Initial Comments:
This report is the result of a Special Monitor survey conducted on Febraury 15, 2024, and completed offsite on March 26, 2024, at St. Luke's Hospital - Upper Bucks Campus. It was determined that the facility was not in compliance with the requirements of the Pennsylvania Department of Health's Rules and Regulations for Ambulatory Care Facilities, Annex A, Title 28, Part IV, Subparts A and F, Chapters 551-573, November 1999.
Plan of Correction:
103.34 LICENSURE
PERSONNEL POLICIES AND PRACTICES
Name - Component - 00
103.34 Personnel policies and
practices
The governing body, through the
chief executive officer, shall ensure
that personnel policies and practices
which adequately support sound patient
care are established and maintained.
The policies shall be reduced to
writing and made available to all
employes, and they shall be reviewed
periodically, but no less often than
two years. The date of the most recent
review shall be indicated on the
written policies. A procedure shall be
established for notifying employes of
changes in the established personnel
polices.
Observations:
Based on review of facility policy and procedures, medical records (MR) and interview with staff (EMP) it was determined the facility failed to follow its established policy to report potential code of conduct compliance issues.
Findings include:
Review on February 15, 2024, of facility policy "Code of Conduct" dated 4/7/2022, revealed "... If you have a work place concern, or if you believe there have been potential violations of rules, policies, laws or our Code you should report it ... Reporting Concerns-
Individuals should promptly report concerns or misconduct as soon as it happens. All reported concerns are taken seriously and investigated appropriately ..."
Review on February 15, 2024, of facility policy "Reporting of Potential Compliance Issues" dated 12/11/23 revealed "... Potential Compliance Issue - A suspected violation, either presumed intentional or unintentional, of the St. Luke ' s Code of Conduct, policies and procedures, or laws and regulations relating to Federal, State of Locally funded health care programs ... Policy. A. All Employees and those associate with St. Luke ' s are expected to report Potential Compliance Issues, and/or Reportable Events immediately upon discovery or notification of the same ..."
During an interview on February 15, 2024, with EMP3 revealed a patient's IV (MR1) became dislodged during care, and was restarted by a member of the anesthesia department at the request of the patient's family, and revealed the member of the anesthesia department did not notify nursing staff [they] restarted the IV. Further interview revealed a physician order was obtained to use the new IV because of concerns the IV was started by a family friend that works at St. Luke's.
During an Interview on February 15, 2024, with EMP1 revealed they were a member of the anesthesia department, and revealed they were a friend of the family to the patient in MR1 and not of member of the patient's care team. Further interview revealed the family of the patient in MR1 called EMP1 and requested EMP1 to restart the IV for the patient after it became dislodged.
Review of nursing documentation "IV Assesment" dated December 21, 2023, at 3:00 PM revealed "... Placement Date: 12/21/23 [initialed by EMP1], Placement Time: 3:00 PM initialed by EMP1] ..."
Review of physican documention "Orders" dated Decembe 21, 2024, at 18:02 PM revealed "Order comments: Pt had a new IV placed by anesthesiology on 12/21/23, IV is functioning well. Can keep in place and use for IV meds .."
Review of MR1 on February 15, 2024, revealed the patient was admitted for medical care that did not require anesthesia services.
Interview on February 15, 2024, at approximately 1:45 PM with EMP1 confirmed they were requested by the family to restart the patient's IV. EMP4 confirmed nursing staff did not request assistance from the anesthesia department to restart the patient's IV. EMP1 confirmed "I was doing them (the family) a favor."
Interview on February 15, 2023, at approximately 3:00 PM with EMP3 confirmed the patient's IV was dislodged during patient care and confirmed [they] requested a team member working on the nursing unit restart the patient's IV. EMP3 confirmed a physician's ordered was obtained to use the new IV because the routine IV protocol was not followed and a the IV was started by a friend of the family that worked at St. Luke's. Further interview confirmed EMP3 did not report a potential code of conduct violation.
____________
Based on review of facility policy, facility documents and interview with staff (EMP) it was determined the facility failed to follow established policy to provide training to their contracted anesthesia providers for 1 of 3 credential files reviewed. (CF1).
