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Based on observation, interviews, clinical record and administrative document review, the facility failed to have a governing body which took full legal responsibility for determining, implementing, and monitoring policies and procedure when:

1) The governing body failed to approve policies and procedures which detailed the process by which physicians, pharmacists and nurses provided oversight of medications received by patients by way of home infusion pump (medical device used to deliver fluids into a patient ' s body in a controlled manner). (refer to A405 findings 1, 2; and A500 findings 1, 2, 3)

2) The governing body failed to monitor and oversee pharmaceutical and nursing services; and policies and procedures meant to minimize drug errors. (refer to A 405 findings 1, 2; A 395 findings 1, 2; A 494; A 500 findings 1, 2, 3, 4)

3) The governing body failed to monitor and evaluate quality indicators related to improved health outcomes and the prevention and reduction of medical errors. (refer to A 309 findings 1 and 2)

The cumulative effects of these systemic problems resulted in the facility's inability to ensure the provision of quality health care in a safe environment.

Based on staff interview, clinical record and administrative document review, the hospital failed to ensure than an ongoing, hospital-wide, data driven quality assessment and performance improvement (QAPI) program was maintained when:

1. The Quality Assessment Performance Improvement (QAPI) committee made no effort, as a result of Patient 1's death, to develop, revise, nor implement new policies and procedures for the practice of monitoring patients on high dose narcotics. (refer to A 309, finding 1, A 500, A 405, A 395)

2. The Quality Assessment Performance Improvement (QAPI) did not have an active surveillance and current project to identify and direct staff on non-hospital medications and equipment use. (refer to A 309, finding 2; A 405, A 500)

a. The QAPI committee was unaware of the hospital staffs' failure to follow policy when patients came to the hospital on intravenous (IV- directly into a vein) medications received at home by an infusion pump (a medical device used to deliver fluids into a patient ' s body in a controlled manner). (refer to A 309, finding 2, A 405, A 395, A 500)

b. Pharmacists did not observe and identify medications being administered to patients by the patients' home infusion pumps; or verify there was a valid physician order for the home infusion while at the hospital, per hospital policy and procedure. (refer to A 309, finding 2)

The cumulative effects of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.

Based on observation, staff interview and clinical record review, the hospital's governing body failed to ensure that an ongoing program for quality improvement and patient safety, which included the reduction of medical errors, was implemented when:

1. The Quality Assessment Performance Improvement (QAPI) committee made no effort, as a result of Patient 1's death, to develop, revise, nor implement new policies and procedures for the practice of monitoring patients on high dose narcotics.

2. The Quality Assessment Performance Improvement (QAPI) did not have an active surveillance and current project to identify and direct staff on non-hospital medications and equipment use. The QAPI committee was unaware of: a) the hospital staffs' failure to identify patients which came to the hospital on intravenous (IV- directly into a vein) medications, brought from home and administered at the hospital, by the patients' home infusion pumps (a medical device used to deliver fluids into a patient ' s body in a controlled manner); and b) Pharmacists did not observe and identify medications being administered to patients by the patients home infusion pump or verify there was a valid physician order for the home infusion to continue.

These failures resulted in QAPI not having an active and robust program to identify care issues in the hospital.
Findings:

1. Patient 1 was admitted on 8/13/13, and administered Dilaudid (an opioid narcotic medication) for abdominal pain. The clinical record indicated Patient 1 was not monitored (Registered Nurse assessments and evaluations) according to hospital policy and procedure. As a result, Patient 1 was found unresponsive and pronounced dead on 8/14/13 at 3:15 a.m. The autopsy report indicated Patient 1's death was attributed to Dilaudid toxicity (poisoning).

On 7/8/14 at 3 p.m., during a group interview, the autopsy report and cause of death for Patient 1 was discussed. The group included the Director of Pharmacy (DOP), the Director of Risk Services (DRS), and the Vice President of Medical Affairs (VPMA). The autopsy report indicated: "Cause of death: sudden cardiorespiratory arrest. Due to: Acute hydromorphone [Dilaudid] intoxication." The autopsy findings indicated, "...10. Postmortem toxicology: supratherapeutic (potentially toxic) blood level of hydromorphone; negative for ethanol [alcohol] and illicit [illegal] drugs..." When the results were discussed with the group, the VPMA stated he interpreted the autopsy report as a basic cardiac arrest. The VPMA stated the hospital's interpretation of the autopsy results was not an overdose of Dilaudid because Patient 1 took oxycontin (potent oral opioid pain reliever) at home.

