Criteria for Adjudication of Echocardiography Facilities May 2018

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1 This document is prepared with the intention of providing full transparency with respect the process by which Echocardiography Facilities will undergo review and assessment under the Echocardiography Quality Improvement (EQI) initiative undertaken by CorHealth Ontario and as directed by the Ministry of Health and Long Term Care (MOH). Reviews are based on a structured assessment of the standards as described in Standards for Provision of Echocardiography in Ontario (April 2015). Section 7: A Process for Echocardiography Laboratories to Achieve the Standards is out of date and this document provides the necessary clarity on the journey towards achieving Standards. Forty-two of these standards pertain to the standard transthoracic examination. Additional standards are provided for laboratories providing stress and transesophageal examinations. Assessments consist of two components; review of submitted material and on-site review of processes, resources and recorded examinations. Reviews are carried out by experienced and specifically trained sonographers who are supported through the process by an assigned physician with advanced training in Echocardiography. The EQI Advisory Panel establishes the standards and advises CorHealth with all aspects of the review and adjudication process. Seventy-two standards, in aggregate, characterize the optimally functioning echocardiography facility. A subset of twelve are regarded as Priority standards because they are considered individually essential to provision of optimal care. A further seventeen standards are regarded as Critical standards because they relate directly to issues of patient safety. The overall facility assessment and action arising from the review is determined as follows:

2 Finding Determination Action All standards in Compliance Full achievement 1. Certificate of achievement provided. 2. MOH notified that facility in full compliance. All Priority and Critical Standards in compliance, but one or more remaining standards are deficient One or more Priority standard in noncompliance Minor concerns Significant concerns 1. Facility notified of deficiencies and provided suggestions and timeline for resolution in Quality Improvement Plan (QIP). 2. Facility notifies CorHealth when all issues have been resolved. 3. When notified, CorHealth issues certificate of achievement and notifies MOH of compliance. 4. CorHealth reserves option to carry out random reviews. Results of such reviews are shared with both Facility and MOH. 1. Facility notified of deficiencies and provided suggestions and timeline for resolution (QIP). 2. Facility submits an Action Plan within one month describing how they will address deficiencies and timeline. 3. Action Plan reviewed by CorHealth and revised if necessary. 4. Attestation, verifying completion of Action Plan and compliance with Standards, is submitted to CorHealth within the timelines established.

3 One or more Critical Standard found in noncompliance Critical concerns 5. When accepted, CorHealth issues certificate of achievement and notifies MOH of compliance. 6. CorHealth reserves option to carry out random reviews. Results of such reviews are shared with both Facility and MOH. 1. Facility notified they are in non-compliance with critical standards. 2. MOH notified that the facility has been found in noncompliance with critical standards. 3. Criteria for resolution established by CorHealth, which will require submitted material and a focused follow-up to be completed within a scheduled timeframe. 4. When completed and all standards found to be in compliance, CorHealth issues certificate of achievement and notifies MOH of compliance. 5. CorHealth reserves option to carry out random reviews. Results of such reviews are shared with both Facility and MOH.

4 Process Summary Quality Improvement Plan issued MOH updated Focused Follow-Up Site Review required Action plan provided to CorHealth and approved Lab reports on compliance Random Follow-Up Site Review is possible Certificate of achievement issued and MOH notified of full compliance Full achievement Minor Significant Critical concerns concerns concerns After successful After After Follow-Up Site resolution of resolution of Review(s) and all Action Plan all issues resolution of issues all Action Plan issues

