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Cardiac Care Network of Ontario Echocardiography Quality Improvement Program Self-Assessment Tool Site: __________________________________ Date Registered: __________________________________ Date Submitted Documents: __________________________________ Date Submitted Case Reviews: __________________________________ Date of Site Visit: __________________________________ Site Reviewer(s): __________________________________ Instructions: This Self-Assessment document is provided for sites to utilize during a self-review of policies and practices, as part of the EQI process, prior to the site review. This document can be printed and/or filled out on-line. Please also refer to the “Standards for Provision of Echocardiography in Ontario” and the “Echocardiography Policy and Procedure Manual” for further information. These are both available on the EQI Website under “Helpful Resources”. Pertinent questions that help to determine status of achievement for each standard are listed under “Questions to Consider” in the middle column. Links to the “Templates” are available in the “Echocardiography Policy and Procedure Manual”. Required Documents for Submission to CCN prior to the site visit, are listed below and highlighted in grey. For easy reference the far right hand column is highlighted in grey in sections where there are required documents. This column can be checked-off once the required document has been prepared for submission to CCN. Criteria Content Meeting the Standard Self-Assessment Tools, Templates, and “Questions to Consider”: Required Documents and Processes Document Process Document on Site in Place Submitted Section 1: Standards regarding the Echocardiographic Examination Standard E1 Echocardiographic facilities will have established protocols that describe the components of the comprehensive examination. Are there protocols in place regarding the acquisition of images for every modality? Are they available to be reviewed and have they been accepted by all sonographers and physicians involved? Template: Guidelines for ordering Echocardiography Exams Template: Adult Transthoracic Study Protocol Protocol for Performing Complete Transthoracic Echocardiograms (TTE) Standard E2 Standard E3 Standard E4 The comprehensive echo exam. Every case study will contain the full complement of views including Doppler tracings and measurements. Does every comprehensive echo contain all of the imaging components mentioned in Standard E2? Please review Section 1 of the Standards for complete views, measurements and Doppler. The comprehensive echo exam with a Doppler assessment component. Specific comments on the study quality relating to any technical deficiencies and or inadequate alignment will be included. Does every echo contain all of the Doppler components listed in Standard E3? The comprehensive examination will contain standard measurements. Standard measurements will be obtained and recorded by either M-mode of 2D for all studies, based on their situational strengths and limitations. Please refer to this template to ensure standard measurements are being utilized for all comprehensive examinations. Template: Echocardiography Imaging Protocols and Measurements Template: Protocols for Measuring Doppler Standard E5 Provision of additional information. Provided according to the established procedures of the facility, where clinical indication warrants. Does your facility have Protocols in place for specific cardiac disease states? Are exams meeting the needs of the patient? Template: TTE Additional Imaging Views for Pathology Section 2: Standards Regarding Echocardiography Facilities, Equipment and Procedures Standard F1 Examining rooms. Echocardiographic examining rooms must provide patient comfort, quality and safety, as well as the appropriate ergonomic environment for the sonographer. Are the exam rooms large enough to provide adequate room for all of the equipment, staff and the patient? Are workplace ergonomics, safety and infection control protocols assessed regularly? Provide a diagram of TTE echocardiography floor plan(s) 2.2 Echocardiography Imaging Systems Standard F2 Standard F3 Imaging systems. Ultrasound diagnostic instruments must include hardware, and software required for proper performance of M-Mode and 2D imaging. Does the facility have the necessary hardware and software in order to provide/produce good quality studies? Equipment maintenance. Equipment must be maintained in good operating condition and be routinely inspected for safety by trained individuals. Are there records maintained and available pertaining to the following: Template: Echocardiography Equipment List Policy and records of safety inspections and testing of electrical equipment. Records of preventative maintenance and required repairs. Infection prevention and control related policy and cleaning schedules including sterile processing policy and processes. 