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555 EAST VALLEY PARKWAY

ESCONDIDO, CA 92025

QAPI GOVERNING BODY, STANDARD TAG

Tag No.: A0308

Based on interview, record, and document review, the hospital failed to ensure a process was in place and implemented related to the following:

Nursing staff did not clarify with a Provider when a Patient's (1) Final X-ray result had a documented discrepancy. A staff Radiologist (MD) 2 dictated Patient 1's small bore feeding tube (thin catheter inserted through a patient's nostril and advanced into the stomach for the administration of medication and nutrition) placement X-ray Final result could not be confirmed. In addition, MD 2 dictated he agreed with MD 3's Preliminary findings. The lack of clarification from Nursing to the Radiology Department did not ensure Patient 1's small bore feeding tube was correctly placed. In addition, there was no established timeframe for Patient 1's physician to review the Final X-ray result. As a result, Patient 1's feeding tube which was intended for placement in the stomach, was placed in the patient's lung. Approximately ten hours after the incorrect insertion of the small bore feeding tube, another physician, (MD) 1, removed the small bore feeding tube. Approximately 366 milliliters (ML) of enteral nutrition was administered into the patient's pleural (lung) space. These failures were not in accordance with the hospital's 2018 Quality Assurance Performance Improvement (QAPI) Plan.

Findings:

On 2/15/18 at 8 A.M., an onsite visit to the hospital's West campus was conducted. The visit was related to the Facilities Reported Incident (FRI) received at the California Department of Public Health (CDPH) on 2/14/18 at 4:57 P.M. via facsimile (Fax). The Fax indicated Patient 1 had a Dobbhoff tube feeding placed on 2/12/18 at approximately 5 A.M. by RN 1. In addition the Fax indicated on 2/12/18 at 8 P.M., the hospital determined Patient 1's Dobbhoff was placed in the patient's left lung. Patient 1 expired on 2/14/18 at 6:33 A.M.

Patient 1's medical record was reviewed on 2/15/18.

Physician orders for Patient 1 indicated the following:

Patient 1 was admitted to the hospital on 2/2/18.

A Physician's order, dated, start date 2/11/18 at 9:02 P.M. and stop date 2/14/18 at 11:02 A.M., indicated the placement of a small bore feeding tube.

According to Patient 1's Intake and Output (I&O) record dated, 2/12/18 to 2/13/18, during the time of the incorrect small bore feeding tube placement, Patient 1 received 366 milliliters (ml) tube feeding.

The hospital's 2018 QAPI plan indicated its plan decreased the "likelihood of problems by identifying areas of opportunity and testing new approaches in order to fix underlying causes of persistent/systematic problems...data driven...identified areas of improvement, addressed gaps in systems or processes...and continuously monitored effectiveness of interventions."

On 2/15/18 at 10:45 A.M., an interview was conducted with the Chief Medical Officer (CMO) and the Quality Patient Safety Regulatory Director (QPSRD). The CMO stated the hospital's Radiology Quality Assurance (QA) process included the following: If staff Radiologist had concerns or disagreed with Preliminary radiology reads, the staff Radiology Department entered the information into an electronic report for review and feedback. The CMO further stated the data was tracked and trended by the hospital.

The hospital was unable to provide data collected related to Radiology QA.

On 2/15/18 at 2:15 P.M., an interview was conducted with MD 1 and the QPSRD. MD 1 stated he read Patient 1's small bore feeding tube placement Final X-ray however, physician's were not obligated to read the films due to an individual physician may not have the expertise of a Radiologist. MD 1 further stated when Nursing staff received the Final X-ray document, there was an obligation "If it does not seem right, report it to a physician and the X-ray would be repeated."

On 2/15/18 at 3:10 P.M., an interview was conducted with the Interim Chair of Radiology (MD 5). MD 5 stated if a feeding tube was properly placed, Radiology did not call Nursing. When a feeding tube was not in place and needed advancement or removal, the Radiologist called the Intensivist or covering Physician. MD 5 further stated if a Preliminary X-ray report indicated proper placement then, the Registered Nurse (RN) started the tube feeding.

On 2/22/18 at 8:10 A.M., an interview was conducted with RN 1, the Director of Intensive Care Unit (ICUD), and the QPSRD. RN 1 stated Nursing does read the Radiology Final X-ray reports. Furthermore, the ICUD stated Nursing reads the Preliminary and Final X-ray reports impressions and do not necessarily question the Radiology findings. In addition, the ICUD stated the hospital expected physicians to review the Final X-ray result in its entirety.

