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414 PAOLI PIKE

MALVERN, PA null

GOVERNING BODY

Tag No.: A0043

Based on the systemic nature of non-compliance with the following deficiencies related to managing the activities of the hospital, the Governing Body failed to assume responsibility to provide oversight and accountability for the facility to comply with this condition.

This condition is not met as evidenced by:

Review of facility policy "Hospital Plan of Care" last reviewed August 2018 revealed "The Hospital Plan of Care is a dynamic process, and is reviewed and/or revised annually. The Senior Management Team, in conjunction with the Main Line Health Board of Governors and Medical Staff, are responsible for the ongoing monitoring and evaluation of the clinical, financial and organizational performance of each Hospital and for implementing changes as necessary to improve performance."

Review of facility policy "Hospital Plan Of Care "last revised August 2018 revealed "H. Organizational Communication/Collaboration/and Integration of Patient Care Services 3. Hospital leaders create the culture, set the expectations and provide support for effective collaboration on patient flow across units, departments, and functions throughout the hospital. Hospital leaders include members of the medical staff and governing body, the Chief Executive Officer and other senior mangers, the Chief Medical Officer, Chief Nursing Officer, clinical leaders, and staff members in leadership positions within the organization."


(482.12(b) Tag - 0057): Chief Executive Officer
The information reviewed during the survey provided evidence the facility failed to ensure application and implementation of established policies for hospital operations (failure to provide a safe environment, noncompliance with Pennsylvania State Regulations for Event Reporting-State Law Act 13, Event Reporting (facility policy), Nationally recognized performance standards for Hand Hygiene Compliance (Center of Disease Control), an effective Quality Assessment and Improvement Program, compliance with completion of medical records and maintenance of the hospital's physical environment for the delivery of patient care services.

(482.13(c)(2) Tag-0144): Patient Rights: Care In Safe Setting
The information reviewed during the survey provided evidence the facility failed to ensure a serious event (patient death) was reported according to the Pennsylvania State Regulations, compliance with nationally recognized performance standards for Hand Hygiene compliance from May 2018 to April 2019, and environmental cleanliness of hospital support areas.

(482.21 Tag-0263) QAPI
The information received during the survey provided evidence the facility failed to ensure the effectiveness of the Quality Committee based upon the hospital's leadership failure to set expectations, develop plans and manage resources (operational and clinical) for serious events, practice guidelines for patient safety and support services.

(482.21(a)(b)(1)(b)(2)(i),(b)(3) Tag -0283) Quality Improvement Activities
The information received during the survey provided evidence the facility failed to ensure an effective review of the delivery of patient care services for a serious event and compliance with nationally recognized standards of practice for hand hygiene performance by staff.

(482.22(a)(2) Tag 0341): Medical Staff Credentialing
The information reviewed during the survey provided evidence the facility failed to ensure the credentialing process for requesting and approving privileges was completed according to the facility's Medical Staff Bylaws.

(482.24 Tag 0431): Medical Record Services
The information reviewed during the survey provided evidence the facility failed to ensure accountability of the CEO/President and Chief Medical Officer to adhere to the role responsibilities as stated in the Medical Staff Bylaws and Medical Staff Rules and Regulations for completion of medical record documentation and medical staff credentialing.

(482.24(b) Tag 0438): Form and Retention of Records
The information reviewed during the survey provided evidence the facility failed to ensure medical records were completed within 30 days of patient discharge for 12 applicable medical records.

(482.24(c)(2) Tag 0454): Consent of Record: Orders Dated and Signed
The information reviewed during the survey provided evidence the facility failed to ensure verbal orders were completed as per the facility's policy for 13 applicable medical records.

(482.41 Tag 0700): Physical Environment

482.41(a) Tag 0701: Maintenance Of Physical Plant
The information reviewed during the survey provided evidence the facility failed to ensure maintenance of the hospital's physical environment for cleanliness in the areas of inpatient rooms, inpatient bathrooms, support and common areas (ceiling vents, pantry ice machines, water fountains and patient laundry rooms).


Cross reference:
482.12(b) Standard: Chief Executive Officer
482.13(c)(2) Standard: Patient Rights: Care In Safe Setting
482.21 Condition of Participation: QAPI (Quality Assurance Performance Improvement)
482.21 (a)(b)(1),(b)(2)(i),(b)(3): Quality Improvement Activities
482.22(a)(2) Standard: Medical Staff Credentialing
482.24 Condition of Participation: Medical Record Services
482.24 Standard: (b) Form And Retention Of Records
482.24(c)(2) Standard: Content Of Record: Orders Dated and Signed
482.41 Condition of Participation: Physical Environment
482.41(a) Maintenance Of Physical Plan

QAPI

Tag No.: A0263

This condition is not met as evidenced by:

Based on the systemic nature of the standard-level deficiencies related to the Quality Assessment and Performance Improvement Program, the facility failed to comply with this condition.

The findings were:

Review of the facility policy "Main Line Hospitals Quality Improvement Plan" approved June 26, 2017, revealed "Section III. Organizational Structure for Quality Improvement. ... The Main Line Hospitals... Board of Trustees has designated the Quality/Patient Safety Committee of the Board (QSCB) to function as the body responsible for the review of Quality/Performance Improvement efforts for Main Line Health member hospitals. The QSCB is the board Committee who duties include consulting, advising, recommending, approving, and reviewing actions related to Quality Improvement. The Main Line Hospitals Quality/Patient Safety Council (MLHQSC) shall function as a subcommittee of the MEC for purposes of ensuring accountability for Quality Improvement activities.

Review of facility policy "Main Line Hospital Quality Improvement Plan" approved June 26, 2017, revealed " Section III. C. As authorized by the QSCB, the MLH Quality Council has the responsibility to continuously assess, measure, and improve the functions of care for both acute and ambulatory patients and attempt to improve processes and systems affecting clinical outcomes. The MLHQSC will prioritize initiatives for hospital-wide and system wide Quality Improvement activities that are designed to improve patient care and outcomes based on... . c. The Health System's priorities for improvement."

