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Based on document review and staff interview it was determined the facility's Governing Body failed to provide oversight and accountability for the Quality Assessment and Performance Improvement program, failed to provide direction and oversight to ensure contracted services were appropriately monitored, failed to ensure Emergency Services were provided in compliance with the Medical Staff Bylaws, failed to provide oversight and accountability for the Medical Staff, and failed to provide oversight and monitoring for the Infection Control Program. The lack of oversight and direction by the Governing Body in these areas failed to ensure the facility provided quality medical care in a safe environment.

Findings included:

1. Following a review of documents and staff interview it was determined the Governing Body failed to ensure the Medical Staff was accountable for the quality of care it provided to patients. (Refer to A0049)

2. Following a review of documents and staff interview it was determined the Governing Body failed to monitor contracted services to ensure contracted services were provided in a safe and effective manner. (Refer to A0084)

3. Following a review of medical records, documents, policies and procedures, and staff interviews it was determined the Governing Body failed to ensure physicians provided emergency medical care and services to patients in compliance with the Medical Staff Bylaws. (Refer to A0092).

The facility was not in compliance with 42 CFR 416.41 the Condition of Participation for Governing Body and Management, requirements for hospitals.

Based on document review and staff interviews, it was determined the Governing Body failed to develop and implement an effective organizational structure to permit the timely, objective, and on-going assessment of the competence and quality of care of the medical staff.

Findings included:

The Medical Staff Bylaws, effective date 9/20/18, indicated each medical staff Department and Division shall be responsible for developing criteria to assure the Medical Staff and the Board that patients will receive quality and safe care. The professional criteria shall at least pertain to evidence of relevant training or experience, current competence, and ability to perform the privileges requested. The Medical Executive Committee (MEC) is empowered to act on behalf of the Medical Staff. The MEC responsibilities included: Provide a liaison between the medical Staff and the CEO, make recommendations to the Board regarding all matters relating to [medical staff] appointments, reappointments, and clinical privileges. The Bylaws indicated the MEC was responsible for the Medical Staff performance-improvement activities and establish a mechanism designed to conduct, evaluate and revise such activities.

The review of John's Hopkins All Children's Hospital Functional Organizational Structure dated 1/3/19 revealed 10 medical staff departments lead by physicians (Interim VP of Medical Affairs, Assistant Dean Population Health, Department of Anesthesia, Department of Surgery, Department of Pediatrics, Cancer Institute, Heart Institute, IF BR Institute, MFN Institute, and the IBPS Institute) reported directly to the Vice Dean/Physician in Chief, who in turn reported to the President. There was no evidence of the Medical Executive Committee or its relationship to the Medical Staff, the President or the Board of Trustees. Neither the Medical Executive Committee or the Board of Trustees were represented on the organizational chart.

The review of John's Hopkins All Children's Hospital Medical Staff Leadership 2019 organizational chart dated 1/3/19 revealed the physician division heads for the 20 medical sub-specialties reported to the Chairman and Vice Chairman of the Department of Pediatric Medicine. The physician division heads for the 12 surgical sub-specialties reported to the Interim Chair for the Department of Surgery. The Department of Pediatric Medicine and the Department of Surgery reported to the Chief of Staff, the Vice Chief of Staff and the Secretary/Treasurer, who in turn reported to the Executive Committee. The Executive Committee and the President reported to the Board of Trustees.

The review of the re-credentialing and annual appraisal criteria for the medical specialties of cardiovascular surgery, general medical cardiology, pediatrics, and pediatric critical care failed to reveal the inclusion of any objective measures that would permit a determination that the physician demonstrated current competency and quality care.

The review of the Medical Executive Committee meeting minutes for the previous 12 months failed to reveal evidence of the review of the clinical criteria for reappraisal or re-credentialing of the Medical Staff.

The review of the Board of Trustees meeting minutes for the previous 12 months failed to reveal evidence of the review of the clinical criteria for reappraisal or re-credentialing of the Medical Staff, but did reflect that the Board of Trustees approved all Medical Executive Committee recommendations for re-appointments to the Medical Staff for the requested privileges approved by the MEC.

An interview was conducted with the Senior Director of Patient Safety and Quality Improvement on 1/11/19 at 10:00 a.m. The Senior Director indicated the facility did not collect, track or trend any data based on objective indicators for individual physician quality of care and/or current competence. Specifically, the facility had no data related to readmissions within 30 days, unplanned returns to surgery, or morbidity and mortality by physician.

An interview was conducted with the President on 1/11/19 at 10:00 a.m. The President indicated each of the department heads were responsible for developing and implementing their own quality criteria, analyzing their own data, and reporting to the Patient Safety and Quality Committee. The President confirmed the finding neither the Medical Executive Committee, the President, nor the Board of Trustees provided oversight on this process. The President acknowledged the finding that this reporting structure and lack of Governing Body oversight was a significant factor in the previous lapses in patient care.

Based on document review and staff interview it was determined the Governing Body failed to ensure contracted services are provided in a safe and effective manner.

The review of the list of Clinical Contracted Services revealed the names of 28 entities providing contracted services to the facility in 2018.

The review of the Board of Trustees meeting minutes dated 7/19/18 included a document titled Clinical Contracted Services CY 2017 performance evaluation summary. The document listed the 28 contracted service providers and documented the performance standards for each contracted service. The document indicated all of the performance standards for each of the 28 contracted service providers had been met.

The document indicated the Department of Pathology and Lab Medicine, and the Quality and Patient Safety Committee were responsible for managing the contract for the service provider for blood products. The document indicated establishing processes for documentation guidelines, standard operation procedures between the service provider and the facility, improving incident reporting, meetings with the service provider manager to discuss any incident reports, and updating the contract with better defined/measurable metrics were listed as improvements in progress. The review of the Board of Trustees meeting minutes for July 2018 through November 2018 failed to reveal any evidence of the reporting or monitoring of the listed improvements in progress for the blood products.

The review of the Cause Analysis Action Plan (no date indicated) described a patient experienced a seizure associated with the administration of blood products. The action plan included developing a process to have all blood product documents scanned into the electronic medical record system. The implementation date was 7/2/18 for inpatients and 8/2/18 for outpatients. The action plan did not include any reference to monitoring or re-evaluating the effectiveness of the plan.

