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Based observation, interview, and record review, the facility did not meet the Condition of Participation in Governing Body by failing to:

1. Assure hemodialysis (a procedure for removing metabolic waste products or toxic substances from the bloodstream by dialysis) contracted services were delivered in a safe and effective manner by failing to ensure patients' vascular access sites and blood line connections were continuously visible throughout the dialysis treatment in accordance with the facility Intradialytic Treatment Monitoring policy and procedure. (Refer to A 0084)

2. Implement a quality assurance and performance improvement (QAPI) program that monitored and assured continuous access site monitoring during hemodialysis treatment. This resulted in patient care being provided in an unsafe environment. (Refer to A 286)

3. Ensure Intensive Care Unit (ICU) nurse hands off patient to another ICU nurse when leaving the ICU temporarily; closely monitor ventilator alarms and respond promptly to assure ICU patients were continually monitored. The registered nurse assigned to care for Patient 2 failed to ensure another licensed staff assume temporary responsibility for the care of Patient 2 when the assigned nurse left the unit. Ensure informed consent was obtained prior to a start hemodialysis treatment in accordance with the facility policy and procedure on informed consent. (Refer to A 395).

4. Ensure the registered nurses develop an individualized care plan for patients who were receiving hemodialysis (Refer to A 396).

5. Ensure patient assessment included monitoring of blood pressure, edema and pain; ensure access site for hemodialysis was visible at all times during hemodialysis treatment; ensure patients in the Intensive Care Unit (ICU) were continually monitored to assure ICU nurses promptly assessed patients when ventilator alarmed in the ICU and ensure ICU nurses hand off patient to another ICU nurse when leaving the ICU temporarily. (Refer to A 397).

6. Ensure non-employee licensed nurses provided hemodiaylsis services in accordance with hospital policies and procedures and the contract agreement and ensure contracted staff was provided orientation prior to start providing care to patients admitted to the general acute care hospital. (Refer to A 398).

The cumulative effect of these systemic problems resulted in the hospital's inability to provide quality health care in a safe environment.

Based on observation, record review and interview, the Governing Body failed to assure hemodialysis (a procedure for removing metabolic waste products or toxic substances from the bloodstream by dialysis) contracted services were delivered in a safe and effective manner by failing to ensure patients' vascular access sites and blood line connections were continuously visible throughout the dialysis treatment in accordance with the facility Intradialytic Treatment Monitoring policy and procedure.

Findings:

During an initial tour, of the Intensive Care Unit (ICU) #3 on 12/13/17 at 11:40 a.m., Patient 16's access site for dialysis was covered. (In hemodialysis, access [vascular] provides a way to remove and return blood to the body.

A review of Patient 35's medical record indicated Patient 35 on 7/26/16 during dialysis developed vital signs instability and the registered nurse (RN) documented the access line was disconnected and blood was observed on the blanket the patient was covered with and a code blue was called.

During an interview with Unit Dir 1 on 12/14/17 at 3:15 p.m., when asked if access site to hemodialysis could be covered during dialysis, she indicated it could be covered as long as it is checked every 15 minutes.

A review of the facility policy and procedure titled, "Intradialytic Treatment Monitoring " dated 7/5/03 indicated : The patient's vascular access site and blood line connections need to be continuously visible throughout the dialysis treatment."

Based on record review and interview, the facility failed to implement a quality assurance and performance improvement (QAPI) program that monitored and assured continuous access site monitoring during hemodialysis treatment. This resulted in patient care being provided in an unsafe environment.

Findings:

During an initial tour, in Intensive Care Unit (ICU) #3 on 12/13/17 at 11:40 a.m., Patient 16's access site for dialysis was covered.

During a closed record review of Patient 35's medical record indicated Patient 35 on 7/26/16 during dialysis developed vital signs instability and the registered nurse (RN) documented the access line was disconnected and blood was observed on the blanket patient was covered with and a code blue was called.

During an interview with Unit Dir 1 on 12/14/17 at 3:15 p.m., when asked if access site to hemodialysis could be covered during dialysis, she indicated it could be covered as long as it is checked every 15 minutes.

During an interview with the director quality management (DQM) on 12/15/17 at 2 p.m., she indicated all hemodialysis services and QAPI studies were completed by the Contracted Company and reviewed by QAPI and Nephrology department monthly. Contracted services attended the weekly meetings and presented the ongoing QAPI studies.

During a review of the QAPI studies documented by the contracted hemodialysis company titled "Acute Clinical Outcome indicators did not evaluate continuous vascular access during dialysis. A second study titled "Quality Care Vascular Access included for 6/17 to 8/17 studied: Physician notified of Vascular access; and sign and symptom of Vascular access infection, did not evaluate for continuous monitor of vascular access during hemodialysis.

A review of the facility policy and procedure titled, "Intradialytic Treatment Monitoring " dated 7/5/03 indicated: The patient's vascular access site and blood line connections need to be continuously visible throughout the dialysis treatment".

