HospitalInspections.org

Based on observation, interview, and record review, the facility failed to provide organized nursing services for one of 30 sampled patients (Patient 1) when:

1. Patient 1's femoral catheter (dialysis access located in the groin) and bloodlines (arterial line draws blood from the patient and venous/return line returns the dialyzed blood to the patient) were not monitored continuously for loose connections during CRRT (Continuous Renal Replacement Therapy) when it was covered with a blanket. The return line became loose and disconnected from the femoral catheter which potentially caused massive blood loss and cardiac arrest on 12/6/15. (Refer to A 395).

2. The CRRT machine was not removed from service after Patient 1's incident on 12/6/15 and continued to be used by Patient 1 until he passed away on 12/8/15. This had the potential for the same faulty/damaged equipment to be used by the patient and repeat the same incident. (Refer to A 395).

3. CRRT bloodlines, fluid bags and all supplies connected to the CRRT machine used by Patient 1 on 12/6/15 were discarded without further investigation of whether the lines were faulty and/or damaged. This had the potential for the same faulty/damaged supplies to be used for other patients and caused the same incident. (Refer to A 395).

4. CRRT monitoring to prevent air embolism was not done for Patient 1 when the deaeration chamber level (part of the CRRT system that collects and removes air while minimizing blood clot) was not monitored every hour per policy. (Refer to A 395).

5. The facility's staffing ratio for 1:1 (one nurse to one patient) for patients on CRRT was not included on the 2015 Plan for Provision of Patient Care. The plan did not include what 1:1 staffing meant and how long the Registered Nurse could leave the patient alone in the room during CRRT. (Refer to A 395).

6. The CRRT Trained Nurses did not have competency evaluation after CRRT certification course, and reevaluation of knowledge and skills on a regular basis. CRRT is a highly specialized dialysis treatment for critically ill patients which put patients at greater risk of death and/or injury if the facility staff was not competent to perform CRRT. (Refer to A 395).

Dialysis is a treatment procedure which removes extra fluids and waste products from the blood which the kidneys could not excrete when the kidneys fail.

Continuous Renal Replacement Therapy (CRRT) is a dialysis modality used to treat critically ill patients with acute kidney failure in the intensive care unit (ICU). CRRT machine and dialyzer (artificial kidney) are used to slowly and continuously remove extra fluids and waste products from the blood which the kidneys could not excrete when the kidneys fail.

Air embolism is a life threatening condition when air enters the bloodstream and causes blockage of a vein or an artery.

The cumulative effect of these systemic problems resulted in the facility's inability to provide the safest and highest standard quality of care to all patients receiving CRRT in the facility.

Based on observation, interview and record review the facility failed to ensure nursing care for one of 30 sampled patients (Patient 1) on Continuous Renal Replacement Therapy (CRRT) was evaluated, and policies and procedures were developed, maintained and implemented when:

1. Patient 1's femoral catheter (dialysis access located in groin) and bloodlines (arterial line draws blood from the patient and venous/return line returns the dialyzed blood to the patient) were not monitored continuously for loose connections during CRRT when it was covered with a blanket. The return line became loose and disconnected from the femoral catheter which potentially caused massive blood loss and cardiac arrest on 12/6/15.

2. CRRT machine was not removed from service after Patient 1's incident on 12/6/15 and continued to be used by Patient 1 until he passed away on 12/8/15. This had the potential for the same faulty/damaged equipment to be used by the patient and repeat the same incident.

3. CRRT bloodlines, fluid bags and all supplies connected to the CRRT machine used by Patient 1 on 12/6/15 were discarded without further investigation of whether the lines were faulty and/or damaged. This had the potential for the same faulty/damaged supplies to be used for other patients and caused the same incident.

4. CRRT monitoring to prevent air embolism was not done for Patient 1 when the deaeration chamber level (part of the CRRT system that collects and removes air while minimizing blood clot) was not monitored every hour per policy.

