ASF ASC User Manual

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AAAASF MEDICARE

Health

tandards and Checklist

ASC

and Physical Environment

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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.

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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.

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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

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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.

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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.

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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”.

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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

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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.

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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.

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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.

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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.

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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.

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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.

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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

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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.

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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.

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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.

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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.

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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.

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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.

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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

Additional methods can be chemical autoclave (Chemclave ©) or gas (ethylene oxide) sterilizer.

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.

Page 26

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

Page 27

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.

Page 28

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.

Page 29

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

Page 30

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.

Page 31

AAAASF Medicare V7.1

200.070

Equipment

200.070.010

Compliant

Deficient

A,B,C-M,C

A biomedical technician annually inspects all equipment (including emergency light and power supplies) and reports in writing that the

equipment is safe and operating according to the manufacturer’s

specifications. Stickers may be placed on individual equipment; however, written records must be maintained for 3 years.

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

Only properly inspected equipment is used in the operating suite.

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

The manufacturer’s specifications and requirements are

kept in an organized file and followed for each piece of equipment.

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

There is an adequate operating room table or chair.

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

The operating room is provided with adequate general lighting in the ceiling.

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

Appropriately sized pediatric medical equipment is available if services are provided to infants/children.

200.070.050 Compliant Deficient B,C-M,C

Equipment and supplies for anesthesia include A reliable source of oxygen, adequate for the length of the surgery (backup should consist of at least one full E cylinder).

Page 32

AAAASF Medicare V7.1

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

Equipment and supplies for anesthesia include If a central source of piped oxygen is used, the system must meet all applicable codes.

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

Equipment and supplies for anesthesia include Sufficient space to accommodate the necessary personnel, equipment, and monitoring devices is available.

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

Equipment and supplies for anesthesia include an adequate and reliable source of suction.

200.070.070 Compliant Deficient C

Equipment and supplies for anesthesia include An adequate and reliable anesthetic scavenging system, if inhalation anesthetics are used.

200.070.075 Compliant Deficient A,B,C-M,C Equipment and supplies for anesthesia include

Self-inflating (Ambu©) bags, if used, are capable of delivering positive pressure ventilation with at least 90% oxygen concentration.

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

Equipment and supplies for anesthesia include Adequate illumination for patients, machines, and monitoring equipment, which can include battery powered illuminating systems.

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

Equipment and supplies for anesthesia include An emergency response cart containing standard ACLS equipment is available independent of procedure room equipment with defibrillator, necessary drugs, and other CPR equipment.

Page 33

AAAASF Medicare V7.1

200.071

Operating Room Equipment List

200.071.010

Compliant Deficient

B,C-M,C

An EKG monitor with pulse readout is present.

200.071.015 Compliant Deficient B,C-M,C

Pulse oximeters must be present in both the operating room and recovery room if both rooms are being used simultaneously.

200.071.020

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

200.071.030 Compliant Deficient B,C-M,C

200.071.035

Compliant Deficient

Blood pressure monitoring equipment is present.

A standard defibrillator or an automated external defibrillator (AED) unit is present, which is checked at least weekly for operability, and the test results are kept for a minimum of 3 years.

Sequential compressive devices (SCD) are employed for surgical procedures of 1 hour or longer, except for procedures carried out under local anesthesia.

Compliant Deficient

Oral airways for each size of patient treated in the facility are present.

A,B,C-M,C

200.071.040 Compliant Deficient B,C-M,C

Nasopharyngeal airways and laryngeal mask airways for each size of patient treated in the facility are present.

200.071.045 Compliant Deficient B,C-M,C

Laryngoscopes with blades of various sizes for each size of patient are present.

Page 34

AAAASF Medicare V7.1

200.071.050 Compliant Deficient B,C-M,C

Endotracheal tubes of various sizes for each patient are present.

200.071.055 Compliant Deficient B,C-M,C

Endotracheal stylet is present.

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

A positive pressure ventilation device (eg, Ambu® bag) is present.

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

A source of oxygen is present.

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

Source of suction is present.

200.071.075 Compliant Deficient C

If a mechanical ventilator is present, it should have a continuous use device which indicates a disconnect via an audible signal.

200.071.080 Compliant Deficient B,C-M,C

Electrocautery with a grounding plate or disposable pad is present

200.071.085 Compliant Deficient C

An anesthesia machine with a purge system to extract exhaled gaseous air to out-of-doors or to a neutralizing system is present. If inhalation anesthesia is used, a carbon–dioxide-neutralizing system is required when using an anesthesia machine.

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. If nitrous oxide alone is used, then an appropriate delivery system that prevents hypoxic mixture is employed.

Page 35

AAAASF Medicare V7.1

200.071.090 Compliant Deficient C

An inspired gas oxygen monitor on the anesthesia machine is present if inhalational anesthesia is used.

200.071.095 Compliant Deficient B, C-M, C

A carbon dioxide monitor is present and used on all moderate sedation, deep sedation and general anesthesia cases.

Page 36

AAAASF Medicare V7.1

200.080 Emergency Power

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

Emergency equipment. The ASC medical staff and governing body of the ASC coordinates, develops, and revises ASC policies and procedures to specify the types of emergency equipment required for use in the ASC's operating room.

Be immediately available for the use of emergency situations.

416.44.d Standard

416.44.d.1Standard

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

Be appropriate for the facility's patient population.

416.44.d.2Standard

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

Be maintained by appropriate personnel.

416.44.d.3 Standard

Page 37

AAAASF Medicare V7.1

200.085 General Environment

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

The ambulatory surgery center is in compliance with all state laws including State licensure requirements. (Found in the Code of Federal Regulations, Part 416.40; Compliance with State Licensure Laws).

416.40 Condition

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

416.2 Definitions

Ambulatory surgical center or ASC means any distinct entity that operates exclusively for the purpose of providing surgical services to patients not requiring hospitalization and in which the expected duration of services would not exceed 24 hours following an admission. The entity must have an agreement with CMS to participate in Medicare as an ASC, and must meet the conditions set forth in subparts B and C of 416.2.

ASC services means, for the period before January 1, 2008, facility services that are furnished in an ASC, and beginning January 1, 2008, means the combined facility services and covered ancillary services that are furnished in an ASC in connection with covered surgical procedures.

Covered ancillary services means items and services that are integral to a covered surgical procedure performed in an ASC as provided in

§416.164(b), for which payment may be made under §416.171 in addition to the payment for the facility services. Covered surgical procedures means those surgical procedures furnished before January 1, 2008, that meet the criteria specified in

§416.65 and those surgical procedures furnished on or after January 1, 2008, that meet the criteria specified in §416.166.

Facility services means for the period before January 1, 2008, services that are furnished in connection with covered surgical procedures performed in an ASC, and beginning January 1, 2008, means services that are furnished in connection with covered surgical procedures performed in an ASC as provided in

§416.164(a) for which payment is included in the ASC payment established under §416.171 for the covered surgical procedure.

416.2 Condition

Page 38

AAAASF Medicare V7.1

200.090 Medical Hazardous Waste

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

All medical hazardous wastes are stored in - Occupational Safety

and Health Act (OSHA) acceptable containers and separated from general refuse for special collection and handling.

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

Used disposable sharp items are placed in secure punctureresistant containers which are located as close to the use area as is practical.

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

There is a written policy for cleaning of spills, especially blood borne pathogens.

Page 39

AAAASF Medicare V7.1

200.095 Appearance and Layout

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

The ASC must have a safe and sanitary environment, properly constructed, equipped, and maintained to protect the health and safety of patients.

416.44 Condition

200.095.015

200.095.020

Compliant Deficient A,B,C-M,C

The ASC must provide a functional and sanitary environment for the provision of surgical services.

416.44.a Standard

Compliant Deficient A,B,C-M,C

There is an adequate, separate waiting room.

