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Tag No.: A0385
Based on review of medical records, staff interview, and review of policy and procedures it was determined the nursing department and staff failed to:
1. Ensure a registered nurse supervised and evaluated nursing care for each patient on an ongoing basis in accordance with hospital policy. Refer to A395
2. Assess patient needs, change in condition, and provide interventions according to standard nursing practice. These inactions lead to a continued deterioration of the patient's condition resulting in cardiac arrest and death. Refer to A395
3. Adequately supervise and evaluate the clinical activities of non-employee nursing personnel. The director of nursing services failed to provide for the adequate supervision and evaluation of the clinical activities of non-employee nursing personnel. Refer to A398
Tag No.: A0286
Based on policy review, medical record review, and staff interviews, it was determined the facility failed to sufficiently analyze an adverse patient event and implement preventive actions and mechanisms that included feedback and learning throughout the hospital to ensure patient safety was maintained for one (#3) of five medical records reviewed.
Findings included:
A review of the policy entitled, "Event Reporting System," # H-ML 04-001, released 06/2016, showed the policy purpose was to establish guidelines to improve patient care and safety. To understand how and why an event occurred and to prevent a similar event from occurring in the future ...in order to understand the causes of these event and opportunities to prevent them, the facility utilizes the Divisions' Event Reporting System (ERS) to track and analyze patient and visitor events. The policy is to ensure the following:
1. All event reports are reviewed periodically by the Quality Council and other relevant committees as part of the hospital's quality assurance and performance improvement program.
2. Hospital personnel are responsible for reporting in a timely and efficient manner, patient and visitor events through the ERS. Event are entered using a five level severity scale.
A Level 4 (Sentinel) Event is any death or major permanent loss of function (sensory, motor, physiologic or intellectual) not related to the natural course of the patient's illness or underlying condition (i.e., acts of commission or omission) ...a level 4 refers to any unexpected occurrence involving death ...not related to the natural course of the patient's illness or underlying condition and other high exposure patient safety and liability issues. The policy indicates the following procedures should be taken;
1. Take any necessary steps to ensure the patient's safety. The staff member that witnesses or identifies an event must notify his/her supervisor of the event as soon as possible ...Level 4 events must be reported immediately.
2. Enter the event into the ERS at the time of the event but no later than 24 hours after it occurs or is discovered.
3. Notify the external state agencies ...if required.
4. The aggregated results of events, including trends, patterns, and corrective action in response will be reported to the Quality Council at each Patient Safety Committee and/or Pharmacy, Nutrition and Therapeutic (ONT) Committee (typically monthly).
A review of the policy entitled, "Investigating Serious & Sentinel Events," #H-ML 04-003; release date 06/2017, showed the facility promotes a "just culture" which acknowledges that unsafe acts can results from systems or individual errors or both. Under a just culture, each event is analyzed for improvement opportunities using both a systems approach ...and safe work habits ...such as through competencies in teamwork, safe communications and specialized skills. The policy of the facility is to ensure the following:
1. Facilitate the determination of the causes of medical errors, rapid performance improvement and, root cause analysis.
2. Compliance with federal and state reporting requirements.
Continued review of the policy showed that interview and information gathering should be facilitated by the Director of Quality Management (DQM), in coordination with the Chief Clinical Officer, Chief Executive Officer or other leader and performs the following tasks as part of the investigation:
1. Interviews of staff who may have helpful information must be initiated immediately, preferably before leaving the hospital. Interview should be conducted by or under the directions of a member of the Quality Council and should include staff who have cared for the patient in the hours prior to and at the time of the event ...the interviews should be aimed at answering the following questions:
Who - identify individuals involved with the event or who have information that can help the understanding of the event
What - Interviews should focus on direct observations and avoid guessing or speculation. Describe the event in chronological order, including routine activities and anything out of the ordinary related to the patient's condition or circumstances.
When - Describe timing or time frame, including sequence of events.
Where - Location of the event, as well as any other information, such as the location of IV's, medications, or other equipment that might be related to the evet.
Why - Factors including system or processing deficiencies ...human error or other factors that may have directly or indirectly contributed to the event.
The policy further shows that a root-cause analysis (RCA) examines what happened, what process or other factors may have contributed to the event and establishes corrective action plan to reduce the likelihood the event could happen again. The RCA showed the following components:
1. Assess the systems and processes that worked well, as well as those that failed. To the extent that individual behavior contributed to the error ...failure to follow process ...focus on correction that will make it more difficult to repeat the effort.
2. Disciplinary actions or other human resources issues should be handled separately.
3. Identify any recovery actions taken that may have mitigated the harm ...when a single person or "cause" seems to be identified, continue asking "Why?' and "Why?" again, until the significant causes are identified.
