The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

ST BERNARDINE MEDICAL CENTER 2101 N WATERMAN AVE SAN BERNARDINO, CA 92404 May 2, 2018
VIOLATION: PATIENT RIGHTS Tag No: A0115
Based on interview, and record review, the hospital failed to implement the policy and procedure of care plans to meet the patients rights for 11 of 34 sampled patients. This failure occurred when:

1. Five (5) out of 34 sampled patients (Patient 2, 3, 9, 12 and 20) did not have a care plan on restraints. (Refer to Tag A0166).

2. Five (5) out of 34 patients (Patient 4, 5, 6, 8 and 14), who received multiple pain medications, did not have a care plan implemented for pain. (Refer to Tag A0130).

3. One (1) out of 34 sampled patients (Patient 15) did not have a care plan for administration of supplemental oxygen. (Refer to Tag A0130).

The cumulative effects of these failures had the potential to result in substandard healthcare by not respecting the residents rights to participate in their plan of care.
VIOLATION: PATIENT RIGHTS: PARTICIPATION IN CARE PLANNING Tag No: A0130
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on interview, and record review, the facility failed to ensure an individualized, goal directed, plan of care for patients when;

1. Five (5) out of 34 sampled patients (Patient 4, 5, 6, 8 and 14) did not have care plan implemented for pain, who received pain medications.

2. One out of 34 sampled patients (Patient 15) did not have a care plan for administration of supplemental oxygen.

These failures had potential for patients not receiving individualized patient care to address their needs.

Findings:

1 a) A review of Patient 4's face sheet indicated that a [AGE] year old male was admitted to the facility with diagnosis of chest pain. Further review of the clinical record indicated that Patient 4 had an open heart surgery on April 20, 2018.

A review of Patient 4's Medication Administration Record (MAR) indicated that Patient 4 received pain medicine as follows:

i. Inj. Hydromorphone (Dilaudid) IV (Intra-venous) on April 25, 2018 at 8:51 PM and April 26, 2018 at 06:52 AM.

ii. Inj. Morphine 4 mg (milligram-a unit of measurement) IV on April 20, 2018 at 4:56 PM and 5:56 PM.

iii. Inj.Demerol 25 mg IV on April 20, 2018, at 7:56 PM.

A concurrent interview and record review of Patient 4's care plan was conducted with Registered Nurse 4 (RN 4) on April 15, 2018 at 9:43 AM, that indicated Patient 4 had no care plan on pain initiated. She further stated that a patient who received pain medication should have a care plan for pain.

1 b) A record review of Patient 5's face sheet indicated a [AGE] year old female was admitted to the facility on on [DATE] for coronary artery bypass graft (CABG- open heart surgery for heart disease).

A review of Patient 5's MAR indicated that Patient 5, received the following medication as follows;

i. Injection Morphine on following days;

-Six (6) doses on April 10, 2018 (at 11:16 AM, 11:31 AM, 3:52 PM,4:07 PM,10:11 PM and 10:26 PM),

-Two (2) doses on April 11, 2018 (at 9:56 AM and 10:11 AM),

-One (1) dose on April 12, 2018 (at 1:40 AM),

-One (1) dose on April 16, 2018 (at 4:40 AM).

ii. Injection Fentanyl on April 15, 2018 at 11:04 AM.

A review of Patient 5's care plan indicated that Patient 5 had no care plan initiated for pain.

1 c) A record review of Patient 6 was conducted with RN 4 on April 25, 2018, at 9:52 AM.

The record review of Patient 6's face sheet, indicated that a [AGE] year old male was admitted to the facility on on [DATE], with diagnosis of cervical disc degeneration (a disease develops when one or more of the cushioning discs in the cervical spine starts to break down due to wear and tear which is symptomatic with intense pain).

A review of Patient 6's MAR indicated that Patient 6 received pain medication as follows:

Injection Morphine on following days;

-Four (4) doses on April 19, 2018 (at 3:54 PM, 4:09 PM, 10:30 PM and 10:45 PM),

-Seven (7) doses on April 20, 2018 (at 12:11 AM, 12:26 AM, 05:00 AM, 05:15 AM, 8:23 AM, 4:58 PM and 5:13 PM),

-Two (2) doses on April 21, 2018 (at 1:38 PM and 1:53 PM),

-Two (2) doses on April 23, 2018 (at 11:24 PM and 11:39 PM).

A review of Patient 6's care plan was done with RN 4 on April 25, 2018, that indicated Patient 6 had no plan of care initiated for pain.

A concurrent interview with RN 4 confirmed this finding.