5. The facility's intensive care staffing ratio for 1:1 (one nurse to one patient) for patients on CRRT was not included on the 2015 Plan for Provision of Patient Care. The plan did not include what 1:1 staffing meant and how long the Registered Nurse could leave the patient alone in the room during CRRT.

6. The CRRT Trained Nurses did not have competency evaluation after CRRT certification course, and reevaluation of knowledge and skills on a regular basis. CRRT is a highly specialized dialysis treatment for critically ill patients which put patients at greater risk of death and/or injury if the facility staff was not competent to perform CRRT.

Dialysis is a treatment procedure which removes extra fluids and waste products from the blood which the kidneys could not excrete when the kidneys fail.

Continuous Renal Replacement Therapy (CRRT) is a dialysis modality used to treat critically ill patients in the intensive care unit (ICU) who developed acute kidney failure. CRRT machine and dialyzer (artificial kidney) are used to slowly and continuously remove extra fluids and waste products from the blood which the kidneys could not excrete when the kidneys fail.

Air embolism is a life threatening condition when air enters the bloodstream and caused blockage of a vein or an artery.

Findings:

1. Patient 1 was admitted to the facility on 12/4/15 after he had a heart attack at home. Prior to Patient 1's admission to the facility, he had placement of multiple stents (a tube or device placed in the blood vessel to keep it open) in his heart to increase blood supply to his heart muscles which were done at another hospital. Patient 1 had history of chronic kidney disease and during hospitalization, Patient 1's kidney function continued to decline and CRRT was initiated on 12/5/15.

Review of 12/6/15 at 2:16 PM nurse's Summary of Patient Progress indicated, "patient alert and oriented (mentation at baseline as per daughter); continue on 2 L (liters) oxygen,....continue CVVH (Continuous Veno-Venous Hemofiltration - a type of CRRT)... patient started on puree diet."

Review of the 12/6/15 at 7:57 PM Cardiology Progress Notes indicated, "Events: overnight - pressors (medication to increase blood pressure) have been weaned down - more interactive ... (this note from am rounds). Subjective: Able to tell us he (Patient 1) feels better ... continue CWH."

Review of the medical records indicated the following nursing interventions for Patient 1 on 12/6/15:
At 7:00 PM - RN 1 documented on CRRT "Flowsheet" which showed all the pressures on the CRRT system were within normal limits and the Blood Flow Rate was 300 ml/min.

At 7:14 PM - the "All Orders and Results" document indicated, RN 1 received a phone call from laboratory indicating critical results for lactate (by-product of cell metabolism when cells lacked oxygen) with a value of 7.3 (normal reference range 0.7 - 1.9 mmol/L).

At 7:30 PM - RN 1 suctioned Patient 1 and obtained rusty and bloody secretions documented on the "Flowsheet."

At 7:48 PM - the "All Orders and Results" document indicated, "acknowledged electronically the physician order for dobutamine (medication for heart failure) and to draw venous blood gas (VBG - test for carbon dioxide and pH [acidity and/or alkalinity] in the blood) at 10:00 PM.

At 8:00 PM - RN 2's Progress Notes indicated, "Returned from break early due to Patient 1 coding (cardiac arrest) care resumed from RN 1. RN 1 states Patient 1 had a bowel movement and brady down (slow heart rate) covers removed to start CPR (cardiopulmonary resuscitation) CPR started and she (RN 1) noticed the line was disconnected and blood was in the bed she was unsure if GI (gastrointestinal)/Line disconnect. Pt was coded for 45 mins (minutes) with ROSC (return of spontaneous circulation) after interventions ... 2200 (10:00 PM) Pt (patient) cleaned for BM (bowel movement) large amount of blood loss."

