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

1. Adequately monitor the safety and effectiveness of the medication administration process by failing to measure and analyze relevant data that was available to them through their information technology system (A273, A405); and,

2. Develop and implement effective procedures to control the use of all controlled substances(CSs), readily identify and resolve CS discrepancies, and minimize the potential time of diversion of CS (A494).

The cumulative effect of these systemic problems resulted in failure to ensure an effective Quality Assessment and Performance Improvement program focused on reducing errors and improving patient safety.

Based on interview and record review, the facility failed to adequately monitor the safety and effectiveness of the medication administration process by failing to measure and analyze relevant data that was available to them through their information technology system. This failed practice resulted in multiple medication errors not identified by the facility, and the potential for patient harm or death.

Findings:

The facility "Performance Improvement and Patient Safety Plan" revised March 2016, was reviewed on October 15, 2016. The plan indicated it was designed to improve performance and patient safety, ultimately reducing risks to patients. The goals of the plan included:

1. Reducing medical/health system errors and hazardous conditions by creating an environment in which actual or potential risks to patient safety could be managed; and,

2. Ensuring the use of continuous process improvement throughout the organization by focusing on interdisciplinary collaboration and cooperation of all services.

The plan indicated the facility leaders were responsible for the establishment of clear expectations of safety, including compliance with the 2016 National Patient Safety Goals (NPSG).

The 2016 NPSG #3 was to improve the safety of using medications.

During the Quality Assessment Performance Improvement (QAPI) interview on November 15, 2016, at 10 a.m., the Director of Pharmacy (DOP) stated late administration of medications and missed doses were not accurately reflected in the quarterly medication error reports, because only the errors reported by staff, using the incident reporting system, were included. He stated the pharmacy did not review medications returned to the pharmacy to determine why they were not administered. He stated he did not use the information entered into the computers by the patient care staff, as he did not have access to the system used for documentation of medication administration, and he was unaware of the type of data he could retrieve from the system.

The DOP stated the pharmacy did not generate reports, look for trends, or identify the reasons for late medication administrations or missed doses to determine what corrective actions could be taken to prevent further errors.

During an interview with the Vice President of Quality (VPQ) on November 16, 2016, at 7 a.m., the "Medication Event Reports," for the first three quarters of 2016 were reviewed. The reports indicated the following:

1. For the first quarter (Jan, Feb, March) of 2016:

a. Medications administered at the wrong time: 9
b. Missed doses of medication: 10

2. For the second quarter (April, May, June) of 2016:

a. Medications administered at the wrong time: 4
b. Missed doses of medication: 5

3. For the third quarter (July, August, September) of 2016:

a. Medications administered at the wrong time: 4
b. Missed doses of medication: 6

The VPQ stated all of the events reviewed were based on incident reports completed by facility staff.

A report titled, "Admin Variance October 2016," generated at the request of the survey team, and provided by the facility, was received on November 15, 2016. The report identified patients who received late medications with the reason, "medication not available," in October 2016.

A second report titled, "Admin Variance October 2016," generated at the request of the survey team, and provided by the facility, was received on November 16, 2016. The report identified patients who missed medication doses that were supposed to be given to them in October 2016.

A review of the two reports indicated for the month of October 2016 (31 days):

a. Medications administered at the wrong time: 616
(vs an average of 6 per quarter (90 days) that were identified in the facility medication event reports); and,

b. Missed doses of medication: 634
(vs an average of 7 per quarter (90 days) that were identified in the facility medication event reports)

During a Quality Assessment and Performance Improvement (QAPI) interview with the Director of Pharmacy (DOP), the Chief Nursing Officer (CNO), the Assistant Chief Nursing Officer (ACNO), and the Vice President of Quality (VPQ) on November 16, 2016, at 10 a.m., the leaders stated they were aware the nurses in the Intensive Care Unit (ICU) were, "frustrated," with the number of medications that were not available. The leaders stated they did not know the unavailability of medications, missed medications, and omitted doses, were occurring throughout the facility.

According to American Society of Health-System Pharmacists (ASHP), a nationally recognized pharmacist organization, in its publication, "ASHP Guidelines on Preventing Medication Errors in Hospitals,"

"...Omission error: The failure to administer an ordered dose to a patient before the next scheduled dose, if any...

Wrong time error: Administration of medication outside a predefined time interval from its scheduled...

Pharmacy staff should review medications that are returned to the department. Such review processes may reveal system breakdowns or problems that resulted in medication errors (e.g., omitted doses and unauthorized drugs)..."

According to ASHP publication, "ASHP Guidelines: Minimum Standard for Pharmacies in Hospitals,"

"Reviewing Patient Responses to Medication Therapy. Medication therapy monitoring shall be conducted by pharmacists. Medication therapy monitoring includes a proactive assessment of patient problems and an assessment of...Therapeutic duplication or omissions in the patient's medication regimen..."

The pharmacy and nursing leaders were not aware of the ongoing, widespread problem of late medications and missed medication doses (medication errors) being made throughout the facility.

Based on observation, interview, and record review, the facility failed to ensure safe administration of medications in accordance with physician's orders, accepted standards of practice, and facility policies and procedures, when:

1. Medications were not available for administration at the time they were due to be given (A405);

2. Medications were withheld without physician's orders or absolute contraindications (a condition or factor that serves as a reason to withhold the medication due to harm it would cause) (A405); and,

3. Insulin was administered in an unsafe manner (A405).

The cumulative effect of these systemic problems resulted in failure to ensure nursing services were delivered in a safe and effective manner.

Based on observation, interview, and record review, the facility failed to ensure, for 19 of 51 sampled patients (Patients 14, 15, 16, 17, 21, 23, 33, 34, 35, 38, 44, 46, 47, 48, 49, 50, 51, 52, and 53), safe administration of medications in accordance with physician's orders, accepted standards of practice, and facility policies and procedures, when medications were not available for administration at the time they were due to be given, medications were withheld without physician's orders or absolute contraindications (a condition or factor that serves as a reason to withhold the medication due to harm it would cause), and insulin was administered in an unsafe manner. These failed practices resulted in the potential for ineffective treatment, increased length of hospital stay, harm, and death.

Findings:

During an interview with the Director of Pharmacy (DOP) and the Lead Pharmacy Technician (LPT) on November 15, 2016, at 1:30 p.m., the LPT stated when medications were not available for nurses to administer at the time they were due, the nurses would complete a missing medication management (MMM) request, in the computer, to alert the pharmacy they did not have the medication for the patient.

The LPT stated the reasons for the medications not being available included:

A. Nurses placing medications in the wrong location when they were sent to the floor using the tube system;

B. Nurses not using the global find application in the automated dispensing cabinet (ADC - used to store and dispense medications as they are needed) and going to nearby ADCs to get the medications; and,

C. Nurses not checking the tube systems located outside of their units to see if the medications had been sent.

During an interview with Medical Surgical Registered Nurse (MSRN) 1 on November 16, 2016, at 11 a.m., the RN stated if a medication was not available to administer to her patient when it was due to be given, she would complete an MMM in the computer to alert the pharmacy to send the medication to the floor. According to MSRN 1, if a medication was given later than an hour after it was due, the computer would prompt the nurse to explain why it was, "late." She stated if the medication was not there to give, she would select the, "medication not available," option. MSRN 1 stated in her experience she completed an MMM, because a medication was not available to administer at the time it was due, "at least once," every shift, and sometimes more than once in a shift.