1 d) A review of Patient 8's face sheet indicated a [AGE] year old male was admitted to the facility on on [DATE] with diagnosis of acute respiratory failure.

A review of Patient 8's MAR indicated that Patient 8 received following medications for pain;

-Tablet Acetaminophen-HYDROcodone (Norco 325/10) ;

-Two (2) doses on April 24, 2018 (at 9:12 AM and 9:42 AM).

A review of Patient 8's care plan indicated that Patient 8 had no care plan for pain.

A concurrent interview with RN 4 confirmed this finding.

1 e) A review of Patient 14's face sheet indicated a [AGE] years old female was admitted to the facility on on [DATE] with diagnosis of acute coronary syndrome (a syndrome associated with decreased blood flow to the coronary arteries which demonstrated with chest pain).

A review of Patient 14's MAR indicated that Patient 14, pain medication as follows;

i. Injection Morphine;

-Six (6) doses on April 21, 2018 (at 3:23 AM, 5:25 AM, 7:38 AM,9:47 AM and 1:38 PM),

-Six (6) doses on April 22, 2018 ( at 12:18 AM, 5:01 AM, 7:41 AM,11:01 AM, 3:16 PM and 6 PM).

ii. Injection Hydromorphone (Dilaudid) ;

-Two (2) doses on April 21, 2018 (at 3:52 PM and 3:55 PM)

iii. Injection Fentanyl;

-Four (4) doses on April 18, 2018 (at 1:14 AM, 11:11 AM, 4:33 PM and 8:31 PM).

-Two (2) doses on April 19, 2018 (at 3:34 AM and 8:55 PM).

-One (1) dose on April 20, 2018 (at 10:33 AM).

iv. Tablet HYDROcodone/acetaminophen (5/325) mg;

-One (1) dose on April 22, 2018 (at 8:56 PM),

-Three (3) doses on April 23, 2018 (at 12:59 AM, 5:18 AM and 6:10 AM),

-Three (3) doses on April 24, 2018 (at 12:28 AM, 5:14 AM and 8:38 PM),

-Three (3) doses on April 25, 2018 (at 10:13 AM, 5:09 PM and 11:03 PM).

A review of Patient 14's care plan indicated that Patient 14 had no care plan for pain.

A concurrent interview with RN 4 confirmed this finding.

2. A review of Patient 15's face sheet indicated a [AGE] year old female was admitted to the facility on on [DATE] with diagnosis of sick sinus syndrome (a group of disorder caused by heart rhythm disorder causes symptoms such as dizziness, shortness of breath and fainting).

A review of Patient 15's MAR indicated that the patient received supplemental oxygen via nasal cannula from April 23, 2018, at 3:09 PM through April 26, 2018, at 6:05 PM.

A review of Patient 15's care plan indicated that Patient 15 did not have a care plan initiated on oxygen administration.

A review of the facility policy and procedure titled "Care of Patient, Critical Care Standards' revised on June 2016, indicated under section 'Assessment":

" ...2. Patient Plan of Care

2.1 Every patient will have an individualized plan of care that reflects the patient's care needs. The nurse will ensure that the patient's plan of care in individualized, goal directed and reflects the patient's current needs.

2.1.1. Initiate the patient's care plan within 98) eight hours of admission.

2.2.2. Identify, initiate and document an appropriate plan of care using the approved list of nursing diagnosis found in the EHR [Electronic Health Record]. Problems should include physical, emotional, learning and/or psychological needs.

2.1.3. Initiate appropriate nursing diagnosis based upon the initial nursing history and assessment and related to the patient's needs or diagnosis.

2.1.4. Choose expected outcomes [goals] that are realistic, measurable and consistent with medical therapy.
2.1.5. Update the patient's plan of care based upon ongoing ..."

A review of the facility policy and procedure titled "Restraint/Seclusion, Use Of" revised on August 2016, indicated under section "Documentation by RN" indicated " ...1.4 Potential for injury is initiated on the Multidisciplinary Plan of Care and updated at least every 24 hours on all restrained or secluded patients ..."
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0166
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview, and record review, the facility failed to ensure an individualized, goal directed plan of care for five (5) out of 34 sampled patients (Patient 2, 3, 9,12 and 20) had a care plan for restraints. These failures had the potential for patients not receiving individualized patient care to meet their needs.

Findings:

1) A record review of Patient 2's "face sheet" (a record that provides the demographic data of the patient) indicated that a [AGE] year old male was admitted to the facility on on [DATE], with a diagnosis of [DIAGNOSES REDACTED]

A review of Patient 2's Physician order for restraints dated April 22, 2018 indicated that bilateral upper extremity soft restraints were initiated for patient safety from April 22, 2018, at 07:00 PM, through April 23, 2018, at 11:35 AM.

