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Based on medical record review, review of incident reports, review of administrative investigation documents, and staff interview, it was determined the facility failed to ensure adverse patient events were analyzed and actions were taken to prevent further incidents for patients who required tracheostomy changes. This affected the care of 1 of 2 patients (Patient #1) who had tracheostomies and whose records were reviewed. This failure had the potential to result in the deterioration of a patient's condition related to an adverse event.

The following occurrence was identified during the review of medical records.

Patient #1 was a 65 year old male who was admitted on 9/13/17, with a diagnosis of West Nile virus meningoencephalitis. Additional diagnoses were functional quadriplegia and debilitation.

On 9/23/17, at approximately 3:00 PM, RT D attempted an initial tracheostomy tube downsizing for Patient #1. RT D performed this procedure without a second RT, or a physician, in the facility. Additionally, RT D did not inform Patient #1's RN (RN D) prior to attempting the procedure.

RT D was unsuccessful in downsizing Patient #1's tracheostomy tube, which resulted in failed recanalization of his airway, and subsequent emergent rapid response at 3:16 PM. EMS arrived at the facility at 3:45 PM, and Patient #1's physician arrived at 3:48 PM. It was determined the failed recanalization by RT D potentially caused a left sided pneumothorax (a collapsed lung). Patient #1 was intubated, sedated, and his physician ordered him transferred to a local acute care hospital for a higher level of care.

Patient #1 was admitted to the local hospital's ICU and required chest tube insertion for his sustained left sided pneumothorax. Patient #1 remained at the local hospital for 5 days and was transferred back to the facility on 9/28/17.

The DOC provided an incident report for Patient #1, which documented the incident occurred on 9/23/17, and was related to a failed procedure. The status of the incident on the report was documented as "investigated" and "completed" as of 10/10/17. The report stated "RCA completed today, action plan and items identified for process improvement. Excellent turnout and great team response."

The Agency for Healthcare Research and Quality website, accessed 12/04/17, stated "Root cause analysis (RCA) is a structured method used to analyze serious adverse events ...A central tenet of RCA is to identify underlying problems that increase the likelihood of errors while avoiding the trap of focusing mistakes by individuals. RCA thus uses the systems approach to identify both active errors (errors occurring at the point of interface between humans and a complex system) and latent errors (the hidden problems within health care systems that contribute to adverse events)."

Documentation related to the RCA was requested for review from the DOC. A form with the title "RCA Meeting," dated 10/20/17, was provided by the DOC at 1:20 PM on 11/30/17. The form included 3 sections titled "Discussion," "Follow Up," and "Resp. [responsible] Person." The form included documentation of the meeting as follows:

- The section "Follow Up" documented supplies needed, whether there was a protocol for administering Propofol (a medication used for sedation and general anesthesia), and "...need to review our override process or the availability of the person able to override." It was not clear what was meant by the term "override."

- The section "Resp. Person" documented the RT Lead was to provide a staffing list for her department and the rapid response box (a small portable box which contains emergency equipment) was " ...shoveled through and disorganized ..." The notes also stated documentation was lacking and the RT (RT D) present during the event did not document the incident in the medical record.

- The section "Discussion" documented "Main problem that day: loss of airway; Cause: attempted to downsize trach [sic]. Atotomy [sic] was difficult." The minutes also documented "Will be looking at Process [sic], staffing and equipment." Additionally, the documentation stated there were 5 patients on ventilators on the day of the event and "Should have staffed 2 high obs [observation] nurses but only had one plus house sup [supervisor]. ICU RN staffed has ICU experience but uncomfortable with vents [ventilators]. We may want to look at competencies for ICU."

The DOC, DNO, and RN Manager were interviewed together regarding the RCA Meeting form beginning at 1:35 PM on 11/30/17. When asked if the RCA meeting occurred on 10/20/17, the DOC stated the date on the form was incorrect and the meeting occurred on 10/10/17. When asked if the nurse staffing issue identified in the RCA meeting notes was addressed, the DOC stated nurse staffing was not identified as a problem. When asked if lack of equipment was an identified issue the DOC stated it was not. The DOC stated the documentation on the RCA Meeting form were ideas of possible problems "thrown out there" by attendees. She stated these were not the actual problems identified.

