HospitalInspections.org

Based on interview, record review and document review, the facility failed to ensure an effective Governing Body was responsible for the conduct of the hospital and failed to:

-Meet the Condition of Participation of Quality Assurance and Performance Improvement.
(Cross-Reference Tag A 0263).

-Ensure administrative leadership in Quality Assurance and Risk and Patient Safety maintained a program to identify, investigate, analyze and implement preventive actions regarding an incident affecting patient safety.
(Cross-Reference Tag A 0286).

-Ensure a Physician dictated operative reports in a timely manner and repeatedly failed to ensure its Medical Record Analysts identified the missed operative reports via auditing processes.
(Cross-Reference Tag A 0959).

The cumulative effect of this systematic practice resulted in the failure of the facility to deliver statutory-mandated care to patients.

Based on record review, document review and interview, the facility failed to implement and maintain an effective ongoing, hospital wide, data driven quality assessment and performance improvement plan (QAPI) regarding an adverse event. Specifically, the hospital failed to analyze and implement preventive actions following a patient adverse event which a Quality Manager was informed of and failed to document for follow-up (See Tag A 0286).

The effect of these systemic practices resulted in the failure to ensure an effective ongoing, hospital wide, data driven quality assessment and performance improvement plan implementation in the delivery of care to patients.

Based on interview, record review, and document review, the hospital failed to track and analyze a patient adverse event in a timely manner for one of 30 sampled patients (Patient #1).

Findings:

Patient #1

Patient #1 was admitted on 01/17/2020 with diagnoses including abdominal pain and perforated appendix.

On 10/22/2020 at 9:52 AM the Pulmonologist revealed on 01/23/2020, Patient #1 was in the Intensive Care Unit. The patient had developed an acute kidney injury secondary to low perfusion from a deep vein thrombosis (DVT) and a pulmonary embolism. The patient required dialysis for decreasing urinary output.

On 01/23/2020, the Pulmonologist placed a hemodialysis catheter (a type of central venous catheter with a thick diameter). The Pulmonologist explained the catheter was to be placed in the right internal jugular vein in the neck, and then threaded through the venous circulation to its final position in the superior Vena Cava (a large vein in the chest near the heart). The Pulmonologist reported no further contact with the patient after the procedure.

In April 2020, another physician made the Pulmonologist aware of the issue of the venous catheter being inserted into the carotid artery. The Pulmonologist reported the hospital had placed no restrictions on the provider's hospital privileges.

On 10/21/2020 at 11:47 AM, the Cardiovascular Thoracic surgeon recalled being consulted for Patient #1 on 01/29/2020. The patient had developed left-sided deficits with ischemic strokes, and a Computerized Tomography (CT) scan revealed a central venous catheter was positioned inside the patient's right carotid artery. The Cardiovascular Thoracic surgeon explained a venous catheter should never be in an artery. The Cardiovascular Thoracic surgeon performed the surgery to remove the central venous catheter from the artery on Patient #1. The surgeon explained the artery was cleanly cannulated (the insertion of a tube into a vessel) and "we pulled the item out" intact. The depth from the skin to the artery was about 8 - 10 centimeters (cm). The catheter had two lumens (channels). The surgeon verbalized blood clots probably came off the tip of the catheter which could have caused the stroke. The surgeon explained the insertion of the central venous catheter into the carotid artery was a serious and uncommon medical error. The surgeon did not know if Patient #1's incorrectly placed dialysis catheter was reported to the Medical Executive Committee (MEC) or if an investigation had been done completed.

On 10/23/2020 at 8:59 AM, the Associate Chief Medical Officer indicated the hospital process for adverse events involved an initial report to Risk/Quality managers, followed by a formal review with the Medical Executive Committee (MEC), the Patient Safety Committee, and the Board of Trustees. Adverse events would be referred to the Patient Safety Committee for development of a Root Cause Analysis (RCA) and a process improvement plan. This plan would involve a Serious Event Analysis and actions to take regarding a serious event, and what actions to take to prevent reoccurrence. The final Root Cause Analysis (RCA) must be completed within 45 days after the incident. The action plan was then would be monitored for four months. The involved practitioner would be subject to peer review by other physicians. Sanctions or limitation could be placed on a physician based on what the event is and how much of the event was related to the physician's actions. The MEC could limit privileges, remove privileges, or take a physician off of the staff.

