Jefferson Einstein Philadelphia Hospital

“GOVERNING BODY CFR(s): 482.12 There must be an effective governing body that is legally responsible for the conduct of the hospital. If a hospital does not have an organized governing body, the persons legally responsible for the conduct of the hospital must carry out the functions specified in this part that pertain to the governing body ... This Condition is not met as evidenced by: 34230 Based on review of facility Bylaws, policy, documents, medical record (MR) and interviews with staff (EMP), it was determined that the Board of Trustees (governing body), failed to ensure the accountability of the radiology providers for timely completion of the process for selecting/creating the electronic patient distribution letter detailing the imaging exam results; failed to ensure facility stakeholders responsible for managing the mammography services evaluated and analyzed data and workflow process to ensure the quality and safety of mammography services and failed to ensure facility policies and procedures were congruent with facility standard operating practices and performance improvement initiatives. The immediate interventions implemented by the facility on July 12, 2024, to remove the Immediate Jeopardy called on July 12, 2024, at 1:00PM included a meeting with the radiologist providers to educate and confirm their accountability and responsibility to complete the radiology report process to support the patient distribution letter notification process. The staff received education on the facility’s process for distribution of the patient distuributuion notification letters containing the results of the mammography imaging exams and ensuring the patient distribution notification letters are accurate prior to the patient receiving the intended patient letter as to their health status. The surveyor confirmed removal of the Immediate Jeopardy on July 12, 2024, at 4:50 PM. Findings include: Review of facility Bylaws “Responsiblities and Powers of the Board: 3.2.1 The Board shall have responsibility for overall policy and clinical direction of the Corporation with a focus on the following: performance improvement and patient safety; licensure and accreditation; professional credentialing; medical staff matters; compliance; disaster planning; supervision...” 1) Review of MR1 on July 11, 2024, at 1:15 PM, with EMP 2, EMP3, and EMP9, revealed a patient (MR1) received a screening mammography exam on May 25, 2023. A letter dated May 31, 2023, was sent to the patient (MR1) which detailed incorrect results of the screening mammography exam completed on May 25, 2023. The following year in June 2024, during the annual mammography screening exam, the patient required three breast biopsies, and was ultimately diagnosed with Breast Cancer. Further review of MR1 revealed the facility failed to ensure the patient (MR1) received the patient distribution letter timely with the correct exam results timely as to their health status for the mammography exam completed on May 25. 2023. An interview conducted on July 11, 2024, at 12:30 PM with EMP2, EMP3 and EMP4 confirmed that the patient had received the incorrect patient distribution letter. In addtion, EMP2 stated “The radiologist did not complete his/her part in the process so that a patient distribution letter could be generated by the system.” An interview conducted on July 12, 2024, at 11:45 AM with EMP7 and EMP8 confirmed that the facility’s Board of Trustees and the facility medical directors had addressed the radiology provider staff as to their accountability for timely completion of the process for selecting/creating the electronic patient distribution letter detailing the imaging exam results. Review of facility policy “Quality Assessment and Performance Improvement Plan FY24” revealed “ IV. Authority and Accountability. A. Board of Trustees: The Board of Trustee (the board) shall be responsible for oversight of AEMC’s commitment to a culture of continuous improvement and the delivery of high-quality, evidence-based healthcare. To meet these responsibilities, the Board shall: Monitor quality metrics as well as trending report, to ensure accountability for the delivery of high-quality care and improvement activities as needed to ensure that care. ...Ensure the development of continuous quality improvement programs at all clinical sites of care. ...Evaluate information systems support for the measurement of quality and the dedication of resources to achieve appropriate inter-operability with clinically integrated partners. B... The Performance Improvement Council (PIC), chaired by the Chief Medical Officer, is responsible for the supervision and coordination of all physician-related quality improvement activities in the AEMC. Such activities include the monitoring and evaluation of quality and appropriateness of patient care and the clinical performance of individuals with clinical privileges in all clinical departments.” Review of facility policy “Event Reporting “ dated June 26, 2019, revealed “ I. Purpose: This policy provides guidance for the process of identifying, reporting events that occur within Einstein hospitals, outpatient locations, physician practices to facilitate improvement of patient care, and to reduce the risk of injury to patients, volunteers, visitors and others as part of quality improve and patient safety activities systematic process for evaluating events will assist in the prevention or the reoccurrence of similar events in the future and to satisfy licensure and accreditation requirements. VI. Quality Improvement Activities: 1. Risk Management will analyze the data and provide summary reports and recommendation to respective Einstein Quality Committees and Patient Safety Committees. 2. Risk Management will provide ad hoc reports to appropriate departments as part of each department’s Quality Improvement Programs as well as hospital Quality Programs.” 