100 GENERAL ENVIRONMENT
100.010.010
The facility displays a professional appearance that is in keeping with a medical facility designed to carry
out surgical procedures. The facility should be neat, comfortable and clean and should include a waiting
area, business office and sanitary lavatory facilities. One or more dedicated exam rooms should be
available that provide for privacy and treatment in a sanitary, orderly environment.
A,B,C-M,C
200 OPERATING ROOM POLICY, ENVIRONMENT AND PROCEDURES
200.010.010
A policy for a ‘surgical pause’ or a ‘time out’ protocol is in place and practiced and documented prior to
every surgical procedure.
This protocol should include:
Pre-operative verification process to include medical records, imaging studies, any implants identified and
reviewed by the operating room team. Missing information or discrepancies must be addressed at this time.
Marking the operative site -
Surgical procedures calling for right/left distinction; multiple structures (breasts, eyes, fingers, toes, etc.)
must be marked while the patient is awake and aware, if possible. The person performing the surgery
should do the site marking. Site must be marked so that the mark will be visible after the patient has been
prepped and draped. A procedure must be in place for patients who refuse site marking.
‘Time Out’ immediately before starting the surgical procedure -
Conduct a final verification by at least two (2) members of the surgical team confirming the correct patient,
surgery, site marking(s) and, as applicable, implants and special equipment or requirements. As a ‘failsafe’
measure, the surgical procedure is not started until any and all questions or concerns are resolved.
Procedures done in non-operating room settings must include site marking for any procedure that involves
laterality, or multiple structures.
B,C-M,C
Environment
200.020.010
The operating suite is physically separate from the general office.
B,C-M,C
200.020.015
The operating suite includes operating room(s), prep/scrub area, clean area, and/or dirty area, and recovery
room.
B,C-M,C
200.020.020
There is a room dedicated for use as an operating room
B,C-M,C
200.020.025
An exam room may function as an operating room.
A
200.020.030
All major surgery is done in the separate and distinct operating room(s).
B,C-M,C
200.020.035
The operating room(s) is adequately ventilated and temperature controlled.
A,B,C-M,C
200.020.040
There is adequate operating room storage space to hold equipment, sterile supplies and medications.
Storage space should be adequate to minimize the need to leave the operating room for frequently used
supplies, equipment and/or medication.
A,B,C-M,C
200.020.045
Storage space provides easy access for identification and inventory of supplies.
A,B,C-M,C
200.020.050
The operating room is properly cleaned, maintained and free of litter and clutter.
A,B,C-M,C
200.020.055
Each operating room is of a size adequate to allow for the presence of all equipment and personnel
necessary for the performance of the surgical procedures, and must comply with applicable local, state or
federal requirements. Additionally, all facilities must have a minimum of four (4) feet (48 inches) of clear
space on each side of the operating table to accommodate emergency personnel and equipment in case of
emergency, and permit the safe transfer of the patient to a gurney for transport
OR:
Facility personnel can physically demonstrate to the inspector that the emergency criteria, as stated above,
can be met in the operating room space available.
A,B,C-M,C
200.020.060
There are no overloaded wall plugs or extensions in use, no altered grounding plugs in use, and wires are
not broken, worn or unshielded.
A,B,C-M,C
200.020.065
Unauthorized individuals are deterred from entering the operating room suite either by locks, alarms, or
facility personnel.
A,B,C-M,C
200.020.070
Sterile supplies are stored away from potential contamination in closed cabinets/drawers or if not, away
from heavy traffic areas.
A,B,C-M,C
200.020.075
Sterile supplies are labeled to indicate sterility, and are packaged and sealed to prevent accidental opening.
A,B,C-M,C
200.020.080
Each sterilized pack is marked with the date of sterilization and, when applicable, with the expiration date.
When more than one autoclave is available, each pack must additionally be labeled to identify in which
autoclave it was sterilized.
A,B,C-M,C
200.020.085
If one sink is used both for dirty instruments and to scrub for surgery, there is a written policy to clean and
disinfect the sink prior to scrubbing hands.
A,B,C-M,C
200.020.090
If a pre-existing sink is present in the operating room, a written policy to prohibit the use of the sink during
sterile surgical procedures must be in place. A sink is permissible in an operating room which is
exclusively used for endoscopic or urological procedures in accordance with the standards of those
professions. Requests by other specialties will be reviewed on a case by case basis.
B,C-M,C
Procedures - Sterilization
200.030.015
Additional methods in use can be chemical autoclave (Chemclave) or gas (ethylene oxide) sterilizer.
A,B,C-M,C
200.030.025
Gas sterilizers must be vented.
A,B,C-M,C
200.030.030
All instruments used in patient care are sterilized, where applicable.
A,B,C-M,C
200.030.035
High-level disinfection is used only for non-autoclavable endoscopic equipment, and in areas that are
categorized as semi-critical where contact will be made with mucus membrane or other body surfaces that
are not sterile. At all times the manufacturers recommendations for usage should be followed.
A,B,C-M,C
200.030.040
If a sterilizer produces monitoring records, they are reviewed and stored for a minimum of three (3) years.
A,B,C-M,C
200.030.045
A weekly spore test, or its equivalent, is performed on each autoclave and the results filed and kept for
three (3) years.
A,B,C-M,C
200.030.050
If a spore test is positive, there is a protocol for remedial action to correct the sterilization process.
A,B,C-M,C
Asepsis
200.040.010
Instrument handling and sterilizing areas are cleaned and maintained.
A,B,C-M,C
200.040.015
There is strict segregation of dirty surgical equipment and instruments that have been cleaned and are in the
preparation and assembly area.
A,B,C-M,C
200.040.020
The instrument preparation and assembly area (clean utility area) is separated by walls or space from the
instrument cleaning area (dirty utility area) or if not, there is a policy to clean and disinfect the dirty utility
area before preparing and assembling packs for sterilization.
A,B,C-M,C
200.040.025
Between cases, the operating room(s) is cleaned with disinfectants.
A,B,C-M,C
200.040.030
Scrub suits, caps or hair covers, gloves, operative gowns, masks and eye protection are used for all
appropriate surgery.
A,B,C-M,C
200.040.035
A sterile field is routinely used during all operations.