An interview was conducted with the Regulatory Compliance Manager on 1/10/19, who indicated she was responsible for the evaluation of the quality of contracted services. The Manager indicated the process for evaluating the quality of contracted services was that once a year she would send a form to the head of each department utilizing a contracted service and ask that person to report if he or she experienced any issues with the contracted service during the course of the previous year. The Manager indicated she was unable to produce the form for calendar year 2018 as it was currently in circulation.

Based on electronic patient medical record reviews, staff interview and review of the facility's policy and procedure, the facility failed to ensure the provision of the Patient's Bill of Rights was provided to the patient or patient's representative prior to providing or discontinuing patient care for 6 of 6 patient medical records reviewed (Patient #1, #2, #3, #4, #5, #6) of forty patients sampled.

The findings included:

On 01/09/2019 a total of 6 random medical records were reviewed, to include one closed record (#2) and five (#1, #3, #4, #5 and #6) open records. The facility was not able to demonstrate the patient or patient's representative received information related to patient rights prior to providing or discontinuing patient care for all 6 of the medical records reviewed. The review of the patient's records was completed with a facility representative to help navigate the electronic medical record. The record navigator was not able to locate this information, and first stated that nursing reviews this information with the patient. A review of the admitting documentation, completed by nursing, did not include information pertaining to patient rights. The Navigator, a Clinical Nurse Manager, then found out that admissions / registration provides this information which is contained in an admission folder with facility specific information. There was no documentation to support that this information was provided to the patient or patient's representative.

A review of the facility's policy and procedure, "Patient's Rights and Responsibilities, Management of," effective 03/06/2018 indicated "..... patients and families are provided Patient's Rights and Responsibilities information as required by law. In order to provide our patient/families with the most appropriate information, three versions of Patient's Rights and Responsibilities are available depending on who is provided services. The three versions available are for: John Hopkins All Children Hospital, which includes hospital based service provided at the Outpatient Care Center; John Hopkins All Children's Home Care and All Children's Specialty Physician Clinics." The policy statement indicated, "All patients and families will be informed of their rights and responsibilities while receiving care and treatment though the services of John Hopkins All Children's. Patients and families will expect to carry out their responsibilities when accessing care and services at John Hopkins All Children's. ....." The procedure indicates "A. The patient/legal guardian will be made aware of the Patient's Rights and Responsibilities upon admission and or available upon registration to John Hopkins All Children's. B. The Patient's Bill of Rights and Responsibilities are available to all patients/families as follows: 1. Hospital: Posted in the main Hospital and all Outpatient Care Centers.... 2. Home Care: Provided upon admission. 3. Specialty Physician Clinical: Posted in clinic; C. Electronic versions of the Patient's Rights and Responsibilities are also available to patients and families on the John Hopkins All Children's website at https://www.hopkinsallchildrens.org/home." The facility failed to identify the process and document that patient's rights information was provided to the patient or patient representative.

A review of the facility's "Consent for Routine Diagnostic Procedures and Medical Treatment" was also conducted and failed to include information related to the provision of Patient Rights.

Based on a review of the facility's documents, policies and procedures, and staff interviews it was determined the facility failed to develop, implement and maintain an effective on-going, data-driven quality assessment and performance improvement (QAPI) program that was integrated into all departments of the facility.

Findings included:
1. The facility failed to ensure objective quality indicator data was collected, tracked, trended, and analyzed across the organization to facilitate the process of providing quality patient care and improving patient safety.
(Refer to A0273)

2. The facility failed to ensure collected data was utilized to identify opportunities for improvement that were prioritized on the basis of high-risk, high-volume, or problem prone areas the affected health outcomes, patient safety, and quality of care.
(Refer to A0283)

4. The Governing Body failed to ensure the management of the organization was structured to ensure the effective implementation of a data-driven quality improvement organization that measurably improved the facility's demonstrated ability to provide quality patient care and improve patient safety.
(Refer to A0309)

The facility was not in compliance with 42 CFR 482.21 the Condition of Participation for Quality Assessment Performance Improvement, requirements for hospitals.

Based on document review and staff interview it was determined the facility failed to ensure objective quality indicator data related to medical care was collected, tracked, trended, and analyzed across the organization to facilitate the process of providing quality patient care and improving patient safety.

Findings included:

The Quality and Patient Safety Plan (the Plan) FY 2019, approved September 20, 2018 was signed by the Patient Safety Officer and the Chair, Board Quality and Patient Safety Committee. The Plan indicated the Patient Safety and Quality Council reported to the Board of Trustees through the Board Quality and Patient Safety Committee. The Plan indicated several Medical Staff committees received or provided reports regarding patient safety and and quality. The Plan included documentation the Clinical Practice council "(members are mainly physicians)" oversees the prioritization, development and deployment of clinical guidelines. The Each department, program and institute conducts quality improvement and safety initiatives that are aligned with the strategic priorities of the organization and/or the population served by that department, program, or institute.

Review of the facility's current written agreement with the OPO revealed section G. Activity Data Review, Reporting and Quality Assessment (QA) and Improvement (QI) stated "G.1 At least annually, the Foundation shall provide Donor Hospital specific data with the appropriate Donor Hospital personnel for the purposes of quality assessment (QA) and improvement (QI), process evaluation, and to analyze outcomes of potential referral/donor situations, allowing for a collaborative plan of corrective action when indicated."

Review of the facility's Board Quality and Patient Safety Committee meeting minutes revealed the last meeting in which specific data was provided was 1/19/2017. Review of requested documentation revealed the OPO provided data for calendar years 2017 and 2018. There was no evidence the data was provided to the facility's Board Quality and Patient Safety Committee for integration into the hospital's QAPI program.

An interview was conducted with the Interim Vice President of Medical Affairs on 1/8/19 regarding the oversight of medical quality of care. The Vice President indicated the Medical Quality of Care Committee would review individual cases that were brought to their attention, but they had no historical data related to that particular problem or that particular physician. He indicated no data was collected or reported as a result of the Committee's review of any individual case.

An interview was conducted with the Interim Chief Executive Officer (CEO), the Senior Vice President Patient Safety Officer, the Interim Vice President of Medical Affairs, the Senior Director of Patient Safety and Quality/Interim Patient Safety Officer, the General Counsel, the Chief Operating Officer, the Regulatory Compliance Manager, the Vice President for Quality and Risk Management Johns Hopkins and other interested parties on 1/11/19 at 9:30 a.m.

