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Based on reviews of facility documents, medical records (MR) and interviews with staff (EMP), it was determined that the governing body failed to assume responsibility to provide oversight and accountability by failing to ensure adverse events related to surgical procedures performed at the facility were reviewed with followed-up on at the Mortality and Morbidity Meetings (A0289), the facility also failed to ensure the Quality Assurance Performance Improvement Plan provided guidance for the method and frequency of data capturing for performance indicators selected by the facility (A0273).

Review of the facility's "2016 Quality and Patient Safety Improvement Plan," approved by the "Governing Body, April 27, 2016," revealed "The SCHC [St. Christopher's Hospital for Children] Quality and Patient Safety Improvement Plan is a description of the organizational, multidisciplinary and systematic quality and safety improvement functions designed to support the Mission, Vision and Values of St. Christopher's Hospital for Children. The purpose of the Quality and Patient Safety Improvement Plan is to identify the organization's systematic approach to improving and sustaining high quality performance through the prioritization, design, implementation, monitoring, and analysis of improvement initiatives ... Assignment of responsibility: Board of Governors Role in the Quality and Patient Safety: The Board of Governors of St. Christopher's Hospital for Children (SCHC) plays an integral role in the leading of the Quality and Patient Safety culture within the organization ... Establish and monitor an executable strategy for quality and patient safety improvement ... Prioritize improvement initiatives and set measureable improvement targets ... reviewing and approving the SCHC Patient Safety Plan ... CQOEPS (Center for Quality, Operational Excellence and Patient Safety) Improvement Responsibilities ... Provide adequate data management guidance to facilitate the collection, management and analysis of data needed for improvement ... Assure the standardization of quality improvement initiatives across the organization ... Measuring and Monitoring Quality: The Quality and Patient Safety Improvement Initiatives must be objective and data driven ... Data collection is systematic and is used to: a.) establish a performance baseline; b) Describe the process performance stability; c) Describe the dimensions of performance relevant to functions, processes, and outcomes."


Review of facility document " SCHC Medical Staff Rules and Regulations, reviewed and approved May 24, 2016," revealed " Section VI. Committees ... 4. A. General Requirements: each medical staff committee shall address the following: 1. Quality Patient Safety and Compliance Monitoring ... 3. Responsibilities and Management: c. refer identified issues that are outside the function of the committee to another committee, individual or other group who can address the issues appropriately ... Evaluate the quality of care provided to patients receiving surgical care ... 9. Monitor outcomes associated with care delivery in surgical services and assist in identifying opportunities for improvement ... Reporting Responsibilities: CQOEPS Quality Metrics: Operative or other procedures that place a patient at risk of disability or death, all significant discrepancies between pre-operative and post-operative diagnosis, including pathological diagnosis, adverse events related to using anesthesia , surgical appropriateness, surgical site infections, unplanned returns to the Operating Room (OR) "

Interview on October 12, 2016, with EMP5 confirmed that the frequency and method of data collection is not indicated in the Quality assurance Performance Improvement Plan.

Interview on October 14, 2016 with EMP6 confirmed the case review that is to take place in the Mortality and Morbidity meeting has not been completed.

cross reference with:
482.21(b)(3) Data Collection and Analysis
482.21(c)(2) Patient Safety, Medical errors & Adverse Events

Based on reviews of policies and procedures, medical records (MR) and interviews with staff (EMP), it was determined that the facility failed to ensure the timely referral of patient concerns regarding quality of care or premature discharge to the appropriate Utilization and Quality Control Quality Improvement Organization for two of 30 medical records reviewed (MR21 and MR24).

Findings include:

Review on October 13, 2016, of facility policy "Medicare Beneficiaries Appeal Rights" last reviewed, January 2013, revealed "...IV Policy: 1) Hospitals must issue the Important Message for Medicare (IM) within two (2) days of admission and must obtain the signature of the beneficiary or his or her representative. Hospitals must also deliver a copy of the signed notice to each beneficiary not more than two (2) days before the day of discharge. Follow-up notice is not required if delivery of the initial IM falls within two (2) calendar days of discharge, if the beneficiary is being transferred from one inpatient hospital setting to another inpatient hospital setting, or when a beneficiary exhausts Part A hospital days. Hospitals must retain a copy of the signed notice."