The lack of provided Radiology QA data and identification of gaps in reporting, implementation of and/or reviewing timelines for Final X-ray results, did not ensure systems or processes were in place in an effort to continuously monitor and sustain patient care and service outcomes in accordance with the hospital's QAPI Plan.

RN SUPERVISION OF NURSING CARE

Tag No.: A0395

Based on interview, record, and document review, the hospital failed to ensure Nursing services documented and re-evaluated the delivery of care provided to a Patient (1) related to the following:

1. Ensure two Registered Nurses (RN's) 1,4 documented three separate small bore feeding tube placement assessments (thin catheter inserted through a patient's nostril and advanced into the stomach for the administration of medication and nutrition) for a Patient (1). The lack of documented assessments did not ensure Nursing accountability of the patient's actual assessment which attested for correct small bore feeding tube placement. Patient 1's small bore feeding tube which was intended for placement in the stomach, was placed in the patient's lung and enteral nutrition was delivered into Patient 1's lung.

2. Ensure when RN 1 reported a change in a Patient's (1) medical condition and requested an assignment of 1:1 (Nursing assigned to one patient) status for Patient 1. As a result, RN 1 was unable to fully provide constant care for Patient 1 during a change of condition.

The lack of implementation did not ensure Patient 1's documented services provided accurately reflected the patient's current status and care needs in an effort to provide continuity of care for the patient in accordance with the hospital's Policies, Procedures, and Professional Standards of Care.

Findings:

1. On 2/15/18 at 8 A.M., an onsite visit to the hospital's West campus was conducted. The visit was related to the Facilities Reported Incident (FRI) received via facsimile (Fax) on 2/14/18 at 4:57 P.M. to the California Department of Public Health (CDPH). The Fax indicated Patient 1 had a small bore feeding tube placed on 2/12/18 at approximately 5 A.M. by RN 1. In addition the Fax indicated on 2/12/18 at 8 P.M., the hospital determined Patient 1's small bore feeding tube was placed in the patient's left lung. Patient 1 expired on 2/14/18 at 6:33 A.M.

Patient 1's medical record was reviewed on 2/15/18.

Physician orders for Patient 1 indicated the following:

Patient 1 was admitted to the hospital on 2/2/18.

A Physician's order, dated, start date 2/11/18 at 9:02 P.M. and stop date 2/14/18 at 11:02 A.M., a small bore feeding tube was placed.

A Physician's order, dated 2/11/18 at 10:17 P.M. and 2/12/18 at 12:39 A.M., indicated Portable abdominal X-Ray for verification of a small bore feeding tube.

A Nursing Narrative, dated, 2/14/18 at 5:59 P.M., documented by RN 1 indicated "Late entry, (name of small bore feeding tube) inserted (2/11/18) per MD's order. Abdominal x-ray done. Noted that pt. is more agitated & tachypneic. Decided to discontinue (name of small bore feeding tube) before it was resulted. Radiologist on call called about the result. @ 12:30 A.M., ask assistance from (RN 4) for reinsertion of the tube. Placed in & confirmed by abdominal x-ray. Due to pt's confusion,(Patient 1) pulled out the tube accidentally. Tube feeding was not started then. @ 0530, attempted to reinsert DHT. Abdominal x-ray done. At this time pt. tolerated the procedure. Pt is calm, not tachypneic or agitated. Resting well. Result came back @0650. Endorsed to am nurse."

A Nursing Narrative, dated, 2/14/18 at 6:51 P.M., documented by RN 4, indicated "Late entry for small bore feeding tube on 2/12/18 at approximately 0030. I was contacted by bedside RN (RN 1) for assistance with (name of small bore feeding tube) placement."

On 2/15/18 at 9:45 A.M., RN 1 and RN 4 were not available for interviews.

On 2/15/18 at 9:20 A.M., an interview was conducted with the Chief Nursing Officer (CNO), a Clinical Nurse Specialist (CNS) 1, and the Quality Patient Safety Regulatory Director (QPSRD). The CNO stated the hospital expected Nursing assessed and documented the placement and verification of patients who received a small bore feeding tube.

On 2/15/18 at 2P.M., an interview was conducted with a Pulmonary Intensivist (MD 1) and the QPSRD. MD 1 stated prior to X-ray verification of small bore feeding tube placement, an auscultation(audible sounds heard through a stethescope) assessment was performed. MD 1 further stated during the auscultation, if there was no audible sound of airflow, correct placement could not be confirmed and the small bore feeding tube was removed.

