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Based on a review of policies and procedures and Medical Staff Bylaws and Rules and Regulations the Governing Body, and staff interviews, the Governing Body failed to effectively oversee the Pharmacy's processing and dispensing of medications, and nursing staff for one (1) of seven (7) sampled patients, resulting in the patient's death.

Cross refer:

A115 Patient's Rights as it relates to the failure of the governing body to protect and promote the patient's right to care in a safe setting.

A385 Nursing Services as it relates to the facility's failure to ensure that nursing services were delivered safely.

A489 Pharmaceutical Services as it relates to the facility's failure to prevent medication errors.

Based on medical record review, policy and procedure the facility failed to protect and promote the right of Patient #1 to care in a safe environment which resulted in harm to Patient #1.

Findings include:-

Cross refer

A405 Nursing Services as related to the facility's failure to protect patient from harm from medication errors.
A489 Pharmaceutical Services as related to the facility's failure to protect the patient from medication errors.

Based on a review of facility's policies and procedure, staff interview, and patient medical records, the facility failed to ensure that safe and effective care was provided for one (1) of seven (7) sampled patient medical records (Patient #1) who was given an overdose of Amlodipine Besylate (a calcium channel blocking medication that decreases the contraction of the heart and dilates [widens] the arteries to reduce the pressure in the arteries, making it easier for the heart to pump blood).

Finding include:

A review of the medical record of Patient #1 revealed that the patient presented to the facility's Emergency Department (ED) from a nursing home on 10/13/17. Patient #1's chief complaint was rectal bleed. The clinical documentation revealed that a Resident Physician (doctor in training, MD#9) and a Hospitalist (Physician, MD #1) performed an examination on Patient #1 which included labs and a chest x-ray. Additionally, it was documented that hypertensives (medications that lower the blood pressure) were to be held.

Review of the electronic Medication Administration Record (eMAR) revealed that MD #1 ordered Amlodipine Besylate Tablet (also known as Norvasc) 100 milligrams, by mouth on 10/13/17 at 3:06 a.m. The normal maximum daily dosage for amlodipine is 10 mg once daily.

On 10/14/17 at 9:02 a.m., RN #2 documented that he/she had administered amlodipine besylate tablet 100 mg P.O. (by mouth) 1(one) time per day to Patient #1.

Nurse's notes dated 10/14/17 at 11:02 a.m. revealed that Patient #1 had been given amlodipine and that Patient #1's systolic blood pressure (the first number that measures the pressure of the blood vessels when the heart beats) was decreasing. The documentation further revealed that Patient #1 was on 2 (two) liters of oxygen, opened his/her eyes spontaneously, was aware of himself/herself, and could move all his/her limbs. The documentation indicated that Patient #1's heart rate was slow. It was also indicated in the note that the physician was called. The documentation further indicated that Patient #1 was administered large amounts of normal saline and the plan was for the nurse to continue to monitor.

RN #2 documented on 10/14/17 at 11:44 a.m. that Patient #1's morning blood pressure was 147/67 and heart rate 64 beats per minute. RN #2 documented that Patient #1' s blood pressure was rechecked and the result was 92/52 with a heart rate of 62. In addition, the patient was passing large, dark blood clots. As indicated in the note, the physician arrived and the patient was transferred to the ICU (Intensive Care Unit - area where nurses with specialized training to provide care for critically ill patients).

Further review of the record revealed a physician's note dated 10/14/17 at 12:24 p.m. revealed that Patient #1 had an overdose of a calcium channel blocker. According to the physician's note, it was too late to try activated charcoal (a substance used to treat drug overdoses or poisoning). Patient #1 developed bradycardia (abnormally slow heart action) and hypotension (abnormally low blood pressure). He/she was placed on Vasopressors (a drug causing the constriction of blood vessels) with norepinephrine (a drug to raise blood pressure) and dopamine (neurotransmitter in the brain). Patient #1 was placed on a ventilator on 10/14/17 at 4:04 p.m. for conscious sedation.

