- Email: [email protected]
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CHAPTER 36
Certification and Accreditation KRISHNA JAIN, MD, FACS
Office-based endovascular center (OEC) is an extension of a medical practice, so no additional certification or accreditation is required by Centers for Medicare and Medicaid Services (CMS) for Medicare or Medicaid reimbursement. Private insurance companies generally follow the same pattern. However, some states (Chapter 2) and insurance companies may require the OEC to be accredited by a national organization. Currently, there are no organizations established to review the appropriateness and/or outcomes of the care being provided in the OEC. Accreditation and certification are two different processes. The process of accreditation for a healthcare organization involves documenting compliance with a set of standards developed by an official accrediting agency that typically relate to the quality of efficiency of services. Accreditation for institutions and agencies in the United States and Canada is voluntary. Certification is a process used to prove that an organization or individual is competent and skilled in a particular area, typically associated with completion of a training or course. Many specialty areas have professional organizations that provide certification to individual practitioners. National associations may control the process and development of certification examinations conducted by their specialty interest groups. Accreditation is provided by nongovernment agencies, while CMS may certify various health organizations. Private organizations also certify various healthrelated programs, e.g., American College of Surgeons certifies trauma and bariatric centers in various hospitals. As mentioned above the CMS does not require the OEC to be accredited or certified. However, accreditation by a national organization provides several benefits like indicating a commitment to quality and patient safety, recognition by insurance companies, improvement in risk reduction and management,
help creating an organizational structure, providing standard operating process for the whole organization, competitive advantages, compliance with HIPAA, meeting state requirements (if any), possible reduction in insurance cost, educational opportunities and patient satisfaction. While there are no accreditation organizations with dedicated framework to accredit an OEC, there are several organizations that provide accreditation for ambulatory surgery centers (ASCs). Accreditation by one of these deemed organizations leads to certification by CMS. This makes the ASC eligible to receive reimbursement from Medicare and Medicaid. Additionally, in almost all states, ASCs must obtain a state license. To obtain Medicare certification, and a state license, an ASC must have a physical inspection conducted by an inspector of the organization that the federal government has deemed fit to conduct that inspection. It may also need an inspection by a state official. Certain states may inspect the OEC or require accreditation by a local state accrediting agency prior to granting the OEC operational status. To accredit the OEC, accrediting bodies in these states have used the same tools that they use to accredit ASC. Many states are struggling with developing guidelines for an OEC and are looking to national societies for guidance. The Society of Vascular Surgery (SVS) in collaboration with American College of Surgeons (ACS) and other societies are developing a certification/accreditation program for OEC.
CURRENT ACCREDITATION ORGANIZATIONS The following organizations accredit ASC, and several of them are being used by OEC for accreditation.1 The American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF)
Office-Based Endovascular Centers. https://doi.org/10.1016/B978-0-323-67969-5.00036-8 Copyright © 2020 Elsevier Inc. All rights reserved.
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The Accreditation Association for Ambulatory Health Care (AAAHC) The Joint Commission Healthcare Facilities Accreditation program (HFAP) Institute for Medical Quality (IMQ) All organizations charge for providing accreditation. The fee schedule varies depending on the size of the facility and number of physicians providing service. All the organizations use the following process with some variation: (1) application, (2) survey, (3) decision, and (4) reaccreditation.
AAAASF The American Association for Accreditation of Ambulatory Plastic Surgery Facilities, Inc. was formed in 1980. In 1992, the AAAASF was created to provide accreditation of all American Board of Medical Specialties (ABMS)-certified surgical specialties office-based surgery units. Its program follows the guidelines provided in the 1994 American College of Surgeons publication, “Guidelines for Optimal Office-Based Surgery.”2 The “AAAASF accreditation programs help facilities demonstrate a strong commitment to patient safety, standardize quality, maintain fiscal responsibility, promote services to patients and collaborate with other health care leaders.”3 The AAAASF claims to be the only accrediting organization that mandates 100% compliance with standards that include peer review as a means to demonstrate safety and quality measures in the accredited facilities. The AAAASF holds office-based facilities to hospital standards, requires surgeons (interventionalists) to be board certified and have hospital privileges for any procedure they perform, requires the use of anesthesia professionals for deeper levels of anesthesia, requires a safe and clean surgical environment that meets stringent standards and requires peer review.
Application As per AAAASF website following list of documentation must be completed for accreditation: Application Form with payment Floor plan for facility A copy of each physician’s State Medical License A copy of each physician’s Board Certificate or letter of admissibility by the physician/surgeon certifying board (ABMS, AOABOS, ABOMS, or ABPS as applicable) A current copy of the delineation of hospital privileges for each physician/surgeon (must state the department of surgical specialty and list the procedures that may be performed at the hospital)
Authorization to Release Information Form signed by each physician on staff HIPAA Business Associate Agreement Facility Identification Form Staff Identification Form Facility Director’s Attestation Form Random Review Form Unanticipated Sequela Form New York OBS Addendum (New York applicants only) Appropriate legal documentation as specified under your entity type on the New York OBS Addendum (New York applicants only) Additional documents may be required after the initial review of documents is completed in 10 business days.
Survey AAAASF facility surveyors are board-certified medical specialists trained to assess the center in following categories: Personnel Medical records Disaster preparedness General safety Quality assurance Clinical practices A survey team, whose size and composition are appropriate for the facility, conducts a thorough and unbiased facility survey based upon the surveyor handbook in accordance with the AAAASF guidelines, survey schedule, and checklist. Surveyor reviews the facility plan, reviews any deficiencies, and recommend any corrections needed. Surveys are documented and submitted to the AAAASF central office.