Based on observation, interview and record review, it was determined that the facility did not meet the Condition of Participation (COP) for Nursing Services by failing to:

1. Ensure Intensive Care Unit (ICU) nurse hands off patient to another ICU nurse when leaving the ICU temporarily; closely monitor ventilator alarms and respond promptly to assure ICU patients were continually monitored. The registered nurse assigned to care for Patient 2 failed to ensure another licensed staff assume temporary responsibility for the care of Patient 2 when the assigned nurse left the unit. Ensure informed consent was obtained prior to a start hemodialysis treatment in accordance with the facility policy and procedure on informed consent. (Refer to A 395)

2. Ensure the registered nurses develop an individualized care plan for patients who were receiving hemodialysis. (Refer to A 396)

3. Ensure patient assessment included monitoring of blood pressure, edema and pain; ensure access site for hemodialysis was visible at all times during hemodialysis treatment; ensure patients in the Intensive Care Unit (ICU) were continually monitored to assure ICU nurses promptly assessed patients when ventilator alarmed in the ICU and ensure ICU nurses hand off patient to another ICU nurse when leaving the ICU temporarily. (Refer to A 397)

4. Ensure non-employee licensed nurses provided hemodiaylsis services in accordance with hospital policies and procedures and the contract agreement and ensure contracted staff was provided orientation prior to start providing care to patients admitted to the general acute care hospital. (Refer to A 398)

The cumulative effect of these systemic problems resulted in the hospital's inability to provide quality health care in a safe environment.

Based on observation, record review and interview, the facility failed to:

1. Ensure Intensive Care Unit (ICU) nurse hand off patient to another ICU nurse when leaving the ICU temporarily; closely monitor ventilator alarms and respond promptly to assure ICU patients were continually monitored. The registered nurse assigned to care for Patient 2 failed to ensure another licensed staff assume temporary responsibility for the care of Patient 2 when the assigned nurse left the unit.
This deficient practice resulted in Patient 2's ventilator being disconnected for eight minutes with no response to the ventilator alarm. Subsequently, Patient 2 went into cardiopulmonary arrest (the sudden, unexpected loss of heart function, breathing and consciousness).

2. Ensure informed consent was obtained prior to a start hemodialysis treatment in accordance with the facility policy and procedure on informed consent.

Findings:

1. During an initial tour in ICU#1 on 12/13/17 at 11:05 a.m., when asked if the alarm will sound if a ventilator is disconnected respiratory therapist (RT) 2 indicated yes. When asked to demonstrate this, RT 2 entered Patient #20's room, which was an isolation room and closed the door. When the ventilator was disconnected it was audible at the nurse's station and next patient room.

During an observation and interview with RT 2 and Dir CR in the respiratory department, RT 2 demonstrated how vents are checked prior to patient use. On 12/14/17 at 3:45 p.m., during an interview Dir CR and RT 2 indicated the alarm sounds within a few seconds when the circuit is disconnected.

During a closed Medical Chart review of Patient # 2 who was in Isolation in the ICU, was documented to have been found by MD disconnected for 8 minutes from the ventilator with the ventilator alarm sounding. The MD documented difficulty reconnecting and a Code blue was called. Further review, the RN assigned to the patient had temporarily left the ICU without endorsing the patient to another RN.

During an interview with Unit Dir 2 on 12/15/17 at 10:15 a.m. he indicated the staff is instructed to respond to all alarm.

A review of the facility policy and procedure titled, "Communication Standard Approach to (SBAR) dated 3/06 indicated "Assuming temporary responsibility for the care when staff leave a unit for a short period of time."

A review of the facility policy and procedure titled "Critical Alarms" dated 01/03 indicated "Alarms are intended to alert hospital personnel that a variable is beyond safe" and "nurses are to "respond to alarms immediately."




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2. a. On December 14, 2017, at 10 a.m., Patient 12 was observed receiving hemodialysis treatment via left lower arm fistula. The patient was dialyzing on a Revaclear dialyzer, on a 3 K (potassium) 2.5 Ca (calcium) bath, BFR of 400 and DFR of 600.

(BFR represents the speed that the patient's blood is moving through the dialysis [a procedure for removing metabolic waste products or toxic substances from the bloodstream by dialysis] tubing). DFR is the rate the dialysate [dialysis solution] is moving through the dialyzer.)

Review of the admission facesheet indicated Patient 12 was admitted to the facility on December 5, 2017, with chief complaint of congested heart failure.

On admission the patient received hemodialysis treatment in the general acute care hospital (GACH). Review of the Consent to Surgery or Special Procedure indicated the physician obtained informed consent on December 14, 2017 (13 days later).

b. Review of the admission facesheet indicated Patient 14 was admitted to the facility on December 10, 2017, with diagnosis of bleeding fistula.

A review of the Acute Hemodialysis Flowsheet indicated the patient received hemodialysis treatment on December 12, 2017.

On December 14, 2017, a copy of the Consent to Surgery or Special Procedure was requested from the floor and it was not filled out. Shortly thereafter, registered nurse quality coordinator (RNQC) provided a copy of the Consent signed by the physician and dated December 12, 2014.