A,B,C-M,C
200.040.040
Surgical scrub soap and/or alcohol cleansers are provided for the surgery room staff consistent with current
CDC guidelines for hand hygiene.
A,B,C-M,C
Maintenance and Cleaning
200.050.010
The entire operating room suite is cleaned and disinfected according to an established schedule adequate to
prevent cross-contamination.
A,B,C-M,C
200.050.015
All blood and body fluid spills are cleaned using germicides that are virucidal, bactericidal, tuberculocidal
and fungicidal.
A,B,C-M,C
200.050.025
All openings to outdoor air are effectively protected against the entrance of insects, animals, etc.
A,B,C-M,C
Surfaces
200.060.010
The operating room ceiling surface or drop-in tiles are smooth, washable and free of particulate matter that
can contaminate the operating room.
B,C-M,C
200.060.015
The walls and counter tops are covered with smooth and easy to clean material that is free from tears,
breaks or cracks.
A,B,C-M,C
200.060.020
The floors are covered with an easily cleaned material which is smooth and free from breaks or cracks. If
the floors contain seams or individual tiles, they are sealed with an impermeable sealant other than silicone.
B,C-M,C
Equipment
200.070.010
A bio-medical technician annually inspects all equipment (including electrical outlets, breaker/fuse boxes,
and emergency light and power supplies) and reports in writing that the equipment is safe and operating
according to the manufacturer’s specifications.
A,B,C-M,C
200.070.015
Only inspected equipment is used in the operating room.
A,B,C-M,C
200.070.020
The equipment’s specifications are kept in an organized file.
A,B,C-M,C
200.070.025
All equipment is on a preventative maintenance schedule with records kept for a minimum of at least three
(3) years. Stickers may be placed on individual equipment; however written records must be maintained.
A,B,C-M,C
200.070.030
All equipment repairs and changes are done by a bio-medical technician with records kept for a minimum
of three (3) years.
A,B,C-M,C
200.070.035
There is an adequate operating room table or chair.
A,B,C-M,C
200.070.040
The operating room is provided with adequate lighting in the ceiling.
A,B,C-M,C
200.071.010
An EKG monitor with pulse read-out is present.
B,C-M,C
200.071.015
Pulse oximeters must be present in both the operating room and recovery room if both rooms are being
used simultaneously.
B,C-M,C
200.071.020
Blood pressure monitoring equipment is present.
A,B,C-M,C
200.071.025
A standard defibrillator, or an Automated External Defibrillator unit (AED), is present which is checked at
least weekly for operability, and the test results are kept for a minimum of three (3) years.
A,B,C-M,C
200.071.030
Sequential compressive devices (SCD) are employed for surgical procedures of one hour or longer, except
for procedures carried out under local anesthesia.
B,C-M,C
200.071.035
Oral airways for each size of patient treated in the facility are present.
A,B,C-M,C
200.071.040
Nasopharyngeal airways and laryngeal mask airways are present.
B,C-M,C
200.071.045
Laryngoscope is present.
B,C-M,C
200.071.050
Endotracheal tubes are present.
B,C-M,C
200.071.055
Endotracheal stylet is present.
B,C-M,C
200.071.060
Positive pressure ventilation device (e.g. Ambu® bag) is present.
A,B,C-M,C
200.071.065
Source of O2 is present.
A,B,C-M,C
200.071.070
Source of suction is present.
A,B,C-M,C
200.071.075
If present, mechanical ventilator should have a continuous use device which indicates a disconnect via an
audible signal.
C
200.071.080
Electrocautery with a grounding plate or disposable pad is present.
B,C-M,C
200.071.085
Anesthesia machine with a purge system to extract exhaled gaseous air to out-of-doors, or to a neutralizing
system is present.
C
200.071.090
An inspired gas oxygen monitor on the anesthesia machine is present.
C
200.071.095
A CO2 monitor is present and is used on all general anesthesia cases.
C
Emergency Power
200.080.010
The operating room has an emergency power source, (e.g., a generator or battery powered inverter), with
capacity to operate adequate monitoring, anesthesia, surgical equipment, cautery and lighting for a
minimum of two (2) hours. If two of more surgery rooms are used simultaneously, an adequate emergency
power source must be available for each operating room.
B,C-M,C
200.080.015
The emergency power source is able to begin generating ample power to operate essential electrical
equipment used in the surgery room within thirty (30) seconds of a power failure.
B,C-M,C
200.080.020
The emergency power equipment is checked monthly to insure proper function, and the test results are filed
and kept for a period of three (3) years.
B,C-M,C
Medical Hazardous Waste
200.090.010
All medical hazardous wastes are stored in OSHA (Occupational Safety and Health Act) acceptable
containers, and separated from general refuse for special collection and handling.
A,B,C-M,C
200.090.015
Used disposable sharp items are placed in puncture-resistant containers located close to the area in which
they are used.
A,B,C-M,C
200.090.020
There is a written policy for cleaning of spills which may contain blood borne pathogens.
A,B,C-M,C
TOP OF PAGE
300 Post-Anesthetic Care Unit (PACU)
300.000.015
The operating room may be used for patient recovery if only one surgical procedure is scheduled that same
day, or if the recovering patient meets all discharge criteria prior to beginning the next surgical procedure,
or if there is another operating room available for the next surgical procedure.
B,C-M,C
300.000.020
Patients transferred to the PACU are accompanied by a member of the anesthesia team who is
knowledgeable about the patient.
B,C-M,C
300.000.025
Patients transferred to the PACU will be continually evaluated and monitored as needed during transport.
B,C-M,C
Evaluation in the PACU will include:
300.005.010
Documentation of patient’s time of arrival.
B,C-M,C
300.005.015
Assessment of the patient by the anesthesia recovery staff, as well as by a responsible physician.
B,C-M,C
300.005.020
Transmission of a verbal report on the patient to the PACU team from a member of the anesthesia team
who accompanies the patient.
B,C-M,C
300.005.025
Transfer of information concerning the preoperative condition of the patient and the surgery - anesthesia
course.
B,C-M,C
300.005.030
A member of the anesthesia team remains in the post-anesthesia area until the post-anesthesia care nurse
accepts responsibility for the patient.
