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Based on observation, interview, and record review, the governing body (GB) failed to effectively responsible for the conduct of the hospital to ensure the quality and safety of patient care.

Findings:

1. The facility's quality assessment and performance improvement (QAPI) failed to ensure that its developed improvement plan had been implemented in the five week period of a medication error which resulted in the death of Patient 1. (Refer to A263)

2. The facility did not meet the condition of participation for nursing services by failing to supervise and evaluate the nursing care for 6 of 12 sampled patients (1, 2, 3, 4, 6, and 9). (Refer to A385)

3. The facility failed to implement the action plan identified after the investigation of a medication error incident resulting in the rapid administration of morphine (controlled narcotic used to treat moderate to severe pain) and subsequent death of Patient 1. (Refer to A 500)

4. The facility failed to ensure override medications are reviewed for appropriateness. Review or verify medication orders in Emergency Department (ED) for therapeutic appropriateness. Ensure their staff clarify incomplete medication order. (Refer to A 500)

The cumulative effects of this systemic failure resulted in the facility's inability to assure quality health care in a safe environment.

Based on observation and interview and record review, the facility's quality assessment and performance improvement (QAPI) failed to ensure that its developed improvement plan had been implemented in the five week period of a medication error which resulted in the death of Patient 1.

A copy of the Quality Performance Council meeting minutes of June 2, 2014 was reviewed on August 25, 2014, at 11 a.m., together with an interview of Staff A. The following action items were from the recommendations of this committee that functions as the quality a QAPI committee of the hospital.

a. Action Plan#1: Immediate removal of 250 cc bags of Morphine from the hospital inventory, completed on 5/6/2014.
b. Action Plan#2: Care Partnership Nursing Care Model to be in effect on MS (medical-surgery 4 & 5 units), shift hand off must be done in patient room. At time IV lines will be traced and infusion device settings will be checked. This to be in effect hospital wide in the next few months. Policy change 6/20/14 and education with implementation by 7/24/14.
c. Action Plan #3: Use of PCA (Patient Controlled Analgesia-self pain control) pumps instead of IV pumps for narcotic drips. Policy change 6/20/14 and presented at Pharmacy and Therapeutics (P&T) committee meeting on 06/25/14.
d. Action Plan #4: When there are multiple lines, nurse must trace each line from the bag containing the intravenous fluid to the patient when starting IVs and at shift change where pumps are in use pump settings must be checked and verified. Verification will be done by a second RN when adding or changing intravenously administered solutions. The meeting minutes contained an entry that Staff A had stated labels will be placed on bags and intravenous lines close to the patient. Policy change was on 6/20/14 and education implementation by 7/24/14.
e. Action Plan #5: The role of the rapid response team (RRT) to be clarified. Policy change was done on 6/20/14 and education implementation by 7/24/14.
f. Action Plan #6: Include and handle all narcotic drip medications in High Risk medication policy. Two nurses must review, verify and document High Risk medication use. Policy change 6/20/14 and education implementation by 7/24/14.
g. Action Plan #7: Acquire and use IV tubing labels for all high risk medications by 7/24/14.
h. Action Plan #8: Review visitor policy and request visitors to step out of the room at time of shift handover report. Education through Nursing Huddles.
i. Action Plan #9: Education on IV practices per the Lippincott manual. Education implemented by 7/24/14.

Findings:

1. Based on a tour of the nursing stations in the neonatal intensive care unit (NICU) and the 4th and 5th Med Surg floor, on August 26, 2014 from 10 a.m. until 11:30 am, while accompanied by Staff B, a variation of findings were observed in relation to the tagging or labeling of intravenous lines (tubing). This resulted in a failure to readily identify medications and flow rates of the contents and fluids patients were receiving. While policy had been developed for this order following the adverse event to Patient 1, what was observed from staff interviews and directly, on three nursing units consisted of a variety of labeling efforts. These were individually implemented at the discretion of the nursing staff. (Refer to A395)

2. Based on document review from the Quality Performance Council meeting of June 2, 2014 and an interview of Staff A on August 26, 2014 at 2:30 pm, it was indicated that no uniform, facility-wide policy in regards to labeling intravenous lines carrying high risk medication such as morphine sulfate, heparin or fentanyl had been instituted on a hospital wide basis at this time, though this had been recommended by the Quality Performance Council on June 2, 2014, and presented to the Medical Executive Committee where the report and its recommendations had been accepted at the August 12, 2014 meeting. A further tour of the hospital failed to demonstrate the distinctively colored intravenous line tags observed in the NICU. During the tours of Med Surg 4 and 5, the plain white tags were observed on bags of intravenous fluid. (Refer to A395)


