Title Page

  • Conducted on

  • Prepared by

  • Location

Medical Record Content

  • A comprehensive medical history and physical assessment completed not more than 30 days before the date of the surgery;

  • Pre-surgical assessments – update of the H&P upon admission, and assessment for the risk of the procedure and anesthesia;

  • Documentation of properly executed informed patient consent;

  • Findings and techniques of the operation, including complications, allergies or adverse drug reactions that occurred;

  • Orders signed by the physician for all drugs and biologicals administered to the patient;

  • Documentation of adverse drug reactions, if any;

  • Documentation of the post-surgical assessment of the patient, including for recovery from anesthesia; Documentation of reason for transfer to a hospital, if applicable;

  • Discharge notes, including documentation of post-surgical needs; and

  • Discharge order, signed by the operating physician.

The ASC must comply with State licensure requirements.

  • Does the center have a current license with the State? And is it posted according to state guidelines?

Governing Body and Management

  • The ASC must have a governing body that assumes full legal responsibility for determining, implementing, and monitoring policies governing the 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 healthcare in a safe environment,

  • develops and maintains a disaster preparedness plan

Delegations of governing body authority should be documented in writing.

  • Ask for an organizational chart of the ASC management. Ask who performs the following functions: Human Resources

  • • Medical staff credentialing and granting of privileges;

  • • Management of surgical services;

  • • Management of nursing services;

  • • Management of pharmaceutical services;

  • • Management of laboratory (if applicable) and radiologic services;

  • • Management of the ASC’s physical plant;

  • • Medical records maintenance;

  • • Infection control;

  • • Quality Assurance and Performance Improvement.

  • meeting minutes or other evidence that the ASC’s policies and procedures have been formally adopted by the governing body

  • how the governing body monitors internal compliance with and reassesses the ASC’s policies

  • how the governing body exercises ongoing oversight of and accountability for the ASC’s QA/PI program.

When services are provided through a contract with an outside resource, the ASC must assure that these services are provided in a safe and effective manner.

  • Contractor services must be included in the ASC’s QAPI program

  • complete list of its currently contracted services

  • Review the personnel files of contract personnel to determine, as applicable, their credentials, privileges, evidence of training, evidence of periodic evaluation, etc.

  • Have all contracts been evaluated on an annual basis?

  • Give an example of what has been done about a contracted service that hasn't met with Center standards?

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. This hospital must be a local, Medicare participating hospital or a local, nonparticipating hospital that meets the requirements for payment for emergency services under §482.2 of this chapter. (3) The ASC must – i. Have a written transfer agreement with a hospital that meets the requirements of paragraph (b)(2) of this section; or ii. Ensure that all physicians performing surgery in the ASC have admitting privileges at a hospital that meets the requirements of paragraph (b)(2) of this section.

  • Written ASC policies and procedures that address the circumstances warranting emergency transfer, including who makes the transfer decision;

  • the documentation that must accompany the transferred patient;

  • and the procedure for accomplishing the transfer safely and expeditiously,

  • including communicating with the receiving hospital.

  • evidence that staff are aware of and can implement the ASC’s policy

  • Provision of emergency care and initial stabilizing treatment within the ASC’s capabilities until the patient is transferred.

  • Arrangement for immediate emergency transport of the patient.

  • Have a written transfer agreement that is in force with a hospital that meets the requirements at §416.41(b)(2); or<br>• Ensure that every physician performing surgery at the ASC has admitting privileges at a hospital that meets the requirements of §416.41(b)(2).

  • Review of any transfer patient's medical records to ensure compliance with policy and regulations.

Disaster Preparedness Plan

  • The ASC must maintain a written disaster preparedness plan that provides for the emergency care of patients, staff and others in the facility in the event of fire, natural disaster, functional failure of equipment, or other unexpected events or circumstances that are likely to threaten the health and safety of those in the ASC.

  • Policy in place that meets guidelines

  • Hazard Vulnerability Analysis (HVA) current with required components

  • Hazard mitigation consists of those activities taken to eliminate or reduce the probability of the event, or reduce the event’s severity or consequences, either prior to or following a disaster or emergency.

  • how the ASC will meet the needs of patients, staff, and others present in the ASC if essential services break down as a result of a disaster.

  • training staff on their role in the emergency plan

  • testing the plan,

  • and revising the plan as needed

  • Memorandum of Understanding (MOU) in place and current? ASC must coordinate its disaster preparedness plan with State and local authorities that have responsibility for emergency management within the State.

  • At least once every year the ASC must conduct a drill to test the plan’s effectiveness, expected to test a significant portion of the plan.

