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Based on record view and interview, the governing body failed to take action to prevent the diversion of controlled substance following a series of five occurring in the hospital. Three of these incidents occurred in 2011 and two in 2012, involving employees in the Department of Nursing and Pharmacy.

Findings:

On April 17, 2012 at 2:30 PM, the governing body minutes from meetings on 02/11, 10/11 and 3/12 were reviewed. These dealt with "Controlled Substances-Nursing." This review coupled with an interview of Staff A, and on April 19, 2012 at 12:45 PM, Rx3 failed to reveal evidence of successful policies and procedures to prevent drug diversion from occurring in the hospital.

Evidence was presented from 2011 and 2012 of the intent to create guidelines for following up on the problem of controlled substance diversion. Proposed were a revision of procedures for wastage and overrides of these medications and the intent to implement monitoring processes to track compliance to the procedures. During the survey, outcome data was provided documenting the effectiveness of these measures.

During the interview of Rx3 on April 19 at 11:00 AM, the Witness Shift Plan concerning the issue of restocking was explained, but no data noting improvement had been generated. In addition, recommendations from root cause analyses relating to daily reports of drugs being wasted and reconciliation of drugs obtained from the pharmacy Omnicells were not being done. No policy for this had been formulated or put in effect.

On April 19, 2012 at 1:30 PM, Staff B's report revealed that a root cause analysis that had gone to the Chief Nursing Officer and Chief Medical Officer failed to result in input coming back to the Risk Management Department from the governing body.

On April 19, 2012 at 2:00 PM, RN5 provided a Self Learning Module entitled, Substance Abuse Among Nurses, dated February 2012. Outcome data related to the use of this tool had not been obtained.

Based on observation, interview and record review, the facility staff failed to ensure that a registered nurse evaluated and implemented the care of each patient with fall risk for 3 of 5 sampled patients (Patients 4, 6, and 7). The facility failed to ensure that registered nurses caring for Patient 1 (P1)evaluated Patient 1's pain as required. The facility failed to ensure that discrepancies in pain assessment were resolved for Patient 1 on 3 occasions.

Findings:

1. On April 18, 2012, at 9:50 a.m., during the tour of the Orthopedic Unit, with the Director of Orthopedic Unit, Patient 4 was observed lying in bed with no "Fall Precaution" sign posted.

A review of the 24 Hour Patient Care Flowsheet dated 4/17/12 disclosed the patient was assessed as high risk for fall.

During a concurrent interview with the Director of Orthopedic Unit on April 18, 2012 at 10:30 a.m., she stated "Fall Precaution" sign should be posted on the door frame.
2. On April 18, 2012, at 11:35 a.m., during the tour of the Medical/Surgical Unit, with the Director of Unit, Patient 6 and Patient 7 were observed lying in bed.

The 24 Hour Patient Care Flowsheet dated 4/17/12 for Patient 6 was reviewed and disclosed there was no documentation the patient's pain had been assessed at 8 a.m., 12 noon, and 5:20 p.m. on 4/17/12.

The 24 Hour Patient Care Flowsheet dated 4/4/12 and 4/17/12 were reviewed and disclosed there was no documentation that Patient 6 had been assessed for fall risk on the day shift (7 a.m. to 7 p.m.) for both aforementioned days.

During a concurrent interview with the Director of Medical/Surgical Unit at 12:10 p.m. on April 18, 2012, she admitted Patient 6's pain had not been assessed at 8 a.m., 12 p.m., and 5:20 p.m., on 4/17/12. According to the Director of Medical/Surgical Unit, Patient 7 was not assessed for fall risk on the day shift (7 a.m. to 7 p.m.) for both 4/4/12 and 4/17/12.

According to the facility's Policy and procedure for "Fall Risk Management" revised on 3/11, under "Procedure":

"D. Ongoing Fall Risk Assessment
1. Fall risk and safety interventions will be reassessed and documented routinely at regular intervals (at least every shift) and with any changes in patient status or condition.

E. Fall risk interventions include as appropriate
1. Fall risk sign at bedside"


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3. The medical record for P1 was reviewed on April 18, 2012 starting at 9:00 a.m. with Rx1, RN1 and RN2. P1's s physician ordered Dilaudid, using a Patient Controlled Analgesia Pump (PCA), with a dose of 0.1 mg and may increase to 0.3 mg as needed with a lockout of 12 minutes. {PCA is a patient controlled analgesia pump which delivers a steady rate (basal rate) of a narcotic intravenously (IV). A patient can also add intermittent amounts of the IV narcotic to the basal rate in order to relieve pain not controlled by the basal rate alone. This is done by pressing a separate button (a bolus button) attached by a length of wire to the PCA pump.}

A hospital approved Flowsheet-Patient Controlled Analgesia (FSPCA) is required to be used according to RN1 and RN2. The FSPCA permits the documentation of the required assessments (i.e.; time and pain score) RN must perform to properly monitor a patient receiving a narcotic via a PCA. The hospital also requires RN to document similar plus additional parameters on a 24 Hour Patient Care Flowsheet (PCFS) and a written narrative regarding a patient ' s status on an Interdisciplinary Progress Record (IPR).