5 Priority and Critical Standards Principle Priority Standards Critical Standards Rationale 1. Patients are F3 Equipment Equipment not not harmed by maintained in maintained in care they receive good operating good operating condition condition can harm a patient and/or compromise the F10 IPAC integrity of the Standards study maintained for prevention of Risk of infection infection 2. Continuous quality improvement and critical oversight is essential to maintain standard of practice Q1 Regular review of study acquisition Q2 Review of study interpretation Q4 External review A robust quality improvement program will result in the evolution and advancement of the other critical standards P2 Medical Director roles and responsibilities Continued improvement of patient care 3. Personnel who P1 Medical P7 Medical staff Lack of qualified provide care are Director qualifications personnel poses a appropriately risk for poor qualified P10 Technical staff quality services P4 Technical qualifications Director 4. There are F1 Examination F9 Protocol for Risk to patient if systems in place rooms communication of processes for the to provide high risk findings communication of

6 appropriate clinical care and urgent/emergent findings are not in patient privacy F7 Recording, storage and place retrieval of images and reports Risk if stored records are not easily retrieved and do not FS6, FT5 Additional maintain patient requirement for Stress and TEE privacy studies Inability to respond to a medical emergency during a patient examination could result in patient harm 5. The Echo F2 Ultrasound E2-E4 Significant errors examinations and reports instruments Comprehensive examination in patient management and demonstrate ES2 Additional identification of quality care is being provided requirement for Stress studies ES3, ET2, ET3 Additional pathology could result in patient requirements for Stress and TEE harm studies Reports not documented in a R1-R5 Reports clear and consistent format could impact quality of patient care

7 6. Only clinically appropriate examinations are conducted I1 Indications Inappropriate use of equipment can harm a patient Exams should be performed for clinically appropriate reasons Timelines for Improvement Because critical standards pose a risk to patient safety, immediate corrective action is required. Facilities are welcome to seek guidance from the EQI Program on appropriate and reasonable corrective actions, including interim measures. Submission of materials and/or follow-up visits are required to confirm evidence of compliance with these standards. As long as constructive and timely improvements continue towards achieving Standards, Facilities shall be considered by CorHealth to be Actively Engaged.

8 Standard E2, E3, E4, ES3, ET2, ET3 E2: The comprehensive transthoracic echocardiographic examination shall contain the following imaging components (describes 13 imaging components) E3: The comprehensive transthoracic echocardiographic examination shall contain the following Doppler components (describes 9 Doppler components) E4: The comprehensive transthoracic echocardiographic examination shall contain the following standard measurements (describes 9 standard measurements) ES3: The comprehensive Stress echocardiographic examination shall contain the following components (describes stages and components) ET2: The comprehensive Transesophageal echocardiographic examination shall contain the following components (describes imaging components) ET3: The comprehensive Transesophageal echocardiographic examination shall contain the following Doppler On site reviews of randomly selected examinations will be carried out. At least 50% of the transthoracic and transesophageal examinations reviewed must contain significant pathology (left ventricular dysfunction, valvular stenosis or regurgitation of at least moderate severity, or significant structural abnormality). At least 60% of the stress examinations reviewed must contain positive results. It is expected that examinations will contain no less than 90% of each of the required imaging, Doppler and comprehensive components at sufficient technical quality to allow for reliable interpretation.

9 Standard F3 F3: Equipment shall be maintained in good operating condition: The accuracy of the data collected by ultrasound instruments is paramount to the interpretation and diagnostic utilization of the information collected. Regular equipment maintenance by appropriately trained individuals is essential. This can be carried out either through maintenance and service agreements with manufacturers, or by other appropriately trained personnel. Guidelines for equipment maintenance include, but are not limited to, the following: Recording of the method and frequency of maintenance of ultrasound instrumentation and digitizing equipment, Establishment of and adherence to a policy regarding routine safety inspections and testing of all facility electrical equipment. Establishment of and adherence to an instrument cleaning schedule that includes routine cleaning of equipment parts, including filters and transducers, according to the specifications of the manufacturer. This standard will be assessed in two ways: Submitted material will include documentation of policy and procedures that ensure these requirements are met. On site reviews will confirm systems are in good operating order and scheduled maintenance procedures are in place.