416.44.a.2 Standard

Page 40

AAAASF Medicare V7.1

300

RECOVERY ROOM ENVIRONMENT, POLICY AND PROCEDURES

300.00

Post-Anesthetic Care Unit (PACU)

300.000.015

Compliant Deficient B,C-M,C

The operating room may be used for patient recovery if only one surgical procedure is scheduled that same day, or if the recovering patient meets all discharge criteria prior to beginning the next surgical procedure, or if there is another operating room available for the next surgical procedure.

300.000.020 Compliant Deficient B,C-M,C

Patients transferred to the PACU are accompanied by a member of the anesthesia team who is knowledgeable about the patient.

300.000.025 Compliant Deficient B,C-M,C

Patients transferred to the PACU will be continually evaluated and monitored as needed during transport.

Page 41

AAAASF Medicare V7.1

300.05

300.005.005

300.005.006

300.005.010 Compliant Deficient B,C-M,C

Evaluation and Transfer of Care

Compliant Deficient A,B,C-M,C

The ASC must ensure each patient has the appropriate pre-surgical and post-surgical assessments completed and that all elements of the discharge requirements are completed.

416.52 Condition

Compliant Deficient A,B,C-M,C

Upon admission, each patient must have a pre-surgical assessment completed by a physician who will be performing the surgery or other qualified practitioner in accordance with applicable State health and safety laws, standards of practice, and ASC policy.

This assessment includes, at a minimum, the patient's medical history and physical examination (if any) and documentation of any allergies to drugs and biologicals. This assessment must be placed in the patient's medical record prior to the surgical procedure.

416.52.a.2; 416.52.a.3; 416.52.a.4 Standard

Evaluation in the PACU will include: Documentation of patient's time of arrival.

300.005.015 Compliant Deficient B,C-M,C

Evaluation in the PACU will include: Assessment of the patient by the anesthesia recovery staff, as well as by a responsible physician.

300.005.020 Compliant Deficient B,C-M,C

Evaluation in the PACU will include Transmission of a verbal report on the patient to the PACU team from a member of the anesthesia team who accompanies the patient.

300.005.025

300.005.030

Compliant Deficient B,C-M,C

Evaluation in the PACU will include Transfer of information concerning the preoperative condition of the patient, the invasive procedure, related medication, and the anesthesia course.

Compliant Deficient B,C-M,C

Evaluation in the PACU will include A member of the anesthesia team remains in the post-anesthesia area until the post-anesthesia care nurse accepts responsibility for the patient.

Page 42

AAAASF Medicare V7.1

300.006 Continued Evaluation

300.006.010

Compliant Deficient B,C-M,C

Continued evaluation in the PACU will consist of

Observation and monitoring by methods appropriate to the patient’s

condition (oxygen saturation, ventilation, circulation, and temperature).

300.006.015

Compliant Deficient B,C-M,C

Continued evaluation in the PACU will consist of Continuous pulse oximetry.

300.006.025 Compliant Deficient B,C-M,C

Continued evaluation in the PACU will consist of All recovering patients must be observed and supervised by trained medical personnel in the recovery area. A physician, CRNA, PA, or RN 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. Local mandates and stricter standards may apply.

300.006.030 Compliant Deficient B,C-M,C

Continued evaluation in the PACU will consist of There is a written policy that whenever parenteral sedation, dissociative drugs, epidural, spinal, or general anesthesia is administered, a physician is immediately available until the patient is discharged from the PACU.

Page 43

300.10 PACU Room(s)

AAAASF Medicare V7.1

300.010.010

Compliant Deficient B,C-M,C

There is a separate and adequately sized PACU within the operating room suite.

416.44.a.2 Standard

300.010.013 Compliant Deficient B,C-M,C

The recovery area is maintained, clean and free of litter.

300.010.015 Compliant Deficient B,C-M,C

The room is equipped and readily accessible to handle emergencies

300.010.017

Compliant Deficient B,C-M,C

Family members may enter the recovery room upon approval from the physician.

300.010.025 Compliant Deficient B,C-M,C

A separate pulse oximeter is available for each patient in the PACU

300.010.030 Compliant Deficient B,C-M,C

There is a PACU record that includes vital signs, level of consciousness, medications and nurse’s notes.

Page 44

AAAASF Medicare V7.1

300.020

Discharge

300.020.005

Compliant

Deficient

A,B,C-M,C

The patient's post-surgical condition must be assessed and documented in the medical record by a physician, other qualified practitioner, or a registered nurse with, at a minimum, post- operative care experience in accordance with applicable State health and safety laws, standards of practice, and ASC policy.

416.52.b.1 Standard

300.020.015 Compliant Deficient B,C-M,C

Patients are required to meet criteria for physiological stability before discharge, including vital signs and level of consciousness.

300.020.020 Compliant Deficient B,C-M,C

Personnel assist with discharge from the recovery area.

300.020.025 Compliant Deficient B,C-M,C

Unless they are having local anesthesia only, patients are transported from the facility by wheelchair or gurney to a waiting vehicle or to another facility with a responsible adult.

300.020.035

Compliant Deficient A,B,C-M,C

Before discharge, a Physician or an anesthetist as defined at 42 CFR

410.69(b), in accordance with applicable State health and safety laws, standards of practice, and ASC policy, must evaluate each patient for

proper anesthesia recovery. The physician’s or anesthetist's name must

be noted on the patient record.

416.42.a.2 Standard

300.020.045 Compliant Deficient B,C-M,C

Approved and standardized discharge criteria are used.

416.52.c Standard

Page 45

AAAASF Medicare V7.1

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

Post-surgical needs must be addressed and included in the discharge notes.

416.52.b.2 Standard

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

Provide each patient with written discharge instructions and overnight supplies. When appropriate, make a follow up appointment with the physician, and ensure that all patients are informed, either in advance of their surgical procedures or prior to leaving the ASC, of their prescriptions, post-operative instructions and physician contact information for follow up care.

416.52.c.1

Standard

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

Ensure each patient has a discharge order, signed by the physician who performed the surgery or procedure in accordance with applicable State health and safety laws, standards of practice, and ASC policy.

416.52.c.2

Standard

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

Ensure all patients are discharged in the company of a responsible adult, except those patients exempted by the attending physician.

416.52.c.3

Standard

Page 46

AAAASF Medicare V7.1

300.030 Extended Stays

300.030.010 Compliant Deficient B,C-M,C

If overnight stays are permitted, the facility is in compliance with all applicable local and state laws and regulations.

300.030.020 Compliant Deficient B,C-M,C

If 23 hour stays are permitted, the facility is in compliance with all pertinent local and state laws and regulations.

Page 47

AAAASF Medicare V7.1

400

GENERAL SAFETY IN THE FACILITY

400.000.000

AAAASF is committed to establishing minimum guidelines to provide safe and effective outpatient surgical care. The facility must comply with all applicable

OSHA, National Fire Protection Association (NFPA), federal, state, and local

codes and regulations. The facility must comply with the stricter regulation

(whether it is the AAAASF standard or local, state, or federal law).

400.010

General

400.010.005

Compliant Deficient A,B,C-M,C

The governing body must assure that all outside services are provided in a safe and effective manner.

416.41.a Standard

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

There is a Facility Safety Manual.

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

The facility safety manual contains all applicable requirements of OSHA.

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

The facility safety manual is in accordance with other federal and state regulations.

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

The facility safety manual provides employees with information about hazardous chemicals used and methods to minimize hazards to personnel.

Page 48

AAAASF Medicare V7.1

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

There is a written exposure control plan, which is reviewed and updated at least annually.

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

There is a written chemical hazard communication program, which is reviewed and updated annually.

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

If a laser is used, safety measures are taken to protect patients and staff from injury.

400.010.045

Compliant Deficient A,B,C-M ,C

Hazardous chemicals are labeled as such.

Page 49

AAAASF Medicare V7.1

400.012 Laboratory, Pathology and X-Ray Services

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

Radiologic Services. (Found in the Code of Federal Regulations, part 416.49(b); Radiologic Services).

416.49 Condition

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

If X-Ray equipment is used, safety measures are taken to protect patients and staff from injury.