During a concurrent interview, RNQC stated the consent should have been dated 12/14/17.

c. Review of the admission facesheet indicated Patient 15 was admitted to the facility on December 11, 2017, with chief complaint of hyperkalemic arrest, hypotension and respiratory failure.

On December 11, 2017, the patient received hemodialysis treatment.

Review of the Consent to Surgery or Special Procedure indicated there was no documentation to indicate the physician obtained informed consent from the patient. There was no patient signature/date on the consent. However, RN 13 signed as a witness in the consent form.

d. Review of the admission facesheet indicated Patient 16 was admitted to the facility on November 25, 2017, with chief complaint of respiratory distress.

A review of the Acute Hemodialysis Flowsheet indicated the patient received hemodialysis treatment on December 8, 9, 11, 12 and 13, 2017.

Review of the Consent to Surgery or Special Procedure indicated the physician signed the inform consent obtained from the patient. However, the date was written over.

Review of the facility policy number 441, titled Documentation, Nurses Notes-DAR indicated draw a single line through the error, write error with the date and date above the entry which has been single lined through.

e. Review of the admission facesheet indicated Patient 17 was admitted to the facility on November 23, 2017, with chief complaint of pneumonia.

A review of the Acute Hemodialysis Flowsheet indicated the patient received hemodialysis treatment on November 23, 24, 26 and 28, 2017 and December 2, 4, 5, 8 and 10, 2017.

Review of the Consent to Surgery or Special Procedure indicated there was no documentation to indicate the physician obtained informed consent from the patient. The patient signed and dated 11/23/17 the consent and an employee signed as a witness in the consent form.

Review of the facility policy number 103 titled, "Consent/Informed Consent" indicated the hospital's role in the informed consent process is to verify that that the physician obtained the patients' informed consent before the physician is permitted to perform the procedure or that (such as the emergency) applies that allows treatment to proceed. The hospital is responsible for ensuring the consent form is completed prior to to the procedure. The nurse is also responsible for witnessing the patient's signature after verifying with the patient that informed consent has been obtained.

Based on interview and record review, the registered nurses failed to develop a individualized care plan for patients who were receiving hemodialysis (a process for purifying the blood of a person whose kidneys are not working normally, patients are connected to a filter by tubes attached to the blood vessels via an access site) services,in accordance with hospital policies and procedures), for 12 of 35 sampled patients ( 12, 13, 14, 15, 16, 17, 18, 19, 24, 26, 30, and 35).

Findings:

On 12/15/17 at 3:37 PM, during an interview, the charge nurse in the intensive care unit (CN 2) stated the plan of care was to be initiated on admission and up to 24 hours, continuously and ongoing, if there are any concerns the primary nurse was responsible for the initiation of the care plan.

On 12/15/17 at 5:22 PM, during an interview, the director of the seventh floor (Unit Dir 1) stated it was the responsibility of the primary nurse to initiate a plan of care for patients who are receiving dialysis, within four hours.

a. Patient 18 was admitted to the facility on 10/13/17 for diagnoses that included complicated pyelonephritis (inflammation of the kidney due to a bacterial infection) and bandemia (too many white blood cells released by the bone marrow into the bloodstream).

A review of Patient 18's "Acute Hemodialysis Flow Sheets" indicated the patient received dialysis treatment on three times a week, continuously on Tuesdays, Thursdays and Saturdays. The first treatment was initiated on 10/23/17 and the last treatment was on completed 12/13/17.

A review of Patient 18's "Individualized Plan of Care and Communication," initiated on 10/13/17, did not include the plan of care regarding a patient while receiving hemodialysis.

b. Patient 19 was admitted to the facility on 12/8/17 for hypotension (low blood pressure) and end stage renal disease (ESRD).

A review of Patient 19's "Acute Hemodialysis Flow Sheets" indicated the patient received dialysis treatment on 12/9/17 and 12/11/17.

A review of Patient 19's "Individualized Plan of Care and Communication," initiated on 12/10/17, did not include the plan of care regarding a patient while receiving hemodialysis.

c. Patient 24 was admitted to the facility on 12/10/17 for chronic renal failure.

A review of Patient 24's "Acute Hemodialysis Flow Sheets" indicated the patient received dialysis treatments on 12/11/17, 12/12/17 and 12/14/17.

A review of Patient 24's "Individualized Plan of Care and Communication," initiated on 12/10/17, did not include the plan of care regarding a patient while receiving hemodialysis.

d. Patient 26 was admitted to the facility on 12/8/17 for diagnoses that included anemia (a deficiency of red blood cells or hemoglobin) and chronic renal failure.

A review of Patient 26's "Acute Hemodialysis Flow Sheets" indicated the patient received dialysis treatments on 12/9/17, 12/10/17 and 12/12/17.

A review of Patient 26's "Individualized Plan of Care and Communication," initiated on 12/8/17, did not include the plan of care regarding a patient while is receiving hemodialysis.

e. Patient 30 was admitted to the facility on 12/12/17 for cellulitis (a bacterial infection involving the inner layers of the skin) to the left leg.

A review of Patient 30's "Acute Hemodialysis Flow Sheets" indicated the patient received dialysis treatment on 12/13/17.

