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

1a. For Patient 1, an appropriate intervention was provided when Patient 1 was hypotensive (suffering from low blood pressure [BP], normal BP was 120/80 millimeter mercury [mmHg, unit of measurement]) during hemodialysis treatment (HD, a procedure using a machine to purify a person's blood whose kidneys are not working normally), in accordance to the facility's policy and procedure (P&P) (A 0395);

b. For Patient 3, there was no documented evidence Patient 3's high blood sugar (BS, normal BS level is 90 to 130 (milligram/deciliter [mg/dl]) level was addressed. In addition, there was no documented evidence the physician was notified for Patient 3's BS level of above 350 mg/dl as ordered (A 395);

2. For Patients 20 and 3, a comprehensive care plan was developed (A 396);

3a. For Patient 1, an appropriate intervention was provided when the patient became hypotensive during hemodialysis treatment and the physician was notified when Patient 1's HD treatment was discontinued prior to prescribed treatment time. In addition, the facility failed to ensure the HD Registered Nurse (RN) notified Patient 1's assigned RN of the patient's medical condition before and after the HD treatment (A 0398);

b. For Patient 3, the physician was notified for the patient's blood sugar level of above 350 mg/dl (A 0398);

In addition, the facility failed to ensure Patient 3's discontinued diltiazem (a medication used to control rapid heartbeat or abnormal heart rhythm) intravenous (IV, administration through the vein) was disposed of properly (A 0398);

c. For Patient 22, hygiene requirements for the prevention of central line associated bloodstream infection (CLABSI, serious infection/s which could occur when bacteria or viruses enter the bloodstream through a thin tube placed into a large blood vessel were conducted (A 398);

4a. For Patient 1, medications were administered as ordered by the physician (A 0405); and

b. For Patient 22, hydromorphone (Dilaudid, medication to treat pain) PRN was administered as ordered and an assessment was done before the pain intervention was provided (A 405).

The cumulative effect of these systemic failures resulted in Patients 1, 3, 20, and 22 to not be provided safe and quality care to meet their needs.

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

1. For Patient 1, an appropriate intervention was provided when Patient 1 was hypotensive (suffering from abnormally low blood pressure [BP], normal BP was 120/80 millimeters of mercury [mmHg, unit of measurement]) during hemodialysis treatment (HD, a procedure using a machine to purify a person's blood whose kidneys are not working normally), in accordance with the facility's policy and procedure (P&P).

This failure resulted in a delay of treatment which may have contributed to the deterioration of the medical condition and subsequent death of Patient 1; and

2. For Patient 3, the high blood sugar (BS, normal BS level is 90 to 130 (milligram/deciliter [mg/dl, unit of measurement]) level was addressed timely and the physician was notified of Patient 3's BS level of above 350 mg/dl as ordered.

These failures had the potential to result in a delay of treatment which may lead to the deterioration of Patient 3's medical conditions.

Findings:

1a. During a concurrent interview and record review, on November 7, 2022, at 1:30 p.m., conducted with the Clinical Nurse Manager (CNM), Patient 1's record was reviewed. The "History & (and) Physical," dated March 7, 2022, indicated, "...from dialysis facility, c/c (chief complaint) lethargy (weakness) and hypotensive systolic (low SBP, the first number of the BP, measurement of the pressure in the arteries [blood vessels carrying oxygenated blood from the heart] when the heart contracted) on the 70's..."

The facility document titled, "Order Information," dated March 10, 2022, indicated HD treatment with a start date of March 11, 2022, for a three-hour duration with a total ultrafiltration (UF, removal of fluid from a patient) of 2000 milliliter (ml, unit of measurement) as tolerated by the patient.

The "Acute Hemodialysis Flow Sheet," dated March 11, 2022, indicated the following:

- At 8 a.m., prior to HD treatment, Patient 1's BP was 110/91 mmHg;

- At 9:10 a.m., Patient 1's BP was 81/57 mmHg, HD treatment was initiated with a UF rate (UFR) of 350;

- At 9:25 a.m., Patient 1's BP was 83/51 mmHg, with a UFR of 510 (was increased from 350) and the total fluid removed was 100 ml; and

- At 9:40 a.m., Patient 1's BP was 87/51 mmHg, with a UFR of 510 and the total fluid removed was 230 ml.

There was no documented evidence the physician was notified of Patient 1's hypotensive condition.

There was no documented evidence treatment orders for hypotension were obtained from the physician.

There was no documented evidence medication for hypotension was administered to Patient 1.

The CNM stated Patient 1 was hypotensive at the start of HD and should have been given treatment for hypotension, in accordance with the facility's P&P.

The CNM stated the facility's P&P for hypotensive treatment was first to give normal saline (NS, an intravenous fluid), then to decrease the UF, followed by the administration of oxygen and albumin (a medication used to treat low blood volume).

The CNM stated if there was no HD order for hypotension treatment, the HD registered nurse (RN) should notify the physician of the patient's hypotensive condition and obtain an order for treatment.

b. Patient 1's "Order Information," dated March 18, 2022, indicated HD treatment with a start date of March 19, 2022, for a three-hour duration with a total UF of 2000 ml as tolerated by the patient.

The "Acute Hemodialysis Flow Sheet," dated March 19, 2022, indicated the following:

- At 9:10 a.m., Patient 1's BP was 107/64 mmHg and HD was initiated;

- At 10:25 a.m., Patient 1's BP was 92/54 mmHg, with a UFR of 510 and the total fluid removed was 611 ml;

- At 10:40 a.m., Patient 1's BP was 72/45 mmHg and UFR was turned off;

- At 10:55 a.m., Patient 1's BP was 75/61 mmHg and UFR was turned off; and

- At 11:10 a.m., Patient 1's BP was 91/56 mmHg, with a UFR of 510 and the total fluid removed was 1300 ml.

- At 11:25 a.m., "...Ended Tx (treatment) early due to issues c (with) needles..."

There was no documented evidence medication for hypotension was administered to Patient 1.

The CNM stated Patient 1 was hypotensive from 10:40 a.m., through 11:10 a.m.

The CNM stated Patient 1 should have been given treatment for hypotension in accordance with the P&P.

