ASF ASC User Manual

AAAASF MEDICARE

Health

tandards and Checklist

ASC

and Physical Environment

AMERICAN ASSOCIATION FOR

ACCREDITATION OF

AMBULATORY SURGERY FACILITIES, INC.

Medicare Standards and Checklist for Accreditation of Ambulatory Surgery

Facilities Version 7.1 ● Published and Implement March 2020

Approved by CMS February 2020

American Association for Accreditation of Ambulatory Surgery Facilities, Inc.

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The Accreditation Program

The American Association for Accreditation of Ambulatory Surgery Facilities, Inc. (AAAASF) is an accreditation program certifying to the medical community and the lay

community at large that a provider/supplier meets recognized standards. The accreditation program is operated by clinical professionals who set and evaluate the standards under the direction of a Board of Directors. AAAASF strives for the highest standards of excellence for its accredited provider/supplier by regularly revising the requirements for patient safety and quality of care.

Unannounced Survey

The provider/supplier is surveyed initially and every three years thereafter. The surveyor cites any non- compliant practices and reviews any deficiencies with the Director. The survey report is submitted to the AAAASF office. The provider/supplier must meet every standard for the program to achieve AAAASF Accreditation. All AAAASF Medicare surveys are unannounced.

Self-Survey

The provider/supplier is evaluated by the Director each year between surveys and the completed Self- Survey is sent to the AAAASF office. A provider/supplier’s AAAASF accreditation remains valid if it continues to meet every standard for its program. Otherwise, the accreditation is revoked.

Denial or Loss of Accreditation

The AAAASF may deny or revoke accreditation of a provider/supplier if the provider/supplier fails to satisfy every standard. If any medical professional providing services at the provider/supplier:

(A)

(B)

(C)

(D)

Has had his/her privileges to restricted or limited due to lack of clinical competence, ethical issues, refusal to take emergency call, or professional problems other than perceived or real economic competition. Has been found to be in violation of the Code of Ethics of any professional society or association for which they are a member. Has had his/her right to practice limited, suspended, terminated or otherwise affected by any state, providence, or country or if he/she has been disciplined by any professional licensing authority Non-reporting of any of the above to the AAAASF office.

Hearing

In case of a disputed finding/citation, the Accreditation Committee may order a resurvey of the provider/supplier or the provider/supplier Director may submit evidence that if provided adequate proof of compliance that surveyor did not accept, AAAASF may remove the citation through correspondence from the AAAASF Board of Directors.

Any provider/supplier whose accreditation has been revoked, denied or placed on emergency suspension or emergency probation by AAAASF, shall have 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 appeal process is described in the AAAASF bylaws available from the AAAASF office.

If revocation is upheld after hearing, the provider/supplier must re-apply for accreditation. AAAASF reserves the right to not accept an application.

Accreditation Review Prior to Revocation of Accreditation

AAAASF has the authority to investigate allegations that, if substantiated, would result in non- compliance with AAAASF standards, including Medicare Conditions where appropriate. Allegations or findings that fall outside of the AAAASF scope of authority are referred to the appropriate federal, state, and/or local agency. When AAAASF is aware that an agency or other body is also conducting an investigation, AAAASF will coordinate with that office to reduce duplicative work and avoid compromising either or both investigations.

Important Notice

Maximal patient safety has always been AAAASF’s guiding concern. We are proud that our Standards may be considered the strongest of any accreditation agency that accredits providers/suppliers 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 Programs require 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 surveyor is permitted as long as patient and staff safety remain uncompromised.

Special Instructions for Medicare Accreditation Please Note: Medicare applicants must meet all standards for the facility class they apply for (A, B, C-M, and C) and

all additional Medicare Standards at the end of each section.