These following regulations were cited and show a systemic nature of non-compliance with regards to quality/performance improvement efforts as follows:

Cross Reference:
482.12 Governing Body
482.12(b) Standard: Chief Executive Officer
482.13(c)(2) Standard: Patient Rights: Care In Safe Setting
482.21 (a)(b)(1),(b)(2)(i),(b)(3): Quality Improvement Activities
482.22(a)(2) Standard: Medical Staff Credentialing
482.24 Condition of Participation: Medical Record Services
482.24 Standard: (b) Form And Retention Of Records
482.24(c)(2) Standard: Content Of Record: Orders Dated and Signed
482.41 Condition of Participation: Physical Environment
482.41(a) Maintenance Of Physical Plan

MEDICAL RECORD SERVICES

Tag No.: A0431

This condition is not met as evidenced by:

Based on the systemic nature of the standard-level deficiencies related to Medical Record Services, the facility failed to comply with this condition.

The findings were:

These following standards were cited and show a systemic nature of non-compliance with regards to Medical Records as follows:

(482.24(b) Tag - 0438)
The information reviewed during the survey provided evidence the facility failed to ensure medical records were completed within 30 days of discharge for 13 applicable medical records reviewed.

(482.24(c)(2) Tag - 0454)
The information reviewed during the survey provided evidence the facility failed to ensure the verbal orders of the medical records were complete (signed) as per the hospital's policy for 13 applicable medical records.

PHYSICAL ENVIRONMENT

Tag No.: A0700

The Condition for Physical Environment was found to be out of compliance during a Life Safety Survey completed on March 5-7, 2019. Further details are outlined in that Division of Life Safety Survey Report.


This condition is not met as evidenced by:

Based on the systemic nature of the standard-level deficiencies related to Medical Record Services, the facility failed to comply with this condition.

The findings were:

These following standards were cited and show a systemic nature of non-compliance with regards to Medical Record Services as follows:

(482.24(b) Tag - 0438)
The information reviewed during the survey provided evidence the facility failed to ensure medical records were completed within 30 days of discharge for 13 applicable medical records reviewed.

(482.24(c)(2) Tag - 0454)
The information reviewed during the survey provided evidence the facility failed to ensure the verbal orders of the medical records were complete as per the hospital's policy for 13 applicable medical records.

CHIEF EXECUTIVE OFFICER

Tag No.: A0057

Based on facility Bylaws, observation, policies, documents, medical records (MR), and interview with staff (EMP), it was determined the Chief Executive Officer/President failed to provide oversight, ensure implementation of facility policies for reporting a serious event, adhering to recognized standards of compliance for hand hygiene practices and maintaining a clean environment for the delivery of safe patient care, fulfilling the required duties as the appointed liaison to the medical staff to address and resolve deficient practices (0341, 0438, 0454), and failure to maintain the physical environment of the facility ensuring patient safety (0701).

Findings include:

Review of the facility's "Amended and Restated Main Line Hospitals, Inc. Bylaws" revealed "Section 5.4. ... the CEO's duties shall include, but not be limited to, providing for compliance with applicable law and regulation, carrying out policies established by the Member and Board and advising on the formation of such policies;... maintaining physical properties in good and safe state of repair and quality care is rendered to patients;... servicing as a liaison between the Board and any of its committees and the Medical Staff and assisting the Staff with its organization and medico (physician) administrative problems and responsibilities ... Section 5.7 Presidents, Senior Vice Presidents and Vice Presidents. The President of each Hospital, the Senior Vice Presidents and Vice Presidents shall perform such duties and have such responsibilities as Board of Trustees or the CEO shall from time to time to prescribe.

Review of facility policy "Hospital Plan Of Care" last revised August 2018 revealed " E. Leadership. The Chief Executive Officer (CEO) of Main Line Health, Inc. is accountable to the Boards of Main Line Hospitals, Inc.... . As a member of the Board, the CEO presents the Main Line Health entities to the Board, and keeps the Board informed of key issues/activities of the hospitals. Presentations and reports to the Board include but are not limited to: Quality Improvement initiatives, risk management and patient safety issues, human resources issues, financial performance of hospitals, operational matters, strategic and business plan initiatives, organizational changes, accreditation, regulatory standards."

Review of facility policy "Hospital Plan Of Care "last revised August 2018 revealed H. Organizational Communication/Collaboration/and Integration of Patient Care Services 3. Hospital leaders create the culture, set the expectations and provide support for effective collaboration on patient flow across units, departments, and functions throughout the hospital. Hospital leaders include members of the medical staff and governing body, the Chief Executive Officer and other senior mangers, the Chief Medical Officer, Chief Nursing Officer, clinical leaders, and staff members in leadership positions within the organization."

Review of facility policy "Event Reporting" last revised October 2017 revealed "An event is unplanned occurrence not consistent with the routine care of a patient, routine service of a department, or routine operation of the hospital or entity. It may occur with or without injury--the potential for injury or property damage is sufficient to require an event report...A Sentinel Event is a patient safety event (not primarily related to the natural course of the patient's illness or underlying condition) that reaches a patient and results in death, permanent harm, severe temporary harm... . Reporting of Events 1. As outlined in PA Act 13, it is a requirement that all employees, physicians, volunteers or students to promptly report events. The person who witnessed, discovered, or to whom the event was reported is responsible for iniating the event report... 2. The person initiating the report is responsible for notifying the appropriate staff such as the attending physician, nursing supervisor, department/program manager. The manager or supervisor will conduct the initial investigation and will note any immediate action taken and any recommendations to prevent a future occurrence...Events the involve serious injury or potentially serious injury or liability should be reported immediately to the Patient Safety/Risk Management Department by telephone or page notification...3. Events Reports will be reviewed by the Patient Safety Specialist (PSS). Serious events should be reported to the program administrator and PSS immediately by telephone or by pager.