The Senior Director of Patient Safety and Quality confirmed that each clinical division and department develops their own criteria and quality indicators, and performs their own investigations of any events. The Senior Director indicated there is no organization wide, integrated assessment based on the tracking, trending, and analysis of objective data used to identify high frequency or high acuity concerns related to the overall quality of care and patient safety provided by the hospital. She indicated the facility has no historical data on objective indicators of quality of care that has been tracked, trended, and analyzed such as unplanned returns to surgery, patient deaths, or morbidity and mortality statistics by physician. The CEO confirmed the findings.

Based on document review and staff interview it was determined the facility failed to ensure collected data was utilized to identify opportunities for improvement that were prioritized on the basis of high-risk, high-volume, or problem prone areas the affected health outcomes, patient safety, and quality of care.

The Quality and Patient Safety Plan (the Plan) FY 2019, approved September 20, 2018 was signed by the Patient Safety Officer and the Chair, Board Quality and Patient Safety Committee. The Plan indicated the Patient Safety and Quality Council reported to the Board of Trustees through the Board Quality and Patient Safety Committee. The Plan indicated several Medical Staff committees received or provided reports regarding patient safety and and quality. The Plan included documentation the Clinical Practice council "(members are mainly physicians)" oversees the prioritization, development and deployment of clinical guidelines. The Each department, program and institute conducts quality improvement and safety initiatives that are aligned with the strategic priorities of the organization and/or the population served by that department, program, or institute.

The Plan did not include any evidence the selection of indicators, quality improvement projects, or the development of criteria were based on any review of the tracking and trending of objective data that identified measurable concerns or issues that were high frequency or high acuity, and was limited primarily to reporting requirements defined by the regulatory or the accrediting agencies.

The review of the Quality and Patient Safety Dashboard dated 12/18/18 displayed data for Serious Harm Events, defined as Central Line - Associated Blood Stream Infections (CLABSI), Catheter-Associated Urinary Tract Infections (CAUTI), Surgical Site Infections(SSI) of Spinal Fusions, Ventricular Shunts, and Cardiac Surgery, Hand Hygiene, Pressure Injury, Falls with moderate or greater injury, Peripheral IV (PIV) infiltrates, Adverse Drug Events (ADE), Unplanned Extubations in ICU, Venous Thromboembolism, Readmissions within 7 days, Employee Harm, Influenza Immunizations, seven indicators for Emergency Center throughput, and Patient Satisfaction. November 2018 was the most recent month for which data was reported, along with Year To Date statistics.

The report displayed no year-to-date improvement was accomplished for CLABSI, CAUTI, SSIs for Spinal Fusions and Ventricular Shunts, Hand Hygiene, Pressure Injuries, Peripheral IV Infiltrates, Unplanned Extubations in ICUs, Serious Employee/Staff Harm, and Influenza Immunizations Inpatient.

The review of the Patient Safety and Quality Council Meeting Minutes dated 12/12/18 included documentation a comprehensive dashboard review was presented to the Council. The area designated to indicate Action Plan Responsibilities and Time Frames next to the minutes of the presentation was blank.

The Regulatory Compliance Manager confirmed the findings in an interview conducted on 1/11/19.

Based on document review and staff interview it was determined the Governing Body failed to ensure the management of the organization was structured to ensure the effective implementation of a data-driven quality improvement organization that measurably improved the facility's demonstrated ability to provide quality patient care and improve patient safety.

The Quality and Patient Safety Plan dated 9/20/18 indicated the governing body was responsible for assuring that the Quality and Patient Safety Plan was effective and in compliance with regulatory requirements.

The organizational chart included in the plan displayed the committees for Environment of Care, Continuous Regulatory Readiness, Quality Council, Safety Coaches, Infection Prevention/Antimicrobial Stewardship, and High Value Care reported to the Patient Safety and Quality Council. The Patient Safety and Quality Council received input from the Ambulatory Networks Council, the Advocacy Council, the Clinical Practice Council, the Research Council, the Education Counsel, the Cultures and Engagement Council, the Medical Staff Committees, the Johns Hopkins Medical Pediatric Quality Group, and the Johns Hopkins Quality, Safety, and Service Executive Committee. The Patient Safety and Quality Council reported to the Board Quality and Patient Safety Committee, who in turn reported to the Board of Trustees. The Risk Management department was not indicated on the organizational chart included included in the Quality and Safety Plan. Nothing in the plan addressed the manner in which objective data would be tracked, trended and analyzed across the organization as a whole in order to identify areas of concern, or monitor the effectiveness of quality improvement projects or plans of correction.

The Johns Hopkins All Children's Hospital Functional Organizational Structure dated 1/3/18 displayed the Risk Management and Insurance Department as the last item in the lower right hand corner of the chart, reporting to Legal Affairs, that in turn reported to the Vice Dean/Physician in Chief. There was no evidence of any lines of communication or accountability between the Risk Management Department and any of the 17 committees, councils and departments shown on the organizational chart as being responsible for the prioritization, development and deployment of clinical guidelines.

The Plan defined the purpose, objectives, membership, meeting frequency, and reporting structures of the Board Quality and Patient Safety Council, Patient Safety Council, the Quality Sub-Council, and Safety Coaches. The Plan defined the roles and responsibilities of the Medical Staff, Senior Leadership, Patient Safety Officer, Senior Director, Institute, Department and Service-line Directors, and Employees. The responsibilities of the Medical Staff were presented as, Department Chairpersons shall be accountable for their assigned divisions' and sections' appropriate, quality and safe patient care services.

The Plan did not include any evidence the selection of indicators, quality improvement projects, or the development of criteria were based on any review of the tracking and trending of objective data that identified measurable concerns or issues that were high frequency or high acuity.

An interview was conducted with the Interim Chief Executive Officer (CEO), the Senior Vice President Patient Safety Officer, the Interim Vice President of Medical Affairs, the Senior Director of Patient Safety and Quality/Interim Patient Safety Officer, the General Counsel, the Chief Operating Officer, the Regulatory Compliance Manager, the Vice President for Quality and Risk Management Johns Hopkins and other interested parties on 1/11/19 at 9:30 a.m.