A. The FSPCA requires an RN to assess a patient's pain every 4 hours after the initial dose is started. There was no pain assessment documented on the FSPCA for 13 hours between 4:45 p.m. on April 17th and 6:00 a.m. on April 18th.

B. a) The FSPCA for P1, at noon on April 17th, showed a pain scale of 4 out of 10. The PCFS showed a pain scale 2 at 11:45 a.m. the same day.
b) The FSPCA for P1, at 4:45 p.m. on April 17th, showed a pain scale 4 out of 10. The PCFS showed a pain scale of 0 out of 10 at 4:00 p.m. the same day.
c) The PCFS showed a pain scale of 0 out of 10 at 8:00 p.m. on April 17th. The IPR showed a pain scale of 2 out of 10 at 7:40 p.m. the same day.

There was no evidence of any documentation in P1's record that these discrepancies were resolved or even noted. RN's 1 and 2 agreed there was no evidence of any resolution in P1's record and could not explain why the discrepancies occurred.

Based on observation, interview, and record review, the facility nursing staff failed to develop a care plan to include appropriate nursing interventions in response to the patients' needs for 2 patients (Patient 3 and Patient 5).


Findings:

1. On April 17, 2012, at approximately 9:50 a.m., during the tour of the Oncology Unit, with Staff C, Patient 3 was observed lying in bed.

A review of the 24 Hour Patient Care Flowsheet dated 4/15/12 disclosed the patient was assessed as high risk for fall. However, there was no documentation that the Interdisciplinary Plan of Care had been developed.

During a concurrent interview with Staff C, she admitted the interdisciplinary Plan of Care had not been developed.

2. On April 17, 2012, at approximately 10:40 a.m., during tour of the Intensive Care Unit (ICU) with Staff D, Patient 5 was observed lying in bed.

A review of the Interdisciplinary Plan of Care dated 4/9/12 disclosed nursing diagnosis in the plan of care for fall risk was initiated on 4/9/12. However, there was no documentation that the interventions and expected outcomes had been specified and developed.

During a concurrent interview with Staff D at 11:25 a.m. on 4/18/12, she admitted the interventions and expected outcomes had not been specified and developed.

According to the policy and procedure for "Care Planning":
III. Procedure
7. Once needs have been identified and prioritized, members of the health care team develop a plan of care for that patient.
a). This plan is documented in the patient's medical record in several ways:
(1) On the care plan or diagnosis specific care guides
(2) In the progress notes"

Based on observations, interviews and record reviews, the facility failed to ensure Patient 3, Patient 8, and Patient 9 were assessed for pain and vital signs while receiving narcotic analgesia via PCA (Patient Control Anesthesia), in accordance with the facility's policy and procedure for PCA. The facility failed to ensure that nurses (RNs) followed hospital policies and procedures for the administration of Dilaudid (a narcotic medication) to Patient 1.

Findings:

1. On April 17, 2012, at approximately 9:40 a.m., during tour of Oncology Unit, with Staff C, Patient 3 was observed lying in bed with PCA.

A review of the Flowsheet-Patient Control Anesthesia dated 4/17/12 disclosed the first dose was given to the patient at 2 p.m., with assessment of vital signs and pain scores. The 2nd dose was given to the patient at 4:35 p.m., with assessment of vital signs and pain scores. However, there was no documentation that Patient 3's vital signs and pain scores were assessed at 3 p.m., and 4 p.m., which was "Q (every) 1 hour x 2".

During a concurrent interview with Staff C at 9:40 a.m. on 4/17/12, she admitted the vital signs and pain should have been assessed, based on the policy and procedure for the PCA.


According to the facility's policy and procedure for PCA:
" V. Patient Assessment
A. Initial and ongoing assessment will include the following every hour x2 hours, then every 4 hours for duration until PCA pump is discontinued (repeating this sequence with each dosage increase)."



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2. During the tour of the Oncology Unit on April 18, 2012, at 9:05 a.m., Patient 8 was observed in bed with a PCA pump.