A concurrent interview and record review of Patient 2's entire clinical record was conducted with Registered Nurse 1 (RN), on April 25, 2018. She stated that each patient who had a restraint intervention should have a care plan. She confirmed that Patient 2 did not have any care plan related to restraints and patient safety.


2) A record review of Patient 3's face sheet indicated that a [AGE]-year-old female was admitted to the facility on on [DATE] with diagnosis of [DIAGNOSES REDACTED]

A review of Patient 3's physician order for restraints was conducted on April 25, 2018, at 9:38 AM, which indicated that Patient 3 had an order for restraints on April 21, 2018, at 5:20 AM and discontinued on April 23, 2018 at 6:10 AM.

A review of Patient 3's restraint assessment sheet was conducted with RN 1, which indicated that Patient 3 was on bilateral soft restraints from April 21, 2018 at 0500 AM through April 23, 2018 at 0700 AM.

During a concurrent interview with RN 1, she stated the staff were required to initiate a care plan for restraints when restraints were implemented.

3) A record review of Patient 9's face sheet indicated that Patient 9 was admitted to the facility on on [DATE] with diagnoses which included hypoxemia (inadequate amount of oxygen on blood which leads to difficulty in breathing) and infection of bilateral toes.

A record review of Patient 9's Physician order for restraints indicated that Patient 9 had an order for bilateral soft wrist restraints for pulling at lines, tubes and dressing initiated on April 23, 2018 at 2:15 AM.

A review of Patient 9's patient assessment sheet for restraints indicated that Patient 9 was on bilateral soft restraints from April 23, 2018 at 2:15 AM, and it was discontinued on April 24, 2018, at 1100. The record review further indicated that the restraints were restarted on April 25, 2018, at 2 AM and continued at the time of record review.

A concurrent interview with RN 1 confirmed the finding and RN 1 stated the Patient should have a care plan for restraints.

4) A review of Patient 12's face sheet indicated a [AGE]-year-old male was admitted to the facility on on [DATE] with diagnoses of [DIAGNOSES REDACTED]

A review of Patient 12's physician order dated April 19, 2018 at 18:55 PM, indicated an order for bilateral soft wrist restraints for patient safety. This order was discontinued on April 19, at 02:00 AM, and then restarted on April 20, 2018, at 0800. Further review indicated that the restraints were discontinued on April 21, 2018, at 07:00 AM and restarted on April 21, 2018 at 07:00 PM.

A review of Patient 12's care plan indicated that Patient 12 had no care plan initiated for restraints. The record was reviewed with RN 1 and RN 1 confirmed the findings.

5) A review of Patient 20's face sheet indicated that a [AGE]-year-old male was admitted to the facility on on [DATE] with diagnoses of [DIAGNOSES REDACTED]

A review of Patient 20's assessment record indicated that Patient 20, was on soft restraints from April 9, 2018 at 4:00 PM through April 10, 2018 at 3:00 PM.

A review of Patient 20's care plan indicated that Patient 20 had no care plan initiated for restraints.

A concurrent interview with the QC confirmed this finding.

A review of the facility policy and procedure titled "Care of Patient, Critical Care Standards" revised on June 2016, indicated under section 'Assessment":

" ...2. Patient Plan of Care

2.1 Every patient will have an individualized plan of care that reflects the patient's care needs. The nurse will ensure that the patient's plan of care in individualized, goal directed and reflects the patient's current needs.

2.1.1. Initiate the patient's care plan within 98) eight hours of admission.

2.2.2. Identify, initiate and document an appropriate plan of care using the approved list of nursing diagnosis found in the EHR [Electronic Health Record]. Problems should include physical, emotional, learning and/or psychological needs.

2.1.3. Initiate appropriate nursing diagnosis based upon the initial nursing history and assessment and related to the patient's needs or diagnosis.

2.1.4. Choose expected outcomes [goals] that are realistic, measurable and consistent with medical therapy.

2.1.5. Update the patient's plan of care based upon ongoing ..."

A review of the facility policy and procedure titled "Restraint/Seclusion, Use Of" revised on August 2016, indicated under section "Documentation by RN" indicated " ...1.4 Potential for injury is initiated on the Multidisciplinary Plan of Care and updated at least every 24 hours on all restrained or secluded patients ..."
VIOLATION: NURSING SERVICES Tag No: A0385
Based on observation, interview, and record review, the hospital failed to prepare and administer medications in accordance with Physician's orders and policies and procedures for two (Patient 1 and 34) of thirty-four sampled patients when:

1. For Patient 1, the Physician's order for infusion of an IV (intravenous- a therapy that delivers liquid medications directly to the vein) cardiac medication amiodarone), and monitoring the heart rate and blood pressure every 15 minutes for the first hour was not followed.