1) Review on October 13, 2016, of MR21, revealed the patient was admitted on August 19, 2016, and discharged on August 25, 2016. The patient was given the IM on August 19 and again on August 22, three days before discharge.

Interview on October 13, 2016, at 10:30 AM, with EMPBarbara Hicks-Quality Coordinator confirmed that the patient was not given the IM within two days before discharge.

2) Review on October 13, 2016, of MR24, revealed the patient was admitted on July 6, 2016, and discharged on July 9, 2016. The patient was given the first IM on July 6. The second IM was not given to the patient.

Interview on October 13, 2016, at 10:30 AM, with EMPBarbara Hicks-Quality Coordinator confirmed that the patient was not given the second IM within two days before discharge.

Based on reviews of policies and procedures, medical records (MR) and interviews with staff (EMP), it was determined that the facility failed to ensure that the patient's right to have a family member or representative of his or her choice notified of admission to the hospital for five of ______ of medical records reviewed (MR9, MR10, MR15, MR23 and MR25).

Findings include:

Review on October 13, 2016, of facility policies failed to reveal a policy to notify the patient's family member or representative of his or her admission to the hospital.

Review on October 13, 2016, of MR9, MR10, MR15, MR23 and MR25, revealed no documented evidence that the patient's family member or representative was notified of his or her admission to the hospital.

Interview on October 13, 2016, at 10:30 AM, with EMPBarbara Hicks-Quality Coordinator confirmed that the facility did not have a policy to notify the patient's family member or representative of his or her admission to the hospital. Further interview with EMPBarbara Hicks-Quality Coordinator confirmed that MR9, MR10, MR15, MR23 and MR25 did not contain any documented evidence that the patient's family member or representative was notified of his or her admission to the hospital.

Based on review of facility policies, medical records (MR) and interview with staff (EMP), it was determined the facility failed to use restraints in accordance with a written modification to the patient's plan of care in four of five restraint medical records reviewed (MR1, MR2, MR4 and MR5).

Findings include:

Review on October 13, 2016, of facility policy "Restraints: Treatment Guidelines," dated October 2012, revealed "V. Procedure: A. Methodology ... 7. When a restraint is implemented, the patient's plan of care must be modified to reflect this change ... C. Documentation ... 1 ... d. Use of restraints must be addressed in the patient's modified plan of care."

1) Review on October 12, 2016, of MR1's Nursing progress notes revealed the patient was in an enclosed bed restraint on September 21, 2016, through September 24, 2016.

Interview with EMP2 on October 12, 2016, at 11:33 AM, confirmed there was documented evidence in MR1 the patient was placed in an enclosed bed restraint on September 21, 2016, through September 24, 2016. EMP1 further confirmed there was no written modification to the patient's plan of care.

2) Review on October 13, 2016, of MR2's Nursing progress notes revealed the patient was in bilateral soft limb restraints on September 14, 2016 at 3:00 PM, through September 17, 2016.

Interview with EMP1 on October 13, 2016, at 10:25 AM, confirmed there was documented evidence in MR2 the patient was placed in restraints on September 14, 2016 at 3:00 PM, through September 17, 2016. EMP1 further confirmed there was no written modification to the patient's plan of care.

3) Review on October 13, 2016, of MR4's physician orders and nursing progress notes revealed the patient was restrained with bilateral upper extremity soft belts on July 21, 2016.

Interview with EMP1 on October 13, 2016, at 11:45 AM, confirmed there was documented evidence in MR4 the patient was placed in restraints on July 21, 2016. EMP1 further confirmed there was no written modification to the patient's plan of care.

4) Review on October 13, 2016, of MR5's physician orders and nursing progress notes revealed the patient was restrained with bilateral upper extremity soft limbs on February 3, 2015.

Interview with EMP1 on October 13, 2016, at 12:05 PM, confirmed there was documented evidence in MR5 the patient was placed in restraints on February 3, 2015. EMP1 further confirmed there was no written modification to the patient's plan of care.