  • written evaluation of each annual drill, identifying problems that arose as well as methods to address those problems

  • The disaster preparedness plan must be promptly updated to reflect the lessons learned from the drill and the needed changes identified in the evaluation.

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

  • Facility has policies and procedures for how credentialing and privileging is conducted at the Center? Check for documentation that the governing body approved these policies and procedures.

  • Medical Staff Bylaws outline credentialing requirements and processes?

  • Credentialing files contain current list of privileges for each physician?

  • Privileges requiring special training have documented training in the file?

  • Privileges are granted within specified time frames?

  • Peer Review is a part of reappointment activities?

  • Documentation is present in the file or in reappointment minutes that peer review was reviewed at the time of reappointment?

  • Events defined in the Peer review policy have had peer review activities completed and placed in the applicable credentialing file.

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

  • The ASC must have approved policies and procedures to assure that the assessment of anesthesia-related and procedural risks is completed just prior to every surgical procedure.

  • (Ideally, the ASC would conduct such an assessment prior to the patient’s admission as well as immediately prior to surgery, but this is not specifically required by the regulations.)

  • The ASC’s policies must address the basis or criteria used within the ASC in conducting these risk assessments, and must assure consistency among assessments.

  • ASC might choose to incorporate consideration of a patient’s ASA Physical Classification into its criteria.

  • any cases where an assessment resulted in a decision not to proceed with the surgery

Before discharge from the ASC, each patient must be evaluated by a physician or by an anesthetist as defined at §410.69(b) of this chapter, in accordance with applicable State health and safety laws, standards of practice, and ASC policy, for proper anesthesia recovery.

  • routine postanesthesia assessment and monitoring, including monitoring/assessment of: Respiratory function, including respiratory rate, airway patency, and oxygen saturation;

  • Cardiovascular function, including pulse rate and blood pressure;

  • Mental status;

  • Temperature;

  • Pain;

  • Nausea and vomiting; and

  • Postoperative hydration.

  • Depending on the specific surgery or procedure performed, additional types of monitoring and assessment may be necessary

  • Postanesthesia evaluation was conducted for each patient.

  • conducted by a practitioner who is qualified to administer anesthesia

  • evaluation was performed prior to the patient’s discharge

Administration of Anesthesia

  • Do the medical records indicate that required physician supervision is provided?

  • ASC’s policies and procedures must include criteria to identify who is qualified to administer anesthesia.

  • The privileges granted must be in accordance with State law and the ASC’s policy.

  • ASC must specify the anesthesia privileges for each practitioner who administers anesthesia, or who supervises the administration of anesthesia by another practitioner

  • When an ASC permits operating physicians to supervise CRNAs administering anesthesia, the governing body must adopt written policies that explicitly provide for this.

  • Prior to the survey, determine whether the State has exercised its CRNA physician supervision opt-out option.

  • Determine that there is documentation of current licensure or current certification status for all persons administering anesthesia

Provision of Safe Surgical Procedures

  • use of standard procedures to ensure proper identification of the patient and surgical site, in order to avoid wrong site/wrong person/wrong procedure errors.

  • A pre-procedure verification process to make sure all relevant documents (including the patient’s signed informed consent) and related information are available, correctly identified, match the patient, and are consistent with the procedure the patient and the ASC’s clinical staff expect to be performed;

  • Marking of the intended procedure site by the physician who will perform the procedure or another member of the surgical team so that it is unambiguously clear; and

  • A “time out” before starting the procedure to confirm that the correct patient, site and procedure have been identified, and that all required documents and equipment are available and ready for use.

  • Conducting surgery in a safe manner also requires appropriate use of liquid germicides in the operating or procedure room.

  • Using skin prep solutions that are: 1) packaged to ensure controlled delivery to the patient in unit dose applicators, swabs, or other similar applicators; and 2) provide clear and explicit manufacturer/supplier instructions and warnings. These instructions for use should be carefully followed;

  • • Ensuring that the alcohol-based skin prep solution does not soak into the patient’s hair or linens. Sterile towels should be placed to absorb drips and runs during application and should then be removed from the anesthetizing location prior to draping the patient;

  • • Ensuring that the alcohol-based skin prep solution is completely dry prior to draping.

  • Verifying that all of the above has occurred prior to initiating the surgical procedure.