2) Review of facility document “Performance Improvement Council Dashboard” revealed “Quality-Result Turn Around Times (Hours)” revealed Target <48 hours. Action Plan: Physician Recruitment...Committed Solis CMO to Reading Screens to Reduce Backlog”...Fiscal Year begins July 1 through June 30. Turnaround Time Statistics: Quarter Two 2022-75 hours; Quarter Three 2022, 111.25 hours; Quarter Four 2022, 115.1 hours; Quarter One 2023, 41.75 hours; Quarter Two 2023, 160.1 hours; Quarter Three 2023,57.2 hours; Quarter Four 2023, 54.1 hours.” A request was made by the surveyor to facility representatives EMP8 and EMP9 for documentation of Radiology Quality Committee Meeting Minutes which reviewed the mammography event that occurred on May 25, 2023, for MR1. No documentation was provided by the facility as was requested by the surveyor. A request was made by the surveyor to facility representative EMP5 for a summary of the facility’s investigation notes pertaining to the outcome of the investigation conducted for the May 25, 2023, mammography event for MR1, based on the facility’s event reporting policy. No documentation was provided by the facility as was requested by the surveyor. A request made by the surveyor to facility representatives EMP2 and EMP3, for the facility”s quality and surveillance audit documentation during the non-compliant performance time frames in Quarter 4 2022, Quarter 2 2023, Quarter 4 2023. No documentation was provided by the facility as was requested by the surveyor. An interview conducted on July 11, 2024, at 1:55 PM with EMP2 and EMP3 confirmed that the facility had not completed quality and surveillance audits to ensure patients were receiving patient notification distribution letters that were appropriate to radiology providers interpretations for the mammography imaging exams completed. Further interview with EMP2 confirmed the facility had not completed quality and surveillance audits pertaining to the event on May 25, 2023. to present day, and for the non-compliant performance time frames in Quarter 4 2022, Quarter 2 2023, and Quarter 4 2023. An interview conducted on July 11, 2024, at 2:05 PM, with EMP3, confirmed that there had been occurrences when staff brought to the attention of the management staff for the mammography services of radiology providers that had failed to timely complete the process for selecting/creating the electronic patient distribution letter process. Further interview with EMP3 who stated “I would need to see somewhat of a trend occurring for these missed opportunities by the radiology providers to report them to the Section Chief of the Radiology Department (EMP2).” Review of facility policy “Policies and Procedures” effective date April 16, 2018, revealed “Purpose: To establish a consistent, formal process for the development, review, approval, distribution, and maintenance of policies and procedures through Albert Einstein Healthcare Network (AEHN). POLICY: Albert Einstein Healthcare Network Develops and maintains policies and procedures that: 1. Establish standards. 2. Provide a framework for consistent action and/or decision-making. 3. Provide accessible information for training and reference. 4. Comply with regulatory requirements. Each entity and its associated department, division and services develop and maintain policies and procedures that follow the same criteria. Each entity and its associated departments, division and services maintain all pertinent polices and associated procedures in a policy and procedure manual, which is accessible to all affected personnel. Each policy and procedure are reviewed at least every three years and revised as needed.” 3) Review of facility policy “Policy for Mammography Reports” 08/2023, revealed “1. The mammography report will be completed within one working day of when the patient had him/her breast imaging evaluation with few exceptions. All mammography reports should describe which views were performed and should also describe the type of breast parenchyma....6. A letter will be sent to the patient in lay terms informing her/him of results and recommendation. “ Review of facility document “Performance Improvement Council” dated October 12, 2023, revealed “Quality-Result Turn Around Times” revealed Target <48 hours. Action Plan: Physician Recruitment...Committed Solis CMO to Reading Screens to Reduce Backlog”...Fiscal Year begins July 1 through June 30. Turnaround Time Statistics: Quarter Two 2022-75 hours; Quarter Three 2022, 111.25 hours; Quarter Four-2022, 115.1 hours; Quarter One 2023-41.75 hours; Quarter Two 2023-160.1 hours” An interview conducted on July 12, 2024, at 2:55 PM with EMP9 confirmed that facility policy “Policy for Mammography Reports” was an approved facility policy but the performance indicator for “turnaround times for completing the mammography report” workflow process for the radiologist providers did not align with the facility’s policy as to the timeframe for completion. Cross Reference: 482,21(a), (c)(2), (e)(3) (Tag0286), Patient Safety The patient received a screening mammography exam on May 25, 2023. A letter dated May 31, 2023, was sent to the patient (MR1) which detailed the incorrect results of the screening mammography exam completed on May 25, 2023. The following year in June 2024, during the annual mammography screening exam, the patient required three breast biopsies, and was ultimately diagnosed with Breast Cancer. The immediate interventions implemented by the facility on July 12, 2024, to remove the immediate jeopardy included a meeting with radiologist providers to educate and confirm their accountability and responsibility to complete the radiology report process to support the patient distribution letter notification process. The staff received education on the facility’s process for distribution of the patient distuributuion notification letters containing the results of the mammography imaging exams and ensuring the patient distribution notification letters are accurate prior to the patient receiving the intended patient letter as to their health status. The surveyor confirmed removal of the Immediate Jeopardy on July 12, 2024, at 4:50 PM.”