3. The action plan for the placement of identifying labels on individual lines when multiple lines going to a patient are failed to be observed. The Quality Council has assessed the adverse event, and the deficient practices determined have been the cause of the incident. While this had been completed little implementation of recommendation were observed. Evidence of efforts to track and trend data being assessed had failed to have been accomplished. The governing body failed to ensure five weeks following the targeted date of completion, the numerous processes of improvement recognized as needing to be put in place. The result of this constitutes a risk to the health and wellbeing of all patients in the facility and prevents the assurance of a level of care enabling practicable clinical outcomes being provided by the hospital. (Refer to A395 and A500)


The cumulative effects of this systemic failure resulted in the facility's inability to assure quality health care in a safe environment.

Based on observation, interview and record review, the facility did not meet the condition of participation for nursing services by failing to supervise and evaluate the nursing care for 6 of 12 sampled patients (1, 2, 3, 4, 6, and 9). The facility failed to:

1. Perform reassessment of Patient 1's condition and response to the intervention (medication) after the initiation of the morphine drip on May 5, 2014 at 4:27 p.m., by RN 1 (day shift).

2. Ensure Patients 2, 6 and 9, who received intravenous (IV) therapy, had IV labels on their IV insertion sites as indicated in the facility policy.

3. Ensure Patient 3 was assessed for pain as indicated in the facility policy.

4. Ensure Patient 2 and 4, who were assessed for pain, received intervention as indicated in the facility policy and plan of care. (Refer to A 395)

The cumulative effects of this systemic failure resulted in the facility's inability to assure quality health care in a safe environment.

Based on observation, interview and record review, the facility failed to supervise and evaluate the nursing care for 6 of 12 sampled patients (1, 2, 3, 4, 6, and 9) by failing to:

1. Perform reassessment of Patient 1's condition and response to the intervention (medication) after the initiation of the morphine drip on May 5, 2014 at 4:27 p.m., by RN 1 (day shift). At approximately 6:42 p.m., the patient's respiratory rate dropped from 28 breaths per minute to 4 breaths per minute and the oncoming shift noted the morphine bag empty.

This deficient practice resulted in the patient's change in condition unnoticed with the rapid infusion of morphine. Patient 1 subsequently expired at 8:38 p.m.

2. Ensure Patients 2, 6 and 9, who received intravenous (IV) therapy, had IV labels on their IV insertion sites as indicated in the facility policy.

3. Ensure Patient 3 was assessed for pain as indicated in the facility policy.

4. Ensure Patient 2 and 4, who were assessed for pain, received intervention as indicated in the facility policy and plan of care.

These deficient practices had the potential to result in not meeting the nursing needs of the patients who were receiving intravenous therapy and had potential for not managing the patient's pain.

Findings:

1. On August 26, 2014 at 2:50 p.m., with the Clinical Manager, RN 1 was interviewed. Registered Nurse (RN 1) stated Patient 1 has a DNR (Do Not Resuscitate - an order not to do cardiopulmonary resuscitation [CPR] when the patient stops breathing or the patient's heart stop beating) order. The patient woke up a couple of times, screaming, the patient's oxygen saturation dropped to 87% (87 percent), the blood pressure dropped and the patient was tachypneic (abnormally fast breathing). Physician 1 ordered morphine drip to Patient 1 for comfort care. RN 1 stated for comfort measure, titrate the morphine to make the patient comfortable. RN 1 stated she set up the morphine drip and connected it to the patient's IV.

RN 1 stated Patient 1 had two lines, PICC line (peripherally inserted central catheter is a form of intravenous access for prolonged period of time, inserted in the big vein of the arm [basilic or cephalic veins] by physicians or specially trained registered nurses and advanced towards the heart) and peripheral line (small flexible tube [catheter] placed into a vein usually the hand). There were two machines (IV pump - medical devise use to deliver intravenous fluids to the patient). The intravenous fluid of 5% Dextrose/0.45% sodium chloride with 20 milliequivalent (mEq) potassium chloride (KCL) fluid at 100 ml (millimeter) per hour and the other was morphine drip at 2 mg (milligram) per hour. RN 1 gave report to the next shift (7 p.m. to 7 a.m.), not at the bedside because the patient's family was in the room. The next shift, RN 11 found the medication error, when he realized the IV morphine bag was empty.

