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Based on staff interviews, record review, review of policy and procedures, and administrative reviews (including Performance Improvement data and internal investigation); the facility failed to ensure adequate supervision by nursing to protect 1 patient (Patient 1) with a continuous bladder irrigation (CBI = a system that continuously flushes the bladder through a tube inserted through the urinary tract into the bladder) from sustaining a bladder rupture [burst] causing fluid to travel into the peritoneal cavity [space within the abdomen that contains the intestines, stomach and liver surrounded by thin membranes) . The staff failed to closely monitor the CBI irrigation, the amount of intravenous (IV) fluid infused into the bladder; and the total amount of intake versus the catheter output. The facility census was 112.


Refer to A-395

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Based on staff interviews, record review, review of policy and procedures, and administrative reviews (including Performance Improvement data and internal investigation); the facility failed to ensure adequate supervision by nursing to protect 1 patient (Patient 1) with a continuous bladder irrigation (CBI = a system that continuously flushes the bladder through a tube inserted through the urinary tract into the bladder) from sustaining a bladder rupture [burst] causing fluid to travel into the peritoneal cavity [space within the abdomen that contains the intestines, stomach and liver surrounded by thin membranes) . The staff failed to closely monitor the CBI irrigation, the amount of intravenous (IV) fluid infused into the bladder; and the total amount of intake versus the catheter output. The total sample size was 10, with only one patient receiving CBI. The facility census was 112.

Findings are:

A. A review of Patient 1's medical record revealed that Patient 1 arrived at the hospital on 7/21/19 at 1441 (2:41 PM) for emergency services with complaints of weakness and hematuria (blood in urine). Patient 1 was evaluated and admitted to the hospital on 7/21/19 at 2043 (8:43 PM). Review of the patient ' s History and Physical (dated 7/21/19 at 6:18 PM) revealed the patient had been having hematuria for 1-2 months and was also experiencing progressive weakness. The patients blood work showed hemoglobin (a lab test to check for anemia) was low at 8.5 (normal levels are 13.5-17.5). A CT Scan (Cat Scan- a specialized scan) was performed on the patient while in the emergency room which identified a 6.8 cm (centimeters) left renal mass with possible tumor thrombus into the Inferior Vena Cava (a kidney tumor extending into the Inferior Vena Cava [IVC] a major blood vessel). The plan for the patient included an urgent urology assessment; holding blood thinner medications; rechecking hemoglobin every 6 hours; and blood transfusions if necessary.

1. A review of Patient 1's Urology Consult note (dated 7/21/19 at 9:12 PM) revealed ... "The patient has RA (Rheumatoid Arthritis) and so has limited activity ...The mass is central and likely the cause of the bleeding ... [the patient] will need outpatient cystoscopy (a procedure to look into the bladder through the urinary tract with a scope) ... complete staging with a chest CT in the morning ... continue to hold Pradaxa (a medication used to try to prevent blood clots from forming) if possible. After CT of the chest tomorrow, ok for discharge from my perspective. I will arrange outpatient follow up scope. I think [the patient's] anemia is not secondary to hematuria (as this seems relatively mild) but more likely secondary to [the patient's] renal cell carcinoma (kidney cancer)."

2. A review of the CT Scan of the Abdomen Pelvis (dated 7/21/19 at 1502) revealed... "a large mass involving the left kidney measuring up to 6.8 cm (centimeters) likely reflects renal cell carcinoma. There is a filling defect involving the IVC and adjacent renal vein. Potential tumor thrombus (blood clot) is not excluded."

A review of Patient 1's medical record (from 3:15 PM on 7/21/19 through 8:27 PM on 7/22/19 - when the patient went into surgery) revealed:

3. The patient was admitted from the emergency room. The patient had received 500 ml (milliliters) of NS (Normal Saline -sterile fluid given in through an IV in the vein) and 100 ml (milliliters) of IV contrast (medication given in the vein for the CT scan used to identify organs and items more clearly during the scan). An IV of NS was started at 11:19 PM to run at 75 cc (cubic centimeters) an hour (hr) to provide additional fluids. Total IV fluid for 7/21/19 equaled 675 cc (cubic centimeters) of fluid. It was documented that Patient 1 had one incontinent (uncontrolled or unexpected loss of urine) output at 10:18 PM. The charting on 7/21/2019 lacked an assessment of the amount of urine, if clots were present and the color of the urine.