The QAPI committee evaluated the hospital's current policy for Dilaudid administration. The committee looked at the wording which indicated Dilaudid should not be given more often than every 3 hours and discussed changing the wording to "shall not be given more often than every 3 hours." The DOP stated the committee had not wanted to change the policy.

On 7/9/14 at 2:05 p.m., during an interview, the DRS stated the incident involving Patient 1 was determined to not be a reportable event and not a medication error. According to the DRS, the contributing issues identified during the root cause analysis (RCA- a method of problem solving that tries to identify faults or problems) included: 1) the geographic location of the patient room assigned to the nurse caring for Patient 1; 2) pain scale assessment; 3) every 2-hour rounding; 4) sedation monitoring after narcotic administration; 5) patient specific health status such as weight, prior history, and opioid tolerance. The DRS stated after completing the RCA, she could not say why the event happened. The DRS stated there had been no modifications to current policy and procedures, and no changes were recommended in nursing practice as a result of the RCA. The DRS stated there was no disciplinary action taken. The DRS stated the incident did not trigger an opportunity to provide education and training. When asked whether or not data was collected or surveillance was initiated in order to substantiate the decision made; or quality improvement programs or projects were initiated as a result of this incident, the DRS stated 'no'.

2. Patient 5 was selected as part of the survey sample by requesting a hospital report on the use of Narcan (a medication to reverse the effects of narcotics) for the previous month (6/9/14 - 7/9/14). The hospital did not use this list to survey for potential problems. The hospital did not identify the use of the home infusion pump, the home medication use and the nursing staff administering of home medications without a valid physician order.

Patient 5 was admitted on 7/1/14, with a Dilaudid (an opioid narcotic) infusion pump from home. The clinical record indicated nursing staff did not know how to use the home infusion pump, did not know the name, type and dose of the medication being infused. Nursing staff continued to administer the medication and use the infusion pump despite not having a valid physician order.

On 7/10/14 at 9:25 a.m., during an interview, the Chief Nursing Officer (CNO) stated there was no documentation in Patient 5's clinical record of the following: a home infusion pump administering a high risk medication; verification by a hospital pharmacist of the medication brought from home; or the dose of Dilaudid being administered. The CNO stated Patient 5's physician order, dated 7/1/14 at 1:50 a.m., for use of Dilaudid was incomplete.

On 7/10/14 at 10:10 a.m., during an interview, the Director of Pharmacy (DOP) stated, "There's no excuse for what pharmacy did. They [pharmacists] should have followed up on the doctor's order. The patient [Patient 5] was still here. They should have followed up on the incomplete physician order that could not be implemented."

On 7/11/14 at 2:05 p.m., during an interview, the 4th floor Clinical Nurse Manager (CNM) 2 stated she should have been notified Patient 5 was receiving a high risk, high alert medication, because charge nurses were supposed to email her that information. CNM 2 stated she was not informed.

On 7/11/14 at 3:30 p.m., during a group interview, the CNO and Director of Risk Management stated there was no active QAPI project or surveillance that would have identified the care issues associated with home infusion pumps, home medications, physician orders, high risk drugs, evaluating and monitoring patient care.

On 7/11/14 at 12:32 p.m., during an interview, the CNM 2 stated, "On 7/1/14 at 3:22 a.m., through 7/2/14 at 8:57 a.m., [Patient 5] received home Dilaudid without staff identifying the medication, the concentration, or the rate of infusion." CNM 2 stated she had never seen a pharmacist come to a nursing unit to look at a patient's home medications and/or equipment.