A review of Patient 1's medical record indicated the patient was admitted to the facility with diagnoses that included leukocytosis (a condition in which the white blood count is high specially during infection), abdominal pain and dementia (loss of mental functions such as thinking, memory and reasoning).

The Nurse Notes dated May 5, 2014 at 11:55 a.m., indicated, Patient 1 was tachypneic (abnormally fast breathing) with a respiratory rate of 24-26 breaths per minute, and very shallow, oxygen saturation (measure of how much oxygen in the blood) at 87% on 40 oxygen flow rate, her blood pressure (BP) had dropped from 95/66 mm Hg (millimeter of mercury) to 92/60 mm Hg (normal blood pressure 120 over 80 mm Hg - 120/80 mm Hg).

The Vital Signs sheet on May 5, 2014 at 4 p.m., indicated a blood pressure (BP) reading of 84/59 mm Hg, pulse rate of 92 beats per minute, respiratory rate of 28 breaths per minute, 88% bedside pulse oxymetry (non invasive procedure to monitor the patient oxygen saturation) and pain intensity of 0 on a 0 to 10 scale. A comment by the certified nurse assistant (CNA) indicated registered nurse notified of blood pressure, oxygen and heartbeat. At 4:27 p.m., the vital signs documented by RN 1 indicated a blood pressure reading of 84/59, pain intensity of 0 on a 0 to 10 scale and respiratory rate of 28 breaths per minute.

On May 5, 2014 at 3:50 p.m., Physician 1 ordered morphine drip at a rate of 2 milligrams (mg) per hour. At 4:27 p.m., RN 1 (day shift) started the morphine drip.

A review of the Order History sheet Medication Detail indicated the following: Physician 1 was the ordering physician. The total dose was 250 ml at 2 ml/hr. The Start Date was May 5, 2014. Label text indicated to call should dosing be ineffective, to titrate upward. Morphine Sulfate/Sodium Chloride (IV fluid) 250 ml bag, Morphine-NS 250 mg/250 ml. Protocol starting rate 2 mg/hr infusion.

A review of the medical record indicated no documentation of reassessment of Patient 1's condition and response to the intervention (medication) after the initiation of the morphine drip on May 5, 2014 at 4:27 p.m.

A review of a facility letter dated May 7, 2014, indicated at approximately 6:42 p.m., the patient's respiratory rate dropped significantly to 4 and the night shift noted the morphine bag was empty. Patient 1 expired at 8:38 p.m. The facility's initial investigation indicated the patient had two intravenous (IV) lines, and "the IV lines were switched by the day shift nurse..."

Patient 1 received 100 mg of morphine at the rate of 100 ml per hour which was 98 mg more than (50 times) the prescribed dose of 2 mg per hour of morphine at a rate of 2 ml per hour of morphine as indicated in the concentration prepared by the pharmacy.

On August 27, 2014 at 11:50 a.m., during a review of the medical record for Patient 1 with the Risk and Patient Relations Coordinator (Admin 3), Admin 3 was not able to find RN 1's reassessment of Patient 1 after initiation of the morphine drip.

A review of the facility policy and procedure titled, "Admission Assessment and Shift Assessment" Dated April 2014, indicated, "The RN will perform a shift assessment and document each shift and more frequently if needed, as the patient's condition changes."


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2. On August 25, 2014, at 10:35 a.m., during the initial tour in Medical-Surgical Unit 4, Patient 2 was observed with a peripheral intravenous (IV) line on the right arm. There was no label present at the IV insertion site to indicate date and time of IV insertion and initials of the licensed nurse who performed the IV insertion.

On August 25, 2014 at 2:25 p.m., in the Direct Observation Unit, Patient 6 was observed with a peripheral IV line right forearm. There was no label present at the IV insertion site to indicate date and time of IV insertion and initials of the licensed nurse that performed the IV insertion.

On August 25, 2014 at 4:05 p.m., in Medical-Surgical Unit 2, Patient 9 was observed with a peripheral IV line on the left hand. There was no label present at the IV insertion site to indicate date and time of IV insertion and initials of the licensed nurse that performed the IV insertion.