The Senior Director of Patient Safety and Quality confirmed that each clinical division and department develops their own criteria and quality indicators, and performs their own investigations of any events. Each clinical division and department develops their own action plans, implements and evaluates the plans for effectiveness, and reports whatever information they determine is relevant or necessary through the channels shown on the organizational chart in the Quality and Patient Safety Plan. The Senior Director indicated there is no organization wide, integrated assessment based on the tracking, trending, and analysis of objective data used to identify high frequency or high acuity concerns related to the overall quality of care and patient safety provided by the hospital. The Senior Director indicated she did not have access to any Risk Management reports or data collection in the 15 months she has been in her position at the facility. She indicated the facility has no historical data on objective indicators of quality of care that has been tracked, trended, and analyzed such as unplanned returns to surgery, patient deaths, or morbidity and mortality statistics by physician. The CEO confirmed the findings.

Based on document review and staff interview it was determined the facility failed to ensure the medical staff was in compliance with the Medical Staff bylaws with regard to ensuring the reappraisal process and the re-credentialing process effectively determined the currently competency and abilities of the medical staff members.

Findings included:

1. Following a review of documents and staff interview it was determined the Medical Staff failed to be fully accountable to the governing body for the quality of care it provided to patients. (Refer to A0347)

2. It was determined the facility failed to ensure the re-credentialing process met the Medical Staff Bylaws requirement to develop criteria to ensure safe care through evidence of current competence and ability to perform requested privileges. (Refer to A0355).

The facility was not in compliance with 42 CFR 482.22, the Condition of Participation for Medical Staff, requirements for hospitals.

The Medical Staff Bylaws, effective date 9/20/18, indicated each medical staff Department and Division shall be responsible for developing criteria to assure the Medical Staff and the Board that patients will receive quality and safe care. The professional criteria shall at least pertain to evidence of relevant training or experience, current competence, and ability to perform the privileges requested. The Medical Executive Committee (MEC) is empowered to act on behalf of the Medical Staff. The MEC responsibilities included: Provide a liaison between the medical Staff and the CEO, make recommendations to the Board regarding all matters relating to [medical staff] appointments, reappointments, and clinical privileges. The Bylaws indicated the MEC was responsible for the Medical Staff performance-improvement activities and establish a mechanism designed to conduct, evaluate and revise such activities.

The review of John's Hopkins All Children's Hospital Functional Organizational Structure dated 1/3/19 revealed 10 medical staff departments lead by physicians (Interim VP of Medical Affairs, Assistant Dean Population Health, Department of Anesthesia, Department of Surgery, Department of Pediatrics, Cancer Institute, Heart Institute, IF BR Institute, MFN Institute, and the IBPS Institute) reported directly to the Vice Dean/Physician in Chief, who in turn reported to the President. There was no evidence of the Medical Executive Committee or its relationship to the Medical Staff, the President or the Board of Trustees. Neither the Medical Executive Committee or the Board of Trustees were represented on the organizational chart.

The review of John's Hopkins All Children's Hospital Medical Staff Leadership 2019 organizational chart dated 1/3/19 revealed the physician division heads for the 20 medical sub-specialties reported to the Chairman and Vice Chairman of the Department of Pediatric Medicine. The physician division heads for the 12 surgical sub-specialties reported to the Interim Chair for the Department of Surgery. The Department of Pediatric Medicine and the Department of Surgery reported to the Chief of Staff, the Vice Chief of Staff and the Secretary/Treasurer, who in turn reported to the Executive Committee. The Executive Committee and the President reported to the Board of Trustees.

The Johns Hopkins All Children's Hospital Functional Organizational Structure dated 1/3/18 failed to provide evidence of any lines of communication or accountability between any of the 17 committees, councils and departments shown on the organizational chart as being responsible for the prioritization, development and deployment of clinical guidelines.

The Senior Director of Patient Safety and Quality confirmed that each clinical division and department develops their own criteria and quality indicators, and performs their own investigations of any events. Each clinical division and department develops their own action plans, implements and evaluates the plans for effectiveness, and reports whatever information they determine is relevant or necessary through the channels shown on the organizational chart in the Quality and Patient Safety Plan. The Senior Director indicated there is no organization wide, integrated assessment based on the tracking, trending, and analysis of objective data used to monitor the overall quality of care and patient safety provided by the hospital. She indicated the facility has no historical data on objective indicators of quality of care that has been tracked, trended, and analyzed such as unplanned returns to surgery, patient deaths, or morbidity and mortality statistics by physician. The CEO confirmed the finding the Medical Staff has not been effectively accountable to the governing body.

Based on document review and staff interview it was determined the facility failed to ensure the re-credentialing process met the Medical Staff Bylaws requirement to develop criteria to ensure safe care through evidence of current competence and ability to perform requested privileges for 1 sampled member of the medical staff, of a total of 2 active members with current privileges in cardiovascular surgery.

Findings included:

The Medical Staff Bylaws indicated each Department and Division shall develop criteria for the granting of Clinical Privileges designed to assure the Medical Staff and the Board that patients will receive quality and safe care. The criteria shall at least pertain to evidence of relevant training or experience, current competence and ability to perform the privileges requested (page 18, section 6.5).

The review of the document titled Cardiovascular Surgery Delineation of Privileges published 5/4/17 included the evidence necessary to satisfy the requirements of Clinical Experience for reappointment to the medical staff with privileges in cardiovascular surgery was evidence of 100 open cases per 2 year cycle.

The credentialing file for Physician A included a list of 244 surgical cases with the date and description of the procedure provided by a community hospital in another city. The document did not indicate whether Physician A was the primary surgeon or the assistant surgeon for the listed cases.

The facility was unable to comply with a request to produce evidence of any objective measurement of the current competency and ability to perform the requested privileges, such as outcomes analysis or morbidity and mortality statistics, for the 244 surgical procedures performed at an outside facility and submitted to satisfy the re-credentialing criteria for privileges in cardiovascular surgery.