Based on observations, staff interviews, clinical record and administrative document review, the hospital failed to ensure nursing service was organized when:

1. Patient 1 was not monitored by the nursing staff in accordance with policy and procedure after being administered Dilaudid (opioid narcotic pain medication) intravenously (IV), a high risk medication (drugs that bear a heightened risk of causing significant patient harm when they are used in error). (Refer to A 395, finding 1)

2. Independent double checks (verification by two licensed nurses) were not done by nursing staff for Patient 5 when changing/decreasing the rate of an opioid narcotic medication infusion as required by hospital policy. (refer to A 405, finding 4)

3. Patient 5 was admitted from home with a high risk narcotic (Dilaudid) infusion pump (a medical device used to deliver fluids into a patient ' s body in a controlled manner) and did not have adequate and accurate nursing oversight for over 28 hours. (refer to A 395, finding 2a, 2b. 2c)

4. Patient 5 was admitted from home and administered a high risk narcotic (Dilaudid) infusion without a hospital physician's order. (Refer to A 405, finding 3)

The cumulative effect of the systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.

Based on observation, staff and family interview, clinical record and administrative document review, the hospital failed to ensure a registered nurse (RN) supervised and evaluated the nursing care for each patient for 2 out of 31 patients sampled (Patients 1 and 5) when:
1. Patient 1 was not monitored according to the hospital's policy and procedure (P&P) by RN 2 after administering several doses of a high risk medication, Dilaudid (opioid narcotic pain medication), intravenously (IV).
2. For Patient 5 on admission:
a. RN 5 inaccurately evaluated and documented the Dilaudid home infusion as a "morphine pump".
b. Nursing staff did not identify, document, and evaluate the concentration, the dose, the rate, the route, and the amount in the Dilaudid bag attached to the home infusion pump for Patient 5.
c. Nursing documentation on the Admission Medication Reconciliation Order/Form (Recap) inaccurately listed the home Dilaudid dose as 6 milligrams (mg) by mouth every 4 hours as needed. The inaccuracy in the Recap was with the route.

These failures resulted in not assessing for adverse effects of Dilaudid and which may have contributed to the death of Patient 1 and the over sedation of Patient 5.

Findings:

1. Patient 1's clinical record indicated he was a 34 year old male admitted to the hospital on 8/13/13, and was prescribed Dilaudid for abdominal pain.

On 7/9/14 at 7:45 a.m., during an interview, RN 2 did not initially remember the dose of pain medicine he gave to Patient 1. When reminded that it was 4 mg, RN 2 stated, "I don't know why that didn't strike me [as a high dose] at the time." (usual IV dosage would be 1-2 mg every 2-3 hours) RN 2 stated he did not recall giving 4 mg Dilaudid IV to any other patient (meaning the high dose of 4 mg). RN 2 stated he is sure he checked on Patient 1 "sometime between 11 p.m. and 12 a.m., but "it probably wasn't 11:30 (as indicated in the electronic record)." RN 2 stated he didn't check on Patient 1 again, until [8/14/13] 2:56 a.m., when he found Patient 1 unresponsive (3 hours and 26 minutes after the last time checked). RN 2 stated most of his documentation was "late entry" because he was very busy that night. He stated he believed the charting was accurate for when Patient 1 was checked on after he received pain medication. RN 2 stated he should have monitored Patient 1 more closely.

According to the electronic medication administration record (e-MAR) dated 8/13/13, RN 2 did not document Patient 1's pain and sedation level following the two Dilaudid 4 mg IV doses administered at 8:02 p.m. and 10:07 p.m.

No documented evidence was provided that RN 2 monitored Patient 1's respiratory status, blood pressure and pain scale after administering the Dilaudid IV doses.

On 7/8/14 at 10 a.m., the 5th floor Clinical Nurse Manager (CNM) 1 stated, "I've tried to emphasize documentation telling nurses to paint a picture of patients' condition. Documentation by both day and night nurses [for Patient 1] was not good."

On 8/14/13 at 2:56 a.m., Patient was found unresponsive and was pronounced dead at 3:15 a.m., after unsuccessful attempts at resuscitation.

The hospital's policy and procedure titled, "Hydromorphone (Dilaudid) Intravenous Dosing of" policy number MM-396, dated 12/11, indicated, "1. Policy: Due to the potential adverse outcomes associated with the use of hydromorphone (Dilaudid) [the hospital] staff will assure that the appropriate dose is administered and appropriate monitoring is performed for all patients who require hydromorphone for pain control... IV. Guidelines: ...D. Hydromorphone should not be administered more frequently than every three (3) hours...E... the administration of hydromorphone is known to cause life threatening respiratory depression even at recommended doses therefore patient monitoring as described below is essential. F. Patient Monitoring: 1. Sedation level requires evaluations of: a. Respiratory status and changes in blood pressure performed within thirty (30) minutes of administration. b. Pain relief requires evaluation with pain scale....G. Documentation 1. Monitoring values for sedation and pain relief will be recorded in the electronic medical record."