The CNM stated if there was no HD order for hypotension treatment, the HD RN should call the physician to notify of the patient's hypotensive condition and obtain an order for treatment.

c. Patient 1's "Order Information," dated April 15, 2022, indicated HD treatment with a start date of April 16, 2022, for a three-hour duration with a total UF of 2000 ml as tolerated by the patient.

In addition, the document indicated the physician ordered Albumin 25 percent (%) 100 ml intravenous as needed (PRN) to be administered for SBP of less than (<) 100.

The "Acute Hemodialysis Flow Sheet," dated April 16, 2022, indicated the following:

- At 9:25 a.m., Patient 1's BP was 111/72 mmHg and HD was initiated;

- At 9:55 a.m., Patient 1's BP was 89/59 mmHg, UFR was turned off and the total fluid removed was 236 ml; and

- At 10:10 a.m., Patient 1's BP was 93/29 mmHg and UFR was turned off.

There was no documented evidence albumin was administered to Patient for SBP < 100 at 10:40 a.m. and 10:55 a.m., as ordered by the physician.

The CNM stated Patient 1 was hypotensive at 9:55 a.m. and 10:10 a.m.

The CNM stated Patient 1 should have been given albumin as ordered by the physician.

d. Patient 1's "Order Information," dated April 24, 2022, indicated HD treatment with a start date of April 25, 2022, for a three-hour duration with a total UF of 2000 ml as tolerated by the patient.

In addition, the record indicated, "...NS 250 ml x 2 (two times) prn SBP < 100. Albumin 25% 100 ml IVP (IV push) q (every) 1h (one hour) prn if still hypotensive...if SBP <100 one time..."

The "Acute Hemodialysis Flow Sheet," dated April 25, 2022, indicated the following:

- At 2:21 p.m., Patient 1's BP was 115/68 mmHg and HD was initiated;

- At 2:37 p.m., Patient 1's BP was 94/52 mmHg, with a UFR of 770 and the total fluid removed was 237 ml;

- At 2:53 p.m., Patient 1's BP was 81/52 mmHg, UFR was turned off, and NS 200 ml IV was given to the patient;

- At 3:13 p.m., Patient 1's BP was 100/64 mmHg, UFR was turned off, and Patient 1 complained of nausea, dizziness, and headache;

- At 3:28 p.m., Patient 1's BP was 84/48 mmHg and UFR was turned off;

- At 3:38 p.m., Patient 1's BP was 74/52 mmHg, UFR was turned off, and NS 200 ml IV was given to the patient;

- At 3:48 p.m., Patient 1's BP was 73/36 mmHg and UFR was turned off;

- At 3:52 p.m., Patient 1's BP was 76/38 mmHg, UFR was turned off, and HD treatment was ended due to hypotension; and

- At 4:35 p.m., Patient 1's BP was 87/47 mmHg.

There was no documented evidence albumin for hypotension was administered to Patient 1 when the SBP was less than 100. There was no documented evidence the physician was notified about stopping Patient 1's HD treatment early due to hypotension.

Patient 1's "Progress Note - Physician," dated April 25, 2022, indicated, "...Code Blue (a code for a life-threatening emergency involving an adult patient) called by RN at 1736 (5:36 p.m.)...Per RN pt (Patient 1) became cold and unresponsive. CPR (cardio pulmonary resuscitation) started...Time of Death: 1752 (5:52 p.m.)...."

Patient 1's "Discharge Summary," dated April 26, 2022, indicated, "...CODE BLUE was called by RN (on April 25, 2022) at 1736. Per RN, patient became cold and unresponsive. Of note, patient had completed her hemodialysis session prior to this episode...CPR was started...Patient deceased. Time of Death 1752...Of note patient's blood pressure was noted to be 74/52 and 76/38 during hemodialysis session. Internal medicine team (group of physicians who specialized in treating adults) was not notified..."

The CNM stated Patient 1 should have been given albumin as ordered by the physician.

The CNM stated the HD RN should have notified the physician when Patient 1's HD treatment was stopped due to hypotension.

During an interview on November 9, 2022, at 1:45 p.m., conducted with Physician 1, Physician 1 stated the patients having HD treatment could suffer from hypotension if they are not able to tolerate the amount of blood volume being drawn from them during HD.

Physician 1 stated when the patient becomes hypotensive during HD, NS would be given as IV bolus to help increase the BP.

Physician 1 stated albumin could be given as ordered during HD when the patient becomes hypotensive because it could also help increase the BP. Physician 1 stated Patient 1 had an order of albumin PRN for hypotension and it should have been given by the HD RN. Physician 1 stated the albumin could have helped to increase Patient 1's BP.

During a review of the facility's P&P titled, "Hypotension," revised in September 2016, the P&P indicated, "...Take vital signs (BP, pulse rate)...

Adjust ultrafiltration (UF) rate as ordered...

Turned off ultrafiltration rate (UFR) per physician order...

Notify nephrologist (physician specializes on kidney problems and diseases) for change in condition. Orders given may include: IV fluids, oxygen, Albumin 25%...

Administer normal saline bolus per nephrologist order...

Administer medications as ordered...

If patient continues to show signs and symptoms of hypotension, notify physician and follow additional physician's orders...

If patient condition requires treatment to be discontinued prior to prescribed treatment time, notify the nephrologist..."

2. During a concurrent interview and record review conducted with the Assistant Chief Nursing Officer (ACNO), on November 9, 2022, at 11:55 a.m., Patient 3's record was reviewed. The "History & Physical," dated November 4, 2022, indicated Patient 3 came into the facility for increased shortness of breath and cough. The document indicated Patient 3's home medication included glimepiride (medication used for treatment of diabetes [condition in which there is an abnormal BS) and glipizide (medication used for treatment of diabetes).

The facility document titled, "Order Information," indicated a physician's telephone order was received on November 4, 2022, at 2:35 p.m. (three hours since Patient 3's last high BSL of 368 mg/dl at 11:17 a.m.), for Insulin Novolog (a rapid acting insulin [medication for high blood sugar used for diabetes) to be given subcutaneously (sq, injection on the fatty tissue under the skin) before meals and at night per sliding scale (a physician's order varying the dose of insulin depending om the patient's BS level). The order indicated, "...Novolog correctional scale Intermediate...sliding scale comment...BG (blood glucose) level (mg/dl)...Greater than 350 = (equal to) 13 units and notify physician..."