When asked what problems were identified during the RCA meeting the DOC, DNO, and RN Manager stated there were 3 problems identified: RT controlling their schedule and staffing for their department, appropriate personnel were present when a tracheostomy change was ordered, and documentation by staff in the patient's medical record was sufficient for incidents or complications which occurred. The DOC and DNO confirmed these problems were not specifically documented on the RCA meeting form.

The DOC, DNO, and RN Manager were asked what actions, if any, the facility had taken for the 3 problems they stated were identified. The DOC stated scheduling for the RT department had changed and was currently the responsibility of the staffing coordinator, not the RTs. The DNO stated the decision was made to have 2 RTs, or 1 RT and 1 physician, present when there was an order for the initial change or downsizing of a tracheostomy. Additionally, the DNO stated she wanted to ensure documentation in the patient's medical record, leading up to and after an adverse event or incident, was appropriate and sufficient by clinical staff.

The DOC, DNO, and RN Manager were asked for documentation of the actions and/or changes to policies and/or processes, and documentation of training and education which was provided to staff. The DOC stated the staff were "verbally" informed of changes regarding staffing for the RT department and the decision to have 2 RTs, or 1 RT and 1 physician, present during tracheostomy changes. The DOC stated the facility had a "small number" of staff and they were aware of these changes by verbal communication from herself, the DNO, and the RN Manager. The DOC, DNO, and RN Manager were asked if there were clinical or staff meeting minutes documenting the identified problems and subsequent changes, they answered no.

The DOC stated there were no "official" changes to policies or clinical processes. She stated RT D had acted outside of the accepted RT standards of practice and facility expectations.

The facility failed to appropriately analyze Patient #1's adverse event and ensure actions were implemented to prevent future adverse events for patients with respiratory care needs.

Based on medical record review, facility policy review, and staff interview, it was determined the facility failed to ensure an RN evaluated the nursing care for 1 of 3 patients (Patient #3) who were transferred to another facility and whose records were reviewed. This failure had the potential to result in adverse patient outcomes. Findings include:

A facility policy "Reassessment," effective 10/07, stated "Patients will also have reassessments occur when: 1. Changes occur in condition and/or diagnosis." This policy was not followed.

Patient #3 was a 76 year old female who was admitted on 8/18/17, with a diagnosis of post-surgical complications. She was transferred to a local hospital for higher level of care on 8/19/17.

Patient #3's medical record included the following documented series of events:

- "HISTORY AND PHYSICAL," dated 8/18/17 at 3:23 PM, signed by the physician, stated "Ileostomy (portion of the small intestine is diverted to an artificial opening in the abdominal wall) right lower quadrant with black liquid stool."

- "PATIENT FLOW SHEET," dated 8/18/17 at 5:15 PM, signed by an RN, documented "Family primary concern is dark dark [sic] stool in ostomy. MD aware."

- "PATIENT FLOW SHEET," dated 8/18/17 at 12:00 AM, signed by an RN, documented "Patient has dark red blood in ileostomy."

- "PATIENT FLOW SHEET," dated 8/18/17 at 5:00 AM, signed by an RN, documented "Pt's ileostomy wafer (an artificial barrier between the ileostomy and ileostomy bag) saturated with blood, and when the wafer was removed [sic] there was a large clot of jelly consistency in the top 1/4 of the ileostomy bag. The remainder of the ileostomy was full of dark-red blood, approximately 200 ml." "Called [MD name] and asked that she evaluate pt as soon as possible."

Patient #3's medical record included documentation she was ordered a blood transfusion on 8/19/17, at approximately 7:00 AM, and was transferred to a local hospital for a higher level of care at approximately 9:20 AM.

The RN did not document Patient #3's physician was contacted at 12:00 AM regarding "dark-red blood" in her ileostomy, which was a change in condition from the previous documentation, 6 hours and 45 minutes earlier. Additionally, the RN did not document she re-evaluated or re-assessed Patient #3's ileostomy/ ileostomy device for 5 hours, from 12:00 AM to 5:00 AM.