The hospital's policy and procedure titled, "Hourly Rounds" implemented 5/2013 indicated, ". . . Nursing personnel will round every hour from 0600 (6 a.m.) - 2200 (10 p.m.) and every two hours from 0000 (12 a.m.) - 0600, and more frequently if the patient's condition requires it. . ."

2. a. On 7/11/14 at 12:32 p.m., during concurrent interview and clinical record review, the 4th Floor Clinical Nurse Manager (CNM) 2 stated the hospital form "Admission History and Physical" dated 7/1/14 at 3:49 a.m., indicated Patient 5 was admitted to the hospital with a "morphine pump." CNM 2 stated the notes which indicated "morphine pump" were not accurate because the pump should have been documented as a 'Dilaudid pump'.

2. b. On 7/11/14 at 12:32 p.m., during a concurrent interview and clinical record review, CNM 2 stated Patient 5 was admitted to the 4th Floor on 7/1/14 at 2:13 a.m. Patient 5 was admitted with a home infusion of Dilaudid- a high risk opioid narcotic. The clinical record did not document the concentration of the home infusion medication, the route of administration, the dose the home pump was set at for the continuous infusion or the additional patient controlled doses which were available upon patient request, if needed, depending on pain. CNM 2 stated, "We need to know these things."

2. c. On 7/11/14 at 12:32 p.m., during a concurrent interview and clinical record review, the CNM 2 stated the recap orders entered by the admission nurse indicated Patient 5's Dilaudid taken at home was recorded as being taken by mouth. The CNM 2 stated, "The nurse documented the Dilaudid as being taken by mouth. I do not see IV Dilaudid, by home infusion pump, which is what it should have said."

Based on observation, staff interview, clinical and administrative record review, the facility failed to ensure policies and procedures (P&P) were implemented for safe administration of medications for 4 of 31 patients, (Patients 1, 5, 19 and 20) when:
1. Patients 1, 5, 19 and 20 were administered opioids (narcotic pain medication) without adequate monitoring of potential adverse effects. This failure had the potential of exposing patients to serious side effects including respiratory depression, over sedation and death.
2. Hospital staff allowed Patient 5's home Dilaudid medication administration to continue at the home infusion rate, on the home infusion pump, without a hospital physician's order, and/or nursing and pharmacy oversight which was not in accordance with hospital policy and procedure.

These failures resulted in unsafe administration of the drug Dilaudid (opioid narcotic pain medication), which may have contributed to the death of Patient 1, and the over sedation of Patient 5.

Findings:
1. a) Patient 1's clinical record indicated he was a 34 year old male admitted to the hospital on 8/13/13, and was prescribed Dilaudid for abdominal pain.

On 7/9/14 at 7:45 a.m., during an interview, RN 2 did not initially remember the dose of pain medicine he gave to Patient 1. When reminded that it was 4 mg, RN 2 stated that he didn't realize, at the time, it was an unusually high dose (usual IV dosage would be 1-2 mg every 2-3 hours). RN 2 stated he did not recall ever giving that high a dose [Dilaudid 4 mg IV] to any other patient. RN 2 stated he was sure he checked on Patient 1 "sometime between 11 p.m. and 12 a.m., but it probably wasn't 11:30 p.m., [as indicated in the electronic record]." RN 2 stated he didn't check on Patient 1 again until 2:56 a.m., (8/14/13) when he found him unresponsive (3 hours 26 minutes after the last time checked). RN 2 stated most of his documentation were "late entries." RN 2 stated he should have monitored Patient 1 more closely.

According to the electronic medication administration record (e-MAR), dated 8/13/13, RN 2 did not document Patient 1's pain and sedation level following the two Dilaudid 4 mg IV doses administered at 8:02 p.m. and 10:07 p.m.

No documented evidence was provided that RN 2 monitored Patient 1's respiratory status, blood pressure and pain scale after administering the Dilaudid IV doses.

