Procedural Standards and Checklist for Accreditation of Ambulatory Facilities

Transcription

1 Procedural Standards and Checklist for Accreditation of Ambulatory Facilities AMERICAN ASSOCIATION FOR ACCREDITATION OF AMBULATORY SURGERY FACILITIES, INC.

2 AMERICAN ASSOCIATION FOR ACCREDITATION OF AMBULATORY SURGERY FACILITIES, INC. Procedural Standards and Checklist for Accreditation of Ambulatory Surgery Facilities Version 3 August Revised Publication 2008 and 2010 American Association for Accreditation of Ambulatory Surgery Facilities, Inc. 1

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4 TABLE OF CONTENTS Page # Facility Identification 5 Current Staff Identification 7 The AAAASF Procedural Facility Accreditation Program 13 Definition of AAAASF Facility Classes 17 Facility Director s Attestation 21 AAAASF Procedural Program Standards Section # 100 Basic Mandates Procedure Room Policy, Environment and Procedures Post-Anesthetic Procedure Recovery Area General Safety in the Facility IV Fluids and Medications Medical Records Quality Assessment / Quality Improvement Personnel Anesthesia 81 Answer Sheets 3

6 AAAASF FACIILTY IDENTIFICATION FORM Washington Street P.O. Box 9500 Gurnee, IL No Information Changes Facility Identification Number Information Changes Noted Below Facility Class: CLASS A CLASS B CLASS C-M CLASS C (Check one) Name of Facility Name of Facility Director (must be M.D. or D.O.) Name of Office Manager or Head Nurse Address Suite City State Zip Phone Fax Website Name of Facility Owner, Controlling Stockholder and/or Beneficial Ownership (List additional names on separate sheet) Facility Licensure Date Not Previously Accredited by Other Accrediting Organization Previously Accredited by Other Accrediting Organization Name(s) of Other Organization: Initial Inspection Date Class Last Re- Inspection Date Class X Facility Director s Signature 5 Date

8 AAAASF CURRENT STAFF IDENTIFICATION FORM Washington Street P.O. Box 9500 Gurnee, IL Please list all practitioners performing any procedures in the facility Name of Practitioner (Please Indicate Credentials - M.D., D.O., M.D./D.D.S., D.P.M.) State Medical License # Specialty(s) ABMS/AOABOS Certifying Board Year Certified or Year Eligible Local Accredited or Licensed Acute Care Hospital at Which Doctor Has Current Admitting Privileges Department or Section Has or has held unrestricted privileges in their specialty at an accredited or licensed acute care hospital within 30 minutes of this facility for all procedures that they perform at this facility? NO YES List Hospital(s) Name of Practitioner (Please Indicate Credentials - M.D., D.O., M.D./D.D.S., D.P.M.) State Medical License # Specialty(s) ABMS/AOABOS Certifying Board Year Certified or Year Eligible Local Accredited or Licensed Acute Care Hospital at Which Doctor Has Current Admitting Privileges Department or Section Has or has held unrestricted privileges in their specialty at an accredited or licensed acute care hospital within 30 minutes of this facility for all procedures that they perform at this facility? NO YES List Hospital(s) 7