Based on review of facility policies, medical records (MR) and interviews with staff (EMP), it was determined the facility failed to use restraints in accordance with physician or other licensed independent practitioners' orders for two of five restraint medical records reviewed (MR1 and MR2).

Findings include:

Review on October 13, 2016, of facility policy "Restraints: Treatment Guidelines," dated October 2012, revealed "V. Procedure: A. Methodology ... 2. Document the physician's order for restraint on the Physician's Order Sheet for Restraint ... C. Documentation 1. Each episode of restraint use shall be documented in the patient's medical record, and shall include but not be limited to: ... b. Relevant orders for use of restraints ..."

Review on October 12, 2016, of MR1's Nursing progress notes revealed the patient was in an enclosed bed restraint on September 21, 2016, through September 24, 2016.

Review on October 12, 2016, of MR1's Physician Orders revealed there was no physician or other licensed independent practitioner's orders for the use of the enclosed bed restraint.

Interview with EMP2 on October 12, 2016, at 11:33 AM, confirmed there was documented evidence the patient was placed in an enclosed bed restraint on September 21, 2016, through September 24, 2016. EMP1 further confirmed there was no physician or other licensed independent practitioner's orders for the use of these restraints.

Review on October 13, 2016, of MR2's Nursing progress notes revealed the patient was in bilateral soft limb restraints on September 14, 2016 at 3:00 PM, through September 17, 2016.

Review on October 13, 2016, of MR2's Physician Orders revealed there was no physician or other licensed independent practitioner's orders for the use of these restraints.

Interview with EMP1 on October 13, 2016, at 10:25 AM, confirmed there was documented evidence the patient was placed in restraints on September 14, 2016 at 3:00 PM, through September 17, 2016. EMP1 further confirmed there was no physician or other licensed independent practitioner's orders for the use of these restraints.

Based on a review of facility policies, medical records (MR) and interviews with staff (EMP), it was determined the facility failed to use alternatives or other less restrictive interventions attempts prior to the use of restraints in two of five restraint medical records reviewed (MR2, and MR3)

Findings include:

Review of facility policy "Restraints: Treatment Guidelines," dated October 2012, revealed "... C. Documentation 1. Each episode of restraint use shall be documented in the patient's medical record, and shall include but not be limited to: ... b. Relevant orders for use of restraints, including least restrictive intervention ..." This policy did not address the use of alternatives prior to the use of restraints.

Review on October 13, 2016, of MR2's Nursing progress notes revealed the patient was in bilateral soft limb restraints on September 14, 2016 at 3:00 PM, through September 17, 2016.

Review on October 13, 2016, of MR2's Physician Orders revealed there was no physician or other licensed independent practitioner's orders for the use of these restraints.

Further review on October 13, 2016, of MR2 revealed no documented evidence that alternatives or other less restrictive interventions were attempted prior to the use of these restraints.

Interview with EMP1 on October 13, 2016, at 10:02 AM, confirmed there was documented evidence the patient was placed in restraints on September 14, 2016 at 3:00 PM, through September 17, 2016. EMP1 further confirmed there was no documented evidence that alternatives or other less restrictive interventions were attempted prior to the use of these restraints in MR2.

Review on October 13, 2016, of MR3's physician orders and nursing progress notes revealed the patient was restrained with bilateral upper extremity handmittens on May 19, 2016.

Further review on October 13, 2016, of MR3 revealed no documented evidence that alternatives or other less restrictive interventions were attempted prior to the use of these restraints.

Interview with EMP1 on October 13, 2016, at 11:00 AM, confirmed there was documented evidence the patient was placed in restraints on May 19, 2016. EMP1 further confirmed there was no documented evidence that alternatives or other less restrictive interventions were attempted prior to the use of these restraints in MR3.

Based on review of policies and procedures, medical records (MR) and interview with staff (EMP), it was determined that the facility failed to document that each patient (or support person) was informed of their visitation rights for 19 of ______ medical records reviewed (MR6, MR7, MR8, MR9, MR10, MR11, MR12, MR13, MR14, MR15, MR16, MR17, MR18, MR19, MR20, MR21, MR22, MR24, and MR25).