During an interview with MSRN 2 on November 16, 2016, at 11:10 a.m., MSRN 2 stated if a medication was not available to administer to a patient at the time it was due to be given, she would complete an MMM in the computer and wait to receive the medication from the pharmacy. MSRN 2 stated if the medication did not get sent by the pharmacy before it was late (given more than one hour after it was due), the computer would prompt her to indicate the reason it was given late. The RN stated she would select the, "medication not available," option in that circumstance. MSRN 2 stated she did not complete an incident report each time a medication was given late. She stated she did not report to the physician each time a medication was given late.

A report titled, "Admin Variance October 2016," generated at the request of the survey team, and provided by the facility, was received on November 15, 2016. The report identified patients who received late medications with the reason, "medication not available," in October 2016.

A second report titled, "Admin Variance October 2016," generated at the request of the survey team, and provided by the facility, was received on November 16, 2016. The report identified patients who missed medication doses that were supposed to be given to them in October 2016.

Records were reviewed during the facility tour.

A random sample of records was reviewed from the, "Admin Variance October 2016," reports.

The records revealed the following:

1. The record for Patient 16 included the following medication orders:

a. September 26, 2016: Valproic Acid (to treat seizure disorders) 500 mg (milligrams), two capsules to be given once daily by mouth. According to the eMAR (electronic medication administration record):

- On September 30, 2016, the 9 a.m. dose was administered at 12:11 a.m. (three hours and 11 minutes after it was due). The reason for the late administration was not indicated by the nurse. There was no evidence the physician was notified of the late medication administration;

- On October 1, 2016, the 9 a.m. dose was administered at 12:55 p.m. (three hours and 55 minutes after it was due). The reason for the late administration was documented as medication not available. There was no evidence the physician was notified of the late medication administration; and,

- On October 3, 2016, the 9 a.m. dose was administered at 3:44 p.m. (six hours and 44 minutes after it was due). The reason for the late administration was documented as medication not available. There was no evidence the physician was notified of the late medication administration.

b. September 26, 2016: Entecavir (to treat liver infection caused by hepatitis B) 1 mg to be given once daily by mouth. According to the eMAR:

- On September 26, 2016, the 9 a.m. dose was administered at 2:48 p.m. (five hours and 48 minutes after it was due). The reason for the late administration was not indicated by the nurse. There was no evidence the physician was notified of the late medication administration;

- On September 27, 2016, the 9 a.m. dose was administered at 6:45 p.m. (nine hours and 45 minutes after it was due). The reason for the late administration was documented as medication not available. There was no evidence the physician was notified of the late medication administration;

- On September 30, 2016, the 9 a.m. dose was administered at 12:10 p.m. (three hours and 10 minutes after it was due). The reason for the late administration was documented as medication not available. There was no evidence the physician was notified of the late medication administration;

- On October 1, 2016, the 9 a.m. dose was administered at 12:56 p.m. (three hours and 56 minutes after it was due). The reason for the late administration was documented as medication not available. There was no evidence the physician was notified of the late medication administration;

- On October 3, 2016, the 9 a.m. dose was administered at 3:45 p.m. (six hours and 45 minutes after it was due). The reason for the late administration was documented as medication not available. There was no evidence the physician was notified of the late medication administration;

- On October 8, 2016, the 9 a.m. dose was administered at 12:54 a.m. (three hours and 54 minutes after it was due). The reason for the late administration was not indicated by the nurse. There was no evidence the physician was notified of the late medication administration;

- On October 10, 2016, the 9 a.m. dose was administered at 11:27 a.m. (two hours and 27 minutes after it was due). The nurse indicated the medication had been requested from the pharmacy. There was no evidence the physician was notified of the late medication administration;

- On October 11, 2016, the 9 a.m. dose was administered at 11:57 a.m. (two hours and 57 minutes after it was due). The reason for the late administration was not indicated by the nurse. There was no evidence the physician was notified of the late medication administration;

- On October 12, 2016, the 9 a.m. dose was administered at 12:07 p.m. (three hours and seven minutes after it was due). The nurse indicated the medication was sent up in the tube system by the pharmacy late. There was no evidence the physician was notified of the late medication administration;

- On October 13, 2016, the 9 a.m. dose was administered at 2:43 p.m. (five hours and 43 minutes after it was due). The nurse indicated, "Pharmacy just sent it." There was no evidence the physician was notified of the late medication administration;

- On October 15, 2016, the 9 a.m. dose was administered at 11:22 a.m. (two hours and 22 minutes after it was due). The reason for the late administration was not indicated by the nurse. There was no evidence the physician was notified of the late medication administration;

- On October 16, 2016, the 9 a.m. dose was administered at 5:14 p.m. (eight hours and 14 minutes after it was due). The nurse indicated, "hospital is out, no shipment for two days." There was no evidence the physician was notified of the late medication administration;

c. October 8, 2016: Mirtazapine (an antidepressant) 15 mg to be given by mouth at bedtime. According to the eMAR:

- On October 8, 2016, the 9 p.m. dose was administered at 10:57 p.m. (one hour and fifty seven minutes after it was due). The reason for the late administration was documented as medication not available. There was no evidence the physician was notified of the late medication administration.

- On October 9, 2016, the 9 p.m. dose was administered at 10:59 p.m. (one hour and fifty nine minutes after it was due). The reason for the late administration was documented as medication not available. There was no evidence the physician was notified of the late medication administration.

Concurrent interview with the Pharmacy Clinical Manger was conducted. She stated this was a scheduled medication and the medication should have been available.

2. The record for Patient 38 included the following medication orders:

a. February 25, 2016: Cefepime (an antibiotic) one gram to be given IV (intravenously - into the vein) every eight hours. According to the eMAR:

- On February 28, 2016, the 8 a.m. dose was administered at 10:16 a.m. (two hours and 16 minutes after it was due). The reason for the late administration was not indicated by the nurse. There was no evidence the physician was notified of the late medication administration;

- On February 28, 2016, the 4 p.m. dose was administered at 5:53 p.m. (one hour and 53 minutes after it was due). The reason for the late administration was not indicated by the nurse. There was no evidence the physician was notified of the late medication administration; and,

- On February 29, 2016, the 8 a.m. dose was not administered to the patient. The reason for the missed dose was documented as medication not available. There was no indication the physician was notified of the missed dose of medication.

b. On February 27, 2016: Metronidazole (an antibiotic) 500 mg IV to be given every eight hours. According to the eMAR:

- On February 28, 2016, the 6 a.m. dose was administered at 7:12 a.m. (one hour and 12 minutes after it was due). The reason for the late administration was not indicated by the nurse. There was no evidence the physician was notified of the late medication administration;

- On February 29, 2016, the 6 a.m. dose was not administered to the patient. The reason for the missed dose was documented as medication not available. There was no indication the physician was notified of the missed dose of medication; and,

- On March 1, 2016, the 10 p.m. dose was administered on March 2, 2016, at 2:50 a.m. (four hours and 59 minutes after it was due). The reason for the late administration was not indicated by the nurse. There was no evidence the physician was notified of the late medication administration.

c. February 28, 2016: Albumin (a human protein used to maintain the patient's blood volume and healing abilities) 500 ml (milliliters) to be given IV every eight hours. According to the eMAR:

- On February 29, 2016, the 2 p.m. dose was administered at 5:16 p.m. (two hours and 16 minutes after it was due). The reason for the late administration was not indicated by the nurse. There was no evidence the physician was notified of the late medication administration.