A review of Patient 30's "Individualized Plan of Care and Communication," initiated on 12/12/17, did not include the plan of care regarding a patient while is receiving hemodialysis.

f. A review of Patient 35's medical records indicated the patient was admitted to the facility on 6/29/16. A review of "History and Physical Report" dated 6/29/16, indicated the patient was admitted with fever and altered mental status, after hemodialysis. The patient diagnoses included end-stage renal disease, hypertension and schizophrenia.

A review of Patient 35's "Acute Hemodialysis Flow Sheets" indicated the patient had received dialysis treatments on 7/1/16, 7/4/16, 7/6/16, 7/9/16, 7/12/16, 7/13/16, 7/15/16, 7/18/16, 7/20/16, 7/22/16, 7/26/16, 7/27/16, and 7/28/16.

A review of Patient 35's "Individualized Plan of Care and Communication," initiated on 6/30/16, did not include the plan of care regarding a patient who is receiving hemodialysis.

A review of the facility's policy and procedure titled, "Patient Care Services, Critical Care and Acute Care Division Policy and Procedure," revised on 7/2011, indicated the registered nurse will be responsible for the initiation of the plan of care and patient/family education on the Individualized Plan of Care and Communication form. Disciplines involved in the care of the patient will document a plan of care, as appropriate, at the time of the initial assessment and or upon patients changing needs.



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g. On December 14, 2017, at 10 a.m., Patient 12 was observed receiving hemodialysis treatment via left lower arm fistula (access where the artery and a vein are joined under the skin). The patient was dialyzing on a Revaclear dialyzer, on a 3 K (potassium) 2.5 Ca (calcium) bath, BFR of 400 and DFR of 600.

Review of the admission facesheet indicated Patient 12 was admitted to the facility on December 5, 2017, with chief complaint of congested heart failure.

(1) A review of the Acute Hemodialysis Flowsheet indicated the patient received hemodialysis treatment on December 5 and 14 , 2017.

Review of the Individualized Plan of Care and Communication initiated on December 5, 2017, did not include a plan of care addressing hemodialysis treatment.

(2) A review of the Acute Hemodialysis Flow Sheet dated 12/14/17 indicated the patient had a pacemaker on the right chest. Further review of the clinical record there was no documentation regarding pacemaker information.

During an interview with RN 14 while reviewing the clinical record on 12/15/17, at 2:30 p.m., indicated there was no documentation of pacemaker information such as when it was implanted, what type to name a few.

Review of the Individualized Plan of Care and Communication initiated on December 5, 2017, did include a plan of care addressing pacemaker but no interventions/information that relates to the patient having a pacemaker.

A review of the facility policy number: 413 titled, Critical Care, Completion of Flowsheet Telemetry Unit indicated Pacemaker Assessment to document rate, mode, MA and demands/asynchronous at the beginning of each shift and every four (4) hours or as ordered by physician and as indicated by patient's condition, as applicable for patient's with temporary pacemaker.

h. Review of the admission facesheet indicated Patient 13 was admitted to the facility on December 10, 2017, with chief complaint of chest pain.

A review of the Acute Hemodialysis Flowsheet indicated the patient received hemodialysis treatment on December 12 and 14, 2017.

Review of the Individualized Plan of Care and Communication initiated on December 10, 2017, did not include a plan of care addressing hemodialysis treatment.

i. Review of the admission facesheet indicated Patient 14 was admitted to the facility on December 10, 2017, with diagnosis of bleeding fistula.

A review of the Acute Hemodialysis Flowsheet indicated the patient received hemodialysis treatment on December 12, 2017.

Review of the Individualized Plan of Care and Communication initiated on December 12, 2017, did not include a plan of care addressing hemodialysis treatment.

j. Review of the admission facesheet indicated Patient 15 was admitted to the facility on December 11, 2017, with chief complaint of hyperkalemic arrest, hypotension and respiratory failure.

The physician ordered hemodialysis treatment on December 11 and 13, 2017. The patient received hemodialysis on those days.

A review of the Acute Hemodialysis Flowsheet indicated the patient received hemodialysis treatment on December 8, 9, 11, 12 and 13, 2017.

Review of the Individualized Plan of Care and Communication initiated on December 11, 2017, did not include a plan of care addressing hemodialysis treatment.

k. Review of the admission facesheet indicated Patient 16 was admitted to the facility on November 25, 2017, with chief complaint of respiratory distress.

A review of the Acute Hemodialysis Flowsheet indicated the patient received hemodialysis treatment on December 8, 9, 11, 12 and 13, 2017.

Review of the Individualized Plan of Care and Communication initiated on November 27, 2017, did not include a plan of care addressing hemodialysis treatment.

l. Review of the admission facesheet indicated Patient 17 was admitted to the facility on November 23, 2017, with chief complaint of pneumonia.

A review of the Acute Hemodialysis Flowsheet indicated the patient received hemodialysis treatment on November 23, 24, 26 and 28, 2017 and December 2, 4, 5, 8 and 10, 2017.