416.49.b.1 Standard

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

Warnings and signage exist to warn those whose health may be affected by x-rays.

416.49.b.1 Standard

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

Staff maintains dosimetry badges and records, if applicable, for at least 3 years.

416.49.b.1 Standard

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

Radiologic services may only be provided when integral to procedures offered by the ASC and must meet the requirements specified in 42CFR482.26(b), (c)(2), and (d)(2).

416.49.b.1

Standard

Page 50

AAAASF Medicare V7.1

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

If radiologic services are utilized, the governing body must appoint an individual qualified

in accordance with State law and ASC policies who is responsible for assuring all

radiologic services are provided in accordance with the requirements of 42 CFR 416.49.

416.49.b.2

Standard

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

If the facility provides laboratory services, the laboratory must meet the requirements of

part 493 of 42 CFR.

If the facility does not provide laboratory services, any referral laboratory must be

certified in the appropriate specialties and sub-specialties of service to perform the

referred tests in accordance with the requirements of part 493 of 42 CFR. The referral

laboratory must be certified in the appropriate specialties and subspecialties of service

to perform the referred tests in accordance with the requirements of Part 493 of this

chapter of the Code of Federal Regulations. (Found in the Code of Federal Regulations;

Part 416 – Ambulatory Surgical Services; 416.49 Laboratory and radiologic services;

Standard: (b) Radiologic Services).

416.49.a Standard

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

The ambulatory surgery facility’s policies and procedures must list the

kinds of laboratory services that are provided directly by the facility and

services that are provided through a contractual agreement.

Page 51

AAAASF Medicare V7.1

400.020 Emergency Protocols

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

There must be a written protocol for security emergencies, such as an intruder in the facility, an unruly patient or visitor, a threat to the staff or patients.

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

There must be a written protocol for fires and fire drills.

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

There must be a written protocol for returning patients to the operating room in the event of patient emergencies.

400.020.025 Compliant Deficient C

There must be a written protocol for malignant hyperthermia (MH).

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

There must be a written protocol for cardiopulmonary resuscitation (CPR).

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

There must be a written protocol for a situation in which the surgeon becomes incapacitated.

400.020.040 Compliant Deficient B,C-M,C

There must be a written protocol for a situation in which the anesthesiologist or CRNA becomes incapacitated.

Page 52

AAAASF Medicare V7.1

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

There must be a written protocol for response to power failure emergencies.

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

There must be a written protocol for transferring patients to a hospital in an emergency.

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

There must be a written plan for emergency evacuation of the facility.

400.020.060

Compliant Deficient A,B,C-M,C

If requested, the facility’s personnel can demonstrate the evacuation of a

patient.

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

Personnel trained in the use of emergency equipment and in cardiopulmonary resuscitation must be available whenever a patient is in the ambulatory surgery facility.

416.44.e Standard

400.020.070

Compliant Deficient A,B,C-M,C

Anesthesia personnel should review and be familiar with the facility’s emergency protocol for cardio-pulmonary emergencies and other internal and external disasters.

Page 53

AAAASF Medicare V7.1

400.021 Transfer Agreement

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

This hospital must be a local, Medicare-participating hospital or a local,

nonparticipating hospital that meets the requirements for payment for

emergency services under 42 CFR 482.2.

416.41.b.2

Standard

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

The ASC must provide the local hospital with written notice of its operations and

patient population served at least annually.

416.41.b.3

Standard

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

The ASC must have an effective procedure for the immediate transfer, to a

hospital, of patients requiring emergency medical care beyond the

capabilities of the ASC. (Found in the Code of Federal Regulation, part

416.41(b)(1); Hospitalization).

416.41.b Standard

416.41.b.1 Standard

Page 54

AAAASF Medicare V7.1

500

IV FLUIDS ANDMEDICATIONS

500.010

Blood & Substitutes

500.010.010

Compliant Deficient

A,B,C-M,C

Intravenous fluids such as Lactated Ringer’s solution and/or normal

saline are available in the facility.

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

If blood were to be used, there is a protocol for it to be typed, cross-

matched, checked, and verified.

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

Blood and blood products must be administered only by

physicians or registered nurses.

416.48.a.2 Standard

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500.020

Medications

500.020.010

Compliant

Deficient

A,B,C-M,C

Emergency Drug Box—all emergency medications as noted in the following standards must be available and in the facility at all times. Licensed personnel in the facility must know their location.

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

There is a dated controlled substance inventory and a control record which includes the use of controlled substances on individual patients. Such records must be kept in the form of a sequentially numbered, bound journal from which pages may not be removed, or in a tamper-proof, secured computer record consistent with state and federal law. A loose-leaf notebook or a spiral-bound notebook does not fulfill this regulation. This log must be kept in the facility.

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

The inventory of controlled substances is verified by 2 licensed members of the operating room team on any day that controlled substances are administered, and in compliance with state and federal regulations.

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

All narcotics and controlled substances are secured and locked under supervised access.

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

Outdated medications are removed.

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

IV Antihistamines (e.g. Diphenhydramine).

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

Short-acting beta-blocker (e.g. Esmolol or Labetalol).

500.020.055 Compliant Deficient C-M,C

Neuromuscular blocking agents including non-depolarizing agents such as rocuronium or depolarizing agents such as succinylcholine.

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500.020.060 Compliant Deficient B,C-M,C

If Benzodiazepine is used in the facility, a reversing agent must be available.

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

There must be a record of receipt and disposition of all controlled drugs.

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

The ambulatory surgery facility must provide drugs and biologicals in a safe and effective manner, in accordance with accepted professional practice and under the direction of an individual designated responsible for pharmaceutical services.

416.48 Condition

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

Drugs must be prepared and administered according to established policies and acceptable standards of practice.

416.48.a Standard

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

If there is an adverse reaction, it must be immediately reported to the physician responsible for the patient and must be documented in the patient’s record.

416.48.a.1 Standard

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

Orders given orally for drugs and biologicals must be followed by a written order and signed by the prescribing physician.

416.48.a.3 Standard

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500.021 ACLS Algorithm

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

A transportable “crash” cart or kit is maintained independent of other operating

room supplies such that emergency equipment is immediately available. It will

contain “first response” essentials of ACLS care, such as suction, positive

pressure ventilation, devices for maintaining an airway, intravenous access, and medications.

500.021.018

Compliant Deficient A,B,C-M,C

The following medication must be available in the facility at all times as required by current ACLS algorithms Seizure arresting medication (a benzodiazepine, e.g. Midazolam).

500.021.019

Compliant Deficient A,B,C-M,C

The following medication must be available in the facility at all times as required by current ACLS algorithms Adenosine

500.021.0 20

Compliant Deficient A,B,C-M,C

The following medication must be available in the facility at all times as required by current ACLS Algorithms: Epinephrine.

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

500.021.0 25

500.021.026

The following medication must be available in the facility at all times as required by current ACLS algorithms Anti-Hypertensives.

Compliant Deficient A,B,C-M,C

The following medication must be available in the facility at all times as required by current ACLS algorithms Lidocaine—plain.

Compliant Deficient A,B,C-M,C

The following medication must be available in the facility at all times as required by current ACLS algorithms Atropine.

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500.021.027

Compliant Deficient A,B,C-M,C

The following medication must be available in the facility at all times as required by current ACLS algorithms nitroglycerine (paste or oral).

500.021.035 Compliant Deficient B,C-M,C

The following medication must be available in the facility at all times as required by current ACLS algorithms If narcotics are used in the facility, a narcotic antagonist (eg, Narcan) should be present.

500.021.040 Compliant Deficient B,C-M,C

The following medication must be available in the facility at all times as required by current ACLS algorithms Anticonvulsant medication.

500.021.045 Compliant Deficient A,B,C-M,C The following medication must be available in the facility at all times as

required by current ACLS algorithms Bronchospasm-arresting medication (inhaled beta-agonist, eg albuterol).

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

The following medication must be available in the facility at all times as required by current ACLS algorithms Intravenous corticosteroids (eg, dexamethasone).