The clinical record for Patient 8 was reviewed at 9:15 a.m. A morphine PCA to run at 1 milligram (mg) per milliliter (ml) was ordered on April 12, 2012, at 12:45 a.m. The facility document titled "Flow sheet-Patient Controlled Analgesia" dated April 14, 2012 at 1 a.m., indicated "Patient assessment is to be done Q1 (every one) hour x 2 with the first dose given and with every dose change. After initial assessments, patient assessments, including vital signs are Q4 (every 4) hours until PCA pump is DC ' d (discontinued)." An entry was made at 1 a.m., recording the pain score and the vital signs. The next entry for pain score and vital signs was documented at 4 a.m.

Staff C was interviewed concurrently with the record review. She reviewed the clinical record and she was unable to find documentation of a 2 a.m., pain and vital signs assessment on April 14, 2012.

3. During the tour of the Intensive Care Unit/Post Critical Care Unit on April 18, 2012, at 10:55 a.m., Patient 9 was observed sitting up in a chair, with a PCA pump.

The clinical record for Patient 9 was reviewed. An order for Hydromorphone 0.4 mg/ml was ordered on April 16, 2012, at 1:30 p.m. The "Flowsheet-Patient Controlled Analgesia" sheet dated April 16, 2012 indicated the PCA pump was started at 8 a.m. on April 17, 2012. The next entry on the flow sheet for the pain and vital signs assessment was timed 12 p.m., which is 4 hours later. The flow sheet indicated for patient assessments including vital signs are to be done one hour after the initial assessment. The facility document titled "24 Hour Critical Care Flowhsheet" dated April 17, 2012 indicated vital signs were done every hour, but pain assessment was documented at 8 a.m., and 1 p.m. The clinical record was reviewed with the Clinical Educator and she confirmed the assessment was not done one hour after the initial assessment.

The facility policy and procedure titled "Patient Controlled Analgesia (PCA)" revised February 2011 indicated "Initial and ongoing assessments will include the following every hour x2 hours, then every 4 hours for duration until PCA pump is discontinued ...1. Self-assessment pain score (0-10) ..."



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4. The medical record for Patient 1 was reviewed on April 18, 2012 starting at 9:00 a.m., with Rx1, RN1 and RN2. P1's physician ordered Dilaudid, using a Patient Controlled Analgesia Pump (PCA), with a dose of 0.1 mg and may increase to 0.3 mg as needed with a lockout of 12 minutes. {PCA is a patient controlled analgesia pump which delivers a steady rate (basal rate) of a narcotic intravenously (IV). A patient can also add intermittent amounts of the IV narcotic to the basal rate in order to relieve pain not controlled by the basal rate alone. This is done by pressing a separate button (a bolus button) attached by a length of wire to the PCA pump.}

This initial PCA order was written on April 16, 2012 at 6:20 p.m., for just the intermittent doses. As described above, a patient may self-administer the intermittent dose of Dilaudid as needed.

Page 1 of the hospital's policy/procedure entitled "Patient Controlled Analgesia (PCA), under II. Policy, reads: "MD (physician) orders for the initial start of PCA will be written on the PCA physician order form (MDPCA). Subsequent orders regarding PCA are written on the routine physician order form." The MDPCA is a medical staff approved form which includes the dose of a drug, dose for breakthrough pain, the required presence of an oxygen flow meter and respiratory rate assessment. Thus, it is a comprehensive form which requires the MD to incorporate several safety precautions.

The initial PCA order for Patient 1 was written on a routine physician order form contrary to hospital policy. The RN should have advised the physician (MD) that the order was written on the wrong form and had to be rewritten. There is no evidence in Patient 1's record that anyone was contacted. Patient 1's record showed that the PCA was started on April 16th. This was confirmed by Rx1, RN1 and RN2. In fact, although Rx1 has the title of Pain Management Pharmacist, she stated she was unaware of the policy that required the initial PCA order to be written on the MDPCA.

Page 2 of the hospital policy entitled "Medication Administration" 5. reads: "If there is a question regarding a medication order, it is the responsibility of the licensed personnel to contact the prescriber or pharmacist prior to administering the medication. Thus, since there is no evidence of any contact, a RN did not comply with hospital policy.
Although the starting dose of 0.1 mg was identified, the MD did not provide guidelines as to how to increase or under what circumstances to increase the Dilaudid dose to 0.3 mg.

Page 5 C.1. of the "Medication Administration" policy reads: "Variable dosages, with indications, may be used only when there is acceptable objective criteria (i.e., pain scale ....) included in the order." There were no scales or any guidelines identified by the MD as to when the dose should be increased to 0.3 mg. Again, contrary to hospital policy, there is no evidence in Patient 1's record an RN contacted the MD to ask for specific directions. This was confirmed by Rx1, RN1 and RN2.