FOR THE APPLICANT

Please complete all required forms listed on the application and submit to the AAAASF office along with all required credentials for review. AAAASF requires a n independent Fire Safety Specialist contracted by AAAASF to perform a Life Safety Code inspection in accordance with the NFPA 2012 Life Safety Codes and 2012 Health Care Facilities Codes, with a report submitted to AAAASF. A copy of the report will be provided to the ASC. The ASC must correct any deficiencies noted by the Fire Safety Specialist. The Fire Safety Specialist may review any corrections and make the final determination for compliance. The ASC is responsible for all costs related to the Life Safety Code inspection.

MEDICAL STAFF QUALIFICATIONS

All individuals using the facility must be Board Certified or Board eligible physicians in an American Board of Medical Specialties (ABMS) medical or surgical specialty, or may be podiatrists certified by the American Board of Foot and Ankle Surgery (ABFAS) or The American Board of Podiatric Medicine (ABPM).

ABMS certified or eligible medical specialists who perform procedures within the accredited facility may only perform those procedures delineated in their ABMS Board Certification and/or covered b y AMA Core Principle #7. Podiatrists may only perform in an AAAASF accredited facility those procedures f or which they hold valid and unrestricted hospital privileges (or Core Privileges) in their specialty at a duly accredited and/or licensed hospital, or which are delineated in their American Board of Foot and Ankle Surgery (ABFAS) Certification. If, however, the privilege–granting hospital does not possess equipment or technology similar to that available at the ambulatory facility, alternate evidence of appropriate training and competence must be provided. Individual consideration will also be given if the Physician can satisfactorily demonstrate that the loss of or inability to maintain such privileges was NOT related in any way to lack of clinical competence, ethical issues, refusal to take emergency call, or professional problems other than perceived or real economic competition.

If the physician or health care provider practices in a specialty that does not normally require hospital privileges, they may only perform in the AAAASF accredited facility those procedures generally accepted by the Board of their specialty and covered by their Board-approved scope of practice.

The initial survey is performed by a team of inspectors after the ASC has performed 10-15 surgical procedures, which can be any combination of Medicare and non-Medicare procedures, in order for the survey team to review medical records and peer-review documentation, and perform a thorough survey.

The AAAASF accreditation committee awards the ASC a three-year term of accreditation when it has determined that the survey findings are accurate, the ASC has proven a commitment to provide high quality care and services, and concludes that the ASC is in compliance with all Medicare conditions for coverage, State and Federal regulations, and AAAASF standards.

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

UNANNOUNCED MEDICARE SURVEY

SELF EVALUATION

Policy for Survey Medical Record Review

Medical record review is conducted as part of the Medicare survey process. The lead surveyor must ensure that a random sample of medical records is reviewed. The following criteria must be met when performing medical record review during a site survey:

The ASC is required to produce a log or other record of close cases for the previous six-month period and the lead surveyor will select a sample of medical records to review. A sample of both open and closed cases must be reviewed. An opened case is defined as a patient that is being treated the day of the survey. The case that was observed on the day of survey should be included in the medical record review.

The sample selected must represent a cross section of the cases performed at the ASC and include both Medicare beneficiaries and non-Medicare patients.

The minimum number of records selected for review is 20 for an ASC with a monthly case volume exceeding 50 and 10 for lower volume ASCs. The total number of records within the six-month case period must be noted on the review form. If deficient practices are noted during the records review, the survey team should request additional record samples to substantiate the findings documented from the initial sample.

A Medical Record Review Form is provided to the survey team by AAAASF. The review form must be completed for ALL records that are reviewed with findings noted. If the team reviews additional records, the team must copy the form and document every record that was included in the sample review. The total number of medical records reviewed must be documented on the form to ensure that the policy has been adhered to.

Policy for Survey Personnel Record Review

The ASC must produce a complete list of all employees. The lead surveyor must ensure that a random sample of personnel records is reviewed.

The minimum number of records selected for review is 50% of the total number of personnel records. If deficient practices are noted during the records review, the survey team should request additional record samples to substantiate the findings documented from the initial sample. If an egregious number of deficient practices are noted, the survey team must document whether the deficiencies constitute a condition level area of non-compliance.