The "Glucose (blood sugar) Level Flowsheet" for November 4, 2022, indicated the following:

- At 6:16 a.m., Patient 3's blood sugar level (BSL) was 399 mg/dl;

- At 11:17 a.m., Patient 3's BSL was 368 mg/dl; and

- At 4:35 p.m., Patient 3's BSL was 368 mg/dl.

Patient 3's "MAR (Medication Administration Record) Summary," indicated the following:

- On November 4, 2022, at 4:59 p.m., Patient 3 was administered 13 units of Novolog sq for BSL of 368 mg/dl (six hours since Patient 3's last high BSL at 11:17 a.m.); and

- On November 6, 2022, at 12:24 p.m., Patient 3 was administered 13 units of Novolog sq for BSL of 372 mg/dl.

There was no documented evidence the physician was notified of Patient 3's BS of 350 mg/dl on November 4, 2022 at 4:49 p.m. and on November 6, 2022, at 12:24 p.m., as ordered by the physician.

The ACNO stated when the patient's BSL was high and there was no medication ordered, the physician should be notified and it should be documented on the patient's medical record.

CA 1 stated the physician should have been notified of Patient 3's BSL as indicated in the physician's order.

The ACNO stated Patient 1's high BSL at 6:16 a.m. and 11:17 a.m., should have been addressed timely and the nurse should have documented what was done to address Patient 1's high BSL.

During a review of the facility's P&P titled, "Medication Administration and Monitoring Policy," revised in June 2021, the P&P indicated, "...The response of the patient to medication will be monitored by the administering nurse or licensed person administering the medication according to the clinical needs of the patient...

The licensed person administering the medication will make a response and take action to communicate the results of this monitoring to the prescriber or pharmacist as appropriate..."

Based on observation, interview, and record review, the facility failed to ensure a comprehensive care plan was developed, for two of 30 patients reviewed (Patients 20 and 3).

This failure had the potential of the needs of Patients 20 and 3 to not be met.

Findings:

1. On November 7, 2022, Patient 20's record was reviewed. The facility document titled. "History and Physical," dated March 2, 2022, at 10:04 a.m., indicated Patient 20 was admitted to the facility on March 2, 2022, with diagnoses which included cough and shortness of breath and had a past medical history of hypertension (abnormally high blood pressure), end stage renal disease (ESRD, disease when the kidneys are not functioning effectively), and dependence on dialysis (the process of removing excess water, solutes, and toxins from the blood using a machine). The document indicated, "...Assessment/Plan Diagnoses Acute pulmonary edema, Uncontrolled hypertension, ESRD on dialysis, Hyperkalemia (high level of potassium [a mineral] in the blood), Fluid overload (condition when excess fluids accumulate in the body), Acute respiratory failure with hypoxia (ineffective breathing resulting in low oxygen level in the blood)..."

The facility document titled, "Nephrology Initial Evaluation Note," dated March 2, 2022, at 10 a.m., indicated, "...He (Patient 20) was also noted to be hypertensive with BP 245/142. He was placed on Bipap (machine used to assist in the patient's breathing) and is currently receiving emergent HD...02 (oxygen) Flow Rate (amount of oxygen delivered) on 50% Bipap..."

There was no documented evidence indicating a comprehensive care plan was developed to address Patient A's medical conditions.

On November 9, 2022, at 3:15 p.m., a concurrent interview and record review was conducted with the Director of Medical/Surgical Telemetry (DMST). The DMST stated Resident 20 was receiving dialysis, was hypertensive, and was on Bipap. The DMST stated there was no comprehensive care plans developed for any of those issues. The DMST stated a comprehensive care plan should have been developed to address Patient A's diagnoses. The DMST stated individualized care plans should have been developed to address Patient 20's renal failure (inefficient kidney function), impaired fluid volume (fluid overload), and impaired gas exchange (inefficient breathing).

2. During a concurrent observation and interview, conducted with Patient 3, on November 8, 2022, at 10:40 a.m., Patient 3 was observed lying in bed, alert, and oriented. Patient 3 stated he was admitted for chest pain and shortness of breath. Patient 3 stated he had a recent heart attack.

During a concurrent interview and record review, conducted with the Director of Medical-Surgical Telemetry (DMST), on November 9, 2022, at 3:15 p.m., Patient 3's record was reviewed. The "History & (and) Physical," dated November 4, 2022, indicated Patient 3 came in to the facility for increased shortness of breath and cough. The document indicated Patient 3 was recently discharged from the facility after being admitted for myocardial infarction (heart attack). In addition, the record indicated Patient 3's home medication included glimepiride (medication used for treatment of diabetes [abnormal blood sugar]) and glipizide (medication used for treatment of diabetes).

Patient 1's "Order Information," indicated a physician's telephone order was received on November 4, 2022, at 2:35 p.m., for Insulin Novolog (rapid acting insulin, medication for diabetes) to be given subcutaneously (sq, injection on the fatty tissue under the skin) before meals and at night per sliding scale (a physician's order for varying dosage of insulin depending on the patient's blood sugar level).

There was no documented evidence a care plan was developed addressing Patient 3's heart condition and diabetes.

The DMST stated an individualized care plan addressing Patient 3's condition to meet his needs and goals should have been developed.

During a review of the facility's policy and procedure (P&P) titled, "Assessment and reassessment of patients," revised in February 2022, the P&P indicated, "...Interdisciplinary Plan of Care...The plan is individualized according to the patient's needs. Problems/needs relate to diagnosis, patient/significant other education, patient care problems, and/or psychosocial problems..."

Based on observation, interview, and record review, the facility failed to ensure the facility's policies and procedures (P&P) were implemented when:

1. For Patient 1, an appropriate intervention was provided when Patient 1 was hypotensive (suffering from abnormally low blood pressure [BP], normal BP was 120/80 millimeters of mercury [mmHg, unit of measurement]) during hemodialysis treatment (HD, a procedure using a machine to purify a person's blood whose kidneys are not working normally) and the physician was not notified when Patient 1's HD treatment was discontinued prior to the prescribed treatment time.