DECISION Once all the requirements are met the center is accredited. The center must display the sign of accreditation.
REACCREDITATION To maintain accreditation the facility is reevaluated through a self-survey every year, and an onsite survey every 3 years.
SELF-SURVEY The following list of documentation must be completed and submitted for the self-survey before the beginning of second and third year. Facility Identification Form
CHAPTER 36 Staff Identification Form Facility Director Attestation Form Completed Standards Manual If there are deficiencies, a report is sent to the facility director allowing 30 days for correction. If there are no deficiencies a new certificate is issued.
RESURVEY Before the 3 years are up, the following documents should be completed. A copy of each physician’s State Medical License A copy of each physician’s Board Certificate or letter of admissibility by the physicians certifying board (ABMS, AOABOS, ABOMS, or ABPS) A current copy of the delineation of hospital privileges for each physician (must state the department of surgical specialty and list the procedures that may be performed at the hospital) Authorization to Release Information Form signed by each physician on staff Facility Identification Form Staff Identification Form Facility Director’s Attestation Form New York OBS Addendum (New York OBS applicants only) Copy of Floor Plan The documents are reviewed in 10 business days and a site visit is scheduled. There is a fee charged for recertification.
THE ACCREDITATION ASSOCIATION FOR AMBULATORY HEALTH CARE AAAHC has been surveying and accrediting ambulatory surgery centers since 1979. The AAAHC was created by six founding members including the American College Health Association, the American Group Practice Association (now known as the American Medical Group Association), the Federated Ambulatory Surgery Association (now known as the Ambulatory Surgery Foundation), the Group Health Association of America (now known as the American Association of Health Plans), the Medical Group Management Association, and the National Association of Community Health Centers.4 The AAAHC aims to promote the highest level of care for patients of ambulatory healthcare organizations in the most efficient and economic manner. This is accomplished by the operation of a peer-based assessment, consultation, education, and accreditation program. The accreditation process includes submission of an application, survey by qualified surveyors followed by a decision to provide accreditation after
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all the requirements are met. Reaccreditation is required every 3 years. The AAAHC has also created an institute for quality improvement.
Institute for Quality Improvement The Institute for Quality Improvement was established in 1999. It is a department within AAAHC. The Institute provides following activities to support AAAHC: National benchmarking studies to improve care Patient safety and disease management toolkits to improve safety Bernard A. Kershner Innovations in Quality Improvement Award is given to accredited organization for quality improvement Analyzing and reporting on data from AAAHC surveys through the annual Quality Roadmap publication Present data at national meetings and publish in peerreviewed journals
Survey Documentation needed to be submitted prior to onsite survey visit is extensive. Surveyors are physicians, nurses, dentists, and administrators selected and trained by AAAHC. Survey fees are based upon information obtained from the facility’s application document. The size and type, as well as the range of services the organization provides, are considered in determining the fee.
Recertification It is done every 3 years. A facility is eligible for participation if it has been providing healthcare services for at least 6 months before the inspection. There is no annual fee, but there is a fee paid at the time of recertification.
THE JOINT COMMISSION The Joint Commission (TJC) provides accreditation to healthcare organizations to improve healthcare for the public by ensuring the care provided is safe and effective with the highest quality and value.4 “In 1951, the American College of Physicians, the American Hospital Association, the American Medical Association, and the Canadian Medical Association joined ACS as corporate members to create the Joint Commission on Accreditation of Hospitals (JCAH), an independent, not-forprofit organization to provide voluntary accreditation. In the late 1980s, the organization name was changed to the Joint Commission on Accreditation of Healthcare Organizations (JCAHO). In 2007, the organization shortened its name to “the Joint Commission.”4 Most physicians know TJC as an organization that accredits
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hospitals. However, there are only about 5000 acute care hospitals, and TJC accredits more than 21,000 healthcare organizations including ASCs.
(ACGME), State Departments of public health managed care organizations and insurance companies.
Survey Application TJC gives free 90-day access to online standards manual (e-edition) to review the requirements. When reviewing the standards, a list of areas of compliance and noncompliance can be made and updated to meet the standards. After completing an application, it is submitted with a deposit. If any changes are required they should be completed before the site visit.
The HFAP standards are based on the Medicare conditions of participation (CoPs) for each facility type.5 Approximately 80% of HFAP standards are annotated to align with the Medicare CoPs and associated requirements. In addition to Medicare standards, the HFAP standards include criteria proven to improve quality and patient safety. Surveyors are experienced medical professionals. The HFAP claims to be the most costeffective accrediting body.
Survey After submitting the application, a survey is commissioned. For comprehensive onsite review, surveyors can consist of physicians, nurses, and other healthcare workers trained to carry out the survey. The surveyor provides the onsite review and a preliminary written report is made available at the end of the survey.
Decision If any changes are needed, they should be made and usually within 60 days the center is accredited. After receiving “The Gold Seal of Approval,” the center should display the gold seal and notify any organizations, insurance companies, State health board requiring the accreditation. Because of accreditation the center may experience reduced rate of insurance.
Reaccreditation Reaccreditation occurs every 3 years. There may be surprise visits during the 3 years’ accreditation period. If there are any major changes within the organization TJC should be informed. There is an annual fee of $1000.00.