AAAASF Medicare 7.1

Surveyor Instructions:

Citation

Include the facts and findings relevant to the deficient practice must answer the questions: who, what, where, when, and how. Illustrate the entity’s noncompliance with the requirement. The deficiency citation must clearly and legibly explain how the entity fails to comply with the regulatory requirements, not how it fails to comply with any guidelines for the interpretation of those requirements. Wherever possible, supply a numerator and denominator to demonstrate

how systemic a deficiency is, for example “4/6 Medical records failed to include an informed

consent”. Refer to the CMS Principles of Documentation for further instruction.

The citation must include a determination of whether the deficiency constitutes Standard or Condition Level Noncompliance. Condition level noncompliance is substantial noncompliance that requires additional surveys to ensure compliance before can be recommended or approved.

Official Forms

Surveyors may not submit custom surveyor materials as the surveyor report to the AAAASF office. The requirement for surveyor report submission is specific to the official AAAASF surveyor materials, which must be completed in full according to AAAASF surveyor guidelines and policies. Any custom materials are only considered to be in support of or as supplements to the official materials. All forms must be completed in ink.

When scoring, please use a clear check mark ( ) to indicate your scoring decision.

Record Review

The survey process requires the completion of two record review components, personnel record review and clinical record review. The AAAASF staff has gathered the appropriate information, such as the monthly case load and number of employees, from the facility to establish the facility specific requirements for both record review components. Please review, at a minimum, the number of record reviews indicated on the review form provided in this manual. You may ask for additional records to facilitate a determination of whether a deficient practice is a rare occurrence or a systemic problem.

Please make additional copies of forms as needed and document your findings. When completing review worksheets simply fill in the circle corresponding to the appropriate answer to document your findings. Please refrain from using symbols and other notes. For any file component that is non-compliant for one or more files, the corresponding standard must be cited as deficient and a deficiency form must be completed.

When conducting the Personnel Record Review please also verify that the number of facility employees matches the number listed on the Personnel Record Review Form.

AAAASF Medicare 7.1

Error Corrections

The AAAASF Surveyor Manual is an official record as such all surveyor notations must be made in ink, corrections and revisions must also be made consistent with AAAASF procedures. Any errors or revisions to narrative or scoring must be corrected using a single horizontal strikethrough with the initials of the surveyor and date of the revision. Do not use liquid paper, scribble out, or “X” over errors or revisions.

JD 1/1/2014

Example: 100.010.065 _Compliant _ Deficient

Extension Site Surveys (OPT Only)

When conducting a survey for an Extension Location, please fully complete the surveyor manual and all appropriate worksheets. If a standard pertains to a function or service not provided at the particular site being surveyed, mark the standard as “Compliant” in the Surveyor Manual for that location. For example, if the site does not employ an occupational therapist, all standards relating to the qualifications and duties of an occupational therapist must be marked “Compliant”.

AAAASF Medicare 7.1

Page #

29 36

9998 - Florida Supplement

103

TABLE OF CONTENTS

ASC Standards and Checklist

Version 7.1

100 - Basic Mandates

200 - Operating Room Policy, Environment and Procedures

300 -Recovery Room Environment, Policy and Procedures

400 - General Safety in the Facility

500 - IV Fluids and Medications

600 - Medical Records

700 - Quality Assessment/Quality Improvement

800 - Personnel

900 - Anesthesia

1000 - Governance

1600 - Emergency Preparedness

9999 - Life Safety Code/Health Care Facility Codes

AAAASF Medicare V7 .1

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AAAASF Medicare V7.1

100

BASIC MANDATES

100.010

Basic Mandates

100.010.005

Compliant Deficient

B,C-M,C

There must be a written screening protocol for venous thromboembolism (VTE) risk placed in the medical record of each surgical patient. This protocol and assessment tool is to be placed in the facility manual for reference.

100.010.010

100.010.011

100.010.015 Compliant Deficient B,C-M,C

Compliant Deficient B,C-M,C

The facility should have a scheduling policy that includes only those procedures and/or combination of procedures of duration and degree that permit safe recovery and discharge from the facility.

