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501 SIXTH AVENUE SOUTH

SAINT PETERSBURG, FL 33701

MEDICAL STAFF ORGANIZATION & ACCOUNTABILITY

Tag No.: A0347

Based on policy review, document review, medical record review, and staff interview, it was determined the medical staff failed to ensure quality medical care was provided for one (#1) of five patient medical records sampled.

Findings included:

A review of the policy entitled, "Patient Assessment and Reassessment," # CLNNPOL058, effective 12/03/2019, showed:
- All patients receiving inpatient ...services received an initial assessment and appropriate follow-up assessments based on individual needs including physical status ...
- The interval update indicates any relevant changes since the last history and physical exam ...
- Each discipline will coordinate it's care with the other by review relevant assessment notes and care/treatment plans with assessments, evaluations, notes and plans understood to be components of the patient's overall plan of care ...
- Reassessments occur at specific regular intervals based on the patient's response to care.
- When there is ongoing significant changes in patient's condition ...
- Ongoing physical assessment will be documented based on clinical condition ...
- Collected data is analyzed to develop a plan that meets the patient's care/treatment needs ...
- Discipline specific information from clinical assessments will be provided in the patient's medical record and identify specific needs...
- Reassessment as the ongoing data collection, which begins on initial assessment, comparing the most recent data with data collect at earlier assessments...
- Screening was defined as the process of obtaining information by means of history or examination to detect health risks or problems requiring further investigation.

A review of Pediatric Normal Vital Signs for Pediatric Infant 1 month - 1 year (PALS Guidelines, 2015)
- Heart Rate (HR) 90- 190
- Respiratory rate (RR) - 30-53
- BP SBP/DBP - 72-104/37-56 Systolic Hypotension <70
- Temperature - 35.5 - 38.0 (37.5 for Oral/Axillary reading) 38 C = 100.4 F
- O2 < 92% should be a cause of concern for respiratory disease or cyanotic heart disease.

A review of Patient #1's physician history and physical (H&P) documentation, dated 04/15/19, showed the patient was born on 04/15/19 with a primary diagnosis of bilateral congenital diaphragmatic hernia (CDH) and admitted for surgery.

A review of Patient #1's physician progress noted dated 10/27/19 showed the patient underwent several surgeries during the admission, which included:
04/15/19 - Bilateral CDH repair without complication
10/09/19 - Inguinal hernia repair without complication.
06/28/19 - Nissen fundoplication with gastrostomy tube placement without complication.
Continued review revealed Patient #1's medical record showed the patient was still at a high risk for sepsis related to technology dependent conditions which included: ventilator dependence and G-tube feedings. The patient was receiving aspirin daily in G-tube feedings, as well as Tylenol and Motrin for ongoing fevers. Additionally, the patient was noted to be on contact isolation precautions for a positive respiratory culture with a multi-drug resistant organism (MDRO).

A review of Patient #1's medical record nursing and physician documentation from 10/27/18 through 11/10/19 showed:

10/27/19 - Physician/ARNP Progress Note - Elevated temperature and required Tylenol. Respiratory syncytial virus (RSV) panel was negative.
Vital signs last 24 hours showed:
" HR 141-201 bpm Cardiovascular: exam showed a regular rate and rhythm (HR was tachycardic)
" RR 28-64 br/min. (Normal high 53)
" O2 sats 88-100% (92% is low normal) - Pulmonary: exam showed baby was tachypneic, with mild subcostal retractions..
RN Physician Notifications:
" 4:00 AM - patient was agitated and restless.
" 6:00 AM - VS's were outside of parameters.
" 9:25 PM - MAP's (mean arterial pressure, is defined as the average pressure in a patient's arteries during one cardiac cycle. It is considered a better indicator of perfusion to vital organs than systolic blood pressure (SBP) in high 80's and low 90's. Order for Tylenol received.
The physician and ARNP documented the HR was a regular rate when it was tachycardic at 201 bpm/min. There were no labs ordered.