HEALTHCARE FACILITIES ACCREDITATION PROGRAM Healthcare Facilities Accreditation Program (HFAP) is authorized by the CMS to survey hospitals for compliance with the Medicare Conditions of Participation and Coverage. HFAP was originally created in 1945 to conduct an objective review of osteopathic hospitals. CMS was formed in 1965. HFAP has maintained its deeming authority for CMS continuously and meets or exceeds the standards required by CMS/Medicare to provide accreditation to all hospitals and ambulatory care/surgical facilities. In addition to others, HFAP also is recognized by National Committee for Quality Assurance (NCQA), Accreditation Council for Graduate Medical Education
INSTITUTE FOR MEDICAL QUALITY IMQ is a 501(c)3 corporation founded in 1996 by the California Medical Association to improve the quality of care for patients in California.6 The IMQ was designed to make it easier to provide quality care and eliminate barriers. IMQ puts great emphasis on education, counseling, and direct involvement of practicing physicians. Some IMQ programs require surveys of facilities. Each program is updated on a regular basis to keep it clinically relevant. IMQ is recognized in a number of states.
Mission “The Institute for Medical Quality’s (IMQ) mission is to be an innovative leader in improving the quality of care provided to patients across the continuum of health care by encouraging, developing, and implementing programs which effectively measure and improve the quality of care provided to people in California and beyond. In support of its mission, IMQ will conduct educational programs and will evaluate health care delivery. It will be responsive to diverse constituencies, and its outcomes will be patient-oriented and population-based.”6
Application An application is filed along with necessary documents. After reviewing the application and supporting documents the IMQ sends a presurvey analysis to the center, allowing the center to make any necessary revisions before the onsite survey begins.
Survey As per website the survey focuses on following areas: Administration: scope of services, patient rights, and administrative policies and procedures Personnel: staff policies and procedures, physician credentialing in both small group settings and larger settings with an organized medical staff
CHAPTER 36 Quality management and peer review Medical records: surgery and invasive diagnostic records, HIPAA, and clinical record confidentiality Care and treatment Facility and environmental safety: infection control, fire safety, preparation for emergencies, medical equipment, and facility design and access Surgical, anesthesia, and invasive diagnostics
Decision This may include full 3-year accreditation or deferred action if the center does not meet the standards.
CERTIFICATION OF OEC IN DEVELOPMENT All of the accrediting bodies described above do not address the appropriateness of care being provided in the OEC. The accreditation process is mainly related to safety measures taken in providing care to the patients as well as the safety of the workers in the facility. The SVS is working with the American College of Surgeons and some other societies to develop a certification process for the OEC. This process will be modeled after some of the other certification processes ACS has developed in the past, i.e., trauma centers, bariatric centers, etc. The procedures that may be included are endovascular management of arterial disease except carotid stenting and abdominal aortic aneurism, management of superficial and deep venous disease, embolization procedures, management of dialysis access, insertion, and removal of intracaval filters and management of central lines and ports. The certification process is expected to be unveiled in the near future. Initial certification may be limited and not include all the procedures carried out in the OEC. The certification process developed by American College of Surgeons to certify trauma centers, etc. is based on five phases of care: Preoperative evaluation and preparation, immediate preoperative readiness, intraoperative care, postoperative care, and postdischarge care.7 The ACS believes in the following principles of care: Shared decision-making between the care provider and patient/family, risk stratification and reduction of risk before the procedure, evidence-based care, and following the safety standards and coordination among team members. When certifying or accrediting the center, adherence to the standard of care in these phases becomes important. The center should strictly follow the written policies and procedures. Let us look at the five phases of care that would have an impact on performing a percutaneous procedure for chronic limb ischemia in an OEC.
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PREPROCEDURE EVALUATION When a patient presents with symptoms of arterial ischemia, the first step is to determine if the symptoms are truly of arterial origin. Patients in older age group may have several causes of pain in the legs, e.g., spinal stenosis, arthritis, etc. The diagnosis is based on history, physical exam and arterial ultrasound findings, and ankle brachial index. In case the patient cannot give reliable history, the patient’s family or caretaker may play an important role. The process is carried out in the physician’s office. Other tests such as an MRI of the spine may be useful in the diagnosis algorithm. Once the diagnosis of arterial ischemia has been made, the medical management must be instituted. The patient should have the benefit of maximal medical benefit. This includes smoking cessation, modification of risk factors, supervised exercise therapy, and use of antiplatelet and other drugs like cilostazol. Other risk factors should be assessed using lab values and additional tests like cardiac stress test, etc. At this point in managing the patient, the appropriateness of care becomes very important. Appropriateness of care is not addressed by the existing accreditation bodies in a meaningful way. The invasive procedure should be recommended only for the appropriate indication and after the medical therapy has failed. All risk factors should be addressed and optimized. The medications that may have bearing on the procedure should be addressed. For example, if the patient is on anticoagulants, there should be a plan in place to manage these before, during, and after the procedure. Appropriate input should be sought from the primary care physician and any other specialists providing care for the patient. Risk and benefits of the procedure and alternative therapies should be discussed with the patient and the family. An informed consent should be signed by the patient. The patient should be educated about the arterial disease and the planned procedure and after care. If there are any medical insuranceerelated issues, those should be resolved. Since OEC is an extension of the practice, this phase of care usually will be provided in the same office where the intervention will be carried out. The office should meet all the safety requirements. There are guidelines by various societies in providing care for these patients. The guidelines should be followed.8,9
IMMEDIATE PREOPERATIVE CARE The patient should be examined and the history and physical should be updated. The patient and the family, interventionalist, nurses and other members of the
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team, and an anesthesia provider if needed should all be involved in care as appropriate. The patient will be seen in the part of the office that is being used as an OEC. The lab values will be rechecked specially for renal function and coagulation perimeters if the patient was on anticoagulants. The procedure should be appropriately discussed with the patient and the family. The informed consent form duly signed by the patient and/or the power of attorney should be in the chart. The surgical site needs to be marked and appropriate groin shaved and prepared. For the arterial procedure, it is preferable to shave both groins and tibial area if tibial approach is contemplated. If the patient is diabetic, blood sugar needs to be checked and the oral intake status needs to be confirmed as per the directions given in advance. If anesthesia is planned, appropriate evaluation needs to be documented (chapter 10). If an anesthesia personnel is not being used, then the interventionalist and the registered nurse giving medication and monitoring the patient during the procedure should be certified in advanced cardiac life support. The patient should be given appropriate drugs as per protocol prior to the procedure and hydrated if there is evidence of renal insufficiency. The availability of patient supervision by a responsible adult for 24 h postprocedure should be confirmed. The area for preprocedure evaluation needs to provide privacy for the patient and be HIPAA compliant. All data should be entered in an EMR.