3. The record for Patient 46 included an order dated October 6, 2016, for Fidaxomicin (an antibiotic) 200 mg to be given twice a day by mouth. According to the eMAR:

- On October 6, 2016, the 9 p.m. dose was not administered. The reason for the missed dose was documented by the nurse as medication not available. There was no evidence the physician was notified of the late medication administration;

- On October 7, 2016, the 9 p.m. dose was administered at 10:52 p.m. (one hour and 52 minutes after it was due). The reason for the late administration was documented by the nurse as medication not available. There was no evidence the physician was notified of the late medication administration; and,

- On October 8, 2016, the 9 a.m. dose was administered at 6:47 p.m. (nine hours and 47 minutes after it was due, and two hours and 13 minutes before the next dose - which was given on time - was due). The reason for the late administration was documented by the nurse as medication not available. There was no evidence the physician was notified of the late medication administration.

4. The record for Patient 47 included an order dated September 26, 2016, for Albumin 250 ml, two bottles, to be given IV 1 hour apart. According to the eMAR:

- On October 26, 2016, the first bottle, due at 6:45 p.m., was administered at 11:59 p.m. (five hours and 14 minutes after it was due). The reason for the late administration was documented by the nurse as medication not available. There was no evidence the physician was notified of the late medication administration.

5. The record for Patient 48 included an order dated October 4, 2016, for Clindamycin (an antibiotic) 450 mg to be given every eight hours by mouth. According to the eMAR:

- On October 6, 2016, the morning dose (due at 9:51 a.m.) was administered at 1:04 p.m. (three hours and 13 minutes after it was due). The reason for the late administration was documented by the nurse as medication not available. There was no evidence the physician was notified of the late medication administration.

6. The record for Patient 49 included an order dated October 24, 2016, for Clindamycin 600 mg to be given IV every eight hours. According to the eMAR:

- On October 24, 2016, the dose due at 7:30 p.m. was administered on October 25, 2016 (the next morning) at 4:46 a.m. (nine hours and 16 minutes after it was due). The reason for the late administration was documented by the nurse as medication not available. There was no evidence the physician was notified of the late medication administration.

7. The record for Patient 50 included an order dated October 20, 2016, for 20 mEq (milliequivalents) of KCL (a potassium supplement) to be added to the IV fluids. According to the eMAR:

- On October 20, 2016, the first dose, due at 12:43 p.m., was started at 6:23 p.m. (five hours and 40 minutes after it was due). The reason for the late administration was documented by the nurse as medication not available. There was no evidence the physician was notified of the late medication administration.

8. The record for Patient 51 included an order dated October 22, 2016, for Nifedipine (to treat high blood pressure) 90 mg to be given by mouth daily. According to the eMAR:

- On October 23, 2016, the 9 a.m. dose was administered at 1:53 p.m. (four hours and 53 minutes after it was due). The reason for the late administration was documented by the nurse as medication not available. There was no evidence the physician was notified of the late medication administration.

9. The record for Patient 52 included an order dated October 12, 2016, for Actos (for treatment of type 2 diabetes) 30 mg to be given by mouth daily. According to the eMAR:

- On October 13, 2016, the 9 a.m. dose was administered at 12:13 p.m. (three hours and 13 minutes after it was due). The reason for the late administration was documented by the nurse as medication not available. There was no evidence the physician was notified of the late medication administration; and,

- On October 14, 2016, the 9 a.m. dose was administered at 11:07 a.m. (two hours and seven minutes after it was due). The reason for the late administration was documented by the nurse as medication not available. There was no evidence the physician was notified of the late medication administration.

10. The record for Patient 53 included an order dated October 19, 2016, for a GI cocktail (a mixture of three different medications used to treat abdominal pain) to be given by mouth every 12 hours. According to the eMAR:

- On October 19, 2016, the 10:30 p.m. dose was administered on October 20, 2016, at 1:54 a.m. (three hours and 24 minutes after it was due). The reason for the late administration was documented by the nurse as medication not available. There was no evidence the physician was notified of the late medication administration;

- On October 26, 2016, the 10:30 a.m. dose was administered at 12:56 p.m. (two hours and 26 minutes after it was due). The reason for the late administration was not documented by the nurse. There was no evidence the physician was notified of the late medication administration;

- On October 28, 2016, the 10:30 a.m. dose was not administered. The reason for the missed dose was documented by the nurse as medication not available. There was no evidence the physician was notified of the missed medication dose; and,

- On November 1, 2016, the 10:30 a.m. dose was administered at 12:48 p.m. (two hours and 18 minutes after it was due). The reason for the late administration was documented by the nurse as, "Barcode won't scan."

11. The record for Patient 44, a dialysis patient, included the following orders:

a. Ceftriaxone (an antibiotic) two grams to be given IV every day. The scheduled time for administration was 5 p.m. The order did not include instructions to hold the medication for dialysis. According to the eMAR:

- On November 14, 2016, the 5 p.m. dose was administered at 7:59 p.m. (two hours and 49 minutes after it was due). The reason for the late administration was documented by the nurse as, "Pt (patient) was on dialysis." There was no evidence the physician was notified of the late medication administration.

During an interview with MS RN 2 on November 16, 2016, at 11:10 a.m. the nurse stated if a patient had medications due during a dialysis treatment, she would check with the dialysis nurse to see if they would be, "dialyzed out (removed from the blood stream during dialysis, making them ineffective)." MS RN 2 stated if the medication would not be dialyzed out, she would give it on time during the dialysis treatment.

During a tour of the Medical Surgical unit on November 16, 2016, at 12:10 p.m., Patient 44 was observed receiving a dialysis treatment by Dialysis Nurse (DN) 1. During a concurrent interview, the DN stated Patient 44 had her dialysis treatment on November 14, 2016, from 3:40 p.m. to 7:10 p.m., and he was the nurse who performed the dialysis. The DN stated the nurse did not check with him to see whether Ceftriaxone was dialyzed out. He stated the medication was not affected by dialysis, and could have been administered at the time it was due.

According to the National Center for Biotechnology Information (NCBI), ceftriaxone is not affected by hemodialysis; and,

b. Micafungin (to treat a fungal infection) 100 mg to be given IV every day. The scheduled time for administration was 7:24 p.m. According to the eMAR:

- On November 15, 2016, the medication was administered at 20 minutes after midnight (four hours and 56 minutes after it was due). The reason for the late administration was documented by the nurse as, "Was awaiting delivery from the pharmacy." There was no evidence the physician was notified of the late medication administration.