The recredentialing file for Physician A revealed the list of requested privileges was signed electronically by the physician on 12/12/17. The list included a request to perform general thoracic surgery, vascular surgery, adult cardiac including use of cardiopulmonary bypass, pediatric cardiac including use of cardiopulmonary bypass, and neonatal cardiac including use of cardiopulmonary bypass, pediatric heart transplants, and bronchoscopy. The Acknowledgement of Applicant statement above the physician's electronic signature read, "I have requested only those privileges for which by education, training, current experience, and demonstrated competency I want to perform and that I wish to exercise at All Children's Hospital. Check boxes next to each requested privilege and the electronic signature of the Division Chair dated 1/24/18 indicated the Division Chair approved all requested privileges.

Additional documentation revealed Physician A was granted all requested privileges and re-appointed as an active member of the medical staff for the two year period from 3/1/18 through 2/29/20.

An interview was conducted with the Interim Vice President of Medical Affairs on 1/8/19 at the time of the review of the credentialing files. The Vice President confirmed the finding the established criteria for granting clinical privileges in cardiovascular surgery to members of the medical staff applying for reappointment failed to meet the standard to ensure current competence and ability to perform the requested procedures as required by the Medical Staff Bylaws.

An interview was conducted with the Interim Chief Executive Officer (CEO), the Senior Vice President Patient Safety Officer, the Interim Vice President of Medical Affairs, the Senior Director of Patient Safety and Quality/Interim Patient Safety Officer, the General Counsel, the Chief Operating Officer, the Regulatory Compliance Manager, the Vice President for Quality and Risk Management Johns Hopkins and other interested parties on 1/11/19 at 9:30 a.m. The Senior Director indicated indicated the facility has no historical data on objective indicators of quality of medical care that has been tracked, trended, and analyzed such as unplanned returns to surgery, patient deaths, or morbidity and mortality statistics by physician. The CEO confirmed the findings.

Based on review of the medical record, review of facility policy and staff interview it was determined the facility failed to ensure a properly executed informed consent form was obtained for a procedure for one (#35) of forty sampled patients.

Findings included:

Review of the facility policy, "Informed Consent for Medical/Surgical Procedures," stated it is the practitioner's responsibility to obtain informed consent from the patient/parent(s)/legal guardian(s) prior to providing care or treatment to patients, except in medical emergencies, and to provide adequate information so that the patient/parent(s)/legal guardian(s) may make educated and informed decisions about proposed care. The policy stated telephone consent may be obtained from a person who has legal authority to consent but who is unable to present in person. The policy stated abbreviations may not be used to describe the intervention on the consent form.

Review of the medical record for patient #35 revealed the patient, a minor child, was admitted on 12/13/2018. Review of the record revealed informed consent, dated 12/15/2018 at 3:11 pm, for Lumbar Puncture to "r/o HSV & Meningitis in CSF fluid." There was no explanation of the abbreviations documented on the informed consent. Review of the informed consent, dated 12/15/2018 at 3:11 pm, revealed the documentation written for relation to patient was "phone consent." There was no documentation from whom the consent was obtained.

Interview with the Director of Accreditation & Survey Readiness on 1/10/2019 at approximately 2:30 pm confirmed the above findings.

Based on observation and interview it was determined the facility failed to secure 9 of 10 portable oxygen e-cylinders within 2 wheeled carts to ensure safe environment.

Findings include,

On 01/07/2019, day one of survey, a tour of the following patient care areas revealed six [6] of six [6] portable Oxygen E-Cylinders not secured within 2 wheeled carts as follows:
- 3 of 3 unsecured in the Emergency Department
- 1 of 1 unsecured in NICU [Neonatal Intensive Care Unit] South 6th floor
- 1 of 1 unsecured in NICU [Neonatal Intensive Care Unit] North 6th floor
- 1 of 1 unsecured in PICU [Pediatric Intensive Care Unit] 5th floor
On 01/09/2019, day three of survey, additional oxygen e-cylinders were found to be unsecured within 2 wheeled carts as follows:
- 1 of 1 unsecured in procedure room 2351
- 1 of 2 unsecured in clean utility room 1154, also room not identified as a storage room for oxidizing gas.
- 1 of 1 unsecured in patient room 115

An interview during the tour with the Director Pediatric Emergency Services, Trauma, Lifeline, Nursing Supervision, Workforce Management and Respiratory Therapy

Based on policy and procedure review, document review, direct observation, and staff interviews, it was determined the facility failed to ensure that the hospital-wide quality assessment and performance improvement (QAPI) program and training incorporated infection control problems identified on a routine basis as evidenced by the following:

1. Facility failed to follow current Infection Control standards for cleaning patient care areas and equipment.
2. Facility failed to identify, investigate, and control potential environmental sources of patient hospital acquired infections (HAI's).
3. Facility failed to report specific findings of ongoing environment of care monitoring to QAPI, Medical staff, and Chief Executive Officer.

See A0749 and A0756

Based on policy review, document review, direct observation, and staff interviews, it was determined the facility failed to provide a sanitary environment and identify, investigate and prevent potential transmission of infections associated with environmental sources as evidenced by the following:

Findings include:

Hand Hygiene:
Review of the facility Infection Prevention Program annual report for calendar year 2017 and Plan for calendar year 2018, revealed concerns were raised at the end of 2016 regarding hand hygiene tracking and therefore implemented a new tracking system in 2017. The goal for 2018 was to sustained hand hygiene compliance at a rate of 96%.

The following inpatient hand hygiene compliance percentages were obtained in 2017:
January 2017- 93.1%
February 2017-99.4%
March 2017-99.0%
April 2017-98.1%
May 2017-98.5%
June 2017-98.9%
July 2017-99.2%
August 2017-94.4%
September 2017-97.5%
October 2017-95.8%
November 2017-99.4%
December 2017-94.0%
2017 Year to date average=97.3%

According to the data collected for 2018 hand hygiene compliance rates decreased from 2017 and fell below the facility's goal range.
January 2018- 96.1%
February 2018-93.8
March 2018-94.5%
April 2018-94.3%
May 2018-97.6%
June 2018-87.9%
July 2018-84.2%
August 2018-85.5%
September 2018-87.9%
October 2018-91.4%
November 2018-84.3%
December 2018-93.7%
2018 Year to date average=90.9%
Based on documentation provided, hand hygiene compliance was decreased 6.4% in 2018.

