Ambulatory surgical facility site review standards

During site visits, Priority Health will examine outpatient surgical facilities (OSF) using the following standards.

Classes of surgical facilities

Class B: Provides for minor or major surgical procedures performed in conjunction with oral, parenteral, or intravenous sedation or under analgesic or dissociative drugs.
Class C: Provides for major surgical procedures that require general or regional block anesthesia and support of vital bodily functions.

Facility standards

B, C
Each outpatient surgical facility (OSF) must have a physical plant adequate for its level of service. (J, D, S)

To reduce the risk of human injury.

B, C
There shall be a minimum of one adequately sized operating room that is used exclusively for surgery. A general treatment room is not adequate. (S)

The room will be designed and equipped for procedures to be performed, in a manner that protects the health and well being of all individuals in the area.

B, C
There must be an adequately sized recovery room or area separate from the rest of the public areas of the facility. (J, D, S)

For patient privacy, comfort and to allow for postoperative monitoring.

B, C
There must be adequate space, equipment, and personnel to provide aseptic treatment and prevention of cross-contamination among patients. (J, D, S)

To prevent the spread of infection and cross-contamination.

B, C
Suitable surgical lighting must be present, and an adequate emergency lighting source must be available. (J, D, S)

To prevent accidental injury.

B, C
Adequate resuscitation and monitoring equipment must be present. (J, S)

To provide treatment/monitoring during the perioperative period as well as in the event of a medical emergency.

B, C
Airways, endotracheal tubes, laryngoscope, oxygen capable of being delivered under positive pressure, suction equipment, and suitable resuscitative drugs. (S)

To provide treatment/monitoring during the perioperative period as well as in the event of medical emergency.

B, C
All room surfaces (including ceilings) must be smooth and washable. Acoustic ceiling tile is not acceptable. Tile flooring must be sealed. (D, S)

To prevent the spread of infection and cross-contamination.

B, C
Adequate scrub and toilet facilities must be present. (D, S)

Sinks should be equipped with wrist, knee or foot controls.

B, C
Fresh cloth or disposable towels must be available for each hand washing. (S)

Disposable paper towels are required. Towels should be in a dispenser or on a dispenser roll. Paper towels laid on the edge of the sink can become contaminated through dripping water from hand washing at the sink. Cloth towels must not be used in order to prevent cross-contamination.

B, C
Any opening to the outer air must be adequately controlled to prevent the entrance of insects. Ventilation and temperature must be adequately controlled. (J, D, S)

Appropriate ventilation and humidity control are provided in order to minimize the risk of infection, prevent the entrance of insects, and to provide for the safety of the patient.

B, C
Operating rooms are appropriately cleaned after each procedure. (J, S)

To prevent the spread of infection and cross-contamination.

B, C
All premises must be kept neat and clean and a cleaning schedule must be maintained that is adequate to prevent cross-contamination. (D, S)

To prevent the spread of infection and cross-contamination.

B, C
Acceptable standards of cleanliness and sterility must be adequate. (J,M,S)

To prevent the spread of infection and cross-contamination.

B, C
Appropriate monitoring equipment must be available: (J, S)

EKG oscilloscope (S)
Defibrillator - one per each procedure room?
If not, explain (location).
Continuous pulse oximeter with alarm - one per each procedure room?
If not, explain (location).
Blood pressure apparatus

To provide treatment/monitoring during the perioperative period as well as in the event of medical emergency.

C
As above with addition of oxygen analyzer with alarm and CO2 monitor. (S) B, C
Appropriate intravenous fluids and administration equipment must be available. (D, S)

To provide access for medications and for fluid replacement.

B, C
Appropriate post-operative observation and monitoring must be provided. (J, D, S)

To provide treatment/monitoring during the perioperative period as well as in the event of medical emergency.

B, C
Appropriate stretchers and wheelchairs must be available.

To facilitate patient transfers.

B, C
Dressing and lounge areas must be provided for surgical personnel that do not adversely affect the care of patients. (D, S)

To provide privacy and confidentiality of the patient/family. To provide a safe environment.