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12. The record for Patient 14 included the following medication orders:

a. October 20, 2016, Potassium Chloride (a potassium supplement) 40 mEq to be given at 1 p.m. According to the eMAR:

- On October 20, 2016, the 1 p.m. dose was administered at 3:01 p.m. (two hours and one minute after it was due). The reason for the late administration was documented as medication not available. There was no evidence the physician was notified of the late medication administration.

b. October 21, 2016, Potassium Chloride 40 mEq to be given at 9 a.m. According to the eMAR:

- On October 21, 2016, the 9 a.m. dose was administered at 3:56 p.m. (six hours and fifty six minutes after it was due). The reason for the late administration was documented as medication not available. There was no evidence the physician was notified of the late medication administration.

13. The record for Patient 15 included the following medication orders:

a. October 14, 2016, Potassium Chloride 40 mEq to be given IV at 9:30 a.m. According to the eMAR:

- On October 14, 2016, the 9:30 a.m. dose was administered at 12:46 p.m. ( three hours and sixteen minutes after it was due). The reason for the late administration was documented as medication not available. There was no evidence the physician was notified of the late medication administration.

b. October 16, 2016, Potassium Chloride 40 mEq to be given IV at 10:42 a.m. According to the eMAR:

- On October 16, 2016, the 10:42 dose was administered at 12:33 p.m. (one hour and fifty one minutes after it was due). The reason for the late administration was documented as medication not available. There was no evidence the physician was notified of the late medication administration.

14. The record for Patient 17 included the following medication orders:

a. October 2, 2016, Nafcillin (an antibiotic) 2 grams to be given IV every four hours. According to the eMAR:

- On October 2, 2016, the 5 p.m. dose was administered at 6:28 p.m. (one hour and twenty eight minutes after it was due). The reason for the late administration was documented as medication not available. There was no evidence the physician was notified of the late medication administration;

- On October 6, 2016, the 5 a.m. dose was administered at 6:03 a.m. (one hour and three minutes after it was due). The reason for the late administration was documented as medication not available. There was no evidence the physician was notified of the late medication administration; and,

- On October 10, 2016, the 9 a.m. dose was administered at 10:29 a.m. (one hour and twenty nine minutes after it was due). The reason for the late administration was documented as medication not available. There was no evidence the physician was notified of the late medication administration.

15. The record of Patient 23 included the following medication orders:

a. November 9, 2016: Meropenem (an antibiotic) 500 milligrams to be given IV every 12 hours. According to the eMAR:

- On November 9, 2016, the 9 p.m. dose was administered at 11:28 p.m. (two hours and twenty eight minutes after it was due). The reason for the late administration was not indicated by the nurse. There was no evidence the physician was notified of the late medication administration.

b. November 9, 2016: Nystatin/Triamcinolone (treatment for skin infection) 15 grams to be applied twice a day. According to the eMAR:

- On November 9, 2016, the 9 p.m. dose was not administered to the patient. The reason for the missed dose was documented as medication not available. There was no indication the physician was notified of the missed dose of medication.

c. November 11, 2016: Tigecycline (an antibiotic) 50 milligrams to be given IV every 12 hours. According to the eMAR:

- On November 11, 2016, the 5:08 p.m. dose was administered at 8:58 p.m. (three hours and fifty minutes after it was due). The reason for the late administration was documented as medication not available. There was no evidence the physician was notified of the late medication administration.

16. The record for Patient 33 included a order dated October 13, 2016, for Ranolazine ER (heart medication - extended release) 500 milligrams by mouth twice a day. According to the eMAR:

- On October 14, 2016, the 9 a.m. dose was administered at 10:53 a.m. (one hour and fifty three minutes after it was due). The reason for the late administration was documented as medication not available. There was no evidence the physician was notified of the late medication administration;

- On October 15, 2016, the 9 a.m. dose was administered at 11:29 a.m. (two hours and twenty nine minutes after it was due). The reason for the late administration was documented as medication not available. There was no evidence the physician was notified of the late medication administration, and;

- On October 17, 2016, the 9 a.m. dose was administered at 11:59 a.m. (two hours and fifty nine minutes after it was due). The reason for the late administration was documented as medication not available. There was no evidence the physician was notified of the late medication administration.

17. The record for Patient 34 included an order dated October 12, 2016, for Ceftriaxone (an antibiotic) two grams to be given IV (intravenously - into the vein) daily. According to the eMAR:

- On October 13, 2016, the 9 a.m. dose was administered at 3:04 p.m. (six hours and four minutes after it was due). The reason for the late administration was documented as medication not available. There was no evidence the physician was notified of the late medication administration;

- On October 14, 2016, the 9 a.m. dose was administered at 1:59 p.m. (four hours and fifty nine minutes after it was due). The reason for the late administration was documented as medication not available. There was no evidence the physician was notified of the late medication administration;

- On October 15, 2016, the 9 a.m. dose was administered at 10:13 a.m. (one hour and thirteen minutes after it was due). The reason for the late administration was documented as medication not available. There was no evidence the physician was notified of the late medication administration, and;

- On October 17, 2016, the 9 a.m. dose was not administered to the patient. The reason for the missed dose was documented as medication not available "...called pharmacy twice still no atbx (antibiotic) sent by the end of shift." There was no indication the physician was notified of the missed dose of medication.

18. The record for Patient 35 included an order dated October 2, 2016, for Ceftriaxone (an antibiotic) two grams to be given IV daily. According to the eMAR:

- On October 3, 2016, the 9 a.m. dose was administered at 11:35 a.m. (two hours and thirty five minutes after it was due). The reason for the late administration was documented as medication not available. There was no evidence the physician was notified of the late medication administration; and,

- On October 4, 2016, the 9 a.m. dose was administered at 11:52 a.m. (two hours and fifty two minutes after it was due). The reason for the late administration was documented as medication not available. There was no evidence the physician was notified of the late medication administration.

19. The record for Patient 21 included the following medication orders:

a. November 5, 2016, Regular Insulin (short acting insulin) 100 unit/milliliter to be given subcutaneous (under the skin) every four hours as follows:
for blood sugar 121-150 = 4 units
for blood sugar 151-200 = 6 units
for blood sugar 201-250 = 8 units
for blood sugar 251-300 = 10 units
for blood sugar 301-350 = 12 units
for blood sugar 351-450 = 14 units
for blood sugar greater than or equal to 400 = call MD (doctor). According to the eMAR:

- On November 5, 2016, the 5:56 p.m. dose was given at 7:55 p.m. (two hours after it was due). Patient 21 was given 8 units of insulin, for a blood sugar level of 201 obtained at 7:47 p.m. The reason for the late administration was documented as "SHOULD HAVE BEEN GIVEN BY DAY SHIFT RN." There was no evidence the physician was notified of the late medication administration, and;

- On November 5, 2016, the 9:56 p.m. dose was given at 10:55 p.m. (one hour after it was due and only three hours after the last dose). Patient 21 was given 4 units of insulin, for a blood sugar level of 150 obtained at 10:52 p.m. The reason for the late administration was not indicated by the nurse. There was no evidence the physician was notified of the late medication administration.