4. Use the results of the analysis in performance improvement efforts.
A review of the facility policy entitled, "Hypotension-Shock During Dialysis," #7089, revised November 2016, showed that when hypotension is a systolic blood pressure (SBP) of less than 100 ...if hypotension occurs, the ultrafiltration rate should be reduced to a minimum.
A review of the facility policy entitled, Assessment/Re-Assessment-Interdisciplinary Patient, released 06/2018, #H-PC 02-001, showed the following purpose:
1. Care provided to each patient is based on an assessment of the patient's relevant physical ...needs.
2. To outline a systematic process for gathering pertinent information about each patient.
3. To establish a comprehensive information base for decision making about each patient's care.
4. To determine the appropriate care, treatment and services to meet the patient's needs during hospitalization.
Assessment and data collection performed by licensed health care professional will include and address:
a. Patient specific needs.
b. Information from ...other health care providers ...paper/electronic documents and/or other services as available.
c. Data analysis to develop a plan of care to meet the patient's care or treatment needs.
d. Prioritized decisions regarding patient care and/or treatment based on assessment data analysis.
5. Transfer of patient information to other caregivers, both internal and external during referral or transfer of care to other providers of care, treatment for services. The transferred patient information will be documented on the hospital's handoff communication tool or within the designated pathway in the electronic medical record (EMR). The patient information may include the patient's condition, care, treatment, medications, services, and any recent or anticipated changes to any of these.
6. Patient assessment is based on, but not limited to the following:
a. To evaluate patient response to care, treatment and services
b. To responds to a significant change is status and/or diagnosis or conditions.
7. Reporting/Notification of a change in condition if an acute change of condition is a clinically important change from a patient's established documented baseline in physical, cognitive, behavioral, of functional domains. An acute change in condition may occur abruptly or over several hours to several days, present as physical changes or as changes in function, mood, cognition, or behavior ...change in condition depends in part on the patient's prior condition ...and may include, but are not limited to:
- Systolic BP < 80
- Respiratory distress (shortness of breath)
- Change in level of consciousness or mental status that is a change in baselines.
- Significant bleeding that doesn't respond to pressure
8. Notification responsibilities when an assessment reveals a change or suspected change in condition.
a. The nurse assigned to the patient or supervising the care of the patient is responsible for notification of and communication to the patient's primary physician or designee using appropriate channels and chain of command for assuring that there is physician response.
b. Significant changes or deterioration of the patient's condition will initiate the facility's rapid response process.
c. Notification of a change of conditions is completed utilizing situational-background-assessment-recommendation (SBAR) technique or framework for communications.
d. Notify the Nursing Supervisor of the patient change in condition.
e. Document change of condition, notification and interventions in the medical record under "Change of Condition" Pathway.
A review of Patient #3's medical record history and physical (H&P) dated 05/29/18 showed a 56 year old man with a history of hypertension, diabetes, coronary disease status post bypass graft (CABG), end stage renal disease (ESRD), and encephalopathy. The patient was admitted to the facility for rehabilitation of weakness, dizziness, and confusion.
A review of the nephrology (kidney) physician note dated 05/30/18 showed Patient #3 had a right upper extremity arteriovenous (AV) fistula that was being utilized for hemodialysis (HD) on Monday, Wednesdays, and Fridays. The physician noted the presence of a hematoma at the site of the AV fistula. The patient was noted to be awake, alert and oriented (A&O) times three (person, place and time) and vital signs (VS's) stable.
A review of Patient #3's labs revealed the following partial thromboplastin time (PTT) (a screening test that helps evaluate a person's ability to appropriately form blood clots, which is measurde in seconds) was high increasing the risk of prolonged bleeding.
05/31/18 Prothrombin time (PTT) 15.8 sec. (High is10.6-12.9)
06/01/18 PTT 17.4 sec. (High is 10.6-12.9)
A review of Patient #3's labs revealed the following hemoglobin and hematocrit (H&H - Hemoglobin is the oxygen-carrying protein pigment in the blood, specifically in the red blood cells. A low hemoglobin can be caused by excessive blood loss):
06/01/18 at 3:46 AM H&H 7.9 g/dl and 24.2%
06/01/18 at 3:20 PM H&H 6.6 g/dl and 20.1%
A review of Patient #3's (HD) Registered Nurse (RN) nursing notes dated 06/01/18 revealed the following entries and times:
11:00 AM - Pre-dialysis treatment. Consent received AV fistula patent. Patient is independently oriented to person, place and time. Behavior is alert and cooperative. (Documentation entered into the medical record at 3:57 PM, four hours later).
11:40 AM - BP 143/49, HR 57 Comment: treatment started. Patient (Pt.) with no complaints, vital signs stable, will continue to monitor during dialysis, Pt. stable given 250 ml normal saline from prime. Ultrafiltration Rate (UFR) 400 ml/hr. (Documentation entered into the medical record at 3:57 PM, four hours later).