Review of the Quality and Patient Safety Plan for 2019 that was presented to the Quality Board on 09/20/18, revealed it included metrics on decreasing HAIs for 2019 but did not include the results on the decreasing hand hygiene compliance or specifically how the facility planned to increase hand hygiene compliance. The 2019 Quality and Safety Plan requires an infection control update once per year.

Surgical Site Infections:

According to review of facility report titled "Hospital Acquired Infections: Trends, Challenges and Action Plans" (no date), the facility identified specific concerns related to surgical site infections on the cardiovascular intensive care unit (CVICU). It was noted there was an increase in surgical site infections for 2017 and 2018 on this unit. The infection site identified was the mediastinum (the chest cavity).
According to the document titled Infection Prevention Program annual report for calendar year 2017 and plan for calendar year 2018, the risk assessment showed the probability of an infection from spinal surgical site as one (1) and the probability of an infection cerebral spinal fluid (CSF) shunt as one (1) for 2018.

A review of the 2017 through 2018 surgical site infection list revealed the facility reported eleven (11) infections from the following sites:
1. Four were from the mediastinum surgical site. Of the four infections, two were from one surgeon and two were from another surgeon. All four of these infections were identified in 2017.
2. Three were from the spinal surgical site. Of the three infections, two were from one surgeon and one was from another surgeon. All three of these infections were identified in 2018.
3. Four were from the cerebral spinal fluid (CSF) shunt. Of the four infections, three were from one surgeon and one was from another surgeon. Two of these infections were identified in 2017 and two were identified in 2018.

According to an interview with the IP nurse on 1/8/19 at 1:30 p.m., education was provided to some surgeons, regarding surgical site infections on 03/20/2018, titled "Surgical Wound Care Protocol in Cardiac Surgery Patients". This training was provided to the surgeons and operating room registered nurses (RN's) however, according to the sign-in sheet, the training was not attended by any of the surgeons listed on the 2017-2018 surgical site infection list.

There was no documentation on the trending of specific organisms related to surgical site infections (SSI) for the spinal surgical site or the cerebral spinal fluid (CSF) shunt site listed on the 2017-2018 SSI list. There was no evidence that all surgical site data was analyzed and presented to QAPI or the Medical Executive Committee (MEC). The IP nurse further stated the facility has not made a connection regarding the cause of the listed hospital acquired infections (HAIs).

Environment of Care (EOC):

According to an interview with the IP nurse on 1/9/19 at 11:30 a.m., the process of monitoring the facility's environment for potential or actual infection related concerns was switched from the infection control department to environmental services (EVS) beginning in 2018. The previous tracking sheets, photos, and emails to department managers, which were being completed by the IP nurse, were now being completed by EVS and safety.

The current environment of care (EOC) tracking report provided by EVS, list all four quarters of 2018, and is broken down by area of the facility checked and impacted, including infection control areas. The report did not deliniate the identified issues by: staff, exact location, corrective action, or follow-up needed.

An example of a listed category on the EOC checklist that was checked each quarter of 2018 is "Medications/medical supplies-have no expired dates." The 2018 compliance results for all four quarter reveal the following:
1. Quarter 1=100%
2. Quarter 2=96.55%
3. Quarter 3=100%
4. Quarter 4=66.67% (testing completed on 10/3/18)
It was not clear by the report what unit this occurred on or how it was corrected.

On 1/11/19 at 11:45 a.m. an interview was conducted with the Director of Safety on regarding the test results above and actions taken. According to the director, the process included emailing the manager of the specific unit on 10/3/18 with a request for corrective action by 11/2/18. The director provided documentation that the issue was resolved on 11/16/18 (44 days after being identified). There was no documentation, within the tracking program, of the specific action/s taken or a prevention plan. The Director of Safety confirmed infection control staff are not included in the email of findings or the action plan.

The IP nurse conformed infection control is not included in the email correspondents to unit managers, even when the subject of concern is infection control. The IP nurse confirmed that the infection control department is not involved in the process of evaluating the environment of care.
Review of an email dated 10/24/17 at 11:32 a.m., from the IP nurse to the manager of EVS, revealed the facility uses Adenosine triphosphate (ATP) testing to determine if the surfaces of various high contact areas throughout the patient and visitor areas of the facility are clean and acceptable for next patient use. ATP is a rapid testing method, whereby an item is swabbed to quickly assess the cleanliness of surfaces. According to the IP nurse, a reading under 250 relative light units (RLU), indicates the item is ready for patient use. The following out of range results were obtained on 10/24/17 and emailed to the Director of EVS:
1. Location: Outpatient Lobby- Three different wheelchairs were tested and yielded results of 450 RLU, 342 RLU, and 714 RLU.
2. Location: Post Anesthesia Care Unit (PACU)-Four different wheelchairs tested and yielded results of 878 RLU, 332 RLU, 509 RLU, and 263 RLU.

According to an interview with the director of EVS on 1/9/19 at 11:30 a.m., training was provided only to the two EVS employees responsible for cleaning wheelchairs during that time. There is no documentation that this training occurred.

According to IP nurse, infection control does not report the EOC rounding data to quality, Medical staff, or the CEO. The director of safety was not able to provide documentation that the data was presented to the above groups.

According to the IC nurse, there is not a policy or procedure on surveillance rounding or the ATP testing and reporting process.

Facility policy titled "Scope of Service-Infection Prevention Program" #08-122 states infection prevention and control are responsible for developing policies governing control of infections and communicable diseases.

During a tour of the main lobby area on 10/10/19 at 11:30 a.m., with the IP nurse and manager of Patient Safety and Quality, it was discovered that the space where the uncleaned wheelchairs are kept, is an unmarked and unsecured area close to where patients and visitors would enter the building. When questioned about individuals taking the uncleaned wheelchairs from this area, the IP nurse confirmed that patients and valet staff can take wheelchairs from this area.

While on tour on with the IP nurse and manager of Patient Safety and Quality, the following random ATP testing and out of acceptable range results were obtained by the IP nurse:
1. Wheelchair main lobby- 305 RLU
2. Seventh floor children's toy room
a. Pink toy car (seat of car tested)-8986 RLU
b. "Rockem Sockem" toy (handles)-1853 RLU
The IP nurse confirmed the above results are unacceptable and increase the risk of transmitting communicable diseases. The toy room was shut for use at the time of the tour until proper cleaning was complete.