INTRAOPERATIVE CARE In the next phase of care, the procedure is carried out in the interventional suite. The interventional suite should have appropriate imaging system, radiolucent table, power injector for contrast, and an ultrasound machine for accessing the vessel. All the disposable equipment like sheathes, wires, and catheters should be available. If there is a plan to use an atherectomy device and/or intravascular ultrasound the appropriate equipment should be available. Appropriate stents and covered stents for a bail out procedure should be available. Availability of these supplies needs to be checked before the procedure is started. There should be an emergency generator in case of power failure. Before the procedure is started an appropriate checklist that includes timeout should be completed. Appropriate personnel should be available and present in the endovascular suite. The personnel should be appropriately dressed and behave professionally. The patient should be appropriately prepped and draped for the arteriogram. Once the procedure starts, appropriate record should be kept and images stored
in PACS. The equipment being used should meet all the manufacture’s recommended service requirements. Since these procedures are carried out using local anesthesia and/or conscious sedation, it is important to keep the patient comfortable using verbal assurance and appropriate medications. After the intervention is completed, appropriate measures should be taken for hemostasis at the site of vessel entry using manual compression or a closure device.
POSTPROCEDURE PHASE Once the patient comes to the recovery room, the patient should be monitored appropriately for vital signs as well as for signs of bleeding at the procedure site. The distal circulation at the pedal level should be checked in both feet. All the findings need to be documented in the EMR. The interventionalist should finish recording the comprehensive procedure note. The interventionalist should be available in case of a complication. Appropriately trained employees should monitor the patient. There should be equipment available for monitoring, like handheld Dopplers. The biological waste and general waste should be disposed of as per the policy. The instruments should be cleaned and sterilized as per the specifications of the autoclave being used.
POSTDISCHARGE PHASE The patient and the caretaker are given appropriate instructions verbally and in writing. If the patient had medications held prior to the procedure, instructions to restart the medication should be given. It must be ascertained that patient will have caretaker with the patient for at least 24 h postprocedure. A follow-up appointment should be given. If the patient needs follow-up appointment with other specialists or primary care doctor, it should be arranged. If the patient is returning to a facility then the facility should be given appropriate instructions. If needed, social service referrals should be made. During these phases of care there are various requirement for the building, equipment, and personnel that need to be met. Once the certification/accreditation process being created by SVS/ACS is in place the OEC may use this particular approach to get certified since the process will be geared specifically toward an OEC. Another requirement for getting accredited under this process may be mandatory participation in a quality clinical data registry. There are various registries a center could participate in.
CHAPTER 36 Currently there are several organizations providing accreditation for the OEC. Though not mandated by CMS, it is prudent to get the OEC accredited by one of the national accreditation bodies. Some states mandate it, and some insurance companies will not pay for the procedure if the center is not accredited. A stamp of approval from an outside organization is always looked upon favorably by regulatory bodies and patients alike.
5. 6. 7. 8.
REFERENCES 1. A.S.C. Association, Accreditation Organizations, (n.d.). 2. Guidelines for Optimal Ambulatory Surgical Care and OfficeBased Surgery. 3rd ed. 2000. 3. American Association for Accredidation of Ambulatory Surgery Facilities, What is Accreditation, (n.d.). https://www. aaaasf.org/who-we-are/what-is-accreditation (accessed April 29, 2019). 4. The Joint Commission, (n.d.). American College Health Association, the American Group Practice Association (now
9.
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Known as the American Medical Group Association), The Federated Ambulatory Surgery Association (now Known as the Ambulatory Surgery Foundation), The Group Health Association (accessed April 29, 2019).. Healthcare Facilities Accreditation Program (HFAP), (n.d.). https://www.hfap.org/about/overview.aspx. Institute for Medical Quality (IMQ), (n.d.). Hoyt D, Clifford K. Optimal Resources for Surgical Quality and Safety. American College of Surgeons; 2017. Aboyans V, Ricco J-B, Bartelink M-LEL, et al. Editor’s choice e 2017 ESC guidelines on the diagnosis and treatment of peripheral arterial diseases, in collaboration with the European society for vascular surgery (ESVS). Eur J Vasc Endovasc Surg. 2018;55:305e368. https://doi.org/10.1016/ J.EJVS.2017.07.018. Olin JW, Allie DE, Belkin M, et al. ACCF/AHA/ACR/SCAI/ SIR/SVM/SVN/SVS 2010 performance measures for adults with peripheral artery disease. Vasc Med. 2010;15: 481e512. https://doi.org/10.1177/1358863X10390838.