10/28/19 - Physician/ARNP Progress Note - Patient is back to baseline and doing well. Required Tylenol overnight possibly related to teething. WBC 14.10 (normal 4.5 - 11.0 and values above normal may indicate infection). Possible DC 11/11/19.
Vital signs last 24 hours showed:
" HR 127-199 bpm Cardiovascular exam showed a regular rate and rhythm
" RR 28-66 br/min. Pulmonary exam showed baby was tachypneic, with mild subcostal retractions.
Physician Notifications:
" 12:20 AM - VS's outside of parameters, MAP of 88.
" 6:55 AM - VS's outside of parameters with increased HR and agitation.
The Physician and ARNP documented the patient was back to baseline, despite an elevated HR 199, RR 66, tachypenia, mild subcostal retractions, elevated WBC count with ongoing need for Tylenol to reduce fevers, and multiple nursing physician notifications related to VS's outside parameters. There were no labs ordered to find cause of abnormal VS's, such as a CBC, WBC's, microbiology cultures or blood gases.

10/29/19 - Physician/ARNP Progress Note - Interval history: Had a fever overnight, resolved with Tylenol.
Assessment/Plan: Patient is back to baseline and doing well on CPAP. If he has another fever we will redraw cultures, RVP, and CXR. Possible DC the week of 11/11/19.
Vital signs last 24 hours showed:
" Tmax 38.6 C/101.4 F (Febrile)
" HR 120-205 bpm Cardiovascular: regular rate and rhythm. (tachycardic)
" RR 26-66 br/min (normal high RR 53) / Pulmonary: clear to auscultation bilaterally, tachypneic, mild subcostal retractions.
RN notifications to physicians:
" 7:53 AM - VS's outside of parameters. Fever 38.6. Okay to give Ibuprofen.
" 4:00 PM -results and values assessed with practitioner at the bedside.
The Physician and ARNP documented the patient was back to baseline, despite a fever of 101.4, an elevated HR at 205, RR 66, tachypenia, mild subcostal retractions, with ongoing need for Tylenol to reduce fevers. There were no labs ordered to find cause of abnormal VS's, such as a CBC, WBC's, microbiology cultures or blood gases.

10/30/19 - Physician/ARNP Progress Note - Interval history: no acute events overnight.
Assessment/Plan: Patient is back to baseline and is doing well on CPAP. Discharge planning in progress, tentative DC 11/08/19 or 11/11/19.
Vital signs last 24 hours showed:
" HR 138-206 bpm Cardiovascular: regular rate and rhythm.
" RR 34-74 br/min. - Pulmonary: clear to auscultation bilaterally, tachypneic, mild subcostal retractions.
" O2 sats 77-100%
RN notifications to physicians - showed a discussion during rounds with the provider regarding VS'S out of parameters.
The Physician and ARNP documented the patient was back to baseline, despite a HR of 206, RR at 74 br/min, O2 sata as low as 77%, tachypenia, mild subcostal retractions, with ongoing need for Tylenol to reduce fevers. There were no labs ordered to find cause of abnormal VS's, such as a CBC, WBC's, microbiology cultures or blood gases.

10/31/19 - Physician/ARNP Progress Note
Vital signs last 24 hours showed:
" RR 26-64 br/min.
RN notifications to physicians - RN note showed a discussion during rounds with the provider regarding vital signs outside parameters .
There were no labs ordered to find cause of abnormal VS's, such as a CBC, WBC's, microbiology cultures or blood gases.

11/01/19 - Physician/ARNP Progress Note - DC meeting w/ the family today, tentative DC 11/08/19 or 11/11/19.
Vital signs last 24 hours showed:
" RR 30-64 br/min.
RN Physician Notifications:
" 2:15 AM - VS's outside of parameters, increased MAP's outside of parameter.
There were no labs ordered to find cause of abnormal VS's, such as a CBC, WBC's, microbiology cultures or blood gases.