According to facility policy titled "Cleaning, Disinfection, and Storage on Non-Disposable Medical Equipment, Devices, Supplies, and Toys, #CLNPOL012 dated 06/29/2018, toys can be a source of hospital-associated infection; they may be colonized with infectious pathogens, therefore must be cleaned in between patient use.
There is not a current tracking system to identify if the toys in the toy room are clean and ready for use.

On 1/7/19 at 11:30 a.m., a tour of the outpatient rehabilitation facility was conducted. During the tour, in the feeding room, it was noted that inside a patient refrigerator labeled "Therapy room 3112 NUT. REFRIG 69-152" was a zip lock type bag labeled "Bryan S. opened 9/26" with food type contents in it and a 14 ounce container of Haagen Dazs strawberry ice cream with a pink colored liquid substance leaking from the bottom of the container.

According to an interview with the Director of Rehabilitation on 1/7/19 at 11:45 a.m., the policy is to discard any patient food items after one week.

The director confirmed it was a patient's food in the zip lock bag and the food and ice cream should have been thrown out.

In the occupational rehabilitation kitchen was patient refrigerator, labeled "Room 3175A ADL KITCHEN REFRIDG. 213-17, with a sign on the door stating it was for patient use only. Within this refrigerator, on the top shelf on the door, were two boxes of a product titled "ROXYLAN 50/50 MIX ELSTROM 240G" the boxes had handwriting on them with the words "Not for consumption". The first box had an expiration date of 2018/03 and the second box had an expiration of 2018/08/04. Both boxes of product were expired. The two boxes of Roxylan were sitting on the top shelf of the refrigerator door, next to 3 containers of cake frosting.

The director confirmed these products should not be kept in the patient refrigerator and should have been discarded when they expired.

On 1/08/2019 at approximately 10:30a.m., a tour of sterile processing revealed sprinklers loaded with dust, debris and corrosion.
Cross contamination observed in Room 2351 with anesthesia cart waste anesthesia gas disposal (WAGD) line connected to vacuum line.
An interview during tour with maintenance, and department leads confirmed the findings.

On 1/9/19 at 10:15 a.m., a tour was conducted on 7 North. During the tour, an interview was conducted with a member of housekeeping 11:00 a.m. The housekeeping staff described the responsibilities of housekeeping, including cleaning of the patient rooms. According to the house keeper, the room is wiped down with a cleaning cloth called Oxivir and must remain wet on the surface for 2 minutes.

According to facility policy "Cleaning, Disinfecting, and Storage of Non-Disposable Medical Equipment, Devises, Supplies, and Toys"
# CLNPOL012, effective 06/29/18,
"Contact time-The amount of time the disinfectant has to remain wet on the surface(s) of the clean object/instrument to completely disinfect that object is 5 minutes for Oxivir and Bleach and alcohol is 5 seconds".

Policies:
A review of all facility infection control related policies provided revealed four policies and nine accompanying appendixes have not been reviewed by infection control since March 2016.

The facility failed to incorporate the infection prevention specialist in its active surveillance and to maintain a sanitary environment in all areas of the hospital.

Based on policy and procedure review, document review, and staff interviews, it was determined the facility failed to ensure that the hospital-wide quality assessment and performance improvement (QAPI) program identified infection control problems and reported specific findings on an ongoing basis to the Chief Executive Officer (CEO) and Medical staff as evidenced by the following:

Findings include:

According to review of facility report titled "Hospital Acquired Infections: Trends, Challenges and Action Plans" (no date), the facility identified specific concerns related to surgical site infections on the cardiovascular intensive care unit (CVICU). It was noted there was an increase in surgical site infections for 2017 and 2018 on this unit. The infection site identified was the mediastinum (the chest cavity).
According to the Infection Prevention Program annual report for calendar year 2017 and plan for calendar year 2018, the risk assessment showed the probability of an infection in 2018 from spinal surgical site as one (1) and the probability of an infection cerebral spinal fluid (CSF) shunt as one (1) for 2018.

Review of the 2017 through 2018 surgical site infection list, the facility reported eleven (11) surgical site infections:
1. Four were from the mediastinum surgical site. Of the four infections, two were from one surgeon and two were from another surgeon. All four of these infections were identified in 2017.
2. Three were from the spinal surgical site. Of the three infections, two were from one surgeon and one was from another surgeon. All three of these infections were identified in 2018.
3. Four were from the cerebral spinal fluid (CSF) shunt. Of the four infections, three were from one surgeon and one was from another surgeon. Two of these infections were identified in 2017 and two were identified in 2018.

According to an interview with the IP nurse on 1/8/19 at 1:30 p.m., education was provided to some surgeons, regarding surgical site infections on 03/20/2018, titled "Surgical Wound Care Protocol in Cardiac Surgery Patients". This training was provided to the surgeons and operating room registered nurses (RN's) however, according to the sign-in sheet, the training was not attended by any of the surgeons listed on the 2017-2018 surgical site infection list. There was no evidence of additional education on surgical site infections provided to surgeons.

There is no documentation that the above findings were reported to QAPI, the CEO and medical staff in order to ensure the implementation of a successful corrective action plan.

According to an interview with the IP nurse on 1/9/19 @ 11:30 a.m., the process of monitoring the facility environment for potential or actual infection related concerns was switched from the infection control department to environmental services (EVS) beginning in 2018. The previous tracking sheets, photos, and emails to department managers, which were being completed by the IP nurse, were now being completed by environmental services and safety staff.

The IP nurse conformed infection control is not included in the email correspondents to unit managers, even when the subject of concern is infection control.

According to IP nurse, infection control does not report the environment of care rounding data to QAPI, Medical staff, or the CEO. The director of safety was not able to provide documentation that the data was presented to the above groups.

The 2019 Quality and Safety Plan requires the board of quality receive an infection control committee update only once per year.

The facility leadership failed to ensure the problems identified by environmental services and infection control and prevention were presented, along with ensuring the implementation of a successful corrective action plan.

Based on review of facility documents for discharge planning process reassessment and staff interview it was determined the facility failed to ensure activities and reassessment of the facility's discharge planning process was reported to the Board Quality and Patient Safety Committee for integration into the hospital-wide QAPI (Quality Assurance Performance Improvement) program.