Review of the Individualized Plan of Care and Communication initiated on November 23, 2017, include a plan of care addressing hemodialysis. The plan of care did not include interventions for the access site, laboratory values, etc.

Review of the facility policy number: 416 titled, Initial Admission Assessment and Interdisciplinary Plan of Care Guidelines for Completion indicated the registered nurse (RN) will be responsible for the initiation of the plan of care..

Based on record review and interview, the facility staff failed to:
a. Ensure access site for hemodialysis was visible at all times during hemodialysis treatment.
b. Ensure patients in the Intensive Care Unit (ICU) were continually monitored to assure ICU nurses promptly assessed patients when ventilator alarmed in the ICU.
c. Ensure ICU nurses hand off patient to another ICU nurse when leaving the ICU temporarily.
d. a. Ensure patient assessment included monitoring of blood pressure (hypotensive), edema and pain.

Findings:

1. During an initial tour, in ICU #3 on 12/13/17 at 11:40 a.m., Patient 16's access site for dialysis was covered.

Review of closed medical record of Patient 35 indicated on 7/26/16 during dialysis developed vital signs instability and the registered nurse (RN) documented the access line was disconnected and blood was observed on the blanket patient was covered with and a code blue was called.

During an interview with Unit Dir 1 on 12/14/17 at 3: 5 p.m., when asked if access site to hemodialysis could be covered during dialysis, she indicated it could be covered as long as it is checked every 15 minutes.

A review of the facility policy and procedure titled, "Intradialytic Treatment Monitoring" dated 7/5/03 indicated the patient's vascular access site and blood line connections needs to be continuously visible throughout the dialysis treatment".

2. During an initial tour in ICU#1 on 12/13/17 at 11:05 a.m., when asked if the alarm will sound if a ventilator is disconnected, respiratory therapist (RT) 2 indicated yes. When asked to demonstrate this, RT 2 entered Patient #20 room, which was an isolation room closed the door. When the vent was disconnected it was audible at the nurse's station and next patient room.

During an observation and interview with RT 2 and Dir CR in the respiratory department, RT 2 demonstrated how ventilators are checked prior to patient use. On 12/14/17 at 3:45 p.m., during an interview Dir CR and RT 2 indicated the alarm sounds within a few seconds when the circuit is disconnected.

During a closed Medical Chart review of Patient # 2 who was in Isolation in the ICU, was documented to have been found by MD disconnected for 8 minutes from the vent [ventilator] with the Vent [ventilator] alarm sounding. The MD documented difficulty reconnecting and a Code blue was called. In further review, the RN assigned to the patient had temporarily left the ICU without endorsing the patient to another RN.

During an interview with Unit Dir 2 on 12/15/17 at 10:15 a.m., he indicated the staff is instructed to respond to all alarm.

A review of the facility policy and procedure titled "Communication Standard Approach to (SBAR) dated 3/06 indicated" Assuming temporary responsibility for the care when staff leave a unit for a short period of time".

A review of the facility policy and procedure titled "Critical Alarms" dated 01/03
Indicated "Alarms are intended to alert hospital personnel that a variable is beyond safe' and "nurses are to "respond to alarms immediately".



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3. A review of Patient 12's Acute Hemodialysis Flow Sheet dated 12/14/17 indicated the Post Treatment Assessment Section of the form was blank such as vascular access, time, blood pressure (BP), temperature, respiratory rate, post weight, skin, lungs, cardiac, edema, and pain.

A review of the contracted Dialysis Agency Policy titled, "Pre and Post Treatment Assessment and Data Collection" indicated post assessment of the following systems includes but is not limited to vital signs to include blood pressure, heart rate, temperature, respiratory rate, weight, vascular access, skin, respiratory, cardiac, peripheral edema, pain, ...

4. A review of Patient 14's Acute Hemodialysis Flow Sheet dated 12/12/17, at 12:35 p.m., indicated the patient's blood pressure (BP) reading was 80/46 and pulse was 108. At 7:05 p.m., the BP reading was 93/74 and pulse was 98 and closely monitor BP.
At 7:20 p.m., the BP reading 97/59 and pulse 99 and BP was low.

A review of the Contracted Dialysis Agency Policy titled, Hypotension indicated .... If patient continues to show signs and symptoms of hypotension, notify physician ..... report patient's medical condition to the primary nurse.

There was no documentation of patient reassessment during hypotensive episodes and notification of the Primary Nurse by the Dialysis Nurse of the hypotensive episode.

5. A review of Patient 16's Acute Hemodialysis Flow Sheet dated 12/13/17 indicated in the Pre and Post Treatment Assessment the RN documented under pain was N/A (not applicable).

A review of the contracted Dialysis Agency Policy titled, "Pre and Post Treatment Assessment and Data Collection" indicated post assessment of the following systems includes but is not limited to vital signs to include blood pressure, heart rate, temperature, respiratory rate, weight, vascular access, skin, respiratory, cardiac, peripheral edema, pain, ...

6. A review of Patient 17's Acute Hemodialysis Flow Sheet dated 12/10/17 indicated during Pre-Treatment Assessment under Edema documented N/A (not applicable). Post-Treatment Assessment indicated the patient has generalized edema.