On 7/8/14 at 10 a.m., the 5th floor Clinical Nurse Manager (CNM) 1 stated, "I've tried to emphasize documentation telling nurses to paint a picture of patients' condition. Documentation by both day and night nurses [for Patient 1] was not good."

On 8/14/13 at 2:56 a.m., according to the clinical record, Patient 1 was found unresponsive and was pronounced dead at 3:15 a.m., after unsuccessful attempts at resuscitation.

1. b) Review of Patient 5's clinical record indicated that she was admitted to the facility on 7/1/14, with diagnoses which included colon cancer, a urinary tract infection, and altered level of consciousness.

Review of Patient 5's 7/2/14, eMAR (electronic Medication Administration Record) indicated a high dose Dilaudid IV infusion 10 mg/ml (Lexicomp indicated for Dilaudid infusion: Usual dosage range: 0.5-3 mg/hour) was initiated at 1:08 p.m., at a rate of 6 mg/hour. The eMAR indicated a reassessment of pain and POSS (Pasero Opioid-Induced Sedation Scale- used to monitor and evaluate sedation level) done 30 minutes later at 1:38 p.m. The next POSS was documented on 7/3/14 at 7:20 a.m. (17 hours later) when the Dilaudid IV bag was changed.

On 7/9/14 at 2:28 p.m., during an interview, the Interim Director of Surgery (Dir) 1 confirmed the POSS was only documented on the eMAR 30 minutes after initiation of an infusion and on changing of the bag (17 hours later).

1. c) Review of Patient 19's clinical record indicated that she was admitted to the facility on 6/19/14 with pelvic pain. Patient 19's physician orders on 6/19/14 included the following PCA's (patient controlled analgesia; which allows a patient to self-administer small amounts of pain medications through the vein as needed): On 6/19/14 at 9:40 a.m., morphine (opioid medication for pain) 1 milligram (mg)/ milliliter (ml); and on 6/19/14 at 3:50 p.m., meperidine (opioid medication for pain) 10 mg/ml.

Review of Patient 19's nurse's notes for 6/19/14 at 4:50 p.m., indicated Patient 19's PCA was changed from morphine to meperidine at 4:40 p.m., due to increased pain.

Review of Patient 19's "24 hour pain management flow sheet" for PCA's, indicated the meperidine PCA was started at 4:40 p.m. Assessment of Patient 19's respiration rate and sedation level was also done at that time. The next assessment for Patient 19's respiration rate and sedation scale was documented at 5:30 p.m. (50 minutes after starting meperidine PCA). The narrative entry at 5:30 p.m. indicated "Pt feeling tired going to take a nap." The next assessment that included a sedation scale was done on 6/20/14 at 1:52 a.m. (8 hours later).


On 7/9/14 at 9:50 a.m., during an interview, the Director of Surgery (Dir1) stated assessments on Patient 19's respiration rate and sedation were not done in accordance with PCA protocol.

Review of "24 hour pain management flow sheet" for PCA, indicated the following PCA assessment intervals: every 15 minutes x 2; every 30 minutes x1, every hour x2, every 4 hours x3 and every 12 hours thereafter. The flow sheet indicated an assessment requirement for pain, respiration rate and level of sedation.

1.d) Review of Patient 20's clinical record indicated she was admitted to the hospital on 6/22/14, with a diagnosis of ectopic pregnancy (when an embryo implants somewhere other than the uterus). Patient 20's physician orders on 6/22/14 at 1 p.m., included meperidine 10 mg/ml PCA.

Review of Patient 20's "24 hour pain management flow sheet" for PCA's indicated meperidine PCA was initiated at 2:14 p.m. and assessments for respiration rate and level of sedation were done at 2:14 p.m., 2:30 p.m., and 2:45 p.m. The next assessments for level of sedation were documented as:
On 6/22/14 at 5:30 p.m. (2 hours and 45 minutes later); On 6/22/14 at 8 p.m. (2 hours and 30 minutes later); On 6/23/14 at 7:55 a.m. (nearly 12 hours later); and 6/23/14 at 8 p.m. (12 hours later).

During an interview on 7/9/14 at 10:22 a.m., Dir 1 stated that PCA monitoring was not done in accordance with protocol and the monitoring intervals of 30 minutes x1, and 1 hour x2, and 4 hours x3 were not followed.