A review of the facility's policy and procedure titled, "Intravenous Therapy-Peripheral, revised June 2014, indicated the "insertion and maintenance of peripheral IV therapy device can be performed by an RN or an LVN with intravenous certification..." The procedures included "applying label with date, time, and initials IV sites must be labeled 100% of the time."

During an interview on August 27, 2014 at 4:45 p.m., the chief nursing officer stated that the licensed nurse should labeled he IV line with date, time and initials as indicated in their policy.

3. On August 27, 2014, a review of the electronic record of Patient 2 indicated the patient was admitted on August 24, 2014 with diagnosis of colitis (inflammation of large intestine). The Pain Assessment dated August 26, 2014 at 9:47 p.m. indicated Patient 2 had generalized hand pain, described as sharp and constant, and pain level was 5 on a 0 to 10 scale. Patient 2 also had an acute pain in the lower abdomen, described as "cramping" and pain level was 2 on a 0 to 10 scale. There was no documentation of interventions as indicated in the patient's plan of care.

A review of the "Patient's Plan of Care-Pain" dated August 24, 2014,
indicated treatments/procedures/educations that included applying
heat, ice, changing positions frequently, calming techniques,providing
cognitive emotional support and ensuring pain management.

During an interview on August 27, 2014 at 9:30 .am., the Risk and Patient Relations Coordinator stated the licensed nurse should have documented the interventions in the electronic record.

The facility's policy and procedure titled, "Pain Management," reviewed February 2013, indicated treatment would be implemented to minimize the level of pain. Interventions are documented in the medical record/pain flow sheet to facilitate regular assessment and follow-up.


4. On August 27, 2014, a review of Patient 3's electronic medical record indicated Patient 3 was admitted to the facility on August 23, 2014, with diagnoses that included clostridium difficile colitis (infectious diarrhea due to a type of spore forming bacteria).

The Pain Assessment dated August 25, 2014 at 9:45 a.m. and August 26, 2014 at 9 p.m., completed by two registered nurses, indicated Patient 3 was not assessed for pain.

During an interview on August 27, 2014 at 10:10 a.m., the Risk and
Patient Relations Coordinator stated the licensed nurses had not completed their pain assessment.

The facility's policy and procedure titled, "Pain Management," reviewed February 2013, indicated pain assessment included pain intensity using the "Numeric Pain Intensity Scaled from 0-10" (0 for no pain, and 10 for the most highest level of pain)

5. A review of Patient 4's electronic medical record indicated Patient 4 was admitted to the facility on August 23, 2014 with diagnoses of cellulitis (bacterial infection of the skin) and history of chronic pain syndrome.

The Pain Assessment dated August 24, 2014, at 6:37 p.m., indicated the patient's pain level was at 10. There was no documentation of interventions. During an interview on August 27, 2014 at 11:10 a.m., the Risk and Patient Relations Coordinator stated pain medication was not documented as given on August 24, 2014.

The facility's policy and procedure titled, "Pain Management" reviewed February 2013, indicated treatment would be implemented to minimize the level of pain. Interventions are documented in the medical record/pain flow sheet to facilitate regular assessment and follow-up.

Based on observation, interview and record review, the facility did not meet the condition of participation for pharmaceutical services by failing to:

1. Implement the action plan identified after the investigation of a medication error incident resulting in the rapid administration of morphine (controlled narcotic used to treat moderate to severe pain) and subsequent death of Patient 1. (Refer to A 500)

2. Ensure override medications are reviewed for appropriateness. Review or verify medication orders in Emergency Department (ED) for therapeutic appropriateness. Ensure their staff clarify incomplete medication order. (Refer to A 500)

The cumulative effects of this systemic failure resulted in the facility's inability to assure quality health care in a safe environment.

Based on observation, interview and record review, the facility failed to provide correct dosage and prevent a medication error incident, for 1 of 12 sample patients, resulting in the rapid administration of morphine (controlled narcotic used to treat moderate to severe pain) and subsequent death of Patient 1.

For Patient 1, the morphine drip was not administered at the correct dosage and infusion rate. Physician 1 ordered morphine drip at 2 milligrams per hour (mg/hr or 2 cubic centimeter/hr) for comfort care. Patient 1 received 100 mg per hour when it was noted the morphine drip was infusing (running) at a rate of 100 cubic centimeter (cc) per hour. As a result, the patient's respiratory rate (breathing) dropped significantly to four breaths from 28 breaths per minute and subsequently died.