4. 7/22/2019 - Pt 1's IV continued to run at 75 cc per hour. The record indicated the patient was continent of urine at 4:00 AM, and charting described the urine as hematuria (blood in the urine). The charting lacked the amount of urine output the patient had and lacked a description of the urine related to clots or shade of hematuria. The record reflected at 4:00am, the Urologist was notified by phone that they patient had 'clots' and ordered a 3-way catheter with Continuous Bladder Irrigation (the placing of a special type of catheter that allows for the constant flushing of the bladder with irrigation fluid - Continuous Bladder Irrigation [CBI]). Per the record, assessment of the abdomen at this time was within normal limits (soft, non tender, and bowel sounds present in all 4 quadrants [areas] of the abdomen). The 3-way catheter was inserted and CBI was started at 5:30 AM. Charting lacked documentation of how the patient tolerated the catheter insertion, the amount of urine returned with the insertion, the color of the urine, if there was a need to manually irrigate the catheter to get a urine flow, and lacked an assessment of the abdomen following the insertion of the catheter. [A catheter is hooked up to the CBI solution to attempt to flush the bladder to eliminate blood clots in the urine with the goal to have the urine a light pink to clear color. CBI irrigation fluid flow is adjusted according to the color and consistency of the urine.]

5. Review of the Urologist operative note (dated 7/23/19 at 12:41AM) revealed... "Retroperitoneum and peritoneum were filled with greater than 3-4 L of fluid making tissues edematous. The patients bladder rupture was in the posterior trigone (back side of the bladder) and into the retroperitoneal space, however, the retroperitoneum ruptured causing fluid to travel into the peritoneal cavity. Large clot in the bladder. No tumors in the bladder were seen."

