Standard
|
Rationale |
FACILITY
STANDARDS
|
|
B, C
Each outpatient surgical facility (OSF) must have a physical plant
adequate for its level of service. (J, O, 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, O, 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, O, 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, O, 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. (O, S)
|
To prevent the spread of infection and
cross-contamination.
|
B, C
Adequate scrub and toilet facilities must be present. (O, 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, O, 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. (O, 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. (O, S)
|
To provide access for medications and for fluid
replacement.
|
B, C
Appropriate post-operative observation
and monitoring must be provided. (J, O,
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.
(O, 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. (O, 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. (O, 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, O, 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 |
return to top |
Handicapped Entrance (O)
|
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 (O)
|
Adequate parking must be available to provide
accessibility to the facility in a safe and convenient manner for all
patients. |
Handicapped Marked Parking Space (O)
|
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 (O)
|
Proper lighting for safety in parking lots is necessary
to ensure patient safety. |
Adequate Maintenance/Cleaning (O)
|
Adequate maintenance/cleaning is necessary to ensure
patient safety. |
Elevator (O)
|
To promote patient accessibility.
|
INTERIOR/GENERAL
PREMISES
|
return to top |
Handicapped Restroom with Rails (O)
|
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) (O)
|
To provide safe exit in case of emergency.
|
Proper Storage of Toxic/Hazardous/Combustible Materials
(O)
|
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 (O)
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 (O)
1. Oxygen
2. Properly Stored
3. Other Gasses _____________
4. 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 (O,
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 ___________ (O)
|
Must be readily accessible to be viewed
by member or regulatory agencies.
|
Office equipment cleaning method
acceptable, i.e., waiting room (J, O, 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 |
return to top |
License Posted.
Expiration Date ________________(O)
|
Must be readily accessible to be viewed
by member or regulatory agencies.
|
RH-100 Form Posted (O)
|
Must be readily accessible to be viewed
by member or regulatory agencies.
|
Registration Tag on Control Panel
(O)
|
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 (O)
|
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 _____________________________ (O, 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, O,
S)
By whom: _____________________________
|
Volume of type of services will
determine the necessity for this.
|
| LABORATORY |
return to top |
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, O, 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. (O)
|
To show consistency of office procedures
and labs that are required for proper preoperative preparation of the
patient.
|
| PHARMACY/MEDICATIONS |
return to top |
Medications Stored Away from Patient Care Areas (except
Local Anesthetics) (O)
|
All medications, except for injectable local anesthetic
agents, must be stored away from patient care areas to ensure patient
safety.
|
All Medications Current (O)
|
Medications that have passed the manufacturer's known
expiration date are not considered safe for use in the treatment of
patients.
|
Narcotics Double-Locked (O)
1. Sign-out sheet (O)
2. Restricted access to keys (O)
|
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
(O)
|
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 (O)
Temperature Checked Twice Daily and Logged (O)
Temperature 36 - 46 Degrees (O)
|
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 (O)
|
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 (O)
License expiration date
_________________
|
Pharmacy services or clinical pharmacy services,
when provided, shall be under the control and
direction of a licensed pharmacist.
|
| BIOMEDICAL
WASTE |
return to top |
Medical Waste Plan Pesent (O)
|
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 (O)
|
The plan should be available for staff review.
|
Syringes Disposed Of in Puncture-Proof Containers
(O)
|
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 (O)
|
Medical waste needs to be disposed of in a covered
container or bag that is color-coded or labeled.
|
| EQUIPMENT/STERILIZATION |
return to top
|
Thermometers (O)
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
(O)
|
Oral and rectal thermometers should never be cleaned or
stored together. To prevent the spread of infection and
cross-contamination.
|
AUTOCLAVE
SUPPLIES/INSTRUMENTS
|
return to top |
Have Date on Package (O)
Weekly Spore Check Documented
Heat-Sensitive Indicators Used (O)
Weekly Log of Indicators Used (O)
|
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
(O)
|
To prevent the spread of infection and
cross-contamination.
|
Instrument Disinfectant Labeled with
Type of Solution (O)
|
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
(O) |
To maintain solution efficacy.
|
BLOOD/BODY FLUID COMPLIANCE
|
return to top
|
Written Exposure Control Plan (O)
|
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
(O)
|
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 (O)
|
To comply with OSHA's bloodborne pathogen standard,
offices must perform and document annual employee training.
|
Universal Precautions (J, O, S)
|
Universal precautions should always be followed for the
protection of patients and staff.
|
Gloves Worn During Blood/Body Fluid
Handling (O)
Safety Glasses/Face Masks/Gowns Available (O)
|
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
(O)
|
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 (O)
|
Demonstrates forethought and planning for
emergencies.
|
Laundry Handled Appropriately (O)
|
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
|
return to top
|
Administrative Records Include:
Record of daily procedures (J, O, S)
Monthly statistics on numbers of
procedures performed (J, O, S)
Transfers to hospital (J, O, S)
|
To insure regulatory agencies that only approved procedures are being
performed.
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 |
return to top |
Immediate Adequate Transportation to Hospital;
when indicated, physician or nurse shall accompany. (J, O, S)
Must be within 30 minutes normal travel time to hospital and have
written emergency arrangements. (O)
|
To insure that patients are transferred immediately,
appropriately, and in numbers that do not indicate a quality of care
issue.
|
| MEDICAL
POLICIES/RULES |
return to top |
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, O,
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
|
return to top |
B, C
The Facility Must Be Under the Supervision 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. (O)
|
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. (O, 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, O, 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, O, 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
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, O, 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,
O, 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 Ggranted Privileges to Perform Surgery in the Facility
(O)
|
To insure that providers are adequately trained and
experienced.
|
B, C
Nurse Anesthetist/Anesthesiologist Administers Anesthesia (PH)
|
To insure that providers are adequately trained
and experienced.
|