Review of the Acute Hemodialysis Flow Sheet dated 12/4/17, indicated the RN failed to perform Pre-Treatment skin assessment.

Review of the Acute Hemodialysis Flow Sheet dated 12/02/17 indicated edema upper extremities. There was no indication which upper extremities, the level of edema from 1+ .

A review of the contracted Dialysis Agency Policy titled, "Pre and Post Treatment Assessment and Data Collection" indicated post assessment of the following systems includes but is not limited to vital signs to include blood pressure, heart rate, temperature, respiratory rate, weight, vascular access, skin, respiratory, cardiac, peripheral edema, pain, .

During an interview on 12/15, 2017, at 12 p.m., QMRN stated the facility had no policy on hypertension and edema.

Based on observation, interview and record review, the hospital failed to ensure non-employee licensed nurses provided hemodiaylsis (a process for purifying the blood of a person whose kidneys are not working normally, patients are connected to a filter by tubes attached to the blood vessels via an access site) services in accordance with hospital policies and procedures and the contract agreement; and failed to ensure contracted staff was provided orientation prior to start providing care to patients admitted to the general acute care hospital (GACH).

1. Non-licensed contracted nurses failed to ensure the dialysis site remained visible at all times, for two of 35 patients (Patient 13 and 35).

2. Non-employee licensed nurses failed to verify the hemodialysis consent was complete, with physician and witness signatures, prior to the initiation of hemodialysis, for # of 35, sampled patients (Patients 14, 18, 24, 26, and 35).

3. The hospital failed to ensure there was documented evidence that non-employee licensed nurses received orientation to the hospital, for two registered nurses (RN 8 and 11).

4. Patient 30's hemodialysis was delayed because the Informed Consent for Hemodialysis could not be found.

5. Dialysis RN failed to follow the policy/procedure on testing for pH of the dialysate prior to start of put on for Patient 30. This deficient practice had the potential for inaccurate results.

This deficient practice resulted in the failure of non-employee licensed nurses to follow the hospital's policies and procedures, which had the potential for the accidental needle dislodgement or line disconnection from the access site to go undetected, and resulted in the patient bleeding out, leading to the significant loss of blood and coma (a state of unconsciousness in which a person cannot be awakened, fails to respond normally to painful stimuli, light or sound) and subsequent death. It also resulted in the failure of non-employees licensed nurses to verify the consent for hemodiaylsis was complete, prior to initiating treatment.

Findings:

1. a. On 12/14/17 at 10 AM, Patient 13 was observed in the seventh floor suite, receiving hemodialysis. The hemodialysis access site was visible and located on the right chest.

Concurrently, the registered nurse (RN 8) providing the dialysis treatment stated she needed to visualize the access at all times, and if the patient gets cold, the site can be covered with a blanket, as long as she checks the site every 15 minutes.

At 10:15 AM, during an observation and interview, the registered nurse (RN 8) covered the right chest area with a blanket, covering the access site. RN 8, then stated the site needed to be visible because the tubing can be dislodged and the site can bleed.

A review of Patient 13's medical record indicated the patient was admitted to the facility on 12/10/17 with a diagnosis of end stage renal disease (ESRD, failure of the kidneys to remove toxins from the blood).

b. A review of Patient 35's medical records indicated the patient was admitted to the facility on 6/29/16. A review of "History and Physical Report" dated 6/29/16, indicated the patient was admitted with fever and altered mental status, after hemodialysis. The patient diagnoses included end-stage renal disease, hypertension (high blood pressure) and schizophrenia (a brain disorder in which people interpret reality abnormally).

A review of Patient 35's "Acute Hemodialysis Flow sheets", indicated the treatment was initiated on 7/1/16.

A review of Patient 35's "Acute Hemodialysis Flow sheet," dated 7/26/16, indicated the treatment started at 7:30 AM. The catheter access was located on the right femoral vein. The current hemoglobin (the protein molecule in red blood cells that carry oxygen from the lungs to the body's tissues and returns carbon dioxide from the tissues back from the lungs) was 9.0 G/DL, (normal range 12.0 - 16.0 G/DL). General assessment of the patient indicated the lungs were clear and was breathing room air. At 9:15, the blood pressure was 94/62 (normal blood pressure range 120/80). At 9:30 AM, the blood pressure increased to 192/158, the nurse documented the patient was stable. At 9:45 AM, a small stain of blood was noted on the blanket, nurse tried to investigate but the patient refused and was very heavy, called the RN because the line was disconnected. The patient was pale, but breathing. A code blue (a term used to indicate a person is in immediate need of resuscitation, most often because of a respiratory or cardiac arrest) was called due to the patient was unresponsive and had blood loss. During the code, the blood pressure was 122/95 with pulse of 123, then 136/104 with pulse of 66 (normal pulse 60-100 beats per minute).

