatric or oral and maxillofacial surgical society or association of which they are a member.

•  has had their right to practice medicine, podiatry or oral and maxillofacial surgery limited, suspended, terminated or otherwise affected by any state, province, or country, or if they have been disciplined by any medical licensing authority.

•  non-reporting of any of the above to the AAAASF.

Hearing

Any facility whose accreditation has been revoked or denied by the AAAASF has the right to a Hearing at which it may present such information as it deems advisable to show that it has satisfied the requirements for accreditation. The Hearing process is described in the AAAASF Bylaws available from the AAAASF Central Office.

Emergency Suspension or Emergency Probation

The AAAASF may place a facility on Emergency Suspension or Emergency Probation status upon receiving information that a state medical, podiatric or oral and maxillofacial surgery board has taken action, or begun formal proceedings which may result in it taking action against a license held by a surgeon, podiatrist or oral and maxillofacial surgeon operating at the facility, or the Board of Directors determining that the facility may no longer meet AAAASF standards for accreditation. A facility that has been placed on Emergency Suspension or Emergency Probation status will remain in such status pending an expedited investigation and possible Hearing conducted in accordance with AAAASF procedures available from the AAAASF Central Office.

Definitions of Facility Classes

Class A:

In a Class A Facility, all surgical, endoscopic and/or pain management procedures may be performed under the following anesthesia:
1. topical anesthesia
2. local anesthesia

Class A facilities must meet all Class A standards.

Class B:

In a Class B facility, all surgical, endoscopic and/or pain management procedures may be performed under the following anesthesia:

•  topical anesthesia

•  local anesthesia

•  parenteral sedation

•  regional anesthesia

•  dissociative drugs ( excluding propofol )

Agents 3 thru 5 may be administered by a physician; a Certified Registered Nurse Anesthetist (CRNA) under physician supervision if required by state or federal law, or by policy adopted by the facility; an anesthesia assistant (as certified by the National Commission for the Certification of Anesthesiologist Assistants under direct supervision of an anesthesiologist); or by a registered nurse under the supervision of a qualified physician.

The use of propofol, endotracheal intubation anesthesia, laryngeal mask airway anesthesia, and/or inhalation general anesthesia (including nitrous oxide) is prohibited in a Class B facility.

Class B facilities must meet all Class A and Class B standards.

Class C-M:

In a Class C-M facility, all surgical, endoscopic and/or pain management procedures may be performed under the following anesthesia:

•  topical anesthesia

•  local anesthesia

•  parenteral sedation

•  regional anesthesia

•  dissociative drugs including propofol

•  spinal anesthesia

•  epidural anesthesia
Agents 3 thru 4 may be administered by either a physician; a Certified Registered Nurse Anesthetist (CRNA) under physician supervision if required by state or federal law, or by policy adopted by the facility; or an anesthesia assistant (as certified by the National Commission for the Certification of Anesthesiologist Assistants under direct supervision of an anesthesiologist). Propofol, spinal anesthesia and epidural anesthesia may be administered only by a CRNA or an anesthesiologist.

The use of endotracheal intubation anesthesia, laryngeal mask airway anesthesia, and/or inhalation general anesthesia (including nitrous oxide) is prohibited in a Class C-M facility.

Class C-M facilities must meet all Class A, Class B, and Class C-M standards.

Class C:

In a Class C facility all surgical, endoscopic, and/or pain management procedures may be performed under the following anesthesia:

•  topical anesthesia

•  local anesthesia

•  parenteral sedation

•  regional anesthesia

•  dissociative drugs, including propofol

•  epidural anesthesia

•  spinal anesthesia

•  general anesthesia
with or without endotracheal intubation or laryngeal mask airway anesthesia

Propofol and agents 6 through 8 may be administered only by an anesthesiologist, a Certified Registered Nurse Anesthetist (CRNA) under physician supervision if required by state or federal law or by policy adopted by the facility; or an anesthesia assistant (as certified by the National Commission for the Certification of Anesthesiologist Assistants under direct supervision of an anesthesiologist).

Class C facilities must meet all Class A, Class B, Class C-M, and Class C standards.