12:10 AM - During HD treatment - BP 95/53, HR 59 Comment: stopped treatment, patient removed one needle. Vital signs stable, will continue to monitor during dialysis. UFR 100 ml/hr. nephrology physician aware. (Documentation entered into the medical record at 3:57 PM, 3 hours and 50 min. later).
12:40 PM - During HD treatment - BP 79/40, HR 53 Comment: treatment restart. Pt with BP low. Given 250 ml normal saline from prime. Will continue to monitor during dialysis. UFR 450 ml/hr. Pt. confused. (Documentation entered into the medical record at 4:10 PM, 3 hours and 30 min. later).
12:58 PM - Nephrology physician order for albumin 25% IV 25 grams STAT (immediately) x 1.
1:10 PM - During HD treatment - BP 82/45, HR 52 Comment: Pt continues with low BP and the system clotted. URF 500 ml/hr. Notified Patient #3's nephrology physician and orders for a complete blood count (CBC). Running treatment tomorrow (Documentation entered into the medical record at 4:14 PM, 3 hours later).
1:25 PM - Post-dialysis. Procedure discontinued, hold pressure to site for 20 min. Total fluids given 550 ml, fluid removed 100 ml, Net fluid balance 450 ml. Access flow: poor fistula type: AVF. Neurological assessment is now oriented to person only and behavior is now confused and uncooperative.
1:30 PM - handoff report received post HD read as follows: discontinue treatment, nephrology physician aware.
2:23 PM - Blood count complete with auto differential, STAT x 1, discontinue order for albumin 25% IV 25 g STAT x 1 per nephrology physician order.
3:43 PM - BP 130/49, HR 57 (Documentation entered into the medical record at 3:44 PM).
4:15 PM - BP 101/43, HR 55 (Documentation entered into the medical record at 4:15 PM).
4:27 PM - Heparin subcutaneous injection 5, 000 units to start 06/01/18 at 10:00 PM per nephrology physician order.
4:18 PM - AV shunt right arm infusing. (Hand off report showing the HD RN was no longer providing care occurred at 1:30 PM).
4:20 PM - AV shunt right arm infusing. (Hand off report showing the HD RN was no longer providing care occurred at 1:30 PM).
On 07/13/18 at 10:00 AM, a second interview was conducted with the Amerirenal Center (ARC) Charge RN related to her review of Patient #3's medical record. The ARC RN stated she had reviewed the documentation of the HD RN that was caring for Patient #3 and that the HD RN documented that she cannulated the HD AV fistula with a 15-gauge needle. The order was for a 16-gauge needle due to the AV fistula being immature, fragile and friable. Additionally, ARC policy, as well as the Nephrology Nurses Association guidelines, state that if a patient has a SBP below 90, the RN should not restart the HD. The charge RN stated that Patient #3's HD RN documented she "primed" with 250 ml's of normal saline (NS). This 250 ml's of NS was only to prime the machine, it was not a bolus given to the patient to assist with the blood pressure. The charge RN stated she knew this was the second setup as evidenced by the verbiage "prime." The HD RN never documented the blood lost in the system or that this was her second HD setup. The HD RN documented the line clotted resulting in approximately 200 ml's of blood lost to the tubing setup and another 86 ml's lost to the HD filter, which is almost a pint of blood (300 ml's).
The charge RN stated that if the nephrology physician had been aware that this was the second setup, he would not have wanted the HD to be performed with a SBP of less than 90. Additionally, this nurse failed to lower the filtration rate. Patient #3 was struggling to maintain his BP and the filtration rate was set at 500. She did not document that she reduced the rate to a lower rate, like 100, which further contributed to the patient's dropping BP.
In summary, the HD RN failed to:
1. Accurately document when the HD needle was pulled out by Patient #3.
2. Document the amount of estimated blood loss (EBL) when the HD needle was pulled out and the amount lost during the second HD setup.
3. Report to Patient #3's primary physician and nephrologist the EBL, low blood pressure, and that HD was on the second setup.
4. Lower the ultrafiltration rate (UFR) as required per policy in the presence of hypotension (low blood pressure).
5. Accurately provide a handoff report to Patient #3's RN of the patient's blood loss, low blood pressure, change in LOC, and the second HD setup.
6. Follow the nephrology physician orders for cannulation of the HD AV fistula with a 16-gauge needle and instead used as 15-gauge needle in a fragile, friable fistula.
A review of Patient #'3's staff RN's notes dated 06/01/18 at 11:15 PM showed a handoff report was given to the HD RN. The report read as follows, pre HD report, consent verified, signed by MD and on chart. Hepatitis B antigen and antibody negative. RN instructed in the event of an incapacitated dialysis staff.
A review of Patient #3's RN nursing notes dated 06/01/18 revealed the following entries and times:
2:15 PM - Blood count complete with auto differential STAT (immediately) x1 per primary care physician order.