B, C
The facility must provide adequate patient and family waiting areas, examination rooms, and storage areas. (D, S)

To provide privacy and confidentiality of the patient/family. To provide a safe environment.

B, C
Corridors must be adequate to allow for ready passage of wheelchairs, stretchers, and emergency equipment. (D, S)

The Fire Marshall requires that corridors, hallways, and doorways are free from obstruction at all times so that a stretcher can be moved down the hallway in case of an emergency. In case of fire, exits and hallways must be clear so that time is not lost in evacuating the building. Nothing can be left in hallways that may obstruct the emergency exit path.

B, C
Smoking must be prohibited in surgical treatment areas.

To provide a safe environment.

B, C
An adequate emergency power source for surgical, anesthesia, and monitoring equipment must be available. (J, D, S)

To insure continuity of care and continuance of surgical preparation, procedure, and/or post-operative monitoring.

B, C All equipment must have periodic calibration and/or preventive maintenance. (S)

To insure equipment safety and accuracy. All equipment (monitoring lab, & emergency) should be calibrated and maintained according to the manufacturers' guidelines.

B, C
When an important opportunity to improve or a problem in the quality of care is identified, action is taken to improve the care or correct the problem. (J)

To correct aspects of care that would put a patient at risk or deprive them of care.

B, C
The findings, conclusions, recommendations, actions taken, and results of the actions taken are documented and reported through established channels. (J)

To correct aspects of care that would put a patient at risk or deprive them of care.

Exterior

Handicapped entrance (D)

An existing public facility, or facility used by the public, undergoing an alteration other than ordinary maintenance, after July 20, 1975, shall meet the barrier-free design requirements contained in the state construction code.

Parking adequate (D)

Adequate parking must be available to provide accessibility to the facility in a safe and convenient manner for all patients.

Handicapped marked parking space (D)

Part 4 of the Building Code rules from the Michigan Department of Labor, (1987) states that off street parking for 1-25 cars must include one (1) handicapped marked parking space.

Adequate lighting (D)

Proper lighting for safety in parking lots is necessary to ensure patient safety.

Adequate maintenance/cleaning (D)

Adequate maintenance/cleaning is necessary to ensure patient safety.

Elevator (D)

To promote patient accessibility.

Interior/general premises

Handicapped restroom with rails (D)

It is recommended that at least one public restroom have handicapped accessibility, with handrails, to allow for barrier free accessibility in a safe and convenient manner for all patients. An existing public facility or facility used by the public undergoing an alteration other than ordinary maintenance after July 20, 1975, shall meet the barrier free design requirements contained in the state construction code.

Exits clear (at least two) (D)

To provide safe exit in case of emergency.

Proper xtorage of toxic/hazardous/combustible materials (D)

Cleaning agents are potentially hazardous and should not be stored in exam rooms. They may leak and contaminate other items stored nearby and also pose a threat to small children. Cleaning supplies may be stored under sinks only in work areas or utility rooms.

All patient care supplies stored off the floor (D) 2-G

To prevent both contamination of patient supplies and injury due to accidents, patient care supplies are to be stored off the floor.

Gasses (D)

Oxygen
Properly stored
Other gasses
Properly stored

Compressed gasses, such as oxygen or nitrous, must be stored in stands built for that purpose or fastened to a strong wall or cabinet. Oxygen may be kept in a case made for that purpose. Compressed gasses are very volatile and may explode if tipped or if the "neck" of the tank is bent or broken.

Medical records stored away from patient care areas (D, N)

To ensure confidentiality.

Organized medical record-keeping system (N)

Medical records must be maintained in a manner that is current, detailed and organized, and permits effective and confidential patient care & quality review.

Release of confidential information (N)

Medical records that contain private and privileged information could be harmful to the member if the information is divulged for other than appropriate, approved purposes. A signed release of information needs to be obtained prior to releasing medical information in order to protect the member's privacy.

Written policies & procedures address confidentiality (N)

It is recommended that a written policy regarding confidentiality of patient information and records is maintained. Priority Health's policy on confidentiality is available upon request.

Surgical facility license posted Expiration date ___________ (D)

Must be readily accessible to be viewed by member or regulatory agencies.