The DNO and RN Manager were interviewed together on 11/28/17, beginning at 9:40 AM, and Patient #3's medical record was reviewed in their presence. They confirmed the RN did not document if Patient #3's change in condition was communicated to her physician, or if Patient #3's ileostomy/ileostomy device was re-evaluated for the 5 hours from 12:00 AM to 5:00 AM. The DNO and RN Manager stated they expected RNs to document re-evaluation whenever there was a change in patient condition.

The facility failed to ensure Patient #3's care was evaluated by his RN.

Based on medical record review and staff interview, it was determined the facility failed to ensure medical record entries were accurately dated for 3 of 5 patients (#1, #2, and #3) whose records were reviewed. This failure resulted in improperly executed patient admission consents. Findings include:

1. Patient #1 was a 65 year old male who was admitted on 9/13/17, with a diagnosis of West Nile virus meningoencephalitis. Additional diagnoses were functional quadriplegia and debilitation. He was transferred to a local hospital for higher level of care on 9/23/17.

Patient #1's medical record included a "[hospital name] CONSENT TO HOSPITAL TREATMENT," signed by a witness and Patient #1's spouse. The top of page 1 of the consent was dated 9/28/17, however the witness's and Patient #1's spouse's signature on the bottom of page 2 did not include a date. It could not be determined what date the witness or Patient #1's spouse signed the consent.

2. Patient #2 was a 22 year old male who was admitted on 11/10/17, with a diagnosis of acute respiratory failure.

Patient #2's medical record included a "[hospital name] CONSENT TO HOSPITAL TREATMENT," signed by a witness and Patient #2's mother. The top of page 1 of the consent was dated 11/10/17, however the witness's and Patient #2's mother's signature on the bottom of page 2 did not include a date. It could not be determined what date the witness or Patient #2's mother signed the consent.

3. Patient #3 was a 76 year old female who was admitted on 8/18/17, with a diagnosis of post-surgical complications. She was transferred to a local hospital for higher level of care on 8/19/17, at approximately 9:45 AM.

Patient #3's medical record included a "[hospital name] CONSENT TO HOSPITAL TREATMENT," signed by a witness and Patient #3. The top of page 1 of the consent was dated 8/18/17, however the witness's and Patient #3's signature on the bottom of page 2 did not include a date. It could not be determined what date the witness or Patient #3 signed the consent.

The DNO was interviewed on 11/27/17, beginning at 3:40 PM, and Patient #1, #2, and #3's medical records were reviewed in her presence. She confirmed the dates on the patient admission consents could not be determined.

The facility failed to ensure patient admission consents were accurately dated.

Based on medical record review and staff interview, it was determined the facility failed to ensure medical records included documented information necessary to monitor patients' conditions for 2 of 5 patients (#1 and #5) whose records were reviewed. This failure had the potential to affect comprehensive patient care. Findings include:

1. Patient #1 was a 65 year old male who was admitted on 9/13/17, with a diagnosis of West Nile virus meningoencephalitis. Additional diagnoses were functional quadriplegia and debilitation. He was transferred to a local hospital for higher level of care on 9/23/17, following tracheostomy tube complications.

Patient #1's medical record included an "ICU FLOW SHEET," dated 9/23/17, signed by RN D. The flow sheet did not include clinical data, from 8:00 AM to 6:00 PM, in the following 7 sections:

- "Temperature"

- "Respiratory Rate"

- "SpO2 % [percentage of oxygen saturation in the blood]"

- "Ventilator Settings"

- "Urine Output"

- "Pain Level"

- "Positioning"

The DNO and RN D were interviewed together on 11/30/17, beginning at 10:30 AM, and Patient #1's medical record was reviewed in their presence. RN D confirmed Patient #1's flow sheet documentation was incomplete. RN D stated she usually filled out all data in patient forms, but failed to do so that day. The DNO and RN D confirmed there was inadequate documentation to monitor Patient #1's condition.

The facility failed to ensure Patient #1's medical record included information necessary to monitor his condition.