Review of a physician's note dated 10/16/17 at 6:33 p.m. revealed that Patient #1 was provided critical care, and was placed on a ventilator (a machine that assists with breathing). Patient #1 developed pulmonary edema (a condition caused by too much fluid in the lungs) and declined further.

A code was initiated on 10/16/17 at 6:22 p.m., and at 6:23 pm. Patient #1 expired on 10/16/17 at 6:30 p.m. The documented indicated that the cause of death was calcium channel blocker overdose.

During an interview on 10/23/17 at 2:34 p.m. in the hospitalist's office, MD #1 (Hospitalist) stated that Patient #1 had been treated at the facility recently and was discharged on 10/9/17. The physician stated that when the patient was re-admitted on 10/13/17 he/she and the resident examined the patient. The patient was alert but confused. The patient had dementia, DVT (a blood clot in the leg) and hypertension. Physician #1 stated that Patient #1's home medications were resumed. Physician #1 entered Patient #1's medication orders while reviewing the patient's medications as listed on the 10/09/17 discharge medication reconciliation list. Physician #1 printed out a copy of the medication order that he/she was referring to. The medication order sheet included Amlodipine 10 mg oral tablet, 10 tab(s) orally once a day. Physician #1 explained that he/she reviewed Patient #1's home medications on the computer by clicking on the home medication tab. Physician #1 stated that he/she did not realize that the order for Amlodipine read 10 tablets. Physician #1 stated that he/she forwarded the order to the pharmacy. Physician #1 stated that if there is a problem with the medication, the Pharmacy would call the physician to confirm what the Physician is prescribing. Physician #1 stated that he/she could not explain what happened, and that he/she trusted the system. Physician #1 stated that a systems failure resulted in the medication error, which directly or indirectly contributed to Patient #1's death.

During an interview on 10/23/17 at 4:30 p.m. in the Pharmacy, the Pharmacy Director, (Staff #7) stated that when patients are admitted, pharmacy receives computerized medication orders from various departments from physicians. Staff #7 stated that each order is selected and verified. If the order does not match what is expected the pharmacist would refer to the home medication order list. If the order still does not make sense or is unclear the pharmacist would call the doctor. Staff #7 stated that if there are alerts on the orders the pharmacy must acknowledge the alert to process the medication order. Staff #7 explained that errors can occur because of "alert fatigue." He/she stated that so many duplicate medications come up that the pharmacist can get overloaded because of distractions such answering emergency codes and can make errors upon returning to the last task.

During an interview at 10:45 a.m. on 10/24/17 RN #2 stated that he/she has been a nurse for three years and works for the facility in the float pool. He/she has worked on different medical/surgical units for the past 11 months. RN #2 stated that he/she worked on unit 4500 on 10/14/17 from the 6:45 a.m. to 7:45 p.m. shift. He/she recalled that Patient #1 had a GI bleed, was alert, withdrawn and confused. RN #2 stated that he/she pulled the patient's medication consisting of 13 pills from the Pyxis (automated medication dispensing system). RN #2 stated that ten of the pills were 10 mg tablets of amlodipine. He/she stated that he/she checked the Pyxis machine in the neighboring unit to see if he/she could find a 100-mg pill of amlodipine but could not find any. RN #2 stated that he/she went to the room and scanned Patient #1's wrist band and the medication packet. A message appeared on the scanner indicating that it was a partial dose, so he/she scanned all 10 of the 10-mg amlodipine pills and assisted the patient with taking them at 9:02 a.m. RN #2 stated that after giving the medication he/she checked the medication order again to compare it to what Patient #1 had received at the facility before admission and noted that the order was the same. RN #2 stated that he/she checked Patient #1 around 10:20 a.m. on 10/14/17. Patient #1 was sitting up in bed leaning against the side rail. RN #2 stated that he/she checked the patient's BP and the top number was 88, so he/she called the charge nurse and then called the physician.