The cumulative effect of these systematic problems is evidence of the inability of the Chief Executive Officer/President to provide the necessary oversight of the staff (operational and clinical) in the delivery of patient care services in a safe maintained physical environment.

These following regulations were cited and show a systemic nature of non-compliance follows:

Cross reference:

482.12 Condition of Participation: Governing Body
482.13(c)(2) Standard: Patient Rights: Care In Safe Setting
482.21 Condition of Participation: QAPI (Quality Assurance Performance Improvement)
482.21 (a)(b)(1),(b)(2)(i),(b)(3) Quality Improvement Activities
482.22(a)(2) Standard: Medical Staff Credentialing
482.24 Condition of Participation: Medical Record Services
482.24 Standard: (b) Form And Retention Of Records
482.24(c)(2) Standard: Content Of Record: Orders Dated and Signed
482.41 Condition of Participation: Physical Environment
482.41(a) Maintenance Of Physical Plan

PATIENT RIGHTS: CARE IN SAFE SETTING

Tag No.: A0144

Based on review of facility policy, medical records (MR) and interview with staff (EMP), it was determined the facility failed to ensure the provision of quality patient care and professional standards were continually reviewed and maintained to ensure patient safety for one of one medical record reviewed (MR1).

Findings include:

A review of facility policy "Main Line Hospitals...Patient Safety Plan" last revised October 2017 revealed "Serious event: An event, occurrence or situation involving the clinical care of a patient in a medical facility that results in death or compromises patient safety and results in an unanticipated injury requiring the delivery of additonal health care services to the patient."

Review of facility policy "Event Reporting" last revised October 2017 revealed "Definitions: Event: An event is any unplanned occurrences not consistent with the routine care of a patient, routine service of a department, or routine operation of the hospital or entity. It may occur with or without injury-the potential for injury or property damage is sufficient to require an event report. Reporting Requirements. 1. All departments within the organization, patient care and non-patient care, are responsible to report patient safety occurrences and potential occurrences to the Hospital PSO (Patient Safety Officer/PSS (Patient Safety Specialist) through the event reporting process. Data regarding Patient Safety Occurrences will be aggregated and reported to the PSO/PSS who will in turn report to the PSC (Patient Safety Committee). The information will be analyzed and further patient safety activities will be determined as appropriate. 2. An effective Patient Safety Program cannot exist without optimal reporting of Patient Safety Occurrences. ... (a) All personnel and medial staff are required to report suspected and identified Patient Safety Occurrences and should do so without the fear of reprisal in relationship to their employment. A health care worker who reasonably believes that a Serious Event, Incident or Infrastructure Failure has occurred shall report the occurrence by completing an Event report, unless the health care worker knows that a report has already been made. The report shall be made immediately or as soon thereafter as reasonably practicable, but in no event later than 24 hours after the occurrence or discovery of the Serious Event, Incident, or Infrastructure Failure."

1. Review on May 3, 2019, of MR1,with EMP15 revealed an admission date of July 3, 2017, and deceased on July 16, 2017, was found by the facility staff, unresponsive, without a pulse, with a dislodged tracheostomy tube (device inserted through the neck into the windpipe for breathing) and a tracheostomy tube holder collar which was unsecured. Further review of MR1 revealed resuscitation efforts were unsuccessful and intravenous access was unsuccessful after multiple attempts. A request was made to the facility for an event report and investigation documentation.

An interview conducted on May 3, 2019, at 10:48 AM with EMP15 confirmed the event was not reported to the "Division of Acute and Ambulatory Care (Department)." EMP 15 further stated "The administration did not report the event to the Governing Board, nor did we complete an investigation into why the event occurred. It was not perceived as a reportable event during our discussion with the hospital's president and administrator after the event occurred. It was something that just happen during the course of the patient's hospitalization. The patient had a tracheostomy. The patient had experienced weaning trials from the tracheostomy."

An interview conducted on May 3, 2019, at 10:55 AM with EMP1 and EMP6 confirmed as of May 3, 2019, the event had not been reported to the "Department". EMP17 also confirmed the event had not been reported to the "Department" or investigated .

________

Based on review of facility policy, documents and interview with staff (EMP), it was determined the facility failed to ensure compliance with nationally recognized hand hygiene performance standards were maintained for the provision of quality patient care.

Findings include:

Review of document "Guidelines for Hand Hygiene in Health-Care Settings. Recommendations of the Healthcare Infection Control Practices Advisory Committee and the ....Hand Hygiene Task Force" last reviewed November 5, 2015, revealed "In the case of improving hand hygiene, the improvement goal typically is to bring compliance above 95% by introducing system improvements, behavioral incentives, education, and other interventions described elsewhere in these guidelines."

Review of facility policy "Infection Prevention and Control Annual Plan" last approved on April 12, 2019, revealed " Scope of the Program... . 2. The Program is a system-wide patient safety component involving all acute care facilities, rehabilitation hospital... The Program includes the:... (c) Evaluation and Improvement Activities. This includes continuous review of the goals and activities of each hospital's program followed by improvement activities. As indicated by the review process the effectiveness of the Plan is evaluated annually, and whenever risks significantly change. ..Risks...2. Risks are reviewed and identified at least annually, and whenever significant changes occur with input from, at a minimum, infection prevention personnel, medical staff, nursing and leadership...Transmission of Infections...D.2. Hand Hygiene (a) The hospital has a competency-based training program for hand hygiene. 1. Training is provided to all healthcare personnel, including all ancillary personnel not directly involved in patient care but potentially exposed to infectious agents (e.g. food tray handlers, housekeeping, and volunteer personnel)...iv. audits are conducted routinely to monitor and document adherence to hand hygiene..vii. Hand hygiene policy-https://mainlinehealth.ellucid.com/documents/view14912/36647."