OTHER IMPORTANT CONSIDERATIONS
CHAPTER 36
Certification and Accreditation KRISHNA JAIN, MD, FACS
Office-based endovascular center (OEC) is an extension of a medical practice, so no additional certification or accreditation is required by Centers for Medicare and Medicaid Services (CMS) for Medicare or Medicaid reimbursement. Private insurance companies generally follow the same pattern. However, some states (Chapter 2) and insurance companies may require the OEC to be accredited by a national organization. Currently, there are no organizations established to review the appropriateness and/or outcomes of the care being provided in the OEC. Accreditation and certification are two different processes. The process of accreditation for a healthcare organization involves documenting compliance with a set of standards developed by an official accrediting agency that typically relate to the quality of efficiency of services. Accreditation for institutions and agencies in the United States and Canada is voluntary. Certification is a process used to prove that an organization or individual is competent and skilled in a particular area, typically associated with completion of a training or course. Many specialty areas have professional organizations that provide certification to individual practitioners. National associations may control the process and development of certification examinations conducted by their specialty interest groups. Accreditation is provided by nongovernment agencies, while CMS may certify various health organizations. Private organizations also certify various healthrelated programs, e.g., American College of Surgeons certifies trauma and bariatric centers in various hospitals. As mentioned above the CMS does not require the OEC to be accredited or certified. However, accreditation by a national organization provides several benefits like indicating a commitment to quality and patient safety, recognition by insurance companies, improvement in risk reduction and management,
help creating an organizational structure, providing standard operating process for the whole organization, competitive advantages, compliance with HIPAA, meeting state requirements (if any), possible reduction in insurance cost, educational opportunities and patient satisfaction. While there are no accreditation organizations with dedicated framework to accredit an OEC, there are several organizations that provide accreditation for ambulatory surgery centers (ASCs). Accreditation by one of these deemed organizations leads to certification by CMS. This makes the ASC eligible to receive reimbursement from Medicare and Medicaid. Additionally, in almost all states, ASCs must obtain a state license. To obtain Medicare certification, and a state license, an ASC must have a physical inspection conducted by an inspector of the organization that the federal government has deemed fit to conduct that inspection. It may also need an inspection by a state official. Certain states may inspect the OEC or require accreditation by a local state accrediting agency prior to granting the OEC operational status. To accredit the OEC, accrediting bodies in these states have used the same tools that they use to accredit ASC. Many states are struggling with developing guidelines for an OEC and are looking to national societies for guidance. The Society of Vascular Surgery (SVS) in collaboration with American College of Surgeons (ACS) and other societies are developing a certification/accreditation program for OEC.
CURRENT ACCREDITATION ORGANIZATIONS The following organizations accredit ASC, and several of them are being used by OEC for accreditation.1 The American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF)
Office-Based Endovascular Centers. https://doi.org/10.1016/B978-0-323-67969-5.00036-8 Copyright © 2020 Elsevier Inc. All rights reserved.
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The Accreditation Association for Ambulatory Health Care (AAAHC) The Joint Commission Healthcare Facilities Accreditation program (HFAP) Institute for Medical Quality (IMQ) All organizations charge for providing accreditation. The fee schedule varies depending on the size of the facility and number of physicians providing service. All the organizations use the following process with some variation: (1) application, (2) survey, (3) decision, and (4) reaccreditation.
AAAASF The American Association for Accreditation of Ambulatory Plastic Surgery Facilities, Inc. was formed in 1980. In 1992, the AAAASF was created to provide accreditation of all American Board of Medical Specialties (ABMS)-certified surgical specialties office-based surgery units. Its program follows the guidelines provided in the 1994 American College of Surgeons publication, “Guidelines for Optimal Office-Based Surgery.”2 The “AAAASF accreditation programs help facilities demonstrate a strong commitment to patient safety, standardize quality, maintain fiscal responsibility, promote services to patients and collaborate with other health care leaders.”3 The AAAASF claims to be the only accrediting organization that mandates 100% compliance with standards that include peer review as a means to demonstrate safety and quality measures in the accredited facilities. The AAAASF holds office-based facilities to hospital standards, requires surgeons (interventionalists) to be board certified and have hospital privileges for any procedure they perform, requires the use of anesthesia professionals for deeper levels of anesthesia, requires a safe and clean surgical environment that meets stringent standards and requires peer review.
Application As per AAAASF website following list of documentation must be completed for accreditation: Application Form with payment Floor plan for facility A copy of each physician’s State Medical License A copy of each physician’s Board Certificate or letter of admissibility by the physician/surgeon certifying board (ABMS, AOABOS, ABOMS, or ABPS as applicable) A current copy of the delineation of hospital privileges for each physician/surgeon (must state the department of surgical specialty and list the procedures that may be performed at the hospital)
Authorization to Release Information Form signed by each physician on staff HIPAA Business Associate Agreement Facility Identification Form Staff Identification Form Facility Director’s Attestation Form Random Review Form Unanticipated Sequela Form New York OBS Addendum (New York applicants only) Appropriate legal documentation as specified under your entity type on the New York OBS Addendum (New York applicants only) Additional documents may be required after the initial review of documents is completed in 10 business days.
Survey AAAASF facility surveyors are board-certified medical specialists trained to assess the center in following categories: Personnel Medical records Disaster preparedness General safety Quality assurance Clinical practices A survey team, whose size and composition are appropriate for the facility, conducts a thorough and unbiased facility survey based upon the surveyor handbook in accordance with the AAAASF guidelines, survey schedule, and checklist. Surveyor reviews the facility plan, reviews any deficiencies, and recommend any corrections needed. Surveys are documented and submitted to the AAAASF central office.