In a phone interview at 11:00 a.m. on 10/25/17, the Clinical Coordinator (RN #8) stated that he/she recalled that on Saturday 10/14/17 just before the daily huddle between 10: 00 a.m. - 10:30 a.m. RN #2 approached him/her and said Patient #1's blood pressure was low (45-80's). RN #8 stated that he/she gave Patient #1 boluses (large amounts) of IV (in the vein) fluids. Patient #1's vital signs were registered at 80-90's systolic. RN #8 stated that while at the patient's bedside RN #2 read his/her report and told RN #8 that RN #2 had given Patient #1 100 mg of Amlodipine. RN #8 stated that he/she and RN #2 turned Patient # 1 over and noted that the patient was bleeding from the rectum. RN #8 stated that the physician arrived on the scene and gave instructions for the patient to be sent to the ICU.

Review of facility policy #CPR-232 titled "Use of Pyxis ES For Medication Control "effective date 4/14/15 revealed that a pharmacist must review all medication orders. Once that review has taken place the pharmacist will enter the order in the pharmacy computer system. The profile of the patient's order/reviewed medications, which are available in the Pyxis, will then display on the Pyxis screen and may be removed.

Review of policy number CPR-132 titled "Medication Administration Guidelines," effective 9/10/15 revealed that the routine process for ALL medications was to verify the correct patient (two identifiers), the medication dose route, time and allergy history prior to administration. Use standard precautions as appropriate throughout the procedure. Explain the procedure and medication name/type to the patient. Record the administration in the electronic medication administration record.

Review of facility policy #CPO-105 titled "Medication Reconciliation," (the act of comparing a list of medications, evaluating the lists and documenting any home medication that has not been ordered) last revised 11/2011, revealed the physician's responsibility is to prescribe the appropriate medications, based on the patient's current condition as well as their current medications. Including a "prior admission" medication list in the patient's history and physical. Reconciling the admission medication list and the patient's admission medication profile. Including a list of discharge medications in the patient's medical record. Working with other healthcare professionals (for example the nurse, pharmacist) when contacted about possible discrepancies. Reviewing medication history list when present in outpatient or physician practice areas. Nurses are responsible for; 1. Taking accurate medication histories as part of the initial assessment or at least making a good faith effort to do so. 2. Using the electronic medication writer to update and document medications the patient is taking when admitted. 3. Documenting any home medications that have been ordered in the electronic Plan of Care. 4. Taking medication histories in outpatient areas as assigned. 5. Reviewing discharge medications with those that the patient is receiving at the time of discharge in the hospital. 6. Giving the patient a complete list of medications upon discharge.

Review of the "Medical Staff Bylaws, Policies and Rules and Regulations, "approved 10/12/04, revealed that the laws, regulations, customs and generally recognized professional standards that govern hospitals require that practitioners practicing at a hospital be appointed to a medical staff by the Board of Directors and that the Board grant the medical staff responsible for the quality of medical care provided patients in the hospital and for the ethical and professional practices of medical staff. The bylaws, rules and regulations and related policies, as amended/changed from time to time, define the respective roles and responsibilities of the medical staff and hospital, and are subject to the Board who has ultimate authority.

Based on medical record review, policy and procedure the facility failed to ensure that nursing care and services were administered in a safe and effective manner for one (1) patient which resulted in harm to Patient #1.

Findings include:-

A review of the medical record of Patient #1 revealed that the patient presented to the facility's Emergency Department (ED) from a nursing home on 10/13/17. Patient #1's chief complaint was rectal bleed. The clinical documentation revealed that a Resident Physician (doctor in training, MD#9) and a Hospitalist (Physician, MD #1) performed an examination on Patient #1 which included labs and a chest x-ray. Additionally, it was documented that hypertensives (medications that lower the blood pressure) were to be held.

Review of the electronic Medication Administration Record (eMAR) revealed that MD #1 ordered Amlodipine Besylate Tablet (also known as Norvasc) 100 milligrams, by mouth on 10/13/17 at 3:06 a.m. The normal maximum daily dosage for amlodipine is 10 mg once daily.

On 10/14/17 at 9:02 a.m., RN #2 documented that he/she had administered amlodipine besylate tablet 100 mg P.O. (by mouth) 1(one) time per day to Patient #1.