2. On May 1, 2019, at 2:30 PM EMP4 and EMP5 presented the survey team with audit documents "Percentage (%) Of Staff Observed Compliant with Hand Hygiene-By Position September 2018 through April 2019 For Bryn Mawr Rehab" Hospital. Further review of the documents revealed the Environmental (EVS) Staff completed a Hand Hygiene audit with compliance results of 67% and the Patient Care Technician (PCT) nursing staff completed a hand hygiene audit with compliance results of 87%. The facility was unable to produce documentation that the results of the audits had been communicated to the department leadership and/or EVS and PCT staff for resolution.

An interview conducted on May 1, 2019, at 2:30 PM with EMP4 and EMP5 confirmed the Environmental Staff completed a hand hygiene audit with compliance results of 67% and the Patient Care Technician nursing staff completed a Hand Hygiene audit with compliance results of 87%. In addition, EMP2 and EMP11 confirmed that the Hand Hygiene audit compliance results of 67% and 87% had not been communicated to the Environmental Services Director and the Director of Nursing to be addressed for non-compliance and resolution.

On May 1, 2019, at 2:40 PM EMP4 and EMP5 presented the survey team with audit documents "Percentage (%) Of Staff Observed Compliant with Hand Hygiene-By Position May 2018 through April 2019 for Bryn Mawr Rehab". Further review of the documents revealed the Neuro Rehab Center completed a Hand Hygiene audit with compliance results of 40%. The facility was unable to produce documentation that the results of the audits had been communicated to the Neuro Rehab Center department leadership and/or Neuro Rehab Center staff for resolution.

An interview conducted on May 1, 2019, at 2:50 PM with EMP1, EMP4 and EMP5 confirmed the Neuro Rehab Center completed a hand hygiene audit with compliance results of 40%. In addition, EMP4 and EMP5 confirmed the Hand Hygiene audit compliance results of 40% had not been communicated to the Neuro Rehab Center Director/Manager.
____________

Based on review of facility policy and interview with staff (EMP), it was determined the facility failed to ensure manufacturer recommendations/instructions were followed as per facility policy to ensure a safe environment for the provision of laundry services were provided for inpatients and family members.


A review of facility policy "Hospital-Laundered Items" last revised April 2019 revealed "C. Clinical Staff. 1. Laundry procedures will be followed by staff who are responsible for laundering unit items. 2. Staff will follow the item manufacturer's instructions for laundering as well as the manufacturer instructions for use of the washer/dryer machine. 3. Clinical staff are responsible for ensuring lint filters on the washing machine and dryer are cleaned between uses and/or according to manufacturer instructions...B. Water temperature will be recorded once daily, on days when the washing machine is used. If the temperature range is not met, the items will not be used until they are properly laundered. If there is not an error message from the machine or a functionality issue than the load should be repeated and temperature re-checked. At least annually, infection prevention will review the laundry rooms and laundry processes.

A request was made by the survey team to the facility for documentation of daily washing machine water temperatures and lint filter changes for the washer and dryer units on nursing units: Oak Unit-3rd floor, Birch and Spruce-1st floor and Maple Unit-2nd floor combo units used by inpatients and family members. In addition, a request for documentation of the Infection Preventionist's annual review of the laundry rooms and laundry processes was also requested for the same nursing units.

An interview conducted on May 1, 2019, at 3:00 PM with EMP2, EMP6 and EMP16 confirmed that the washer/dryer combo units on Oak, Birch, Spruce and Maple nursing units were used by patients and family members. EMP6 confirmed that the facility did not have documentation of the washing machine water temperatures and lint filter changes for the washer/dryer units on the Oak, Birch, Spruce and Maple nursing units. EMP4 confirmed that an annual review of the laundry rooms and laundry processes had not been completed as per the facility's policy by the Infection Preventionist.

Cross Reference:
482.12 Governing Body
482.12(b) Standard: Chief Executive Officer
482.13(c)(2) Standard: Patient Rights: Care In Safe Setting
482.21 Condition of Participation: QAPI (Quality Assessment Performance Improvement)
482.21 (a)(b)(1),(b)(2)(i),(b)(3): Quality Improvement Activities
482.24 Condition of Participation: Medical Record Services
482.22(a)(2) Standard: Medical Staff Credentialing
482.24 Condition of Participation: Medical Record Services
482.24 Standard: (b) Form And Retention Of Records
482.24(c)(2) Standard: Content Of Record: Orders Dated and Signed
482.41 Condition of Participation: Physical Environment
482.41(a) Maintenance Of Physical Plan

QUALITY IMPROVEMENT ACTIVITIES

Tag No.: A0283

Based on review of facility policy, documents, medical records (MR), and interview with staff interview (EMP), it was determined the facility failed to ensure the provision of quality patient care and high professional standards were continually maintained to ensure patient safety.

Findings include:

Review of facility policy "Main Line Hospital Quality Improvement Plan" approved June 26, 2017, revealed " Section III. A. Responsibilities and Authority for Quality Improvement...The Main Line Hospitals... Board of Trustees has designated the Quality/Patient Safety Committee of the Board (QSCB) to function as the body responsible for the review of Quality Performance Improvement efforts for Main Line Health member hospitals. The QSCB is the Board committee who duties include consulting, advising, recommending, approving and reviewing actions related to Quality Improvement. As such, reports on Quality Improvement activities for Main Line Hospitals will be reported to the QSCB through Medical Executive Committee (MEC). The Main Line Hospitals Quality/Patient Safety Council (MLHQSC) shall function as a subcommittee of the MEC for purposes of ensuring accountability for Quality Improvement Activities.... As authorized by the QSCB, the MLH Quality Council has the responsibility to continuously assess, measure, and improve the functions of care for both acute and ambulatory patients and attempt to improve processes and systems affecting clinical outcomes. The MLHQSC will prioritize initiatives for hospital-wide and system wide Quality Improvement activities that are designed to improve patient care and outcomes based on... . f. High risk, high volume, problem-prone, resource intensive issues...h. Variances from comparative databases, and published practice guidelines. i. Input from employees, medical staff, patients, and others. j. Review of all quality data relevant to the functions of care."