On 2/15/18 at 3:46 P.M., an interview and Review of Patient 1's medical record was conducted with RN 1, the QPSRD, CNS 1, and the Director of the Intensive Care Unit (ICUD). RN 1 stated the hospital expected a Nursing assessment was performed and documented after the placement of a patient's Dobbs. In addition, RN 1 stated she was aware of the Nursing Professional Standards of Care. She further stated when assessing patients after small bore feeding tube placement, she administered 10 cubic centimeters (CC's) of an air bolus into the open end of the small bore feeding tubing and simultaneously placed a stethoscope over the patient's abdomen while she auscultated (listened) for airflow. She further stated the purpose of the auscultation was for verification of correct placement of the small bore feeding tube. RN 1 acknowledged she did not document her assessment for Patient 1 when she placed the patient's small bore feeding tube on two separate occasions.

On 2/22/18 at 8:40 A.M., an interview and Review of Patient 1's medical record was conducted with RN 1, the QPSRD, CNS 1, and the Director of the Intensive Care Unit (ICUD). RN 4 stated the hospital expected a Nursing assessment was performed and documented after the placement of a patient's small bore feeding tube. In addition, RN 1 stated she was aware of the Nursing Professional Standards of Care. RN 4 acknowledged she did not document her assessment for Patient 1 when she placed the patient's small bore feeding tube.

The hospital's Standards of Patient Care for the Adult Inpatient, dated 3/31/2017, indicated small bore feeding tubes insertion was documented in the electronic medical record (EMR) in the tubes, drains, and devices section and interventions were documented in clinical notes.

2. On 2/15/18 at 4:15 P.M., an interview and Review of Patient 1's medical record was conducted with RN 1, the QPSRD, CNS 1, and the Director of the Intensive Care Unit (ICUD). RN 1 stated on 2/11/18 she was assigned to care for Patient 1 and Patient (2) in the Intensive Care Unit (ICU). Furthermore, she stated during her shift, Patient 1 and 2 both had a change of condition and she asked the Charge Nurse (RN) 5 to decrease her patient assignment to one patient instead of two. RN 1 stated Patient 1 was restless, agitated, and trying to get out of bed, and it was difficult for her to leave the patient's room. RN 1 further stated Patient 2 had increased Blood Pressure, was crying, had increased pain, and needed frequent monitoring. In addition, RN 1 stated her assignment was based on her patient's acuity (algorithm based on patient level of care needed to determine nurse to patient ratio). The medical record indicated on 2/11/18, Patient 1's acuity was documented as level 8 and Patient 2's acuity was documented as level 8.

Furthermore during the same interview, RN 1's Nursing Narrative was reviewed. A Nursing Narrative, dated, 2/14/18 at 5:59 P.M., documented by RN 1 indicated "Late entry, (name of small bore feeding tube) inserted (2/11/18) per MD's order. Abdominal x-ray done. Noted that pt. is more agitated & tachypneic..." RN 1 stated she was unable to document her assessments due to Patient 1's increased agitation and every time she left the patient's room, the patient's became agitated and tried to get out of bed.

On 2/15/18 at 4:30 P.M., RN 5 was not available for interview subsequently, an interview was conducted with the ICUD. The ICUD stated the ICU staffing ratio was determined by a patient's acuity and typically a score of 8-10 was 1:2 and a score of 11-12 was 1:1. In addition, the ICUD stated the electronic medical record (EMR) pulled data inputted by staff and calculated the score based on the input. There was no documented evidence of data which reflected RN 1's interview on 2/15/18 at 4:15 P.M., and request for patient's assignment change. The ICUD further stated the EMR acuity system may not reflect real time situations as data is collected from various areas of the chart however, when Nursing has a concern with the patient's assignment, the Charge Nurse can override the acuity and reassign the nurse to patient's ratio.

Per the hospital's Procedure entitled Patient Acuity Classification System, dated 8/13/17, "A Registered Nurse is responsible for assessing and documenting patient's conditions, interventions, and procedures... (name of software) will pull data every four hours to generate an automated patient's Acuity level..."

The lack of communication between Nursing staff related to patient's increase care needs, did not ensure RN 1 was able to fully provide constant care for Patient 1 or 2 as indicated during her interview on 2/15/18 at 4:15 P.M., during her reported patients change of conditions which reportedly, resulted in the lack of RN 1's documentation of Patient 1's small bore feeding tube assessment.