14 The AAAASF Procedural Facility Accreditation Program The American Association for Accreditation of Ambulatory Surgery Facilities, Inc. (AAAASF) conducts a procedural facility accreditation program that verifies that a facility meets nationally recognized safety standards. The procedural facility accreditation program is conducted by physicians and nurses who determine the standards under the direction of a Board of Directors. The procedural facility accreditation is intended for ambulatory facilities performing procedures under sedation in which therapeutic and diagnostic procedures are carried out, which would include gastroenterologists, urologists, gynecologists, pain management physicians, and others. These procedures may include minimally invasive procedures and minor surgical procedures. (e.g. Intra-oral maxillo-facial procedures, minor urological procedures to include circumcisions, vasectomies, etc.) The AAAASF strives for the highest standards of excellence for its facilities by regularly revising and updating its requirements for patient safety and quality of care. Both procedural and surgical standard facilities are accredited in classes (A-C) determined by anesthesia criteria. Basic Mandates Patients receiving anesthetic agents other than topical or local anesthesia should be supervised in the immediate post discharge period by a responsible adult for at least hours, depending on the procedure and anesthesia used. Changes in facility ownership must be reported to the AAAASF Office within thirty (30) days of the change. Any death occurring in an accredited facility, or any death occurring within thirty (30) days of a procedure performed in an accredited facility, must be reported to the AAAASF office within five (5) business days after the facility is notified or otherwise becomes aware of that death. In addition to this notification, the death must also be reported as an unanticipated procedure sequela in the semi-annual Peer Review report. In the event of a death occurring within thirty (30) days of a procedure done in an AAAASF accredited facility, an unannounced inspection may be done by a senior inspector. The facility director is responsible for establishing and enforcing policies that protect patients. The director monitors all members of the medical and facility staff for compliance with this policy. AAAASF Patient s Bill of Rights should be posted, followed and promoted. All individuals using the facility must meet one of the following criteria (throughout this document the terms physician, medicine and medical apply to both M.D. and D.O. degrees): 1. A physician certified or eligible for certification by one of the member boards of the American Board of Medical Specialties (ABMS). 2. A Doctor of Osteopathy certified or eligible for certification by the American Osteopathic Association Bureau of Osteopathic Specialists (AOABOS). All physicians practicing in an AAAASF accredited facility must hold, or must demonstrate that they have held, unrestricted hospital privileges in their specialty at an accredited and/or licensed acute care hospital within thirty (30) minutes of the accredited facility for all procedures that they perform within the facility. Only procedures included in those hospital privileges may be performed within the AAAASF accredited facility. A physician must be present when anesthesia other than strictly local is being administered in Class B, Class C-M or Class C accredited facilities. If pediatric patients are treated in the facility, a minimum of one staff member who is PALS certified (Pediatric Advanced Life Support Course), must be present in the facility until all pediatric patients recovering from anesthesia have met criteria for discharge from the facility. Failure to adhere to the basic mandates of AAAASF will result in referral to the Investigations Committee. Sanctions by the Board of Directors may result in emergency suspension and revocation. 13

15 Pain Medicine (PM) is the medical discipline concerned with the diagnosis and treatment of the entire range of painful disorders. Because of the vast scope of the field, pain medicine is a multidisciplinary sub-specialty. The expertise of several disciplines is brought together in an effort to provide the maximum benefit to each patient. Although the care of patients is heavily influenced by the primary specialty of physicians who subspecialize in pain medicine, each member of the pain treatment team understands the anatomical and physiological basis of pain perception, the psychological factors that modify the pain experience, and the basic principles of pain medicine. (Reprinted from the 2009 American Board of Anesthesiology website.) 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 or the AOABOS 5. All physicians practicing in an AAAASF accredited facility must hold, or must demonstrate that they have held, unrestricted hospital privileges in their specialty at an accredited and/or licensed acute care hospital in the area of the accredited facility for all procedures that they perform within the facility. Only procedures included in those hospital privileges may be performed within the AAAASF accredited facility. 14

16 Onsite Inspection A facility is inspected every three years. The facility inspector will review any deficiencies with the facility director and forward the Standards and Checklist answer sheet to the AAAASF Central Office. To be accredited by AAAASF, a facility must meet every standard for its Class (A, B, C-M or C). Onsite Inspection Privacy Policy Onsite AAAASF Inspections typically involve the attention of the facility Medical Director, the anesthesia provider, and the facility staff working intently with the AAAASF surveyor(s). The inspection process must remain focused, and therefore, AAAASF has directed that equipment representatives not be present during AAAASF s announced or unannounced inspections/surveys. Accreditation consultants may be present during the surveys; however AAAASF asks that consultants remain silent during the inspection process until it is completed. All AAAASF surveyor(s) have the authority to request any participants to leave the inspection process if interference becomes a problem. AAAASF greatly appreciates the cooperation of all concerned parties by complying with this directive. Self-Evaluation Inspection A facility is evaluated by the facility director each year between inspections, and the Standards and Checklist answer sheet is sent to the AAAASF Office. A facility s AAAASF accreditation remains valid if it continues to meet every standard for its Class (A, B, C-M or C). Otherwise, accreditation is revoked. 15