On 10/23/2020 in the morning, the Vice President of Quality verified medical staff including a Radiologist and the Cardiovascular Thoracic surgeon, had become aware of Patient #1's incorrectly placed dialysis catheter. The radiologist detected the incorrect catheter placement on a CT scan on 01/28/2020. The Cardio-Thoracic surgeon became aware on 01/29/2020 when Patient #1 underwent surgery to remove the dialysis catheter.



26251


On 10/23/2020 in the morning, the Vice President of Quality verbalized the Quality/Risk managers were first made aware of the incident on 09/24/2020, when the hospital received a letter from an external party.

On 01/15/2021 at 11:00 AM, a Registered Nurse verbalized the process of adverse event reporting included an entry in Meditech (electronic documentation system) and following the chain of command to report the event. Adverse events were reported when someone was either directly involved in the incident or when the person was functioning as a charge nurse. The first person aware of an adverse event should report it.

On 01/15/2021 at 11:20 AM, an Intensive Care Unit Physician (ICUP) indicated being asked to inform the Pulmonologist of the missing dictation following the placement of the dialysis catheter. The ICUP could not recall exactly who asked or when but verbalized usually it would be someone from the Quality department.

On 01/15/2021 at 3:50 PM, a Radiologist who documented the dialysis catheter was within the right common carotid artery at 5:10 PM on 01/28/2020 verbalized the adverse event was verbally reported (no more than a week afterward) to the Quality Manager assigned to the radiology department at the time of the incident.

On 01/15/2021 at 4:45 PM, the Director of Quality Management (DQM) explained an initial adverse event report did not necessarily require escalation for a full review if there were no paths for improvement. The Quality Management (QM) Module (computer module for reporting) method of initially reviewing adverse events did not necessarily result in the event to be escalated or formally documented. The DQM indicated the Quality Manager referred to by the Radiologist had retired in May of 2020.

Pages 3-4 of the Medical Staff Professional Practice Evaluation document read as follows:

C. All cases requiring single case review will be entered into the Quality Management (QM) Module and will be tracked and trended by Provider and indicator.

G. All cases requiring single case review will have the final conclusions, recommendations, and case or event Code recorded in the QM Module.

The Director of Quality Management acknowledged the policy contradicted not having to document the lowest level, single case review.

On 01/15/2021 at 11:38 AM, the Vice President of Quality verbalized physicians were trained during orientation to report adverse patient events verbally to a Quality Manager. Physicians were not provided access to the electronic incident reporting system and did not enter incident reports into the system. Physicians were not provided access to the incident report system because they were not hospital employees.

On 01/15/2021 in the afternoon, the Vice President of Quality explained Patient #1's dialysis catheter was inserted on 01/23/2020 and was detected by a radiologist on 01/28/2020 to have been incorrectly placed (in the artery versus the vein). The hospital Quality program initiated an investigation of the incident on 09/24/2020. The investigation of the incident was completed and was submitted to Patient Safety Committee on 11/23/2020. An Event Analysis was completed, and the conclusion was submitted to the Patient Safety Committee on 12/09/2020. The conclusion went to the Medical Executive Committee and to the Board of Trustees on 12/17/2020. The Vice President of Quality verbalized not knowing why the Quality Program did not become aware of the incident until approximately seven months after it was detected and reported by the Radiologist. The Vice President of Quality acknowledged incidents should be investigated by the hospital starting within five days of detection.

The Facility Event and Close Call Reporting policy, last approved 05/2019, documented:

A. Policy is intended to minimize risk to patients, non-patients, visitors, and employees through the development and implementation of an event and close call reporting system based upon the affirmative duty of all health care providers and all agents and employees of the licensed health care facility to report events and close calls to the Risk Manager, Patient Safety Director, or to his or her designee.

Based on record review, policy review and interview, the facility failed to ensure a continuous Heparin infusion was titrated in a timely manner and lab draws were spaced out according to policy for 1 of 30 sampled patients (Patient #1).