11/02/19 - Physician/ARNP Progress Note - Discharge planning in progress, tentative DC 11/08/19 or 11/11/19.
Vital signs last 24 hours showed:
" HR 118-198 bpm - Cardiovascular: regular rate and rhythm.
" RR 32-64 br/min. - Pulmonary: clear to auscultation bilaterally, tachypneic, mild subcostal retractions.
RN physician notifications:
" 12:30 PM - updated team on assessment, vitals, and irritability
" 1:32 PM - VS's outside of parameters. Provider aware of vitals and that Tylenol was given. No orders.
" 3:00 PM - provider at the bedside to assess patient and provider aware of increased VS's
" 3:50 PM - provider requested that bedside nurse give Motrin now.
" 4:15 PM - provider notified of temperatures.
The Physician and ARNP documented plan to continue DC planning, despite a HR of 198, RR at 64, tachypenia, mild subcostal retractions, and multiple notifications from nursing of VS's outside of parameters. There were no labs ordered to find cause of abnormal VS's, such as a CBC, WBC's, microbiology cultures or blood gases.

11/03/19 - Physician/ARNP Progress Note - Interval History showed the note summarized care for the patient from 11/02/19 through 11/03/19. Included review of the medical record, nursing notes, physical exam, radiology and lab studies.
Assessment/Plan: Discharge planning in progress, tentative DC 11/08/19 or 11/11/19.
Vital signs last 24 hours showed:
" Tmax 38.7 C / 101.6 F
" HR 132-198 bpm - Cardiovascular: regular rate and rhythm. (normal high 190)
" RR 36-78 br/min. - Pulmonary: clear to auscultation bilaterally, tachypneic, mild subcostal retractions.
" O2 sats - 83-100% - (hypoxic at 83%)
RN notifications to physicians:
" 7:51 AM - VS's outside of parameters.
" 10:56 AM -VS's outside parameters discussed.
" 3:06 PM - VS's outside of parameters.
" 5:45 PM - Charge nurse notified - discussed VS's outside of parameters.
The Physician and ARNP documented plan to continue DC planning, despite a fever of 101. 6 F, HR of 198, RR at 78, O2 sats as low as 83%, tachypenia, mild subcostal retractions, and multiple notifications from nursing of VS's outside of parameters. There were no labs ordered to find cause of abnormal VS's, such as a CBC, WBC's, microbiology cultures or blood gases.

11/04/19 - Physician/ARNP Progress Note- Assessment/Plan: Discharge planning in progress, tentative DC 11/08/19 or 11/11/19.
Vital signs last 24 hours showed:
" HR 131-198 bpm Cardiovascular: regular rate and rhythm.
" RR 33-85 br/min. -O2 sats - 86-100% - Pulmonary: clear to auscultation bilaterally, tachypneic, mild subcostal retractions
RN physician notifications:
" 11:50 AM - Provider at bedside. Discussed VS's outside of parameters.
" 4:50 PM - Charge nurse at the bedside. Discussed VS's outside of parameters.
The Physician and ARNP documented plan to continue DC planning, despite a HR of 198, RR at 85, O2 sats as low as 86%, tachypenia, mild subcostal retractions, and multiple notifications from nursing, including the charge nurse, of VS's outside of parameters. There were no labs ordered to find cause of abnormal VS's, such as a CBC, WBC's, microbiology cultures or blood gases.

11/05/19 - Physician/ARNP Progress Note: Patient administered vaccines, which included; Hepatitis B, Polio, Dtab, HIB, and PCV.