2.3 Operating Procedures Standard F4 Requisitions. Echocardiographic procedures orders/requisitions will include the study type, indications, and name of ordering physician. Does all staff at the facility understand the importance of including study type, indications and ordering physician information on all echo requisitions? Standard F5 Sufficient time must be allotted for each examination. Generally, 30 to 45 minutes should be allotted to complete a transthoracic image examination, including Doppler assessment. An additional 10 15 minutes is required for analysis, reporting, preparation for the next examination. Are patients scheduled into the facility allotted the appropriate time for their test according to Standard F5? Will a review of the clinics appointment schedule confirm this? Standard F6 Echocardiographic reports. Echocardiographic reports must be provided to the referring physician within specific timeframes: Inpatients and urgent outpatients; by the end of the next working day. All other outpatients; within 5 working days. High risk findings should be communicated immediately. When are the reports provided to the referring physician for inpatients and urgent/non-urgent outpatients? Are high risk findings communicated immediately? Data storage. Echocardiographic data and final reports must be formatted to allow for the ready retrieval of recorded, stored and archived information and ensure patient confidentiality. What system does the facility have in place to ensure easy retrieval of recorded, stored and archived studies? How does this system provide patient confidentiality? Standard F7 Standard F8 Standard F9 Record retention. A permanent record of the echocardiographic images and interpretation must be made and retained in accordance with provincial guidelines for medical records. What is this facility’ policy and practice regarding permanent record retention? Please submit a copy of the clinics’ specific process regarding record retention. Unexpected high risk findings. Protocols will be in place whereby unexpected high risk findings can be communicated immediately by the interpreting physician to the referring physician. How is high risk findings communicated? What is the time frame and who is responsible to provide follow up care for the patient? Please submit your policy. Site Process for Record Retention (regarding retaining echocardiography imaging as a permanent record ensuring patient confidentiality) Site Policy for Communication of High Risk Findings 2.4 Additional considerations for transesophageal echocardiography (TEE) Standard FT1 Staff training. The facility is required to have appropriately trained and qualified personnel for the provision of patient sedation and monitoring throughout the procedure and recovery period. Physicians with adequate training perform TEE’s. Who is providing sedation and monitoring throughout the exam and recovery? Standard FT2 Informed consent. All transesophageal procedures must be explained to the patient and/or the guardian of those unable to give informed consent. How is informed consent documented? Who obtains it and at what step in the process is it obtained? Transesophageal transducers. Transesophageal transducers must be readily available and meet the specific standards. All transesophageal transducers provide multiplane imaging. 3D capabilities are available. Standard FT3 Facility Protocol for Performing Transesophageal Examinations (TEE) Protocol for Performing Transesophageal Examinations (TEE) Standard FT4 Adequate room size to perform transesophageal echocardiography. Larger rooms, in which to perform transesophageal echocardiography, must be provided. The recommended room size is 150 to 200 square feet which can accommodate extra equipment, personnel and potential resuscitation procedures. What are the dimensions of the transesophageal echo exam room? Does the layout accommodate all of the required equipment, personnel and potential resuscitation procedures? Please document any challenges that may have presented in meeting this standard. Please provide a diagram of the floor plan in the TEE procedure room. Standard FT5 Examination room content. Laboratories providing transesophageal echocardiography require the following features: Blood pressure monitoring, suction, oxygen, pulse oximetry, resuscitation, medications and equipment, intravenous equipment, lockable cabinets, a means of rapidly calling for help with an unstable patient and a large sink. Where is the emergency cart located in conjunction with the TEE exam room? Is it easily accessed? Does the TEE procedure room have a large sink for the purpose of rinsing scopes? How are medications, including sedatives and analgesics, managed? Standard FT6 Cleaning and disinfection. The echocardiography laboratory must follow proper cleaning, disinfection, and maintenance procedures. What is the process in following infection prevention & control standards? Where does the cleaning of probes occur? Is there a log kept? Provide