Review of facility policy "Main Line Hospital quality Improvement Plan" approved June 26, 2017, revealed "E. Main Line Hospitals Leadership Responsibilities. 1. Leadership shall provide resources, set expectation, develop plans, and manage processes to measure, assess and improve the quality of Main Line Hospitals' governance, management, clinical and support activities. Leasers include those who set expectations, develop plans, and implement procedures to assess and improve the quality of the governing body, management, and clinical and support functions and processes. They are responsible for the integration of safety priorities into the design and redesign of relevant organizational processes. The leaders of Main Line Hospitals include the leaders of a. Main Line Hospitals/Board of Trustees; b. The Chief Executive Officer; c. Other Senior Leaders; d. The elected and the appointed leaders of the Medical Staff and the Clinical Departments; e. Other Medical Staff members in Administrative positions; and f. The Chief Nurse Executive. F. Directors, Managers and Other Leaders Responsibilities include: 1. Develop and implement a departmental plan for providing high quality care...G. Quality improvement teams/system initiatives responsibilities include: 1. Identify and develop a statement of purpose; 2. State goals, timeliness and accountabilities; 3. Utilize continuous quality improvement tools to identify, develop, implement and measure improvements; 4. Establish continuous measures to assure effective improvements; 5. Provide periodic reports to the MLH Quality Council; and 6. Present results and processes leading to improvements to medical staff committees, governing body committees and other Hospital committees, as requested...I.2. Reports from performance improvements teams and on regulatory compliance are also included in local Clinical Effectiveness Workgroup (CEW) meeting minutes. At the monthly MLH Quality Council meeting there are presentations regarding local/system quality initiatives and data; regulatory initiatives and data; performance improvement initiatives and data. Action item logs are produced after MLH Quality Council meeting to assure appropriate follow-up, action with responsible parties identified for any quality, regulatory or performance issue."

1. Review of MR1 revealed an admission date of July 3, 2017 and a deceased date of July 16, 2017. Further review revealed MR1 was found with a dislodged tracheostomy tube (a tube placed in an opening in the neck for breathing), unresponsive and without a pulse. Further review of MR1 revealed resuscitation efforts were unsuccessful. The facility was unable to present documentation that the event was investigated related quality and performance issues.

2. On May 1, 2019, at 2:30 PM, EMP2, EMP4 and EMP5 presented the survey team with audit documents "Percentage (%) Of Staff Observed Compliant with Hand Hygiene-By Position September 2018 through April 2019 For Bryn Mawr Rehab (BMR)". Further review of the documents revealed the Environmental (EVS) Staff completed a Hand Hygiene audit with compliance results of 67% and the Patient Care Technician (PCT) Staff completed a hand hygiene audit with compliance results of 87%.

3. On May 1, 2019, at 2:40 PM, EMP2, EMP4 and EMP5 presented the survey team with audit documents "Percentage (%) Of Staff Observed Compliant with Hand Hygiene-By Position May 2018 through April 2019 for Bryn Mawr Rehab". Further review of the documents revealed the Neuro Rehab Center completed a Hand Hygiene audit with compliance results of 40%.

A review of facility documents "BMR Clinical Operations Committee Meeting" (Quality Committee) Meeting minutes dated September 5, 2018, October 3, 2018, November 7, 2018, December 5, 2018. and April 3, 2019, revealed no documented evidence the serious event and the Hand Hygiene audit compliance results for EVS, PCT staff and Neuro Rehab Center staff had been presented to the "BMR Clinical Operations Meeting ( Quality Committees) to establish effective and ongoing documented performance action plans to address the performance outcomes.

An interview conducted on May 1, 2019, at 4:40 PM with EMP5 confirmed that the facility had not submitted the serious event on July 16, 2017, and the Hand Hygiene compliance audit data dated September 2018 through April 2019 and May 2018 through April 2019 to the "BMR Clinical Operations Committee Meeting" (Quality Committee). EMP1 and EMP5 confirmed that to date the serious event had not been submitted to the "Department" and no investigation as to the performance outcome of the event had been completed. Further interview confirmed performance action plans for Hand Hygiene compliance for EVS, PCT and Neuro Rehab Center staff still needed to be developed and submitted to the "BMR Clinical Operations Committee Meeting" (Quality Committee) .

MEDICAL STAFF CREDENTIALING

Tag No.: A0341

Based on review of facility Medical Staff Bylaws, credential files (CF), and interview with staff (EMP), it was determined the facility failed to ensure the delineation of clinical privileges were requested and approved as granted for two of two credential files reviewed. (CF6 and CF7).

Findings include:

A review of the facility's "Bylaws Of the Medical Staff" last dated January 2019 revealed "Section 3 Delineation of Clinical Privileges-Every physician practicing at this Hospital by virtue of Staff membership...shall in connection with such practice, be entitled to exercise on those clinical privileges specifically granted to him/her by the Quality and Safety Committee of the Board (pursuant to a specific delegation of authority from the Board of Trustees) and as recommended by the Credentials Committee and Executive Committee."

Review on May 2, 2019, of CF6, a physician revealed a medical staff reappointment approval from March 13, 2019, through March 12, 2021. Further review revealed the privileges for this reappointment had not been requested by the the physician.

Review on May 2, 2019, of CF7, a certified registered nurse practitioner revealed medical staff appointment approval from January 4, 2019, through January 3, 2021. Further review revealed the requested privileges were not signed as approved by the supervising physician.