SCOPE OF RADIOLOGIC SERVICES

Tag No.: A0529

Based on interview, record, and document review, the hospital failed to ensure the staff Radiologist (MD) 2 communicated an X-ray discrepancy received from MD 3, to the Radiology Department and/or ordering physician for a patient (1). MD 3 dictated Patient 1's Preliminary result for the placement of a small bore feeding tube (thin catheter inserted through a patient's nostril and advanced into the stomach for the administration of medication and nutrition) . MD 2 dictated Patient 1's Final result could not be confirmed. In addition, MD 2 dictated he agreed with MD 3's Preliminary findings. The lack of communication did not ensure the intended result was interpreted for Nursing and the ordering physician in accordance with the hospital's Radiology Standards of Practice. As a result, Patient 1's small bore feeding tube which was intended for placement in the stomach, was placed in the patient's lung.

Findings:

On 2/15/18 at 8 A.M., an onsite visit to the hospital's West campus was conducted. The visit was related to the Facilities Reported Incident (FRI) received at the California Department of Public Health (CDPH) on 2/14/18 at 4:57 P.M. via facsimile (Fax). The Fax indicated Patient 1 had a Dobbhoff tube feeding placed on 2/12/18 at approximately 5:00 A.M. by RN 1. In addition the Fax indicated on 2/12/18 at 8 P.M., the hospital determined Patient 1's small bore feeding tube was placed in the patient's left lung. Patient 1 expired on 2/14/18 at 6:33 A.M.

Patient 1's Medical Record was reviewed on 2/15/18.

Physician orders for Patient 1 indicated the following:

Patient 1 was admitted to the hospital on 2/2/18.

A Physician's order, dated, start date 2/11/18 at 9:02 P.M. and stop date 2/14/18 at 11:02 A.M., indicated the placement of a small bore feeding tube.

A Physician's order, dated 2/11/18 at 10:17 P.M. and 2/12/18 at 12:39 A.M., indicated Portable abdominal X-Ray for verification of a small bore feeding tube.

Patient 1's Preliminary small bore feeding tube X-ray, interpreted by a Radiologist (MD) 3 dated 2/12/18 at 6:03 A.M., indicated "Dobbhoff tube terminates in the stomach..." In addition, the preliminary X-ray indicated any discrepancy found between the preliminary and final report was reported to Quality Assurance.

Patient 1's Final small bore feeding tube X-ray, interpreted by a Radiologist (MD) 2 dated 2/12/18 at 9:20 A.M., indicated " Findings: ... Previously seen enteric (intestinal) tube presumably was removed. New somewhat tortuous course of a presumed new enteric catheter which projects towards the left chest and then redirects towards the midline with tip terminating in the left upper quadrant, presumably within the stomach, (however) not definitely confirmed on this exam due to somewhat aberrant (abnormal) course." "Impression: As above, This interpretation is consistent with the preliminary (name of Radiology group) report by MD 3."

On 2/15/18 at 10:50 A.M., an interview and review of Patient 1's Preliminary and Final small bore feeding tube placement X-rays were conducted with MD 2 and the Quality Patient Safety Regulatory Director (QPSRD). MD 3 stated he received and read Patient 1's Preliminary result and recalled the Preliminary "was a strange looking read, it read normal but did not look normal." MD 3 further stated his Final exam interpretation meant the course of the tubing placement "jetted down to the left lung, then to the gastroesophageal junction, and the tip of the tubing overlaid the upper abdominal quadrant." MD 3 further stated he suspected the tubing went in deep and punctured Patient 1's lung, however, it was not "clear cut" and he was not "quite sure" if the patient had an underlying diagnosis for the tubing to flow in a different course." MD 3 stated he did not call the Nursing staff or ordering physician and neither called him to discuss the Final X-ray.

The hospital's Procedure entitled Communications of Imaging Findings, reviewed 1/17, indicated Radiology Standards of Practice, derived from American College of Radiology (ACR), identified three types of exam results as significant. One of those types included an interpretation that disagreed with the original physician's interpretation. The procedure indicated the Radiologist flagged the significant result and those results were given to the ordering provider.

The lack of communication The lack of clarification did not ensure the intended result was interpreted or an additional X-ray was ordered for clarification. As a result, Patient 1's feeding tube which was intended for placement in the stomach, was placed in the patient's lung.