11/06/19 at 9:02 AM - Physician/ARNP Progress Note - Interval history: note summarized the cared for Patient #1 from 11/05/19-11/06/19, which included review of the medical record, nursing notes and physical exam. No acute events were reported overnight.
Assessment/Plan: Discharge planning in progress, tentative DC 11/08/19 or 11/11/19.
Vital signs last 24 hours showed:
" Tmax 38.8 C / 101.8 F
" RR 26-68 br/min. Pulmonary: clear to auscultation bilaterally, tachypneic, mild subcostal retractions
RN notifications to physicians:
" 9:00 AM - VS'S out of parameters - Infant oxygen saturations 91% during rounds and was fussy.
The Physician and ARNP documented there were no acute event overnight, and continue DC planning, despite a fever of 101.8 F, RR at 68 br/min. tachypenia, mild subcostal retractions, notification from nursing that VS's were outside parameters and O2 sats were as low as 91%.T here were no labs ordered to find cause of abnormal VS's, such as a CBC, WBC's, microbiology cultures or blood gases.

11/07/19 at 7:00 AM- Physician/ARNP Progress Note - No acute events overnight. Working on dc planning.
Assessment/Plan: Patient had a small amount of wheezing this morning on exam's. Discharge planning in progress, tentative DC 11/11/19.
Vital signs last 24 hours showed:
" HR 121-206 / bpm Cardiovascular: regular rate and rhythm. MD: baby tachycardic this am
" RR 26-80 br/min./ O2 sats 86% -100% Pulmonary: clear to auscultation bilaterally, tachypneic, mild subcostal retractions.
RN Notifications:
" 11:47 AM - RN note showed a discussion during rounds with the provider regarding VS'S out of parameters
The Physician and ARNP documented there were no acute events overnight, and working on DC planning, despite HR OF 206, RR at 80 br/min, O2 sats as low as 86% with, wheezing, tachypenia, mild subcostal retractions, and notification from nursing that VS's were outside parameters. There were no labs ordered to find cause of abnormal VS's, such as a CBC, WBC's, microbiology cultures or blood gases.

11/08/19 at 9:00 AM - Physician/ARNP Progress Note:- Interval history note summarized patient care from 11/07/19-11/08/19. It included review of the medical record, nursing notes and physical exam.
Assessment/Plan: Discharge planning in progress, tentative DC 11/11/19
Vital signs last 24 hours showed
" HR 130-206/ bpm Cardiovascular: regular rate and rhythm.
" RR 30-80 br/min. / 24 hr. O2 sats 86% -100% Pulmonary: clear to auscultation bilaterally, tachypneic, mild subcostal retractions.
RN notifications to physicians:
" 6:30 AM - VS'S out of parameter.
The Physician and ARNP documented DC planning in progress, despite HR OF 206, RR at 80 br/min, O2 SATS AS LOW AS 86%, wheezing, tachypenia, mild subcostal retractions, and notification from nursing that VS's were outside parameters. There were no labs ordered to find cause of abnormal VS's, such as a CBC, WBC's, microbiology cultures or blood gases.

11/09/19 at 8:00 AM Physician/ARNP Progress Note showed the patient was crying, inconsolable and a documented fever of 102 F with Tylenol and Motrin being given. DC planning in progress with a tentative DC 11/11/19. The patient's parents do not believe the patient has returned to his normal disposition and remain very hesitant to discuss any DC date.
Assessment/Plan: Patient does not seem to be as baseline today with increased temperatures, crying and inconsolability. RVP panel ordered due to increased temperatures and need for 7 liters oxygen. (RVP had previously been ordered on 10/27/19 and was negative).
Vital signs last 24 hours showed:
" Tmax 38.2 C / 101.8 F - MD noted showed 39.2 C / 102.5 F
" HR 125-194/ bpm Cardiovascular: regular rate and rhythm.
" RR 30-78 br/min. / O2 sats 87% -100% - Pulmonary: clear to auscultation bilaterally, tachypneic, mild subcostal retractions.
RN Physician Notifications:
" 10:05 AM - VS's out of parameters. Tmax 38.8 C / 102 F and HR above parameters.
" 12:31 PM - VS's out of parameters. Temp 38.6 C / F 101.4
" 5:11 PM - VS's out of parameters. Still febrile 38.4 C / F
" 5:17 PM - Advised the NP that the RVP was negative.
" 7:53 PM - providers assessed patient and ears.
" 8:00 PM - Patient's father requested that a physician examine the baby due to ongoing fussiness and fever, Physician examined the patient's ears and diagnosed the baby with otitis media (ear infection).
" 10:30 PM - Charge Nurse Notified that patient could not be consoled and unresolving
" 11:30 PM - VS's out of parameter. Patient increased head wobbling.
11:30 PM - A review of the physician note at 11:30 PM showed the physician was called to the bedside by the charge nurse for worsening fussiness, hypoxia and tachycardia. Axillary tempt noted to be 101.5.
Physician ordered a chest x-ray, blood cultures, and other lab work.
The physician documented, "before labs came back, the patient became bradycardic with asystole. Of note, patient was examined during rounds at 10:30 AM, and was fussy, febrile with perfusion and work of breathing not concerning. And received Tylenol and improved and continued to run fevers throughout day."
" 11:54 PM - Code Blue Team - patient asystole.