Based on a review of hospital's Omnicell (ADC) use, pharmacy document reviews, patient health record reviews and staff interviews, the facility failed to provide pharmaceutical services which meets the needs of its patients. The facility failed to meet condition of participation for pharmaceutical services as follows:

1. The facility's Pharmacists failed to ensure that narcotics for 2 patients were ordered correctly and safely. The facility's Pharmacy failed to see and review for appropriateness 60,000 doses of medications ordered in the ED on average each year. The facility's pharmacist failed to make certain there was an adequate number of Pharmacists to properly monitor and correct physician orders before entering them into the pharmacy computer. (Refer to A 0493).

2. The facility's Pharmacy failed to resolve 2 conflicting hospital policies and procedures to avoid confusion in order to prevent the inappropriate use of Omnicell Machines (ADC's). The facility's Pharmacists failed to ensure that medications removed as overrides from the Omnicell Machines (ADC's) on the nursing units were appropriate and safe for patients. The facility's Pharmacists failed to ensure that medications removed from non-profiled ADC's were appropriate to ensure patient safety. (refer to A 0500)

3. The facility's pharmacy failed to ensure that the narcotic waste procedure was validated and that the unused portions of narcotics are properly discarded and not abused. (Refer to A 0509)

The cumulative effect of these systemic problems resulted in the facility's inability to ensure that Pharmaceutical Services provides a safe patient care environment.

Based on interviews and records review, the pharmacy director failed to develop and implement effective procedures of scheduled drugs (as known as controlled substances or narcotics) usage throughout the facility.

Findings:

On April 17, 2012, at 10 a.m., during an interview, Rx3 and Staff E stated narcotics usage reports were generated automatically by pharmacy system, emailed to and reviewed by respective nursing directors. Pharmacist did not review these usage reports and did not reconcile usage against actual medication orders to ensure safe and appropriate use, as well as accurate documentation of wastages. (Reference A-509)

The facility's policy and procedure, titled "Controlled substances - nursing", was reviewed on 4/19/2012. There was no evidence of a pharmacy policy on controlled substances.

According to the facility's reports, a series of five narcotic diversion occurred in the past seven months, involving employees from both nursing and pharmacy departments. Three of those five cases involved improper discrepancies in wastage documentation and questionable accuracy of wastages. Two of those three cases were discovered by police departments during traffic violation investigations. In both cases, police departments found apparently used but not finished narcotics that were not prescribed to the employees; the police departments then informed the facility.

Based on interviews, document review and record review:
1. Pharmacists failed to ensure that there was a dose included in the order for Dilaudid (a narcotic) for Patient 2.
2. Pharmacists failed to ensure that Dilaudid for Patient 2 was ordered correctly and was safe for Patient 2.
3. Pharmacists failed to ensure that Dilaudid was ordered correctly for Patient 1.
4. Pharmaceutical Services failed to ensure that approximately 60,000 doses of medications removed from the Emergency Department (ED) Omnicell Dispensing Machines (ADC's) on average per year and administered in the ED were reviewed by a Pharmacist for their appropriateness and safety.

An ADC is an automated dispensing machine which is located on the nursing unit and permits quick access to medications by a registered nurse (RN). The ADC is filled by pharmacy with medications approved by the Pharmacy & Therapeutics Committee. When properly programmed (profiled) the ADC electronically permits a nurse to remove a medication only after a pharmacist has reviewed and entered the new physician's order into the correct patient profile in the pharmacy computer. This releases the medication dose for that patient. This release is authorized because the computer located in the pharmacy is electronically connected to the ADC.
If an RN wishes to remove a medication before a pharmacist has reviewed and entered the order into the pharmacy computer, the nurse must use an override. An override usually occurs when a pharmacist is not present in the hospital to review the order or in an emergency. Use of an override generates a medication order override report which should include:
a. The name of the patient.
b. The name and dosage of the medication. Usually occurs when a pharmacist is not present in the hospital to review the order or in an emergency. Use of an override generates a medication order override report which should include:
a. The name of the patient.
b. The name and dosage of the medication.
c. The number of doses removed.
d. The reason the dose(s) were removed.
e. The nurse who removed the dose.

5. An inadequate amount of time is allocated for a Pharmacist to review, verify and enter a physician's medication order into the pharmacy computer.
c. The number of doses removed.
d. The reason the dose(s) were removed.
e. The nurse who removed the dose.

The aforementioned deficiencies identify a serious gap in Pharmaceutical Services which points to a potentially inadequate number of employed Pharmacists and an unsafe patient care environment.