A review of Patient 35's nursing note titled, "Unscheduled Code Blue Event Documentation," dated 7/26/16 at 9:48 AM, indicated the dialysis nurse yelled for help. Primary nurse went to room and found patient saturated in blood, patient pulled over not responding, gray in color, code blue called while chest compressions started. Primary doctor arrives, as well as the clinical supervisor and code blue team. Patient then transferred to ICU (intensive care unit) after being intubated (the placement of a flexible plastic tube into the trachea to maintain an open airway).

A review of Patient 35's laboratory results dated 7/25/16 at 7:35 AM, indicated the hemoglobin was 9.0 G/DL. On 7/26/16 at 10:10 AM, the hemoglobin dropped to 5.4 G/DL, after the patient bled out during dialysis.

A review of of Patient 35's "Consultation Report" dated 7/27/16, indicated the patient had the dialysis done yesterday and the patient lost a significant amount of blood, unknown amount, but substantial. The patient had dropped her blood pressure significantly low and she had a hemoglobin of 5. The patient reportedly has no pulse and CPR (cardiopulmonary resuscitation) was ran on her. The patient became comatose (in a state of deep unconsciousness) after that and neurological consultation was requested. The patient is comatose and is on a ventilator (a machine used to provide breathing for a patient who is physically unable to breath, or breathing insufficiently. The patient suffered significant amount of blood loss after she unscrewed the connection of the dialysis catheter. She dropped her blood pressure for a long period of time and had significant bradycardia (slow heart rate) or possibly cardiac arrest, which was resuscitated, but the patient remained comatose afterwards.

A review of Patient 35's, "Death Summary," dated 7/28/16, indicated the cause of death included status post bleeding related during dialysis. During dialysis, the patient possibly pulled the line and there was a severe bleeding and the patient had an episode of hypotension (low blood pressure) and dropping the blood pressure. Code blue was ordered and the patient has severe hypertension, went into cardiac arrest (sudden, unexpected loss of heart function, breathing and consciousness). The brain scans showed no evidence of cerebral blood flow and the patient was pronounced dead on 7/28/17.

On 12/14/17 at 2 PM, during an interview, the director of the seventh floor (Dir 7th fl.) stated she also oversees the hemodialysis services. The Dir 7th fl. stated it was okay to cover the hemodiaylsis access site as long as the site was checked every 15-30 minutes, however, she also stated, she had not read the policy and procedure regarding dialysis.

On 12/14/17 at 4:22 PM, during an interview, the director of quality management (DQM) stated it was not okay to cover the dialysis access site with a blanket, at all.

On 12/15/17 at 11 AM, during an interview, regarding Patient 35, the DQM stated there was a breach in the policy and procedure because the patient's access site was covered with a blanket and the patient bled out.

A review of the facility's policy and procedure titled, "Intradialytic Treatment Monitoring," dated 3/2016, indicated the patient's vascular access site and the blood needs to be continuously visible throughout the dialysis treatment. Allowing patients to cover access sites and line connections provides an opportunity for accidental needle dislodgement or a line disconnection to go undetected.

2. On 12/14/17 at 9 AM, during the observation of the intensive care unit (ICU), the dialysis registered nurse (RN 7) was preparing Patient 14 for hemodialysis.

On 12/14/17 at 9 AM, during an interview, the dialysis registered nurse (RN 7) stated he could not start the dialysis treatment on Patient 14 before the doctor signed the informed consent for hemodialysis. RN 7 stated the patient had signed the informed consent and it had been witnessed by the nurse, however, the physician had not signed and everyone needed to sign the consent prior to the patient receiving dialysis. RN 7 stated this would be the third dialysis treatment since Patient 14 was admitted. RN 7 stated that prior to today he was told, by everyone, it was okay to give dialysis treatment, without the physicians signature, as long as the patient signed the consent. But, today, he was told that everyone had to sign the consent, including the physician, prior to starting dialysis treatment.

Concurrently, the review of Patient 14's "Consent to Surgery or Special Procedure," dated 12/12/17, indicated the procedure was for hemodialysis. The consent was not signed by the physician. This was also verified by RN 7.

a. Patient 14 was admitted to the facility on 12/12/17, admitting diagnoses included syncope (temporary loss of consciousness caused by a fall in blood pressure) and chronic renal failure (gradual loss of kidney function).

On 12/14/17 at 9:31 AM, during an interview, the chief of staff (COS) stated it was the responsibility of the physician to obtain consent for all procedures and offer alternatives to treatment and answer any questions. The consent must be signed by the physician, the patient and the witness prior to performing the procedure. The COS stated no procedure should be performed without a complete informed consent.

b. Patient 18 was admitted to the facility on 10/13/17 for diagnoses that included complicated pyelonephritis (inflammation of the kidney due to a bacterial infection) and bandemia (too many white blood cells released by the bone marrow into the bloodstream).

A review of a document titled, "Consent to Surgery or Special Procedure," indicated the consent for hemodiaylsis was completed on 10/25/17.

A review of Patient 18's "Acute Hemodialysis Flow Sheets" indicated the patient received dialysis treatment on 10/23/17, prior to having a completed informed consent.

c. Patient 19 was admitted to the facility on 12/8/17 for hypotension (low blood pressure) and end stage renal disease (ESRD).