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500.023 Malignant Hyperthermia

This section applies if potential MH triggering agents such as the potent inhalation anesthetics halothane, enflurane, isoflurane, sevoflurane, and desflurane are ever used or are present in the facility.

500.023.005 Compliant Deficient C-M,C

If the depolarizing muscle relaxant succinylcholine is present only for use in emergency airway rescue, the facility must document a protocol to manage the possibility of malignant hyperthermia (MH) following its use.

500.023.010 Compliant Deficient C-M,C

There must be adequate screening for MH risk that includes but is not limited to a family history of unexpected death(s) following general anesthesia or exercise; a family or personal history of MH, a muscle or neuromuscular disorder, high temperature following exercise; a personal history of muscle spasm, dark or chocolate-colored urine, or unanticipated fever immediately following anesthesia or serious exercise.

500.023.015 Compliant Deficient C-M,C

The facility director and all operating surgeons and anesthesiology providers should be aware of genetic and/or caffeine-halothane contracture testing (CHCT) for MH and refer patients for appropriate testing if there is a suspicious history as above prior to permitting surgery to take place in the facility.

500.023.020 Compliant Deficient C-M,C

The medical director should be able to demonstrate that all operating surgeons and anesthesia providers have familiarity with the early recognition of impending MH crisis as defined by the Malignant Hyperthermia Association of the United States (MHAUS).

500.023.025 Compliant Deficient C-M,C

The medical director will ensure that all staff are trained and annual drills are conducted for MH crisis and management including actual dilution of at least one vial of actual Dantrolene (expired OK). Staff should be assigned roles prior to drills and a written protocol outlining those personnel and their roles is on file. Documentation of drills is required.

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500.023.030 Compliant Deficient C

A supply of sterile water for injection USP (without a bacteriostatic agent) is available to mix with dantrolene before injection (ie. 60ml/vial for Dantrium® and Revonto®, 5ml/vial for Ryanodex®)

500.023.035 Compliant Deficient C

A minimum of 4 ampoules, 50cc’s each, of sodium bicarbonate (NaHCO3).

500.023.040 Compliant Deficient C

A minimum supply of dantrolene/ryanodex should be stocked to treat a patient of average weight (approximately 70kg) with an initial dose: Dantrium®/Revonto® - 12 vials (20 mg/vial) Ryanodex® - 1 vial (250 mg/vial)

500.023.045 Compliant Deficient C

An additional* supply of dantrolene/ryanodex and diluents are stored in the facility, or the facility has a written agreement with another source that will provide additional* dantrolene/ryanodex and diluents on a STAT basis within 15 minutes for continued treatment and stabilization of a patient experiencing a MH episode. **additional supply of dantrolene is defined as: Dantrium®/Revonto® - 24 vials (20 mg/vial) Ryanodex® - 2 vials (250 mg/vial)

500.023.050 Compliant Deficient C-M,C

The MHAUS malignant hyperthermia algorithms must be available on the emergency cart.

500.023.055 Compliant Deficient C-M,C

Flow sheets for any MH intervention, as well as forms to rapidly communicate progress of intervention with receiving facilities, are on the emergency cart and all facilities must document and report any “adverse metabolic or

musculoskeletal reaction to anesthesia.” This documentation must be

transportable with the patient when transferred to a receiving facility.

500.023.060 Compliant Deficient C-M,C

Facilities should establish the best destination as a transfer standard, which means the facility director has pre-planned for MH transfer and established the capabilities of a facility within a reasonable distance (eg, a tertiary care center that is further away may be better than a community-type emergency room that is closer). The facility must make advanced arrangements with an emergency medical service (EMS) provider to

accommodate the facility’s MH transfer plan. The facility’s medical director must also

ensure the ability of the receiving transport team to continue the MHAUS protocol.

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AAAASF Medicare V7.1

600.010

General

600

MEDICAL RECORDS

600.010.001

600.010.002

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

Compliant Deficient A,B,C-M,C

The facility must maintain separate, complete, comprehensive and accurate medical records to ensure adequate patient care.

416.47 Condition

Compliant Deficient A,B,C-M,C

The facility must develop and maintain a system for the proper collection, storage, and use of patient records.

416.47.a

Electronic medical records (EMR) must comply with security and privacy obligations under current HIPPA regulations.

Standard

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

Medical records for each patient must be accurate, legible, and promptly completed.

416.47.b

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

Medical records must be retained for the number of years required by state and/or federal law; or for a minimum of 3 years to comply with the AAAASF 3-year survey cycle.

Standard

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AAAASF Medicare V7.1

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

Medical records are filed for easy accessibility and must be maintained in the facility regardless of the location of the operating surgeon’s office.

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

Records contain appropriate patient identification.

416.47.b.1 Standard

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

Medical records must be kept secure and confidential, consistent with HIPAA regulations.

600.010.030 Compliant Deficient

The ASC must develop and maintain a policy that identifies those patients who require a medical history and physical examination prior to surgery.

The policy must:

-Include the 30-day time frame for medical history and physical examination to be completed prior to surgery.

-Address, at minimum, the following factors: patient age, diagnosis, the type and number of procedures scheduled to be performed on the same surgery date, known comorbidities, and the planned anesthesia level.

-Be based on any applicable nationally recognized standards of practice and guidelines, and any applicable State and local health and safety laws.

416.52.a.1; 416.52.a.1.i; 416.52.a.1.ii; 416.52.a.1.iii Standard

600.010.035

Compliant

Deficient

Significant medical history and a physical examination covering the organs and systems commensurate with the procedure(s) are recorded on all patients and placed in the clinical record prior to the surgical procedure.

A,B,C-M,C

600.010.050

416.47.b.2 Standard

Compliant Deficient A,B,C-M,C

All medical records must include a discharge diagnosis.

416.47.b.8 Standard

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AAAASF Medicare V7.1

600.011

Pre-operative Medical Record

"The medical record includes responses to the following questions:"

600.011.005

Compliant Deficient A, B,C-M,C

A pregnancy testing policy must be in place that requires a discussion and documentation of the issue with each patient.

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

The pre-operative medical record includes responses regarding any allergies and abnormal drug reactions.

416.47.b.5 Standard

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

The pre-operative medical record includes responses regarding current medications.

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

The pre-operative medical record includes responses regarding previous serious illness.

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

The pre-operative medical record includes responses regarding current and chronic illness.

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

The pre-operative medical record includes responses regarding previous surgeries.

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AAAASF Medicare V7.1

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

The pre-operative medical record includes responses regarding perioperative bleeding risk including medical conditions and medication taken up to the day of the procedure.

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

Treating physicians or consultants are contacted in cases where warranted by the history and physical examination.

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

Appropriate laboratory procedures are performed where indicated.

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

The medical history includes pre-operative diagnostic studies (entered before surgery), if performed.

416.47.b.3 Standard

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AAAASF Medicare V7.1

600.020 Informed Consent Forms

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

Properly executed informed consent forms are always obtained, which authorizes the surgeon by name to perform surgery and describes the operative procedure.

416.47.b.7 Standard

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

Expectations, alternatives, risks, and complications are discussed with the patient, and these are documented.

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

The informed consent provides consent for administration of anesthesia or sedatives under the direction of the surgeon, CRNA, or anesthesiologist.

600.020.0 25

600.020.0 26

600.020.0 27

Compliant Deficient A,B,C-M,C

Advance Directives. The ASC must comply with the following requirement: Provide the patient or, as appropriate, the patient’s representative with written information concerning its policies on advance directives, including a description of applicable State health and safety laws, and, if requested, official State advance directive forms.

416.50.c Standard

416.50.c.1 Standard

Compliant Deficient A,B,C-M,C

Advance Directives. The ASC must comply with the following requirement:

Inform the patient or, as appropriate, the patient’s representative or surrogate of the patient’s

right to make informed decisions regarding the patient's care.

416.50.c.2 Standard

Compliant Deficient A,B,C-M,C

Advance Directives. The ASC must comply with the following requirement: Document in a prominent part of the patient’s current medical record, whether or not the individual has executed an advance directive.