Following the medication error incidence resulted in the death of Patient 1, the facility developed an immediate action plan to include acquiring intravenous tubing labels for high risk medication. During observation of the patient care areas with the exception of the Neonatal Intensive Care Unit (NICU), the medication labels for the intravenous tubing were not available. Staff interviews indicated variations in labeling the intravenous tubing per staff preferences.

The facility also failed to:

1. Ensure the Pharmacy clarified physician orders for completeness,
2. Ensure all override medications are reviewed for appropriateness and
3. Review or verify medication orders in Emergency Department (ED) for therapeutic appropriateness prior to administration or at least retrospectively in cases of life-threatening emergency.

These deficient practices had the potential to result in medication errors that could lead to patient harm.

Findings:

1. A review of a facility letter dated May 7, 2014, indicated Patient 1 was significantly declining and the attending physician ordered morphine drip at 2 mg per hour for comfort care. The morphine drip was started at 4:27 p.m., by the day shift and at approximately 6:42 p.m., the patient's respiratory rate dropped significantly to 4 and the night shift noted the morphine bag was empty. Patient 1 expired at 8:38 p.m. The facility's initial investigation indicated the patient had two intravenous (IV) lines, and " the IV lines were switched by the day shift nurse..."

A review of Patient 1's medical record indicated the patient was admitted to the facility with diagnoses that included leukocytosis (a condition in which the white blood count is high specially during infection), abdominal pain and dementia (loss of mental functions such as thinking, memory and reasoning).

A review of the facility document (internal investigation) indicated, the immediate removal of 250 cc bag from the inventory, use 100 cc bag for infusion of morphine, use patient controlled analgesia infusion pump instead of intravenous pump for morphine drip, acquire intravenous tubing labels for high risk medication and handle morphine drip as high risk medication, two nurses must review and document.

A review of the facility policies and procedures titled, Intravenous Therapy - Peripheral and Central Venous Access Devise (CVAD), dated June 2014, indicated "The verification of infusions and correct infusion rates includes tracing the line from the pump to the patient."

During an interview on August 26, 2014 at 10:35 a.m., registered nurse (RN 2) stated, she uses a white label to write the name of the medicine for patients with multiple lines.

At 11:20 a.m., the same day, RN 3 stated for patients with multiple lines, she uses a piece of tape as a label and place the tape on the IV pump (medical devise use to deliver intravenous fluids to the patient).

During an interview at 11:30 a.m., the Director of Medical/Surgical 4 and 5 (Admin 1) stated there was a clinical practice council meeting on July 10, 2014, and staff meeting on July 17, 2014. Admin 1 stated it was an informal staff meeting and the staff were informed regarding tracing the IV line, labeling the tubing and the staff were encouraged to use PCA (patient controlled analgesia) pump. Admin 1 also stated the labels were ordered. (PCA pump is a method of pain control, allowing a person in pain to administer his own pain relief. A computerized pump called patient controlled analgesia (PCA) contains a syringe of pain medication prescribed and connected to patient's intravenous line. The pump is programmed to either deliver a small continuous pain medication and additional doses for self -administration or both. For patient safety, the total amount has a set limit and the pump is locked.)

At 11:50 a.m., in the Medical Surgical Unit 4 (MS 4) medication room, the medication labels for the IV tubing were not available.

At 11:58 a.m., in Medical Surgical Unit 5 (MS 5) medication room, the medication labels for the IV tubing were not available.

On August 26, 2014 at 2:50 p.m., with the Clinical Manager (RN 10), RN 1 was interviewed. RN 1 stated Patient 1 was a DNR (Do Not Resuscitate - an order not to do cardiopulmonary resuscitation [CPR] when the patient stops breathing or the patient's heart stop beating). The patient woke up a couple of times, screaming, the patient's oxygen saturation dropped to 87% (87 percent), the blood pressure dropped and the patient was tachypneic (abnormally fast breathing). Physician 1 ordered morphine drip to Patient 1 for comfort care. The patient had multiple antibiotics and she started a new primary line. RN 1 stated usually, there was one IV line to keep the vein open with the morphine drip but in this case the patient had two lines, PICC line (peripherally inserted central catheter is a form of intravenous access for prolonged period of time, inserted in the big vein of the arm [basilic or cephalic veins] by physicians or specially trained registered nurses and advanced towards the heart) and peripheral line (small flexible tube [catheter] placed into a vein usually the hand).