2. For Patient 1, the heart rate, blood pressure, electrical activity strip every 15 minutes for the first hour, and documenting the electrocardiogram (the process of recording the electrical activity of the heart, over a period of time) in the clinical record during IV treatment of amiodarione were not adequately documented, which can result in not being able to identify abnormal heart activities.

3. For Patient 34, the hospital failed to label an opened intravenous (IV - into the patient's vein) fluid solution bag with the date and time hung. This failure had the potential to result in infection(s). (Please see A-405).

4. For Patient 34, the hospital failed to ensure a Physician's order was obtained prior to administering IV normal saline (saltwater) solution to the patient. This failure had the potential to expose the patient to medication errors and an incomplete medical record. (Please see A-405).

5. For Patient 34, the hospital failed to ensure IV normal saline solution administered to the patient was documented in the patient's medical record. This failure had the potential to expose the patient to medication errors and an incomplete medical record. (Please see A-405).

6. For Patient 34, the hospital failed to ensure reassessment of IV pain medication within the time frame specified in policies and procedures. This failure had the potential to expose the patient to inadequate pain management. (Please see A-405).

The cumulative effects of these systemic problems had the potential to result in substandard healthcare which could subsequently lead to harm, disability, and death for all facility patients.
VIOLATION: ADMINISTRATION OF DRUGS Tag No: A0405
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, interview, and record review, the facility failed to follow their emergency and critical care medication dosing guidelines, for infusion of an intravenous (IV-infusing a medication in a vein) medications in the Intensive Care Unit (ICU), prepare and administer medications in accordance with Physician's orders and policies and procedures for two (Patient 1, and 34) of thirty-four sampled patients when:

1. For Patient 1, a Physician's order for infusion of an IV cardiac medication (amiodarone), and monitoring the heart rate and blood pressure every 15 minutes for the first hour was not followed.

2. For Patient 1, the heart rate, blood pressure, electrical activity strip every 15 minutes for the first hour, and documenting the electrocardiogram (EKG, the process of recording the electrical activity of the heart, over a period-of-time, by using electrodes placed on the skin) in the clinical record during IV treatment of amiodarone were not adequately documented.

These failures had the potential to have contributed to Patient 1's death and the potential to endanger the health and well-being of all patients receiving IV medications requiring EKG monitoring, in a universe of 40 patients, in the ICU.

3. For Patient 34, the hospital failed to label an opened intravenous (IV - into the patient's vein) fluid solution bag with the date and time hung. This failure had the potential to result in infection(s) when the time the medication was out of controlled environment is unknown.

4. For Patient 34, the hospital failed to ensure a Physician's order was obtained prior to administering IV normal saline (saltwater) solution to the patient. This failure had the potential to expose the patient to medication errors and an incomplete medical record.

5. For Patient 34, the hospital failed to ensure IV normal saline solution administered to the
patient was documented in the patient's medical record. This failure had the potential to
expose the patient to medication errors and an incomplete medical record.

6. For Patient 34, the hospital failed to ensure reassessment of IV pain medication within the time frame specified in policies and procedures. This failure had the potential to expose the patient to inadequate pain management.

Findings:

On April 26, 2018 at 11:25 AM, an Immediate Jeopardy situation was declared in the presence of the facility Chief Executive Officer (CEO), Chief Operations Officer (COO), Administration Chief Nursing Executive Officer (CNEO), Director of Quality, and the Manager of Patient Safety. The facility Administrators were verbally notified, of the failure of nursing staff not following the Medical Doctor's order for infusion of an intravenous (IV) cardiac medication, by not following their policy and procedure for titrating, administering, and by not appropriately documenting the infusion of an IV cardiac medication. The facility failed to identify a patient's change of condition by not following their policy and procedure for assessing, monitoring, and documenting the electrocardiogram (EKG) rhythm and posting the strips in the clinical record. The facility failed to follow their policy and procedure for nurse break coverage, when the nurse left the unit without prior notification to the charge/resource/break nurse. These failures had the potential to have contributed to the death of a patient in the Intensive Care Unit (ICU,) and jeopardized the health and safety of other patients receiving any IV medications affecting the cardiac system in a universe of 40 patients.

1. During an interview with Registered Nurse (RN 1) on April 24, 2018, at 3:11 PM, RN 1 stated on April 11, 2018, at 12 PM, he remembered Patient 1 had [DIAGNOSES REDACTED]with rapid ventricular response (afib with rvr - fluttering of the heart causing the ventricles of the heart to beat too fast). RN 1 stated he contacted the Medical Doctor 1 (MD 1) and received an order to start Amiodarone (an antiarrhythmic medication used to treat certain types of serious [possibly fatal] irregular heartbeat) per protocol.