a diagram of the floor plan in the TEE procedure room Infection prevention and control related policies and processes regarding cleaning schedules and sterile processing is dependent on the echocardiography system. Please refer to the following link for Infection Prevention guidelines: http://www.publichealthontario.ca/en/eRepository/IPAC_Clinical_Office_P ractice_2013.pdf Standard FT7 Observation rooms. Facilities and procedures must be available for observation/recovery of patients by trained and qualified personnel. Is there a dedicated recovery space for patients, where they are monitored by qualified personnel? If not, what impact does this have on the operations of the clinic? Qualified personnel available to conduct stress echocardiography. Appropriately trained and qualified personnel are required to monitor the patient, operate the treadmill or supine bicycle, record the electrocardiogram and/or, administer medication specific to the type of examination. What are the qualifications of the personnel monitoring the patient; operating the treadmill or supine bicycle; administering medication; and carrying out the examination? 2.5 Stress Echo Standard FS1 Standard FS2 Informed consent. Stress echocardiography procedures must be explained to the patient and/or the guardian of those unable to give informed consent. If applicable please submit: Protocol for Performing Stress Echocardiography Examinations Template: Protocol for the addition of Contrast to Echocardiography Studies Template: Treadmill Exercise Stress Echo Procedure Template: Bicycle Stress Echocardiography Protocol Template: Agitated Saline Echocardiography Study Protocol Template: Comprehensive Dobutamine Stress Echo Procedure How is informed consent documented for stress echo? Who’s responsibility is it and at what step in the process is it obtained? Standard FS3 Adequate room size to perform stress echocardiography. Larger rooms must be provided to perform stress echocardiography with the purpose of accommodating extra equipment, personnel and potential resuscitation procedures. Observation rooms. Facilities and procedures must be in place for the observation and recovery of patients, and staffed by trained and qualified personnel. Does the size of the stress echo exam room accommodate all of the required extra equipment, personnel and potential resuscitation procedures? Please provide a floor plan including equipment configuration of the stress echocardiography procedure room. Standard FS5 Echocardiographic imaging equipment requirements. Additional echocardiography equipment with reasonable memory and dual imaging must be present to allow for the “triggered image acquisition and side-by-side image display, utilized in stress echocardiography studies. Is the sites’ stress echo imaging system able to perform the required processes according to the standard? Standard FS6 Additional facilities required for stress echocardiography. Provision of additional facilities are required to perform stress echo procedures which include a treadmill, ECG monitor, blood pressure, oxygen, resuscitation equipment, medications, available IV and emergency call access. Does the stress procedure room contain all of the necessary equipment and space that allows for safe patient care? Is the clinic a comfortable and safe work environment that is ergonomically sound? Standard FS4 Provide a diagram of Stress echocardiography floor plan(s) Is there a dedicated recovery space for patients, where they are monitored by qualified personnel? If not, what impact does this have on the operations of the clinic? Section 3: Standards for Reporting of Echocardiography Examinations Standard R1 Are required targeted imaging and hemodynamic assessments specifically indicated on the standard report form? Is there a specific area to document data acquisition limitations on the standard report form? If not, how is this documented? Echo report. Echocardiographic reports should be standardized and in accordance to Appendix A outlined in the Standards for Provision of Echocardiography in Ontario (2012), to include specific information (1) patient demographics, (2) echocardiographic findings, and (3) a summary/interpretation, provided in a clinically relevant, useful manner. Are the echo reports standardized to include all of the required components mentioned in Standard R1? Does the document flow according to the study review process so that priorities are specified in predominant areas of the report? For example the summary of the study should be located at the beginning of the report. Standard R2 Specific evaluations. Specific indications or pathologies require further targeted imaging and/or hemodynamic assessment in addition to the standard outlined in Appendix A. Standard R3 Assessment and limitation of study quality. It is recognized that a full set of interpretable echocardiography data may not be possible for all patients due to technologic limitations. Data acquisition limitations must