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2. Patient #5 was a 65 year old male admitted to the facility on 8/10/17, for acute respiratory failure and pneumonia. Additional diagnoses included COPD, cellulitis of lower extremities, acute kidney failure, hypokalemia (low potassium), malnutrition, depression, varicose veins, cervicalgia (neck pain), osteoarthritis, and morbid obesity. Patient #5 died on 9/09/17.

Patient #5's record included inconsistent documentation related to his weight and an incomplete admission assessment by the RN.

a. Patient #5's record included an "Admission Assessment," dated 8/10/17, which documented his weight was 62.5 kg per a bed scale. His H&P, dated 8/10/17, documented his weight was 83.6 kg. A "Clinical Record Medical/Surgical Flow Sheet," dated 8/10/17, documented Patient #5's weight was 82.5 kg. It was unclear which weight was the correct weight for Patient #5.

b. Patient #5's "Admission Assessment," dated 8/10/17, was incomplete. The neurological section of the assessment did not include depression in his history. Patient #5's admission H&P, dated 8/10/17, stated he had depression and was treated with Prozac (a medication used to treat depression). Additionally, the gross motor skills assessment was left blank related to his hand grasp strength.

The genitourinary section of the admission assessment was also incomplete. The form documented Patient #5's pre-illness bladder function was continent and incontinent. However, the current assessment portion of this section was left blank. It was unclear whether Patient #5 was currently experiencing bladder function problems.

The skin assessment section of the admission assessment was not completed. The form documented Patient #5 had erythema and bruising, but did not document where this was on his body. The skin section also included a picture of a human figure which stated Patient #5 had "mottled, red, edematous, open area" on his bilateral lower extremities. However, there was no documentation of the number of open areas or measurements of these possible open wounds.

During an interview at 2:40 PM on 11/30/17, the DNO and RN Manager reviewed Patient #5's record and confirmed the weights documented were inconsistent. The DNO and RN Manager confirmed it was unclear how much Patient #5 actually weighed on admission. The DNO also confirmed the admission assessment by nursing was incomplete and missing documentation related to his history, current status, and skin integrity.

Patient #5's medical record did not include accurate documentation of his weight on admission and included an incomplete nursing admission assessment.

Based on medical record review and staff interview, it was determined the facility failed to ensure an adequate number of RTs, or other medical staff, were available to meet patients' respiratory needs for 1 of 3 patients (Patient #1) who were transferred to another facility and whose records were reviewed. This failure directly resulted in an adverse patient event and had the potential to negatively impact all patients in the facility. Findings include:

Patient #1 was a 65 year old male who was admitted on 9/13/17, with a diagnosis of West Nile virus meningoencephalitis. Additional diagnoses were functional quadriplegia and debilitation. He was transferred to a local hospital for higher level of care on 9/23/17, following tracheostomy tube complications.

1. Patient #1's medical record included the following documented series of events:

- "VENTILATOR FLOW SHEET." RT D was assigned to Patient #1 during the physician ordered initial tracheostomy tube downsizing on 9/23/17. The last entry by RT D on the flow sheet was documented on 9/23/17 at 9:20 AM, "Trach care without inner cannula change without incident."

- "PHYSICIAN ORDERS," dated 9/23/17 at 11:10 AM, signed by the physician, stated "RT downsize trach #7 Portex." This was Patient #1's initial tracheostomy tube downsizing.

- "NURSING PROGRESS NOTE," dated 9/23/17 at 12:00 PM, signed by RN D stated "Orders to down size trach today. RT is aware."

- "RAPID RESPONSE TEAM RECORD," dated 9/23/17 at 3:16 PM, signed by RN D, stated "pt had trach downsized, trach canula [sic] became dislodged, recanulization [sic] resulted in canulization [sic] of interstitial space."

- "PHYSICIAN ORDERS," dated 9/23/17 at 5:45 PM, signed by the physician, stated "Transfer pt to [hospital name] downtown for evaluation of possible L PTX [left pneumothorax; deflated lung]...".

Following Patient #1's failed initial tracheostomy tube downsizing, he was emergently transferred to a local hospital for a higher level of care, which included a chest tube, for a pneumothorax. Patient #1 remained at the local hospital for 5 days and was transferred back to the facility on 9/28/17.