An interview conducted on May 3, 2019, at approximately 12:40 PM with EMP6 and EMP14 confirmed CF6 had not requested privileges for the reappointment period granted for March 13, 2019, through March 12, 2021. Further interview confirmed the privileges of CF7 had not been approved by the supervising physician listed in the collaborative agreement. EMP14 stated "The privileges requested by CF7 have not been approved as requested by any physician in the facility. I can not offer an explanation of what happen. "I am temporary personnel filling in for this position until the facility can hire a full-time permanent person."


Review of facility policy "Main Line Hospital Quality Improvement Plan" approved June 26, 2017, revealed " Section III. C. As authorized by the QSCB, the MLH Quality Council has the responsibility to continuously assess, measure, and improve the functions of care for both acute and ambulatory patients and attempt to improve processes and systems affecting clinical outcomes. The MLHQSC will prioritize initiatives for hospital-wide and system wide Quality Improvement activities that are designed to improve patient care and outcomes based on... . c. The Health System's priorities for improvement."

Review of the facility's policy "Event Reporting" last revised October 2017 revealed " Definitions: Event: An event is any unplanned occurrences not consistent with the routine care of a patient, routine service of a department, or routine operation of the hospital or entity. It may occur with or without injury-the potential for injury or property damage is sufficient to require an event report... Reporting Requirements. 1. All departments within the organization, patient care and non-patient care, are responsible to report patient safety occurrences and potential occurrences to the Hospital PSO (Patient Safety Officer/PSS (Patient Safety Specialist) through the event reporting process. Data regarding Patient Safety Occurrences will be aggregated and reported to the PSO/PSS who will in turn report to the PSC (Patient Safety Committee). The information will be analyzed and further patient safety activities will be determined as appropriate."

A review of facility policy "Admission Criteria" last revised May 2018 revealed "PURPOSE: To outline general and disability-specific criteria for admission to Bryn Mawr Rehab Hospital as an inpatient. ...Patients being considered for admission should have: 1. An impairment of function with problems in two or more of the following area: self care, cognitive function, mobility, bowel and bladder management, pain, safety precautions and the need for rehabilitation therapy hours with 24-hour nursing care. ... If the patient is unable to follow and retain instructions, there is reasonable expectation that either their mental status will improve sufficiently during the rehabilitation program for the patient to achieve the established goals, or the family will participate in the rehabilitation program in order to achieve the family's goal. ...II. Neurocognitive Division A. Stroke Program...B. Brain Injury Program...III Orthomedical Division. A. Medical Rehab/Program...B. Spinal Cord Disorders Program."

1. Review of MR1 revealed an admission date of July 3, 2017 and a deceased date of July 16, 2017. Further review revealed MR1 was found with a dislodged tracheostomy tube (a tube placed in an opening in the neck for breathing), unresponsive and without a pulse. Further review of MR1 revealed resuscitation efforts were unsuccessful. An incident report was requested, the facility was unable to produce an incident report.

An interview conducted on May 3, 2019, at 10:48 AM with EMP15 confirmed the incident was not reported to the "Division of Acute and Ambulatory Care." EMP 15 stated" We did not consider it to be a serious event; it was something that just happen during the course of the patient's hospitalization. The administration did not report the event to the Governing Board, nor did we complete an investigation into why the event occurred. It was not perceived as a reportable event. This patient was in the process of being weaned from the tracheostomy."
________________

Based on review of facility policy, documents and interview with staff (EMP), it was determined the facility failed to ensure compliance with acceptable nationally recognized hand hygiene standards were maintained for the provision of quality patient care.

Findings include:

Review of document "Guidelines for Hand Hygiene in Health-Care Settings. Recommendations of the Healthcare Infection Control Practices Advisory Committee and the ....Hand Hygiene Task Force" last reviewd November 5, 2015, revealed "In the case of improving hand hygiene, the improvement goal typically is to bring compliance above 95% by introducing system improvements, behavioral incentives, education, and other interventions described elsewhere in these guidelines."

Review of the facility policy "Infection Prevention and Control Annual Plan" last approved on April 12, 2019, revealed " Scope of the Program... . 2. The Program is a system-wide patient safety component involving all acute care facilities, rehabilitation hospital... The Program includes the:... (c) Evaluation and Improvement Activities. This includes continuous review of the goals and activities of each hospital's program followed by improvement activities. As indicated by the review process the effectiveness of the Plan is evaluated annually, and whenever risks significantly change. ..Risks...2. Risks are reviewed and identified at least annually, and whenever significant changes occur with input from, at a minimum, infection prevention personnel, medical staff, nursing and leadership...Transmission of Infections...D.2. Hand Hygiene (a) The hospital has a competency-based training program for hand hygiene. 1. Training is provided to all healthcare personnel, including all ancillary personnel not directly involved in patient care but potentially exposed to infectious agents (e.g. food tray handlers, housekeeping, and volunteer personnel)...iv. audits are conducted routinely to monitor and document adherence to hand hygiene..vii. Hand hygiene policy-https://mainlinehealth.ellucid.com/documents/view14912/36647."

2. On May 1, 2019, at 2:30 PM, EMP2, EMP4 and EMP5 presented the survey team with audit documentation "Percentage (%) Of Staff Observed Compliant with Hand Hygiene-By Position September 2018 to April 2019 For Bryn Mawr Rehab". Further review of the documentation revealed the Environmental (EVS) Staff completed a Hand Hygiene audit with compliance results of 67% and the Patient Care Technician (PCT) Staff completed a hand hygiene audit with compliance results of 87%. The facility was unable to produce documentation that the results of the audits had been communicated to the department leadership and or EVS and PCT staff.

An interview conducted on May 1, 2019, at 2:30 PM with EMP2, EMP4 and EMP5 confirmed the Environmental Staff completed a hand hygiene audit with compliance results of 67% and the Patient Care Technician Staff completed a Hand Hygiene audit with compliance results of 87%. In addition, EMP11 and EMP2 confirmed that the Hand Hygiene audit compliance results had not been communicated to the Environmental Services Director and the Director of Nursing to be addressed for non-compliance.