Compliant Deficient B,C-M,C

A pre-operative surgical safety checklist should be used for each patient and noted in the patient record.

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

100.010.020 Compliant Deficient A,B,C-M,C

Changes in facility ownership must be reported to the AAAASF office within 30 days of the change.

AAAASF Medicare V7.1

100.010.025 Compliant Deficient A,B,C-M,C

Any death occurring in an accredited facility or any death occurring within 30 days of a surgical procedure performed in an accredited facility must be reported to the AAAASF office within 5 business days after the facility is notified or otherwise becomes aware of that death. In addition to this notification, the death must be reported as an unanticipated operative sequela in the semiannual peer review report. In the event of a death occurring within 30 days of an operation done in an AAAASF-accredited facility, an unannounced survey will be done by a senior surveyor unless waived by the investigative committee.

100.010.030

Compliant Deficient A,B,C-M,C

All individuals using the facility must meet one of the following criteria (throughout this document the terms physician, medicine, and medical apply to MD, DO, and DPM degrees)

A doctor of medicine certified or eligible for certification by one of the member boards of the American Board of Medical Specialties (ABMS)

A doctor of osteopathy certified or eligible for certification by the American Osteopathic Association Bureau of Osteopathic Specialists (AOABOS)

A podiatrist certified or eligible for certification by the American Board of Foot and Ankle Surgery (ABFAS) or The American Board of Podiatric Medicine (ABPM)

An oral and maxillofacial surgeon certified or eligible for certification by the American Board of Oral and Maxillofacial Surgery (ABOMS)

100.010.032 Compliant Deficient A,B,C-M,C

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.

100.010.035 Compliant Deficient A,B,C-M,C

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

AAAASF Medicare V7.1

100.010.040 Compliant Deficient A,B,C-M,C

Onsite AAAASF surveys typically involve the attention of the facility medical director, the anesthesia provider, and the facility staff working intently with the AAAASF surveyor(s). The survey process must remain focused, and therefore, AAAASF has directed that

equipment representatives not be present during AAAASF’s

announced or unannounced surveys. Accreditation consultants may be present during the surveys; however, AAAASF asks that consultants remain silent during the survey process until it is completed. All AAAASF surveyor(s) have the authority to request that any participants leave the survey process if interference becomes a problem. AAAASF greatly appreciates all concerned parties’ cooperation in complying with this directive.

100.010.045 Compliant Deficient A

Class A: In a Class A facility, all surgical, endoscopic, and/or pain

management procedures may be performed under the following anesthesia

Topical anesthesia Local anesthesia

If oral medications are used, only minimal sedation levels are permitted in Class A facilities.

In a Class A facility, no more than 500cc’s of aspirate should be

removed when performing liposuction. Class A facilities must meet all Class A standards. Minimal sedation (axiolysis)-a drug-induced state during which

patients respond normally to verbal commands. Although cognitive function and coordination may be impaired, ventilator and cardiovascular functions are unaffected.

AAAASF Medicare V7.1

100.010.050

Compliant Deficient B

Class B: In a Class B facility, all surgical, endoscopic, and/or pain

management procedures may be performed under the following moderate anesthesia

Topical anesthesia

Local anesthesia

Parenteral sedation

Field and peripheral nerve blocks

Dissociative drugs (excluding propofol).

Agents 3 through 5 may be administered by a/an Physician Certified registered nurse anesthetist (CRNA) under physician supervision if required by state or federal law, or by policy adopted by the facility Anesthesia assistant (as certified by the National Commission for the Certification of Anesthesiologist Assistants (NCCAA)) under direct supervision of an anesthesiologist 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.

In a Class B facility, no more than 5000 cc’s of aspirate should be removed while performing liposuction, unless the patient is monitored overnight within the facility.

Class B facilities must meet all Class A and Class B standards. Moderate Sedation - an induced state of sedation

characterized by a minimally depressed consciousness such that the patient is able to continuously and independently maintain a patent airway, retain protective reflexes, and remain responsive to verbal commands and physical stimulation.