Findings include:

Patient #1 was admitted on 01/15/2020, with diagnoses including abdominal pain and perforated appendix.

A physician ordered dated 01/21/2020 at 10:22 AM, documented Heparin infusion for deep vein thrombosis/ pulmonary embolism protocol. The electronic medical record showed the order was in effect until 1:30 AM on 1/25/2020.

On 01/22/2020 at 11:33 AM, a partial thromboplastin time (PTT) blood draw revealed a critical test result of 118. At 12:39 PM, the result was verbally verified with a Registered Nurse.

The Adult Continuous Infusion Heparin Protocol revealed for a PTT result greater than 112: Call Provider. HOLD for 60 minutes. Decrease by 200 units/hour.

The Adult Critical Care Flowsheet documented the patient continued with the same infusion rate until the 5:00 PM. The infusion was stopped for an hour and restarted at 6:00 PM, decreasing the infusion rate by 200 units. The medical record lacked documented evidence a nurse contacted a physician according to the protocol and was told to wait over 4 hours before stopping the infusion.

From 12:39 PM to 5:00 PM, roughly 4 hours and 21 minutes elapsed before a nurse adjusted the rate in relation to the critical PTT result. Another rate change occurred after the 11:30 PM result on 01/22/2020.

According to the Heparin protocol, monitoring included obtaining another PTT every 6-hours after an infusion rate change. The medical record showed there was no PTT lab drawn until 11:55 AM on 01/23/2020, twelve plus hours after the 11:30 PM result on 01/22/2020.

On 01/23/2020 at 11:55 AM, a PTT blood draw revealed a test result of 47. At 12:20 PM, the lab entered the result for nurses to assess for rate adjustment.

The Adult Continuous Infusion Heparin Protocol revealed for a PTT result of 47 the nurse should have increased the infusion rate by 100 units.

The Adult Critical Care Flowsheet documented the patient continued to receive the same infusion rate until the 2:30 PM, 2 hours beyond the availability of the result to adjust the rate.

On 01/24/2020 to 01/25/2020 during the night shift, the Adult Critical Care Flow Sheet documented the Heparin was discontinued per order at 1:30 AM.

The lab continued to draw PTT labs on 01/25/2020 at 5:33 AM and again at 10:02 AM. The order was not entered as canceled until 4:00 PM on 01/25/2020.

On 10/22/2020 from 11:30 AM to Noon, the facility designated a Registered Nurse/Charge Nurse from its Intensive Care Burn Unit to answer questions regarding the Adult Continuous Infusion Heparin Protocol. The Registered Nurse explained the Heparin protocol, which was ordered for Patient #1.

The Registered Nurse focused on the lab values and the protocol ranges for rate adjustment rather than on the time frame for the blood draws and the infusion rate changes. In response to what was reasonable lag time to adjust the rate, the Registered Nurse continued to focus on the lab value and the correctness of the infusion rate in the protocol range for infusion rate adjustment. The Registered Nurse failed to respond to what was a reasonable time for nurses to adjust the infusion rate.

On 10/23/2020 at 8:30 AM, a Lab Manager acknowledged the times when Patient #1's PTT results were available to nurses.

On 10/23/2020 at 10:30 AM, the Chief Nursing Officer indicated nurses would be expected to titrate the new rate within an hour of the lab result being finalized and entered into the computer system or within an hour of the results being called to the floor.

Based on observation, interview, record review, and document review the facility failed to ensure the medical records contained the reasons and narrative explanation for the patient's refusal and non-application of physician ordered intermittent pneumatic compression device (sequential compression device/SCD) for 6 of 30 sampled patients (Patient #10, #5, #6, #12, #18, and #20); and a physician's order for the application of intermittent pneumatic compression-thigh and foot pump for 1 of 30 sampled patients (Patient #10).

Findings include:

The facility's policy titled Evidence Based Clinical Documentation (EBCD) Provision of Care approved in May 2020, indicated documentation in the electronic health record (EHR) was focused on patient care activities, clinical decisions, and patient response to care. Key elements of the patient centered EHR included assessment and care activities. Patient Notes were used in a limited capacity to document unusual assessments or events which were not addressed in the standardized documentation.