A concurrent review of Patient 1's electronic medical record (EMR) conducted with RN 1, RN 1 identified the order dated April 11, 2018, at 12:07 PM, "Amiodarone bolus (a single dose) 150 milligrams (mg) intravenous (IV- through the vein), every 15 minutes whenever necessary (PRN) for heart rate - see order comments; may repeat up to 2 additional doses, for a total of 3 doses if needed, for heart rate greater than 120 for 2 doses/times."

Concurrently, RN 1 identified the additional order "Amiodarone infusion 360 milligrams (mg-a unit of measure) 1mg/minute for 6 hours, then .5 mg/minute" stating the order is to start after the infusion of the 3 bolus doses if the heart rate is still greater than 120.

RN 1 confirmed the order by stating "according to the order, bolus with 150, if Patient 1 does not convert (return to normal rate and rhythm of the heart) then give one more bolus of 150, then start with 1 mg maintenance and then 0.5 mg continuation," and "see order comments" refers to the "heart rate."

A review of the facility document titled "Orders" dated April 11, 2018, at 12:01 PM the record reflects the following:

"Medications - Order: Amiodarone (Amiodarone Bolus IV (150 mg)
Order Date/Time: 4/11/2018 12:01 Pacific Daylight Time (PDT) ...
Order Details: 150 mg, IV, every (q) 15 minutes, priority: Routine, whenever necessary (PRN) Heart Rate - see order comments, may repeat up to two (2) additional doses for a total of three (3) doses if needed for heart rate greater than 120, Infuse over: 10 minutes, for two (2) Dose/Time, Start: 4/11/18 - 12:01:00 PM ..."

A review of the facility document titled "Hemodynamics/Vitals" reflected on April 11, 2018, at 12:00 PM, RN 1 documented a heart rate of 178. The systolic (the amount of pressure in the arteries during contraction of the heart muscle) blood pressure is documented at 156, and the diastolic (refers to the amount of pressure when the heart is between beats) blood pressure is documented at 112. RN 1 was unable to locate documented vital signs as order 15 minutes after the infusion of the first bolus.

During a concurrent interview, RN 1 stated he was continuously monitoring Patient 1, it was not a titrating drip, every hour documentation was his understanding, and he was watching the heart rate on the monitor.

During an interview with the Critical Care Unit Manager (CCUM) she stated the facility did not have a Policy and Procedure for infusion of a Amiodarone bolus/drip, or any guidelines for Amiodarone infusion.

A review of the facility document titled "Emergency & Critical Care Medication Dosing Guidelines" un-dated, reflected the following:

"Amiodarone: ...Dosing: Loading dose: 150-300 mg/100 ml D5W over 10 minutes ...Monitor: Electrocardiogram (EKG,) Heart Rate (HR,) Blood Pressure (BP,) every (q) 15 minutes for the first hour, then q 1h; ..."

A review of the facility document titled "Hemodynamics/Vitals" dated April 11, 2018, between 12:00 PM and 1:00 PM, the record was without documented evidence RN 1 recorded into the electronic medical record vital signs at 12:15 PM, 12:30 PM, and 12:45 PM. RN 1 stated he did not have anything documented but he was watching on the monitor.

A review of the facility document title "Orders - Nursing Communication" dated April 11, 2018, at 12:01 PM, "Order Start Date/Time:4/11/2018 12:01PDT ...Order Details: Hold Amiodarone for junctional rhythm or heart rate less the 50 bpm ..."

During an interview with Registered Nurse 2 (RN 2) on April 25, 2018, at 3:14 PM, she stated she was "covering" Patient 1, while RN 1 went for a break. Concurrently, RN 2 stated she "accidentally glanced" at the central monitor and noticed a sudden drop of Patient 1's heart rate, 'he became bradycardic, down from 150 to 39-38 and then went asystole (absence of heartbeat) within 10 seconds' ..."

"[Name of facility] Pharmacy Policy and Procedure- Medication Administration: Standardized Time Schedule - Purpose: To provide established guidelines for administering and documenting medications and delineate the standard administration times to be observed by the nursing staff in the administration of medications ordered by the medical staff. - Policy: Approved standardized administration times will be utilized for medication administration for scheduled doses. Timing of Medication Administration - Appropriate timing of medication administration takes into account the complex nature and variability among medications ...1. Medications not eligible for scheduled dosing times must be timely administered all throughout the hospital according to clinical need ....1.4 Loading doses (initial dose of a drug given to bring blood, tissue or fluid levels to an effective concentration quickly) ...Time-critical medications are those for which an early or late administration of greater than thirty minutes might cause harm or have significant, negative impact on the intended therapeutic or pharmacological effect ...7. Standard Medication Administration times - Instructions for use: 7.1 When a prescriber indicates a specific dosing time for a medication will be administered according to the prescriber's order ..."