Important Notice -

Maximal patient safety has always been our guiding concern. We are proud that our Standards may be considered the strongest of any agency that accredits ambulatory surgery facilities, and that many consider them to be the Gold Standard . We recognize, however, that they need to be part of a living document, and we continually re-evaluate and revise these Standards in the light of medical advances and changing legislative guidelines.

The AAAASF Accreditation Program requires 100% compliance with each Standard to become and remain accredited. There are no exceptions. However, when a Standard refers to appropriate or proper or adequate, reasonable flexibility and room for individual consideration by the inspector is permitted as long as patient and staff safety remain uncompromised.

Accreditation consists of a three-fold review that includes a site visit, committee assessment of site visit findings, and successful participation in a peer review/quality assurance program requiring on-line reporting to AAAASF semi-annually.

Trained inspectors who are qualified physicians, retired physicians and nurses perform the inspections.. Nurse inspectors participate in pre-survey inspections and are part of a Physician/Nurse inspection team for Medicare inspections. To promote objectivity and fair review, reciprocal inspections are not permitted.

The on-site interaction and inspection process verifies compliance with standards, provides a resource to the facility's management through the inspector's experience and expertise, and offers a unique educational opportunity between the surgeons and facility staff. We strongly believe this is the ultimate in peer evaluation and quality assurance since the inspector is from an accredited facility with invaluable expertise and insight. Every aspect of the center is reviewed including (but not limited to) patient charts, personnel records and qualifications, safety procedures and patient selection criteria. The inspector also assesses the scope of procedures performed in the outpatient center to assure that the surgeon has comparable core hospital privileges covering the procedures performed.

Findings are returned to the Association's Accreditation Committee for review, who makes the final decision to issue full accreditation, provisional accreditation for 6 months, or deny accreditation.

The establishment of standards and the site visit process enable surgeons who operate outpatient surgery centers develop a quality facility, verify that quality with objective assessment against measurable standards, correct and identify deficiencies, and ultimately improve the quality and safety of patient care.

It should be noted that this process also encourages cost containment. By certifying quality in the ambulatory setting, it promotes outpatient surgery which typically generates charges 60 to 75% below those of comparable inpatient care. Governmental programs such as Medicare do not yet routinely reimburse such a facility unless it has a Medicare certification. However, private insurance carriers may recognize the accredited outpatient surgery center and may reimburse the ambulatory surgery facility for covered procedures.

The AAAASF accreditation process is a voluntary one for most facilities; yet it has received overwhelming recognition and support from both the medical and the regulatory communities. To date, approximately 1100 ambulatory surgery centers have been accredited and many more facilities are in the process, making this the largest office-based surgery facility accreditation system in the nation. State governments and their regulatory agencies have recognized our standards, and have often used them as a model for laws and regulations mandating accreditation of ambulatory surgery facilities.

Medicare Certification

AAAASF granted continued Deeming Authority by CMS.

AAAASF is also able to perform the health survey to "deem" that facilities are in compliance with the standards for Medicare certification, offering an alternative to the State inspection process. A life safety code inspection is also required in order to obtain Medicare certification, which AAAASF arranges, and the entire process is significantly simplified. Surgical peers are used for the health survey just as in the basic accreditation inspection, and the same basic standards are used for both processes, with additional standards required for Medicare certification. Medicare surveys must be unannounced, and a specially trained group of inspectors is used. Most of the other aspects of the inspection and approval process are the same as for the basic accreditation program, including compliance with 100% of the standards. Here is an outline of our Medicare Standards with several examples:

 