  • policies and procedures to reduce the associated risk of fire

  • The surgical equipment and supplies are sufficient so that the type of surgery conducted can be performed in a manner that will not endanger the health and safety of the patient;

  • • Surgical devices and equipment are monitored, inspected, tested, and maintained by the ASC in accordance with Federal and State law, regulations and guideline, and manufacturer’s recommendations; and that

  • • Access to the operative and recovery area is limited to authorized personnel and that the traffic flow pattern adheres to accepted standards of practice;

  • The conformance to aseptic and, when applicable, sterile technique by all individuals in the surgical area;

  • • That there is appropriate cleaning between surgical cases and appropriate terminal cleaning applied;

  • • That operating room attire is suitable for the kind of surgical case performed;

  • • That equipment is available for rapid “emergency” high-level disinfection or, as applicable, sterilization of operating room materials;

  • • That sterilized materials are packaged, handled, labeled, and stored in a manner that ensures sterility e.g., in a moisture- and dust-controlled environment, and policies and procedures for expiration dates have been developed and are followed in accordance with accepted standards of practice.

  • • That, as applicable, temperature and humidity are monitored and maintained within accepted standards of practice; and

  • • §416.44(c) & (d), concerning emergency equipment and personnel – for example:

  • • That surgical staff are trained in the use of emergency equipment.

Quality Assessment and Performance Improvement

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

  • effective, ongoing system in place for identifying problematic events, policies, or practices and taking actions to remedy them, and then following up on these remedial actions to determine if they were effective in improving performance and quality.

  • collection by the ASC of quality data at regular intervals;

  • analysis of the updated data at regular intervals;

  • and updated records of actions taken to address quality problems identified in the analyses, as well as new data collection to determine if the corrective actions were effective.

  • Data-driven – i.e., the program must identify in a systematic manner what data it will collect to measure various aspects of quality of care;

  • the frequency of data collection;

  • how the data will be collected and analyzed;

  • and evidence that the program uses the data collected to assess quality and stimulate performance improvement.

  • 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.

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

  • Consider incidence, prevalence and severity of problems in those areas.

  • Affect health outcomes, patient safety and quality of care.

  • Ask what the rationale is for the particular indicators that the ASC has chosen to track.

  • Ask the staff responsible for QAPI what the method and frequency is for data collection for each QAPI program indicator.

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

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

  • Identify opportunities that could lead to improvements and changes in its patient care.

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

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

  • The ASC must also have a method to ensure that the improvements it makes are sustained over time

  • ASC is required to make all staff aware of the strategies it has adopted for prevention of adverse events.

  • All staff involved in the preparation and administration of injectable medications should be aware of standard safe injection practices designed to avoid the transmission of infectious disease

  • Is the ASC collecting data on all of the indicators/measures it identified for its QAPI program? Is it collecting the data at the frequency specified in its QAPI program?

  • who is responsible for the data collection and analysis, and what their qualifications are?

  • provide examples of instances where it used QAPI data to identify opportunities for improving processes for providing care

  • how it trains staff on ways to prevent adverse events from occurring.

  • Ask ASC staff what they know about the ASC’s QAPI program, focusing in particular on staff awareness of policies and procedures for preventing adverse events.

Performance Improvement Projects

  • The number and scope of distinct improvement projects conducted annually must reflect the scope and complexity of the ASC’s services and operations. One or more specific quality improvement projects each year.

  • 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.

  • ASC must keep records on its performance improvement projects.

  • Each project must, at a minimum, include an explanation of why the project was undertaken.

  • how the impact of the project is being monitored

  • documentation that explains what the results of the project were,

  • and what actions, if any, the ASC took in response to those results.

  • If the project was successful, ask the ASC how it is sustaining the improvement.

Governing body responsibilities

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

  • Addresses the ASC’s priorities and that all improvements are evaluated for effectiveness.

  • Specifies data collection methods, frequency, and details.

  • Clearly establishes its expectations for safety.

  • Adequately allocates sufficient staff, time, information systems and training to implement the QAPI program.

  • Is defined, in writing, for example in the minutes of a meeting where the governing body established the program;

  • Is actually implemented, with written evidence of this implementation, as well as evidence of knowledge of the program by the ASC’s staff;

  • Is implemented on an ongoing basis;

  • Employs quality and patient safety indicators that reflect appropriate prioritization, as required by §416.43(c);

  • Describes in detail the indicator data to be collected, how it will be collected, how frequently it will be collected;

  • Uses the data collected and analyzed to improve the ASC’s performance;

  • Evaluates changes designed to improve the ASC’s performance to determine whether they are effective, and takes appropriate actions to make further changes as needed;

  • Is designed to establish clearly the governing body’s expectations that patient safety is a priority, not only by the tracking of all adverse events, but also by the program’s processes for analyzing and making changes in ASC operations to prevent future such events; and

  • Has sufficient resources

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

Physical Environment - The ASC must provide a functional and sanitary environment for the provision of surgical services. (1) 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.