B,C-M,C
300.6
Continued evaluation in the PACU will consist of:
300.006.005
Continued evaluation in the PACU will consist of:
300.006.010
Observation and monitoring by methods appropriate to the patient’s condition (O2 saturation, ventilation,
circulation, temperature).
B,C-M,C
300.006.015
Continuous pulse oximetry.
B,C-M,C
300.006.020
A written, accurate post-anesthetic care report is maintained.
B,C-M,C
300.006.025
All recovering patients must be observed and supervised by trained medical personnel in the recovery area.
A physician, CRNA, P.A., or R.N. currently licensed and certified in Advanced Cardiac Life Support
(ACLS) is immediately available until the patient has met PACU discharge criteria for discharge from the
surgical facility.
B,C-M,C
300.006.030
There is a written policy that whenever parenteral sedation, dissociative drugs, epidural, spinal or general
anesthesia is administered, a physician is immediately available until the patient is discharged from the
PACU.
B,C-M,C
Discharge from PACU
300.007.010
Approved and standardized discharge criteria are used.
B,C-M,C
300.007.015
A physician determines that the patient meets discharge criteria based upon input from the PACU nurse,
and that physician’s name must be noted on the record.
B,C-M,C
300.8 Equipment and Supplies for Anesthesia should include:
Equipment and Supplies for Anesthesia should include:
300.008.010
A reliable source of oxygen, adequate for the length of the surgery (back up should consist of at least one
full E cylinder).
B,C-M,C
300.008.010
A written protocol has been developed for use by housekeeping personnel for cleaning of floors, tables,
walls, ceilings, counters, furniture and fixtures of the surgical suite.
A,B,C-M,C
300.008.015
If a central source of piped oxygen is used, the system must meet all applicable codes.
A,B,C-M,C
300.008.015
The facility has at least one autoclave which uses high pressure steam and heat.
A,B,C-M,C
300.008.020
Sufficient space to accommodate the necessary personnel, equipment and monitoring devices is available.
A,B,C-M,C
300.008.025
There is an adequate and reliable source of suction.
A,B,C-M,C
300.008.030
An adequate and reliable anesthetic scavenging system exists if inhalation anesthetics are used.
C
300.008.035
Self inflating (Ambu©) bags, if used, are capable of delivering positive pressure ventilation with at least
90% oxygen concentration.
A,B,C-M,C
300.008.040
An anesthesia machine is required if volatile agents or nitrous oxide are available in the facility. If total
intravenous anesthesia (TIVA), spinal or epidural anesthesia is used exclusively, and no inhalation agents
(volatile or nitrous oxide) are available, an anesthesia machine is not required.
C
300.008.045
Sufficient electrical outlets are available, labeled and grounded to suit the location (e.g. wet locations,
cystoscopy-arthroscopy) and connected to emergency power supplies where appropriate.
A,B,C-M,C
300.008.050
Adequate illumination for patients, machines and monitoring equipment, which can include battery
powered illuminating systems.
A,B,C-M,C
300.008.055
Emergency cart is available with defibrillator, necessary drugs and other CPR equipment.
A,B,C-M,C
Quality of Care
300.009.010
A licensed or qualified anesthesia provider supervising or providing care in the facility should participate in
quality assurance and risk management in the facility. (STD 710-720)
B,C-M,C
300.009.015
The surgeon and the licensed or qualified anesthesia provider should concur on the appropriateness of
surgical procedures performed at the facility. This is based on the medical status of the patients and
qualifications of the providers and the facility resources.
B,C-M,C
300.009.020
A patient who, by reason of pre-existing or other medical conditions, is at significant risk for outpatient
surgery in this facility should be referred to alternative facilities.
A,B,C-M,C
300.010 PACU Room(s)
300.010.010
There is a separate and adequately sized recovery room within the operating room suite.
B,C-M,C
300.010.015
The room is equipped and readily accessible to handle emergencies.
B,C-M,C
300.010.020
All recovering patients must be observed and supervised by trained medical personnel in the recovery area.
A physician, CRNA, PA or R.N. with Advanced Cardiac Life Support (ACLS) certification, is immediately
available until the patient has met PACU discharge criteria for discharge from the surgical facility.
B,C-M,C
300.010.025
A separate pulse oximeter is available for each patient in the recovery room.
B,C-M,C
300.010.030
There is a recovery room record that includes vital signs, sensorium, medications and nurse’s notes.
B,C-M,C
Discharge
300.020.010
Written post-operative instructions, including procedures for emergency situations, are given to an adult
who is responsible for the patient’s care and transportation.
B,C-M,C
300.020.015
Patients are required to meet criteria for physiological stability before discharge, including vital signs and
sensorium.
B,C-M,C
300.020.020
Personnel assist with discharge from the recovery area.
B,C-M,C
Extended Stays
300.030.010
If overnight stays are permitted, the facility is in compliance with all applicable local and state laws and
regulations.
B,C-M,C
TOP OF PAGE
400 GENERAL SAFETY IN THE FACILITY
AAAASF is committed to establishing minimum guidelines to provide safe and effective outpatient
surgical care. The Facility must comply with all applicable Occupational Safety and Health
Administration (OSHA), National Fire Protection Association (NFPA), federal, state and local codes
and regulations. The Facility must comply with the stricter regulation (whether it is the AAAASF
Standard or local, state, or federal law).
400.010.005
There is a facility safety manual:
400.010.015
Facility safety manual contains all applicable requirements of OSHA.
A,B,C-M,C
400.010.020
Facility safety manual is in accordance with other federal and state regulations.
A,B,C-M,C
400.010.025
Facility safety manual provides employees with information about hazardous chemicals used and methods
to minimize hazards to personnel.
A,B,C-M,C
400.010.030
There is a written exposure control plan which is reviewed and updated at least annually.
A,B,C-M,C
400.010.035
There is a written chemical hazard communication program which is reviewed and updated annually.
A,B,C-M,C
400.010.040
If a laser is used, safety measures are taken to protect patients and staff from injury.
A,B,C-M,C
400.010.045
If x-ray equipment is used, safety measures are taken to protect patients and staff from injury.