17 Denial or Loss of Accreditation The AAAASF will deny or revoke accreditation of a facility if the facility fails to satisfy every standard for its Class (A, B, C-M or C), or if any physician performing procedures at the facility that: Has had their privileges to perform procedures restricted or limited by any hospital at which the physician has privileges, related to lack of clinical competence, ethical issues, or professional problems other than economic competition. Has been found to be in violation of the Code of Ethics of any professional medical society or association of which they are a member. Has had their right to practice medicine limited, suspended, terminated or otherwise affected by any state, province, or country, or if they have been disciplined by any medical licensing authority. Non-reporting of any of the above to the AAAASF. Hearing Any facility whose accreditation has been revoked or denied by the AAAASF has the right to a Hearing at which it may present such information as it deems advisable to show that it has satisfied the requirements for accreditation. The Hearing process is described in the AAAASF Bylaws available from the AAAASF Central Office. Emergency Suspension or Emergency Probation The AAAASF may place a facility on Emergency Suspension or Emergency Probation status upon receiving information that a state medical or osteopathic board has taken action, or begun formal proceedings which may result in it taking action against a license held by a physician practicing at the facility, or the Board of Directors determining that the facility may no longer meet AAAASF standards for accreditation. A facility that has been placed on Emergency Suspension or Emergency Probation status will remain in such status pending an investigation and possible Hearing, conducted in accordance with AAAASF procedures that are available from the AAAASF Central Office. 16

18 Definitions of Facility Classes Class A: In a Class A Facility, all endoscopic and/or pain management procedures may be performed under the following anesthesia: 1. Topical Anesthesia 2. Local Anesthesia If oral medications are used, only minimal and moderate sedation levels are permitted in Class A Facilities. Class A Facilities must meet all Class A standards. Class B: In a Class B Facility, all endoscopic and/or pain management procedures may be performed under the following anesthesia: 1. Topical Anesthesia 2. Local Anesthesia 3. Parenteral Sedation 4. Regional Anesthesia 5. Dissociative Drugs (excluding Propofol) Agents 3 thru 5 may be administered by: - A Physician - A Certified Registered Nurse Anesthetist (CRNA) under physician supervision if required by state or federal law, or by policy adopted by the facility - An Anesthesia Assistant (as certified by the National Commission for the Certification of Anesthesiologist Assistants) under direct supervision of an Anesthesiologist - A Registered Nurse, only under the supervision of a qualified physician The use of Propofol, Spinal Anesthesia, Epidural Anesthesia, Endotracheal Intubation Anesthesia, Laryngeal Mask Airway Anesthesia, and/or Inhalation General Anesthesia (including Nitrous Oxide) is prohibited in a Class B facility. Class B Facilities must meet all Class A and Class B standards. 17

19 Class C-M: In a Class C-M facility, all endoscopic and/or pain management procedures may be performed under the following anesthesia: 1. Topical Anesthesia 2. Local Anesthesia 3. Parenteral Sedation 4. Regional Anesthesia 5. Dissociative Drugs (including Propofol) 6. Spinal Anesthesia 7. Epidural Anesthesia Agents 3 thru 5 may be administered by: - A Physician - A Certified Registered Nurse Anesthetist (CRNA) under physician supervision if required by state or federal law, or by policy adopted by the facility - An Anesthesia Assistant (as certified by the National Commission for the Certification of Anesthesiologist Assistants) under direct supervision of an Anesthesiologist - A Registered Nurse only under the supervision of a qualified physician (excluding Propofol) Propofol, Spinal Anesthesia and Epidural Anesthesia may be administered only by: A - CRNA (under physician supervision if required by state or federal law or by policy adopted by the facility) - An Anesthesia Assistant (as certified by the National Commission for the Certification of Anesthesiologist Assistants) under direct supervision of an Anesthesiologist - An Anesthesiologist The use of Endotracheal Intubation Anesthesia, Laryngeal Mask Airway Anesthesia, and/or Inhalation General Anesthesia (including Nitrous Oxide) is prohibited in a Class C-M facility. Class C-M facilities must meet all Class A, Class B, and Class C-M standards. 18

20 Class C: In a Class C facility all endoscopic, and/or pain management procedures may be performed under the following anesthesia: 1. Topical Anesthesia 2. Local Anesthesia 3. Parenteral Sedation 4. Regional Anesthesia 5. Dissociative Drugs (including Propofol) 6. Epidural Anesthesia 7. Spinal Anesthesia 8. General Anesthesia (with or without Endotracheal Intubation or Laryngeal Mask Airway Anesthesia) Agents 3 thru 5 may be administered by: - A Physician - A Certified Registered Nurse Anesthetist (CRNA) under physician supervision if required by state or federal law, or by policy adopted by the facility - An Anesthesia Assistant (as certified by the National Commission for the Certification of Anesthesiologist Assistants) under direct supervision of an Anesthesiologist - A Registered Nurse only under the supervision of a qualified physician (excluding Propofol) Propofol and agents 6 through 8 may be administered only by: - A Certified Registered Nurse Anesthetist (CRNA) under physician supervision if required by state or federal law, or by policy adopted by the facility - An Anesthesia Assistant (as certified by the National Commission for the Certification of Anesthesiologist Assistants) under direct supervision of an Anesthesiologist - An Anesthesiologist Class C facilities must meet all Class A, Class B, Class C-M, and Class C standards. 19