Findings include:
1.Review on February 15, 2024, of the contract service agreement between "St. Luke's University Health Network and Anesthesia Specialists of Bethlehem and Anesthesia Specialists of Warren Hospital" date July 1, 2021, revealed "... Amended and Restated Agreement for Services ... Standards for the Services ... the Providers shall perform the Services under the Direction of the Senior Vice President of Medical and Academic Affairs of the Network and/or designee and in accordance with ... (7) the applicable rules, policies and procedures of the Network and any Hospital at which the Provider provides Services ..."
Review on Febraury 15, 2024, of facility policy "St. Luke's Code of Conduct" dated 4/7/2022, revealed "The Code is distributed ... to all employees annually during general compliance training ..."
Review on February 15, 2024, of facility document "Enterprise Training Report" dated February 14, 2024, revealed no documention CF1 completed the compliance training.
Interview via email communication with EMP2 dated February 21, 2024, revealed "Per our Chief Compliance Officer, the CRNA's are not required by their contract to complete the compliance training." Further interview confirmed the contract with the anesthesia group is current.
Plan of Correction:Implementation of the plan of correction will be the responsibility of the Chief Compliance and Privacy Officer. All staff working at the Upper Bucks campus will complete general compliance education. This includes all anesthesia providers and staff involved in the noted event. The education will explain and emphasize the Code of Conduct and how to report compliance issues. The key components of the Health Insurance Portability and Accountability Act (HIPAA) will be reviewed and will stress that providers and staff may only access a record when a 'current, legitimate, work-related need exists'. Moving forward, the anesthesia staff will complete compliance education annually along with the staff. The Chief Compliance and Privacy Officer or designee will monitor education completion by anesthesia providers and staff and will track and trend all compliance issues occurring at the Upper Bucks campus. Individual members of the anesthesia team will be counseled by network anesthesia leadership. Staff will be counseled by their department manager. Data collected regarding education completion and identified compliance issues will be shared/discussed with the Network Chair of Anesthesia who will have ultimate responsibility for the plan of correction.
115.27 LICENSURE
CONFIDENTIALITY OF MEDICAL RECORDS
Name - Component - 00
115.27 Confidentiality of medical
records
All records shall be treated as
confidential. Only authorized
personnel shall have access to the
records. The written authorization of
the patient shall be presented and
then maintained in the original record
as authority for release of medical
information outside the hospital.
Observations:
Based on review of facility policy, medical records (MR) and interview with staff (EMP) it was determined the facility to follow its established policy for access to medical records for 1 of 1 medical records reviewed. (MR1)
Findings include:
Review on February 15, 2023, of facility policy "Access Control Policy," reviewed 3/7/2023, revealed "... Scope. This policy applies to any individual who is responsible for an account or any form of access, including but not limited to workforce members, trainees, volunteers, students, contractors, vendors and anyone else given access to SLUHN ... Access Control Privileges. Access rights and privileges to SLUHN information systems, network domains, and cloud services must be allocated based on the specific requirement of a user's SLUHN role/function rather than on their status ..."
Review on February 15, 2024, of MR1 nursing documentation "Flowsheets" dated December 21, 2023, at 3:11 PM revealed "... IV Properties. Placement date: 12/23/23, [initialed by EMP1] ..." Further review of MR1 revealed no documentation the patient was admitted for care that required surgical services or anesthesia services.
Interview on February 15, 2024, at approximately 10:30 AM with EMP1 confirmed they placed the IV for the patient in MR1 on December 21, 2023, and confirmed they accessed MR1 to document the placement of IV. Further interview with EMP1 confirmed they were not a member of the patient's care team.
Plan of Correction: Implementation of the plan of correction will be the responsibility of the Chief Compliance and Privacy Officer. All staff working at the Upper Bucks campus will complete general compliance education. This includes all anesthesia providers and staff involved in the noted event. The education will explain and emphasize the Code of Conduct and how to report compliance issues. The key components of the Health Insurance Portability and Accountability Act (HIPAA) will be reviewed and will stress that providers and staff may only access a record when a 'current, legitimate, work-related need exists'. Moving forward, the anesthesia staff will complete compliance education annually along with the staff. The Chief Compliance and Privacy Officer or designee will monitor education completion by anesthesia providers and staff and will track and trend all compliance issues occurring at the Upper Bucks campus. Individual members of the anesthesia team will be counseled by network anesthesia leadership. Staff will be counseled by their department manager. Data collected regarding education completion and identified compliance issues will be shared/discussed with the Network Chair of Anesthesia who will have ultimate responsibility for the plan of correction.
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