2:30 PM - Change in level of Consciousness/Change of Condition. Assisted nursing assistant to clean the patient Noted fresh blood on his shirt, bed sheet and pillows. Noted clots of blood. Pt. is pale and cold to touch. Pt. had a bowel movement and urinated on his shorts. Pt. is unresponsive to questions. Pt. states he cannot breath. Pulse oximetry was performed and cannot get a number. Respiratory therapist called to respond to treatment. Skin is pink but cold to touch. Pt. is sleepy. Pt was asked if he has family and states no and he makes his own decisions. Pt. was cleaned and left to get some sleep. Came back again after 15 min. to get blood for STAT CBC. Pt. still responsive to questions and pain. Came back again in 30 min. to start IV, but not successful (Documentation entered into the medical record at 8:10 PM, 4 hours and 40 min. later).
2:45 PM - BP 110/76, HR 77
3:19 PM - Blood count complete with auto differential.
5:15 PM - Peripheral venous midline, type and cross match for 1 unit of blood, packed red blood cells 1 unit IV infusion STAT x 1 per nephrology physician order.
5:40 PM - Change of Condition. Arrest observed, cardiac arrest, respiratory arrest, CPR started at 5:43 PM by respiratory therapist.
5:50 PM - Electrocardiography (EKG) performed
5:52 PM - Pt was noted unresponsive, pale, cold to touch, rapid response called. No pulse, Code Blue was called. Treatment initiated. Response to treatment: Pt. was pronounced dead by physician running the code.
I.V. Epinephrine 1m g at 6:02 PM
I.V. Epinephrine 1m g at 6:05 PM
I.V. Epinephrine 1m g at 6:10 PM
I.V. Epinephrine 1m g at 6:13 PM
I.V. Epinephrine 1m g at 6:17 PM
Resuscitation ended at 6:20 PM. Patient status: deceased
(Documentation entered into the medical record at 7:52 PM, 2 hours later).
On 07/13/18 at 9:18 AM, an interview was conducted with Patient #3's RN. She stated she gave a handoff report to the HD RN about 11:00 AM. She stated shortly after she gave a handoff report to the HD RN, she heard her yelling and asking for help for someone to get her some gauze. Patient #3's RN stated she saw the HD RN holding the patient' fistula and was trying to tape the needle down but the patient kept moving. I asked the HD RN if she needed any further help and she stated no, I got this, I'm okay. Patient #3's RN stated that HD had not been started when the HD needle was pulled out. She stated she left and did not know what happened after that. She stated she was at lunch when the HD RN came in to give her report. Patient' #3's RN stated the report she received was that the HD RN had ran dialysis and had taken zero fluids off during the run. She also stated that the patient's BP was low and she gave a liter of normal saline. She also indicated that she would help the nursing assistant to clean up the patient. Patient' #3's RN stated that was all the information she received during the handoff report. Patient' #3's RN stated that after she finished her lunch she ran into Patient #3's primary physician in the hallway and he asked what was wrong with the patient because he saw blood in the bed. Patient' #3's RN stated she told the physician the HD needle was pulled out before HD had started. At that time, she was told to obtain a complete blood count (CBC). Patient' #3's RN stated she than went to the room to assist the nursing assistant with cleaning up the patient. She stated the patient was responsive and the patient told her he was very weak. She stated that when the patient was turned she saw blood down his shoulder, gown and onto the bed. She stated that was not normal and that she noticed blood clots and about a 1/4 of the mattress was saturated with blood. At this point, the patient stated he was having a hard time breathing and she called respiratory therapy (RT) for a breathing treatment. Patient' #3's RN stated the HD RN did not tell her during handoff report that the patient had lost any blood. Although she acknowledges seeing the blood in the bed. After she called RT, she asked the patient if she could call his family for a change of clothing and he indicated that he did not have any family. She stated she thought the patient was confused because she knew he had a sister. Patient' #3's RN stated she spent the next two hours attempting to obtain an intravenous (IV) site. She stated that she was so busy with cleaning up the blood and attempting to find an IV site and she knew the BP was already running low. After two hours, she called the physician to make a request for a midline. After the STAT order for a midline was obtained, the unit secretary made a call to Access RN for a STAT midline. Patient' #3's RN stated after she received the order for the midline it was time to perform accuchecks (blood sugar analysis). She stated it was about 5:00 PM when she started doing accuchecks. A review of physician orders showed the nephrology physician was called for the midline at 5:15 PM. Patient' #3's RN stated she told her supervisor that she was waiting for the Access RN to come and start a midline IV site. She further stated she decided to do Patient #3's accucheck first and at that time, she stated he looked different and was not responsive and was moaning despite having the oxygen. Patient' #3's RN stated at this time the Access RN also showed up but was unable to get a midline because the patient was coding. She stated she was not really in the room when this was occurring because she was attempting to contact the family.