AAAASF Medicare V7.1

100.010.055

Compliant Deficient C-M

Class C-M: In a Class C-M facility, all surgical, endoscopic, and/or

pain management procedures may be performed under the following anesthesia

Topical anesthesia

Local anesthesia

Parenteral sedation

Field and peripheral nerve blocks

Dissociative drugs (including propofol)

Spinal anesthesia

Epidural anesthesia

Agents 3 through 5 may be administered by a/an

Physician

CRNA under physician supervision if required by state or

federal law, or by policy adopted by the facility

Anesthesia assistant (as certified by the NCCAA) under direct

supervision of an anesthesiologist

Registered nurse, only under the supervision of a qualified

physician (excluding propofol) Propofol, spinal anesthesia, and epidural anesthesia

may be administered only by a/an

CRNA (under physician supervision if required by state or

federal law or by policy adopted by the facility)

Anesthesia assistant (as certified by the NCCAA) under direct

supervision of an anesthesiologist

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.

In a Class C-M facility, no more than 5000 cc’s of aspirate should be removed while performing liposuction, unless the patient is monitored overnight within the facility.

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

Deep sedation-an induced state of sedation characterized by depressed consciousness such that the patient is unable to continuously and independently maintain a patent airway and experiences a partial loss of protective reflexes and ability to respond to verbal commands or physical stimulation.

AAAASF Medicare V7.1

100.010.060

Compliant Deficient C

Class C: In a Class C facility, all surgical, endoscopic, and/or pain

management procedures may be performed under the following anesthesia

Topical anesthesia

Local anesthesia

Parenteral sedation

Field and peripheral nerve blocks

Dissociative drugs (including propofol)

Epidural anesthesia

Spinal anesthesia

General anesthesia (with or without endotracheal intubation or

laryngeal mask airway anesthesia)

Agents 3 through 5 may be administered by a/an Physician

CRNA under physician supervision if required by state or

federal law, or by policy adopted by the facility

Anesthesia assistant (as certified by the NCCAA) under

direct supervision of an anesthesiologist

Registered nurse, only under the supervision of a qualified

physician (excluding propofol) Propofol and agents 6 through 8 may be administered only by a/an

CRNA (under physician supervision if required by state or

federal law or by policy adopted by the facility)

Anesthesia assistant (as certified by the NCCAA) under

direct supervision of an anesthesiologist

Anesthesiologist

In a Class C facility, no more than 5000 cc’s of aspirate should

be removed while performing liposuction, unless the patient is monitored overnight within the facility.

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

Deep sedation- an induced state of sedation characterized by depressed consciousness such that the patient is unable to continuously and independently maintain a patent airway and experiences a partial loss of protective reflexes and ability to respond to verbal commands or physical stimulation.

AAAASF Medicare V7.1

100.010.065 Compliant Deficient A,B,C-M,C

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 American Medical Association (AMA) Core Principle #7. American Osteopathic Association (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 within an accredited facility may perform only those surgical procedures delineated in their ABFAS 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.

100.010.070 Compliant Deficient A,B,C-M,C

Practitioners of pain management are required to meet all of the following criteria

Have an MD or DO degree Have appropriate fellowship training in pain management Possess ABMS/AOABOS board certification or board eligibility in one of the

following specialties anesthesiology, physical medicine and rehabilitation (PM&R), psychiatry/neurology

Possess a sub-specialty certification or eligibility from the American Board of Anesthesiology, the AOABOS, or specifically Pain Medicine sub-specialization in PM&R or Psychiatry/Neurology.