A,B,C-M,C
400.010.050
Warnings and signage exists to warn those whose health may be affected by x-ray.
A,B,C-M,C
400.010.055
Staff maintains dosimetry badges and records, if applicable, for at least three (3) years.
A,B,C-M,C
400.020 Emergency Protocols
400.020.005
There is a written protocol for:
400.020.010
There must be a written protocol for security emergencies, such as an intruder in the facility, an unruly
patient or visitor, a threat to the staff or patients.
A,B,C-M,C
400.020.015
There must be a written protocol for fires and fire drills
A,B,C-M,C
400.020.020
There must be a written protocol for the return to the operating room for patient emergencies.
A,B,C-M,C
400.020.025
Unless they are having local anesthesia only, patients are transported from the facility by wheelchair or
gurney to a waiting vehicle or to another facility with a responsible adult.
B,C-M,C
400.020.025
There must be a written protocol for Malignant hyperthermia.
C
400.020.030
There must be a written protocol for Cardiopulmonary resuscitation.
A,B,C-M,C
400.020.035
There must be a written protocol for a situation in which the surgeon becomes incapacitated.
A,B,C-M,C
400.020.040
There must be a written protocol for a situation in which the anesthesiologist or CRNA becomes
incapacitated.
B,C-M,C
400.020.045
There must be a written protocol for response to power failure emergencies.
A,B,C-M,C
400.020.050
There must be a written protocol for transferring patients in an emergency.
A,B,C-M,C
400.020.055
There must be a written protocol for a Plan for emergency evacuation of the facility.
A,B,C-M,C
Transfer Agreement
400.021.010
There is a written transfer agreement with a local accredited or licensed acute care hospital within 30
minutes driving time and is approved by the facility’s medical staff, or the operating surgeon has privileges
to admit patients to such a hospital.
A,B,C-M,C
Hazardous Agents
400.030.010
All explosive and combustible materials are stored and handled in a safe manner according to state, local
and/or National Fire Protection Association (NFPA) codes.
A,B,C-M,C
400.030.015
Compressed gas cylinders are stored and handled according to state, local and/or National Fire Protection
Association (NFPA) codes.
A,B,C-M,C
400.030.020
Hazardous chemicals are labeled as hazardous.
A,B,C-M,C
400.040.010
The facility is equipped with heat sensors and/or smoke detectors.
A,B,C-M,C
400.040.015
An adequate number of fire extinguishers are available.
A,B,C-M,C
400.040.020
Fire extinguishers are inspected annually and conform to local fire codes.
A,B,C-M,C
Exits
400.050.010
Fire exit signs are posted and illuminated consistent with state, local and/or the NFPA codes and OSHA
codes.
A,B,C-M,C
400.050.015
There are sufficient emergency lights for exit routes and patient care areas in case of power failure.
A,B,C-M,C
400.050.020
Hallways, stairways and elevators are sufficiently wide to allow emergency evacuation of a patient by
emergency personnel and their equipment.
A,B,C-M,C
400.050.025
If requested, the facility’s personnel can demonstrate safe evacuation of a patient.
A,B,C-M,C
TOP OF PAGE
500 IV FLUIDS AND MEDICATIONS
Blood & Substitutes
500.010.010
Intravenous fluids such as Lactated Ringer’s solution and normal saline are available in the facility, and the
facility has the means to obtain and administrate blood or blood substitutes such as Dextran, if necessary.
A,B,C-M,C
500.010.015
If blood were to be used, there is a protocol for it to be typed, cross-matched, checked and verified.
A,B,C-M,C
500.020.010
Emergency Drug Box - all emergency medications as noted in the following standards must be available
and in the facility at all times, and operating room personnel know their location.
A,B,C-M,C
500.020.015
There is a dated narcotic inventory and control record which includes the use of narcotics on individual
patients. Such records must be kept in the form of a sequentially numbered bound journal from which pages
may not be removed, or in a tamper-proof and secured computer record, consistent with state and federal
law. A loose leaf notebook or a spiral bound notebook does not fulfill this regulation.
A,B,C-M,C
500.020.020
The inventory of narcotics is verified by two licensed members of the operating room team at least weekly,
and on any day that narcotics are administered, and according to state regulations.
A,B,C-M,C
500.020.025
All narcotics and controlled substances are secured and locked under supervised access.
A,B,C-M,C
500.020.030
Outdated medications are removed.
A,B,C-M,C
ACLS Algorithm
500.021.015
A copy of the current, complete ACLS Algorithms must be available on the emergency cart.
The following medications must be available in the facility at all times as required by current ACLS
Algorithms:
A,B,C-M,C
500.021.020
Epinephrine
A,B,C-M,C
500.021.025
Lidocaine – plain
A,B,C-M,C
500.021.026
Atropine
A,B,C-M,C
500.021.027
Oral nitroglycerine
A,B,C-M,C
500.021.030
Vasopressors, other than epinephrine (e.g. Ephedrine)
A,B,C-M,C
500.021.035
Narcotic antagonist (e.g. Narcan®)
B,C-M,C
500.021.040
Seizure arresting medication (a benzodiazepine, e.g. Midazolam)
A,B,C-M,C
500.021.045
Bronchospasm arresting medication (inhaled beta agonist, e.g. Albuterol)
A,B,C-M,C
500.021.050
Intravenous corticosteroids (e.g. Dexamethasone)
A,B,C-M,C
Other drugs:
500.022.045
IV Antihistamines (e.g. Diphenhydramine)
A,B,C-M,C
500.022.050
Short-acting beta-blocker (e.g. Esmolol or Labetalol)
A,B,C-M,C
500.022.055
Neuromuscular blocking agents including non-depolarizing agents such as rocuronium or depolarizing
agents such as succinylcholine
C-M,C
500.022.060
Benzodiazephine reversing agent (e.g. Mazicon®, Flumazenil®)
B,C-M,C
Malignant Hyperthermia
500.023.005
If potential malignant hyperthermia triggering agents such as the potent inhalation anesthetics halothane,
enflurane, isoflurane, sevoflurane, and desflurane and the depolarizing muscle relaxant succinylcholine, are
ever used or are present in the facility the following requirements apply:
500.023.010
There must be adequate screening for MH risk that includes but is not limited to a family history of
unexpected death(s) following general anesthesia or exercise; a family or personal history of MH, a muscle
or neuromuscular disorder, high temperature following exercise; a personal history of muscle spasm, dark
or chocolate colored urine, or unanticipated fever immediately following anesthesia or serious exercise.