Findings:

1. The medical record for Patient 2 was reviewed on April 17, 2012 starting at 11:10 a.m. with Rx1 and RN1. At 1:45 a.m. on April 12, 2012, MD1 ordered " Morphine 1 mg IVP (intravenous push) every 2 H (hours) prn (as needed) for pain, if not effective may give Dilaudid IVP. There was no dose identified for Dilaudid. The medication administration record (MAR - which is generated by the pharmacy computer when a Pharmacist enters the order into the computer) for Patient 2 listed Dilaudid 1 mg IVP every 2 hours as needed and dated April 12, 2012 starting at 1:45 a.m. There is no evidence in Patient 2's record that a dose of Dilaudid 1 mg was ordered. There is no evidence in Patient 2's record that MD1 was called to order a dose. No record indicated a Pharmacist called MD1 for a dose and notified the RN caring for Patient 2 before entering and verifying the order in the pharmacy computer. The Pharmacist failed to write a new order in Patient 2's record.

2. With respect to the narrative regarding Patient 2 in (1) above, the very serious danger is that intravenous (IV) Dilaudid is about 10 times stronger than Morphine. (Lexicomp, a nationally recognized source for drug information identifies that the initial IV dose for Morphine is 2.5 to 5 mg every 3 to 4 hours while the initial IV dose for Dilaudid is 0.2 to 0.6 mg every 2 to 3 hours.) Since 1 mg of Morphine was ordered with no specific dose for Dilaudid, it is conceivable for an RN to presume that the dose of Morphine would also apply to Dilaudid. A Pharmacist failed to recognize the potential serious adverse effect of a change to the same 1 mg dose for Dilaudid, called Patient 2's physician (MD1) and wrote a new order in Patient 2's record. There was no evidence in Patient 2's record a Pharmacist had contacted MD1 and no record of a confirmation of the 1 mg Dilaudid dose identified in Patient 2's MAR.

3. The medical record for Patient 1 was reviewed on April 18, 2012 starting at 9:00 a.m. with Rx1, RN1 and RN2. P1's physician (MD2) ordered Dilaudid, using a Patient Controlled Analgesia Pump (PCA), with a dose of 0.1 mg and may increase to 0.3 mg as needed.

(A PCA is a patient controlled analgesia pump which delivers a steady rate (basal rate) of a narcotic intravenously (IV). A patient can also add intermittent amounts of the IV narcotic to the basal rate in order to relieve pain not controlled by the basal rate alone. This is done by pressing a separate button (a bolus button) attached by a length of wire to the PCA pump.) In this case the MD2 just ordered intermittent doses controlled by P1.

However, there are no guidelines as to when (what pain scale) an RN should adjust the dose; No incremental dosing time to identify how quickly the dose should be increased. Upon reviewing this order a Pharmacist should have recognized the incomplete information, called MD2 and wrote a new order in P1's record. There was no evidence in P1's record a Pharmacist had written a correct order or even contacted MD2.

4. The ED was visited on April 17, 2012 starting at 11:25 a.m. During an interview with RN3, she stated the ED sees about 80 - 100 patients per day and that about 75% of them are not admitted to the hospital. A list of ED transactions from April 1 to April 17, 2012 was provided by Rx2 on April 18, 2012. The list identified that there were a total of 3,500 doses removed from both ADC's in the ED during that period. That yields about 84,000 doses on average per year (3,500 x 2 x 12). During an interview with Rx2 the same day starting at 3:30 p.m., he stated that the pharmacy does not receive any of the ED MD orders if a patient is not admitted to the hospital. Since about 75% of the patients in the ED are not admitted, Pharmacists never see about 60,000 doses of medications (.75 x 84,000) removed from the ED ADC's and administered to patients.

5. Rx2 provided a list which identified the number of medication order entries per hour and stated the number of Pharmacists on duty during those hours. During a meeting on April 18, 2012 start at 3:15 p.m. he confirmed that the list shows:
a) At the 3:00 p.m. hour there is an average of 135 entries with 3 Pharmacists entering orders.
b) At the 5:00 p.m. hour there is an average of 117 orders also with 3 Pharmacists entering orders.
c) At the 9:00 a.m. hour there is an average of 57 orders with 2 Pharmacists entering orders.
d) At the 10:00 a.m. hour there is an average of 81 orders with 2 Pharmacists entering orders.
Thus, at the 3:00 p.m. hour a Pharmacist must process an order in about 1.3 minutes. At the 5:00 p.m. hour a Pharmacist must process an order in about 1.5 minutes. At the 9:00 a.m. hour a Pharmacist must process an order in about 2 minutes. At the 10:00 a.m. hour a Pharmacist must process an order in about 1.5 minutes.