2. During a review of Patient 1's clinical record, for EKG rhythm documentation from April 6, 2018 (day of admission) through April 11, 2018 (day of death) indicated there was no documented evidence EKG rhythm strips on the following scheduled times;

April 7, 2018, at 4 AM, 10 AM, 4 PM and 10 PM,
April 8, 2018, at 10 AM, 4 PM and 10 PM,
April 9, 2018, at 10 AM and 4 PM,
April 10, 2018, at 10 AM, 4 PM and 10 PM,
April 11, 2018, at 4 AM, 10 AM and 4 PM.

During an interview with RN 1, conducted on April 25, 2018, at 2:51 PM, she stated the registered nurses in the cardiac care unit (CCU) are required to post cardiac rhythm strips into the clinical record every six (6) hours and whenever necessary.

During an interview with the Chief Nursing Executive Officer (CNEO) conducted on April 30, 2018, at 3:50 PM, she reviewed "Care of the Patient, Critical Care Standards" policy and procedure, and stated her expectation of the nursing staff is to follow the policy and procedure for monitoring and documenting EKG rhythm strips.

A review of the facility document titled "Care of the Patient, Critical Care Standards" revised on June 2016,

"Subject: Care of the Patient, Critical Care Standards - Departments: Critical Care Unit ...Purpose: To define the standard of care for patients in the Critical Care Unit - Policy: ...3.7.3. Cardiovascular: The RN will assist the patient to achieve and/or maintain optimal cardiovascular status and will document achievement. 3.7.3.1. Continuous cardiac monitor with documentation every six (6) hours and PRN[whenever necessary] ..."

On May 1, 2018, at 1:15 PM, the Immediate Jeopardy situation was abated in the presence of the Director of Quality, the Manager of Quality, and the Dignity Health Licensing and Certification Administrator. The facility Corrective Action Plan was approved through observation, interview and record review, as evidenced by the Intensive Care nursing staff's knowledge of appropriate assessing, monitoring and documenting, the nursing management of a critical care patient receiving IV medications that have the potential to affect the rhythm of the cardiac system.

The Corrective Action Plan included the following components:
1. Education to be conducted with all nursing staff of the documentation, monitoring, and infusion of a medication (amiodarone) affecting the cardiac rhythm during IV administration and during a code situation, to be completed by May 11, 2018, or prior to the RN's next shift worked.
2. Coverage of Registered Nursing (RN) staff's break/lunch relief by means of assigning a break coverage nurse.
3. Documentation of assessing, monitoring, and posting EKG rhythm strips during an infusion of a cardiac medication.
4. Performance Improvement Monitoring with reports to the Quality Improvement Committee.
5. Education and additional training is to be conducted with all clinical RN's working in areas requiring telemetry monitoring, to be completed by May 25, 2018, or prior to the RN's next shift worked.







3 . On May 1, 2018, at 9:40 AM, during an observation and concurrent interview in Patient 34's Room with Registered Nurse 31 (RN 31), an inspection of an opened and unlabeled IV fluid solution bag containing normal saline 250 milliliters (mLs - a unit of measurement) was conducted. The IV normal saline bag was observed being administered to the patient at a rate of 10 mLs per hour. RN 31 stated IV normal saline 250 mLs bag was not labeled with any stickers and should have been labeled with the date and time it was hung.

On May 2, 2018, at 2:15 PM, during an interview, the Chief Nurse Executive Operations (CNEO) stated all IV fluid bags should be labeled with the date and time hung.


A review of the undated hospital policy and procedure titled, "Access Devices; Guidelines for the Prevention of Catheter-Related [tube inserted into body] Infections; Intravascular [in blood vessel]", policy number PCS 0, indicated "IV fluids are to be labeled with at least the date and time hung, and initial."

A review of the hospital policy and procedure titled, "Medication Administration, Barcode Medication Administration & eMAR [electronic version of Medication Administration Record - for documentation of medications]" dated December 6, 2017, indicated "label all intravenous solutions."