At 9:28 PM - physician Progress Notes indicated, Code blue (a medical emergency in which a team of healthcare personnel work to revive an individual in a cardiac arrest) called at 2000 (8:00 PM) after patient (Patient 1) became unresponsive and bradycardic (slow heart rate) ... Pt. (patient) noted to be in PEA arrest (pulseless electrical activity - heart monitor will show heart rhythm but there was no palpable pulse) .... He was intubated (tube inserted in the trachea or windpipe to maintain open airway and assist the patient in breathing) and underwent 10 rounds of CPR ... Massive transfusion protocol was followed with transfusion of 2U (2 units of blood approximately 250 - 300 milliliters per unit) PRBC (packed red blood cell) ... He (Patient 1) was transfused and additional 4U PRBCs, 2U FFP (fresh frozen plasma - liquid part of blood indicated to stop massive bleeding) and 1U platelets (cells in the blood that are essential for normal blood clotting) ... Family updated at bedside still wanting full interventions ... "

PEA may be caused by many conditions, but its most frequent causes are hypovolemia (low blood volume) and hypoxemia (lack of oxygen). If your patient has lost a great deal of blood, hypovolemia should be considered as a cause of PEA. (Source: acls.com)

Review of physician Progress Notes dated 12/7/15 at 12:05 AM, indicated, "Patient s/p (status post) PEA arrest ...Family collectively have come to conclusion that they do not want CPR or shocks and would want their family member to die peacefully. However, they would like to continue full medical management with continued intubation, CVVH and pressors. Code status changed to DNR [do not resuscitate] (ok for intubation, pressors)."

Review of the physician Progress Notes dated 12/8/15 at 1:17 PM, indicated, "The family expressed concern for his (Patient 1) comfort and acknowledged that he is worse since the resuscitation (CPR) ...They also expressed concern and became very emotional when describing the resuscitation they witnessed. They reported seeing bleeding from the catheter and the patient in a large amount of blood under a blanket. They reported that he (Patient 1) was improving before this and find it difficult to accept that this 'mistake will take his life.'"

Review of the Multidisciplinary Notes dated 12/8/15 at 3:27 PM indicated, "Charting and extubation (removal of the tube for artificial breathing) done by RT (Respiratory Therapist)."

Review of the Certificate of Death indicated Patient 1 passed away on 12/8/15 at 3:20 PM and the Immediate Cause of Death was cardiogenic shock (The heart is not able to pump enough blood to meet the body's needs. The most common cause of cardiogenic shock is damage to the heart muscle from a severe cardiac arrest).

Review of the CRRT Machine Data History print-out and Prismaflex (CRRT machine) Operator's Manual, indicated alarms were triggered on 12/6/15 as indicated by the following:

At 19:54:07 (7:54:07 PM) - WARNING: Return Pressure Dropping. According to operator's manual - Possible Cause(s) - Patient is moving or being moved, Possible leak in return line or catheter and Return catheter disconnected.

At 19:54:20 (7:54:20 PM) - WARNING: Return Pressure Dropping. According to operator's manual - Possible Cause(s) - Patient is moving or being moved, Possible leak in return line or catheter. Return catheter disconnected.

At 19:57:06 (7:57:06 PM) - WARNING: Access Extremely Negative. According to operator's manual - Possible Cause(s) - Patient is moving or coughing, or being moved or suctioned; access line clamped or kinked.

At 19:57:15 (7:57:15 PM) - WARNING: Access Extremely Negative. According to operator's manual - Possible Cause(s) - Patient is moving or coughing, or being moved or suctioned; access line clamped or kinked.

At 20:03:39 (8:03:39 PM) - WARNING: Access Extremely Negative. According to operator's manual - Possible Cause(s) - Patient is moving or coughing, or being moved or suctioned; access line clamped or kinked.

Review of the Prismaflex outside vendor letter to the Biomed Manager regarding the Prismaflex (CRRT machine used by Patient 1) inspection and analysis, dated 2/23/16, indicated, "Analysis:... one treatment matching the description of the event was found.... December 6th at 1954 (7:54 PM): The warning alarm 'Return Pressure Dropping' was issued and cleared 13 seconds after it was issued. December 6th at 1957 (7:57 PM): A warning 'Access Extremely Negative' alarm was issued which effectively ended the treatment, no further pump movements recorded after this time. December 6th at 2004 (8:04 PM): Blood return was attempted following this alarm however due to unresolvable 'Access Extremely Negative' alarms only 11 ml (milliliters) of the filter set (dialyzer and bloodlines) volume was returned... Blood flow rate 300 ml/min... Blood loss: 1,008 ml."