The American Society of Health-Systems Pharmacists (ASHP) the internationally recognized professional organization for Pharmacists in acute settings on page 439 in its "Minimum Standard for Pharmacies in Hospitals" reads: "All prescribers' medication orders (except in emergency situations) must be reviewed for appropriateness by a pharmacist before the first dose is dispensed. Any questions regarding the order must be resolved with the prescriber at this time, and a written notation of these discussions must be made in the patient's medical record .... " Medication-therapy monitoring includes the assessment of: The therapeutic appropriateness; Therapeutic duplication; Route and method of administration appropriateness; Drug interactions; and an assessment of the clinical and pharmacokinetic laboratory data.

Clearly, it is not possible for Pharmacists to perform all the tasks described by the ASHP in 1.3 to 2 or even 5 minutes which resulted in:
a) The Dilaudid doses for Patient 1 and Patient 2 were not properly corrected.
b) An improper Dilaudid order was written and not corrected for P1.
c) Medications removed from ADC's as overrides are not properly monitored. (Reference A-0500)
d) Medications removed from ADC's in the ED and Labor & Delivery (L&D) are not properly monitored. (Reference A-500)
e) Narcotic waste disposal is not monitored or confirmed by a Pharmacist. (Reference A-509)

Based on interviews and record reviews, pharmacy failed to monitor the movement of scheduled drugs and maintain accountability of scheduled drugs.

Findings:

On April 17, 2012, at 10 a.m., during an interview, Rx1 and Staff D stated narcotics usage reports were generated automatically by pharmacy system and reviewed by respective nursing directors. Pharmacist did not review these usage reports and did not reconcile usage against actual medication orders to ensure safe and appropriate use, as well as accurate documentation of wastages.

According to the facility's reports, a series of five narcotic diversion cases occurred in the past seven months, involving employees from both nursing and pharmacy departments. Three of those five cases involved improper discrepancies in wastage documentation and questionable accuracy of wastages. Two of those three cases were discovered by police departments during traffic violation investigations. In both cases, police departments found apparently used but not finished narcotics that were not prescribed to the employees; the police departments then informed the facility.

One of the five narcotic diversion cases involved reconciliation of narcotic where nine oral tablets of methadone (Class II scheduled drug used to treat severe pain) were missing from a locked storage.

A review of the facility's investigation reports on 4/17/2012, at 1:40 p.m., revealed that Rx2 did not attend the interdisciplinary root-cause analysis meetings on drug diversions held on 11/08/2011, 1/24/2012, and 2/15/2012.

During an interview on 4/17/2012 at 1:30 p.m., Rx2 stated he did not have any summary report regarding the drug diversion cases. With regard to the latest diversion case, the pharmacy director stated he did not conduct interviews or participate in the investigation process. Furthermore, the pharmacy director did not notice the controlled substance inventory sheet, dated 1/6/2012, was not reconciled properly according to the facility's policy.

During an interview on 4/19/2012 at 1:20 p.m., Staff D stated the policy and procedures for controlled substance record were not followed.

Based on interviews and document reviews:
1. There are 2 conflicting hospital policies which can create confusion for nurses and pharmacists and potentially adversely affect patient care. The pharmacy in concert with medical staff should have resolved the conflicting policies to minimize the potential for drug errors.
2. Pharmacists failed to ensure that medications removed as overrides from the Omnicell Machines (ADC's) on the nursing units were appropriate and safe for patients.
3. Pharmacists failed to ensure that medications removed from non-profiled ADC's were appropriate to ensure patient safety.

An ADC is an automated dispensing machine which is located on the nursing unit and permits quick access to medications by a nurse. The ADC is filled by pharmacy with medications approved by the Pharmacy & Therapeutics Committee. When properly programmed (profiled) the ADC electronically permits a nurse to remove a medication only after a pharmacist has reviewed and entered the new physician's order into the correct patient profile in the pharmacy computer. This releases the medication dose for that patient. This release is authorized because the computer located in the pharmacy is electronically connected to the ADC.
If a nurse (RN) wishes to remove a medication before a pharmacist has reviewed and entered the order into the pharmacy computer, the nurse must use an override. An override usually occurs when a pharmacist is not present in the hospital to review the order or in an emergency. Use of an override generates a medication order override report which should include:
a. The name of the patient.
b. The name and dosage of the medication.
c. The number of doses removed.
d. The reason the dose(s) were removed.
e. The nurse who removed the dose.