C
500.023.015
The facility director and all operating surgeons and anesthesiology providers should be aware of genetic
and/or CHCT (Caffeine-Halothane Contracture Testing) for MH and refer patients for appropriate testing if
there is a suspicous history as above prior to permitting surgery to take place in the facility.
C
500.023.020
The medical director should be able to demonstrate that all operating surgeons and anesthesia providers
have familiarity with the early recognition of impending MH crisis as defined by MHAUS.
C
500.023.025
The medial director will insure that all staff are trained and annual drills are conducted for MH crisis and
management including actual dilution of at least one vial of actual Dantrolene (expired OK). Staff should
be assigned roles prior to drills and a written protocol outlining those personnel and their roles is on file.
Documentation of drills is required.
C
500.023.030
A minimum of 1000 ML (IV bag or similar container) of preservative- free H2) diluents for Dantrolene
C-M,C
500.023.035
A minimum of four (4) 50cc ampoules of NaHCO3
B,C-M,C
500.023.040
A minimum of twelve (12) vials of Dantrolene
C-M,C
500.023.045
An additional 24 vials of Dantrolene and diluents are stored in the facility, or the facility has a written
agreement of another source that will provide those 24 vials of Dantrolene and diluents on a STAT basis
within 15 minutes.
C
500.023.050
The MHAUS Malignant Hyperthermia Algorithms must be available on the emergency cart.
C-M,C
500.023.055
Flow sheets for any MH intervention as well as forms to rapidly communicate progress of intervention with
receiving facilities are on the emergency cart and all ASC's must document and report any "adverse
metabolic or musculoskeletal reaction to anesthesia". This documentation must be transportable with the
patient when transferred to receiving facility.
C-M,C
500.023.060
Facilities should establish the best destination as a transfer standard, which means the facility director
would preplan for MH transfer and establish the capabilities of a facility within a reasonable distance. e.g.
a tertiary care center that is further away may be better than a community type ER which is closer.
Arrangements must be made in advance with EMS system if that is to be activated. Ability of receiving
transport team to continue MHAUS protocol must be ensured in advance as well as by the medical director.
C-M,C
TOP OF PAGE
600 MEDICAL RECORDS
General
600.010.010
Medical records must be legible, documented and completed accurately.
A,B,C-M,C
600.010.015
Medical records must be retained the number of years as required by state and/or federal law; or a
minimum of three (3) years to comply with the AAAASF three year inspection cycle.
A,B,C-M,C
600.010.020
Medical records are filed for easy accessibility, and must be maintained in the facility regardless of the
location of the operating surgeon’s office.
A,B,C-M,C
600.010.025
Medical records must be kept secure and confidential consistent with HIPAA regulations.
A,B,C-M,C
600.010.030
Medical clearance should be recorded, if applicable. A current history and physical examination by the
surgeon, anesthesia provider, or the patient’s personal physician is recorded within two weeks of surgery on
all patients for major surgery, and for those patients for minor surgery who require a physical exam. The
medical record must contain a current medical history taken on the same day as the surgical procedure, and
recorded by the surgeon or anesthesia provider prior to the administration of anesthesia.
A,B,C-M,C
600.010.035
The history and physical examination should cover the organs and systems commensurate with the surgical
procedure(s).
A,B,C-M,C
The pre-operative medical record includes the following information:
Drug allergies/sensitivities.
600.011.010
The pre-operative medical record includes the following information:
Drug allergies/sensitivities.
A,B,C-M,C
600.011.015
Current medications.
A,B,C-M,C
600.011.020
Previous serious illness.
A,B,C-M,C
600.011.025
Current and chronic illness.
A,B,C-M,C
600.011.030
Previous surgery.
A,B,C-M,C
600.011.035
Bleeding tendencies.
A,B,C-M,C
600.011.040
Treating physicians or consultants are contacted in cases where the history and physical examination
warrant.
A,B,C-M,C
600.011.045
Appropriate laboratory procedures are performed where indicated.
A,B,C-M,C
Informed Consent Forms
600.020.010
An informed consent is always obtained which authorizes the surgeon by name to perform surgery and
describes the operative procedure.
A,B,C-M,C
600.020.015
Expectations, alternatives, risks and complications are discussed with the patient, and these are
documented.
A,B,C-M,C
600.020.020
The informed consent provides consent for administration of anesthesia or sedatives under the direction of
the surgeon, CRNA or anesthesiologist.
A,B,C-M,C
Laboratory, Pathology, X-Ray, Consultation and Treating Physician Reports
600.030.010
Printed or written copies of these reports are kept in the medical record.
A,B,C-M,C
600.030.015
All laboratory results must be reviewed by the registered nurse or surgeon. All abnormal results must be
reviewed and initialed by the surgeon within one (1) week of receipt of results.
A,B,C-M,C
600.030.020
All other reports, such as pathology reports and medical clearance reports, must be reviewed and initialed
by the surgeon.
A,B,C-M,C
600.030.025
Outside clinical laboratory procedures must be performed by a licensed and accredited facility.
A,B,C-M,C
600.030.030
The name of the pathologist must be on all pathology reports.
A,B,C-M,C
Operating Room Records (Major Cases)
600.040.010
A separate surgical log of major cases is maintained, either in a hard copy bound log with sequentially
numbered pages, or in a secured computer log. Procedures done solely under local anesthesia are not
required to be recorded in this log.
B,C-M,C
600.040.015
A Surgical Log must include:
Sequential numerical listing of patients either consecutive numbering from the first case carried out in the
facility or consecutive numbers starting each year.
B,C-M,C
600.040.020
Date of surgery.
B,C-M,C
600.040.025
Patient’s name and/or identification number.
B,C-M,C
600.040.030
Surgery(s).
B,C-M,C
600.040.035
Surgeon’s name.
B,C-M,C
600.040.040
Type of anesthesia.