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 34230 Based on review of facility policy, medical record (MR), and interview with staff (EMP), it was determined the facility failed to ensure a patient received accurate and timely health information as to the results of a mammography imaging exam completed on May 25, 2023, for one of one medical record reviewed. It was determined the facility failed to ensure a radiologist completed the radiology report process to support the patient (MR1) distribution letter process for the mammography imaging exam completed on May 25, 2023, for the patient (MR1). It was determined the facility failed to ensure the patient received accurate and timely health status information specific to the mammography imaging exam completed on May 25, 2023. The patient received a screening mammography exam on May 25, 2023. A letter dated May 31, 2023, was sent to the patient (MR1) which detailed the incorrect results of the screening mammography exam completed on May 25, 2023. The following year in June 2024, during the annual mammography screening exam, the patient required three breast biopsies, and was ultimately diagnosed with Breast Cancer. The immediate interventions implemented by the facility on July 12, 2024, to remove the Immediate Jeopardy included a meeting with the radiologist providers to educate and confirm their accountability and responsibility to complete the radiology report process to support the patient distribution letter notification process. The staff received education on the facility’s process for distribution of the patient distuributuion notification letters containing the results of the mammography imaging exams and ensuring the patient distribution notification letters are accurate prior to the patient receiving the intended patient letter as to their health status. The surveyor confirmed removal of the Immediate Jeopardy on July 12, 2024, at 4:50 PM. Cross Reference: 482.13 (b)(2), Tag (0131): Patient Rights Informed Consent”

“PATIENT RIGHTS: INFORMED CONSENT CFR(s): 482.13(b)(2) The patient or his or her representative (as allowed under State law) has the right to make informed decisions regarding his or her care. The patient’s rights include being informed of his or her health status, being involved in care planning and treatment, and being able to request or refuse treatment. This right must not be construed as a mechanism to demand the provision of treatment or services deemed medically unnecessary or inappropriate. This Standard is not met as evidenced by: 34230 Based on review of facility policy, medical record (MR) and interview with staff (EMP), it was determined the facility failed to ensure the patient or the patient’s representative was provided information about his/her health status pertaining to the mammography exam results to permit the patient to make the necessary informed decision about his/her care for one of one medical record reviewed (MR1). Findings include: Review of facility policy “Policy for Mammography Reports” revealed 1. The mammography report will be completed within one working day of when the patient had her/him breast imaging evaluation with few exceptions. a. If the patient has had previous outside films, we will still dictate a preliminary report and we will issue a complete report when the previous film become available. 2. All mammography reports should describe which views were performed and should also describe the type of breast parenchyma. 3. The radiologist will classify all lesions into the ACR BIRADS categories. 5. The recommendation of the radiologist will be clearly documented in the impression. a. If a patient is to return for a routine mammogram in a year, this should be stated including the month and year of the next mammogram. b. If a six-month follow-up is recommended, this should be documented also using the month and year. c. If a biopsy recommendation is made, this also should be documented...6. A letter will be sent to the patient in lay terms informing her/him of results and recommendations.” Review of MR1, date of service, May 25, 2023, revealed a procedure for an Annual/Routine Digital Screening Mammography Exam was conducted by the facility. Further review revealed “Findings...additional imaging is recommended, No findings suggestive of malignancy in the contralateral breast. The above findings and recommendations will be mailed to the patient. Federal regulations require all breast imaging reports to have an overall final assessment. Based on the above findings, this examination is classified as BI-RADS “0”: Incomplete, need [for] additional imaging.” Review of MR1, revealed a patient notification letter dated May 31, 2023, detailing the results of the mammography exam received on May 25, 2023, “...Dear Ms. [XXX]. Relevant to: Your breast imaging exam done on May 25, 2023, Thank you for your recent visit.... We are pleased to report that the result of your recent mammogram shows no sign of breast cancer.” A request was made by the surveyor to EMP9 and EMP2 for the revised patient notification letter sent to the patient (MR1) for the mammography exam conducted on May 25, 2023. No information was provided to the surveyor by the facility representatives for the request made by the surveyor. An interview conducted July 11, 2024, at 12:45 PM with EMP2 confirmed the radiologist failed to complete the radiology report process to support the patient notification letter distribution process for the mammography imaging exam completed on May 25, 2023, for the patient (MR1). In addition, EMP2 confirmed the notification letter sent to the patient by the facility did not contain the correct information for the mammography imaging exam conducted on May 25, 2023. Cross Reference: 482.13, (Tag: 0115): Patient Rights”