Findings:

1. Provision of Care Policy entitled Medication Administration (MA - dated 3/12) reads: "VI A. The pharmacist reviews each prescription/order prior to dispensing the medication (except where a licensed, independent practitioner (LIP) with appropriate clinical privileges controls prescription, ordering, preparation, and administration (i.e., L&D, ED, PACU and Cardiac Cath Lab)."
Pharmaceutical Services' policies and procedures entitled "Omnicell Override Drug Dispensing Policy (ODD - dated 5/19/12) reads: " 2.1 Specifically defined medications are readily available in the Omnicell for emergency patient conditions. 3.2 Examples of Emergency Patient Conditions:
Allergic Reaction Hypotension
Anaphylaxis Emergency Intubation
Hypoglycemia Emergency Bedside procedure by MD
Cardiac Event Seizures
Narcotic Overdose Rigors
Benzodiazepine overdose Intractable Nausea & Vomiting
Uncontrolled severe pain/urgent and immediate pain relief requirement
Immediate pre-operative and pre-transfusion requirement in the AMU"
"3.11 Each time a medication is taken out of the Omnicell on override; the nurse shall enter the reason .... "

The MA requires that a Pharmacist review each prescription (order) except where an LIP is present before a nurse may remove a medication from an ADC in, for example, the L&D, ED, PACU and Cardiac Cath Lab. The ODD permits a nurse to remove a medication from an ADC using an override, but, only in defined emergencies. The ODD does not exclude any ADC from this policy. That is, all ADC's require the use of an override but only in an emergency as defined by the ODD. The MA conflicts with the ODD as the only exception defined by the MA is where an LIP controls the prescription, ordering, preparation and administration of the medication. (The implications for the MA policy is that a nurse may remove a medication from an ADC without a Pharmacist ' s first review during a procedure where the prescribing physician is present performing the procedure.) So, which policy is to be followed for the removal of medication; only for an emergency or the removal of the dose only when an LIP is present?

It is noted that the MA is not a pharmacy policy. It is signed only by the Vice President of Patient Care Services (also known as the Chief Nursing Officer) and not by the Director of Pharmacy. There was no evidence provided of a pharmacy or nursing/pharmacy policy which allows for the LIP exception and no evidence the MA policy ensured patient safety such as requiring a Pharmacist to review the LIP order retrospectively (after the fact) to ensure appropriateness. Without such interdisciplinary coordination, it is noted that the MA and ODD are in conflict.

However, this should have been recognized by pharmacy and resolved with medical staff assistance to ensure that medications were being removed from the ADC's appropriately to minimize the potential for a drug error.

2. During a meeting with Rx3 on April 17, 2012 starting at 10:30 a.m., she stated that Pharmaceutical Services are provided 24 hours each day every day. Rx3 also provided a list of overrides which occurred between April 1 and April 17, 2012 and reviewed on April 18, 2012.
a) For Med Surg 1 - of a sample of 68 out of 159 overrides; 14 were for medications removed for reasons such as pain, nausea or emergency. None of the reasons documented are approved in the ODD. Thus the overrides were used contrary to hospital policy.
b) For Telemetry - of a total of 9 overrides, 7 were for emergency, 1 was for an MD order and 1 reason was for a procedure. All overrides were removed for reasons other than those approved by the ODD contrary to hospital policy.
c) For ICU (intensive care unit) 2nd Floor - 90 samples of 301 overrides revealed: 31 medications were removed for an emergency, 1 reason was new order and 1 reason was for pain. None of the reasons used were approved by the ODD contrary to hospital policy.
The purpose of using an override, according to the ODD, is "1.1 To ensure medications are securely and appropriately dispensed to patients in emergency situations" which the ODD defined in 3.2.

There is no evidence a Pharmacist intervened in the use overrides, as shown in a, b and c above, to determine why medications were removed contrary to hospital policy. There is no evidence a Pharmacist ensured that the medications removed in Med Surg 1, Telemetry and the ICU were appropriate and safe for patients.

3. Lists of medications removed from ADC's were provided by Rx3 and reviewed on April 18, 2012 starting at 3:30 p.m. with Rx2. The lists included medications removed from ADC's in the L&D, ED, PACU, GI Lab, Radiology, CC, Pre-Op, Operating Room (OR), ASC Recovery Room (ASCRR) and Cath lab. Rx2 stated the ED, GI Lab, Radiology, Pre-Op, OR and Cath Lab were not really nursing units and so the ADC's are not profiled. Rx2 also stated that L&D, PACU, ASCRR and CC required immediate access to the medications in their ADC ' s and were also not profiled. Therefore overrides for these areas are not applicable. However, the ODD does not distinguish between ADC's. The ODD reads under purpose: "To ensure that medications are securely and appropriately dispensed to patients in emergency situations." Under procedure the ODD reads: "Certain medications ....will be available in the Omnicell by override .... "