4. On May 1, 2018, at 9:40 AM, during an observation and concurrent interview in Patient 34's Room with Registered Nurse 31 (RN 31), an inspection of an opened and unlabeled IV fluid solution bag containing normal saline 250 milliliters (mLs- a unit of measurement) was conducted. The IV normal saline bag was observed being administered to the patient at the rate of 10 mLs per hour. RN 31 stated the IV normal saline 250 mLs bag was currently being administered to the patient "TKO (abbreviation for "to keep open"- infusing IV fluid at a low rate)".

On May 1, 2018, at 10:05 AM, during record review and concurrent interview, Patient 34's medical record was reviewed with the Director of Pharmacy 2 (DOP 2). The medical record indicated there was no current Physician's order for the IV normal saline observed infusing to Patient 34 in their room at 9:40 AM. The DOP 2 stated a medication order was needed to infuse IV normal saline administered "TKO".

On May 1, 2018 at 10:05 AM, during a telephone interview, RN 31 stated she could not locate the Physician order in the medical record for the IV normal saline that was observed infusing to Patient 34 in their room at 9:40 AM.

A review of the hospital policy and procedure titled, "Medication Administration: Medication Administration, Barcode Medication Administration, and eMAR use" dated December 6, 2017, indicated "all medication to be administered by a Nurse, RCP [Respiratory Care Practitioner], or RPT [Respiratory Therapist] must be ordered by a Staff Physician, Dentist, Podiatrist [Physician specializing in foot disorders], or Pharmacist, PA [Physician Assistant], or NP [Nurse Practioner] working within established guidelines."


5. A review of Patient 34's medical record indicated a Physician's order dated April 30, 2018 at 9:57 AM, for IV normal saline at a rate of 20 mLs per hour for blood transfusion for on dose/time. The medical record indicated Patient 34 received a blood transfusion (to replace blood) on April 30, 2018, at 10:00 AM, from RN 31.

On May 1, 2018, at 10:27 AM, during a record review, Patient 34's medical record was reviewed with the Nurse Manager 33 (NM 33). The medical record indicated no documentation of administration of the ordered IV normal saline when the patient received a blood transfusion on April 30, 2018 at 10:00 AM.

On May 1, 2018, at 2:27 PM, during a record review and concurrent interview, RN 31 stated she administered a blood transfusion and IV normal saline ordered for Patient 34 on April 30, 2018 at 10:00 AM. RN 31 stated she should have scanned the IV solution bag to document the administration of the ordered IV normal saline when the patient received a blood transfusion on April 30, 2018 at 10:00 AM.

A review of the hospital policy and procedure titled, "Medication Administration: Medication Administration, Barcode Medication Administration & eMAR use" dated December 6, 2017, indicated "Log into the computer at the bedside and scan the patient's armband and then all medications to be administered" and "all one-time orders are charted [documented] appropriately on the patient's medication record."


6. On May 1, 2018, at 10:52 AM, during record review and concurrent interview, Patient 34's medical record was reviewed with DOP 2. The medical record indicated IV morphine (pain medication) was administered on April 29, 2018 at 3:24 PM for a pain intensity (severity) of 8 of 10 (numeric pain scale of 0 (least) to 10 (most) out of 10). The medical record indicated the next pain assessment of 10 of 10 was documented on April 29, 2018 at 5:32 PM. The time period calculated between the pain assessments was 2 hours and 8 minutes. The DOP 2 stated the IV morphine was administered on April 29, 2018, at 3:24 PM and the next pain reassessment was at 5:32 PM.

On May 1, 2018, at 2:45 PM, during an interview, RN 32 stated pain reassessment should occur 15 minutes after an IV pain medication is given.

A review of the hospital policy and procedure titled, "Pain Assessment and Management" dated April 6, 2016, indicated, "Reassessment and documentation of pain control should be as follows: For IV [intravenous pain medications], reassessment in fifteen (15) minutes."
VIOLATION: Condition of Participation: Pharmaceutical Se Tag No: A0489
Based on interview and record review, the hospital failed to implement pharmaceutical services policies and procedures to meet the needs of patients for one (Patient 1) of thirty-four sampled patients. This occurred when electronic clinical screenings that alerted for drug-drug interactions (harmful and unsafe if medications administered together) and therapeutic duplications (taking at least 2 medications from same category) involving three antipsychotic medications (haloperidol, olanzapine, and quetiapine) were not clarified and resolved between the Pharmacist and the Prescriber. Antipsychotics are a class of medications used to treat patients diagnosed with schizophrenia (thought disorder) or bipolar (mood disorder). Haloperidol is categorized as a typical (also known as first generation or older) antipsychotic. Olanzapine and quetiapine are categorized as atypical (also known as second generation or newer) antipsychotics. This failure had the potential to expose the patient to serious side effects. (Please refer to A-500).