21 Important Notice Maximal patient safety has always been our guiding concern. We are proud that our Standards may be considered the strongest of any agency that accredits ambulatory surgery facilities, and that many consider them to be the Gold Standard. We recognize, however, that they need to be part of a living document, and we continually re-evaluate and revise these Standards in the light of medical advances and changing legislative guidelines. The AAAASF Accreditation Program requires 100% compliance with each Standard to become and remain accredited. There are no exceptions. However, when a Standard refers to appropriate or proper or adequate, reasonable flexibility and room for individual consideration by the inspector is permitted as long as patient and staff safety remain uncompromised. Definition Adequate is meant to encompass size, space, maintenance, cleanliness, free of clutter, lighting, appropriately equipped, etc. The facility director must attest that the facility meets all local, state, and federal regulations, since such governmental regulations may supersede AAAASF Standards. Please note, however, that the stricter regulation applies, whether it is the federal, state, local, or AAAASF standard. Please complete and sign the following Facility Director s Attestation document and return it to the AAAASF office. 20

22 Facility Director s Attestation As director of the (name of facility), located at, I attest that this facility meets all applicable local, state and federal zoning, licensure and construction codes and regulations, including Certificate of Need requirements and laboratory regulations if mandated. I further acknowledge that wherever governmental regulations or codes differ from AAAASF Standards, the stricter rule is applicable. Facility director s signature Date Print name of facility director Return this signed and completed form to: AAAASF P.O. Box 9500 (mailing address) Gurnee, IL Toll-free: Phone: Fax:

24 The following Standards are the property of the Association For Accreditation of Ambulatory Surgery Facilities, Inc. Unauthorized use in prohibited. Copyright 2011 American Association For Accreditation of Ambulatory Surgery Facilities, Inc. All rights reserved. AAAASF P.O. Box 9500 (mailing address) Gurnee, IL Toll-free: Phone: Fax: Web: FOR THE SURVEYOR VERSION ONLY Each Standard Question Must Have a Response! If a standard for the Class (A, B, C-M or C) does not apply to the situation in this facility, indicate such by marking N/A on the answer sheet. Each numbered Standard question in this booklet must have a response. If a Standard for a facility does not apply to the situation in the facility, the inspector must indicate such by marking N/A on the answer sheet. For every N/A, there must be an explanation noted by the inspector on the answer sheet to justify that response. All NO answers should be discussed with the facility director or appropriate staff, and the inspector should make recommendations as to how the deficiencies should be corrected. 23

26 100 Basic Mandates Basic Mandates and Facility Classifications Patients receiving anesthetic agents other than topical or local anesthesia should be supervised in the immediate post discharge period by a responsible adult for at least hours, depending on the procedure and anesthesia used Changes in facility ownership must be reported to the AAAASF office within thirty (30) days of the change Any death occurring in an accredited facility, or any death occurring within thirty (30) days of a procedure performed in an accredited facility, must be reported to the AAAASF office within five (5) business days after the facility is notified or otherwise becomes aware of that death. In addition to this notification, the death must also be reported as an unanticipated procedure sequela in the semi-annual Peer Review report. In the event of a death occurring within thirty (30) days of a procedure done in an AAAASF accredited facility, an unannounced inspection may be done by a senior inspector AAAASF Patient s Rights should be posted, followed and promoted All practitioners using the facility must meet one of the following criteria (throughout this document the terms physician, medicine and medical apply to both M.D. and D.O.): 1. A physician certified or eligible for certification by one of the member boards of the American Board of Medical Specialties (ABMS). 2. A Doctor of Osteopathy certified or eligible for certification by the American Osteopathic Association Bureau of Osteopathic Specialists (AOABOS). 25