A review of a document titled, "Consent To Surgery or Procedure," dated 12/9/17, indicated it was a consent for hemodialysis treatment. The patient (19) and the physician had signed the consent. There was no witness signature on the consent, the area was blank.

A review of Patient 19's "Acute Hemodialysis Flow Sheets" indicated the patient received dialysis treatment on 12/9/17 and 12/11/17.

d. Patient 24 was admitted to the facility on 12/10/17 for chronic renal failure.

A review of a documented titled, "Consent to Surgery or Procedure," indicated the procedure to be performed was hemodialysis, the patient (24) and a witness signed the consent on 12/11/17, however, the physician signed the consent on 12/14/17.

A review of Patient 24's "Acute Hemodialysis Flow Sheets" indicated the patient received dialysis treatments on 12/11/17, 12/12/17 and 12/14/17.

e. Patient 26 was admitted to the facility on 12/8/17 for diagnosis that included anemia (a deficiency of red blood cells or hemoglobin) and chronic renal failure.

A review of a documented titled, "Consent to Surgery or Procedure," indicated the procedure to be performed was hemodialysis, the patient (26) and witness signed the consent on 12/9/17, however, the physician did not sign the consent, the area was blank.

A review of Patient 26's "Acute Hemodialysis Flow Sheets" indicated the patient received dialysis treatments on 12/9/17, 12/10/17 and 12/12/17.

f. A review of Patient 35's medical records indicated the patient was admitted to the facility on 6/29/16. A review of "History and Physical Report" dated 6/29/16, indicated the patient was admitted with fever and altered mental status, after hemodialysis. The patient diagnoses included end-stage renal disease, hypertension and schizophrenia.

A review of a document titled, "Consent to Surgery or Special Procedure," dated 7/1/16, indicated that hemodialysis and it's necessity was explained to the patient (Patient 35), the patient answered it was "okay". The document was signed by the nurse. There was no physician signature present on the consent for hemodialysis, the area was blank.

A review of Patient 35's "Acute Hemodialysis Flow Sheets" indicated the patient had received dialysis treatments on 7/1/16, 7/4/16, 7/6/16, 7/9/16, 7/12/16, 7/13/16, 7/15/16, 7/18/16, 7/20/16, 7/22/16, 7/26/16, 7/27/16, and 7/28/16.

A review of the facility's policy and procedure titled, "Pre and Post Treatment Assessment and Data Collection," dated 10/2017, indicated the purpose was to obtain information for planning the dialysis treatment, assessing and reviewing the patient's response to the treatment.
Pre-treatment data collection was to obtain pre-treatment hand off report from the patient's primary nurse to including, verification of signed treatment consent. Patient assessment included the licensed nurse teammate verifies consent for treatment has been obtained.

3. On 12/15/17 at 9:42 AM, during an interview, the DQM stated the hospital started doing hospital orientation in 11/2017 for contracted staff. The DQM stated the hospital did not have a policy regarding orientation for contracted staff.

A review of personnel files indicated RN 8 and RN 11 (non-employee licensed nurses) did not have documented evidence of receiving a hospital orientation in their file.



11683

During review of the personnel and health file of the contracted dialysis nurses on December 15, 2017, at 8 a.m., the following was noted that 3 of 3 Dialysis RN failed to have orientation to the general acute hospital prior to start of work.

During an interview with QMRN at the time of record review, she confirmed that Dialysis RN do not have orientation provided prior to start of work in the GACH.

4. On December 13, 2017, at 1:30 p.m., Patient 30 was observed to receive hemodialysis treatment via left lower arm arteriovenous fistula (AVF, is an access where the artery and a vein are joined under the skin). The patient will be dialyzing on 3 K (potassium) and 2.5 Ca (calcium) on a Revaclear dialyzer (artificial kidney). It was delayed because the Informed Consent for Hemodialysis could not be found.

5. The Dialysis RN was observed conducting a pH (a measure of acidity in liquid) and conductivity (the ability of an object or substance to transmit heat, electricity, or sound)
and conductivity test on the machine's dialysate. The RN used the EZ Residual Chlorine Test Strips which was opened and undated. The RPC strip was used to check the ph. The RN took a dialysate sample from the Hansen connector in a plastic cup. The RN took a strip and dip into the well and lift the strip and compare the color scale from the bottle. The result was 7.6.

A review of the contracted agency policy/procedure number: 7/11-04A titled, "Testing ph of dialysate using RPC E-Z Check 100-0117 6.8 -8.5 Test Strips" indicated obtain a disposable collection cup and collect a sample of dialysate to be tested. Dip the strip into the solution to be tested and move the strip back and forth in the solution for one (1) second. Dip the strip and shake off excess dialysate. After 10 seconds, compare the strip to the scale on the vial. Match the strip as closely as possible to one of the vial scales and read the pH range listed above the matched color. pH results should be between 6.9 to 7.6.

During an interview with Dialysis Clinical Manager (CM 1), he was made aware the RN failed to follow the policy/procedure on testing for pH of the dialysate prior to start of put on for Patient 30.