416.50.c.3 Standard

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AAAASF Medicare V7.1

600.030 Laboratory, Pathology, X-Ray, Consultation and Treating Physician Reports

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

Printed or written copies of these reports are kept in the medical record.

600.030.015

600.030.016

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

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

Compliant Deficient A,B,C-M,C

All laboratory results must be reviewed and initialed by the CRNA, anesthesiologist, registered nurse or surgeon.

Compliant Deficient A,B,C-M,C

All abnormal laboratory results must be reviewed and initialed by the surgeon within 1 week of receipt of results.

All other reports, such as pathology reports and medical clearance reports, must be reviewed and initialed by the surgeon.

The name of the pathologist must be on all pathology reports.

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

All surgical specimens must get submitted for pathological processing except those exempted by the governing body.

416.47(b)(4) Standard

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AAAASF Medicare V7.1

600.040 Operating Room Records (Major Cases)

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

A separate surgical log of all cases is maintained, either in a tamper proof log with sequentially numbered pages, or in a secured computer log.

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

A surgical log must include a numerical listing of patients with either consecutive numbering from the first case carried out in the facility, or consecutive numbers starting each year.

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

A surgical log must include the date of surgery.

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

A Surgical Log must include: Patient's name and/or identification number.

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

A surgical log must include: Record of surgery(ies) and other invasive procedures to be conducted during the case.

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

A surgical log must include: The surgeon’s name.

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AAAASF Medicare V7.1

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

A surgical log must include: Record of the type of anesthesia used.

416.47.b.6 Standard

600.040.045 Compliant Deficient B,C-M,C

A Surgical Log must include: Name of person(s) administering anesthesia.

416.47.b.6 Standard

600.040.050 Compliant Deficient B,C-M,C

A surgical log must include the name of the person(s) assisting the surgeon (MD,

RN, scrub tech/circulating RN, PA).

600.040.060 Compliant Deficient B,C-M,C

A separate anesthesia record is maintained in which all medications given to a patient are recorded, including date, time, amount, and route of administration.

416.47.b.6 Standard

600.040.065 Compliant Deficient B,C-M,C

A separate anesthesia record is maintained in which all intravenous and subcutaneous fluids given pre-operatively, intra-operatively, and postoperatively are recorded.

416.47.b.6 Standard

600.040.070 Compliant Deficient B,C-M,C

A separate anesthesia record is maintained in which post-operative vital signs are recorded until the patient is discharged from the facility.

416.47.b.6 Standard

416.52.b Standard

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AAAASF Medicare V7.1

600.040.075

Compliant

Deficient B,C-M,C

There is an operative report which includes operative technique and findings.

600.040.080 Compliant Deficient B,C-M,C

Post-operative progress notes are recorded.

600.040.085

Compliant

Deficient B,C-M,C

A separate anesthesia record is maintained in which: Vital signs are recorded during surgery.

416.47.b.6 Standard

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AAAASF Medicare V7.1

700

QUALITY ASSESSMENT/QUALITY IMPROVEMENT

700.010

Quality Improvement

700.010.005

Compliant Deficient A,B,C-M,C

The ASC must develop, implement and maintain an ongoing, data-driven quality assessment and performance improvement (QAPI) program.

416.43 Condition

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

The facility has a written quality improvement program implemented which includes surveys or projects that monitor and evaluate patient care

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

The facility has a written quality improvement program implemented which includes surveys or projects that evaluate methods to improve patient care

416.43.c Standard

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

The facility has a written quality improvement program implemented which includes surveys or projects that identify and correct deficiencies within the facility

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

The facility has a written quality improvement program implemented which includes surveys or projects that alert the medical director to identify and resolve problems

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AAAASF Medicare V7.1

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

The facility has a written quality improvement program implemented which includes documentation of quarterly peer review meetings for the prior 3 years, which should be available for the surveyor

700.010.0 40

700.010.0 41

700.010.046

Compliant Deficient A,B,C-M,C

The program must include, but not be limited to, an ongoing program that demonstrates measurable improvement in patient health outcomes and improves patient safety by using quality indicators or performance measures associated with improved health outcomes and by the identification and reduction of medical errors.

416.43.a Standard

416.43.a.1 Standard

Compliant Deficient A,B,C-M,C

The ASC must measure, analyze, and track quality indicators, adverse patient events, infection control and other aspects of performance that includes care and services furnished in the ASC.

416.43.a.2 Standard

Compliant Deficient A,B,C-M,C

700.010.0 47

The ASC must set priorities for its performance improvement activities that focus on high risk, high volume, and problem-prone areas.

416.43.c.1 Standard

416.43.c.1.(i) Standard

Compliant Deficient A,B,C-M,C

The ASC must set priorities for its performance improvement activities that consider incidence, prevalence, and severity of problems in those areas.

416.43.c.1.(ii) Standard

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AAAASF Medicare V7.1

700.010.048

700.010.049

700.010.050

Compliant Deficient A,B,C-M,C

The ASC must set priorities for its performance improvement activities that affect health outcomes, patient safety, and quality of care.

416.43.c.1.(iii) Standard

Compliant Deficient A,B,C-M,C

Performance improvement activities must track adverse patient events, examine their causes, implement improvements, and ensure that improvements are sustained over time.

416.43.c.2 Standard

Compliant Deficient A,B,C-M,C

The ASC must implement preventive strategies throughout the facility targeting adverse patient events and ensure that all staff are familiar with these strategies.

416.43.c.3 Standard

700.010.052

700.010.053

Compliant Deficient A,B,C-M,C

The number and scope of distinct improvement projects conducted annually must reflect the scope and complexity of the ASC’s services and operations.

416.43.d Standard

416.43.d.1 Standard

Compliant Deficient A,B,C-M,C

The ASC must document the projects that are being conducted. The documentation, at a minimum, must include the reason(s) for implementing the project, and a description of the project’s results.

416.43.d.2 Standard

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AAAASF Medicare V7.1

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

The program must incorporate quality indicator data, including patient care and other relevant data regarding services furnished in the ASC.

416.43.b Standard

416.43.b.1 Standard

700.010.0 57

700.010.058

700.010.0 61

Compliant Deficient A,B,C-M,C

The ASC must use the data collected to monitor the effectiveness and safety of its services, and quality of its care.

416.43.b.2 Standard

416.43.b.2.(i) Standard

Compliant

Deficient A,B,C-M,C

The ASC must use the data collected to identify opportunities that could lead to improvements and changes in its patient care.

416.43.b.2.(ii) Standard

Compliant Deficient A,B,C-M,C

The governing body must ensure that the QAPI program is defined, implemented, and maintained by the ASC.

416.43.e Standard

416.43.e.1 Standard

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AAAASF Medicare V7.1

700.010.062

700.010.063

700.010.064

Compliant Deficient A,B,C-M,C

The governing body must ensure that the QAPI program addresses the ASC’s priorities

and that all improvements are evaluated for effectiveness.

416.43.e.2 Standard

Compliant Deficient A,B,C-M,C

The governing body must ensure that the QAPI program specifies data collection methods, frequency, and details.

416.43.e.3 Standard

Compliant Deficient A,B,C-M,C

The governing body must ensure that the QAPI program clearly establishes its expectations for safety.

416.43.e.4 Standard

700.010.065

Compliant Deficient A,B,C-M,C

The governing body must ensure that the QAPI program adequately allocates sufficient staff, time, information systems and training to implement the QAPI program.

416.43.e.5 Standard

Page 75

700.020 Peer Review

AAAASF Medicare V7.1

700.020.000 Compliant Deficient

A,B,C-M,C

Note: To be HIPAA compliant, a copy of the HIPPA Business Associate Agreement must be signed by each physician working outside the facility participating in peer review, and a copy must be retained on file in the facility. For an example of a confidentiality agreement, contact the AAAASF central office.