Patient #10 (P10)

P10 was admitted on 10/02/2020 and discharged on 10/15/2020, with a diagnosis of left lower extremity deep venous thrombosis (DVT).

The physician's order dated 10/02/2020 at 7:07 PM, documented intermittent pneumatic compression device. The placement/length was knee high bilaterally.

P10's medical record documented the placement of intermittent pneumatic compression device and foot pump, "None" for non-application of intermittent pneumatic compression device, and "Refused" on the following dates and times:
- 10/02/2020 at 10:54 PM, None
- 10/03/2020 at 8:13 PM, None
- 10/06/2020 at 9:41 AM, Intermittent pneumatic compression - thigh
- 10/11/2020 at 8:08 AM, Refused
- 10/11/2020 at 8:00 PM, Refused
- 10/12/2020 at 8:58 AM, Refused
- 10/13/2020 at 7:45 PM, Refused
- 10/14/2020 at 9:19 AM, Foot pump
- 10/14/2020 at 7:27 PM, Refused
- 10/15/2020 at 8:37 AM, None

The patient's medical record lacked documented evidence of a physician's order for intermittent pneumatic compression-thigh and foot pump, reason for the non-application of intermittent pneumatic compression device, and interventions when the patient refused intermittent pneumatic compression device as ordered.

On 10/22/2020 at 9:01 AM, a Registered Nurse (RN) confirmed the findings and explained a mechanical prophylaxis such as intermittent pneumatic compression device or foot pump should have been applied within the next two hours from the time the intervention was ordered, unless specified in the physician's order. The nurses documented the placement/length of intermittent pneumatic compression device and other mechanical prophylaxis such as foot pump in the Nursing Assessment portion of the electronic charting at least every shift. The physician's order specified the placement/length of intermittent pneumatic compression device such as thigh high bilaterally, thigh high left leg only, thigh high right leg only, knee high bilaterally, knee high left leg only and right leg only. The order could have also specified foot pumps on both feet, left foot, or right foot. The nurses should have applied and documented the correct mechanical prophylaxis and placement/length of intermittent pneumatic compression device as ordered.

The RN revealed the nurses would have documented "None" if the patient had no intermittent pneumatic compression device in place or "Refused". A narrative nurse's notes should have been documented on the reason why the intermittent pneumatic compression device was not applied. Nursing interventions such as health teachings should have been documented when the patient refused the application of intermittent pneumatic compression device as ordered.

On 10/23/2020 at 9:42 AM, a Performance Improvement Coordinator confirmed there was no physician's order for P10's intermittent pneumatic compression-thigh and foot pump. The physician's order contained in the patient's medical record was intermittent pneumatic compression-knee high bilaterally.

Patient #5 (P5)

P5 was admitted on 10/07/2020, with a diagnosis of left knee infection.

The physician's order dated 10/08/2020, documented intermittent pneumatic compression device. The placement/length was knee high bilaterally.

P5's medical record documented "None" for non-application of intermittent pneumatic compression device and "Refused" on the following dates and times:
- 10/09/2020 at 8:30 PM, None
- 10/10/2020 at 8:00 PM, None
- 10/17/2020 at 7:34 PM, Refused
- 10/20/2020 at 8:00 PM, None

The patient's medical record lacked documented evidence on the rationale for the non-application of intermittent pneumatic compression device and patient's refusal.

Patient #6 (P6)

P6 was admitted on 10/06/2020, with diagnosis including positive COVID-19 and pneumonia.

The physician's order dated 10/06/2020, documented intermittent pneumatic compression device. The placement/length was knee high bilaterally.

P6's medical record documented "None" for non-application of intermittent pneumatic compression device and "Refused" on the following dates and times:
- 10/08/2020 at 8:00 PM, None
- 10/11/2020 at 8:00 PM, Refused
- 10/12/2020 at 8:00 AM, Refused
- 10/12/2020 at 7:45 PM Refused
- 10/13/2020 at 8:00 AM, None
- 10/13/2020 at 8:30 PM, Refused
- 10/14/2020 at 7:45 PM, Refused
- 10/15/2020 at 8:00 PM, None
- 10/17/2020 at 8:00 AM, None
- 10/18/2020 at 7:57 AM, None

The patient's medical record lacked documented evidence on the rationale for the non-application of intermittent pneumatic compression device and patient's refusal.