  • ORs must be designed in accordance with industry standards for the types of surgical procedures performed in the room, including whether the OR is used for sterile and/or non-sterile procedures.

  • Existing ORs must meet the standards in force at the time they were constructed, while new or reconstructed ORs must meet current standards.

  • Although the term “OR” includes both traditional ORs and procedure rooms, this does not mean that procedure rooms must meet the same design and equipment standards as traditional operating rooms.

  • In all cases, the OR design and equipment must be appropriate to the types of surgical procedures performed in it.

  • The OR must also be appropriately equipped for the types of surgery performed in the ASC. Equipment includes both facility equipment (e.g., lighting, generators or other back-up power, air handlers, medical gas systems, air compressors, vacuum systems, etc.) and medical equipment (e.g., biomedical equipment, radiological equipment if applicable, OR tables, stretchers, IV infusion equipment, ventilators, etc.).

  • Medical equipment for the OR includes the appropriate type and volume of surgical and anesthesia equipment, including surgical instruments.

  • Surgical instruments must be available in a quantity that is commensurate with the ASC’s expected daily procedure volume, taking into consideration the time required for appropriate cleaning and, if applicable, sterilization.

  • In addition, emergency equipment determined to be necessary in accordance with §416.44(c) must be either in or immediately available to the OR.

  • The OR equipment must be inspected, tested and maintained appropriately by the ASC, in accordance with Federal and State law (including regulations) and manufacturers’ recommendations.

  • Temperature, humidity and airflow in ORs must be maintained within acceptable standards to inhibit microbial growth, reduce risk of infection, control odor, and promote patient comfort.

  • ASCs must maintain records that demonstrate they have maintained acceptable standards.

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

  • ASC must have a separate recovery room and waiting area

  • The recovery room must be equipped to allow appropriate monitoring of the patient’s recovery.

  • The type of equipment required depends on the type(s) of surgery performed in the ASC. The size of the recovery room must be commensurate with the number of ORs in the ASC and the expected volume of patients who will be in recovery simultaneously.

  • The recovery room may also be used for preoperative preparation of patients as well as for post-operative recovery, consistent with accepted standards of practice. Under no circumstances, however, may the recovery room also be used as a general waiting area for patients awaiting preoperative preparation or for people who accompany patients. Likewise, patients recovering from surgery may not be placed in a waiting room or area,

Safety From Fire -2000 edition of the Life Safety Code of the National Fire Protection Association

  • An ASC must be in compliance with Chapter, Emergency Lighting, beginning on March 13, 2006.

  • Notwithstanding any provisions of the 2000 edition of the Life Safety Code to the contrary, an ASC may place alcohol-based hand rub dispensers in its facility if- Use of alcohol-based hand rub dispensers does not conflict with any State or local codes that prohibit or otherwise restrict the placement of alcohol-based hand rub dispensers in healthcare facilities;

  • The dispensers are installed in a manner that minimizes leaks and spills that could lead to falls;

  • The dispensers are installed in a manner that adequately protects against inappropriate access; and

  • The dispensers are installed in accordance with the following provisions: Where dispensers are installed in a corridor, the corridor shall have a minimum width of 6 ft (1.8m);

  • The maximum individual dispenser fluid capacity shall be 0.3 gallons (1.2 liters) for dispensers in rooms, corridors, and areas open to corridors.

  • 0.5 gallons (2.0 liters) for dispensers in suites of rooms;

  • The dispensers shall have a minimum horizontal spacing of 4 feet (1.2m) from each other;

  • Not more than an aggregate of 10 gallons (37.8 liters) of ABHR solution shall be in use in a single smoke compartment outside of a storage cabinet;

  • Storage of quantities greater than 5 gallons (18.9 liters) in a single smoke compartment shall meet the requirements of NFPA 30, Flammable and Combustible Liquids Code;

  • The dispensers shall not be installed over or directly adjacent to an ignition source;

  • In locations with carpeted floor coverings, dispensers installed directly over carpeted surfaces shall be permitted only in sprinklered smoke compartments; and

  • The dispensers are maintained in accordance with dispenser manufacturer guidelines.

Emergency Power will be provided via an emergency generator sufficient in size for the building it serves.

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. The equipment must meet the following requirements:

  • Be immediately available for use during emergency situations.

  • Be appropriate for the facility’s patient population.