The multidisciplinary notes dated November 11, 2016, at 1:11 a.m. indicated "PT (patient) FINGER GLUCOSE 62 mg/dl (too low - hypoglycemia - blood glucose below 70 milligram per deciliter)..." The note further indicated Patient 21 had to be given 12.5 grams of dextrose 50 % (indicated in the treatment of insulin induced hypoglycemia to restore the blood glucose level).

The 2011 Institute of Safe Medication Practices (ISMP) Acute Care Guidelines for Timely Administration of Scheduled Medications indicated time-critical scheduled medications include, "...Certain medications that require administration within a specified period of time...for example, rapid-, short-, or ultra-short-acting insulins..." The guideline further indicated, "Time-critical scheduled medications are those where early or delayed administration of maintenance doses of greater than 30 minutes before or after the scheduled dose may cause harm or result in substantial sub-optimal therapy or pharmacological effect."

Failure to adhere to the physician's order and administer insulin, a time critical medication, within 30 minutes of the scheduled dose resulted in insulin doses given three hours apart instead of four as ordered, and the blood sugar falling to an avoidable dangerously low level.

b. November 7, 2016, Pregabalin (for neuropathic pain) 50 milligram cap by mouth three times a day. According to the eMAR:

- On November 8, 2016, the 9:00 a.m. dose was not administered to the patient. The reason for the missed dose was documented as "PT VERY DROWSY THIS AM." There was no indication the physician was notified of the missed dose of medication;

- On November 8, 2016, the 9:00 p.m. dose was not administered to the patient. The reason for the missed dose was documented as "PT VERY DROWSY AND SLEEPING." There was no indication the physician was notified of the missed dose of medication; and,

- On November 9, 2016, the 9:00 a.m. dose was not administered to the patient. The reason for the missed dose was documented as "Not Given - Not Indicated." There was no indication the physician was notified of the missed dose of medication.

On November 16, 2016, at 4:00 p.m., Patient 21's record was reviewed with RN 1. There was no documented evidence of a physician's order to hold Pregabalin doses for Patient 21.

On November 17, 2016, at 10:30 a.m., the Pharmacy Clinical Director stated scheduled medication administration could only be held if there was a physician's order indicating parameters for holding medication doses.

The facility policy titled, "Medication Administration," was reviewed on November 16, 2016. According to the policy:

a. Medications would be administered in compliance with hospital guidelines;

b. Medications should be administered, "exactly as ordered by the physician;" and,

c. Medications must be administered within 60 minutes before or after the scheduled administration time.

The facility policy titled, "Medication Errors," was reviewed on November 16, 2016. According to the policy:

a. A medication error was defined as any preventable event that may cause or lead to inappropriate medication use or patient harm;

b. Medication occurrences (errors) included medications given at the wrong time (one hour or more before or after the time it was due), and omitted doses (medication that was not administered as ordered);

c. Such events (errors) may be related to systems and procedures, including medication administration;

d. It was the responsibility of any licensed professional administering medications to report any...medication errors... promptly and accurately...and to contact the physician.

Further review of the, "Admin Variance October 2016," reports on November 16, 2016, indicated for the month of October 2016 (31 days):

- Medications were given more than one hour past the time they were due a total of 616 times; and,

- Medication doses were withheld by the nursing staff a total of 634 times.

During a Quality Assessment and Performance Improvement (QAPI) interview with the Director of Pharmacy (DOP), the Chief Nursing Officer (CNO), the Assisstant Chief Nursing Officer (ACNO), and the Vice President of Quality (VPQ) on November 16, 2016, at 10 a.m., the leaders stated they were aware the nurses in the Intensive Care Unit (ICU) were, "frustrated," with the number of medications that were not available. The leaders stated they did not know the unavailability of medications, missed medications, and omitted

Based on observation, interview, and record review, the facility failed to provide pharmaceutical services that met the needs of the patients by failing to ensure:

1. Effective procedures were developed and implemented to:

a. Control the use of all controlled substances(CSs);

b. Readily identify and resolve CS discrepancies; and,

c. Minimize the potential time of diversion of CS (A494);

2. Medications were available to the nursing staff for timely administration to patients (A500);

3. Emergency medication supplies in the adult crash carts were stocked in accordance with the current facility policy and procedure (See A500);

4. No medications were left at the patient's bedside without a physician's order in accordance with the facility policy and procedure (A500); and,

5. Cleaning of the Pharmacy IV (intravenous) compounding area was performed in accordance with the facility policy and procedure, and consistent with the federal United States Pharmacopeia (USP) <797> standards (A501).

The cumulative effect of these systemic problems resulted in the hospital's failure to ensure the provision of pharmaceutical services in a safe and effective manner that met the needs of their patients.

Based on interview and record review, the facility failed to ensure effective procedures were developed and implemented to control the use of all controlled substances(CSs), readily identify and resolve CS discrepancies, and minimize the potential time of diversion of CS. These failed practices resulted in the potential for diversion of CS away from patients, ineffective treatment of patients, and harm or death in patients and healthcare providers.

Findings:

During an interview with Pharmacy Technician (PT) 1 and the Director of Pharmacy (DOP) on November 16, 2016, at 3:15 p.m., PT 1 stated anesthesia records for surgical cases were sent to the Pharmacy on a daily basis.

PT 1 stated she reviewed 10% of the records every quarter for accurate documentation of CS used by the anesthesiologists, and audited the records to ensure all CSs accessed from the Pyxis machine (an automated dispensing cabinet for medications) were accurately accounted for.

PT 1 stated it took her several days to review 10% of three months of anesthesia records each quarter.

PT 1 stated quarterly reports would identify anesthesiologists with CS discrepancies below the compliance rate of 90%. PT 1 stated CS discrepancies were identified, but they were not followed through by the pharmacy to resolve them.

In a concurrent interview, the DOP stated anesthesiologists whose compliance rate failed to reach the minimum of 90% were identified and reported to the Chief of Anesthesiology for follow-up. The DOP stated he did not know if the discrepancies had been resolved. He stated he did not follow up to determine the action taken to resolve the discrepancy.

The facility policy and procedure titled, "Medication Diversion Prevention Policy" last revised, September 2015, read, in part:

"Anesthesia and Operational Medications (Operating Room and other Anesthetizing Areas)...

All discrepancies will be resolved by the provider by the end of the provider's shift...

All discrepancies must be tracked, using the QI/PI (Quality Improvement/Performance Improvement) process, by provider, for trending and identification (as defined by the Medical Executive Committee), and reported to the Multidisciplinary Medication Diversion Team..."

The DOP was not tracking or trending discrepancies to identify possible patterns and prevent diversion of CS.

Based on observation, interview, and record review, the pharmacy failed to ensure effective control and distribution of medications by failing to ensure:

1. Medications were available to the nursing staff for timely administration to patients;

2. Emergency medication supplies in the adult crash carts were stocked in accordance with the current facility policy and procedure; and,

3. No medications were left at the patient's bedside without a physician's order in accordance with the facility policy and procedure.

These failed practices resulted in multiple medication errors related to late or missed doses, and the potential for delay in emergency treatment, patient harm, or death.

Findings:

1. During an interview with the Director of Pharmacy (DOP) and the Lead Pharmacy Technician (LPT) on November 15, 2016, at 1:30 p.m., the LPT stated when medications were not available for nurses to administer at the time they were due, the nurses would complete a missing medication management (MMM) request, in the computer, to alert the pharmacy they did not have the medication for the patient.