RN 1 stated the pharmacy delivered the morphine in 250 cc IV bag, not PCA. RN 1 stated for morphine drip, it is not required to have another RN, and she set up the morphine drip by herself. There were two machines (IV pump), one for the intravenous fluid at 100 cc per hour and the other was morphine drip at 2 cc per hour. RN 1 stated for comfort measure, titrate the morphine to make the patient comfortable. RN 1 stated she changed the site. She wanted to make sure the morphine drip was in the PICC line. She gave report to the next shift, not at the bedside because the patient's family was in the room. The next shift, RN 11 found the medication error when he realized the IV morphine bag was empty.

RN 1 stated the hospital conducted an internal investigation and concluded that the IV lines were in reversed. The morphine drip had been infusing at a rate of 100 ml per hour and the 5% Dextrose water/0.45% sodium chloride with 20 mEq potassium chloride (KCL) was infusing at a rate of 2 ml per hour.

A review of the Order History sheet Medication Detail indicated the following: MD 1 was the ordering physician. Total dose of 250 ml at 2 mls/hr. The Start Date was May 5, 2014. Label text to call should dosing be ineffective, to titrate upward. Morphine Sulfate/Sodium Chloride (IV fluid) 250 ml bag, Morphine-NS 250 mg / 250 ml. Protocol starting rate 2 mg/hr infusion.

Patient 1 received 100 mg of morphine at the rate of 100 ml per hour which was 98 mg more than (50 times) the prescribed dose of 2 mg per hour of morphine at a rate of 2 ml per hour of morphine as indicated in the concentration prepared by the pharmacy.

As a result of the medication error incident, the facility developed an action plan which included acquiring intravenous tubing labels for high risk medication and handling morphine drip as high risk medication, two nurses must review, verify and document.

During the tour of the facility and staff interviews on August 26, 2014 from 10:35 a.m. to 11:58 a.m., the medication labels for the IV tubing were not available in the Medical/Surgical patient care areas and review of the revised policies and procedures titled, Intravenous Therapy - Peripheral and Central Venous Access Devise (CVAD), dated June 2014, did not address tracing the IV tubing from the intravenous bag through the pump to the patient.

According to the Nursing practice reference: Fundamentals of Nursing, Wilkinson Treas (2nd ed), from section on regulating and maintaining intravenous infusion, "When a patient has multiple IV solutions and multiple lines, you must label each line to identify what is infusing in it. Label the IV tubing close to the catheter so that it is easy to see which fluid is infusing the line."

On August 26, 2014 at 5 p.m., an immediate jeopardy situation was declared with the chief executive officer (CEO), chief nursing officer (CNO) and Director of Risk management.

At 6:50 p.m., the same day, the Immediate Jeopardy was abated in the presence of the CNO. The CNO submitted an acceptable plan of correction (POC) in response to the Immediate Jeopardy. The facility revised the policies and procedures for intravenous therapy titled, Central Venous Access Devices (CVAD) and Intravenous Therapy-Peripheral. The intravenous therapy policies and procedures indicated, "The verification of infusions and correct infusion rates includes tracing the line from the IV bag through the pump to the patient. All intravenous infusions containing medications will be labeled with a label containing the name of the medication. The label will be placed as near as possible to the patient insertion site." The facility also initiated staff education on August 26, 2014.



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2. On August 26, 2014, a review of the clinical record revealed Patient 1 was admitted on April 17, 2014, for Leukocytosis (A condition in which the number of white blood cells is higher than normal), abdominal pain, and dementia (a decline in mental ability severe enough to interfere with daily life). Patient 1 was in a declining state of health due to multiple co-morbidities (two or more diseases existing at the same time in the body).

A review of the electronic physician medication order dated May 5, 2014 and timed at 4:00 p.m. for Patient 1 indicated morphine sulfate 250 milligrams (mg) in normal saline 250 milliliters (ml) to be infused at a rate of 2 ml per hour. The physician's directions indicated, "Call me should dosing be ineffective, to titrate upward." The electronic physician medication order did not include indication for use, morphine infusion concentration, or dosage.

During an interview on August 26, 2013, at 2:22 p.m., the Chief Nurse of Operation (CNO) reviewed the morphine physician order for Patient 1 and stated the physician order should have an indication for use. The CNO further stated if the physician's order was not clear, it should be clarified all the way back to the pharmacy.