DECISION Once all the requirements are met the center is accredited. The center must display the sign of accreditation.
REACCREDITATION To maintain accreditation the facility is reevaluated through a self-survey every year, and an onsite survey every 3 years.
SELF-SURVEY The following list of documentation must be completed and submitted for the self-survey before the beginning of second and third year. Facility Identification Form
CHAPTER 36 Staff Identification Form Facility Director Attestation Form Completed Standards Manual If there are deficiencies, a report is sent to the facility director allowing 30 days for correction. If there are no deficiencies a new certificate is issued.
RESURVEY Before the 3 years are up, the following documents should be completed. A copy of each physician’s State Medical License A copy of each physician’s Board Certificate or letter of admissibility by the physicians certifying board (ABMS, AOABOS, ABOMS, or ABPS) A current copy of the delineation of hospital privileges for each physician (must state the department of surgical specialty and list the procedures that may be performed at the hospital) Authorization to Release Information Form signed by each physician on staff Facility Identification Form Staff Identification Form Facility Director’s Attestation Form New York OBS Addendum (New York OBS applicants only) Copy of Floor Plan The documents are reviewed in 10 business days and a site visit is scheduled. There is a fee charged for recertification.
THE ACCREDITATION ASSOCIATION FOR AMBULATORY HEALTH CARE AAAHC has been surveying and accrediting ambulatory surgery centers since 1979. The AAAHC was created by six founding members including the American College Health Association, the American Group Practice Association (now known as the American Medical Group Association), the Federated Ambulatory Surgery Association (now known as the Ambulatory Surgery Foundation), the Group Health Association of America (now known as the American Association of Health Plans), the Medical Group Management Association, and the National Association of Community Health Centers.4 The AAAHC aims to promote the highest level of care for patients of ambulatory healthcare organizations in the most efficient and economic manner. This is accomplished by the operation of a peer-based assessment, consultation, education, and accreditation program. The accreditation process includes submission of an application, survey by qualified surveyors followed by a decision to provide accreditation after
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all the requirements are met. Reaccreditation is required every 3 years. The AAAHC has also created an institute for quality improvement.
Institute for Quality Improvement The Institute for Quality Improvement was established in 1999. It is a department within AAAHC. The Institute provides following activities to support AAAHC: National benchmarking studies to improve care Patient safety and disease management toolkits to improve safety Bernard A. Kershner Innovations in Quality Improvement Award is given to accredited organization for quality improvement Analyzing and reporting on data from AAAHC surveys through the annual Quality Roadmap publication Present data at national meetings and publish in peerreviewed journals
Survey Documentation needed to be submitted prior to onsite survey visit is extensive. Surveyors are physicians, nurses, dentists, and administrators selected and trained by AAAHC. Survey fees are based upon information obtained from the facility’s application document. The size and type, as well as the range of services the organization provides, are considered in determining the fee.
Recertification It is done every 3 years. A facility is eligible for participation if it has been providing healthcare services for at least 6 months before the inspection. There is no annual fee, but there is a fee paid at the time of recertification.
THE JOINT COMMISSION The Joint Commission (TJC) provides accreditation to healthcare organizations to improve healthcare for the public by ensuring the care provided is safe and effective with the highest quality and value.4 “In 1951, the American College of Physicians, the American Hospital Association, the American Medical Association, and the Canadian Medical Association joined ACS as corporate members to create the Joint Commission on Accreditation of Hospitals (JCAH), an independent, not-forprofit organization to provide voluntary accreditation. In the late 1980s, the organization name was changed to the Joint Commission on Accreditation of Healthcare Organizations (JCAHO). In 2007, the organization shortened its name to “the Joint Commission.”4 Most physicians know TJC as an organization that accredits
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hospitals. However, there are only about 5000 acute care hospitals, and TJC accredits more than 21,000 healthcare organizations including ASCs.
(ACGME), State Departments of public health managed care organizations and insurance companies.
Survey Application TJC gives free 90-day access to online standards manual (e-edition) to review the requirements. When reviewing the standards, a list of areas of compliance and noncompliance can be made and updated to meet the standards. After completing an application, it is submitted with a deposit. If any changes are required they should be completed before the site visit.
The HFAP standards are based on the Medicare conditions of participation (CoPs) for each facility type.5 Approximately 80% of HFAP standards are annotated to align with the Medicare CoPs and associated requirements. In addition to Medicare standards, the HFAP standards include criteria proven to improve quality and patient safety. Surveyors are experienced medical professionals. The HFAP claims to be the most costeffective accrediting body.
Survey After submitting the application, a survey is commissioned. For comprehensive onsite review, surveyors can consist of physicians, nurses, and other healthcare workers trained to carry out the survey. The surveyor provides the onsite review and a preliminary written report is made available at the end of the survey.
Decision If any changes are needed, they should be made and usually within 60 days the center is accredited. After receiving “The Gold Seal of Approval,” the center should display the gold seal and notify any organizations, insurance companies, State health board requiring the accreditation. Because of accreditation the center may experience reduced rate of insurance.
Reaccreditation Reaccreditation occurs every 3 years. There may be surprise visits during the 3 years’ accreditation period. If there are any major changes within the organization TJC should be informed. There is an annual fee of $1000.00.