Findings include:

Review on October 12, 2016, of facility policy "Visitation Policy" last revised December 2013, revealed "...1) Inform each patient (or support person) of his or her visitation rights, including any clinical restriction on such rights, when he or she is informed of his or her other rights under this section. 2) Inform each patient (or support person) of the right, subject to his or her consent, to receive the visitors whom he or she designates, including, but not limited to, a spouse, a domestic partner (including same sex domestic partner), other family member, or a friend, and his or her right to withdraw or deny such consent at any time. 3) Inform each patient of the right to designate a support person that may include, but not be limited to, a spouse, a domestic partner (including same sex domestic partner), other family member, or a friend. This support person will be authorized to stay with the patient 24 hours a day. ..."

Review on October 12-13, 2016, of MR6, MR7, MR8, MR9, MR10, MR11, MR12, MR13, MR14, MR15, MR16, MR17, MR18, MR19, MR20, MR21, MR22, MR24, and MR25, revealed no documentation that each patient (or support person) was informed of their visitation rights.

Interview on October 13, 2016, at 10:30 AM, with EMPBarbara Hicks-Quality Coordinator confirmed that MR6, MR7, MR8, MR9, MR10, MR11, MR12, MR13, MR14, MR15, MR16, MR17, MR18, MR19, MR20, MR21, MR22, MR24, and MR25 did not contain documentation that the patient's visitation rights were provided to the patient (or support person).

Based on a review of facility documents and interviews with staff (EMP), it was determined that the facility failed to establish an ongoing Quality Assessment Performance Improvement (QAPI) program that included a method and frequency of data collection for the hospital-wide quality program and failed to include the method and frequency of data collection in one of two quality indicators reviewed. (Extracorporeal Membrane Oxygenation Perfrormance Improvement).

Findings include:

Review of the facility's "2016 Quality and Patient Safety Improvement Plan," approved by the "Governing Body, April 27, 2016," revealed "The SCHC [St. Christopher's Hospital for Children] Quality and Patient Safety Improvement Plan is a description of the organizational, multidisciplinary and systematic quality and safety improvement functions designed to support the Mission, Vision and Values of St. Christopher's Hospital for Children. The purpose of the Quality and Patient Safety Improvement Plan is to identify the organization's systematic approach to improving and sustaining high quality performance through the prioritization, design, implementation, monitoring, and analysis of improvement initiatives ... Assignment of responsibility: Board of Governors Role in the Quality and Patient Safety: The Board of Governors of St. Christopher's Hospital for Children (SCHC) plays an integral role in the leading of the Quality and Patient Safety culture within the organization ... Establish and monitor an executable strategy for quality and patient safety improvement ... Prioritize improvement initiatives and set measureable improvement targets ... reviewing and approving the SCHC Patient Safety Plan ... CQOEPS (Center for Quality, Operational Excellence and Patient Safety) Improvement Responsibilities ... Provide adequate data management guidance to facilitate the collection, management and analysis of data needed for improvement ... Assure the standardization of quality improvement initiatives across the organization ... Measuring and Monitoring Quality: Quality and Patient Safety Improvement Initiative must be objective and data driven ... Data collection is systematic and is used to: a.) establish a performance baseline; b) Describe the process performance stability; c) Describe the dimensions of performance relevant to functions, processes, and outcomes."

Review on October 13, 2016, of the facility document "2016 Quality and Patient Safety Improvement Plan, approved April 27, 2016, " revealed no provisions for the methodology of data data collection and the frequency of data collection for facility-wide and department Performance Improvement indicators.

Review on September 13, 2016, of the performance improvement indicators for the ECMO program revealed " Quality Management Plan 2016-7(since September 2016) Data Collection for 2016. Data collection: 1. Number of days of narcotic use after ECMO; 2. Presence and length of and identified abstinence syndrome; 3. MRI ' s done at discharge for neonatal ECMO patients. Further review revealed no documented evidence for the frequency and method of data collection for the indicators.