In summary, Patient #3's RN failed to:
1. Report to the primary care physician and unit supervisor of the patient's change in conditions related to difficulty breathing, change in level of consciousness (LOC), ongoing low blood pressure, and inability to obtain IV access in a timely manner.
2. Identify the significance and relevance of the patient's change in condition and thereby failed to rescue the patient.
3. Assess and evaluate the significant change in the patient's H&H and PTT blood work.
4. Increase patient monitoring and vital signs.
5. Initiate a rapid response as required by facility policy.
6. Document the change of condition in the medical record using situational-background-assessment-recommendation (SBAR) technique or framework for communications as required by policy.
7. Report in a timely and efficient manner events through the ERS.
On 07/13/18s at 4:00 PM, an interview with the Risk Manager (RM) revealed she was not aware of the all of the events identified during staff interviews performed during this complaint investigation. The RM stated the medical record did not capture the real truth and therefore had not identifed Patient #3's death as a sentinel event requiring investigation.
On 07/13/18 at 4:10 PM, an interview with the DON revealed the facility had performed an investigation that included a timeline of events, but did not feel there were any findings for process improvement. The DON stated she was unaware of the events that were identified by this surveyor during the staff interviews conducted with Patient #3's RN and the ARC charge nurse on 07/12/18 and 07/13/18. The DON stated the facility had not idenfitied Patient #3's death as a serious sentinel event that required investigation.
Tag No.: A0395
Based on policy review, medical record review, and staff interview it was determined nursing failed to ensure a registered nurse supervised and evaluated nursing care for each patient on an ongoing basis in accordance with hospital policy. Failed to assess patient needs, change in condition, and provide interventions according to standard nursing practice, resulting in cardiac arrest and death for one (#3) of 5 medical records sampled.
Findings included:
A review of the facility policy entitled, Assessment/Re-Assessment-Interdisciplinary Patient, released 06/2018, #H-PC 02-001, showed the following purpose:
1. Care provided to each patient is based on an assessment of the patient's relevant physical ...needs.
2. To outline a systematic process for gathering pertinent information about each patients.
3. To establish a comprehensive information base for decision making about each patient's care.
4. To determine the appropriate care, treatment and services to meet the patient's needs during hospitalization.
Assessment and data collection performed by licensed health care professional will include and address:
a. Patient specific needs.
b. Information from ...other health care providers ...paper/electronic documents and/or other services as available.
c. Data analysis to develop a plan of care to meet the patient's care or treatment needs.
d. Prioritized decisions regarding patient care and/or treatment based on assessment data analysis.
5. Transfer of patient information to other caregivers, both internal and external during referral or transfer of care to other providers of care, treatment for services. The transferred patient information will be documented on the hospital's handoff communication tool or within the designated pathway in the electronic medical record (EMR). The patient information may include the patient's condition, care, treatment, medications, services, and any recent or anticipated changes to any of these.
6. Patient assessment is based on, but not limited to the following:
a. To evaluate patient response to care, treatment and services
b. To responds to a significant change is status and/or diagnosis or conditions.
7. Reporting/Notification of a change in condition if an acute change of condition is a clinically important change from a patient's established documented baseline in physical, cognitive, behavioral, of functional domains. An acute change in condition may occur abruptly or over several hours to several days, present as physical changes or as changes in function, mood, cognition, or behavior ...change in condition depends in part on the patient's prior condition ...and may include, but are not limited to:
- Systolic BP < 80
- Respiratory distress (shortness of breath)
- Change in level of consciousness or mental status that is a change in baselines.
- Significant bleeding that doesn't respond to pressure
8. Notification responsibilities when an assessment reveals a change or suspected change in condition.
a. The nurse assigned to the patient or supervising the care of the patient is responsible for notification of and communication to the patient's primary physician or designee using appropriate channels and chain of command for assuring that there is physician response.
b. Significant changes or signification deterioration of the patient's condition will initiate the facility's rapid response process.
c. Notification of a change of conditions is completed utilizing situational-background-assessment-recommendation (SBAR) technique or framework for communications.
d. Notify the Nursing Supervisor of the patient change in condition.
e. Document change of condition, notification and interventions in the medical record under "Change of Condition" Pathway.
A review of Patient #3's medical record history and physical (H&P) dated 05/29/18 showed a 56 year old man with a history of hypertension, diabetes, coronary disease status post bypass graft (CABG), end stage renal disease (ESRD), and encephalopathy. The patient was admitted to the facility for rehabilitation of weakness, dizziness, and confusion.
A review of the nephrology (kidney) physician note dated 05/30/18 showed the patient has a right upper extremity ateriovenous (AV) fistula that was being utilized for hemodialysis (HD) on Monday, Wednesdays, and Fridays. The physician noted the presence of a hematoma at the site of the AV fistula. The patient was noted to be awake, alert and oriented (A&O) times three (person, place and time) and vital signs (VS's) stable.