Patient #12 (P12)

P12 was admitted on 10/17/2020, with a diagnosis of cardiac arrest.

The physician's order dated 10/17/2020 at 3:51 PM, documented intermittent pneumatic compression device. The placement/length was knee high bilaterally.

P12's medical record documented "None" for non-application of intermittent pneumatic compression device on the following dates and times:
- 10/17/2020 at 8:30 PM, None
- 10/18/2020 at 12:00 AM, None

The patient's medical record lacked documented evidence on the rationale for the non-application of intermittent pneumatic compression device.

On 10/23/2020 at 10:01 AM, the Chief Nursing Officer (CNO) explained the nurses were expected to apply foot pump or intermittent pneumatic compression device as soon as possible when ordered by a physician. The physician's order on the type of mechanical prophylaxis such as foot pump or intermittent pneumatic compression device including placement/length should have been followed. The nurses should have documentation in the patient's medical record if there was a deviation from the order. A narrative explanation should have been documented for patient's refusal, non-application of intermittent pneumatic compression device, and application of different placement/length of intermittent pneumatic compression device from the one ordered by the physician. A patient's medical record should have contained the physician's order for the intermittent pneumatic compression device applied to the patient.

On 10/23/2020 at 10:31 AM, a Performance Improvement Coordinator confirmed there was no documentation in the medical records of P10, P5, P6, and P12 on the rationale for the refusal and non-application of intermittent pneumatic compression device.


39418


The facility policy titled Thrombosis Prevention Guidelines last reviewed 01/2018, documented the following data will be documented in the daily care intervention in Meditech (an electronic charting system used by the facility) or the relevant section of the medical record: The application and removal times each shift of all compression devices, skin and neurovascular inspections, size of stockings as applicable, cleaning of stocking and pneumatic devices.

Patient #18 (P18)

P18 was admitted on 04/04/2020 with diagnoses including end stage renal failure and uncontrolled blood pressure during hemodialysis.

A physician order dated 04/04/2020, documented intermittent pneumatic compression device. Placement: knee high bilateral.

Review of the daily care intervention documentation from Meditech titled Evidence Based Clinical Documentation (ECBD) Mechanical Prophylaxis Group from 10/01/2020 to 10/21/2020 revealed daily entries at 8:00 AM and 8:00 PM was recorded as "None" or as "Refused".

The medical record lacked documented evidence as to why the patient did not had the device applied to the lower extremities and the rationale for the refusal.

On 10/20/2020 at 3:15 PM, a Charge Nurse indicated application of an intermittent pneumatic compression device was a shared duty between the nurses and the Patient Care Technicians. The Charge Nurse indicated the nurse caring for the patient was responsible for the documentation of the application of the device. The Charge Nurse confirmed if a patient had refused an application of the device the expectation was to document the rationale as to why the device was not applied.

On 10/22/2020 at 1:55 PM, P18 was observed in the room with no intermittent pneumatic compression device applied to the lower extremities. There was no device noted inside the room.

On 10/22/2020 at 2:00 PM, a Registered Nurse (RN) caring for P18 indicated the patient had been continuously refusing the application of the device for months. The RN confirmed there was an active physician order for the application of the intermittent pneumatic compression device and the physician should have been notified for the continuous refusal and the order should have been discontinued. The RN verbalized a narrative should have been entered into Meditech for every "None" or "Refused" entry.

Patient #20 (P20)

P20 was admitted on 09/01/2020 with diagnoses including end stage renal failure and diabetic foot ulcer.

A physician order dated 09/01/2020, documented Intermittent Pneumatic Compression Device. Placement: knee high bilateral.

Review of the daily care intervention documentation from Meditech titled Evidence Based Clinical Documentation (ECBD) Mechanical Prophylaxis Group from 10/04/2020 to 10/21/2020 revealed daily entries at 8:00 AM and 8:00 PM recorded as "None" or as "Refused".

The medical record lacked documented evidence as to why the patient did not have the device applied to the lower extremities and the rationale for the refusal.