The cumulative effects of these systemic problems had the potential to result in substandard healthcare which could subsequently lead to harm, disability, and death for all facility patients.
VIOLATION: DELIVERY OF DRUGS Tag No: A0500
Based on interview and record review, the hospital failed to ensure the safe distribution of medications for one (Resident 1) of thirty-four sampled patients. This occurred when electronic clinical screenings that alerted for drug-drug interactions (harmful and unsafe if medications administered together) and therapeutic duplications (taking at least 2 medications from same category) involving three antipsychotic medications (haloperidol, olanzapine, and quetiapine) were not clarified and resolved between the Pharmacist and the Prescriber. Antipsychotics are a class of medications used to treat patients diagnosed with schizophrenia (thought disorder) or bipolar (mood disorder). Haloperidol is categorized as a typical (also known as first generation or older) antipsychotic. Olanzapine and quetiapine are categorized as atypical (also known as second generation or newer) antipsychotics.

This failure had the potential to expose the patient to serious side effects affecting the heart and the breathing.

Findings:

A review of Patient 1's History and Physical (H&P - exam and medical history by Physician) dated April 6, 2018, did not indicate the patient with diagnoses of schizophrenia or bipolar disorders before hospital admission.

A review of Patient 1's "Home Medications" upon admission to the hospital included: chlordiazepoxide (an anti-anxiety drug), carvedilol (for high blood pressure), furosemide (for fluid retention), apixaban (blood thinner), and diltiazem (for high blood pressure). The "Home Medications" list did not indicate the patient was receiving any antipsychotic medications before hospital admission.

A review of Patient 1's medical record indicated Registered Pharmacist 3 (RPh 3) verified (approved) the antipsychotic medication haloperidol on April 10, 2018, at 10:52 AM. The RPh 3 also verified the antipsychotic medications olanzapine and oral quetiapine on April 10, 2018, at 10:55 AM. The Pharmacy's computer system's "Alert History" indicated RPh 3 was alerted to drug-drug interactions and therapeutic duplications with major alert severity warnings before RPh 3 verified each of the three antipsychotic medications (haloperidol, olanzapine, and quetiapine).

A review of Patient 1's Consultation Note from a Psychiatrist (Physician specialist in mental disorders) dated April 11, 2018, indicated to hold antipsychotic medications while patient was over sedated. The Psychiatrist indicated in the Consultation Note to discontinue (stop) the medications haloperidol, olanzapine, and quetiapine.

A review of the package insert (document on how to safely use medications) for injectable haloperidol, obtained from the hospital, indicated haloperidol was an antipsychotic drug.

A review of the package insert for olanzapine tablets, obtained from the hospital, indicated olanzapine was an atypical antipsychotic drug.

A review of the package insert for quetiapine tablets, obtained from the hospital, indicated quetiapine was an atypical antipsychotic drug.

A review of the 2013 "ASHP [American Society of Health-System Pharmacy - a professional organization that represents pharmacists] Guidelines: Minimum Standard for Pharmacies in Hospitals", in the section titled "Review of Medication Orders", indicated "all medication orders shall be prospectively reviewed by a pharmacist and assesses in relation to pertinent patient and clinical information before the first dose is administered ...any questions regarding an order shall be resolved with the prescriber prior to administration, and any action taken as a result of this intervention should be documented in the patient's medical record."

On May 2, 2018, at 1:15 PM, during record review and concurrent interview, RPh 3 stated she had access to review Patient 1's home medications during the Pharmacist verification process. She stated haloperidol, olanzapine, and quetiapine are antipsychotic medications. RPh3 stated she received the "Alert History" for the drug-drug interactions and therapeutic duplications with major severity warnings for each of the three antipsychotic medications she verified. She stated she generally contacts the Physician when she is alerted to drug-drug interactions or therapeutic duplications, but in Patient 1's case, she did not contact the Physician or make any written note or documentation in Patient 1's profile.

On May 2, 2018, at 3:00 PM, during record review and concurrent interview, Patient 1's medical record was reviewed with the Clinical Quality Coordinator. The Clinical Quality Coordinator stated there was no medical history of Schizophrenia or Bipolar disorder in Patient 1's medical record.

A review of the hospital policy procedure titled, "Medication Order Processing" dated February 2016, indicated the Pharmacist should review drug orders for appropriateness before the first dose is administered. The policy indicated the Pharmacist will review the order for appropriateness including drug-drug interactions. The policy indicated questionable or inappropriate orders must be clarified and resolved by the Pharmacist with the Prescriber prior to the dispensing and administration of the drug. The policy indicated the medication order is verified in the Pharmacy order entry system where clinical screening for therapeutic duplications and interactions occur.