27 100 Basic Mandates The facility director is responsible for establishing and enforcing policies that protect patients. The director monitors all members of the medical and facility staff for compliance with this policy All physicians practicing in an AAAASF accredited facility must hold, or must demonstrate that they have held, unrestricted hospital privileges in their specialty at the nearest accredited and/or licensed acute care hospital in the area of the accredited facility for all procedures that they perform within the facility. Only procedures included in those hospital privileges may be performed within the AAAASF accredited facility. A physician must be present when anesthesia other than strictly local is being administered in Class B, Class C-M or Class C accredited facilities Onsite AAAASF Inspections typically involve the attention of the facility Medical Director, the anesthesia provider, and the facility staff working intently with the AAAASF surveyor(s). The inspection process must remain focused, and therefore, AAAASF has directed that equipment representatives not be present during AAAASF s announced or unannounced inspections/surveys. Accreditation consultants may be present during the surveys; however AAAASF asks that consultants remain silent during the inspection process until it is completed. All AAAASF surveyor(s) have the authority to request any participants to leave the inspection process if interference becomes a problem. AAAASF greatly appreciates the cooperation of all concerned parties by complying with this directive A Class A: In a Class A Facility, all endoscopic and/or pain management procedures may be performed under the following anesthesia: 1. Topical Anesthesia 2. Local Anesthesia If oral medications are used, only minimal and moderate sedation levels are permitted in Class A Facilities. Class A Facilities must meet all Class A standards. 26

28 100 Basic Mandates B Class B: In a Class B Facility, all endoscopic and/or pain management procedures may be performed under the following anesthesia: 1. Topical Anesthesia 2. Local Anesthesia 3. Parenteral Sedation 4. Regional Anesthesia 5. Dissociative Drugs (excluding Propofol) Agents 3 thru 5 may be administered by: A Physician A Certified Registered Nurse Anesthetist (CRNA) under physician supervision if required by state or federal law, or by policy adopted by the facility An Anesthesia Assistant (as certified by the National Commission for the Certification of Anesthesiologist Assistants) under direct supervision of an Anesthesiologist A Registered Nurse, only under the supervision of a qualified physician The use of Propofol, Spinal Anesthesia, Epidural Anesthesia, Endotracheal Intubation Anesthesia, Laryngeal Mask Airway Anesthesia, and/or Inhalation General Anesthesia (including Nitrous Oxide) is prohibited in a Class B facility. Class B Facilities must meet all Class A and Class B standards. 27

29 100 Basic Mandates C-M Class C-M: In a Class C-M facility, all endoscopic and/or pain management procedures may be performed under the following anesthesia: 1. Topical Anesthesia 2. Local Anesthesia 3. Parenteral Sedation 4. Regional Anesthesia 5. Dissociative Drugs (including Propofol) 6. Spinal Anesthesia 7. Epidural Anesthesia Agents 3 thru 5 may be administered by: A Physician A Certified Registered Nurse Anesthetist (CRNA) under physician supervision if required by state or federal law, or by policy adopted by the facility An Anesthesia Assistant (as certified by the National Commission for the Certification of Anesthesiologist Assistants) under direct supervision of an Anesthesiologist A Registered Nurse only under the supervision of a qualified physician (excluding Propofol) Propofol, Spinal Anesthesia and Epidural Anesthesia may be administered only by: A CRNA (under physician supervision if required by state or federal law or by policy adopted by the facility) An Anesthesia Assistant (as certified by the National Commission for the Certification of Anesthesiologist Assistants) under direct supervision of an Anesthesiologist An Anesthesiologist The use of Endotracheal Intubation Anesthesia, Laryngeal Mask Airway Anesthesia, and/or Inhalation General Anesthesia (including Nitrous Oxide) is prohibited in a Class C-M facility. Class C-M facilities must meet all Class A, Class B, and Class C-M standards. 28

30 100 Basic Mandates C Class C: In a Class C facility all endoscopic, and/or pain management procedures may be performed under the following anesthesia: 1. Topical Anesthesia 2. Local Anesthesia 3. Parenteral Sedation 4. Regional Anesthesia 5. Dissociative Drugs (including Propofol) 6. Epidural Anesthesia 7. Spinal Anesthesia 8. General Anesthesia (with or without Endotracheal Intubation or Laryngeal Mask Airway Anesthesia) Agents 3 thru 5 may be administered by: A Physician A Certified Registered Nurse Anesthetist (CRNA) under physician supervision if required by state or federal law, or by policy adopted by the facility An Anesthesia Assistant (as certified by the National Commission for the Certification of Anesthesiologist Assistants) under direct supervision of an Anesthesiologist A Registered Nurse only under the supervision of a qualified physician (excluding Propofol) Propofol and agents 6 through 8 may be administered only by: A Certified Registered Nurse Anesthetist (CRNA) under physician supervision if required by state or federal law, or by policy adopted by the facility An Anesthesia Assistant (as certified by the National Commission for the Certification of Anesthesiologist Assistants) under direct supervision of an Anesthesiologist An Anesthesiologist Class C facilities must meet all Class A, Class B, Class C-M, and Class C standards. 29