6. Nursing documentation flowsheets for Patient 1 revealed:
-6:00 AM: 1000 cc of irrigation fluid into the bladder and 1000 cc of fluid was emptied from the catheter bag. Urine was identified as bloody, cherry red color with clots. The charting lacked any additional urine output since the initiation of the CBI.
-7:00 AM: 3000 cc of irrigation fluid into the bladder and 3200 cc of fluid was emptied from the catheter bag. The urine was identified as a bloody, burgundy color with clots.
-7:10 AM: (per the physician progress note) Urologist in to see patient. Patient had increased bleeding and difficulty voiding overnight. 3-way catheter placed. Patient denies any pain this morning. [Catheter] in place with bloody urine in bag with clot. Minimal CBI. Catheter irrigated without return of much clot and CBI increased.
-8:04 AM: [patient] complained of burning in [urinary tract] from [catheter].
-8:30 AM: 4500cc of irrigation fluid into the bladder and 3800cc of fluid was emptied from the catheter bag. The urine was identified as a bloody, cherry red color with clots. Charting lacked an assessment of the abdomen and bladder area to check for retention as a decrease in the amount of output was noted, no indication or documentation of manual irrigation of the catheter to check for clots and to increase the output of fluid.
-9:20 AM: [patient]complained of pain with urination, and urgency [a feeling of the need to urinate immediately]. An assessment of the abdomen indicated hyperactive bowel sounds and a non-tender abdomen. The patient ate 75% of breakfast meal and took 240cc of fluids in with the meal.
-9:40 AM: 2000cc of irrigation fluid into the bladder and 2400cc of fluid was emptied from the catheter bag. The urine was identified as a bloody, cherry red color with clots.
-9:25 AM: (per the physician progress note) Hospitalist in to see patient. Patient hemoglobin below 7 (normal hemoglobin is 14 to 17 for male patients and 12 to 16 for female patients). Urine is cherry colored with 3-way catheter and irrigation. Abdomen soft, bowel sounds are normal, no distention. Plan to transfuse (providing a patient with red blood cells due to low hemoglobin levels).
-11:02 AM: Transfusion of 350cc of blood started.
-11:19 AM: 2700cc of irrigation fluid was ran into the bladder and 3800cc of fluid was emptied from the catheter bag. The urine was identified as a clear cherry red color.
-11:34 AM: Total IV intake at 75cc/hr totaled 918cc.
-11:43 AM: (per the physician progress note) Oncologist (cancer doctor) in to see patient for a consult. "Patient with Alzheimer's disease. The patient is receiving red blood cell transfusion. Abdomen soft, bowel sounds are present, nondistended (not swollen) without hepatosplenomegaly (enlarged spleen). Status post catheter placement and draining dark pink urine. No lower extremity edema noted.
-12:09 PM: 1500cc of irrigation fluid into the bladder and 2000cc of fluid was emptied from the catheter bag. The urine was identified as a clear pink color. The documentation lacked any abdominal assessment.
-1:37 PM: Transfusion of 2nd bag of 350cc of blood was started.
-1:49 PM: Transfusion stopped, see charting, rest of blood sent to lab
-1:58 PM: 2000cc of irrigation fluid into the bladder and 4020cc of fluid was emptied from the catheter bag. The urine was identified as a clear pink color. Hospitalist notified of a change in status for Patient 1.
-2:52 PM: RN P sent a message to the Hospitalist (via the physician messaging system) "[Patient's room number] receiving 2nd unit of PRBC (packed red blood cells-a bag of blood), started to get SOB (short of breath) and lung sounds are worse. Hgb (hemoglobin) was 8.1 after the 1st unit. Can I discontinue 2nd or continue? I also put [the patient] on O2 [oxygen] for SOB." The message to the physician lacked evidence of an abdominal or urinary assessment.
-3:00 PM: patient complaining of pain with urination and urgency. Abdominal assessment revealed the patient's abdomen is bloated, rigid and bowel sounds are hyperactive.
-5:11 PM: A block of nurses notes by RN P revealed, "Patient was receiving blood and CBI, complained of SOB (shortness of breath). Assessed patient, abdomen was rigid, CBI was not draining into catheter bag, stopped CBI, clamped both bags, tried to withdraw any potential clots from catheter, it flushed well but no clots withdrawn. Very hard to withdraw out of catheter, called for assistance, RN could not draw back any fluid, bladder scanned patient [an ultrasound test to determine the amount of fluid in the bladder] with a result of 248. Applied 02 at 2L[2 liters per minute], patient at 100% [oxygen level], still complained of SOB and wanted head flat. Patient complained of feeling full and could not get comfortable, audible lung sounds, patient becoming edematous [swelling] throughout thighs, [genital area] and abdomen. Patient was also receiving blood while CBI, stopped 2nd unit of blood after patient complained of feeling full, called (Hospitalist) to see if blood should be discontinued. (Hospitalist) ordered Lasix (medication to reduce amount of fluids in body) and chest X-ray but to continue 2nd unit of blood. Continued 2nd unit but slowed rate back down to 75 ml/hr. Blood running until patient again complained of feeling full. Stopped blood [and at] same time the CBI was stopped. Lasix was given, Patient cold to the touch and difficult to get an oral temperature or axillary(armpit) temperature. Tried to warm patient up with warm blanket and still could not get result. Patient A&O (alert & oriented), able to answer questions, still had complained of "feeling full", laid bed flat for [patient] comfort. Hospitalist arrived at that time and also wanted a CT of abdomen as well, Patient went down to CT. Chart lacked evidence of the catheter being manually irrigated, of the notification to the Urologist of the decrease of the output, documentation of the time of arrival of the Hospitalist, and of any examination or assessment of Patient 1 before the patient left the unit to get the CT scan completed.
-6:47 PM: (per the physician progress note) Urologist in to see patient. "I was called this evening with concern for possible intraperitoneal (area in the abdomen that contains the bladder, kidneys, stomach, intestines and other organs) bladder rupture. Around 3:30 or 4, the patient's catheter was noted to be occluded (blocked) with the CBI running. [The patient] became uncomfortable and belly significantly distended (swollen). Nursing staff was having difficulty irrigating the catheter and the CBI was turned off. Has abdominal distention, CT scan was performed which I reviewed and which demonstrated significant new free fluid through out the abdomen. Given clinical history, concern for intraperitoneal bladder rupture secondary to irrigation and catheter occlusion (blockage)."

The record lacked documentation of any abdominal assessment information between 9:20 AM and 3:00PM. The record lacked documentation of the total intake and output for this time period. The patient received 3315.75cc of IV and blood fluids, 16700 cc irrigation solution, 240 cc of oral fluids equaling a total of 20255cc. The patient had 20220cc of output emptied from the catheter bag, with a difference of 35.75cc urine output. The record lacked documentation of the number of times or amount of fluid that was used to irrigated the catheter manually and lacked evidence of physician notification of decreased output.

B. Interviews with RN T and RN J (on 9/5/19 at 10:06 AM) about the care they provided to Patient 1 on night shift (7/21-7/22/19) revealed... "[Patient 1] voided in the urinal 1 time, and it was slightly bloody, no clots and watermelon color, and no complained of pressure, felt empty." When asked why [RN T and RN J] contacted Urologist at 5:30 AM for a CBI set up, RN T stated "About 5:15-5:30AM an aide came out of the patients room and said [they] needed some help. There were a lot of small clots and bright red blood in the brief (diaper) the patient had on, and as we turned [the patient] to clean [patient] up, [the patient] was 'spurting' some bloody urine. I bladder scanned [the patient] and it said greater than 350cc." RN T denied the patient was distended, and no complaints of pain. "So we called the Urologist and it was ok to set up the CBI and so I put the catheter in, but only got a trickle of blood tinged urine. I hand irrigated it, not difficult but got nothing. The 2nd time I irrigated it I got clots out and it started to flow well so I kicked the CBI on. It was a steady drip flowing and the urine was cherry red." When asked where the catheter, irrigation and output was charted, RN T stated, "I guess it wasn't."