PREFACE	Our Process ………………………………………………………..…….	2
DEFINITION OF FACILITY CLASSES ………………………………………………….		3
IMPORTANT NOTICE …………………………………………………………………….		4
SECTION I	Facility ID, Staff ID, Equipment & Procedures ...……………….……....	6
SECTION II	Surgeon Staff Identification …………………………………….…….…  examples: 2.000.00.0 All surgeons using the facility must be board certified or board eligible in an ABMS surgical specialty.   B,C 2.000.01.0 The facility director must be board certified in an ABMS surgical specialty or an anesthesiologist.   B,C	11
SECTION III	Facility Physical Layout …………………………………………………  examples: 3.001.00.0 Is there an adequate waiting room area?   B,C 3.001.01.0 Is the waiting room area adequately ventilated and temperature controlled?   B,C	11
SECTION IV	Records …………………………………………………………..……...  examples: 4.001.02.0 The ASC must develop and maintain a system for the proper collection, storage, and use of patient records.  Medical records must be retained the number of years as required by state and/or federal law.   B,C 4.001.03.0 Medical records are filed for easy accessibility, and must be maintained in the facility regardless of the location of the operating surgeon’s office.   B,C	17
SECTION V	Facility Safety Manual ……………………………………………..……  examples: 5.001.00.0 Does the Facility have a Facility Safety Manual containing all of the requirements of OSHA (as a minimal requirement) and meet all other “standards of the industry?”   B,C 5.001.01.0 Is this Manual maintained in a central file to better meet and demonstrate compliance with all the various OSHA and other federal and state standards and regulations?   B,C	23
SECTION VI	Peer Review & Quality Assurance ………………………………..…….  examples: 6.000.04.4 d)  In-house Peer Review?   B,C 6.000.04.5 As a form of In-house Peer Review, have the “off years” AAAASF’s self inspections been adequately carried out and all deficiencies noted sufficiently corrected? B,C	28
SECTION VII	Operating Room Suite Personnel …………………………………..……  examples: 7.001.00.0 Are registered nurses, who are currently licensed in the same state as the facility, employed?   B,C 7.001.01.0 There is a regularly employed Registered Nurse in accordance with State Law, currently licensed in the same state as the facility, designated as the person responsible for patient care in the facility.   B,C	29
SECTION VIII	Operating Room Suite Operations & Management ……………..………  examples: 8.000.02.0 Are appropriate laboratory procedures performed where indicated?   B,C 8.000.03.0 Is a CBC routinely performed preoperatively on all major cases?   B,C	33
SECTION IX	Operating Room Suite Equipment ……………………………...……….  examples: 9.001.05.0 Is cold sterilization alone prohibited as the sole method of sterilization of instruments in surgery or for patient care?   B,C 9.001.06.0 Does the facility have at least one Autoclave which utilizes high pressure steam and heat?   B,C	40
SECTION X	Operating Room Suite/Office Complex Sanitation & Housekeeping …..  examples: 10.001.07.0 Are employees and outside contracted cleaners aware of the state and local definitions of regulated wastes?   B,C 10.001.08.0 Is all waste stored in appropriate containers according to OSHA and state regulations?   B,C	44
SECTION  XI	Governance ……………………………………………………..……….  examples: 11.000.00.2 Are the rules and regulations of the governing body reviewed and revised at least annually? B,C 11.000.00.3 Are deficiencies within the practice or within the rules and regulations identified and remedied?   B,C	45

The Accreditation Standards

A Standards and Checklist Booklet along with a Resource Guide CD have been created to foster the initial development of quality outpatient centers as well as for use in subsequent evaluation and accreditation processes. The standards and their related criteria are classified and tiered according to the three classes of outpatient surgery facilities described above.

Pivotal to the program, the Standards and Checklist Booklet serves as the primary tool for site inspection. This document is a detailed list of requirements designed to access compliance. The inspector answers each question according to his/her investigation during the site visit. Then, an automated analysis of responses is compiled into an objective facility assessment for review by the Association's Accreditation Committee.

The Three Year Accreditation Cycle

The accreditation process operates on a three-year cycle. The first year review consists of the site inspection already described. Originally, first year reviews resulted in only 40% of all inspected facilities receiving full accreditation, 55% receiving provisional approval, and 5% failing. Now, approximately 95% of inspected facilities receive full accreditation, 2% Provisional and only 3% are denied certification.

The second and third years of accreditation include a self-evaluation conducted by the facility director and staff using the same Standards and Checklist Booklet. Designed to help facilities maintain voluntary standards throughout the accreditation period, results of this self-evaluation are also computer analyzed and returned to the center for review.