According to the facility policy, titled "Medication-Orders", Number: MM.414, dated "1/2013", "...In those areas where Computerized Physician Order Entry (CPOE) is active... Those orders will be reviewed by a pharmacist and the order will be sent to the ordering physician's queue to be signed. Pharmacist shall check for: Completeness of the drug order ...Correctness of the drug order...Appropriate dosage, route, frequency and indications..."

A review of the facility's policy and procedure, titled, "Medication Administration, Preparation, Control, Distribution and Documentation, Number MM.411," dated "8/2012", indicated, "...A medication order is generated by the physician, including: The name of the medication, exact dose, frequency, route of administration, and directions for use...The prescriber will be contacted if any medication order is incomplete, illegible (unable to be read by two licensed health care professions) or unclear ...The Pharmacy Department is responsible for reviewing the order for appropriateness, processing the order, preparing the medication, and dispensing the medication in an accurate and timely manner ...Prior to administration of all medication, the nurse will: Any unresolved issues should be discussed with the patient's physician, prescriber or other relevant staff before the medication is administered. Prior to administration of high risk medication, the amount ordered and amount prepared must be checked by (2) Licensed Nurses..."

3. During an interview on August 26, 2014, at 12:15 p.m., the Director of Pharmacy stated the pharmacy department does not review medication override report. The pharmacy forwards the medication override report to the patient care director of each unit for review. However, he did not have any way of knowing if the patient care directors review the medication override reports.

At 12:35 p.m., during an interview the Director of Quality and Risk Management stated she was sure there is nothing in writing as to what the patient care director does with the medication override report.
According to the facility policy, titled "Medication-Dispensing Machine", Number: MM.416, dated "9/2012", indicated, "Override medication should only be used if the patient will experience harm if there is a delay in therapy. Pharmacists will review orders for items removed through override at the earliest opportunity."

4. On August 26, 2014, at 12:15 p.m., during a discussion of the medication process, the Director of Pharmacy stated the pharmacy department does not review or reconcile medication removal report from the automated dispensing cabinet (ADC) located in the emergency department.

On August 27, 2014, at 4:35 p.m., the Director of Pharmacy stated the Emergency Department is Computerized Physician Order Entry (CPOE) and the medication orders are auto verified by the ordering physician. There is no retrospective review of ADC medication usage by the pharmacist in the Emergency Department (ED).

On August 27, 2014, at 4:55 p.m., during a discussion of ED admission rate, the Emergency Department Clinical Manager in the presence of the Director of Pharmacy presented a report that indicated approximately 21 percent (%) of the ED patients were admitted to the hospital in the previous eight months.


The Emergency Department Clinical Manager further stated the ADC in the ED was not profiled and a nurse could pull more medication than one dose if she does not document the medication removal in the computer.


During a concurrent interview the Director of Pharmacy stated he would not get a report if a medication from the ED was taken out of the ADC without a physician order. The pharmacy did not review ED medication usage. The Director of Pharmacy acknowledged that ED orders were not reconciled or retrospectively reviewed by pharmacists for appropriateness, and the pharmacy department missed opportunities to identify medication errors, and potential diversion, or drug loss.


The DOP further stated there was no policy and procedure to reconcile non-profiled ADCs.

According to the facility policy, titled "Medication-Orders", Number: MM.414, dated "1/2013", "...In those areas where Computerized Physician Order Entry (CPOE) is active ...Those orders will be reviewed by a pharmacist and the order will be sent to the ordering physician's queue to be signed. Pharmacist shall check for: Completeness of the drug order ...Correctness of the drug order ...Appropriate dosage, route, frequency and indications..."

According to a nationally recognized professional association, American Society of Health-System Pharmacists (ASHP, which published numerous authoritative guidelines in pharmacy practice referred by the industry as the standard of practices), the guideline titled "Minimum Standard for Pharmacies in Hospitals", dated 4/13/2012, indicated "All medication orders shall be prospectively reviewed by a pharmacist and assessed in relation to pertinent patient and clinical information before the first dose is administered or made available in an automated dispensing device, except in emergent situations... There shall be a procedure for retrospective review of these orders." The guideline further suggested "use of [ADC] shall be structured so as to not hinder the pharmacist's review of (and opportunity to intervene in) medication orders before the administration of first doses...