“PATIENT SAFETY CFR(s): 482.21(a), (c)(2), (e)(3) (a) Standard: Program Scope (1) The program must include, but not be limited to, an ongoing program that shows measurable improvement in indicators for which there is evidence that it will ... identify and reduce medical errors. (2) The hospital must measure, analyze, and track ...adverse patient events ... (c) Program Activities ..... (2) Performance improvement activities must track medical errors and adverse patient events, analyze their causes, and implement preventive actions and mechanisms that include feedback and learning throughout the hospital. (e) Executive Responsibilities, The hospital’s governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the hospital), medical staff, and administrative officials are responsible and accountable for ensuring the following: ... (3) That clear expectations for safety are established. This Standard is not met as evidenced by: 34230 Based on a review of facility policy, document and interview with staff (EMP), it was determined that facility stakeholders responsible for managing mammography services failed to evaluate the services for safe and effective service delivery through developing clear expectations for standards of operation to ensure mammography services were provided in a safe and effective manner. Findings include: Review of facility policy “Quality Assessment and Performance Improvement Plan FY24” revealed “ IV. Authority and Accountability. A. Board of Trustees: The Board of Trustee (the board) shall be responsible for oversight of AEMC’s commitment to a culture of continuous improvement and the delivery of high-quality, evidence-based healthcare. To meet these responsibilities, the Board shall: Monitor quality metrics as well as trending report, to ensure accountability for the delivery of high-quality care and improvement activities as needed to ensure that care. ...Ensure the development of continuous quality improvement programs at all clinical sites of care. ...Evaluate information systems support for the measurement of quality and the dedication of resources to achieve appropriate inter-operability with clinically integrated partners. B... The Performance Improvement Council (PIC), chaired by the Chief Medical Officer, is responsible for the supervision and coordination of all physician-related quality improvement activities in the AEMC. Such activities include the monitoring and evaluation of quality and appropriateness of patient care and the clinical performance of individuals with clinical privileges in all clinical departments.” Review of facility policy “ Event Reporting “ dated June 26, 2019, revealed “I. Purpose: This policy provides guidance for the process of identifying, reporting events that occur within Einstein hospitals, outpatient locations, physician practices to facilitate improvement of patient care, and to reduce the risk of injury to patients, volunteers, visitors and others as part of quality improve and patient safety activities systematic process for evaluating events will assist in the prevention or the reoccurrence of similar events in the future and to satisfy licensure and accreditation requirements. VI. Quality Improvement Activities: 1. Risk Management will analyze the data and provide summary reports and recommendation to respective Einstein Quality Committees and Patient Safety Committees. 2. Risk Management will provide ad hoc reports to appropriate departments as part of each department ’ s Quality Improvement Programs as well as hospital Quality Programs. “ Review of facility document “Performance Improvement Council Dashboard” revealed “Quality-Result Turn Around Times (Hours)” revealed Target <48 hours. Action Plan: Physician Recruitment...Committed Solis CMO to Reading Screens to Reduce Backlog”...Fiscal Year begins July 1 through June 30. Turnaround Time Statistics: Quarter Two 2022-75 hours; Quarter Three 2022, 111.25 hours; Quarter Four 2022, 115.1 hours; Quarter One 2023, 41.75 hours; Quarter Two 2023, 160.1 hours; Quarter Three 2023,57.2 hours; Quarter Four 2023, 54.1 hours.”’ Review of MR1 on July 11, 2024, at 1:15 PM, with EMP2, EMP3, and EMP9, revealed a patient (MR1) received a screening mammography exam on May 25, 2023. A letter dated May 31, 2023, was sent to the patient (MR1) which detailed incorrect results of the screening mammography exam completed on May 25, 2023. The following year in June 2024, during the annual mammography screening exam, the patient required three breast biopsies, and was ultimately diagnosed with Breast Cancer. Further review of MR1 revealed the facility failed to ensure the patient received the timely an accurate patient distribution letter as to their health status for the exam completed on May 25. 2024. A request was made by the surveyor to facility representatives EMP8 and EMP9 for documentation of the Radiology Quality Committee Meeting Minutes to determine whether a review of the mammography event on May 25, 2023, for MR1 had occurred. No documentation was provided by the facility as was requested by the surveyor. A request made by the surveyor to facility representatives EMP2 and EMP3, for quality audit and surveillance documentation to ensure the event that occurred on May 25, 2023, for MR1 had not occurred during the non-compliant performance time frames in Quarter 4 2022, Quarter 2 2023, and Quarter 4 2023. No documentation was provided by the facility as was requested by the surveyor. The facility failed to identify clear defined expectations under the direction of the Board of Trustees (governing body) in managing and delivery of the mammography services related to timely completion of the process for selecting/creating the electronic patient distribution letter detailing the imaging exam results Cross Reference: 482.12: (Tag-0043)-Governing Body”