So, given the ODD, all the medication doses removed from the above referenced areas before a Pharmacist's review should only be for an emergency and show a reason for their removal. There is no evidence in any of the above lists that a reason was given for the removal of a drug.
a) For the ED - the list identified a total of 3,500 medication doses removed from the ED ADC ' s between April 1 and April 17, 2012. That yields about 84,000 doses for a year (3,500 x 2 x 12). Medications removed included, anti-emetics (for nausea), oral antacids, oral analgesics, oral potassium, oral anti-anxiety meds (relaxants), vaccines, inhalation medication, oral anti-inflammatories, aspirin and oral anti-hypertensives. Oral medications are not used during a procedure (as implied by the MA) and would not be used in any emergency identified by the ODD or otherwise. A true emergency requires the use of an injectable dose not an oral dose. Oral doses take too long to be effective. Thus, the medications described above were removed from the ED ADC's contrary to hospital policy. There was no evidence provided which showed that Pharmacists intervened in the inappropriate use of the ED ADC's. Further, during an interview with Rx2, identified above, he stated that pharmacy never sees medication orders for patients who are not admitted to the hospital from the ED. During an interview with RN3 on April 17, 2012 starting at 11:25 a.m., she stated the ED sees about 80 - 100 patients per day and that about 75% of them are not admitted to the hospital.

In addition to Pharmacists not monitoring use of the ADC's in the ED, Pharmacists do not even see 75% of the 84,000 medication orders written, on average per year, (more than 60,000 medication doses) and administered in the ED.

b) For the L&D - there were 900 medication doses removed from the ADC during the 2 week period. Of a sample of 100, 44 were for oral medications such as iron and vitamin supplements, oral anti-inflammatories, oral analgesics and oral anti-hypertensives. These oral medications are certainly not needed during any procedure (as implied by the MA) and would not be used in an emergency as identified by the ODD or otherwise.

There was no evidence provided which showed that Pharmacists monitored or intervened in the inappropriate use of the L&D ADC.
Pharmacists are available 24 hours a day every day and certainly could provide medications in non-emergency situations throughout the hospital.

The American Society of Health-Systems Pharmacists (ASHP) the internationally recognized professional organization for Pharmacists in acute care settings, in its "Minimum Standard for Pharmacies in Hospitals" on page 439 reads: "All prescribers' medication orders (except in emergency situations) must be reviewed for appropriateness by a pharmacist before the first dose is dispensed.
The Institute for Safe Medication Practices (ISMP) a nationally recognized group that monitors the occurrence of medication errors in its "Guidance on the Interdisciplinary Safe Use of Automated Dispensing Cabinets (ADC's) under Core Process #3, indicates that "The use of a 'profiled' ADC ensures that the pharmacist will validate the new medication order, including first doses, in the pharmacy computer system prior to the medication being dispensed or accessed by the nurse or other healthcare professional. "

Clearly, the standard for professional practice is that ALL ADC's should be profiled and that no medication should be removed from any ADC without a Pharmacists' review except in an emergency. The ODD concurs with those standards.

The deficiencies described above show that pharmaceutical services are not in compliance with standards for professional practice or even with its' own policy and do not control the distribution and use of medications stored throughout the hospital. Such non-compliance and lack of control places patients in an unsafe environment.

Based on interviews and record review, the pharmacy failed to ensure that narcotic waste (unused remains of narcotics) was properly discarded and not abused. Pharmacy, therefore, would be unable to report such losses if they occurred. According to Title 22 section 70263(q)(11)(A), "Drug list in Schedules II, III or IV of the Federal Comprehensive Drug Abuse Prevention and Control Act of 1970, as amended, shall be destroyed in the presence of two pharmacists or a pharmacist and a registered nurse employed by the hospital. The name of the patient, the name of the strength of the drug, the prescription number, the amount destroyed, the date of destruction and the signatures of the witnesses required above shall be recorded in the patient's medical record or in a separate log. Such log shall be retained for at least three years."

Findings:

During a meeting with Rx2 on April 18, 2012 starting at 8:30 a.m., he stated that nurses monitor narcotic waste not pharmacy. During an interview with RN3 on April 17, 2012 starting at 11:25 a.m., she stated she monitors the use of narcotics but cannot always ensure all unused portions are being wasted appropriately as she is very busy. During a meeting with Staff D on April 19, 2012 starting at 1:30 p.m., she provided a document which identified her review for the use and waste of narcotics on her unit. Although there were OK's marked on the document there were no initials of the reviewing person and no date which identified when the document was reviewed. Staff D stated she does not initial or date her reviews. Staff D was asked for previous review documentation. Staff D could not provide the documentation and stated she does not save them. Staff D stated that if there is a problem she notifies pharmacy.

There is no evidence of who reviewed the narcotic waste or when such a review occurred. There are no records kept of such a review. There is no evidence Pharmacy is notified or involved. Therefore, there is no evidence Pharmacy ensures that narcotic waste is controlled, disposed of properly and not abused.