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

Peer review is performed and submitted to the online system or sent to the AAAASF office for upload at least every 6 months and includes reviews of both random cases and unanticipated operative sequelae using the AAAASF forms and reporting format. A random sample of the cases for each surgeon must include the first case done by each surgeon each month during the reporting period for a total of 6 cases. If a surgeon using the facility has done fewer than 6 cases during a reporting period, that must be reported to the AAAASF Central Office and all of that surgeon’s cases during that period must be reviewed. The facility must maintain a record of its compliance onsite for a minimum of three years.

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

If peer review sources external to the facility are used to evaluate delivery of medical care, the HIPPA business agreement is so written as to waive confidentiality of the medical records.

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

Peer review may be done by a recognized peer review organization or a physician, podiatrist, or oral and maxillofacial surgeon other than the operating surgeon.

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AAAASF Medicare V7.1

700.030 Random Case Review

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

A minimum of 6 cases for each surgeon operating in the facility are reviewed every 6 months, or all cases performed by surgeons who have fewer than 6 cases completed for the period.

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

Random case reviews must include, at a minimum, record of the adequacy and legibility of history and physical exam.

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

Random case reviews must include, at a minimum, record of the adequacy of surgical and anesthesia consent.

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

Random case reviews must include, at a minimum, record of the presence of appropriate laboratory, EKG, and radiographic reports.

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

Random case reviews must include, at a minimum, record of the presence of a written operative report.

700.030.035 Compliant Deficient B,C-M,C

Random case reviews must include, at a minimum, anesthesia and recovery record (with IV sedation or general anesthesia).

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

Random case reviews must include, at a minimum, record of the Presence of instructions for post-operative care.

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

Random case reviews must include, at a minimum, record of the documentation of any complications.

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AAAASF Medicare V7.1

700.040 Unanticipated Operative Sequelae

All unanticipated operative sequelae which occur within 30 days of surgery are reviewed, including but not limited to:

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

Review record of any unplanned hospital admission.

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

Review record of any unscheduled return to the operating room for a complication of a previous surgery.

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

Review record of any complications such as infection, bleeding, wound dehiscence, or inadvertent injury to another body structure.

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

Review record of any cardiac or respiratory problems during the patient’s

stay at the facility or within 48 hours of discharge.

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

Review record of any allergic reactions.

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

Review record of any incorrect needle or sponge count.

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

Review record of any patient or family complaint.

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AAAASF Medicare V7.1

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

Review record of any equipment malfunction leading to injury or potential injury to the patient.

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

Review record of any a death occurring within 30 days of a procedure done in an AAAASF-accredited facility must be reported to the AAAASF office within 5 days of notification of the death.

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

Each unanticipated operative sequelae chart review must include the following information, in addition to the operation performed, identification of the problem.

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

Each unanticipated operative sequela chart review must include the following information, in addition to the operation performed, immediate treatment or disposition of the case.

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

Each unanticipated operative sequela chart review must include the following information, in addition to the operation performed, outcome.

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

Each unanticipated operative sequela chart review must include the following information, in addition to the operation performed, reason for the problem.

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

Each unanticipated operative sequela chart review must include the following information, in addition to the operation performed, assessment of the efficacy of treatment.

Page 79

AAAASF Medicare V7.1

700.050 Patient’s Bill of Rights

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

A copy of the AAAASF Patient’s Rights is prominently displayed in a place or places likely to be noticed by patients waiting for treatment or by the patient's representative or surrogate if applicable and a copy is provided to each patient, patients representative or surrogate. Facility personnel must adhere to, protect, and promote the Patient's Rights.

416.50.a Condition

700.050.050

700.050.051

700.050.052

Compliant Deficient A,B,C-M,C

The ASC must provide the patient or the patient’s representative with verbal and written notice of the patient’s rights prior to the start of the surgical

procedure in a language and manner that the patient or the patient’s representative understands.

416.50.a Standard

Compliant Deficient A,B,C-M,C

The ASC’s notice of rights must include the name, address, and telephone number of a representative in the State agency to whom patients can report complaints, as well as the Web site for the Office of the Medicare Beneficiary Ombudsman.

416.50.a

Standard

Compliant Deficient A,B,C-M,C

The ASC must also disclose, where applicable, physician financial interests or ownership in the ASC facility, and where applicable, provide a list of physicians who have financial interest or ownership in the ASC facility in accordance with the intent of 42 CFR 420. Disclosure of information must be in writing and furnished to the patient in advance of the date of the procedure.

416.50.b

Standard

Page 80

AAAASF Medicare V7.1

700.60

700.060.015

700.060.016

700.060.027

Competency, Grievances

Compliant Deficient A,B,C-M,C

If a patient is adjudged incompetent under applicable State laws by a court of proper jurisdiction, the rights of the patient are exercised by the person appointed under State law to act on the patient’s behalf.

416.50.e.2 Standard

Compliant Deficient A,B,C-M,C

If a State court has not adjudged a patient incompetent, any legal representative or surrogate designated by the patient in accordance with State law may exercise the patient's rights to the extent allowed by State law.

416.50.e.3 Standard

Compliant Deficient A,B,C-M,C

700.060.028

700.060.029

The patient has the right to: Be free from any act of discrimination or reprisal.

416.50.e Standard

416.50.e.1 Standard

416.50.e.1.(i) Standard

Compliant Deficient A,B,C-M,C

The patient has the right to: Voice grievances regarding treatment or care that is (or fails to be) provided.

416.50.e.1.(ii) Standard

Compliant Deficient A,B,C-M,C

The patient has the right to: Be fully informed about a treatment or procedure and the expected outcome before it is performed.

416.50.e.1.(iii) Standard

Page 81

AAAASF Medicare V7.1

700.060.030

700.060.041

700.060.042

Compliant Deficient A,B,C-M,C

The ASC must comply with the Department of Health and Human Services' rules for the privacy and security of individually identifiable health information, as specified at 45 CFR parts 160 and 164.

416.50.g Standard

Compliant Deficient A,B,C-M,C

The ASC must establish a grievance procedure for documenting the existence,

submission, investigation, and disposition of a patient’s written or verbal grievance to

the ASC.

416.50.d Standard

Compliant Deficient A,B,C-M,C

All alleged violations/grievances relating, but not limited to, mistreatment, neglect, verbal, mental, sexual, or physical abuse, must be fully documented.

416.50.d.1 Standard

700.060.0 43

700.060.0 44

Compliant Deficient A,B,C-M,C

All allegations must be immediately reported to a person in authority in the ASC.

416.50.d.2 Standard

Compliant Deficient A,B,C-M,C

Only substantiated allegations must be reported to the State authority or the local authority, or both.

416.50.d.3 Standard

Page 82

AAAASF Medicare V7.1

700.060.045

700.060.046

700.060.047

Compliant Deficient A,B,C-M,C

The grievance process must specify timeframes for review of the grievance and the provisions of a response.

416.50.d.4 Standard

Compliant Deficient A,B,C-M,C

The ASC, in responding to the grievance, must investigate all grievances made by a patient, the patient’s representative, or the patient's surrogate regarding treatment or care that is (or fails to be) furnished.

416.50.d.5 Standard

Compliant Deficient A,B,C-M,C

The ASC must document how the grievance was addressed, as well as provide the patient, the patient's representative, or the patient's surrogate with written notice of its decision. The decision must contain the name of an ASC contact person, the steps taken to investigate the grievance, the results of the grievance process, and the date the grievance process was completed.

416.50.d.6 Standard

700.060.051

700.060.052

700.060.053

Compliant Deficient A,B,C-M,C

The patient has a right to personal privacy.

416.50.f Standard

416.50.f.1 Standard

Compliant Deficient A,B,C-M,C

The patient has a right to receive care in a safe setting. 416.50.f.2 Standard

Compliant Deficient A,B,C-M,C

The patient has a right to be free from all forms of abuse or harassment.

416.50.f.3 Standard

Page 83

AAAASF Medicare V7.1

800

PERSONNEL

800.005 Medical Director

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

The medical director must have an MD or DO degree.

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

The medical director must be a physician currently licensed by the state in which the facility is located.