Findings included:

The Quality and Patient Safety Plan (the Plan) FY 2019, approved September 20, 2018 was signed by the Patient Safety Officer and the Chair, Board Quality and Patient Safety Committee. The Plan indicated the Patient Safety and Quality Council reported to the Board of Trustees through the Board Quality and Patient Safety Committee. The Plan indicated several Medical Staff committees received or provided reports regarding patient safety and quality. The Plan included documentation the Clinical Practice council "(members are mainly physicians)" oversees the prioritization, development and deployment of clinical guidelines. Each department, program and institute conducts quality improvement and safety initiatives that are aligned with the strategic priorities of the organization and/or the population served by that department, program, or institute.

The Plan did not include any evidence the selection of indicators, quality improvement projects, or the development of criteria were based on any review of the tracking and trending of objective data that identified measurable concerns or issues that were high frequency or high acuity, and was limited primarily to reporting requirements defined by the regulatory or the accrediting agencies.

Review of requested documents revealed on-going data collection of specific indicators and quality improvement projects. An interview was conducted with the Senior Director of Care Coordination and the Manager of Case Management on 1/11/2019 at 5:00 pm. The interview revealed there is no set timeframe for reporting to the Board Quality and Patient Safety committee but identified concerns would be shared with the quality council.

Review of the Quality and Patient Safety Dashboard revealed data displayed for readmissions within 7 days. November 2018 was the most recent month for which data was reported, along with year-to-date statistics. Review of the Patient Safety and Quality Council Meeting Minutes, dated 12/12/2018, included documentation a comprehensive dashboard review was presented to the Council. The area designated to indicate Action Plan Responsibilities and Time Frames next to the minutes of the presentation was blank.

Based on review of facility documents and staff interview it was determined the facility failed to ensure that the organ, tissue and eye donation program was integrated into the hospital's QAPI (Quality Assurance Performance Improvement) as stated and agreed upon in the OPO (Organ Procurement Organization) agreement.

Findings included:

Review of the facility's current written agreement with the OPO revealed section G. Activity Data Review, Reporting and Quality Assessment (QA) and Improvement (QI) stated "G.1 At least annually, the Foundation shall provide Donor Hospital specific data with the appropriate Donor Hospital personnel for the purposes of quality assessment (QA) and improvement (QI), process evaluation, and to analyze outcomes of potential referral/donor situations, allowing for a collaborative plan of corrective action when indicated."

Review of the facility's Board Quality and Patient Safety Committee meeting minutes revealed the last meeting in which specific data was provided was 1/19/2017. Review of requested documentation revealed the OPO provided data for calendar years 2017 and 2018. There was no evidence the data was provided to the facility's Board Quality and Patient Safety Committee for integration into the hospital's QAPI program.

Interview with Physician Chief of Critical Care Medicine on 1/11/18 at 3:00 pm confirmed the OPO provided data for calendar year 2017 and 2018 with no evidence the data was provided to the facility's Board Quality and Patient Safety committee, at least annually, for integration into the hospital's QAPI program.

Based on document review and staff interview it was determined the facility failed to ensure Medical Staff Bylaws were followed for determination of surgical privileges and competencies of practitioners for one (physician #14) of two active cardiovascular surgeons of fourteen practitioner's reviewed.

Findings included:

Review of the facility's Medical Staff Bylaws revealed each Department and Division shall develop criteria for the granting of Clinical Privileges designed to assure the Medical Staff and the Board that patients will receive quality and safe care. The criteria shall at least pertain to evidence of relevant training or experience, current competence and ability to perform the privileges requested (page 18, section 6.5).

Review of the facility document, "Cardiovascular Surgery Delineation of Privileges," published 5/4/2017, stated the evidence necessary to satisfy the requirements of Clinical Experience for reappointment to the medical staff with privileges in cardiovascular surgery was evidence of 100 open cases per 2 year cycle.

Review of the credentialing file for Physician #14 included a list of 244 surgical cases with the date and description of the procedure provided by another acute care facility located in another city. The document did not indicate whether Physician #14 was the primary surgeon or the assistant surgeon for the listed cases.

The facility did not provide any further evidence of any objective measurement for the current competency and ability to perform the requested privileges, such as outcomes analysis or morbidity and mortality statistics, for the 244 surgical procedures performed at another acute care facility which was submitted to satisfy the re-credentialing criteria for privileges in cardiovascular surgery.

Review of the Credential file for Physician #14 revealed the list of requested privileges was signed electronically by the physician on 12/12/2017. The list included a request to perform general thoracic surgery, vascular surgery, adult cardiac including use of cardiopulmonary bypass, pediatric cardiac including use of cardiopulmonary bypass, and neonatal cardiac including use of cardiopulmonary bypass, pediatric heart transplants, and bronchoscopy. The Acknowledgement of Applicant statement, above the physician's electronic signature, read, "I have requested only those privileges for which by education, training, current experience, and demonstrated competency I want to perform and that I wish to exercise." Check boxes next to each requested privilege and the electronic signature of the Division Chair dated 1/24/2018 indicated the Division Chair approved all requested privileges.

Additional documentation revealed Physician #14 was granted all requested privileges and re-appointed as an active member of the medical staff for the two year period from 3/1/2018 through 2/29/2020.

An interview was conducted with the Interim Vice President of Medical Affairs on 1/8/2019 at the time of the review of the credential files. The Vice President confirmed the finding the established criteria for granting clinical privileges in cardiovascular surgery to members of the medical staff applying for reappointment failed to meet the standard to ensure current competence and ability to perform the requested procedures as required by the Medical Staff Bylaws.

An interview was conducted with the Interim Chief Executive Officer (CEO), the Senior Vice President Patient Safety Officer, the Interim Vice President of Medical Affairs, the Senior Director of Patient Safety and Quality/Interim Patient Safety Officer, the General Counsel, the Chief Operating Officer, the Regulatory Compliance Manager, the Vice President for Quality and Risk Management Johns Hopkins and other interested parties on 1/11/2019 at 9:30 a.m. The Senior Director indicated the facility has no historical data on objective indicators of quality of medical care that has been tracked, trended, and analyzed such as unplanned returns to surgery, patient deaths, or morbidity and mortality statistics by physician. The CEO confirmed the findings.