The outside vendor's analysis of the Prismaflex machine warning alarm for "Return Pressure Dropping" and how the warning alarm was cleared after 13 seconds indicated the following:

"Return pressure dropping: This alarm occurs if return pressure is 50 mmHg or 70 mmHg (with blood flow>200ml/min) below its operating point. Return Disconnection: Alarm occurs if return pressure is lower than +10 mmHg and the return pressure operating point is higher than +10 mmHg. The alarm is cleared by either pressing CONTINUE or DISCONNECT whichever action is most relevant to the current situation. Which option should be used is a clinical decision dependent on the findings while troubleshooting the alarms (actions and other possible causes is described on screen). When using one of the two options pressing CONTINUE or DISCONNECT you are telling the machine that you want to end the treatment or continue the treatment which removes the alarm state. If you want to mute the alarm this can be done by the MUTE button which will not clear the alarm. The alarm can be issued again if the criteria is met a second time however this is dependent on the value of the return pressure operating point which is set when treatment is continued."

During an interview on 1/12/16 at 11:06 AM, the complainant stated Patient 1 had a heart attack at home and had stents done at another hospital before transfer to the facility. The complainant stated Patient 1 was conscious and talking to his family and thought he would recover from the heart attack. The complainant stated on 12/6/15, family members were at the bedside when the dialysis machine alarmed with a "warning message about return pressure". The complainant stated RN 1 "silenced the alarm without checking Patient 1 and walked out of the room for several minutes". The complainant stated the family member called RN 1 and when RN 1 came back, Patient 1 looked like he was having seizure. The complainant stated when RN 1 pulled the blanket, there was pool of blood on the bed and the line was disconnected and sprayed blood all over the room. The complainant stated Patient 1 had cardiac arrest and had blood transfusion. The complainant stated the family witnessed the event and made them really upset and angry. The complainant stated after the cardiac arrest, Patient 1's health declined and died on 12/8/15.

During an interview on 1/13/16 at 3:05 PM, Physician 1 stated on 12/6/15, he heard a commotion in the hallway and he saw staff moving rapidly to Patient 1's room. Physician 1 stated when he got in to the room, Patient 1 was in obvious distress and poorly responding. Physician 1 stated the bedsheets were pulled down and he saw a pool of blood around Patient 1's groin where his femoral catheter was, a port (bloodline) was disconnected from the CWH machine and there was a free-flowing blood coming out from the catheter. Physician 1 stated he called a code and Patient 1 was resuscitated (CPR), massive transfusion was initiated and patient was intubated. Physician 1 stated the blood loss was approximately 1000 ml.. Physician 1 stated he was told by RN 1 the disconnection of the line just occurred and there was large amount of blood per rectum. Physician 1 stated the large amount of blood per rectum was not verified by him or any of the physicians because Patient 1 was very ill to have any diagnostic tests done. When asked if blood in the stool were tested, Physician 1 stated that although Patient 1 had history of gastrointestinal bleeding, there were no tests done while patient was at the facility. Physician 1 stated Patient 1's family was on the bedside and witnessed the code which was very traumatic to the family. When asked if the incident was considered an adverse event, Physician 1 stated the incident could be classified as sentinel event (patient safety event [not primarily related to the natural course of the patient's illness or underlying condition] that reaches a patient and results in death, permanent harm and severe temporary harm) because of the line disconnection and massive blood loss.