2a. For Patient 1, a pre and post HD assessment was not conducted.

b. For Patient 1, the HD Registered Nurse (RN) did not report the patient's medical condition to Patient 1's assigned RN after the HD treatment.

These failures resulted in a delay in treatment which may have contributed to the deterioration of the medical condition and the subsequent death of Patient 1;

3a. For Patient 3, there was no documented evidence the physician was notified for the patient's blood sugar (BS) level of above 350 milligrams per deciliter (mg/dl, unit of measurement); and

b. For Patient 3, the discontinued diltiazem (medication used to control rapid heartbeat or abnormal heart rhythm) intravenous (IV, administered through the vein) medication was not disposed properly.

These failures had the potential to result in a delay of treatment and for an unauthorized person to have access to the medication; and

4. For Patient 22, the nursing staff did not follow hygiene requirements for the prevention of central line associated bloodstream infection (CLABSI, a serious infection which could occur when bacteria or viruses enter the bloodstream through a thin tube placed into a large blood vessel near the center of the body).

This failure had the potential to lead to the development and transmission of CLABSI, which could negatively affect the patients' health and safety and may lead to prolonged hospitalization and/or death for Patient 22.

Findings:

1a. During a concurrent interview and record review, on November 7, 2022, at 1:30 p.m., conducted with the Clinical Nurse Manager (CNM), Patient 1's record was reviewed. The "History & (and) Physical," dated March 7, 2022, indicated, "...from dialysis facility, c/c (chief complaint) lethargy (weakness) and hypotensive systolic (low SBP, the first number of the BP, measurement of the pressure in the arteries [blood vessels carrying oxygenated blood from the heart] when the heart contracted) on the 70's..."

The facility document titled, "Order Information," dated March 10, 2022, indicated HD treatment with a start date of March 11, 2022, for a three-hour duration with a total ultrafiltration (UF, removal of fluid from a patient) of 2000 milliliter (ml, unit of measurement) as tolerated by the patient.

The "Acute Hemodialysis Flow Sheet," dated March 11, 2022, indicated the following:

- At 8 a.m., prior to HD treatment, Patient 1's BP was 110/91 mmHg;

- At 9:10 a.m., Patient 1's BP was 81/57 mmHg, HD treatment was initiated with a UF rate (UFR) of 350;

- At 9:25 a.m., Patient 1's BP was 83/51 mmHg, with a UFR of 510 (was increased from 350) and the total fluid removed was 100 ml; and

- At 9:40 a.m., Patient 1's BP was 87/51 mmHg, with a UFR of 510 and the total fluid removed was 230 ml.

There was no documented evidence the physician was notified of Patient 1's hypotensive condition.

There was no documented evidence treatment orders for hypotension were obtained from the physician.

There was no documented evidence medication for hypotension was administered to Patient 1.

The CNM stated Patient 1 was hypotensive at the start of HD and should have been given treatment for hypotension, in accordance to the facility's P&P.

The CNM stated the facility's P&P for hypotensive treatment was first to give normal saline (NS, an intravenous fluid), then to decrease the UF, followed by the administration of oxygen and albumin (a medication used to treat low blood volume).

The CNM stated if there was no HD order for hypotension treatment, the HD registered nurse (RN) should notify the physician of the patient's hypotensive condition and obtain an order for treatment.

b. Patient 1's "Order Information," dated March 18, 2022, indicated HD treatment with a start date of March 19, 2022, for a three-hour duration with a total UF of 2000 ml as tolerated by the patient.

The "Acute Hemodialysis Flow Sheet," dated March 19, 2022, indicated the following:

- At 9:10 a.m., Patient 1's BP was 107/64 mmHg and HD was initiated;

- At 10:25 a.m., Patient 1's BP was 92/54 mmHg, with a UFR of 510 and the total fluid removed was 611 ml;

- At 10:40 a.m., Patient 1's BP was 72/45 mmHg and UFR was turned off;

- At 10:55 a.m., Patient 1's BP was 75/61 mmHg and UFR was turned off; and

- At 11:10 a.m., Patient 1's BP was 91/56 mmHg, with a UFR of 510 and the total fluid removed was 1300 ml.

- At 11:25 a.m., "...Ended Tx (treatment) early due to issues c (with) needles..."

There was no documented evidence medication for hypotension was administered to Patient 1.

The CNM stated Patient 1 was hypotensive from 10:40 a.m., through 11:10 a.m.

The CNM stated Patient 1 should have been given treatment for hypotension in accordance to the P&P.

The CNM stated if there was no HD order for hypotension treatment, the HD RN should call the physician to notify of the patient's hypotensive condition and obtain an order for treatment.

c. Patient 1's "Order Information," dated April 15, 2022, indicated HD treatment with a start date of April 16, 2022, for a three-hour duration with a total UF of 2000 ml as tolerated by the patient.

In addition, the document indicated the physician ordered Albumin 25 percent (%) 100 ml intravenous as needed (PRN) to be administered for SBP of less than (<) 100.

The "Acute Hemodialysis Flow Sheet," dated April 16, 2022, indicated the following:

- At 9:25 a.m., Patient 1's BP was 111/72 mmHg and HD was initiated;

- At 9:55 a.m., Patient 1's BP was 89/59 mmHg, UFR was turned off and the total fluid removed was 236 ml; and

- At 10:10 a.m., Patient 1's BP was 93/29 mmHg and UFR was turned off.

There was no documented evidence albumin was administered to Patient for SBP < 100 at 10:40 a.m. and 10:55 a.m., as ordered by the physician.

The CNM stated Patient 1 was hypotensive at 9:55 a.m. and 10:10 a.m.

The CNM stated Patient 1 should have been given albumin as ordered by the physician.

d. Patient 1's "Order Information," dated April 24, 2022, indicated HD treatment with a start date of April 25, 2022, for a three-hour duration with a total UF of 2000 ml as tolerated by the patient.

In addition, the record indicated, "...NS 250 ml x 2 (two times) prn SBP < 100. Albumin 25% 100 ml IVP (IV push) q (every) 1h (one hour) prn if still hypotensive...if SBP <100 one time..."