A review of the infectious disease physician progress note dated 05/31/18 showed the patient was A&O with improvement in the encephalopathy. The patient's blood pressure (BP) was noted to be 168/82 with a heart rate (HR) of 82.
A review of Patient #3's labs revealed the following partial thromboplastin time (PTT) (a screening test that helps evaluate a person's ability to appropriately form blood clots, which is measured in seconds) was high increasing the risk of prolonged bleeding.
05/31/18 Prothrombin time (PTT) 15.8 sec. (High is10.6-12.9)
06/01/18 PTT 17.4 sec. (High is 10.6-12.9)
A review of Patient #3's labs revealed the following hemoglobin and hematocrit (H&H - Hemoglobin is the oxygen-carrying protein pigment in the blood, specifically in the red blood cells. A low hemoglobin can be caused by excessive blood loss):
06/01/18 at 3:46 AM H&H 7.9 g/dl and 24.2%
06/01/18 at 3:20 PM H&H 6.6 g/dl and 20.1%
A review of Patient #'3's staff RN's notes dated 06/01/18 at 11:15 PM showed a handoff report was given to the HD RN. The report read as follows, pre HD report, consent verified, signed by MD and on chart. Hepatitis B antigen and antibody negative. RN instructed in the event of an incapacitated dialysis staff.
A review of Patient #3's RN nursing notes dated 06/01/18 revealed the following entries and times:
2:15 PM - Blood count complete with auto differential STAT (immediately) x1 per primary care physician order.
2:30 PM - Change in level of Consciousness/Change of Condition. Assisted nursing assistant to clean the patient Noted fresh blood on his shirt, bed sheet and pillows. Noted clots of blood. Pt. is pale and cold to touch. Pt. had a bowel movement and urinated on his shorts. Pt. is unresponsive to questions. Pt. states he cannot breath. Pulse oximetry was performed and cannot get a number. Respiratory therapist called to respond to treatment. Skin is pink but cold to touch. Pt. is sleepy. Pt was asked if he has family and states no and he makes his own decisions. Pt. was cleaned and left to get some sleep. Came back again after 15 min. to get blood for STAT CBC. Pt. still responsive to questions and pain. Came back again in 30 min. to start IV, but not successful (Documentation entered into the medical record at 8:10 PM, 4 hours and 40 min. later).
2:45 PM - BP 110/76, HR 77
3:19 PM - Blood count complete with auto differential.
5:15 PM - Peripheral venous midline, type and cross match for 1 unit of blood, packed red blood cells 1 unit IV infusion STAT x 1 per nephrology physician order.
5:40 PM - Change of Condition. Arrest observed, cardiac arrest, respiratory arrest, CPR started at 5:43 PM by respiratory therapist.
5:50 PM - Electrocardiography (EKG) performed
5:52 PM - Pt was noted unresponsive, pale, cold to touch, rapid response called. No pulse, Code Blue was called. Treatment initiated. Response to treatment: Pt. was pronounced dead by physician running the code.
I.V. Epinephrine 1m g at 6:02 PM
I.V. Epinephrine 1m g at 6:05 PM
I.V. Epinephrine 1m g at 6:10 PM
I.V. Epinephrine 1m g at 6:13 PM
I.V. Epinephrine 1m g at 6:17 PM
Resuscitation ended at 6:20 PM. Patient status: deceased
(Documentation entered into the medical record at 7:52 PM, 2 hours later).