B,C-M,C
600.040.045
Name of person(s) administering anesthesia.
B,C-M,C
600.040.050
Name of person(s) assisting surgeon (M.D., registered nurse, scrub tech/circulating registered nurse,
physician’s assistant).
B,C-M,C
600.040.055
A separate anesthesia record is maintained in which:
Vital signs are recorded during surgery.
B,C-M,C
600.040.060
All medications given to a patient are recorded including date, time, amount and route of administration.
B,C-M,C
600.040.065
All intravenous and subcutaneous fluids given pre-operatively, intra-operatively and post-operatively are
recorded.
B,C-M,C
600.040.070
Post-operative vital signs are recorded until the patient is discharged from the facility.
B,C-M,C
600.040.075
There is an operative report which includes operative technique and findings.
B,C-M,C
600.040.080
Post-operative progress notes are recorded.
B,C-M,C
TOP OF PAGE
700 QUALITY ASSESSMENT/QUALITY IMPROVEMENT
Quality Improvement
700.010.010
The facility has a written quality improvement program in place which should include surveys of projects
which:
A,B,C-M,C
700.010.015
Monitor and evaluate patient care.
A,B,C-M,C
700.010.020
Evaluate methods to improve patient care.
A,B,C-M,C
700.010.025
Identifies and correct deficiencies within the facility.
A,B,C-M,C
700.010.030
Alert the Medical Director to identify and resolve problems.
A,B,C-M,C
Note: To be HIPAA compliant, a copy of the HIPAA Business Associates Agreement must be signed by each
physician participating in Peer Review, and a copy is retained on file in the facility. For an example of a
generic HIPAA Business Associates Agreement, contact the AAAASF central office.
700.020.010
Peer review is performed at least every six months (biannually) and includes reviews of both random cases
and unanticipated operative sequelae using the AAAASF forms and reporting format. A random sample of
the cases for each surgeon must include the first case done by each surgeon each month during the
reporting period for a total of six cases. If a surgeon using the facility has done less than six cases during a
reporting period, that must be reported to the AAAASF Central Office and all of that surgeon’s cases
during that period must be reviewed.
A,B,C-M,C
700.020.015
If peer review sources external to the facility are used to evaluate delivery of medical care, the HIPAA
Business Associates Agreement is so written as to waive confidentiality of the medical records.
A,B,C-M,C
700.020.020
Peer review may be done by a recognized peer review organization or a physician, podiatrist, or oral and
maxillofacial surgeon other than the operating surgeon.
A,B,C-M,C
Random Case Review
700.030.010
A minimum of six cases for each surgeon operating in the facility are reviewed every six months, or all
cases of the surgeons who have cases must be reviewed if less than six cases have been completed.
A,B,C-M,C
700.030.015
Random case reviews must include at a minimum:
Adequacy and legibility of history and physical exam.
A,B,C-M,C
700.030.020
Adequacy of surgical consent.
A,B,C-M,C
700.030.025
Presence of appropriate laboratory, EKG and radiographic reports.
A,B,C-M,C
700.030.030
Presence of a written operative report.
A,B,C-M,C
700.030.035
Anesthesia and recovery record (with IV sedation or general anesthesia).
B,C-M,C
700.030.040
Presence of instructions for post-operative care.
A,B,C-M,C
700.030.045
Documentation of complications.
A,B,C-M,C
700.040.005
All unanticipated operative sequelea which occur within thirty (30) days of surgery are reviewed, including
but not limited to:
700.040.010
Unplanned hospital admission.
A,B,C-M,C
700.040.015
Unscheduled return to the operating room for a complication of a previous surgery.
A,B,C-M,C
700.040.020
Complications such as infection, bleeding, wound dehiscence or inadvertent injury to other body structure.
A,B,C-M,C
700.040.025
Cardiac or respiratory problems during stay at facility or within 48 hours of discharge.
A,B,C-M,C
700.040.030
Allergic reactions.
A,B,C-M,C
700.040.035
Incorrect needle or sponge count.
A,B,C-M,C
700.040.040
Patient or family complaint.
A,B,C-M,C
700.040.045
Equipment malfunction leading to injury or potential injury to patient.
A,B,C-M,C
700.040.050
Death occurring within 30 days of a procedure done in an AAAASF accredited facility.
Each Unanticipated Operative Sequelae chart review must include the following information, in addition to
the operation performed:
A,B,C-M,C
700.040.055
Identification of the problem.
A,B,C-M,C
700.040.060
Immediate treatment or disposition of the case.
A,B,C-M,C
700.040.065
Outcome.
A,B,C-M,C
700.040.070
Reason for problem.
A,B,C-M,C
700.040.075
Assessment of efficacy of treatment.
A,B,C-M,C
Patient's Rights
700.050.010
A copy of the Patient’s Rights is prominently displayed, or a copy is provided to each patient. The Patient’s
Rights is also adhered to by facility personnel.
A,B,C-M,C
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800 PERSONNEL
The Medical Director must have an M.D. or D.O. degree.
800.005.010
The medical director must be a physician currently licensed by the State in which the facility is located.
A,B,C-M,C
800.005.015
The medical director must be a physician certified or eligible for certification by either an American Board
of Medical Specialties (ABMS medical or surgical specialty certifying boards), or by The American
Osteopathic Association Bureau of Osteopathic Specialists (AOABS).
A,B,C-M,C
800.005.020
The medical director must be actively involved in the direction and management of the facility.
A,B,C-M,C
800.10 Staff Physicians, Podiatrists, and Oral Surgeons
Staff Physicians, Podiatrists, and Oral Surgeons
800.010.010
Each physician, podiatrist, or oral and maxillofacial surgeon using the facility is credentialed and qualified
for the surgical procedures they perform.
A,B,C-M,C
800.010.015
Each physician, podiatrist, or oral and maxillofacial surgeon using the facility has core privileges in their
specialty at a licensed acute care hospital.