On May 1, 2019, at 2:40 PM, EMP2, EMP4 and EMP5 presented the survey team with audit documentation " Percentage (%) Of Staff Observed Compliant with Hand Hygiene-By Position May 2018 to April 2019 for Bryn Mawr Rehab". Further review of the documentation revealed the Neuro Rehab Center completed a Hand Hygiene audit compliance results of 40%. The facility was unable to produce documentation that the results of the audits had been communicated to the department leadership and or Neuro Rehab Center staff.

FORM AND RETENTION OF RECORDS

Tag No.: A0438

Based on review of facility policy,Bylaws, documents and interview with staff (EMP) it was determined the facility failed to ensure medical record deficiencies were completed within 30 days of discharge for 13 applicable medical records.

Findings include:

Review of the facility's policy "Medical Record" last revised March 2019 revealed "Section I. A. Delinquent Records. Any medical record not completed within 30 days after discharge shall be considered delinquent. Physicians with delinquent records shall be subject to Administrated Suspension of admitting privileges and possible relinquishment of clinical privileges as per Rules and Regulations of the Medical Staff."

Review of the facility's "Rules and Regulations of The Medical Staff " last approved January 2016, revealed "... Section II: B. 11. All chart deficiencies must be completed within 30 days of discharge per the Pennsylvania Department of Health and the Medical Staff Rules and Regulations. Those that remain incomplete more than 30 days after discharge shall be considered delinquent and the physician shall be subject to a monetary penalty. Any physician who is delinquent for failure to complete medical records three or more times within the physical year (a rolling 12 month period) shall be deemed a chronic offender. Chronic offenders shall have an assessment placed on their annual dues equal to $10 for each chart on the delinquent list subsequent to the establishment of their chronic offender status. Additional dues assessment will be levied cumulatively on a bi-weekly basis until all delinquent records are completed."

Review of the facility's "Bylaws of the Medical Staff" dated January 2019 revealed "Section 4:...(c) Administrative Suspension-failure to comply with the Hospital's MLHS (Main Line Health System), and BMRH (Bryn Maw Rehabilitation Hospital) Medical Staff policies a Staff member may be placed on administrative suspension and member's clinical privileges suspended until compliance is met or an approved exception is obtained. ...(e) Enforcing Suspensions-It shall be the duty of all Staff appointees to cooperate with the President of the Hospital, the Vice President of Medical Affairs and the President of the Medical Staff in enforcing all suspensions."

Review on May 3, 2019, of facility document "Rehab Delinquent Charts as of May 3, 2019," revealed:

One (1) Medical Record delinquent as of September 26, 2018, omission of a signature for a verbal order, by OTH1, a physician assistant.

Seven (7) Medical Records delinquent as of February 1, 4, 7, 10, 18, 22, 28, 2019, omission of co-signature and signatures for a progress note and medical orders, by OTH2, a physician.

Four (4) Medical Records delinquent as of September 22, 24, 2018, February 18, 2019, and March 25, 2019, omission of signatures and co-signatures for verbal orders, by OTH3, a physician.

One (1) Medical Record delinquent as of March 9, 2019, omission of a signature for a verbal order, by OTH4, a physician.

An interview conducted on May 3, 2019, at 3:15PM with EMP1 and EMP6 confirmed the medical records for the medical staff (OTH1, OTH2, OTH3 and OTH4) as listed were delinquent. EMP1 further confirmed that the facility had failed to send formal notification to each medical staff member and no monetary penalties had been imposed upon each of the medical staff as per the facility's policy. In addition, EMP1 confirmed that the physician staff classified as chronic offenders (OTH2 and OTH3) had not been subject to an assessment placed on their annual dues as per the facility's Medical Staff Rules and Regulations nor had either physician's privileges been adversely affected.

Cross Reference:
482.12 Condition of Participation: Medical Records
482.22(a)(2) Standard: Medical Staff Credentialing
482.24(c)(2) Standard: Content Of Record: Orders Dated and Signed

CONTENT OF RECORD: ORDERS DATED & SIGNED

Tag No.: A0454

Based on a review of facility policy, document and interview with staff (EMP), it was determined that the facility failed to ensure verbal orders were countersigned by a practitioner within seven calendar days according to the facility's policy..

Findings include:

Review of the facility's policy "Medical Record" last revised March 2019 revealed "Section I. A. Delinquent Records. Any medical record not completed within 30 days after discharge shall be considered delinquent. Physicians with delinquent records shall be subject to Administrative Suspension of admitting privileges and possible relinquishment of clinical privileges as per Rules and Regulations of the Medical Staff."

Review of facility policy "Verbal Orders" last revised June 2017 revealed "Oral orders are to be given only under circumstances or when it is impractical for such orders to be written. These orders must be countersigned by a physician within 7 (seven) calendar days of issuance."

Review of facility document" Rehab Delinquent Charts as of May 3, 2019," revealed MR6 with a delinquent verbal order as of September 22, 2018. Further review revealed the verbal order required a physician's signature.

Review of facility document "Rehab Delinquent Charts as of May 3, 2019, revealed MR7 with a delinquent verbal order as of September 24, 2018. Further review revealed the verbal order required a physician's signature.

Review of facility document "Rehab Delinquent Charts as of May 3, 2019, revealed MR8 with a delinquent verbal order as of February 28, 2019. Further review revealed the verbal order required a physician's signature.

Review of facility document "Rehab Delinquent Charts as of May 3, 2019, revealed MR9 with a delinquent verbal order as of March 25, 2019. Further review revealed the verbal order required a physician's signature.