Office equipment cleaning method acceptable, i.e., waiting room (J, D, S)

Priority Health recommends that toys be cleaned every day, or when they are played with, to decrease the spread of common viruses. A 1:100 bleach solution or Wescodyne, an effective nontoxic antiviral and antituberculodical agent, are suggested. Entrances and waiting rooms should be cleaned regularly, including floors and other horizontal surfaces.

Radiology/x-ray unit

License posted Expiration date ________________(D)

Must be readily accessible to be viewed by member or regulatory agencies.

RH-100 form posted (D)

Must be readily accessible to be viewed by member or regulatory agencies.

Registration tag on control panel (D)

To promote proper use of radiologic equipment, x-ray machines must be certified by State regulatory agencies. The license, RH 100 form "Warning to Employees", confirms that the machine is registered with the Division of Radiologic Health.

Part 5 of ionizing rules (D)

A copy of Radiology Rules must be posted or there should be a notice posted of where the rules may be found in the facility.

Warning sign for pregnant women (PH)

Priority Health recommends that a warning sign for pregnant women be posted near the x-ray machine.

Chest x-rays overread _____________ by ___________
The State of Michigan recommends that a reasonable percentage of x-rays be overread by a radiologist.

The State of Michigan recommends that a reasonable percentage of x-rays be overread by a radiologist.

Thoracic views overread _________________
by ___________________________________

Reader must be a board-certified or board-eligible radiologist.

Films outside area of expertise overread ______________________________
by _____________________________ (D, PH)

Reader must be a board-certified or board-eligible radiologist.

Arrangements must be in place for obtaining appropriate radiology services if not available on site (J, D, S)
By whom: _____________________________

Volume of type of services will determine the necessity for this.

Laboratory

License posted
Expiration date ___________________ (C)

Surgical facilities performing laboratory tests must be licensed by the State of Michigan. The CLIA license may be posted or placed in a file where it is readily accessible.

Lab reagents current (C)

To prevent the use of reagents that are beyond the manufacturer's known effective date.

Arrangements must be in place for obtaining appropriate laboratory services if not available on site (J, D, S)

Volume or type of services will determine necessity.

Routine lab by whom:
__________________________________

PCP selects the laboratory used.

Pathology by whom:
___________________________________

PCP selects the laboratory used.

Written policy specifying laboratory testing required for specific procedures. (D)

To show consistency of office procedures and labs that are required for proper preoperative preparation of the patient.

Pharmacy/medications

Medications stored away from patient care areas (except local anesthetics) (D)

All medications, except for injectable local anesthetic agents, must be stored away from patient care areas to ensure patient safety.

All medications current (D)

Medications that have passed the manufacturer's known expiration date are not considered safe for use in the treatment of patients.

Narcotics fouble-locked (D)

Sign-out sheet (D)
Restricted access to keys (D)

Double locking of narcotics (Class II - V medications) is a Federal regulation and must be adhered to by providers who maintain narcotics on site. Restricted access to keys is important to the doctor whose name is on the DEA license for (s)he is the one who may be audited. A log documenting narcotic administration is required and must include date, patient name, drug name, dosage, physician prescribing, and individual administering the narcotic. This helps to prevent potential abuse of narcotics and accounts for narcotics within the facility.

Medications requiring refrigeration are refrigerated (D)

Medications must be stored as the manufacturer's label requires (refrigerate when necessary), to ensure the integrity and effectiveness of the product. Medications requiring refrigeration must never be left on the counter during the day and simply refrigerated at night, no matter how convenient this may be for staff.

Thermometer in refrigerator (D)

Temperature checked twice caily and logged (D)

Temperature 36 - 46 degrees F. (D)

The optimal temperature for medications that require refrigeration is 36º-46º Fahrenheit or 2º-8º Centigrade. A thermometer should be placed in the refrigerator and a daily log maintained to monitor adequate temperature control.

Medications only in refrigerator (D)

Food and medications must never be stored in the same refrigerator to prevent cross contamination. There is no standard stating that laboratory specimens and medications should not be stored in the same refrigerator. It is strongly recommended that they not be stored together in the same refrigerator.