A,B,C-M,C
800.010.020
Physicians, podiatrists or oral and maxillofacial surgeons who operate in facilities accredited by AAAASF
must hold or demonstrate that they have held valid, unrestricted hospital privileges in their specialty at an
accredited and/or licensed hospital. Only surgical procedures included within those hospital privileges may
be performed within the AAAASF accredited facility. If the privilege-granting hospital does not possess
equipment or technology to allow a physician, oral surgeon or podiatrist to be credentialed for a specific
surgery, the physician, podiatrist, or oral and maxillofacial surgeon may provide alternative evidence of
training and competence in that surgery. Individual consideration will be given if the physician, podiatrist,
or oral and maxillofacial surgeon no longer possesses or cannot obtain such privileges, and can
demonstrate that loss of, or inability to obtain such privileges was not related to lack of clinical
competence, ethical issues, or problems other than economic competition.
A,B,C-M,C
800.010.025
If the physician, podiatrist, or oral and maxillofacial surgeon does not hold admitting privileges at a
hospital within 30 minutes driving time, there must be a signed and dated document from a person in the
same specialty who has admitting privileges in a hospital within 30 minutes driving time that indicates their
willingness to admit the patient to the hospital.
A,B,C-M,C
800.010.030
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 certifying boards).
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).
ABMS certified or eligible medical specialists who perform surgical procedures within the accredited
facility may perform only those surgical procedures delineated in their ABMS board certification and/or
covered by AMA Core Principle #7. AOA certified or eligible physicians who perform surgical procedures
within the accredited facility may perform only those surgical procedures delineated in their AOA Board
Certification and/or covered by AMA Core Principle #7. Podiatrists certified or eligible for certification
who perform surgical procedures with accredited facility may perform only those surgical procedures
delineated in their ABPS Board Certification and/or covered by AMA Core Principle #7. Oral and
maxillofacial surgeons certified or eligible for certification who perform surgical procedures with
accredited facility may perform only those surgical procedures delineated in their ABOMS Board
Certification and/or covered by AMA Core Principle #7.
The AMA Core Principle #7
(from AMA Resolution dated April, 2003):
“AMA Core Principal #7 - Physicians performing office-based surgery must be currently board
certified/qualified by one of the boards recognized by the American Board of Medical Specialties,
American Osteopathic Association, or a board with equivalent standards approved by the state medical
board. The surgery must be one that is generally recognized by that certifying board as falling within the
scope of training and practice of the physician providing the care.”
A,B,C-M,C
800.010.035
Each physician, podiatrist or oral and maxillofacial surgeon must currently be licensed by the state in which
they practice. Copies of each physician’s, podiatrist’s or oral surgeon’s current license must be maintained
on file in the facility.
A,B,C-M,C
800.010.040
Any change in the physician, podiatrist or oral and maxillofacial surgeon staff must be reported in writing
to the AAAASF Central Office within thirty days of such changes. Copies of the credentials of any new
staff, including their current medical license, ABMS Board Certification, AOA Board Certification or other
approved Boards, letter of eligibility or equivalent documentation for podiatrists, oral surgeons and current
documentation of hospital privileges or satisfactory explanation for the lack thereof must also be sent to the
AAAASF Central Office.
A,B,C-M,C
800.010.045
Any action affecting the current professional license of the facility director, a member of the medical staff,
a member of the physician pain management staff or other licensed facility staff must be reported in writing
to the AAAASF Central Office within ten days of the time the facility director becomes aware of such
action.
A,B,C-M,C
Anesthesiologist/CRNA
800.020.050
If anesthesiologists and/or CRNA’s participate in patient care at the facility, they are qualified for the
procedures they perform and their credentials have been verified.
B,C-M,C
800.020.055
Must be licensed or accredited by the state in which they practice.
B,C-M,C
800.020.060
Must be responsible for the administration of dissociative anesthesia with propofol, spinal or epidural
blocks, or general anesthesia and monitoring of all life support systems.
C-M,C
800.020.065
Ensure that all anesthesia equipment is in proper working order.
B,C-M,C
800.020.070
Anesthesiologist/CRNA can not function in any other capacity (e.g., surgical assistant or circulating nurse)
during the surgery.
C-M,C
800.020.075
Practitioners of Pain management would be required to meet all of the following criteria:
1. Have an M.D. or D.O. degree
2. Appropriate fellowship training in pain management
3. Possess ABMS Board certification in one of the following specialties: Anesthesiology, Physical
Medicine and Rehabilitation (PM&R), Psychiatry/Neurology
4. Possess a sub-specialty certification from the American Board of Anesthesiology
5. Have, or have held, hospital privileges from a hospital located within a 30 minute driving distance
concerning the applicable scope of practice for Pain Management
A,B,C-M,C
800.030.010
All operating suite personnel are under the immediate supervision of a registered nurse, a physician other
than the operating physician, or physician’s assistant.
B,C-M,C
800.030.015
Must meet acceptable standards as defined by their professional governing bodies, where applicable.
B,C-M,C
800.030.020
There is a regularly employed and licensed registered nurse, physician other than the operating surgeon, or
physician’s assistant designated as the person responsible for patient care in all areas of the facility, in
accordance with state law.
B,C-M,C
800.030.025
This person is responsible for the operation of the operating room suite and patient care areas.
B,C-M,C
800.40 Personnel Records
IMPORTANT: Employee information such as previous employment, health information (except state required
immunization and test) disabilities, employment and performance reviews are protected and of no interest to the
AAAASF inspector. However, the inspector does need to confirm that an adequate file is kept on each
romplyee related to the items listed below. Please have only this data available for each employee, separate
from the employee files.
800.040.010
There is a manual outlining personnel policies
A,B,C-M,C
800.040.015
The manual contains personnel policies and records which are maintained according to OSHA and HIPAA
guidelines.
A,B,C-M,C
800.040.020
IMPORTANT: Employee information must remain strictly confidential.
Individual or personal information such as previous employment, health information (except state required
immunization and tests), disabilities, performance reviews and employment are protected and of no interest
to the AAAASF inspector. However, the inspector does need to confirm that an adequate file is kept on
each employee relating to the items listed below. Please have only this data available for each employee,
separate from the employee files.
Personnel records should contain the following:
Any health problems of the individual which may be hazardous to the employee, other employees or
patients, and a plan of action or special precautions delineated as needed.
A,B,C-M,C
800.41
Resume of training and experience.
800.041.010
Resume of training and experience.