On 07/13/18 at 9:18 AM, an interview was conducted with Patient #3's RN. She stated she gave a handoff report to the HD RN about 11:00 AM. She stated shortly after she gave a handoff report to the HD RN, she heard her yelling and asking for help for someone to get her some gauze. Patient #3's RN stated she saw the HD RN holding the patient' fistula and was trying to tape the needle down but the patient kept moving. I asked the HD RN if she needed any further help and she stated no, I got this, I'm okay. Patient #3's RN stated that HD had not been started when the HD needle was pulled out. She stated she left and did not know what happened after that. She stated she was at lunch when the HD RN came in to give her report. Patient #3's RN stated the report she received was that the HD RN had ran dialysis and had taken zero fluids off during the run. She also stated that the patient's BP was low and she gave a liter of normal saline. She also indicated that she would help the nursing assistant to clean up the patient. Patient' #3's RN stated that was all the information she received during the handoff report. Patient' #3's RN stated that after she finished her lunch she ran into Patient #3's primary physician in the hallway and he asked what was wrong with the patient because he saw blood in the bed. Patient' #3's RN stated she told the physician the HD needle was pulled out before HD had started. At that time, she was told to obtain a complete blood count (CBC). Patient' #3's RN stated she than went to the room to assist the nursing assistant with cleaning up the patient. She stated the patient was responsive and the patient told her he was very weak. She stated that when the patient was turned she saw blood down his shoulder, gown and onto the bed. She stated that was not normal and that she noticed blood clots and about a ¼ of the mattress was saturated with blood. At this point, the patient stated he was having a hard time breathing and she called respiratory therapy (RT) for a breathing treatment. Patient' #3's RN stated the HD RN did not tell her during handoff report that the patient had lost any blood. Although she acknowledges seeing the blood in the bed. After she called RT, she asked the patient if she could call his family for a change of clothing and he indicated that he did not have any family. She stated she thought the patient was confused because she knew he had a sister. Patient' #3's RN stated she spent the next two hours attempting to obtain an intravenous (IV) site. She stated that she was so busy with cleaning up the blood and attempting to find an IV site and she knew the BP was already running low. After two hours, she called the physician to make a request for a midline. After the STAT order for a midline was obtained, the unit secretary made a call to Access RN for a STAT midline. Patient' #3's RN stated after she received the order for the midline it was time to perform accuchecks (blood sugar analysis). She stated it was about 5:00 PM when she started doing accuchecks. A review of physician orders showed the nephrology physician was called for the midline at 5:15 PM. Patient' #3's RN stated she told her supervisor that she was waiting for the Access RN to come and start a midline IV site. She further stated she decided to do Patient #3's accucheck first and at that time, she stated he looked different and was not responsive and was moaning despite having the oxygen. Patient' #3's RN stated at this time the Access RN also showed up but was unable to get a midline because the patient was coding. She stated she was not really in the room when this was occurring because she was attempting to contact the family.
In summary, Patient #3's RN failed to:
1. Report to the primary care physician and unit supervisor of the patient's change in conditions related to difficulty breathing, change in level of consciousness (LOC), ongoing low blood pressure, and inability to obtain IV access in a timely manner.
2. Identify the significance and relevance of the patient's change in condition and thereby failed to rescue the patient.
3. Assess and evaluate the significant change in the patient's H&H and PTT blood work.
4. Increase patient monitoring and vital signs.
5. Initiate a rapid response as required by facility policy.
6. Document the change of condition in the medical record using situational-background-assessment-recommendation (SBAR) technique or framework for communications as required by policy.
Tag No.: A0398
Based on medical record review, policy review and staff interview, the Director of Nursing (DON) failed to adequately supervise and evaluate the clinical activities of non-employee nursing personnel.
Findings included:
A review of Patient #3's medical record history and physical (H&P) dated 05/29/18 showed a 56 year old man with a history of hypertension, diabetes, coronary disease status post bypass graft (CABG), end stage renal disease (ESRD), and encephalopathy. The patient was admitted to the facility for rehabilitation of weakness, dizziness, and confusion.
A review of the nephrology (kidney) physician note dated 05/30/18 showed Patient #3 had a right upper extremity arteriovenous (AV) fistula that was being utilized for hemodialysis (HD) on Monday, Wednesdays, and Fridays. The physician noted the presents of a hematoma at the site of the AV fistula. The patient was noted to be awake, alert and oriented (A&O) times three (person, place and time) and vital signs (VS's) stable.
A review of Patient #3's labs revealed the following partial thromboplastin time (PTT) (a screening test that helps evaluate a person's ability to appropriately form blood clots, which is measured in seconds) was high increasing the risk of prolonged bleeding.
05/31/18 Prothrombin time (PTT) 15.8 sec. (High is10.6-12.9)
06/01/18 PTT 17.4 sec. (High is 10.6-12.9)
A review of Patient #3's labs revealed the following hemoglobin and hematocrit (H&H - Hemoglobin is the oxygen-carrying protein pigment in the blood, specifically in the red blood cells. A low hemoglobin can be caused by excessive blood loss):
06/01/18 at 3:46 AM H&H 7.9 g/dl and 24.2%
06/01/18 at 3:20 PM H&H 6.6 g/dl and 20.1%
A review of the facility policy entitled, "Hypotension-Shock During Dialysis," #7089, revised November 2016, showed that when hypotension is a systolic blood pressure (SBP) of less than 100 ...if hypotension occurs, the ultrafiltration rate should be reduced to a minimum
A review of Patient #3's (HD) Registered Nurse (RN) nursing notes dated 06/01/18 revealed the following entries and times:
11:00 AM - Pre-dialysis treatment. Consent received AV fistula patent. Patient is independently oriented to person, place and time. Behavior is alert and cooperative. (Documentation entered into the medical record at 3:57 PM, four hours later).
11:40 AM - BP 143/49, HR 57 Comment: treatment started. Patient (Pt.) with no complaints, vital signs stable, will continue to monitor during dialysis, Pt. stable given 250 ml normal saline from prime. Ultrafiltration Rate (UFR) 400 ml/hr. (Documentation entered into the medical record at 3:57 PM, four hours later).