During an interview with Medical Surgical Registered Nurse (MSRN) 1 on November 16, 2016, at 11 a.m., the RN stated if a medication was not available to administer to her patient when it was due to be given, she would complete an MMM in the computer to alert the pharmacy to send the medication to the floor. According to MSRN 1, if a medication was given later than an hour after it was due, the computer would prompt the nurse to explain why it was, "late." She stated if the medication was not there to give, she would select the, "medication not available," option. MSRN 1 stated in her experience she completed an MMM, because a medication was not available to administer at the time it was due, "at least once," every shift, and sometimes more than once in a shift.

During an interview with MSRN 2 on November 16, 2016, at 11:10 a.m., MSRN 2 stated if a medication was not available to administer to a patient at the time it was due to be given, she would complete an MMM in the computer and wait to receive the medication from the pharmacy. MSRN 2 stated if the medication did not get sent by the pharmacy before it was late (given more than one hour after it was due), the computer would prompt her to indicate the reason it was given late. The RN stated she would select the, "medication not available," option in that circumstance.

A report titled, "Admin Variance October 2016," generated at the request of the survey team, and provided by the facility, was received on November 15, 2016. The report identified patients who received late medications with the reason, "medication not available," in October 2016.

A second report titled, "Admin Variance October 2016," generated at the request of the survey team, and provided by the facility, was received on November 16, 2016. The report identified patients who missed medication doses that were supposed to be given to them in October 2016.

Records were reviewed during the facility tour.

A random sample of records was reviewed from the, "Admin Variance October 2016," reports.

The records revealed the following:

A. The record for Patient 16 included the following medication orders:

aa. September 26, 2016: Valproic Acid (to treat seizure disorders) 500 mg (milligrams), two capsules to be given once daily by mouth. According to the eMAR (electronic medication administration record):

- On October 1, 2016, the 9 a.m. dose was administered at 12:55 p.m. (three hours and 55 minutes after it was due). The reason for the late administration was documented as medication not available; and,

- On October 3, 2016, the 9 a.m. dose was administered at 3:44 p.m. (six hours and 44 minutes after it was due). The reason for the late administration was documented as medication not available.

bb. September 26, 2016: Entecavir (to treat liver infection caused by hepatitis B) 1 mg to be given once daily by mouth. According to the eMAR:

- On September 27, 2016, the 9 a.m. dose was administered at 6:45 p.m. (nine hours and 45 minutes after it was due). The reason for the late administration was documented as medication not available;

- On September 30, 2016, the 9 a.m. dose was administered at 12:10 p.m. (three hours and 10 minutes after it was due). The reason for the late administration was documented as medication not available;

- On October 1, 2016, the 9 a.m. dose was administered at 12:56 p.m. (three hours and 56 minutes after it was due). The reason for the late administration was documented as medication not available;

- On October 3, 2016, the 9 a.m. dose was administered at 3:45 p.m. (six hours and 45 minutes after it was due). The reason for the late administration was documented as medication not available;

- On October 10, 2016, the 9 a.m. dose was administered at 11:27 a.m. (two hours and 27 minutes after it was due). The nurse indicated the medication had been requested from the pharmacy;

- On October 12, 2016, the 9 a.m. dose was administered at 12:07 p.m. (three hours and seven minutes after it was due). The nurse indicated the medication was sent up in the tube system by the pharmacy late;

- On October 13, 2016, the 9 a.m. dose was administered at 2:43 p.m. (five hours and 43 minutes after it was due). The nurse indicated, "Pharmacy just sent it;" and,

- On October 16, 2016, the 9 a.m. dose was administered at 5:14 p.m. (eight hours and 14 minutes after it was due). The nurse indicated, "hospital is out, no shipment for two days."

cc. October 8, 2016: Mirtazapine (an antidepressant) 15 mg to be given by mouth at bedtime. According to the eMAR:

- On October 8, 2016, the 9 p.m. dose was administered at 10:57 p.m. (one hour and fifty seven minutes after it was due). The reason for the late administration was documented as medication not available; and,

- On October 9, 2016, the 9 p.m. dose was administered at 10:59 p.m. (one hour and fifty nine minutes after it was due). The reason for the late administration was documented as medication not available. ;

A concurrent interview with the Pharmacy Clinical Manager was conducted. She stated this was a scheduled medication and the medication should have been available.

B. The record for Patient 38 included the following medication orders:

aa. February 25, 2016: Cefepime (an antibiotic) one gram to be given IV (intravenously - into the vein) every eight hours. According to the eMAR:

- On February 29, 2016, the 8 a.m. dose was not administered to the patient. The reason for the missed dose was documented as medication not available.

bb. On February 27, 2016: Metronidazole (an antibiotic) 500 mg IV to be given every eight hours. According to the eMAR:

- On February 29, 2016, the 6 a.m. dose was not administered to the patient. The reason for the missed dose was documented as medication not available.

C. The record for Patient 46 included an order dated October 6, 2016, for Fidaxomicin (an antibiotic) 200 mg to be given twice a day by mouth. According to the eMAR:

- On October 6, 2016, the 9 p.m. dose was not administered. The reason for the missed dose was documented by the nurse as medication not available;

- On October 7, 2016, the 9 p.m. dose was administered at 10:52 p.m. (one hour and 52 minutes after it was due). The reason for the late administration was documented by the nurse as medication not available; and,

- On October 8, 2016, the 9 a.m. dose was administered at 6:47 p.m. (nine hours and 47 minutes after it was due, and two hours and 13 minutes before the next dose - which was given on time - was due). The reason for the late administration was documented by the nurse as medication not available.

D. The record for Patient 47 included an order dated September 26, 2016, for Albumin 250 ml, two bottles, to be given IV 1 hour apart. According to the eMAR:

- On October 26, 2016, the first bottle, due at 6:45 p.m., was administered at 11:59 p.m. (five hours and 14 minutes after it was due). The reason for the late administration was documented by the nurse as medication not available.

E. The record for Patient 48 included an order dated October 4, 2016, for Clindamycin (an antibiotic) 450 mg to be given every eight hours by mouth. According to the eMAR:

- On October 6, 2016, the morning dose (due at 9:51 a.m.) was administered at 1:04 p.m. (three hours and 13 minutes after it was due). The reason for the late administration was documented by the nurse as medication not available.

F. The record for Patient 49 included an order dated October 24, 2016, for Clindamycin 600 mg to be given IV every eight hours. According to the eMAR:

- On October 24, 2016, the dose due at 7:30 p.m. was administered on October 25, 2016 (the next morning) at 4:46 a.m. (nine hours and 16 minutes after it was due). The reason for the late administration was documented by the nurse as medication not available.

G. The record for Patient 50 included an order dated October 20, 2016, for 20 mEq (milliequivalents) of KCL (a potassium supplement) to be added to the IV fluids. According to the eMAR:

- On October 20, 2016, the first dose, due at 12:43 p.m., was started at 6:23 p.m. (five hours and 40 minutes after it was due). The reason for the late administration was documented by the nurse as medication not available.