Interview with the Urologist (on 9/4/19 at 5:18 PM) revealed... "I don't recall being called about (Patient 1) that whole day (7/22/19). I had seen the patient about 7:00 AM there was a lot of blood in the bag, minimal CBI running, I did irrigate the catheter, without return of much clots and CBI increased." During the surgery, "there was not any cancer in the bladder - it was in the kidney and IVC. The ureter and bladder were fine. The patient had underlying dementia and possibly felt pain differently. Most patients would have been complaining. There was so much fluid in the abdomen, I was literally squeezing fluid out of mysentary (a set of tissues that attaches the intestines to the abdominal wall). I absolutely feel the nurses had no ill intent but I do feel it was a knowledge issue with the management of CBI. I believe the patients hematuria was due to the mass bleeding. (The Hospitalist) called me at the office about 3:45-4:00PM, and notified me that the nurses were told to turn off the CBI and get a CT Scan. During surgery there was liters of fluid gushing in the retroperitoneum (abdominal area that contains some of the intestines and other organs) and tissues. I would have expected the nurses call me if they were having to hand irrigate frequently and they should have shut off the irrigation if the output wasn't adequate. A normal bladder volume can hold up to 2000cc if having retention. It would depend on how fast the irrigant was running to rupture the bladder."

Interview with the Hospitalist (on 9/5/19 at 2:00 PM) related to Patient 1 revealed... "To my best recollection... I believe we lost significant amount of time, no one had called me about this patient until around 3:30PM, the nurse said that (the Urologist) was called but hadn't heard back so calling you, but I don't know any timeframe's. I had seen [the patient] in the morning and [patient] was doing ok. They had called me and said [patient] was short of breath, getting 2nd unit of blood. I told them to give [the patient] some Lasix and get a chest x ray, thinking [patient] may be getting overloaded, and told them I would be up. I was in ED at the time writing orders. When I got to the bedside [the patient] was distended, [patient's spouse] told me when [spouse] returned from lunch and errands at 2PM [the patient] was already uncomfortable and distended. I ordered the CT of the abdomen and pelvis because we needed to determine if it was CBI or blood in the abdomen. I think it was about 5:30PM and radiology called me with the abnormal results. The nurse had told me that [the patient's] CBI had decreased output over time. They should monitor the output closely with CBI. I feel like we should have been notified sooner about decreased output."

Interview with RN P (on 9/5/19 at 11:11 AM) about the care RN P provided to Patient 1 on day shift 7/22/19 revealed... "Per the night nurse, they had a very difficult time getting the catheter into Patient 1. The Urologist was in the room early, there was thick red blood in the [catheter]. The Urologist irrigated the bladder and I changed the drainage bag. The patient was complaining of [genital area] hurting. I had taken care of CBI before with other patients, I didn't open it full blast because I had 4 other patients, but it was a good steady drip. By mid morning it was more a strawberry color, [I] got a big stringy clot out, and it stayed strawberry color through lunch. I started 2nd unit of blood about noon and stayed with [the patient] for the 15 minute check." When asked where the nurses chart the bladder irrigant being hung, RN P responded "No where in the system to chart it". RN P said "there were 2 hanging, 2 in the box I hung, then I called for another box of 4 and used those, then called for another box but [the patient]went to CT and I capped it off about 2 PM, but unsure what was left in the bags hanging." (8 bags at 3000 cc per bag equals 24000 cc). When the patient was experiencing the SOB and fullness with the rigid abdomen, I asked another RN to notify (Dr. B) and the unit secretary/nurse aid left a message with the Urologist's office to call back." Surveyor reviewed the Intake and Output sheet and asked RN P if 4020cc of urine/irrigant at 1358 (1:58 PM) was correct? RN P stated, "Did I write that? That can't be right, I will have to go back and see who wrote that number. The output bag doesn't hold greater than 4000, I wouldn't let get that full. I don't think that's correct. The patient complained of [pain in genital area] throughout the shift but not belly pain and it was flat until the 1:45PM assessment. I had noticed that the drainagebag wasn't getting full as quickly as it had been. The floor nurse educator came in and bladder scanned the patient and there was 350cc in the bladder. The educator asked if I irrigated and I had."