During an interview on 1/13/16 at 3:50 PM, RN 1 stated she was a "break nurse" on 12/6/15. RN 1 stated she relieved RN 2 at around 7:00 PM for Patient 1 who was having CRRT. RN 1 stated when a patient was on CRRT, it was a 1:1 staffing (one nurse to one patient). RN 1 stated she checked Patient 1's dialysis access, bloodlines, vital signs (blood pressure, heart rate, respirations etc.). When asked if she documented that she checked the dialysis access and the CRRT system for kinks, loose disconnections and/or air, RN 1 stated she did not document that she checked the CRRT bloodlines and dialysis access. RN 1 stated at around 7:15 PM, she stepped out of Patient 1's room because she received a phone call from the laboratory that Patient 1's lactate was at critical value and she was looking for the physician. RN 1 stated the physician came and talked to the family about the laboratory results and medications. RN 1 stated she received an order to suction the patient which she did and got a bit of bloody secretions at around 7:30 PM. RN 1 stated after she suctioned Patient 1, the family told her Patient 1 had a bowel movement and she checked the stool was colored black but looked a normal stool. RN 1 stated she told the family that she would get supplies and get help of another nurse to clean Patient 1. RN 1 stated when she got back to Patient 1's room, approximately before 8:00 PM, the patient was having violent jerking movement. RN 1 stated she uncovered the blankets and saw blood gushing out from the venous bloodline and blood was also coming from the femoral catheter. When asked how long she was away from the room, RN 1 stated she could not remember how many minutes she was away from Patient 1's room. When asked if she heard or seen an alarm on the CRRT machine before she left Patient 1's room to get cleaning supplies, RN 1 stated, she did not hear any alarm from the CRRT machine.

During an interview on 1/14/16 at 12:55 PM, RN 6 stated she had been doing CRRT for 7 years. RN 6 stated, "We're not supposed to cover the femoral catheter when a patient was having CRRT, however, patient was cold and needed privacy so the catheter and lines were covered."

During an interview on 1/15/16 at 2:30 PM, RN 3 stated patient on CRRT had their access and bloodlines covered during treatment because the patient was cold and if the access was a femoral catheter, it's covered for privacy reasons. RN 3 stated on 12/6/15, she was part of the Rapid Response Team (facility staff that responds to medical emergency in the hospital). RN 3 stated at around 7:45 PM, she was at another floor responding to a call for a patient who was having low blood pressure. RN 3 stated when it was almost 8:00 PM, she heard on the overhead page that there was a code in ICU. RN 3 stated when she got into Patient 1's room, she could not get in the room right away because blood was everywhere. RN 3 stated the blood looked like it was sprayed all over the room that it even reached the board on the wall where staff write patient instructions and name of assigned staff. RN 3 stated there was blood on the equipment, bed and floor. RN 3 stated CRRT machine was not connected to the patient and she noticed the blood on the CRRT system was not returned to the patient which was approximately 200 ml. RN 3 stated the blood clotted and the bloodlines and dialyzer were discarded. RN 3 stated the CRRT machine did not have emergency supplies like clamps and fluid spike needed to return the blood to Patient 1. RN 3 stated the emergency supplies should be on the CRRT machine so the blood could be return during an emergency. RN 3 stated Patient 1 had blood from the abdomen to the groin area. RN 3 stated after the code was finished, she stayed to help clean the patient. When asked if she saw a large bloody stool, RN 3 stated, the stool looked normal, it didn't look like melena (black tarry stool associated with upper gastrointestinal bleeding) and it didn't look like the blood was coming from the rectum when she helped cleaned Patient 1.

During an interview on 3/3/16 at 2:45 PM, RN 2 stated she was the nurse assigned to Patient 1 on 12/6/15. RN 2 stated RN 1 relieved her for break. RN 2 stated she was coming back from break when she heard the code was called and pushed the crash cart to Patient 1's room. RN 2 stated when she got to Patient 1's room, the code was on-going and Patient 1 was being intubated. RN 2 stated she knew the CRRT return line was disconnected because the room looked like the blood was sprayed on the walls of the room and there was lots of blood underneath the patient. RN 2 stated blood transfusion was initiated. RN 2 stated family members were present and witnessed the code. When asked if she witnessed bleeding from the rectum, RN 2 stated she could not tell if the blood was coming from the rectum or from the return line but Patient 1 did not have rectal bleeding after the incident.