Have, or have held, hospital privileges from a hospital located within 30 minutes of the facility, concerning the applicable scope of practice for pain management

AAAASF Medicare V7.1

100.010.075

Compliant Deficient A,B,C-M,C

Practitioners of Interventional Radiology must meet all of the following criteria:

MD or DO

Board certification or board eligibility by the American Board of Radiology (ABR) or the American Osteopathic Board of Radiology (AOBR)

Fellowship training as approved by the ABR or AOBR

Current certificate of added qualifications in interventional/ vascular radiology

100.010.080 Compliant Deficient B,C-M,C

A licensed anesthesia provider supervising or providing care in the facility should participate in quality assurance and risk management in the facility.

100.010.085 Compliant Deficient B,C-M,C

The surgeon and the licensed or qualified anesthesia provider should concur on the appropriateness of surgical procedures performed at the facility. This is based on the medical status of the patients and qualifications of the providers and the facility resources.

100.010.090

Compliant Deficient A,B,C-M,C

A patient who by reason of pre-existing or other medical condition is at undue risk should be referred to alternative facilities that are more appropriate.

AAAASF Medicare V7.1

200

OPERATING ROOM POLICY, ENVIRONMENT AND PROCEDURES

200.010

Policy

200.010.010

Compliant Deficient B,C-M,C

A “surgical pause” or a “time out” protocol is in place, practiced, and

documented prior to every surgical procedure and is documented in the operative chart.

This protocol should include a pre-operative verification process including medical records, imaging studies, and any implants identified, and be reviewed by the operating room team. Missing information or discrepancies must be addressed in the chart at this time.

Marking the operative site-Surgical procedures calling for right/left distinction; multiple structures (breasts, eyes, fingers, toes, etc.) must be marked while the patient is awake and aware, if possible. The person performing the surgery should do the site marking. The site must be marked so that the mark will be visible after the patient has been prepped and draped. A procedure must be in place for patients who refuse site marking.

“Time Out”-Immediately before starting the surgical procedure, conduct a final verification by at least 2 members of the surgical team confirming the correct patient, surgery, site marking(s) and, as applicable, implants and special equipment or requirements. As a “fail-safe” measure, the surgical procedure is not started until any and all questions or concerns are resolved.

Procedures done in non–operating-room settings must include site marking for any procedures involving laterality, or multiple structures.

AAAASF Medicare V7.1

200.020 Environment

200.020.005 Compliant Deficient A,B,C-M,C

The facility displays a professional appearance that is in keeping with a medical facility designed to carry out surgical procedures. The facility should be neat, comfortable, clean and should include a waiting area, business office, and sanitary lavatory facilities. One or more dedicated exam rooms should be available that provide for privacy and treatment in a sanitary, orderly environment.

200.020.010 Compliant Deficient B,C-M,C

The operating suite is physically separate from the general office.

200.020.015 Compliant Deficient B,C-M,C

The operating suite includes operating room(s), a prep/scrub area, a clean area and/or dirty area, and a post-anesthesia care unit.

200.020.020 Compliant Deficient B,C-M,C

There is a room dedicated for use as an operating room.

200.020.025 Compliant Deficient A

An exam room may function as an operating room.

AAAASF Medicare V7.1

200.020.027 Compliant Deficient A,B,C-M,C

Each operating room must be designed and equipped so that the types of surgery conducted can be performed in a manner that protects the lives and assures the physical safety of all individuals in the area.

416.44.a.1 Standard

200.020.030 Compliant Deficient A,B,C-M,C

All major surgery is done in the separate and distinct operating room(s).

200.020.035 Compliant Deficient A,B,C-M,C

The operating room(s) is adequately ventilated and temperature controlled.

200.020.050 Compliant Deficient A,B,C-M,C

The operating room is properly cleaned, maintained and free of litter and clutter.

200.020.055 Compliant Deficient A,B,C-M,C

Each operating room is of a size adequate to allow for the presence of all equipment and personnel necessary for the performance of the surgical procedures, and must comply with applicable local, state, or federal requirements. Additionally, all facilities must have a minimum of 4 feet (48 inches) of clear space on each side of the operating table to accommodate emergency personnel and equipment in case of emergency, and permit the safe transfer of the patient to a gurney for transport, or facility personnel can physically demonstrate to the surveyor that the emergency criteria as stated above can be met in the operating room space available.