H. The record for Patient 51 included an order dated October 22, 2016, for Nifedipine (to treat high blood pressure) 90 mg to be given by mouth daily. According to the eMAR:

- On October 23, 2016, the 9 a.m. dose was administered at 1:53 p.m. (four hours and 53 minutes after it was due). The reason for the late administration was documented by the nurse as medication not available.

I. The record for Patient 52 included an order dated October 12, 2016, for Actos (for treatment of type 2 diabetes) 30 mg to be given by mouth daily. According to the eMAR:

- On October 13, 2016, the 9 a.m. dose was administered at 12:13 p.m. (three hours and 13 minutes after it was due). The reason for the late administration was documented by the nurse as medication not available; and,

- On October 14, 2016, the 9 a.m. dose was administered at 11:07 a.m. (two hours and seven minutes after it was due). The reason for the late administration was documented by the nurse as medication not available.

J. The record for Patient 53 included an order dated October 19, 2016, for a GI cocktail (a mixture of three different medications used to treat abdominal pain) to be given by mouth every 12 hours. According to the eMAR:

- On October 19, 2016, the 10:30 p.m. dose was administered on October 20, 2016, at 1:54 a.m. (three hours and 24 minutes after it was due). The reason for the late administration was documented by the nurse as medication not available;

- On October 28, 2016, the 10:30 a.m. dose was not administered. The reason for the missed dose was documented by the nurse as medication not available; and,

- On November 1, 2016, the 10:30 a.m. dose was administered at 12:48 p.m. (two hours and 18 minutes after it was due). The reason for the late administration was documented by the nurse as, "Barcode won't scan."

K. The record for Patient 44, a dialysis patient, included an order dated November 15, 2016, for Micafungin (to treat a fungal infection) 100 mg to be given IV every day. The scheduled time for administration was 7:24 p.m. According to the eMAR:

- On November 15, 2016, the medication was administered at 20 minutes after midnight (four hours and 56 minutes after it was due). The reason for the late administration was documented by the nurse as, "Was awaiting delivery from the pharmacy."

L. The record for Patient 14 included the following medication orders:

aa. October 20, 2016, Potassium Chloride (a potassium supplement) 40 mEq to be given at 1 p.m. According to the eMAR:

- On October 20, 2016, the 1 p.m. dose was administered at 3:01 p.m. (two hours and one minute after it was due). The reason for the late administration was documented as medication not available.

bb. October 21, 2016, Potassium Chloride 40 mEq to be given at 9 a.m. According to the eMAR:

- On October 21, 2016, the 9 a.m. dose was administered at 3:56 p.m. (six hours and fifty six minutes after it was due). The reason for the late administration was documented as medication not available.

M. The record for Patient 15 included the following medication orders:

aa. October 14, 2016, Potassium Chloride 40 mEq to be given IV at 9:30 a.m. According to the eMAR:

- On October 14, 2016, the 9:30 a.m. dose was administered at 12:46 p.m. ( three hours and sixteen minutes after it was due). The reason for the late administration was documented as medication not available.

b. October 16, 2016, Potassium Chloride 40 mEq to be given IV at 10:42 a.m. According to the eMAR:

- On October 16, 2016, the 10:42 dose was administered at 12:33 p.m. (one hour and fifty one minutes after it was due). The reason for the late administration was documented as medication not available.

N. The record for Patient 17 included the following medication orders:

aa. October 2, 2016, Nafcillin (an antibiotic) 2 grams to be given IV every four hours. According to the eMAR:

- On October 2, 2016, the 5 p.m. dose was administered at 6:28 p.m. (one hour and twenty eight minutes after it was due). The reason for the late administration was documented as medication not available;

- On October 6, 2016, the 5 a.m. dose was administered at 6:03 a.m. (one hour and three minutes after it was due). The reason for the late administration was documented as medication not available; and,

- On October 10, 2016, the 9 a.m. dose was administered at 10:29 a.m. (one hour and twenty nine minutes after it was due). The reason for the late administration was documented as medication not available.

O. The record of Patient 23 included the following medication orders:

aa. November 9, 2016: Nystatin/Triamcinolone (treatment for skin infection) 15 grams to be applied twice a day. According to the eMAR:

- On November 9, 2016, the 9 p.m. dose was not administered to the patient. The reason for the missed dose was documented as medication not available.

bb. November 11, 2016: Tigecycline (an antibiotic) 50 milligrams to be given IV every 12 hours. According to the eMAR:

- On November 11, 2016, the 5:08 p.m. dose was administered at 8:58 p.m. (three hours and fifty minutes after it was due). The reason for the late administration was documented as medication not available.

P. The record for Patient 33 included a order dated October 13, 2016, for Ranolazine ER (heart medication - extended release) 500 milligrams by mouth twice a day. According to the eMAR:

- On October 14, 2016, the 9 a.m. dose was administered at 10:53 a.m. (one hour and fifty three minutes after it was due). The reason for the late administration was documented as medication not available;

- On October 15, 2016, the 9 a.m. dose was administered at 11:29 a.m. (two hours and twenty nine minutes after it was due). The reason for the late administration was documented as medication not available; and,

- On October 17, 2016, the 9 a.m. dose was administered at 11:59 a.m. (two hours and fifty nine minutes after it was due). The reason for the late administration was documented as medication not available.

Q. The record for Patient 34 included an order dated October 12, 2016, for Ceftriaxone (an antibiotic) two grams to be given IV (intravenously - into the vein) daily. According to the eMAR:

- On October 13, 2016, the 9 a.m. dose was administered at 3:04 p.m. (six hours and four minutes after it was due). The reason for the late administration was documented as medication not available;

- On October 14, 2016, the 9 a.m. dose was administered at 1:59 p.m. (four hours and fifty nine minutes after it was due). The reason for the late administration was documented as medication not available;

- On October 15, 2016, the 9 a.m. dose was administered at 10:13 a.m. (one hour and thirteen minutes after it was due). The reason for the late administration was documented as medication not available, and;

- On October 17, 2016, the 9 a.m. dose was not administered to the patient. The reason for the missed dose was documented as medication not available "...called pharmacy twice still no atbx (antibiotic) sent by the end of shift."

R. The record for Patient 35 included an order dated October 2, 2016, for Ceftriaxone (an antibiotic) two grams to be given IV daily. According to the eMAR:

- On October 3, 2016, the 9 a.m. dose was administered at 11:35 a.m. (two hours and thirty five minutes after it was due). The reason for the late administration was documented as medication not available; and,

- On October 4, 2016, the 9 a.m. dose was administered at 11:52 a.m. (two hours and fifty two minutes after it was due). The reason for the late administration was documented as medication not available.

The facility policy titled, "Medication Administration," was reviewed on November 16, 2016. According to the policy:

a. Medications would be administered in compliance with hospital guidelines;

b. Medications should be administered, "exactly as ordered by the physician;" and,

c. Medications must be administered within 60 minutes before or after the scheduled administration time.