Nurse's notes dated 10/14/17 at 11:02 a.m. revealed that Patient #1 had been given amlodipine and that Patient #1's systolic blood pressure (the first number that measures the pressure of the blood vessels when the heart beats) was decreasing. The documentation further revealed that Patient #1 was on 2 (two) liters of oxygen, opened his/her eyes spontaneously, was aware of himself/herself, and could move all his/her limbs. The documentation indicated that Patient #1's heart rate was slow. It was also indicated in the note that the physician was called. The documentation further indicated that Patient #1 was administered large amounts of normal saline and the plan was for the nurse to continue to monitor.

RN #2 documented on 10/14/17 at 11:44 a.m. that Patient #1's morning blood pressure was 147/67 and heart rate 64 beats per minute. RN #2 documented that Patient #1' s blood pressure was rechecked and the result was 92/52 with a heart rate of 62. In addition, the patient was passing large, dark blood clots. As indicated in the note, the physician arrived and the patient was transferred to the ICU (Intensive Care Unit - area where nurses with specialized training to provide care for critically ill patients).

Further review of the record revealed a physician's note dated 10/14/17 at 12:24 p.m. revealed that Patient #1 had an overdose of a calcium channel blocker. According to the physician's note, it was too late to try activated charcoal (a substance used to treat drug overdoses or poisoning). Patient #1 developed bradycardia (abnormally slow heart action) and hypotension (abnormally low blood pressure). He/she was placed on Vasopressors (a drug causing the constriction of blood vessels) with norepinephrine (a drug to raise blood pressure) and dopamine (neurotransmitter in the brain). Patient #1 was placed on a ventilator on 10/14/17 at 4:04 p.m. for conscious sedation.

Review of a physician's note dated 10/16/17 at 6:33 p.m. revealed that Patient #1 was provided critical care, and was placed on a ventilator (a machine that assists with breathing). Patient #1 developed pulmonary edema (a condition caused by too much fluid in the lungs) and declined further.

A code was initiated on 10/16/17 at 6:22 p.m., and at 6:23 pm. Patient #1 expired on 10/16/17 at 6:30 p.m. The documented indicated that the cause of death was calcium channel blocker overdose.

During an interview on 10/23/17 at 2:34 p.m. in the hospitalist's office, MD #1 (Hospitalist) stated that Patient #1 had been treated at the facility recently and was discharged on 10/9/17. The physician stated that when the patient was re-admitted on 10/13/17 he/she and the resident examined the patient. The patient was alert but confused. The patient had dementia, DVT (a blood clot in the leg) and hypertension. Physician #1 stated that Patient #1's home medications were resumed. Physician #1 entered Patient #1's medication orders while reviewing the patient's medications as listed on the 10/09/17 discharge medication reconciliation list. Physician #1 printed out a copy of the medication order that he/she was referring to. The medication order sheet included Amlodipine 10 mg oral tablet, 10 tab(s) orally once a day. Physician #1 explained that he/she reviewed Patient #1's home medications on the computer by clicking on the home medication tab. Physician #1 stated that he/she did not realize that the order for Amlodipine read 10 tablets. Physician #1 stated that he/she forwarded the order to the pharmacy. Physician #1 stated that if there is a problem with the medication, the Pharmacy would call the physician to confirm what the Physician is prescribing. Physician #1 stated that he/she could not explain what happened, and that he/she trusted the system. Physician #1 stated that a systems failure resulted in the medication error, which directly or indirectly contributed to Patient #1's death.

During an interview on 10/23/17 at 4:30 p.m. in the Pharmacy, the Pharmacy Director, (Staff #7) stated that when patients are admitted, pharmacy receives computerized medication orders from various departments from physicians. Staff #7 stated that each order is selected and verified. If the order does not match what is expected the pharmacist would refer to the home medication order list. If the order still does not make sense or is unclear the pharmacist would call the doctor. Staff #7 stated that if there are alerts on the orders the pharmacy must acknowledge the alert to process the medication order. Staff #7 explained that errors can occur because of "alert fatigue." He/she stated that so many duplicate medications come up that the pharmacist can get overloaded because of distractions such answering emergency codes and can make errors upon returning to the last task.