31 100 Basic Mandates 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. 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. The physician's hospital has the right to limit the type of procedures the physician may perform within the specified scope of practice. This limitation will apply to the AAAASF certified facility as well. Granting of hospital privileges outside the scope of training and practice recognized by the individual practitioner certifying board will not apply to the AAAASF accredited facility 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 or the AOABOS 5. All physicians practicing in an AAAASF accredited facility must hold, or must demonstrate that they have held, unrestricted hospital privileges in their specialty at an accredited and/or licensed acute care hospital in the area of the accredited facility for all procedures that they perform within the facility. Only procedures included in those hospital privileges may be performed within the AAAASF accredited facility. 30

32 100 Basic Mandates Practitioners of Interventional Radiology would be required to meet all of the following criteria: 1. M.D. or D.O. 2. Board certification by the American Board of Radiology 3. Fellowship training as approved by the American Board of Radiology 4. Current certificate of added qualifications in Interventional/Vascular Radiology 5. All physicians practicing in an AAAASF accredited facility must hold, or must demonstrate that they have held, unrestricted hospital privileges in their specialty at an accredited and/or licensed acute care hospital in the area of the accredited facility for all procedures that they perform within the facility. Only procedures included in those hospital privileges may be performed within the AAAASF accredited facility. 31

33 200 PROCEDURE ROOM POLICY, ENVIRONMENT AND PROCEDURES Written Policies A policy for a procedure pause or a time out protocol is in place and practiced prior to every procedure. This protocol should include: Pre-procedure verification process to include medical records and imaging studies to be reviewed by the procedure room team. Missing information or discrepancies must be addressed at this time. Marking the procedure site where appropriate Procedures must include site marking for any procedure that involves laterality, or multiple structures (ovaries, eyes, fingers, toes, etc.) must be marked while the patient is awake and aware, if possible. The person performing the procedure should do the site marking. The site must be marked so that the mark will be visible after the surgical area(s) has been prepped and draped. Time Out immediately before starting the procedure - Conduct a final verification by at least two (2) members of the procedure team confirming the correct patient, procedure, site marking(s) and, as applicable, special equipment or requirements. As a fail-safe measure, the procedure is not started until any and all questions or concerns are resolved Environment The facility displays a professional appearance in keeping with a medical facility designed to carry out procedures. The facility must be neat, comfortable and clean and should include a waiting area, business office and sanitary lavatory facilities. One or more dedicated exam rooms must be available that provide for privacy and treatment in a sanitary, orderly environment There is a room dedicated for use as a procedure room A An exam room may function as a procedure room. 32

34 200 PROCEDURE ROOM POLICY, ENVIRONMENT AND PROCEDURES The procedure room(s) is adequately ventilated and temperature controlled There is adequate procedure room storage space to hold equipment, supplies and medications. Storage space should be adequate to minimize the need to leave the procedure room for frequently used supplies, equipment and/or medications Storage space provides easy access for identification and inventory of supplies The procedure room(s) is properly cleaned, maintained and free of litter and clutter Each procedure room is of a size adequate to allow for the presence of all equipment and personnel necessary for the performance of the procedures, and must comply with applicable local, state or federal requirements. There must be ample clear space on each side of the procedure 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 procedure room space available There are no overloaded wall plugs or extension cords in use, no altered grounding plugs in use, and wires are not broken, worn or unshielded. 33

35 200 PROCEDURE ROOM POLICY, ENVIRONMENT AND PROCEDURES Unauthorized individuals are deterred from entering the procedure room by locks, alarms, or facility personnel Sterile supplies are stored away from potential contamination in closed cabinets/drawers or if not, away from heavy traffic areas Sterile supplies are labeled to indicate sterility, and are packaged and sealed to prevent accidental opening 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 be labeled to identify in which autoclave it was sterilized If one sink is used both for dirty instruments and to scrub for procedures, there is a written policy to clean and disinfect the sink prior to scrubbing hands Procedures - Sterilization The facility has at least one autoclave which uses high pressure steam and heat, or all sterile items are single use disposable. 34