A,B,C-M,C
800.041.015
Current certification or license if required by the state.
A,B,C-M,C
800.041.020
Date of employment.
A,B,C-M,C
800.041.025
Description of duties.
A,B,C-M,C
800.041.030
Record of continuing education.
A,B,C-M,C
800.041.035
Inoculations or refusals.
A,B,C-M,C
800.42 Personnel records document training in the following:
Personnel records document training in the following:
800.042.010
Hazard safety training.
A,B,C-M,C
800.042.015
Blood borne pathogens.
A,B,C-M,C
800.042.020
Universal precautions.
A,B,C-M,C
800.042.025
Other safety training such as operation of a fire extinguisher.
A,B,C-M,C
800.042.030
At least Basic Cardiopulmonary Life Support (BCLS) certification, but preferably Advanced Cardiac Life
Support (ACLS) for each operating room and recovery room team member.
A,B,C-M,C
Knowledge, Skill & CME Training
800.050.010
The operating room personnel have knowledge to treat cardiopulmonary and anaphylactic emergencies. At
least one member of the operating room team, preferably the surgeon or the anesthesia care giver, holds
current ACLS certification.
A,B,C-M,C
800.050.015
The operating room personnel are familiar with equipment and procedures utilized in the treatment of the
above emergencies.
A,B,C-M,C
800.050.020
If a gas sterilizer is used, personnel are thoroughly familiar with the operating instructions.
A,B,C-M,C
Personnel Safety
800.060.010
If a gas sterilizer is used, appropriate personnel are badge tested to insure that there is no significant
ethylene oxide exposure.
A,B,C-M,C
800.060.015
Personnel are properly trained in the control procedures and work practices that have been demonstrated to
reduce occupational exposures to anesthetic gases.
C
800.060.020
There is a written policy for what is considered to be personal protective equipment for specific tasks in the
facility (e.g., instrument cleaning, disposal of biological waste, surgery, etc.).
A,B,C-M,C
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900 ANESTHESIA
900.000.010
Delivery of Anesthesia
900.000.015
All anesthetics other than topical or local anesthetic agents are delivered by either an anesthesiologist, or by
a CRNA (under physician supervision if required by state or federal law or by a policy adopted by the
facility), or by an anesthesiology assistant as certified by the National Commission for the Certification of
Anesthesiologist Assistants under direct supervision of an anesthesiologist. Parenteral sedation, other than
propofol, may be administered by a registered nurse under the supervision of a qualified physician.
B,C-M,C
900.000.020
The physician responsible for supervising the administration of anesthesia must have knowledge of
anesthetics and resuscitative techniques. Podiatrists and oral surgeons must use an anesthesiologist, or a
supervising physician to administer anesthesia.
B,C-M,C
900.10
The following anesthesia standards apply to all patients who receive anesthesia or sedation/analgesia. In
extreme emergencies or life-threatening circumstances, these standards may be modified, and all such
circumstances should be documented in the patient’s record.
900.010.005
If children are operated upon in the facility, there should be a written policy defining the unique and perioperative
care of pediatric patients. This is based upon considerations of age, risk categories, surgery,
facility equipment and capability.
900.010.010
Written policy for pediatric patients is available and current.
A,B,C-M,C
900.010.015
A physician is responsible for determining the medical status of the patient and must examine the patient
immediately before surgery and must:
A,B,C-M,C
900.010.020
Verify that an anesthesia care plan has been developed and documented.
A,B,C-M,C
900.010.025
Verify that the patient or a responsible adult has been informed about the anesthesia care plan.
A,B,C-M,C
900.010.030
A physician must be present when any anesthesia, other than local anesthesia, is administered.
B,C-M,C
900.010.035
The anesthesia care plan is based on:
A review of the medical record.
A,B,C-M,C
900.010.040
Medical history.
A,B,C-M,C
900.010.045
Prior anesthetic experiences.
A,B,C-M,C
900.010.050
Drug therapies.
A,B,C-M,C
900.010.055
Medical examination and assessment of any conditions that might affect the preoperative risk.
A,B,C-M,C
900.010.060
A review of the medical tests and consultations.
A,B,C-M,C
900.010.065
A determination of preoperative medications needed for anesthesia.
A,B,C-M,C
900.010.070
Providing preoperative instructions.
A,B,C-M,C
900.20 Anesthetic Monitoring
Continual is defined as "repeated regulary and frequently in steady, rapid succession", whereas continuous
means "prolonged without interruption at any time."
900.020.005
Continual is defined as “repeated regularly and frequently in steady, rapid succession,” whereas continuous
means “prolonged without any interruption at any time.”
900.020.015
If responsible for supervising anesthesia or providing anesthesia, the qualified physician must be present in
the operating suite throughout the anesthetic.
Patient monitoring during anesthesia will consist of:
Oxygenation:
B,C-M,C
900.020.020
Assessment by O2 analyzer if an anesthesia machine is used during general anesthesia. The anesthesia
machine has an alarm for low O2 concentration.
C
900.020.025
Pulse oximetry.
B,C-M,C
900.22 Circulation Monitoring
900.022.010
900.022.015
Continuous EKG during surgery.
B,C-M,C
900.022.020
Blood pressure.
B,C-M,C
900.022.025
Heart rate every 5 minutes (minimum).
B,C-M,C
900.022.030
Pulse oximetry.
B,C-M,C
900.022.035
Heart auscultation.
C-M,C
900.022.040
Intra-arterial pressure.
C-M,C
900.022.045
Ultrasound peripheral pulse monitor, pulse plethysmography or oximetry.
C-M,C
900.022.050
Temperature should be monitored when clinically significant changes in body temperature are expected.
C-M,C
900.022.055
“Forced air warmers,” blanket warmers, or other devices are used to maintain patient temperature.
C-M,C
Transfers/Emergencies
900.031.015
Anesthesia personnel should review and be familiar with the facility’s emergency protocol for cardiopulmonary
emergencies and other internal and external disasters.
A,B,C-M,C
900.031.020
Anesthesia personnel should be trained and knowledgeable about the facility’s protocols for safe and timely
transfer of a patient to an alternative care facility when extended or emergency services are required.
B,C-M,C
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