Review of the Prismaflex Operator's Manual indicated, "Chapter 4: Alarm System - The operator is notified of an alarm condition via a red or yellow status light, an audible alarm and an alarm screen on the display. Each alarm screen has instructions for how to respond to the alarm ... page 23 ... WARNINGS: The control unit may not be able to detect disconnections of the set from the blood access and return connections, which can result in blood loss. Ensure the patient's blood access and return connections are firmly secured ... Carefully observe the set and all operation while using the Prismaflex System for a patient treatment."

Review of the facility's policy and procedure entitled Continuous Extracorporeal Blood Therapy with the Prismaflex System revised 1/12, indicated, "13. Continuously monitor the system for kinks, loose connections, air and the presence of blood in the ultrafiltrate (pink tinge). 23. Stopping Treatment: a. If therapy needs to be held, return blood to the patient and follow the recirculation procedure ... b. If therapy needs to be discontinued, follow the end of treatment procedure, returning patient blood whenever possible. c. Keep a 250 ml. bag of NS (normal saline) with an adapter spike available at the bedside to return blood to the patient when the treatment is discontinued or held ... 25. In a Code Blue situation, return blood to the patient if possible, stop treatment and clamp lines."

2. During an interview on 1/14/16 at 12:25 PM, the Risk Manager stated the machine was sent to Biomed for testing and maintenance to verify RN 1's report that the CRRT machine did not alarm when the line was disconnected. The Risk Manager stated Patient 1 continued to use the same CRRT machine after the line disconnection incident on 12/6/15 until 12/8/15. The Risk Manager stated the CRRT machine was sent to Biomed on 12/9/15 after Patient 1 discontinued the treatment.

During an interview and record review on 1/14/16 at 2:35 PM, the Area Clinical Technology Manager (ACTM) stated the CRRT machine used by Patient 1 was serviced on 12/10/15. ACTM verified the report on the document Clinical Technology - Service Report dated 12/10/15 which indicated, "Ran functional checks per ACTM request. Was told no equipment do not need to be sequestered. There were multiple pressure alarm event observed on the history screen. Ran pressure calibrations, functional performance checks. Unit is working normally." ACTM stated the CRRT machine was not sequestered because on 12/10/15, it was found out the machine was working properly so the CRRT machine was put back to service. ACTM stated after Patient 1's event on 12/6/15, the CRRT machine should have been sent for service and all lines connected to it should have been sequestered.

Review of the facility's Sentinel, significant, and Other Event Management policy and procedure, reviewed 4/15, indicated, "4.1 Event Categories 4.1.1. (Level 1) Sentinel Events: A patient safety event (not primarily related to the natural course of the patient's illness or underlying condition) that reaches a patient and results in death, permanent harm, severe temporary harm, and other defined events ...5. Medical Center: Intervention and Communication Following an Event ... 5.2. Situation Stabilization: Immediate actions are to be taken to reduce the likelihood of further occurrences. Such actions may include discontinuing use of and removing faulty or suspect equipment ..."5.3. Preservation of Evidence: Preservation of evidence, such as documents or supplies, is necessary to ensure an effective analysis and record of the occurrence. Appropriate actions may include obtaining statements from witnesses, securing medical records and/or biological specimens, and sequestering suspect medications and medical equipment (such equipment shall be referred to clinical engineering or other appropriate department for examination and testing to determine if the equipment is faulty)."

3. During an interview on 1/14/16 at 12:25 PM, the Risk Manager stated the CRRT machine was sent to Biomed for testing and maintenance to verify RN 1's report that the CRRT machine did not alarm when the line was disconnected. The Risk Manager stated the CRRT machine was sent to Biomed after Patient 1 discontinued the treatment on 12/8/15, however, only the CRRT machine was sent. The Risk Manager stated Patient 1's incident happened on a weekend and all the equipment and supplies connected to the CRRT machine were discarded.

During an interview on 1/14/16 at 2:35 PM, the Area Clinical Technology Manager stated usually if there was an "event", all consumables were supposed to be saved like the machine and all lines connected to the machine for investigation of faulty or defective equipment.

4. Review of Patient 1's CRRT monitoring record indicated the deaeration chamber level was documented to have been checked every change of shift (8 hours).