Pharmacy services under licensed pharmacist (D)
License expiration date
_________________

Pharmacy services or clinical pharmacy services, when provided, shall be under the control and direction of a licensed pharmacist.

Biomedical waste

Medical waste plan pesent (D)

All offices must have a medical waste plan. The plan should also be available for staff review. The Department regulates the management of medical waste to ensure that the public health and the environment are adequately protected.

Employee access to medical waste plan (D)

The plan should be available for staff review.

Syringes disposed of in puncture-proof containers (D)

Syringes, once used, must be disposed of in their entirety in the proper manner. Do not bend, break or remove the needle to prevent accidental needle puncture with contaminated needles. Place the entire syringe in a container that complies with the Michigan Medical Waste Regulatory Act.

All waste handled appropriately (D)

Medical waste needs to be disposed of in a covered container or bag that is color-coded or labeled.

Equipment/sterilization

Thermometers (D)

Glass

Glass thermometers, both oral and rectal, should be cleaned in soap and water and soaked in an approved sterilizing solution for longer than 30 minutes before being rinsed, dried and placed in the examination rooms for use. To prevent the spread of infection and cross-contamination.

Disposable Electronic/digital

Digital thermometers covered with a soft plastic sheath should be wiped with alcohol between uses. If a digital thermometer is covered with a hard plastic sheath, it is not necessary to wipe with alcohol between uses. To prevent the spread of infection and cross contamination.

Cleaning method/storage acceptable (D)

Oral and rectal thermometers should never be cleaned or stored together. To prevent the spread of infection and cross-contamination.

Autoclave supplies/instruments

Have date on package (D)

Weekly spore check documented
Heat-sensitive Indicators used (D)
Weekly log of indicators used (D)

Autoclaved supplies can be marked with either the date of sterilization OR the date of expiration, for time frames specified by individual office policy. Autoclaved supplies must be checked regularly for expiration of sterility. Sterility is maintained unless the integrity of the pack has been compromised by contact with moisture, dust accumulation or other pack integrity infractions. The Center for Disease Control recommends reprocessing the instruments at one year, even if the pack integrity has been maintained.

A live spore test must be done at least monthly and immediately after servicing. Priority Health, however, recommends weekly spore checks to ensure consistent sterilization. A record of spore tests must be maintained for one year.

Heat sensitive indicators must be used every time the autoclave is used. Results of the heat strip indicators should be documented at least weekly. A record must be maintained for one year.

Separate clean/dirty work areas (D)

To prevent the spread of infection and cross-contamination.

Instrument disinfectant labeled with type of solution (D)

All boats or pans of disinfectant or sterilizing solution must be labeled with the name of the solution each contains and the date that each was last changed, or needs to be changed. This prevents the use of improper or outdated solutions. A 2% glutaraldehyde solution is recommended.

Date solution last changed/needs to be changed (D)

To maintain solution efficacy.

Blood/body fluid compliance

Written exposure control plan (D)

To comply with OSHA's bloodborne pathogen standard, offices must develop a written exposure control plan detailing who in the office is at risk for exposure to blood borne pathogens, how to protect staff and patients from exposures, what to do in case of exposures, etc. Also, any training related to this OSHA standard must be documented. OSHA resource www.OSHA.gov.

Employees involved in direct patient care have been offered the hepatitis B vaccine at no charge (D)

Hepatitis B vaccines must be provided for employees who are at risk. If the employee declines the Hepatitis B vaccines, a signed declination form must be on file.

Documentation of annual employee training (D)

To comply with OSHA's bloodborne pathogen standard, offices must perform and document annual employee training.

Universal precautions (J, D, S)

Universal precautions should always be followed for the protection of patients and staff.

Gloves worn during blood/body fluid handling (D) Safety glasses/face masks/gowns available (D)

To comply with OSHA's bloodborne pathogen standard, gloves, face masks, gowns and safety glasses should be available to staff. Personal protection equipment decreases the risk of exposure to blood and body fluids.

MSDs sheets for non-household items (D)

Material Safety Data Sheet (MSDS) sheets must be obtained for all chemicals used in the office. An MSDS is a form that the supplier or manufacturer of a product must provide, upon request, describing the hazards of the product.