36 200 PROCEDURE ROOM POLICY, ENVIRONMENT AND PROCEDURES Gas sterilizers and automated endoscope reprocessors (AER) must be vented as per manufacturer s specifications All instruments used in patient care are sterilized, where applicable A room with acceptable ventilation and space that is separate from the procedure room is required for reprocessing of scopes. If the facility is unable to use two separate rooms they must be able to document that they are using a closed reprocessing system with ventilation that exchanges the room air times per hour or an active charcoal filtration system is in place. All situations must meet requisite standards (OSHA, CDC, Federal, State, etc.) for air exchange ratios and vapor particle standards A written protocol is in place and followed that specifically addresses and requires enumerated steps to accomplish the below goals: - The cleaning of the scope. The location of the manual rinsing and cleaning of endoscopes prior to HLD may be carried out in the procedure room away from the patient. Specific steps must be in place to minimize spraying and aerosolizing of the bio-burden. - Processing of the scopes must be in the location that meets requisite standards of air exchange ratios and vapor particle standards. For example, a room that is separate from the procedure room is required for manual HLD reprocessing of endoscopes. This room must be adequate sized and segregated from patient and staff. Necessary protective equipment for personnel performing this function must be included in the protocol as well as readily available. - Scope cleaning functions should be limited to properly trained personnel. - If there is not a separate room (see previous standard) being utilized for processing of the scopes, then the protocol must include steps that directs that the contaminated equipment will be cleaned and placed in the reprocessor prior to bringing the next patient into the room. In addition, the clean scope coming out of the reprocessor is to be removed only when the room is clean and free of dirty instruments. - Cross contamination should be avoided no matter where cleaning and processing takes place. There must always be some distinct type of separation of clean and dirty areas in any location. - Clean (reprocessed) endoscopes should be stored in a closed cabinet exclusively dedicated for scope storage to avoid contamination prior to use. 35

37 200 PROCEDURE ROOM POLICY, ENVIRONMENT AND PROCEDURES 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 manufacturer s recommendations for usage should be followed Monitoring records are retained for the sterilization or other disinfection process and should be reviewed and stored for a minimum of three (3) years A weekly spore test, or its equivalent, is performed on each autoclave and the results filed and kept for three (3) years. The sterility of each load in the autoclave is checked with indicator tape, chemical monitors, or other effective means both on the outside and inside of the pack If a spore test is positive, there is a protocol for remedial action to correct the sterilization process. 36

38 200 PROCEDURE ROOM POLICY, ENVIRONMENT AND PROCEDURES Asepsis Instrument handling and reprocessing areas are cleaned and maintained There is strict segregation of dirty procedure equipment and instruments that have been cleaned and are in the preparation and assembly area A written protocol is present for the reprocessing all instruments and equipment used in patient care Between cases, the procedure room(s) is cleaned with disinfectants Personal protective equipment is available for all appropriate procedures Hand hygiene is performed in accordance with current CDC guidelines The facility policy manual should include infection control policies and procedures that are consistent with current CDC guidelines. 37

39 200 PROCEDURE ROOM POLICY, ENVIRONMENT AND PROCEDURES Reuse of single-use disposable biopsy forceps is strictly prohibited. Purchase records must be retained for 3 years and available for comparison to procedural and pathology specimen logs Maintenance and Cleaning The entire procedure room suite is cleaned and disinfected according to an established schedule adequate to prevent cross-contamination All blood and body fluid spills are cleaned using germicides that are virucidal, bactericidal, tuberculocidal and fungicidal A written protocol has been developed for use by housekeeping personnel for cleaning of floors, tables, walls, ceilings, counters, furniture and fixtures of the procedure suite All openings to outdoor air are effectively protected against the entrance of insects, animals, etc Surfaces 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. 38

40 200 PROCEDURE ROOM POLICY, ENVIRONMENT AND PROCEDURES Equipment 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 Only inspected equipment is used in the procedure room The equipment s specifications are kept in an organized file All equipment is on a 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 All equipment repairs and changes are done by a bio-medical technician with records kept for a minimum of three (3) years There is an adequate procedure room table or chair The procedure room is provided with adequate lighting in the ceiling. 39