During an observation and interview on 1/13/16 at 4:30 PM, RN 4 pointed the location of the deaeration chamber on the Prismaflex filter system. RN 4 stated the deaeration chamber was checked continuously to prevent air entering the patient, however, the documentation was done every change of shift. RN 4 stated there was no section in the electronic health record CRRT monitoring to document the deaeration chamber level every hour.

Review of the Prismaflex Operator's Manual, indicated, "The fluid level in the deaeration chamber may vary due to procedures during treatment. A small amount of air may be introduced each time (e.g. when changing bags). Frequent monitoring of the line is necessary."

Review of the facility's policy and procedure entitled Continuous Extracorporeal Blood Therapy with the Prismaflex System revised 1/12, indicated, "13 ... Monitor the deaeration chamber fluid level hourly."

5. During an interview on 1/13/16 at 3:50 PM, RN 1 stated when a patient was on CRRT, it was a 1:1 staffing (one nurse to one patient). RN 1 stated at around 7:15 PM, she stepped out of Patient 1's room because she received a phone call from the laboratory that Patient 1's lactate was at critical value and she was looking for the physician. RN 1 stated she could not remember how long she was away from Patient 1's room to look for the physician but the physician came right away to talk to the family. RN 1 stated after she suctioned Patient 1 at around 7:30 PM, the family told her Patient 1 had a bowel movement and she checked the stool was colored black but looked like a normal stool. RN 1 stated she told the family that she would get supplies and get help of another nurse to clean Patient 1. RN 1 stated when she got back to Patient 1's room approximately before 8:00 PM, the patient was having violent jerking movement. RN 1 stated she uncovered the blankets and saw blood gushing out from the venous/return bloodline and blood was also coming from the femoral catheter. When asked how long she was away from the room, RN 1 stated she could not remember how many minutes she was away from Patient 1's room.

During an interview on 3/4/16 at 11:05 AM, the Quality Assurance Performance Improvement (QAPI) committee verified the intensive care unit had enough staff to provide nursing care but the 1:1 staffing ratio had to be clarified with regards to how long the RN could step out of the room and leave the patient during CRRT. The Chief Nursing Officer (CNO) stated the RN could step out for brief periods to get supplies or medications but not more than 5 minutes. The facility was informed that if the CRRT blood pump was set at 300 ml./min., the patient could lose 1,500 ml. (300x5=1500) of blood if the return line was disconnected and the RN was away for 5 minutes.

Review of the ICU and CVICU (Cardiovascular ICU) 2015 Plan for Provision of Patient Care indicated, "Consideration for staffing include: Needs of patient population, risk factors of the patient population, complexity of the services provided, support services available and educational needs of employees." The Plan did not include what 1:1 staffing meant and how long the Registered Nurse could leave the patient alone in the room during CRRT.


6. Review of RN 1, RN 2, RN 5 and RN 7 personnel files indicated they all attended Prismaflex Training, however, there was no competency evaluation after the course and there was no annual competency evaluation.

During an interview on 1/15/16 at 1:00 PM, the Adult Services Director (ASD) stated CRRT had one day classroom training and after the training, the ICU RN will work with an experienced CRRT Nurse to check their competency. ASD stated there was no written record for the competency after course certification and there was no written annual reevaluation. ASD stated CRRT Nurses can go to refresher course if they chose to.

During an interview on 1/15/16 at 2:30 PM, RN 3 stated she was not sure how often CRRT competency was checked and for refresher course, it was hard to get a seat because it was very limited.

Review of the facility's Continuous Extracorporeal Blood Therapy with the Prismaflex System, revised 1/12, indicated, "1. Only critical care RNs who have completed the certification course and/or demonstrated competency may provide continuous extracorporeal blood therapy (CEBT) in the intensive care units." The policy did not address validation of CRRT knowledge and skills after the certification course, how often should CRRT Nurses be reevaluated for skill competencies, how to determine a need for refresher course, Continuous Quality Improvement (CQI) projects to maintain and/or raise standards for safe and effective CRRT procedure.