The facility policy titled, "Medication Errors," was reviewed on November 16, 2016. According to the policy:

a. A medication error was defined as any preventable event that may cause or lead to inappropriate medication use or patient harm;

b. Medication occurrences (errors) included medications given at the wrong time (one hour or more before or after the time it was due), and omitted doses (medication that was not administered as ordered);

c. Such events (errors) may be related to systems and procedures, including medication administration;

d. It was the responsibility of any licensed professional administering medications to report any...medication errors... promptly and accurately...and to contact the physician; and,

e. All medication occurrences would be reviewed and trended through the Treatment and Surveillance Committee.

According to American Society of Health-System Pharmacists (ASHP), a nationally recognized pharmacist organization, in its publication, "ASHP Guidelines on Preventing Medication Errors in Hospitals,"

"...Omission error: The failure to administer an ordered dose to a patient before the next scheduled dose, if any...

Wrong time error: Administration of medication outside a predefined time interval from its scheduled...

Pharmacy staff should review medications that are returned to the department. Such review processes may reveal system breakdowns or problems that resulted in medication errors (e.g., omitted doses and unauthorized drugs)..."

According to ASHP publication, "ASHP Guidelines: Minimum Standard for Pharmacies in Hospitals,"

"Reviewing Patient Responses to Medication Therapy. Medication therapy monitoring shall be conducted by pharmacists. Medication therapy monitoring includes a proactive assessment of patient problems and an assessment of...Therapeutic duplication or omissions in the patient's medication regimen..."

Further review of the, "Admin Variance October 2016," reports on November 16, 2016, indicated for the month of October 2016 (31 days):

- Medications were given more than one hour past the time they were due a total of 616 times; and,

- Medication doses were withheld by the nursing staff a total of 634 times.

During an interview during the Quality Assessment Performance Improvement (QAPI) discussion on November 15, 2016, at 10 a.m., the Director of Pharmacy (DOP) stated late administration of medications and missed doses were not accurately reflected in the quarterly medication error reports, because only the errors reported using the Meditech incident reporting system were included.

The DOP stated the pharmacy did not generate reports, look for trends, or identify the reasons for late medication administrations or missed doses to determine what corrective actions could be taken to prevent further errors.

During a Quality Assessment and Performance Improvement (QAPI) interview with the Director of Pharmacy (DOP), the Chief Nursing Officer (CNO), the Assistant Chief Nursing Officer (ACNO), and the Vice President of Quality (VPQ) on November 16, 2016, at 10 a.m., the leaders stated they were aware the nurses in the Intensive Care Unit (ICU) were, "frustrated," with the number of medications that were not available. The leaders stated they did not know the unavailability of medications, missed medications, and omitted doses were occurring throughout the facility.

2. [Crash carts, located at each nursing station, contain emergency medications and supplies for immediate treatment of life-threatening emergencies such as a heart attack].

a. During inspection of the Progressive Care Unit (PCU) on November 16, 2016, at 9:40 a.m., an adult crash cart was observed with the content list on top of the cart. Inspection of the cart revealed the medications on the list did not match the actual medications in the crash cart.

The crash cart did not contain two injectable vials of vasopressin (a medication used to increase blood pressure during heart attack) 20 units/milliliter as indicated on the crash cart content list.

In a concurrent interview, Pharmacy Technician (PT) 2 stated the list was old.

b. During inspection of the Surgical Intensive Care Unit (ICU) Medication Room on November 16, 2016, at 10 a.m., one injectable vial of vasopressin 20 units/milliliter was observed inside the Pyxis (an automated dispensing cabinet for medications) refrigerator.

The Pyxis inventory indicated there should have been three vasopressin vials instead of only one vial on hand.

Review of the crash cart content list indicated there would be zero vials of vasopressin in the crash cart, and vasopressin would be located in the Pyxis refrigerator.

In a concurrent interview, PT 1 acknowledged there was only one vasopressin vial in the refrigerator.

c. During inspection of the Cardiac Catheterization Lab (CCL) Room 1 on November 11, 2016, at 1 p.m., an adult crash cart was observed with the content list on top of the cart. The content list indicated two injectable vials of vasopressin 20 units/milliliter would be located inside the cart.

Inspection of the cart revealed it did not contain any vasopressin inside.

In a concurrent interview, Registered Nurse (RN) 2 stated there were five vasopressin vials in the Pyxis refrigerator.

The facility policy and procedure titled, "Emergency Carts Crash Carts" last revised, April 2016, read, in part:

"All crash carts will be stocked in accordance with a supply list that addresses both contents and location of each item in order to assure uniform supplies and presentation in emergency situations...

The contents of the container shall be listed on the outside cover...

Adult Crash Cart Drug Tray Contents...vasopressin 20 units/1 ml (milliliter) VL (vial) 2 (two vials)..."

3. During medication pass observation on November 16, 2016, at 8:30 a.m., a 5-ml (milliliter) bottle of atropine sulfate (an eye medication used to dilate pupil or decrease eye inflammation) 1% Ophthalmic (pertaining to eye) solution was observed on Patient 18's bedside tray in his room.

Review of the patient's electronic medical record indicated there was a physician's order on November 14, 2016, for atropine sulfate eye drops, one drop in each eye, as needed for dry eye.

In a concurrent interview, RN 3 confirmed there was no physician's order to keep atropine at the patient's bedside.

The facility policy and procedure titled, "Medication Administration" last revised, August 2016, read, in part:

"Medications are not to be kept at the patient's bedside..."

Based on observation, interview, and record review, the facility failed to ensure cleaning of the intravenous (IV) compounding area of the pharmacy was performed in accordance with the facility policy and procedure, and consistent with the federal United States Pharmacopeia (USP) <797> standards.

Findings:

[The USP convention is a scientific, nonprofit organization, that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed, and consumed worldwide. USP's drug standards are enforceable in the United States by the Food and Drug Administration.

USP Chapter <797> provides procedures and requirements for compounding sterile preparations. General Chapter <797> describes conditions and practices to prevent harm to patients that could result from microbial contamination, excessive bacterial endotoxins, variability in intended strength, unintended chemical and physical contaminants, and ingredients of inappropriate quality in compounded sterile preparations].

The Pharmacy IV Compounding (mixing) Area with IV hoods (enclosed workbenches where compounding takes place) was inspected on November 15, 2016, at 2 p.m.

Review of the monthly, "Pharmacy Room Cleaning Log," for the hoods, during the last four months, indicated the daily hood cleaning was not performed consistently.

In a concurrent interview, Registered Pharmacist (RPH) 1 stated the daily cleaning of the hood would take place by the pharmacy technician in the morning, before the morning shift started. RPH 1 acknowledged the cleaning of the IV hood was not consistently performed daily.

The facility policy and procedure titled, "Laminar Airflow Workbench-Cleaning and Maintenance" dated, August 2014, read, in part:

"The inside of the hood must be cleaned at a minimum at the beginning of each shift, before each batch...

The Pharmacy Director or designee shall be responsible for checking the hood cleaning logs daily to confirm that documentation of hood cleaning has been done per shift..."

According to USP <797>, Table 3, the Primary Engineering Control (e.g., IV laminar airflow hood) would need to be cleaned at a minimum, "At the beginning of each shift, before each batch, not longer than 30 minutes following the previous surface disinfection when ongoing compounding activities are occurring, after spills, and when surface contamination is known or suspected..."