41 200 PROCEDURE ROOM POLICY, ENVIRONMENT AND PROCEDURES Procedure Room Equipment List Self inflating (Ambu ) bags, if used, are capable of delivering positive pressure ventilation with oxygen A reliable source of oxygen, adequate for the length of the surgery (back up should consist of at least one full E cylinder). Back up oxygen source should have a regulator on it and be ready to use If a central source of piped oxygen is used, the system must meet all applicable codes Sufficient space to accommodate the necessary personnel, equipment and monitoring devices is available There is an adequate and reliable source of suction An EKG monitor with pulse read-out is present Pulse oximeters must be present in both the procedure room and recovery area if both rooms are being used simultaneously. 40

42 200 PROCEDURE ROOM POLICY, ENVIRONMENT AND PROCEDURES Blood pressure monitoring equipment is present 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 Oral and nasopharyngeal airways for each size of patient treated in the facility are present Nasopharyngeal airways are present Laryngoscope is present Endotracheal tubes are present Endotracheal stylet is present. 41

43 200 PROCEDURE ROOM POLICY, ENVIRONMENT AND PROCEDURES C If present, mechanical ventilator should have a continuous use device which indicates a disconnect from the O2 source via an audible signal When uni-polar electrocautery is used, a single use disposable grounding pad is used Medical Hazardous Waste 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 Used disposable sharp items are placed in puncture-resistant containers located close to the area in which they are used There is a written policy for cleaning of spills which may contain blood borne pathogens Emergency Power The procedure room has an emergency power source, (e.g., a generator or battery powered inverter), with capacity to operate adequate monitoring, anesthesia, procedure equipment, cautery and lighting for a minimum of thirty (30) minutes. If two of more procedure rooms are used simultaneously, an adequate emergency power source must be available for each procedure room. (OR in case of a power failure, the facility has back-up power on all monitoring equipment.) 42

44 200 PROCEDURE ROOM POLICY, ENVIRONMENT AND PROCEDURES The emergency power source is able to begin generating ample power to operate essential electrical equipment used in the procedure room within thirty (30) seconds of a power failure 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. 43

45 300 POST-ANESTHETIC PROCEDURE RECOVERY AREA Post-Anesthetic Recovery Area There is an adequate recovery area within the procedure suite The recovery area is equipped and readily accessible to handle emergencies 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 A separate pulse oximeter is available for each patient in the recovery area There is a recovery record that includes vital signs, sensorium, medications and nurse s notes The procedure room may be used for patient recovery if only one procedure is scheduled that day, or if the recovering patient meets all discharge criteria prior to beginning the next procedure, or if there is another procedure room available for the next procedure. 44

46 300 POST-ANESTHETIC PROCEDURE RECOVERY AREA Patients transferred to the post-anesthetic recovery area are accompanied by a member of the anesthesia team who is knowledgeable about the patient Patients transferred to the post-anesthetic recovery area will be continually evaluated and monitored as needed during transport Evaluation in the recovery area following an anesthetic procedure will include: Documentation of patient s time of arrival Assessment of the patient by the anesthesia recovery staff, as well as by a responsible physician Transmission of a verbal report on the patient to the recovery staff from a member of the anesthesia team who accompanies the patient Transfer of information concerning the pre-procedure condition of the patient and the procedure anesthesia course A member of the anesthesia team remains in the post-anesthesia area until the post-anesthesia care nurse accepts responsibility for the patient. 45

47 300 POST-ANESTHETIC PROCEDURE RECOVERY AREA A minimum of one ACLS certified staff member must be present in the facility until all patients recovering from anesthesia have met criteria for discharge from the facility. 46

48 300 POST-ANESTHETIC PROCEDURE RECOVERY AREA Discharge from the post-anesthetic procedure recovery area 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 recovery area Approved and standardized discharge criteria are used A physician determines that the patient meets discharge criteria based upon input from the post-anesthetic procedure recovery staff. That physician s name must be noted on the record Written instructions, including procedures for emergency situations, are given to an adult who is responsible for the patient s care and transportation following a procedure Unless a patient is having only local anesthesia, they must be discharged from the facility in the company of a responsible adult Personnel assist with discharge from the recovery area. 47

49 300 POST-ANESTHETIC PROCEDURE RECOVERY AREA Procedure Room Equipment List C 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 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 Adequate illumination for patients, machines and monitoring equipment, which can include battery powered illuminating systems Emergency cart is available with defibrillator, necessary drugs and other CPR equipment Quality of Care A licensed or qualified anesthesia provider supervising or providing care in the facility should participate in quality assurance and risk management in the facility The physician and the anesthesia provider should concur on the appropriateness of procedures performed at the facility. This is based on the medical status of the patients and qualifications of providers and facility resources. 48