On 10/20/2020 at 3:15 PM, a Charge Nurse indicated application of an intermittent pneumatic compression device was a shared duty between the nurses and the Patient Care Technicians. The Charge Nurse indicated the nurse caring for the patient was responsible for the documentation of the application of the device. The Charge Nurse confirmed if a patient had refused an application of the device the expectation was to document the rationale as to why the device was not applied.

On 10/22/2020 at 9:45 AM, the Performance Improvement Coordinator indicated an entry of "None" reflected the patient did not have any device applied to the lower extremity for the shift and "Refused" reflected the patient had refused the application of the device.

On 10/23/2020 at 9:20 AM, the Chief Nursing Officer (CNO) indicated the expectation was for the nurses to enter a narrative every time a patient refused or the nonapplication of an Intermittent Pneumatic Compression Device. The CNO confirmed if the entry was "None" and a physician order was active, the physician's order was not followed.

Based on record review, document review and interview, the facility failed to ensure a physician completed dictation of operative reports within 72 hours for 4 of 4 sampled patients (Patient #1, #2, #3, and #4).

Findings include:

Patient #1

On 01/17/2020, Patient #1 was admitted with appendicitis and subsequent appendectomy via laparoscopy.

On 01/23/2020, Physician #1 placed a hemodialysis catheter in the right internal jugular vein. The medical record showed Physician #1 failed to dictate the operative report until 03/31/2020.

The authenticated dictation, dated 04/02/2020, revealed a statement left unclarified within the operative report: "The catheter was packed and (blank space) were placed."

The Medical Staff General Rules and Regulations regarding Physician Entries documented all blanks left in dictated reports must be filled in by the dictating physician at the time the report is authenticated.

Patient #2

On 08/29/2020, Patient #2 was admitted with severe sepsis, hypoxia, Covid pneumonia and fluid overload.

On 09/02/2020, Physician #1 placed a hemodialysis catheter in the right internal jugular vein. The medical record showed Physician #1 failed to dictate the operative report until 09/08/2020.

Patient #3

On 07/27/2020, Patient #3 was admitted with pneumonia, respiratory failure and hypoxemia.

On 08/03/2020, Physician #1 intubated Patient #3 and placed an arterial line in the right femoral vein. The medical record showed Physician #1 failed to dictate the operative reports until 08/13/2020.


Patient #4

On 09/03/2020, Patient #4 was admitted with compromised airway.

On 09/04/2020, Physician #1intubated Patient #4. The medical record showed Physician #1failed to dictate the operative report until 09/08/2020.

The authenticated dictation, dated 09/09/2020, revealed statements left unclarified within the operative report: "Unfortunately, the tube ended up in esophagus and therefore I pulled it out, (blank space) the patient again until the oxygen saturation was about 90% to 95% again...A chest x-ray was ordered as well as placing her back on the same setting (blank space) FiO2 of 100% temporarily."

The Medical Staff General Rules and Regulations regarding Physician Entries documented all blanks left in dictated reports must be filled in by the dictating physician at the time the report is authenticated.

On 10/22/2020 at 10:00 AM, Physician #1 acknowledged dictation was required to be completed within 72 hours and blank information completed. The Physician acknowledged being approached months after the missing operative report for Patient #1. The Physician was unaware of the electronic template the facility required physicians to use to document the brief operative note prior to the dictated version.

The Medical Staff General Rules and Regulations regarding Operative Reports documented:

2.4.1 A dictated operative report must be completed immediately following surgery for outpatients as well as inpatients. Any physician with undictated operative reports within seventy-two (72) hours following the day of the operation shall be subject to temporary limitation of privileges, pursuant to Section 2.14 of these Rules and Regulations. A "brief operative note" must be entered into the medical record immediately after surgery and include pertinent information that is necessary for any care provider who will be attending the patient. Immediately after surgery is defined as "upon completion of surgery." The written postoperative note must include at least the following elements:

A. Primary surgeon and assistant(s)
B. Pre and postoperative diagnosis(es)
C. Name and description of specific surgical procedure(s) performed
D. Description of the findings
E. Tissues removed or altered
F. Estimated blood loss

On 10/21/2020 at 1:37 PM, the Director of Medical Records acknowledged the following operative reports were expected to be dictated within 72 hours.