Respiratory Care Journal website, accessed 12/04/17, stated "The First Tracheostomy Tube Change...In general, it is advisable to have 2 people present for any tracheostomy tube change."

RT D did not document information regarding Patient #1's initial tracheostomy tube downsizing complications. It could not be determined by available documentation why RT D took 4 hours to carry out the physician's order. Additionally, it could not be determined by available documentation, if a physician, or more than 1 RT, was in the facility at the time of Patient #1's initial tracheostomy tube downsizing.

RN D was interviewed on 11/30/17, beginning at 10:30 AM, and Patient #1's medical record was reviewed in her presence. When asked if she was the RN who was assigned to Patient #1 on 9/23/17, and if she was familiar with his initial tracheostomy tube downsizing complications on that date, she stated yes. RN D stated RT D did not inform her he was going to attempt Patient #1's initial tracheostomy tube downsizing prior to performing the procedure. When asked why it took RT D 4 hours to carry out the physician's order, RN D stated she did not know.

The DOC was interviewed on 11/27/17, beginning at 2:15 PM, and Patient #1's medical record was reviewed in her presence. When asked if she was familiar with Patient #1's initial tracheostomy tube downsizing complications on 9/23/17, she stated yes. The DOC stated the facility had performed an RCA and placed RT D on disciplinary action. She stated RT D was no longer employed by the facility. The DOC stated RT D was working with the RT Lead on 9/23/17, however the RT Lead left work early that day without informing management. She stated there should have been 2 RTs, or 1 RT and 1 physician, in the facility when Patient #1's initial tracheostomy tube was downsized.

The Medical Director was interviewed on 11/28/17, beginning at 10:56 AM, and Patient #1's medical record was reviewed in her presence. When asked if she was familiar with Patient #1's initial tracheostomy tube downsizing complications on 9/23/17, she stated yes. When asked what her timeframe expectations for carrying out an order for tracheostomy tube downsizing was, the Medical Director stated "within the next hour or 2 from the order." The Medical Director stated she was not in the facility when RT D attempted to downsize Patient #1's tracheostomy tube and was "surprised" the order was carried out 4 hours after being written.

The DNO and RN Manager were interviewed together on 11/27/17, beginning at 3:40 PM, and Patient #1's medical record was reviewed in their presence. When asked if they were familiar with Patient #1's initial tracheostomy tube downsizing complications on 9/23/17, they stated yes. The DNO and RN Manager stated there should have been 2 RTs, or 1 RT and 1 physician, in the facility when Patient #1's initial tracheostomy tube was downsized. They stated the RT Lead had informed the Charge Nurse when she left early for the day on 9/23/17, but not management. When asked if there was a facility policy or procedure related to RT staffing for initial tracheostomy tube changes, the DNO and RN Manager stated no. When asked why it took RT D 4 hours to carry out the physician's order, they stated they did not know.

The facility failed to ensure an adequate number of RTs, or other medical staff, were available to meet Patient #1's respiratory needs.

2. Refer to A286 as it relates to the facility's failure to ensure adverse patient events were analyzed, and actions were taken to prevent further incidents for patients who required tracheostomy changes.

Based on medical record review, facility policy review, facility respiratory clinical standards of practice review, and staff interview, it was determined the facility failed to ensure required supervision for personnel to carry out specific procedures was in writing for 1 of 2 active inpatients (Patient #1) whose records were reviewed. This failure resulted in a respiratory care service being provided without a written policy or procedure. Findings include:

Patient #1 was a 65 year old male who was admitted on 9/13/17, with a diagnosis of West Nile virus meningoencephalitis. Additional diagnoses were functional quadriplegia and debilitation. He was transferred to a local hospital for higher level of care on 9/23/17, following tracheostomy tube complications.

Patient #1's medical record included an "ADMISSION ORDER SET," dated 9/13/17, signed by the physician. The physician ordered "NPO [nothing by mouth]."

Patient #1's medical record included a "VENTILATOR FLOW SHEET." On 9/23/17 at 4:20 AM, RT E documented "SX [suctioned] large amount blue dye. Blue from dye test for aspiration. Nurse informed." Patient #1's medical record did not include a physician order for a blue dye test for aspiration.