10 Standard F7 F7: Echocardiographic data (images, measurements and final reports) obtained for diagnostic purposes shall be recorded, stored and archived in a format that ensures ready retrieval such that the parameters outlined in Standard F6 are met (complete review, clear communication and patient confidentiality). This standard will be assessed in two ways: Submitted material will include documentation of policy and procedures that ensure these requirements are met. Recording and archiving processes will be tested during site review. Standard F9 F9: Laboratories shall have protocols whereby unexpected high-risk findings are communicated immediately by the interpreting physician to the referring physician and managed as required by the interpreting/responsible echocardiologist. Assessment criteria applied in the review process: This standard will be assessed in two ways: Submitted material will include documentation of policy and procedures that ensure this requirement is met. On site reviews will confirm that all personnel are aware of the appropriate procedures and the process is operational.

11 Standard F10 F10: Echocardiography laboratories shall have Infection Prevention and Control (IPAC) Policies and Procedures in place. All health care providers shall follow routine IPAC Practices for all patients during all care in all echocardiography facility settings. Protocols shall contain the following elements of routine IPAC practices: Hand hygiene Risk assessment Personal protective equipment Control of the environment Cleaning of the environment Safe administration of injectable medications Cleaning of medical equipment Healthy workplace policy This standard will be assessed in two ways: Submitted material will include documentation of policy and procedures that ensure these requirements are met. On site reviews will ensure appropriate practices are in place.

12 Standard P7 P7: Members of Medical Staff shall be licensed physicians who hold one of the following qualifications: Level 2 or 3 training in Adult Echocardiography, or Documented performance in an established facility, with interpretation of at least 400 Echo/Doppler studies per year and maintenance of competence as defined in Standard P3 for the preceding 3 years. Submitted material will include attestations from all Medical Staff documenting: Their qualifications as per either of the above two options. The training or practice site The period during which training/practice occurred The physician who supervised their training or Medical Director of their practice site Permission for CORHEALTH to confirm these points

13 Standard P10 P10: All technical staff performing echocardiographic examinations shall meet one of the following criteria: Appropriate credentialing from ARDMS or equivalent agency, as approved by the Medical and Technical Directors Successful completion of an accredited Echocardiography training program which includes both didactic teaching and supervised clinical experience Sonographers who have recently completed an accredited echocardiography training program may be engaged in echocardiography for 2 years prior to qualifying for ARDMS, or equivalent credentialing. Submitted material will document qualifications of all sonographers carrying out examinations within the facility under review Standards R1-R4 Citations as per Standards for Provision of Echocardiography in Ontario R1: All echocardiographic reports shall include the information outlined in Appendix A. R2: In addition to the standard information outlined in Appendix A, specific evaluation will be provided regarding the presenting problem. R3: An assessment of study quality shall be included in every report and, where appropriate, a statement regarding any study limitations. R4: Amended reports shall be identified as such and shall include the date and time of the change, as well as the specific changes from the original report. During site visits, a random selection of completed reports will be reviewed with respect to these standards with expectation that 90% of reviewed reports will be in compliance.

14 Standard R5 R5: Final reports should be consistent in format and completed only after full review of all acquired data and necessary re-measurement and include the following: 1. Overall interpretation/summary of findings, including any pertinent positive and negative findings, as it relates to the assessment of the presenting issue/reason for the study. 2. Consistent with the qualitative and quantitative data elements. 3. Findings of other significant pathology. 4. Relevant comparisons to prior studies or reports as available. If prior studies are not available, this should be documented. 5. Study limitations. 6. Recommendations regarding alternatives or additional investigations where appropriate. 7. Routine patient demographics, including Blood Pressure, Heart Rate and Rhythm and Body Surface Area. During site visits, a random selection of recorded examinations will be reviewed together with their finalized reports. Deficiencies in any of the R5 criteria must be confirmed by a physician reviewer. In the case of conflicting results, a second physician review will be undertaken. To assist in assessing meaningful recommendations for patient s clinical management, CorHealth reserves the right to contact referring physicians.