An interview on 12/06/19 at 10:30 AM with the Director of Respiratory Therapy, revealed that based on the documentation on 11/09/19, Patient #1 should have been intubated and blood gases ran at 7:40 AM, when the baby went from 6 to 7 liters of oxygen and O2 sats were 87%. The RT Director stated that moderate retractions meant an increased workload. The Director confirmed that daily documentations by the physicians and ARNP's, showed the exact same pulmonary assessment from 10/27/19 through 11/09/19; clear to auscultation bilaterally, tachypneic, with mild subcostal retractions.

An interview on 12/05/19 at 1:30 PM with the Vice President Medical Affairs (VPMA) regarding facility sepsis protocols and Patient #1 revealed:
- Multi-disciplinary team huddles upon trigger of sepsis score that is equal to or greater than 4.0.
- "We don't trend WBC's, so no we would not run another WBC it the patient had an abnormal/high WBC because there were no other symptoms of sepsis. There was no reason to think Patient #1 was septic. I wish there were a blood culture, although it would have been negative."

An interview performed on 12/05/19 at 3:40 PM with the Chief Safety & Quality Officer, revealed the facility had performed a quality review of Patient #1's medical record and found that the patient should have been intubated sooner. The Chief Safety & Quality Officer stated, "A couple things gave me pause. I was concerned with the tachycardia and fever. The team thought it was due to the vaccines. The team wished they had performed blood cultures (BC's), but don't feel that it would have shown anything."

An interview on 12/06/19 at 11:15 AM with a Pediatric Intensivist responsible for reviewing the facility pediatric sepsis mortalities. The physician stated, "white blood cell counts and lactic acid are not relative in the pediatric population." The physician stated he had reviewed Patient #1's medical record, and felt the patient did not have any signs or symptoms of sepsis. The physician stated that when he performed the review of Patient #1's medical record, he had only reviewed the last 48 hours and had no findings or concerns. A review of the QAPI meeting agenda dated 10/09/19 was reviewed with the physician confirmed he spoke about opportunities for improving recognition of signs and symptoms of sepsis. The physician confirmed he provided the committee an example of a sepsis mortality child that had developed tachycardia and fever; and none of the staff entertained the idea that it could be sepsis. The physician was asked what criteria are used to assess for the presence of sepsis. The physician confirmed that fever (38.5 C/ 101.3 F), heart rate (tachycardia), inconsolability/crying, technology dependent (ventilator), and hypotension are the criteria utilized and each received one point, except for hypotension, which receives 3 points.

An interview on 12/06/19 at 2:00 PM with the Senior Director Regulatory Affairs regarding the facility's quality of care review of Patient #1's medical record, revealed the facility had identified opportunities related to the care of Patient #1. The facility noted the patient could have been intubated earlier. The Director stated the facility review did not reveal any concerns related to Patient #1's abnormal VS's not being addressed for days or that sepsis may have been the potential cause of the symptoms. The Director confirmed the above medical record findings related to Patient #1.

A review of Patient #1's discharge summary dated 11/10/19 showed the patient expired 11/10/19 at 12:42 AM.