The "Acute Hemodialysis Flow Sheet," dated April 25, 2022, indicated the following:

- At 2:21 p.m., Patient 1's BP was 115/68 mmHg and HD was initiated;

- At 2:37 p.m., Patient 1's BP was 94/52 mmHg, with a UFR of 770 and the total fluid removed was 237 ml;

- At 2:53 p.m., Patient 1's BP was 81/52 mmHg, UFR was turned off, and NS 200 ml IV was given to the patient;

- At 3:13 p.m., Patient 1's BP was 100/64 mmHg, UFR was turned off, and Patient 1 complained of nausea, dizziness, and headache;

- At 3:28 p.m., Patient 1's BP was 84/48 mmHg and UFR was turned off;

- At 3:38 p.m., Patient 1's BP was 74/52 mmHg, UFR was turned off, and NS 200 ml IV was given to the patient;

- At 3:48 p.m., Patient 1's BP was 73/36 mmHg and UFR was turned off;

- At 3:52 p.m., Patient 1's BP was 76/38 mmHg, UFR was turned off, and HD treatment was ended due to hypotension; and

- At 4:35 p.m., Patient 1's BP was 87/47 mmHg.

There was no documented evidence albumin for hypotension was administered to Patient 1 when the SBP was less than 100. There was no documented evidence the physician was notified about stopping Patient 1's HD treatment early due to hypotension.

Patient 1's "Progress Note - Physician," dated April 25, 2022, indicated, "...Code Blue (a code for a life-threatening emergency involving an adult patient) called by RN at 1736 (5:36 p.m.)...Per RN pt (Patient 1) became cold and unresponsive. CPR (cardio pulmonary resuscitation) started...Time of Death: 1752 (5:52 p.m.)...."

Patient 1's "Discharge Summary," dated April 26, 2022, indicated, "...CODE BLUE was called by RN (on April 25, 2022) at 1736. Per RN, patient became cold and unresponsive. Of note, patient had completed her hemodialysis session prior to this episode...CPR was started...Patient deceased. Time of Death 1752...Of note patient's blood pressure was noted to be 74/52 and 76/38 during hemodialysis session. Internal medicine team (group of physicians who specialized in treating adults) was not notified..."

The CNM stated Patient 1 should have been given albumin as ordered by the physician.

The CNM stated the HD RN should have notified the physician when Patient 1's HD treatment was stopped due to hypotension.

During an interview on November 9, 2022, at 1:45 p.m., conducted with Physician 1, Physician 1 stated the patients having HD treatment could suffer from hypotension if they are not able to tolerate the amount of blood volume being drawn from them during HD.

Physician 1 stated when the patient becomes hypotensive during HD, NS would be given as IV bolus to help increase the BP.

Physician 1 stated albumin could be given as ordered during HD when the patient becomes hypotensive because it could also help increase the BP. Physician 1 stated Patient 1 had an order of albumin PRN for hypotension and it should have been given by the HD RN. Physician 1 stated the albumin could have helped to increase Patient 1's BP.

During a review of the facility's P&P titled, "Hypotension," revised in September 2016, the P&P indicated, "...Take vital signs (BP, pulse rate)...

Adjust ultrafiltration (UF) rate as ordered...

Turned off ultrafiltration rate (UFR) per physician order...

Notify nephrologist (physician specializes on kidney problems and diseases) for change in condition. Orders given may include: IV fluids, oxygen, Albumin 25%...

Administer normal saline bolus per nephrologist order...

Administer medications as ordered...

If patient continues to show signs and symptoms of hypotension, notify physician and follow additional physician's orders...

If patient condition requires treatment to be discontinued prior to prescribed treatment time, notify the nephrologist..."

2a. During a concurrent interview and record review, on November 7, 2022, at 1:30 p.m., conducted with the Clinical Nurse Manager (CNM), Patient 1's "Acute Hemodialysis Flow Sheet," dated March 11, 2022, indicated, "...Primary Nurse Report: First Initial/Last name/Title Pre-Dialysis (before dialysis, no written name of the RN) Time (no written time)....

Primary Nurse Report: First Initial/Last name/Title Post-Dialysis (after dialysis, no written name of the RN) Time (no written time)...."

The CNM stated the HD RN should give pre and post (after) dialysis report to the patient's assigned RN and the name of the RN who received the report should be documented on the flowsheet.

b. A concurrent interview and record review, on November 7, 2022, at 2:50 p.m., conducted with Nurse Manager (NM) 1. Patient 3's "Progress Note - Nurse," dated April 25, 2022, indicated, "...Hemodialysis treatment (for Patient 1) initiated at 1421 (2:21 p.m.) Returned from lunch break (RN) at 1638 (4:38 p.m.)...Asked both covering RNs (names of the charge nurse and of the resource nurse) whether Dialysis RN gave either post-hemodialysis Report; both denied...Arrived at bedside; pt unresponsive; no pulse or respirations noted; CPR initiated; activated Code Blue (facility code for life threatening emergency). Patient s/p (status post, after) hemodialysis..."

NM 1 stated she was the manager who responded when the Code Blue was initiated for Patient 1 on April 25, 2022. NM 1 stated she made a phone call to the dialysis nurse manager to inform her that she needed to get hold of the HD RN because the HD RN did not give report to Patient 1's assigned RN after the HD treatment and Patient 1 had a Code Blue.

NM 1 stated she received a call back from the dialysis nurse manager stating the HD RN "will come back to the facility." The NM stated she remembered telling the dialysis nurse manager, "How can she (HD RN) leave when she did not give report to anyone or had any dialysis documentation left on the chart?"

During an interview on November 8, 2022, at 11 a.m., conducted with Clinical Supervisor (CS) 1, CS 1 stated he was the charge nurse who relieved Patient 1's RN on April 25, 2022.

CS 1 stated when he relieved Patient 1's RN for her lunch break, he was told Patient 1 was on HD treatment.

CS 1 stated when Patient 1's RN came back from her break, he did not know Patient 1's HD was done because he did not receive a report from the HD RN.

CS 1 stated when a patient is on HD treatment, the HD RN should give pre and post HD reports to the patient's assigned RN.

During a review of the facility's P&P titled, "Hemodialysis," revised in March 2015, the P&P indicated, "...Purpose: To ensure that every patient undergoing hemodialysis is monitored by the contracted dialysis nurse and that (name of the facility) staff nurse is kept informed during and after the dialysis is completed...