During an interview at 10:45 a.m. on 10/24/17 RN #2 stated that he/she has been a nurse for three years and works for the facility in the float pool. He/she has worked on different medical/surgical units for the past 11 months. RN #2 stated that he/she worked on unit 4500 on 10/14/17 from the 6:45 a.m. to 7:45 p.m. shift. He/she recalled that Patient #1 had a GI bleed, was alert, withdrawn and confused. RN #2 stated that he/she pulled the patient's medication consisting of 13 pills from the Pyxis (automated medication dispensing system). RN #2 stated that ten of the pills were 10 mg tablets of amlodipine. He/she stated that he/she checked the Pyxis machine in the neighboring unit to see if he/she could find a 100-mg pill of amlodipine but could not find any. RN #2 stated that he/she went to the room and scanned Patient #1's wrist band and the medication packet. A message appeared on the scanner indicating that it was a partial dose, so he/she scanned all 10 of the 10-mg amlodipine pills and assisted the patient with taking them at 9:02 a.m. RN #2 stated that after giving the medication he/she checked the medication order again to compare it to what Patient #1 had received at the facility before admission and noted that the order was the same. RN #2 stated that he/she checked Patient #1 around 10:20 a.m. on 10/14/17. Patient #1 was sitting up in bed leaning against the side rail. RN #2 stated that he/she checked the patient's BP and the top number was 88, so he/she called the charge nurse and then called the physician.

In a phone interview at 11:00 a.m. on 10/25/17, the Clinical Coordinator (RN #8) stated that he/she recalled that on Saturday 10/14/17 just before the daily huddle between 10: 00 a.m. - 10:30 a.m. RN #2 approached him/her and said Patient #1's blood pressure was low (45-80's). RN #8 stated that he/she gave Patient #1 boluses (large amounts) of IV (in the vein) fluids. Patient #1's vital signs were registered at 80-90's systolic. RN #8 stated that while at the patient's bedside RN #2 read his/her report and told RN #8 that RN #2 had given Patient #1 100 mg of Amlodipine. RN #8 stated that he/she and RN #2 turned Patient # 1 over and noted that the patient was bleeding from the rectum. RN #8 stated that the physician arrived on the scene and gave instructions for the patient to be sent to the ICU.

Review of facility policy #CPR-232 titled "Use of Pyxis ES For Medication Control "effective date 4/14/15 revealed that a pharmacist must review all medication orders. Once that review has taken place the pharmacist will enter the order in the pharmacy computer system. The profile of the patient's order/reviewed medications, which are available in the Pyxis, will then display on the Pyxis screen and may be removed.

Review of policy number CPR-132 titled "Medication Administration Guidelines," effective 9/10/15 revealed that the routine process for ALL medications was to verify the correct patient (two identifiers), the medication dose route, time and allergy history prior to administration. Use standard precautions as appropriate throughout the procedure. Explain the procedure and medication name/type to the patient. Record the administration in the electronic medication administration record.

Review of facility policy #CPO-105 titled "Medication Reconciliation," (the act of comparing a list of medications, evaluating the lists and documenting any home medication that has not been ordered) last revised 11/2011, revealed the physician's responsibility is to prescribe the appropriate medications, based on the patient's current condition as well as their current medications. Including a "prior admission" medication list in the patient ' s history and physical. Reconciling the admission medication list and the patient's admission medication profile. Including a list of discharge medications in the patient ' s medical record. Working with other healthcare professionals (for example the nurse, pharmacist) when contacted about possible discrepancies. Reviewing medication history list when present in outpatient or physician practice areas. Nurses are responsible for; 1. Taking accurate medication histories as part of the initial assessment or at least making a good faith effort to do so. 2. Using the electronic medication writer to update and document medications the patient is taking when admitted. 3. Documenting any home medications that have been ordered in the electronic Plan of Care. 4. Taking medication histories in outpatient areas as assigned. 5. Reviewing discharge medications with those that the patient is receiving at the time of discharge in the hospital. 6. Giving the patient a complete list of medications upon discharge.