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

The medical director must be a physician certified or eligible for certification by either an ABMS medical or surgical specialty certifying boards or by the AOABS.

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

The medical director must be actively involved in the direction and management of the facility.

Page 84

AAAASF Medicare V7.1

800.010 Staff Physicians, Podiatrists, or Oral Surgeons

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

Each physician, podiatrist, or oral and maxillofacial surgeon using the facility is credentialed and qualified for the surgical procedures they perform.

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

Procedures must be performed in a safe manner by qualified physicians who have been granted clinical privileges by the governing body in accordance with approved policies and procedures of the facility.

416.42 Condition

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

Physicians, podiatrists, or oral and maxillofacial surgeons who operate in facilities accredited by AAAASF must hold or demonstrate that they have held valid, unrestricted hospital privileges in their specialty at an accredited and/or licensed hospital. Only surgical procedures included within those hospital privileges may be performed within the AAAASF-accredited facility. If the privilege-granting hospital does not possess equipment or technology to allow a physician, podiatrist, or oral and maxillofacial surgeon to be credentialed for a specific surgery, the physician, podiatrist, or oral and maxillofacial surgeon may provide alternative evidence of training and competence in that surgery. Individual consideration will be given if the physician, podiatrist, or oral and maxillofacial surgeon no longer possesses or cannot obtain such privileges and can demonstrate that loss of or inability to obtain such privileges was not related to lack of clinical competence, ethical issues, or problems other than economic competition.

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

If the physician, podiatrist, or oral and maxillofacial surgeon does not hold admitting privileges at a hospital within 30 minutes of the facility, there must be a signed and dated document from a person in the same specialty who has admitting privileges in a hospital within 30 minutes of the facility that indicates their willingness to admit the patient to the hospital.

Page 85

AAAASF Medicare V7.1

800.010.035 Compliant Deficient A,B,C-M,C Each physician, podiatrist, or oral and maxillofacial surgeon must currently be

licensed by the state in which they practice. Copies of each physician’s,

podiatrist’s, or oral and maxillofacial surgeon’s current license must be

maintained on file in the facility.

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

Any change in the physician, podiatrist, or oral and maxillofacial surgeon staff must be reported in writing to the AAAASF Central Office within 30 days of such changes. Including copies of the following credentials of any new staff Current medical license ABMS board certification, AOABS board certification, or other approved board certification, letter of eligibility to any of the listed boards, or equivalent documentation for podiatrists or oral and maxillofacial surgeons. Current documentation of hospital privileges or satisfactory explanation for the lack thereof, must also be sent to the AAAASF Central Office.

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

Any action affecting the current professional license of the facility director, a member of the medical staff, a member of the physician pain management staff, or other licensed facility staff must be reported in writing to the AAAASF Central Office within 10 days of the time the facility director becomes aware of such an action.

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

Members of the medical staff must be legally and professionally qualified for the positions to which they are appointed and for the performance of privileges granted. The ASC grants privileges in accordance with recommendations from qualified medical personnel.

416.45.a

Standard

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

Medical staff privileges must be periodically reappraised by the ASC and the scope of procedures must be periodically reviewed and amended as appropriate.

416.45.b

Standard

Page 86

AAAASF Medicare V7.1

800.020 Anesthesiologist/CRNA

800.020.050 Compliant Deficient B,C-M,C

If anesthesiologists, anesthesia assistants (as certified by the NCCAA) under direct supervision of the anesthesiologist and/or CRNAs participate in patient care at the facility, they are qualified for the procedures they perform and their credentials have been verified.

800.020.055 Compliant Deficient B,C-M,C

All anesthesiologists and CRNAs must be licensed or accredited by the state in which they practice.

800.020.060 Compliant Deficient C-M,C

All anesthesiologists and CRNAs must be responsible for the administration of dissociative anesthesia with propofol, spinal or epidural blocks, or general anesthesia and monitoring of all life support systems.

800.020.070 Compliant Deficient C-M,C

An anesthesiologist/CRNA cannot function in any other capacity (eg, surgical assistant or circulating nurse) during the surgery.

Page 87

AAAASF Medicare V7.1

800.025 Nurse

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

There must be a registered nurse available for emergency treatment whenever there is a patient in the ambulatory surgery facility.

416.46.a Standard

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

Patient care responsibilities must be delineated for all nursing service personnel.

416.46.a Standard

800.025.020 Compliant Deficient A,B,C-M,C The nursing services of the ASC must be directed and staffed to assure that

the nursing needs of all patients are met and must be provided in accordance with recognized standards of practice.

416.46.a Standard

416.46 Condition

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

If the ASC assigns patient care responsibilities to practitioners other than physicians, it must have established policies and procedures, approved by the governing body, for overseeing and evaluating their clinical activities.

416.45.c Standard

Page 88

AAAASF Medicare V7.1

800.030 Operating Room Personnel

800.030.010 Compliant Deficient B,C-M,C

All operating suite personnel are under the immediate supervision of a

registered nurse, a physician other than the operating physician, or physician’s

assistant.

800.030.015 Compliant Deficient B,C-M,C

All operating suite personnel must meet acceptable standards as defined by their professional governing bodies, where applicable.

800.030.020 Compliant Deficient B,C-M,C

When a patient is present in the facility to undergo a procedure under a higher level of anesthesia than meets the AAAASF definition of Class A, there is a regularly employed and licensed registered nurse, physician other than the

operating surgeon, or physician’s assistant designated as the person

responsible for patient care in all areas of the facility (ie, operating room and patient care areas), in accordance with state law.

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

No nurse provides coverage in the ASC and in an adjacent clinic (or hospital) at the same time.

Page 89

AAAASF Medicare V7.1

800.040 Personnel Records

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

IMPORTANT: Employee information such as previous employment, health information (except state required immunization and test) disabilities, employment and performance reviews are protected and of no interest to the AAAASF surveyor. However, the surveyor does need to confirm that an adequate file is kept on each employee related to the items listed below. Please have only this data available for each employee, separate from the employee files.

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

There is a manual outlining personnel policies.

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

The manual contains personnel policies and records which are maintained according to OSHA and HIPAA guidelines.

IMPORTANT: Employee information must remain strictly confidential.

Page 90

AAAASF Medicare V7.1

800.041

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

800.041.010

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

Records and Experience

Personnel records contain Any health problems of the individual which may be hazardous to the

employee, other employees or patients, and a plan of action or special precautions delineated as needed.

Compliant Deficient A,B,C-M,C

Personnel records contain Resume of training and experience

Personnel records contain Current certification or license if required by the state

800.041.020

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

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

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

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

Personnel records contain Date of employment

Personnel records contain Description of duties

Personnel records contain Record of continuing education

Personnel records contain Inoculations or refusals

Page 91

AAAASF Medicare V7.1

800.042 Personnel Records: Safety Training

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

Personnel records contain training documentation relative to hazard safety training.

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

Personnel records contain training documentation relative to blood-borne pathogens.

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

Personnel records contain training documentation relative to universal precautions.

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

Personnel records contain training documentation relative to other safety training, such as operation of a fire extinguisher.

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

Personnel records contain training documentation relative to at least basic cardiopulmonary life support (BCLS) certification for each operating room and recovery room team member, and ACLS certification for one team member, is required.

Page 92

AAAASF Medicare V7.1

800.050 Knowledge, Skill & CME Training

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

The operating room personnel have knowledge of MH, cardiopulmonary, and anaphylactic emergencies. At least one member of the operating room team, preferably the surgeon or the anesthesia care giver, holds current ACLS certification.

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

The operating room personnel are familiar with equipment and procedures utilized in the treatment of the above emergencies.

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

If a gas sterilizer is used, personnel are thoroughly familiar with the operating instructions.

Page 93

AAAASF Medicare V7.1

800.060 Personnel Safety

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

If an ethylene oxide gas sterilizer is used, appropriate personnel are badge-tested to ensure that there is no significant exposure.