HEALTHCARE FACILITIES ACCREDITATION PROGRAM Healthcare Facilities Accreditation Program (HFAP) is authorized by the CMS to survey hospitals for compliance with the Medicare Conditions of Participation and Coverage. HFAP was originally created in 1945 to conduct an objective review of osteopathic hospitals. CMS was formed in 1965. HFAP has maintained its deeming authority for CMS continuously and meets or exceeds the standards required by CMS/Medicare to provide accreditation to all hospitals and ambulatory care/surgical facilities. In addition to others, HFAP also is recognized by National Committee for Quality Assurance (NCQA), Accreditation Council for Graduate Medical Education
INSTITUTE FOR MEDICAL QUALITY IMQ is a 501(c)3 corporation founded in 1996 by the California Medical Association to improve the quality of care for patients in California.6 The IMQ was designed to make it easier to provide quality care and eliminate barriers. IMQ puts great emphasis on education, counseling, and direct involvement of practicing physicians. Some IMQ programs require surveys of facilities. Each program is updated on a regular basis to keep it clinically relevant. IMQ is recognized in a number of states.
Mission “The Institute for Medical Quality’s (IMQ) mission is to be an innovative leader in improving the quality of care provided to patients across the continuum of health care by encouraging, developing, and implementing programs which effectively measure and improve the quality of care provided to people in California and beyond. In support of its mission, IMQ will conduct educational programs and will evaluate health care delivery. It will be responsive to diverse constituencies, and its outcomes will be patient-oriented and population-based.”6
Application An application is filed along with necessary documents. After reviewing the application and supporting documents the IMQ sends a presurvey analysis to the center, allowing the center to make any necessary revisions before the onsite survey begins.
Survey As per website the survey focuses on following areas: Administration: scope of services, patient rights, and administrative policies and procedures Personnel: staff policies and procedures, physician credentialing in both small group settings and larger settings with an organized medical staff
CHAPTER 36 Quality management and peer review Medical records: surgery and invasive diagnostic records, HIPAA, and clinical record confidentiality Care and treatment Facility and environmental safety: infection control, fire safety, preparation for emergencies, medical equipment, and facility design and access Surgical, anesthesia, and invasive diagnostics
Decision This may include full 3-year accreditation or deferred action if the center does not meet the standards.
CERTIFICATION OF OEC IN DEVELOPMENT All of the accrediting bodies described above do not address the appropriateness of care being provided in the OEC. The accreditation process is mainly related to safety measures taken in providing care to the patients as well as the safety of the workers in the facility. The SVS is working with the American College of Surgeons and some other societies to develop a certification process for the OEC. This process will be modeled after some of the other certification processes ACS has developed in the past, i.e., trauma centers, bariatric centers, etc. The procedures that may be included are endovascular management of arterial disease except carotid stenting and abdominal aortic aneurism, management of superficial and deep venous disease, embolization procedures, management of dialysis access, insertion, and removal of intracaval filters and management of central lines and ports. The certification process is expected to be unveiled in the near future. Initial certification may be limited and not include all the procedures carried out in the OEC. The certification process developed by American College of Surgeons to certify trauma centers, etc. is based on five phases of care: Preoperative evaluation and preparation, immediate preoperative readiness, intraoperative care, postoperative care, and postdischarge care.7 The ACS believes in the following principles of care: Shared decision-making between the care provider and patient/family, risk stratification and reduction of risk before the procedure, evidence-based care, and following the safety standards and coordination among team members. When certifying or accrediting the center, adherence to the standard of care in these phases becomes important. The center should strictly follow the written policies and procedures. Let us look at the five phases of care that would have an impact on performing a percutaneous procedure for chronic limb ischemia in an OEC.
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PREPROCEDURE EVALUATION When a patient presents with symptoms of arterial ischemia, the first step is to determine if the symptoms are truly of arterial origin. Patients in older age group may have several causes of pain in the legs, e.g., spinal stenosis, arthritis, etc. The diagnosis is based on history, physical exam and arterial ultrasound findings, and ankle brachial index. In case the patient cannot give reliable history, the patient’s family or caretaker may play an important role. The process is carried out in the physician’s office. Other tests such as an MRI of the spine may be useful in the diagnosis algorithm. Once the diagnosis of arterial ischemia has been made, the medical management must be instituted. The patient should have the benefit of maximal medical benefit. This includes smoking cessation, modification of risk factors, supervised exercise therapy, and use of antiplatelet and other drugs like cilostazol. Other risk factors should be assessed using lab values and additional tests like cardiac stress test, etc. At this point in managing the patient, the appropriateness of care becomes very important. Appropriateness of care is not addressed by the existing accreditation bodies in a meaningful way. The invasive procedure should be recommended only for the appropriate indication and after the medical therapy has failed. All risk factors should be addressed and optimized. The medications that may have bearing on the procedure should be addressed. For example, if the patient is on anticoagulants, there should be a plan in place to manage these before, during, and after the procedure. Appropriate input should be sought from the primary care physician and any other specialists providing care for the patient. Risk and benefits of the procedure and alternative therapies should be discussed with the patient and the family. An informed consent should be signed by the patient. The patient should be educated about the arterial disease and the planned procedure and after care. If there are any medical insuranceerelated issues, those should be resolved. Since OEC is an extension of the practice, this phase of care usually will be provided in the same office where the intervention will be carried out. The office should meet all the safety requirements. There are guidelines by various societies in providing care for these patients. The guidelines should be followed.8,9
IMMEDIATE PREOPERATIVE CARE The patient should be examined and the history and physical should be updated. The patient and the family, interventionalist, nurses and other members of the
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Other Important Considerations
team, and an anesthesia provider if needed should all be involved in care as appropriate. The patient will be seen in the part of the office that is being used as an OEC. The lab values will be rechecked specially for renal function and coagulation perimeters if the patient was on anticoagulants. The procedure should be appropriately discussed with the patient and the family. The informed consent form duly signed by the patient and/or the power of attorney should be in the chart. The surgical site needs to be marked and appropriate groin shaved and prepared. For the arterial procedure, it is preferable to shave both groins and tibial area if tibial approach is contemplated. If the patient is diabetic, blood sugar needs to be checked and the oral intake status needs to be confirmed as per the directions given in advance. If anesthesia is planned, appropriate evaluation needs to be documented (chapter 10). If an anesthesia personnel is not being used, then the interventionalist and the registered nurse giving medication and monitoring the patient during the procedure should be certified in advanced cardiac life support. The patient should be given appropriate drugs as per protocol prior to the procedure and hydrated if there is evidence of renal insufficiency. The availability of patient supervision by a responsible adult for 24 h postprocedure should be confirmed. The area for preprocedure evaluation needs to provide privacy for the patient and be HIPAA compliant. All data should be entered in an EMR.