An interview conducted on May 3, 2019,at 3:25 PM with EMP1 confirmed the above findings and revealed "We have not formally addressed any of these delinquency issues formally including the physician signature for the delinquent verbal orders. In addition, EMP1 confirmed the delinquent verbal orders in MR6, MR7, MR8 and MR9 required the signature of OTH3, a physician.

2. Review of facility document "Rehab Delinquent Charts as of May 3, 2019, revealed MR10 with a delinquent verbal order as of September 26, 2018. Futher review revealed the verbal order was written by OTH1, a physician's assistant. Further review revealed the verbal order required a physician's signature.

An interview conducted on May 3, 2019, at approximately 3:27 PM with EMP1 confirmed MR10 had a delinquent verbal order as of September 26, 2018. EMP1 also confirmed that the delinquent verbal order in MR10 required the signature of a physician.

482.24 Condition of Participation: Medical Records Services
482.22(a)(2) Standard: Medical Staff Credentialing
482.24 Standard: (b) Form And Retention Of Records

MAINTENANCE OF PHYSICAL PLANT

Tag No.: A0701

Based on a tour of the facility, observation, facility policy and interview with staff (EMP), it was determined that the facility failed to maintain a clean and safe environment.

Findings include:

1. A tour conducted on April 30, 2019, at 10:40 AM with EMP2 and EMP6 of the 1st floor Spruce patient care unit (Orthopaedic/Spinal) revealed the following observations:

Observation of Room 116 bathroom ceiling light revealed brown matter scattered within the dome of the light. Further observation revealed thick layer of high dust on the overhead bed light unit and the bathroom light unit.

Observation of Room 122 bathroom ceiling light revealed the lighting bulb fixture needed to be replaced. Futher observation revealed a thick layer of high dust on the overhead bed light unit and the bathroom light unit.

An interview conducted on April 30, 2019, at 10:55 AM with EMP2 and EMP6 confirmed the above findings.


2. A tour conducted on April 30, 2019, at 11:05 AM with EMP2 and EMP6 of the 2nd floor Maple patient care unit (Brain Injury) revealed the following observations:

Observation of a hallway water fountain with a large amount of green/white substance on the water sprout.

Observation of Ceiling Vents and the Ceiling Vents in the Dining Room revealed the vent blades contained a thick layer of gray matter.

Observation of the Pantry "Ice Machine" revealed a large amount of a white substance on the machine grates.

Observation of Room 210 (clean room ready to receive a patient) revealed the window blinds were covered with a thick gray matter.

An interview conducted on April 30, 2019, at 11:15 AM with EMP2 and EMP6 confirmed the above findings.

______________

A review of facility policy "Hospital Laundered Items" last revised April 2019, revealed "Laundry Area. The laundry area will be cleaned by environmental services. B. Washing Machines. The washing machine will be cleaned according to the manufacturer's instructions for use. 9. Dryers. The dryer will be cleaned according to the manufacturer's instructions for use. The lint trap will be cleaned after each use. C. Clinical Staff. 3. Clinical staff are responsible for ensuring lint filters on the washing machine and dryer are cleaned between uses and/or according to manufacturer instructions.

A tour conducted on April 30, 2019, at 11:30 AM with EMP2 and EMP6 of the 3rd floor QAK patient care unit (Stroke) revealed the following observations:

Observation of the Laundry Room revealed a thick grayish/black matter covering areas of the back wall of the washer and dryer, grayish-black matter covering the pipes and lines of the washer and dryer unit.

Observation of the Laundry Room dryer revealed a thick a grayish-black matter covering the top of the dryer.

An interview conducted on April 30, 2019, 11:55 AM with EMP2 and EMP6 confirmed the thick grayish-black matter covering the back wall of the washer and dryer and the grayish-black matter covering the pipes and lines connecting to the washer and dryer and the gray matter coating the top of the dryer was dust. EMP2 and EMP6 both stated "The Laundry Room needs to be cleaned by environmental services and the clinical staff.
________________


Based on observation and interview with staff (EMP), it was determined the facility failed to maintain a controlled and safe infrastructure environment for patient safety.

Findings include:

1. A tour of the facility conducted on April 30, 2019, at approximately 10:40 AM to 11:30 AM revealed the following:

Observation of the wood doors of patient rooms 102, 108, 112 and 316 revealed gouged areas within the wooden door frame. Further observation revealed the doorways of rooms 147 and 152 were in need of painting due to paint chipping of the doorways.

An interview conducted on April 30, 2019, at approximately 10:40 AM through 12:15 PM with EMP2 and EMP6 confirmed the wooden doors of patient rooms 102, 108, 112 and 316 had gouged areas within the wooden door frame. Further interview confirmed the doorways of rooms 147 and 152 were in need of painting due to paint chipping of the doorways.

2. Observation of the "Main Entrance" to the facility revealed numerous areas of broken and crumbled pavement exiting the sliding glass door and waiting the sidewalk leading to the main entrance. In addition, further observation during the tour with EMP 2 and EMP6 revealed a discharged patient exiting the main entrance of the facility with a wheel walker accompanied by a family member and staff member. Upon existing the main entrance-sliding glass doors of the facility, the discharged patient experienced loss of balance due to the walker making contact with the broken and crumbled pavement. The family member and staff member further supported the patient at the time of the incident to prevent the patient from falling to the ground.

An interview conducted on April 30, 2019, at approximately 1:15 PM with EMP2 and EMP 6 confirmed the pavement beyond the facility's main entrance-sliding glass doors and the pavement of the sidewalk leading to the main entrance was in need of repair. EMP6 presented the survey team with a quote for repairs obtained by the facility from a contractor, quote dated April 13, 2019 for pavement replacement at the front (main) entrance, front (main) sidewalk, Garden Area (Herrace) and the Ambulance Entrance. EMP2 further stated the facility administration was still in the process of reviewing the quote outlining the repairs needed.


Cross Reference:
482.13(c)(2): Patient Rights: Care in Safe Setting