The contracted dialysis nurse will keep the patient's nurse informed of any changes in the patient's condition, including changes necessitating a call to the physician...

At the completion of the dialysis run, the contracted dialysis nurse will give a verbal report to the staff nurse. In addition the dialysis nurse will summarize the dialysis run in the Hemodialysis Record. This note will contain the name of the nurse to whom the verbal report was given..."

During a review of the facility's P&P titled, "Hypotension," reviewed in April 2019, the P&P indicated, "...Report patient's medical condition to the patient's primary nurse..."

During a review of the facility's P&P titled, "Pre and Post Treatment Assessment and Data Collection," reviewed in June 2020, the P&P indicated, "...Provide post treatment hand off report to the patient's primary nurse to include but not limited to: summary of dialysis treatment..."

3a. During a concurrent interview and record review, on November 9, 2022, at 2:35 p.m., conducted with Clinical Analyst (CA) 1, Patient 3's record was reviewed. The "History & (and) Physical," dated November 4, 2022, indicated Patient 3 came to the facility for increased shortness of breath and cough. Patient 3's home medication included glimepiride (medication used for treatment of diabetes [a disease that occurs when blood sugar is too high]) and glipizide (medication used for treatment of diabetes).

Patient 3's "Order Information," indicated a physician's telephone order was received on November 4, 2022, at 2:35 p.m. (3 hours since Patient 3's last high blood sugar level [BSL] of 368 milligrams per deciliter [mg/dl, a unit of measurement]), for Insulin Novolog (rapid acting insulin used for diabetes) to be given subcutaneously (sq, injection on the fatty tissue under the skin) before meals and at night per sliding scale (a physician order for varying the dosage of insulin based on the patient's blood sugar level).

In addition, the telephone order indicated for BSL greater than 350, to give Insulin Novolog 13 units and notify the physician.

Patient 3's "MAR (Medication Administration Record) Summary," indicated the following:

- On November 4, 2022, at 4:59 p.m., Patient 3 was administered 13 units of Novolog sq for BSL of 368 mg/dl (six hours since Patient 3's last high BSL at 11:17 a.m.); and

- On November 6, 2022, at 12:24 p.m., Patient 3 was administered 13 units of Novolog sq for BSL of 372 mg/dl.

There was no documented evidence the physician was notified of Patient 3's BS of 350 mg/dl on November 4, 2022 at 4:49 p.m. and on November 6, 2022, at 12:24 p.m., as ordered by the physician.

CA 1 stated the physician should have been notified of Patient 3's BSL as indicated in the physician's order.

During a review of the facility's P&P titled, "Medication Administration and Monitoring Policy," revised in June 2021, the P&P indicated, "...The response of the patient to medication will be monitored by the administering nurse or licensed person administering the medication according to the clinical needs of the patient...

The licensed person administering the medication will make a response and take action to communicate the results of this monitoring to the prescriber or pharmacist as appropriate..."

b. During a concurrent observation and interview on November 8, 2022, at 10:40 a.m., conducted with Clinical Supervisor (CS) 2, Patient 3 was observed lying in bed, alert, and oriented. Patient 3 was observed to have an intravenous (IV) pole (a stand used to hang IV medication when administering IV medication to the patient) at the bedside with a bag of IV medication labeled Diltiazem with IV tubing connected to the bag hanging on it.

During a concurrent interview with Patient 3, Patient 3 stated he was admitted for chest pain and shortness of breath. Patient 3 stated he had a recent heart attack. Patient 3 stated, "They stop that med (diltiazem) yesterday."

CS 2 stated if the patient's medication had been discontinued, it should not be left in the patient's room and it should be discarded in the medication waste bin.

During an interview on November 8, 2022, at 10:50 a.m., with Registered Nurse (RN) 2, RN 2 stated Patient 3's Diltiazem had a discontinue order on November 7, 2022. RN 2 stated the medication should have been discarded and not left in Patient 3's room.

During a concurrent interview and record review on November 8, 2022, at 3:10 p.m., with the Pharmacy Director (PD), Patient 3's record was reviewed. The "History & (and) Physical," dated November 4, 2022, indicated Patient 3 came in to the facility for increased shortness of breath and cough. Patient 3 was recently discharge from the facility after being admitted for myocardial infarction (heart attack).

Patient 3's "MAR (Medication Administration Record) Summary," indicated, "...Continuous Infusion...diltiazem 125 mg (milligram, unit of measurement)/125 ml (milliliter, unit of measurement)...IV 10 ml/hr (hour)...1128 (11:28 a.m.) Begin Bag..."

Patient 3's "Order Information" indicated Patient 3's diltiazem IV medication was discontinued on November 7, 2022, at 5:42 p.m.

The PD stated the facility's process for discontinued IV infusion medication was to discard the medication if there was no intention of restarting it back.

The PD stated Patient 3's diltiazem had a discontinue order on November 7, 2022, and it should have been discarded and not left in Patient 3's room.

During a review of the facility's P&P titled, "Secure Medication Storage and Access to Medications," revised in February 2022, the P&P indicated, "...No medication is to be left at the patient's bedside, with the exception of inhalers in isolation rooms...

Medication removed for administration to a patient and not administered must be returned to the properly designated storage as soon as possible..."



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4. During a concurrent observation and interview, on November 7, 2022, at 2:45 p.m., conducted with the Dialysis Registered Nurse (DRN 1), in Patient 22's room, Patient 22 was observed lying in bed and a dialysis machine was at the bedside. DRN 1 stated she just completed the dressing change for Patient 22's central line and will be starting the dialysis treatment. DRN 1 further stated this was Patient 22's first dialysis treatment since being admitted to the facility.

During a record review, on November 9, 2022, at 9:37 a.m., conducted with the Clinical Effectiveness Coordinator (CEC), Patient 22's "History and Physical (H&P)," indicated, Patient 22 was admitted on November 5, 2022 for abdominal pain. The "H&P" also indicated Patient 22 had a history of end-stage renal disease (ESRD, kidney failure) and was on hemodialysis (HD, a treatment to filter wastes and water from the blood). The "H&P" further indicated Patient 22 had a "right IJ (internal jugular, large vein in the neck) tunneled dialysis catheter (a thin tube placed under the skin and into a large vein near the heart used for HD)..."