be clearly stated within the report, in order to avoid the assumption of normality by the referring physician. Template: Standardized Report for Adult Transthoracic Echo Standard R4 Amendments to reports. Amended reports must be identified as such, including the date and time of the change, as well as the specific changes from the original report. How are amendments to the reports identified? Are the amendments dated? Standard R5 Final reports. Final reports should be completed only after full review of all acquired data and must include the following: Summary of interpretations of positive and negative findings, as it relates to the presenting issue assessment, Summary of other significant pathological findings, Relevant comparisons to prior studies or reports, Study limitations and Recommendations regarding alternative or additional investigations. When are the final reports completed? Do they include all of the requirements mentioned in Standard R5? Does the document flow according to the needs of the reviewer? Mechanism in communication of urgent findings. How are urgent findings communicated? Is this communication included in the documentation for auditing purposes? Standard R6 Site Policy for Validation by Study Comparison Section 4: Standards Regarding Personnel Involved in Echocardiography Examinations Standard P1 Standard P2 Standard P3 Qualifications of the facility Medical Director. Laboratories will have a designated Medical Director, who must be a licensed physician and hold one of the following qualifications: 1) Level 3 training in echocardiography 2) Level 2 training and continuing echocardiography practice including interpretation of a minimum of a minimum of 1800 echo/Doppler examinations over the previous 3 years. Submit a completed attestation form for Medical Director. Have role profile and CME record available on site. Template: Reporting responsibilities Submit a copy of the Staff Organizational Chart Roles and responsibilities of the Medical Director. The Medical Director is responsible for: 1) clinical services, quality of medical care, 2) Medical and technical staff compliance to facility standards, 3) Participation in the interpretation of studies performed in the laboratory. Continuing maintenance of competence of the Medical Director. The Medical Director will maintain medical competence by attending 24 hours of accredited CME relevant echocardiography activities over a 2 year period and interpreting a minimum of 400 transthoracic echo studies. For laboratories performing transesophageal echocardiography, the Medical Director must perform and interpret a minimum of 25 examinations per year. For laboratories providing stress echocardiography, the Medical Director must interpret at least 75 stress echocardiograms per year. 4.2 Standards Regarding the Technical Director Standard P4 Qualifications of the facility Technical Director. Laboratories must have a designated Technical Director who has credentialing from the American Registry of Diagnostic Medical Sonography (ARDMS) or equivalent credential, and experience as assessed and approved by the Medical Director. In laboratories without appropriately qualified sonographers, a physician assumes the role of Technical Director and must have at Level 2 or 3 training. Submit a copy of Credentials/Registration for the Technical Director. Please have a copy of role profile and CME record available on site. Standard P5 Roles and responsibilities of the Technical Director. Technical Director has oversight for the following: 1) Performance of echocardiography examinations. 2) Supervision of technical and support staff. 3) Delegation of responsibilities to technical staff. 4) Daily laboratory administration. 5) Operation and maintenance of laboratory equipment. 6) Compliance of technical staff to standards. 7) Maintenance of quality of patient care. 8) Training of technical staff. Standard P6 Continuing medical education (CME) for the Technical Director. Technical director must document a minimum of 30 hours of echocardiography related continuing medical education credits (CME) over a 3 years period. 4.3 Standards Regarding Medical Staff Standard P7 Qualifications of medical staff. Members of the Medical Staff must be licensed physicians and have formal training in adult echocardiography level II/III, and interpretation of 400 Echo/Doppler exams per year. Standard P8 Roles and responsibilities of the Medical Staff. Members of the medical staff are responsible for interpreting exams, reporting, supervising/triaging emergency cases, performing transthoracic echocardiography, transesophageal and/or supervising stress echocardiography. Continuing education (CME) for Medical staff. Members of the Medical Staff must undertake and document continuing maintenance of competence as described in Section P3. Standard P9 Submit completed attestation forms for Medical Staff. Have role profiles and CME records available on site. 4.4 Standards Regarding Technical