Review of the "Medical Staff Bylaws, Policies and Rules and Regulations, "approved 10/12/04, revealed that the laws, regulations, customs and generally recognized professional standards that govern hospitals require that practitioners practicing at a hospital be appointed to a medical staff by the Board of Directors and that the Board grant the medical staff responsible for the quality of medical care provided patients in the hospital and for the ethical and professional practices of medical staff. The bylaws, rules and regulations and related policies, as amended/changed from time to time, define the respective roles and responsibilities of the medical staff and hospital, and are subject to the Board who has ultimate authority.


Review of facility policy #CPR-232 titled "Use of Pyxis ES For Medication Control "effective date 4/14/15 revealed that a pharmacist must review all medication orders. Once that review has taken place the pharmacist will enter the order in the pharmacy computer system. The profile of the patient's order/reviewed medications, which are available in the Pyxis, will then display on the Pyxis screen and may be removed.



Review of policy number CPR-132 titled "Medication Administration Guidelines," effective 9/10/15 revealed that the routine process for ALL medications was to verify the correct patient (two identifiers), the medication dose route, time and allergy history prior to administration. Use standard precautions as appropriate throughout the procedure. Explain the procedure and medication name/type to the patient. Record the administration in the electronic medication administration record.

Review of facility policy #CPO-105 titled "Medication Reconciliation," (the act of comparing a list of medications, evaluating the lists and documenting any home medication that has not been ordered) last revised 11/2011, revealed the physician's responsibility is to prescribe the appropriate medications, based on the patient's current condition as well as their current medications. Including a "prior admission" medication list in the patient ' s history and physical. Reconciling the admission medication list and the patient's admission medication profile. Including a list of discharge medications in the patient ' s medical record. Working with other healthcare professionals (for example the nurse, pharmacist) when contacted about possible discrepancies. Reviewing medication history list when present in outpatient or physician practice areas. Nurses are responsible for; 1. Taking accurate medication histories as part of the initial assessment or at least making a good faith effort to do so. 2. Using the electronic medication writer to update and document medications the patient is taking when admitted. 3. Documenting any home medications that have been ordered in the electronic Plan of Care. 4. Taking medication histories in outpatient areas as assigned. 5. Reviewing discharge medications with those that the patient is receiving at the time of discharge in the hospital. 6. Giving the patient a complete list of medications upon discharge.

Review of the "Medical Staff Bylaws, Policies and Rules and Regulations, "approved 10/12/04, revealed that the laws, regulations, customs and generally recognized professional standards that govern hospitals require that practitioners practicing at a hospital be appointed to a medical staff by the Board of Directors and that the Board grant the medical staff responsible for the quality of medical care provided patients in the hospital and for the ethical and professional practices of medical staff. The bylaws, rules and regulations and related policies, as amended/changed from time to time, define the respective roles and responsibilities of the medical staff and hospital, and are subject to the Board who has ultimate authority.

Review of credential file #1 revealed that the Hospitalist (Physician #1) had all requirements for medical staff privileges and had no prior reprimands or sanctions.

Review of four (4) RN files revealed that all had current licenses, initial applications with references, had received annual training which included patient rights, patient safety, nursing medication administration, and information technology, during their orientation and annually. In addition, all had received annual evaluations and competency testing and had current BLS and/or ACLS, certification, as appropriate.

Review of two (2) weeks of staffing for the weeks of 10/01/17 to 10/16/17 revealed the required number of staff on the medical-surgical unit (4500) in accordance with the facility's staffing matrix.

Based on record review, interviews and policy and procedure the facility failed to ensure oversight of the Pharmacy's processing and dispensing of medication in a safe manner resulting in a medication error and an overdose of medication which caused harm to Patient #1.

Findings include:-

Cross refer A0405 Nursing Services as related to the facility's failure to protect patient from harm from medication errors.