200.020.060 Compliant Deficient A,B,C-M,C

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.

AAAASF Medicare V7.1

200.020.065 Compliant Deficient A,B,C-M,C

Unauthorized individuals are deterred from entering the operating room suite either by locks, alarms, or facility personnel.

200.020.071 Compliant Deficient A,B,C-M,C

Sterilizers have appropriately maintained logs for all routine checks.

200.020.075 Compliant Deficient A,B,C-M,C

Sterile supplies are labeled to indicate sterility and are packaged and sealed to prevent accidental opening.

200.020.080 Compliant Deficient A,B,C-M,C

Each sterilized pack is marked with the date of sterilization and, when applicable, with the expiration date. When more than one autoclave is available, each pack must additionally be labeled to identify in which autoclave it was sterilized.

200.020.085 Compliant Deficient A,B,C-M,C

If one sink is used both for dirty instruments and to scrub for surgery, there is a written policy to clean and disinfect the sink prior to scrubbing hands.

200.020.090 Compliant Deficient B,C-M,C

If a pre-existing sink is present in the operating room, a written policy to prohibit the use of the sink during sterile surgical procedures must be in place. A sink is permissible in an operating room which is exclusively used for endoscopic or urological procedures in accordance with the standards of those professions. Requests for allowance by other specialties will be reviewed on a case-by-case basis.

200.020.095 Compliant Deficient A,B,C-M,C

Each operating room: Has appropriate lighting.

AAAASF Medicare V7.1

200.025 Storage

200.025.001 Compliant Deficient A,B,C-M,C

The O.R. storage space is: Properly cleaned, maintained and free of litter and clutter.

200.025.005 Compliant Deficient A,B,C-M,C

There is adequate operating room storage space to hold equipment, sterile supplies, and medications. Storage space should be adequate to minimize the need to leave the operating room for frequently used supplies, equipment, and/or medication.

200.025.010 Compliant Deficient A,B,C-M,C

Storage space provides easy access for identification and inventory of supplies.

200.025.015 Compliant Deficient A,B,C-M,C

Sterile supplies are stored away from potential contamination in closed cabinets/drawers or, away from heavy traffic areas.

AAAASF Medicare V7.1

200.030

Procedures - Sterilization

200.030.010

Compliant

Deficient

A,B,C-M,C

The facility has at least one autoclave that uses high-pressure steam and heat.

200.030.015 Compliant Deficient A,B,C-M,C

200.030.025 Compliant Deficient A,B,C-M,C

Gas sterilizers must be vented.

200.35

200.035.028

200.035.029

High Level Disinfection of Endoscopes

Compliant Deficient A,B,C-M,C

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. The manufacturer’s recommendations for usage

should be followed at all times.

Compliant Deficient A,B,C-M,C

Endoscopes are processed in accordance with protocol based on national standards. These standards address how scopes are cleaned, reprocessed, and stored and documents training for personnel who do the reprocessing.

AAAASF Medicare V7.1

200.040

Instrument Processing

200.040.010

Compliant

Deficient

A,B,C-M,C

Instrument handling and sterilizing areas are cleaned and maintained.

200.040.015 Compliant Deficient A,B,C-M,C

There is strict segregation of dirty surgical equipment and instruments that have been cleaned and are in the preparation and assembly area.

200.040.020 Compliant Deficient A,B,C-M,C

The instrument preparation and assembly area (clean utility area) is separated by walls or space from the instrument cleaning area (dirty utility area) or, there is a policy to clean and disinfect the dirty utility area before preparing and assembling packs for sterilization.

200.040.025 Compliant Deficient A,B,C-M,C

Between cases, the operating room(s) is cleaned with medical grade disinfectants.

200.040.030 Compliant Deficient A,B,C-M,C

Scrub suits, caps or hair covers, gloves, operative gowns, masks, and eye protection are used for all appropriate surgery.