Interview on October 13, 2016, at 2:40 PM with EMP9 confirmed the provision for the frequency and method of data collection was not indicated in the hospital-wide Quality Plan or the ECMO performance improvement indicators.

cross reference with:
482.12 Condition of Participation: Governing Body

Based on review medical records (MR), facility documents and interview with staff (EMP), it was determined that the facility failed to adequately analyze and follow-up adverse events related to surgical procedures performed at the facility for four of four medical records reviewed (MR27, MR28, MR29, MR30).


Findings include:

Review on October 12, 2016, of facility's "2016 Quality and Patient Safety Improvement Plan," approved by the "Quality Improvement Committee"April 27, 2016, revealed "... 2016 Quality and Patient Safety Improvement Plan, St. Christopher's Hospital for Children (SCHC) is committed to improving the safety and quality of care and services for the patients and communities it serves ... Assignment of Responsibility: Board of Governors Role in Quality and Patient Safety: The Board has the responsibility of overseeing progress toward achieving organization-wide goals for quality and patient safety ... Medical Executive Committee (MEC) Role in Quality and Patient Safety:The Medical Staff Executive committee of SCHC receives, analyzes and acts on quality and safety improvement findings ... CQOEPS Quality Improvement Responsibilities: CQOEPS is made up of hospital and medical staff representation and is responsible for maintaining the quality vision of the organization ... receive and review reports from MEC Committees, hospital committees, clinical service lines and departments ...Critically analyze reports received, recommend actions and ensure follow-up until satisfactory conclusion is achieved.


Review of facility document "SCHC Medical Staff Rules and Regulations, reviewed and approved May 24, 2016," revealed "Section VI. Committees ... 4. A. General Requirements: each medical staff committee shall address the following: 1. Quality Patient Safety and Compliance Monitoring ... 3. Responsibilities and Management: c. refer identified issues that are outside the function of the committee to another committee, individual or other group who can address the issues appropriately ... M. Surgical Care Evaluation Committee: Description: Assure the quality of care for surgical patients through the development of policy and procedures, quality improvement programs ... Committee Responsibilities: 2. Evaluate the quality of care provided to patients receiving surgical care ... 9. Monitor outcomes associated with care delivery in surgical services and assist in identifying opportunities for improvement ... Reporting Responsibilities: CQOEPS Quality Metrics: Operative or other procedures that place a patient at risk of disability or death, all significant discrepancies between pre-operative and post-operative diagnosis, including pathological diagnosis, adverse events related to using anesthesia , surgical appropriateness, surgical site infections, unplanned returns to the Operating Room (OR) ... "

Review on October 12, 2016, of the "Department of Surgery Meeting Minutes, dated July 25, 2016," revealed the patient in MR27 experienced an adverse advent related to a surgical procedure performed at the facility. A request was made on October 13, 2016, for documentation regarding the outcome of the review. None was provided.

Review on October 12, 2016, of the "Department of Surgery Meeting Minutes, dated July 25, 2016, "revealed the patient in MR28 experienced an adverse event related to pre-surgical management for a procedure performed at the facility. A request was made on October 13, 2016, for documentation regarding the outcome of the review. None was provided.

Review on October 12, 2016, of the "Department of Surgery Meeting Minutes, dated July 25, 2016, revealed the patient in MR29 was transferred to the facility for further treatment and expired. Review of facility documents revealed MR29 case was reviewed and referred to another hospital department, Radiology, for further case review. A request was made on October 13, 2016, for documentation regarding the outcome of the review that was to be completed by the Radiology Department. None was provided.

Review on October 12, 2016, of the "Department of Surgery Meeting Minutes, dated August 22, 2016, revealed the patient in MR30 experienced an adverse event related to a procedure that was performed at the facility. Review of facility documents revealed MR30 case was reviewed and referred to another hospital department, ID (Infectious Diseases) and Infection control, for further case review. A request was made on October 13, 2016, for documentation regarding the outcome of the reviews that was to be completed by ID and Infection Control departments. None was provided.

Interview on October 12, 2016, at 11:50 AM, with EMP5 confirmed there was no documented evidence regarding the outcome of reviews for adverse events presented at the Mortality and Morbidity Meeting.


Cross reference with:
482.12 Condition of Participation: Governing Body