C. A review of the facility procedure titled "Urinary Catheter: Closed Continuous (foley) irrigation" [undated] revealed:
- Monitoring and care: calculate the fluid used to irrigate the bladder and catheterand subtract it from the volume of drainage to determine accurate urinary output. Empty the drainage bag frequently to prevent the weight of the drained fluid from disconnecting the drainage system.
- Assess the characteristics of the output: viscosity (thickness), color and presence of clots. Observe catheter for patency to ensure the bladder empties freely. Assess the patients for signs and symptoms of infections, including fever, elevated white blood cell count, and cloudy malodorous (foul-smelling) urine. Report catheter obstruction, sudden bleeding infection, or increased pain to the practitioner. Assess, treat, and reassess pain.
- Expected Outcomes: output is greater than the volume of irrigating solution. Patient does not experience bladder or discomfort. Patient does not experience fever, lower abdominal pain, or cloudy or malodorous urine. The urinary catheter remains patent, and urine can freely from the catheter. Clot formation in the bladder or indwelling urinary catheter is prevented or minimized.
- Unexpected outcomes: Irrigating solution does not flow a the prescribed rate. Fever, cloudy urine, and malodorous urine are present, indicating infection. Bladder spasm increase, indicating blockage of catheter with a blood clot.
- Documentation: Irrigation method, solution, amount of irrigation solution used, amount of drainage returned, characteristics of output, urine output, patient and family education, unexpected outcomes and related nursing interventions, pain assessment and management.
-Gerontological (elderly) Considerations: Benign prostatic hypertrophy (enlarged prostrate gland) or urethral (entrance into urinary tract) obstruction may make catheter insertion difficult in an older male. Do not force the catheter through the urethra.

D. A review of the 7/23/19 Root Cause Analysis (RCA - a facility review of an incident that occurs which is used to identify causal factors and to determine interventions to prevent recurrence) Investigation Worksheet revealed:
-The Brief Event Description identified that the patient was admitted through the emergency room for hematuria. The CT scan demonstrated a 6-7cm left central renal mass with a tumor thrombus into the inferior venal cava. At 2PM the RN noted that more CBI fluid was going in than draining out. The CBI was stopped. The Hospitalist was notified at 1:58 PM. The Cardiologist was at the bedside at 2 PM and the Urologist was notified at 3:30 PM. At 3PM, the patient was noted to be restless with swelling in abdomen, thighs and [genital area]. CT scan showed the bladder ruptured. Op [operative] note states greater than 3 Liters of saline suctioned out of the abdomen. On 7/25/19 the patient was found unresponsive in room, and a code blue (Cardio Pulmonary Resuscitation) called. [The patient] later expired on 7/30/19.

Individuals interviewed for the RCA:
1. RN P "They had a hard time placing the CBI catheter. There was a lot of bleeding. Pt was alert and oriented at the time although [the patient] has dementia. CBI started well to begin with. [Patient] hgb (hemoglobin) required blood & [patient] received a unit. (RN P) noticed the CBI drainage slowed, (RN P) slowed the infusion, stopped the blood and called (the Hospitalist). (RN P) got a small clot out and (the Hospitalist said to restart blood... The CBI never ran dry and 2 bags had been used (6000 cc)...Around 2:00 PM, [the patient] felt like [the patient] couldn't breath ([patient] was wheezing but does use O2 (oxygen) at home) and wanted to lay flat. Saw that the CBI wasn't draining and stopped it immediately...At 3:00 PM, noticed that [patient's] abdomen was as a rock and [genital area] was swollen. Paged the (Urologist). (RN P) tried to pull back on the CBI fluid to remove clots without anything coming. Did not infuse/flush. No one flushed with any amount....Output for (RN P's) shift to that point was net zero... Patient never stated [patient] had abdominal pain. [The patient] described [pain in genital area] ever since the catheter was inserted that morning." "(The Urologist) flushed with plunger in the AM. Patient indicated no pain at the time...Lasix given prior to surgery, 40mg at 3:14PM and was still dry -100cc after Lasix. No evidence of pain."
2. RN T stated, "Called (the Urologist) to initiate CBI because of lots of clots and bleeding. [Urologist] had trouble placing CBI because of clots although did get it started."
3. Medical Director stated, "[Spouse] thought there was discussion on either shutting off the CBI or decreasing the rate to very slow and leaving it on."

RCA identified Outcome - The patient had dementia and was not a reliable source for reporting of pain. No inappropriate acts identified.