INTRAOPERATIVE CARE In the next phase of care, the procedure is carried out in the interventional suite. The interventional suite should have appropriate imaging system, radiolucent table, power injector for contrast, and an ultrasound machine for accessing the vessel. All the disposable equipment like sheathes, wires, and catheters should be available. If there is a plan to use an atherectomy device and/or intravascular ultrasound the appropriate equipment should be available. Appropriate stents and covered stents for a bail out procedure should be available. Availability of these supplies needs to be checked before the procedure is started. There should be an emergency generator in case of power failure. Before the procedure is started an appropriate checklist that includes timeout should be completed. Appropriate personnel should be available and present in the endovascular suite. The personnel should be appropriately dressed and behave professionally. The patient should be appropriately prepped and draped for the arteriogram. Once the procedure starts, appropriate record should be kept and images stored
in PACS. The equipment being used should meet all the manufacture’s recommended service requirements. Since these procedures are carried out using local anesthesia and/or conscious sedation, it is important to keep the patient comfortable using verbal assurance and appropriate medications. After the intervention is completed, appropriate measures should be taken for hemostasis at the site of vessel entry using manual compression or a closure device.
POSTPROCEDURE PHASE Once the patient comes to the recovery room, the patient should be monitored appropriately for vital signs as well as for signs of bleeding at the procedure site. The distal circulation at the pedal level should be checked in both feet. All the findings need to be documented in the EMR. The interventionalist should finish recording the comprehensive procedure note. The interventionalist should be available in case of a complication. Appropriately trained employees should monitor the patient. There should be equipment available for monitoring, like handheld Dopplers. The biological waste and general waste should be disposed of as per the policy. The instruments should be cleaned and sterilized as per the specifications of the autoclave being used.
POSTDISCHARGE PHASE The patient and the caretaker are given appropriate instructions verbally and in writing. If the patient had medications held prior to the procedure, instructions to restart the medication should be given. It must be ascertained that patient will have caretaker with the patient for at least 24 h postprocedure. A follow-up appointment should be given. If the patient needs follow-up appointment with other specialists or primary care doctor, it should be arranged. If the patient is returning to a facility then the facility should be given appropriate instructions. If needed, social service referrals should be made. During these phases of care there are various requirement for the building, equipment, and personnel that need to be met. Once the certification/accreditation process being created by SVS/ACS is in place the OEC may use this particular approach to get certified since the process will be geared specifically toward an OEC. Another requirement for getting accredited under this process may be mandatory participation in a quality clinical data registry. There are various registries a center could participate in.
CHAPTER 36 Currently there are several organizations providing accreditation for the OEC. Though not mandated by CMS, it is prudent to get the OEC accredited by one of the national accreditation bodies. Some states mandate it, and some insurance companies will not pay for the procedure if the center is not accredited. A stamp of approval from an outside organization is always looked upon favorably by regulatory bodies and patients alike.
5. 6. 7. 8.
REFERENCES 1. A.S.C. Association, Accreditation Organizations, (n.d.). 2. Guidelines for Optimal Ambulatory Surgical Care and OfficeBased Surgery. 3rd ed. 2000. 3. American Association for Accredidation of Ambulatory Surgery Facilities, What is Accreditation, (n.d.). https://www. aaaasf.org/who-we-are/what-is-accreditation (accessed April 29, 2019). 4. The Joint Commission, (n.d.). American College Health Association, the American Group Practice Association (now
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Known as the American Medical Group Association), The Federated Ambulatory Surgery Association (now Known as the Ambulatory Surgery Foundation), The Group Health Association (accessed April 29, 2019).. Healthcare Facilities Accreditation Program (HFAP), (n.d.). https://www.hfap.org/about/overview.aspx. Institute for Medical Quality (IMQ), (n.d.). Hoyt D, Clifford K. Optimal Resources for Surgical Quality and Safety. American College of Surgeons; 2017. Aboyans V, Ricco J-B, Bartelink M-LEL, et al. Editor’s choice e 2017 ESC guidelines on the diagnosis and treatment of peripheral arterial diseases, in collaboration with the European society for vascular surgery (ESVS). Eur J Vasc Endovasc Surg. 2018;55:305e368. https://doi.org/10.1016/ J.EJVS.2017.07.018. Olin JW, Allie DE, Belkin M, et al. ACCF/AHA/ACR/SCAI/ SIR/SVM/SVN/SVS 2010 performance measures for adults with peripheral artery disease. Vasc Med. 2010;15: 481e512. https://doi.org/10.1177/1358863X10390838.