The facility policy and procedure table of contents was provided by the DOC on 11/27/17, at 9:50 AM. The table of contents did not list a policy or procedure for a blue dye test for aspiration.

A facility policy "Clinical Standards of Practice," revised 8/15, stated the facility's respiratory department followed "Egan's Fundamentals of Respiratory Care".

The DOC provided an excerpt of "Egan's Fundamentals of Respiratory Care," undated, on 11/28/17 at 8:00 AM. She stated this excerpt documented that an RT could perform a blue dye test for aspiration. Upon review, a section of the excerpt titled "Minimizing Likelihood of Aspiration" stated "These tests can be performed by various clinicians, including speech therapists, nurses, and RTs. To perform this test, blue food coloring is added to the patient's feedings or the patient swallows a small amount of blue food coloring in water." However, Patient #1 could not tolerate oral feeding or water as he was NPO.

The blue dye test for aspiration referenced in the provided respiratory clinical standards of practice did not outline how the test was to be performed for a patient who was NPO.

Facility RT staff were inconsistent in their explanation of how a blue dye test for aspiration procedure was performed as follows:

1. The RT Lead was interviewed on 11/27/17, beginning at 10:50 AM. When asked how a blue dye test for aspiration procedure is performed, she stated "apply blue dye drops on patient's tongue and then suction it out."

2. RT A was interviewed on 11/28/17, beginning at 10:08 AM. When asked how a blue dye test for aspiration procedure was performed, she stated "apply blue dye to patient's tongue, but I don't know how much." RT A stated she had never performed the procedure before and was unsure if there was a facility policy or procedure which governed the process.

3. RT B was interviewed on 11/28/17, beginning at 10:45 AM. When asked how a blue dye test for aspiration procedure was performed, she stated "SLP does that test, not RTs." RT B stated she had never performed the procedure before.

4. RT C was interviewed on 11/30/17, beginning at 11:00 AM. When asked how a blue dye test for aspiration procedure was performed, he stated "saturate a sponge and paint the patient's tongue."

The DOC, DNO, and RN Manager were interviewed together on 11/30/17, beginning at 1:20 PM, and Patient #1's medical record was reviewed in their presence. When asked if the facility had a policy or procedure which governed how a blue dye test for aspiration was performed, they stated no. When asked if there was documentation regarding required supervision for personnel to carry out a blue dye test for aspiration, the DOC and DNO stated no.

The facility failed to ensure required supervision for personnel to carry out a blue dye test for aspiration for Patient #1.

Based on medical record review and staff interview, it was determined the facility failed to ensure all respiratory care orders were documented in the medical record for 1 of 2 active inpatients (Patient #1) whose records were reviewed. This failure resulted in respiratory care services being provided without a physician's order. Findings include:

Patient #1 was a 65 year old male who was admitted on 9/13/17, with a diagnosis of West Nile virus meningoencephalitis. Additional diagnoses were functional quadriplegia and debilitation. He was transferred to a local hospital for higher level of care on 9/23/17, at approximately 6:00 PM, following tracheostomy tube complications.

Patient #1's medical record included a "VENTILATOR FLOW SHEET." On 9/23/17 at 4:20 AM, RT E documented "SX [suctioned] large amount blue dye. Blue from dye test for aspiration. Nurse informed." Patient #1's medical record did not include a physician order for a blue dye test.

RT A was interviewed on 11/28/17, beginning at 10:08 AM. When asked if a blue dye test required a physician order, she stated yes.

RT B was interviewed on 11/28/17, beginning at 10:45 AM. When asked if a blue dye test required a physician order, she stated yes.

RT C was interviewed on 11/30/17, beginning at 11:00 AM. When asked if a blue dye test required a physician order, he stated yes.

The SLP was interviewed on 11/30/17, beginning at 11:14 AM. When asked if a blue dye test required a physician order, she stated yes.

The DOC, DNO, and RN Manager were interviewed together on 11/30/17, beginning at 1:20 PM, and Patient #1's medical record was reviewed in their presence. They confirmed Patient #1's medical record did not include a documented physician order for a blue dye test.

The facility failed to ensure all respiratory care orders were documented in Patient #1's medical record.