12:10 AM - During HD treatment - BP 95/53, HR 59 Comment: stopped treatment, patient removed one needle. Vital signs stable, will continue to monitor during dialysis. UFR 100 ml/hr. nephrology physician aware. (Documentation entered into the medical record at 3:57 PM, 3 hours and 50 min. later).
12:40 PM - During HD treatment - BP 79/40, HR 53 Comment: treatment restart. Pt with BP low. Given 250 ml normal saline from prime. Will continue to monitor during dialysis. UFR 450 ml/hr. Pt. confused. (Documentation entered into the medical record at 4:10 PM, 3 hours and 30 min. later).
12:58 PM - Nephrology physician order for albumin 25% IV 25 grams STAT (immediately) x 1.
1:10 PM - During HD treatment - BP 82/45, HR 52 Comment: Pt continues with low BP and the system clotted. URF 500 ml/hr. Notified Patient #3's nephrology physician and orders for a complete blood count (CBC). Running treatment tomorrow (Documentation entered into the medical record at 4:14 PM, 3 hours later).
1:25 PM - Post-dialysis. Procedure discontinued, hold pressure to site for 20 min. Total fluids given 550 ml, fluid removed 100 ml, Net fluid balance 450 ml. Access flow: poor fistula type: AVF. Neurological assessment is now oriented to person only and behavior is now confused and uncooperative.
1:30 PM - handoff report received post HD read as follows: discontinue treatment, nephrology physician aware.
2:23 PM - Blood count complete with auto differential, STAT x 1, discontinue order for albumin 25% IV 25 g STAT x 1 per nephrology physician order.
3:43 PM - BP 130/49, HR 57 (Documentation entered into the medical record at 3:44 PM).
4:15 PM - BP 101/43, HR 55 (Documentation entered into the medical record at 4:15 PM).
4:27 PM - Heparin subcutaneous injection 5, 000 units to start 06/01/18 at 10:00 PM per nephrology physician order.
4:18 PM - AV shunt right arm infusing. (Hand off report showing the HD RN was no longer providing care occurred at 1:30 PM).
4:20 PM - AV shunt right arm infusing. (Hand off report showing the HD RN was no longer providing care occurred at 1:30 PM).
On 07/13/18 at 10:00 AM, a second interview was conducted with the Amerirenal Center (ARC) Charge RN related to her review of Patient #3's medical record. The ARC RN stated she had reviewed the documentation of the HD RN that was caring for Patient #3 and had some concerns she wanted to share. She stated that the HD RN documented that she cannulated the HD AV fistula with a 15-gauge needle. The order was for a 16-gauge needle due to the AV fistula being immature, fragile and friable. Additionally, ARC policy, as well as the Nephrology Nurses Association guidelines, state that if a patient has a SBP below 90, the RN should not restart the HD. The charge RN stated that Patient #3's HD RN documented she "primed" with 250 ml's of normal saline (NS). This 250 ml's of NS was only to prime the machine, it was not a bolus given to the patient to assist with the blood pressure. The charge RN stated she knew this was the second setup as evidenced by the verbiage "prime." The HD RN never documented the blood lost in the system or that this was her second HD setup. The HD RN documented the line clotted resulting in approximately 200 ml's of blood lost to the tubing setup and another 86 ml's lost to the HD filter, which is almost a pint of blood (300 ml's).
The charge RN stated that if the nephrology physician had been aware that this was the second setup, he would not have wanted the HD to be performed with a SBP of less than 90. Additionally, this nurse failed to lower the filtration rate. Patient #3 was struggling to maintain his BP and the filtration rate was set at 500. She did not document that she reduced the rate to a lower rate, like 100, which further contributed to the patient's dropping BP.
In summary, the HD RN failed to:
1. Accurately document when the HD needle was pulled out by Patient #3.
2. Document the amount of estimated blood loss (EBL) when the HD needle was pulled out and the amount lost during the second HD setup.
3. Report to Patient #3's primary physician and nephrologist the EBL, low blood pressure, and that HD was on the second setup.
4. Lower the ultrafiltration rate (UFR) as required per policy in the presence of hypotension (low blood pressure).
5. Accurately provide a handoff report to Patient #3's RN of the patient's blood loss, low blood pressure, change in LOC, and the second HD setup.
6. Follow the nephrology physician orders for cannulation of the HD AV fistula with a 16-gauge needle and instead used as 15-gauge needle in a fragile, friable fistula.
A review of the facility organization chart confirmed the DON is responsible for nursing services.
On 07/13/18 at 4:10 PM, an interview with the DON revealed the facility had performed an investigation that included a timeline of events, but did not feel there were any findings for process improvement. The DON stated she was unaware of the events that were identified by this surveyor during the staff interviews conducted with Patient #3's RN and the ARC charge nurse on 07/12/18 and 07/13/18.