  • Be maintained by appropriate personnel

  • ASC is expected to maintain a comprehensive, current and appropriate set of emergency equipment, supplies and medications that meet current standards of practice and are necessary to respond to a patient emergency in the ASC.

  • qualified personnel necessary to meet the emergency needs of the ASC’s entire patient population

  • The ASC’s policies must address whether the equipment and supplies must be present in each OR, or in what quantity and locations they will be available to all ORs as needed

  • The type and quantity of emergency equipment and supplies that must be present in each OR; and

  • For equipment not present in each OR, how many items must be available and in which locations so that the equipment is immediately available when needed in each OR.

  • there must always be staff present capable of using the emergency equipment

  • ASC uses anesthetics that carry a risk for malignant hyperthermia, then the ASC is expected to have supplies of medications required to treat this emergency condition

  • An ASC that performs bariatric procedures on obese patients would need to have more emergency medications available than would an ASC that specializes in pediatric procedures.

  • ASC must ensure that mechanical and electrical equipment must be regularly inspected, tested, and maintained to assure their availability when needed

  • Are emergency supplies and medications current or expired?

Emergency Personnel

  • Personnel trained in the use of emergency equipment and in cardiopulmonary resuscitation must be available whenever there is a patient present in the building.

  • staff present in the ASC who are trained in cardiopulmonary resuscitation (CPR) techniques.e is a patient in the ASC.

  • there must be sufficient trained personnel to deal with multiple simultaneous emergencies

  • Interview staff identified as having emergency responsibilities to determine if they are aware of their role in handling an emergency. Do they know where the emergency equipment/suppliers are kept?

  • Ask staff with emergency responsibilities what the ASC’s procedures are when a staff member designated to handle emergencies is participating in a procedure on another patient? What type of back-up system is available?

Medical Staff - The medical staff of the ASC must be accountable to the governing body.

  • the ASC must have an explicit, written policy that indicates how the medical staff is held accountable by the governing body.

  • Medical staff privileges may be granted both to physician and non-physician practitioners, consistent with their permitted scope of practice in the State, as well as their training and clinical experience.

  • It is possible for an ASC to be owned and operated by one physician, who could be both the sole member of the governing body and also the sole member of the ASC’s medical staff. In such cases the physician owner must nevertheless implement a formal process for complying with all medical staff regulatory requirements.

  • Ask the ASC’s leadership for its policy detailing how the governing body holds the medical staff accountable.

Membership and Clinical Privileges 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.

  • must be granted privileges by the governing body, in writing, that specify in detail the types of procedures they may perform within the ASC.

  • The ASC’s governing body must assure that medical staff privileges are granted only to legally and professionally qualified practitioners. Licensed in the State of Oklahoma.

  • The ASC must verify that each practitioner has a current professional license and document the license in the practitioner’s file.

  • Competence is demonstrated through evidence of specialized training and experience, e.g., certification by a nationally recognized professional board.

  • The governing body is also required to solicit the opinion of qualified medical personnel on the competence of applicants for privileges. Peer References

  • Ask the ASC’s leadership to explain its process for granting clinical privileges.

  • If the governing body granted privileges against the recommendation of the qualified medical personnel, its rationale for doing so.

Reappraisals - Medical staff privileges must be periodically reappraised by the ASC. The scope of procedures performed in the ASC must be periodically reviewed and amended as appropriate.

  • CMS recommends a reappraisal at least every 24 months.

  • The reappraisal must include: Review of the practitioner’s current credentials; and

  • The practitioner’s ASC-specific case record, including measures employed in the ASC’s quality assurance/performance improvement program, such as emergency transfers to hospitals, post-surgical infection rates, other surgical complications, etc.

  • Ask the ASC’s leadership how it re-evaluates the professional qualifications of practitioners with privileges to practice in the ASC?

  • Review the personnel records for all practitioners with privileges to practice in the ASC to determine whether they have been reappraised

Other Practitioners 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.

  • governing body must approve written policies and procedures that establish a system for overseeing and evaluating the quality of the clinical services provided by other practitioners

  • The policies must address:

  • The specific types of clinical activities that each class of practitioner will be able to perform.

  • The process by which the ASC exercises oversight over each class of practitioner

  • The process and criteria for reviewing the qualifications of each individual practitioner before he/she is permitted to provide patient care; and

  • The process, criteria and frequency for evaluating the performance in providing clinical services by practitioners other than physicians.

  • Does each file contain evidence of the practitioner’s qualifications, consistent with the ASC’s policy?

  • Does each file contain evidence of periodic evaluation of the practitioner’s performance?

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