Patient 22's care plan for "CLABSI Prevention and Management," dated November 7, 2022, through November 9, 2022, indicated, "...chlorhexidine bath..."

During a concurrent interview and record review, on November 9, 2022, at 10:32 AM, with the CEC, Patient 22's nursing care documentation for chlorhexidine (CHG) bath, dated November 7, 2022, through November 9, 2022, was reviewed. The CEC stated she was unable to find documentation CHG baths were completed for Patient 22 from November 5, 2022 through November 9, 2022.

During an interview, on November 10, 2022, at 10:00 a.m., with the Registered Nurse (RN) 1, RN 1 stated CHG baths should be done for all patients with central lines every shift. RN 1 also stated, CHG baths were supposed to be done every shift and documented in the patient's EMR.

During a review of the facility's P&P titled, "Central Line Insertion and Maintenance - 1226," dated May 2019, the P&P indicated,

" ...Purpose...To prevent central line associated blood stream infections...To reduce mechanical, infectious or other adverse outcomes associated with central line insertion...To provide guidance regarding placement, insertion and management of central lines...

HYGIENE REQUIREMENTS...Bed bath every 24 hours...CHG bath every shift...CHG bath and linen change 1 hr before HD...Change dressing EVERY Friday...Alcohol caps on at all times ..."

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

1. For Patient 1, medications were administered as ordered by the physician.

This failure resulted in a delay of treatment which may have contributed to the deterioration of the medical condition and the subsequent death of Patient 1.

2. For Patient 22, the PRN (as needed) hydromorphone (Dilaudid, medication to treat pain) was administered as ordered by the physician. In addition, there was no documented evidence a pre-intervention (before the intervention for pain was provided) assessment was conducted.

This failure had the potential to cause adverse health outcomes, such as preventable medication errors, inadequate patient monitoring, ineffective pain management, unrelieved pain, and unnecessary medication use which could negatively affect the patient's health and safety due to unsafe medication administration and may lead to prolonged hospitalization and/or death.

Findings:

1a. During a concurrent interview and record review conducted with the Director of Medical-Surgical Telemetry (DMST), on November 8, 2022, at 3:10 p.m., Patient 1's record was reviewed. The "History & (and) Physical," dated March 7, 2022, indicated, "...from dialysis facility, c/c (chief complaint) lethargy (weakness) and hypotensive systolic (SBP, the first number of the BP, measurement of the pressure in the arteries [blood vessels carrying oxygenated blood from the heart]) on the 70's..."

Patient 1's "Order Information," dated April 5, 2022, indicated, "...Epoetin (medication used for treatment of severe anemia for patients on kidney dialysis) 20,000 units (unit of measurement), 2 ml (two milliliter, unit of measurement)...IV (intravenous, administered through the vein) push...thrice weekly post HD (hemodialysis, a procedure using a machine to purify a person's blood whose kidneys are not working normally)..."

Patient 1's "MAR (Medication Administration Record) Summary" indicated Epoetin was not given on April 16, 19, and 22, 2022, and the reason indicated was "No IV site."

There was no documented evidence the physician was notified Epoetin was not administered to Patient 1 on April 16, 19, and 22, 2022.

The DMST stated "No IV site" was not an acceptable comment because Epoetin should be given by HD RN after each dialysis using the patient's HD IV access.

The DMST stated Patient 1's assigned RN should have informed the HD RN Epoetin should be given to Patient 1 after each HD treatment.

The DMST stated Patient 1 should have been given all her Epoetin doses as ordered by the physician.

b. During a concurrent interview and record review conducted with the Clinical Nurse Manager (CNM), on November 7, 2022, at 1:30 p.m., Patient 1's "Order Information," dated April 15, 2022, indicated HD treatment with a start date of April 16, 2022, for a three-hour duration with a total UF of 2000 ml as tolerated by the patient.

In addition, the physician ordered to administer Albumin 25 percent (%) 100 ml intravenous as needed for SBP of less than 100.

The "Acute Hemodialysis Flow Sheet," dated April 16, 2022, indicated the following:

- At 9:25 a.m., Patient 1's BP was 111/72 mmHg and HD was initiated;

- At 9:55 a.m., Patient 1's BP was 89/59 mmHg, UFR was turned off and the total fluid removed was 236 ml; and

- At 10:10 a.m., Patient 1's BP was 93/29 mmHg and UFR was turned off.

There was no documented evidence medication for hypotension was administered to Patient 1 when the SBP was less than 100 at 9:25 a.m. and 10:10 a.m.

The CNM stated Patient 1 was hypotensive at 9:55 a.m. and 10:10 a.m. The CNM stated Patient 1 should have been given albumin as ordered by the physician.

c. Patient 1's "Order Information," dated April 24, 2022, indicated HD treatment with a requested start date of April 25, 2022, for a three-hour duration with a total UF of 2000 ml as tolerated by the patient.

In addition, the record indicated, "...NS 250 ml x 2 (times two) prn SBP < (less than) 100. Albumin 25% 100 ml IVP (IV push) q (every) 1h (one hour) prn if still hypotensive...if SBP <100 one time..."

The "Acute Hemodialysis Flow Sheet," dated April 25, 2022, indicated the following:

- At 2:21 p.m., Patient 1's BP was 115/68 mmHg and HD was initiated;

- At 2:37 p.m., Patient 1's BP was 94/52 mmHg, with a UFR of 770 and the total fluid removed was 237 ml;

- At 2:53 p.m., Patient 1's BP was 81/52 mmHg, UFR was turned off, and NS 200 ml IV was given to the patient;

- At 3:13 p.m., Patient 1's BP was 100/64 mmHg, UFR was turned off, and Patient 1 complaint of nausea, dizziness, and headache;

- At 3:28 p.m., Patient 1's BP was 84/48 mmHg and UFR was turned off;

- At 3:38 p.m., Patient 1's BP was 74/52 mmHg, UFR was turned off, and NS 200 ml IV was given to the patient;

- At 3:48 p.m., Patient 1's BP was 73/36 mmHg and UFR was turned off;

- At 3:52 p.m., Patient 1's BP was 76/38 mmHg, UFR was turned off, and HD treatment ended due to hypotension; and,

- At 4:35 p.m., Patient 1's BP was 87/47 mmHg.