416.51.a Standard

AAAASF Medicare V7.1

200.040.035 Compliant Deficient A,B,C-M,C

A sterile field is routinely used during all operations.

200.040.040 Compliant Deficient A,B,C-M,C

Surgical scrub soap and/or alcohol cleansers are provided for the

surgery room staff consistent with current CDC guidelines for hand

hygiene.

200.040.045 Compliant Deficient A,B,C-M,C

All instruments used in patient care are sterilized,

where applicable.

200.040.050 Compliant Deficient A,B,C-M,C

Sterilizer logs/monitoring records are reviewed and

stored for a minimum of three (3) years.

200.040.055 Compliant Deficient A,B,C-M,C

A weekly spore test, or its equivalent, is performed on each autoclave

and the results filed and kept for 3 years.

200.040.060 Compliant Deficient A,B,C-M,C

There is a protocol for remedial action to correct the sterilization

process if a spore test is positive.

AAAASF Medicare V7.1

200.050 Maintenance and Cleaning

200.050.005 Compliant Deficient A,B,C-M,C

The ASC must provide a functional and sanitary environment for the provision of surgical services by adhering to professionally acceptable standards of practice.

416.51.a Standard

200.050.010 Compliant Deficient A,B,C-M,C

The entire operating room suite is cleaned and disinfected according to an established schedule that is adequate to prevent cross-contamination.

416.51.a Standard

200.050.015 Compliant Deficient A,B,C-M,C

All blood and body fluid spills are cleaned using medicalgrade germicides that are virucidal, bactericidal, tuberculocidal, and fungicidal.

200.050.020 Compliant Deficient A,B,C-M,C

A written protocol has been developed for use by housekeeping personnel for cleaning floors, tables, walls, ceilings, counters, furniture, and fixtures of the surgical suite.

200.050.025 Compliant Deficient A,B,C-M,C

All openings to outdoor air are effectively protected against the entrance of insects, animals, etc.

AAAASF Medicare V7.1

200.55

200.055.020

200.055.021

200.055.023 Compliant Deficient A,B,C-M,C

Infection Control

Compliant Deficient A,B,C-M,C

The Infection Control program isUnder the direction of a designated and qualified professional who has training in infection control;

416.51.b.1 Standard

Compliant Deficient A,B,C-M,C

The Infection Control program is-

An integral part of the ASC’s quality assessment and performance improvement

program; and

416.51.b.2

The Infection Control program is-Responsible for providing a plan of action for preventing, identifying, and managing infections and communicable diseases and for immediately implementing corrective and preventive measures that result in improvement. The infection control and prevention program must include documentation that the ASC has considered, selected, and implemented nationally recognized infection control guidelines.

Standard

416.51.b.3

200.055.030 Compliant Deficient A,B,C-M,C

416.51 Conditions for coverage - Infection control.

The ASC must maintain an infection control program that seeks to minimize infections and communicable diseases.

416.51 Condition

200.055.045 Compliant Deficient A,B,C-M,C

The ASC must maintain an ongoing program designed to prevent, control, and investigate infections and communicable diseases. In addition, the infection control and prevention program must include documentation that the ASC has considered, selected, and implemented nationally recognized infection control guidelines.

416.51.b Standard

200.055.050 Compliant Deficient A,B,C-M,C

Appropriate scrub facilities are provided for the O.R. staff consistent with current CDC guidelines for hand hygiene and surgical scrub.

Standard

AAAASF Medicare V7.1

200.060

Surfaces

200.060.010 Compliant Deficient B,C-M,C

The operating room ceiling surface or drop-in tiles are smooth, washable, and free of particulate matter that could contaminate the operating room.

200.060.015 Compliant Deficient A,B,C-M,C

The walls and counter tops are covered with smooth, and easy to clean material which is free from tears, breaks or cracks.

200.060.020 Compliant Deficient B,C-M,C

The floors are covered with smooth and easy-to-clean material that is free from breaks, or cracks. If the floors contain seams or individual tiles, they are sealed with an impermeable sealant other than silicone.

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