800.060.015 Compliant Deficient C

Personnel are properly trained in the control procedures and work practices that have been demonstrated to reduce occupational exposures to anesthetic gases.

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

There is a written policy for what is considered to be personal protective equipment for specific tasks in the facility (eg, instrument cleaning, disposal of biological waste, surgery, radiology protection, etc.).

Page 94

AAAASF Medicare V7.1

900

ANESTHESIA

900.000.000

The following anesthesia standards apply to all patients who receive anesthesia or sedation/analgesia. In extreme emergencies or lifethreatening circumstances, these standards may be modified; all such circumstances should be documented in the patient’s record.

900.005

Delivery of Anesthesia

900.005.006

Compliant Deficient A,B,C-M,C

An ASC may be exempted from the requirement for physician supervision of CRNAs as described in AAAASF Standard 900.005.015, if the State in which the ASC is located submits a letter to CMS signed by the Governor, following consultation with the State’s Boards of Medicine and Nursing, requesting exemption from physician supervision of CRNAs. The letter from the Governor must attest that he or she has consulted with the State Boards of Medicine and Nursing about issues related to access to and the quality of anesthesia services in the State and has concluded that it is in the best interests of the State’s citizens to opt-out of the current physician supervision requirement, and that the opt out is consistent with State law. (Found in 42 CFR 416.42)

416.42.c

416.42.c.1

Standard

900.005.007

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

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

Compliant Deficient A,B,C-M,C

The request for exemption and recognition of State laws and the withdrawal of the request may be submitted at any time and are effective upon submission.

416.42.c.2

All anesthetics other than topical or local anesthetic agents are delivered by either an anesthesiologist, or by a CRNA (under physician supervision if required by state or federal law or by a policy adopted by the facility), or by an anesthesiology assistant certified by the NCCAA (under direct supervision of an anesthesiologist). Parenteral sedation, other than propofol, may be administered by a registered nurse under the supervision of a qualified physician.

416.42.b.1

416.42.b.2

The physician responsible for supervising the administration of anesthesia must have knowledge of anesthetics and resuscitative techniques. Podiatrists and oral and maxillofacial surgeons must use an anesthesiologist or a supervising physician to administer anesthesia.

416.42.b Standard

Standard

Standard Standard

Page 95

AAAASF Medicare V7.1

900.010

900.010.000

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

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

Pre-Anesthesia Care

Compliant Deficient A,B,C-M,C

If children are operated upon in the facility, there should be a written policy defining the unique perioperative care of pediatric patients. This is based upon considerations of age, risk categories, surgery, facility equipment, and capability.

A physician must examine the patient immediately before surgery to evaluate the risk of the procedure to be performed.

416.42.a.1 Standard

416.42.a.1.i Standard

A physician or anesthetist as defined at 42 CFR 410.69(b) of this chapter must examine the patient immediately before surgery to evaluate the risk of anesthesia.

416.42.a.1 Standard

416.42.a.1.i

Standard

900.010.012 Compliant Deficient C-M,C

A physician or anesthesia provider must verify that all anesthesia equipment is in proper working order.

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

A physician must verify that an anesthesia care plan has been developed and documented.

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

A physician must verify that the patient or a responsible adult has been informed about the anesthesia care plan.

900.010.030

Compliant Deficient A,B,C-M,C

The anesthesia care plan is based on a review of the medical record.

Page 96

AAAASF Medicare V7.1

900.010.035 Compliant Deficient

The anesthetic care plan is based on: Medical history.

900.010.040

Compliant Deficient A,B,C-M,C

The anesthetic care plan is based on: Prior anesthetic experiences.

900.010.045

Compliant Deficient

The anesthetic care plan is based on: Drug therapies.

900.010.050

Compliant Deficient A,B,C-M,C

The anesthesia care plan is based on medical examination and assessment of any conditions that might affect the preoperative risk.

A,B,C-M,C

900.010.055

900.010.060

900.010.065

900.010.070

Compliant Deficient A,B,C-M,C

The anesthesia care plan is based on a review of the medical tests and consultations.

Compliant Deficient A,B,C-M,C

The anesthesia care plan is based on a determination of preoperative medications needed for anesthesia.

Compliant Deficient A,B,C-M,C

The anesthesia care plan is based on providing preoperative instructions.

Compliant Deficient A,B,C-M,C

The operating surgeon concurs with the anesthesia plan developed by the anesthesia professional and documents agreement in the medical record.

Page 97

AAAASF Medicare V7.1

900.020

900.020.000

900.020.005

900.021

900.021.010

Anesthetic Monitoring

Compliant Deficient A,B,C-M,C

Continual is defined as “repeated regularly and frequently in steady, rapid succession,”

whereas continuous means “prolonged without interruption at any time.”

Compliant Deficient A,B,C-M,C

If responsible for supervising anesthesia or providing anesthesia, the qualified physician must be present in the operating suite throughout the administration of anesthesia.

Oxygenation

Compliant Deficient C

Patient monitoring during anesthesia consists of assessment by oxygen analyzer if an anesthesia machine is used during general anesthesia. The anesthesia machine has an alarm for low oxygen concentration.

900.021.015

900.021.016

Compliant Deficient B,C-M,C

Patient monitoring during anesthesia consists of pulse oximetry.

Compliant Deficient B, C-M,C

Patient monitoring during anesthesia consists of end tidal carbon dioxide sampling on all moderate sedation, deep sedation or general anesthetics.

-Continual monitoring for the presence of expired carbon dioxide shall be performed unless invalidated by the nature of the patient, procedure, or equipment. Quantitative monitoring of the volume of expired gas is strongly encouraged.

-Continual end-tidal carbon dioxide analysis, in use from the time of endotracheal tube/laryngeal mask placement until extubation/removal or initiating transfer to a postoperative care location, shall be performed using a quantitative method such as capnography, capnometry, or mass spectroscopy. When capnography or capnometry is utilized, the end tidal carbon dioxide alarm shall be audible to the anesthesiologist or the anesthesia care team personnel.

Page 98

AAAASF Medicare V7.1

900.022

Circulation Monitoring

900.022.010

Compliant

Deficient

B,C-M,C

Circulation may be monitored by one or several of the following:

-Continuous EKG during procedure

-Blood pressure

-Heart rate every 5 minutes (minimum)

-Pulse oximetry

-Heart auscultation

-Intra-arterial pressure

-Ultrasound peripheral pulse monitor, pulse plethysmography, or

oximetry

900.022.050 Compliant Deficient C-M,C

Temperature should be monitored when clinically significant changes in body temperature are expected.

900.022.055 Compliant Deficient C-M,C

“Forced air warmers,” blanket warmers, or other devices are used to

maintain the patient’s temperature.

Page 99

900.023 Ventilation

AAAASF Medicare V7.1

900.023.005

900.023.010

900.023.015

Compliant Deficient C

Every patient receiving general anesthesia shall have the adequacy of ventilation continually evaluated. Qualitative clinical signs such as chest excursion, observation of the reservoir breathing bag, and auscultation of breath sounds are useful.

Compliant Deficient C

When an endotracheal tube or laryngeal mask is inserted, its correct positioning must be verified by clinical assessment and by identification of carbon dioxide in the expired gas.

Compliant Deficient C

When ventilation is controlled by a mechanical ventilator, there shall be in continuous use a device that is capable of detecting the disconnection of any

of the breathing system’s components. The device must give an audible

signal when its alarm threshold is exceeded.

Page 100

AAAASF Medicare V7.1

1000

GOVERNANCE

1000.010

Governing Body

1000.010.010

Compliant Deficient

A,B,C-M,C

The ASC has a governing body with full legal responsibility for determining, implementing, and monitoring policies governing ASC's total operation. The governing body has oversight and accountability for the quality assessment and performance improvement program, ensures that the facility policies and programs are administered so as to provide quality health care in a safe environment, and develops and maintains a disaster preparedness plan.

416.41 Condition

1000.010.050 Compliant Deficient A,B,C-M,C

The minutes of each official “Governance” meeting are recorded and filed

with the original governing rules and regulations.