Written disaster plan for fire, explosion, or other emergency (D)

Demonstrates forethought and planning for emergencies.

Laundry handled appropriately (D)

OSHA prohibits employees from taking laundry home. Laundry must be done at the office or by a laundry service that has been contracted by the employer.

Administrative records

Administrative records Include:

Record of daily procedures (J, D, S)
Monthly statistics on numbers of procedures performed (J, D, S)
Transfers to hospital (J, D, S)

To insure regulatory agencies that only approved procedures are being performed.

To insure that patients are transferred immediately, appropriately, and in numbers that do not indicate a quality of care issue.

Transportation services

Immediate adequate transportation to Hospital; when indicated, physician or nurse shall accompany. (J, D, S) Must be within 30 minutes normal travel time to hospital and have written emergency arrangements. (D)

To insure that patients are transferred immediately, appropriately, and in numbers that do not indicate a quality of care issue.

Medical polices/rules

Written policies Written medical staff rules, regulations, policies shall be developed and adopted by staff. (i.e. Scrub policy, patient confidentiality, patient comfort, patient nourishment, registration, standing orders, transportation and disposal of surgical specimens, verbal orders) (J, D, S) {Hospital-owned facilities should follow hospital policy procedure}

To insure that the quality of care is being provided.

Patients' rights document available for patient review. (S)

A patients' rights document protects the practice and promotes quality of care. See Guidelines for Optimal Ambulatory Surgical Care and Office-based Surgery, Third Edition.

Personnel

B, C
The facility must be under the dupervision of a qualified surgeon. (S)

A qualified surgeon is a physician who has an unrestricted license to practice medicine and surgery in his or her locale, who has satisfactorily completed a training program recognized by the American Board of Medical Specialties (ABMS), or who has initiated or completed the process of becoming certified by an ABMS recognized board. He or she must also have admitting privileges at a hospital in the area where he or she can perform the same procedures that may be performed in an office surgery facility (OSF).

B, C
Freestanding surgical facilities must have an RN on premises until discharge. (D)

To provide the special skills and expertise necessary to supply and supervise all nursing care needs of patients.

B, C
A qualified physician shall be on premises during the post-operative period. (D, S)

To provide the special skills and expertise necessary to supply and supervise all medical needs of patients.

B, C
Staff licensing
All personnel such as nurses and technicians should be licensed in their respective fields. Any surgical technician not licensed must be under the immediate supervision of an MD or an RN. (J, D, S)

To insure that all staff is adequately trained and working under appropriate supervision or direction.

B, C
Surgeon licensing
All surgeons utilizing the facility must be duly licensed by the state, be eligible to take the surgical board examination, or be certified by an ABMS/AOA-recognized board. They must be practicing within the generally recognized scope of their specialty and must have privileges to perform similar procedures in a local accredited hospital or ambulatory care facility. (J, D, S)

B, C
Responsible manager
A responsible individual must be designated who will manage all areas of the surgical facility with respect to personnel, cleanliness, aseptic techniques, supplies, patient supervision, and so on. In B & C class facilities, this must be a person certified in operating room techniques such as an RN, LPN or registered surgical technologist, physician's assistant, or licensed vocational nurse. (J, D, S)

To maintain quality of care.

B, C
All surgical personnel must be trained in basic lfe support (CPR) and must be recertified as required by their community standard but no longer than three years. (S)

To provide an adequate level of care in case of a medical emergency.

B, C
All physicians must be ACLS-certified. (S)

To provide an adequate level of care in case of a medical emergency.

B, C
All surgical personnel must be trained in basic aseptic techniques. (J, D, S)

To prevent the spread of infection and cross-contamination.

B, C
All surgical personnel must wear suitable attire such as scrub suits, caps, masks, and shoe coverings, and protective eye wear. (S)

To prevent the spread of infection and cross-contamination.

B, C
Records of the educational training and experience background on each person granted privileges to perform surgery in the facility (D)

To insure that providers are adequately trained and experienced.

B, C
Nurse snesthetist/snesthesiologist sdministers snesthesia (PH)

To insure that providers are adequately trained and experienced.