Patient 1's "Progress Note - Physician," dated April 25, 2022, indicated, "...Code Blue (an emergency code system for a medical life threatening situation involving an adult patient) called by RN at 1735 (5:36 p.m.)...

Per RN pt (Patient 1) became cold and unresponsive. CPR (cardio pulmonary resuscitation) started...Time of Death: 1752 (5:52 p.m.)...."

Patient 1's "Discharge Summary," dated April 26, 2022, indicated, "...CODE BLUE was called by RN (on April 25, 2022) at 1736. Per RN, patient became cold and unresponsive. Of note, patient had completed her hemodialysis session prior to this episode...CPR was started...Patient deceased. Time of Death 1752...Of note patient's blood pressure was noted to be 74/52 and 76/38 during hemodialysis session. Internal medicine team (group of physicians specialize in adult medicine) was not notified..."

There was no documented evidence Patient 1 was administered Albumin for hypotension.

The CNM stated Patient 1 should have been given Albumin as ordered by the physician.

During an interview on November 9, 2022, at 1:45 p.m., with Physician 1, Physician 1 stated the patients having HD treatment could suffer from hypotension if they are not able to tolerate the amount of blood volume being drawn from them during HD.

Physician 1 stated when the patient becomes hypotensive during HD, NS would be given as IV bolus to help increase the BP. Physician 1 stated albumin could be given as ordered during HD when the patient becomes hypotensive because it could also help increase the BP. Physician 1 stated Patient 1 had an order of albumin PRN for hypotension and it should have been given by the HD RN. Physician 1 stated the albumin could have helped to increase Patient 1's BP.

During a review of the facility's P&P titled, "Hypotension," revised in September 2016, the P&P indicated, "...Administer medications as ordered...

If patient continues to show signs and symptoms of hypotension, notify physician and follow additional physician's orders..."

During a review of the facility's P&P titled, "Medication Administration and Monitoring Policy," revised in June 2021, the P&P indicated, "...Before administration, the individual administering the medication will confirm the following...Identify the appropriate time-critical administration status. Verify that the medication is being administered at the proper time, in the prescribed dose...Discuss any unresolved concerns about medication with the patient's attending physician...

Errors of Omission and Late Doses:

Errors of omission or late doses may be required to be reported to the LIP (Licensed Independent Practitioner) depending on the medication and the potential harm the omitted dose could have on the patient..."



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2. During a concurrent interview and record review conducted with the Clinical Effectiveness Coordinator (CEC), on November 9, 2022, at 10:30 a.m., Patient 22's record was reviewed. The "History and Physical (H&P)" indicated, Patient 22 was admitted on November 5, 2022 for abdominal pain associated with acute pancreatitis (an inflammation of the pancreas).

Patient 22's "Medication Administration Record (MAR) Summary" for hydromorphone, was reviewed: The "MAR Summary" for PRN hydromorphone, dated November 5, 2022, indicated, "HYDROmorphone (Dilaudid) 1 (one) mg (milligram, unit of measurement) = 1 mL (milliliter, unit of measurement), Injection, IV (intravenous, into the vein) Push, q4H (every 4 hours) PRN (as needed for) Pain 7-10 (Severe) (numeric pain scale: 0- no pain; 1-3 mild pain; 4-6 moderate pain; 7-10 severe pain)...

HYDROmorphone 0.5 mg = 0.5 mL, injection, IV Push, q4H PRN Pain 4-6 (Moderate)..."

The "MAR Summary" for PRN hydromorphone and pain assessments, dated November 5, 2022, through November 6, 2022, were reviewed. There was no documented evidence pre-intervention assessments (assessment related to pain prior to the administration of pain medications) were conducted to Patient 22 on the following dates and time:

- On November 5, 2022, at 8:52 p.m., hydromorphone 1 mg was given; and

- On November 6, 2022, at 1:45 a.m., hydromorphone 1 mg was given.

The CEC stated she was unable to find documentation of pre-intervention assessments for pain before the hydromorphoine was administered to Patient 22 on November 5, 2022, at 8:52 p.m., and on November 6, 2022, at 1:45 a.m.

During a concurrent interview and record review conducted with Registered Nurse (RN) 1, on November 10, 2022, at 9:51 a.m., RN 1 stated when administering PRN pain medications, a pain assessment should be done before giving the pain medication. RN 1 also stated a PRN pain medication should be given as ordered. RN 1 further stated the pain assessments should be documented in the patient's record and if the pain assessment was not documented, it was not done. RN 1 stated the RN did not document a pain assessment prior to giving hydromorphone on November 5, 2022, at 8:52 p.m., and on November 6, 2022, at 1:45 a.m. RN 1 stated the RN should have documented a pain assessment before giving the medication either in the vital signs/pain assessment or in the MAR.

During a review of the facility's policy and procedure (P&P) titled, "Pain Assessment and Management for the Hospital Patient," dated March 2022, the P&P indicated,

"...PURPOSE: To outline components of an effective pain identification and management program that meets or exceeds regulatory and accreditation requirements, and are consistent with evidence-based guidelines and nationally recognized best practices....

The hospital will treat a patient's pain and refer the patient for treatment, consistent with the patient's care and treatment needs. Treatment strategies should include non-pharmacologic, pharmacologic, or a combination of approaches...The hospital will provide pharmacologic and non-pharmacological pain treatment modalities...A pre-intervention assessment is completed and documented within 60 minutes of pharmacological interventions....

Assessment/Reassessment of Pain...Following patient complaints of pain, a pain assessment/reassessment is documented in the electronic health record. Pain management will be added as a problem to the patient's Plan of Care ....

Documentation - Pain assessment/re-assessment will be documented in EMR or other identified specific pain documentation forms..."

During a review of the facility's P&P titled, "Medication Administration and Monitoring Policy," dated June 2021, the P&P indicated, "...Before administration, the individual administering the medication will confirm the following...Verify that the medication is being administered at the proper time, in the prescribed dose, and by the correct route...Identify medications using the manufacturer's medication label and/or the pharmacy medication label and the bar code, if applicable, against the source document to confirm the following "7 Rights"...Correct reason...Correct documentation...."