Staff Standard P10 Qualifications the Technical Staff. Technical staff performing echocardiographic exams must meet one of the following criteria: Credentialing from ARDMS Submit a copy of Credentials/Registration for all technical staff. Have a role profile and CME record available on site for all technical staff. Standard P11 or equivalent agency, as approved by the Medical and Technical Directors. Completion of an accredited echocardiography program. Completion of one year of full time clinical echocardiographic examinations and a two year program in another allied health profession. Roles and responsibilities of the Technical Staff. Under the direction of the Technical Director, responsibilities of technical staff include: Ensuring the patient’s identity, information documentation, comfort and safety. Acquisition and recording of all echocardiographic images and data. Alerting supervising physicians as to any technical acquisition deficiencies, urgent conditions, significant symptoms or patient distress identified in the course of the examination, or while in the echocardiography laboratory. Standard P12 Continuing medical education (CME) for the Technical Staff. The Technical Staff must document a minimum of 30 hours of related echocardiography CME every 3 years. Section 5: Indications for Echocardiography Examination Standard I1 Indications for echocardiography examination. What is the mechanism used to ensure that all referrals have a primary indication code? Standard I2 Referrals without a standard indication. What is the process in place to clarify the reason for the referral when an indication code is not documented on the referral? Is staff aware of this mechanism? Are echo’s done without a primary indication? Site Policy for requisitions without indication codes Standard I3 Echocardiographic laboratories must ensure policies for indications for echocardiograms. Mechanisms are required to be in place to: Track indications of completed studies, ensuring that at least 95% of studies meet standard indications (as per Appendix B in the What is the method used to track indications of completed studies in order to ensure that a minimum of 95% of completed studies include standard indications? Do you have a standard approach to educating referring physicians regarding appropriate study indications? Is this documented? Template: Indications for Echo Standards). Provide education to referring physicians regarding appropriate study indications. Section 6: Continuing Quality Assurance in the Echocardiography Laboratory Please submit: The following past year statistics are to be submitted with all other “required documents” prior to site review: All Echocardiography Statistics are done on an annual basis with monthly subtotals for the following: TTE inpatient/outpatient/emergency; TEE inpatient/outpatient/emergency; DSE inpatient/outpatient/emergency; ESE inpatient/outpatient/emergency Standard Q1 Regular review of study acquisition. Regular review of the study acquisitions by the Medical Director to assess image quality and accuracy of measurements by sonographers. Is it regular practice for the Medical Director of this site to assess image quality and accuracy by the sonographers? How many random studies are reviewed and how frequently is this done? Is a pre-defined scoring system with pre-set standards of accuracy utilized in order to provide feedback? What is this facilities’ process for Regular Review of Study Acquisition? Standard Q2 Review of study interpretation. Regular random report reviews, over Director to assess accuracy, completeness and timeliness of the reports. How often does the Medical Director (or designate) review random reports for accuracy, completeness and timeliness of each interpreting physician? Site Policy for Review of Study Interpretation and Report turnaround times Standard Q3 Staff meetings. Conduct routine staff meetings to review and discuss the results of the QA process and introduce changes or improvements. Are regularly scheduled staff meetings held in order to review this sites quality assurance processes and for the purpose of introducing improvement measures? How frequently do they occur and are minutes recorded and distributed? Standard Q4 External review. Processes for external reviews that allow for constructive feedback and review of any discordant findings. What is the process for external review? Standard Q5 Validation against other diagnostic modalities. Processes for validating test findings by the correlation with other diagnostic procedures, intraoperative findings and pathologies. How are test findings validated against other diagnostic modalities? Standard Q6 Case review. Conduct rounds or case reviews, focusing on relevant instructional content of interesting cases or specific disease entities. Please describe the educational opportunities offered to staff, such as attending clinical rounds/reviews or conferences, in order to maintain competencies and advance skills.