The hospital's policy and procedure titled, "Hydromorphone (Dilaudid) Intravenous Dosing of" policy number MM-396, dated 12/11, indicated, "1. Policy: Due to the potential adverse outcomes associated with the use of hydromorphone (Dilaudid) [the hospital] staff will assure that the appropriate dose is administered and appropriate monitoring is performed for all patients who require hydromorphone for pain control... IV. Guidelines: ...D. Hydromorphone should not be administered more frequently than every three (3) hours...E... the administration of hydromorphone is known to cause life threatening respiratory depression even at recommended doses therefore patient monitoring as described below is essential. F. Patient Monitoring: 1. Sedation level requires evaluations of: a. Respiratory status and changes in blood pressure performed within thirty (30) minutes of administration. b. Pain relief requires evaluation with pain scale....G. Documentation 1. Monitoring values for sedation and pain relief will be recorded in the electronic medical record."

The hospital's policy and procedure titled, "Hourly Rounds" implemented 5/2013 indicated, ". . . Nursing personnel will round every hour from 0600 (6 a.m.) - 2200 (10 p.m.) and every two hours from 0000 (12 a.m.) - 0600, and more frequently if the patient's condition requires it. . ."

Review of facility policy " Pain, Assessment and Management of " dated 9/13 indicated, "Use the POSS to monitor sedation in patients receiving any form of opioids (oral, topical, IV, rectal)." The policy did not address frequency of the POSS scale assessment.

According to Lexi-Comp, a nationally recognized drug information provider for health care professionals, patients on opioids should be monitored for respiratory, mental status, blood pressure and pain relief. Overdose of opioids may cause excessive sedation, respiratory depression, low blood pressure and slow heart rate which may lead to serious adverse outcome if not intervened timely.

The Institute for Safe Medication Practices (ISMP), a non-profit organization educating the healthcare community and consumers about safe medication practices, issued a medication safety alert, dated 5/30/2013, which indicated, "...Sedation is an extremely useful assessment parameter to observe the clinical effects of opioids. In fact, sedation is the most important predictor of respiratory depression in patients receiving IV opioids-a fact that only 22% of physicians, pharmacists, and nurses knew when taking a recent opioid knowledge assessment.(5) Sedation generally precedes significant respiratory depression. While pain can counteract opioid-induced respiratory depression, sleep can intensify the depressant effects. In addition, as carbon dioxide levels increase with respiratory depression, patients experience a reduced level of consciousness that is additive to the opioid sedative effects.(1) Thus, for patients receiving PCA, early recognition of excessive sedation and intervention is essential... "

2. On 7/10/14 at 9:25 a.m., during a concurrent interview and record review, the Chief Nursing Officer (CNO) stated Patient 5's home Dilaudid medication administration continued without documentation in the clinical record of the pump name, drug verification by a hospital pharmacist, or dose of Dilaudid that was being administered to Patient 5. The CNO stated the physician order, dated 7/1/14 at 1:50 a.m., for Patient 5's Dilaudid was not complete.

On 7/10/14 at 9:40 a.m., during a concurrent interview and review of the clinical record, the Director of Pharmacy (DOP) stated Patient 5 received an unknown amount of Dilaudid for at least 24 hours. The DOP stated a phone call placed by a pharmacist to the physician for clarification of the Dilaudid 1-7 mg (milligrams - a measure of weight) per hour order (written on 7/1/14 at 1:50 a.m.), was not documented. The pharmacy put the order on hold because the medication order was written incorrectly and could not be implemented. He stated the pharmacy did not follow up on the request for clarification of the order. The DOP stated the pharmacy should have followed up on a hold order. He stated a hospital pharmacist did not verify the home pain pump until 7/2/14 at 6 a.m. (28 1/2 hours after admission of 7/1/14 at 1:30 a.m.)

On 7/11/14 at 9 a.m., during an interview, the Registered Nurse (RN) 4 stated she was assigned to care for Patient 5 on 7/1/14. RN 4 stated she had "no idea" how much Dilaudid was being administered to Patient 5 via the home pump. RN 4 stated she did not document in the clinical record that Patient 5 was receiving Dilaudid via the home infusion pump. RN 4 stated, "I should have."

On 7/11/14 at 12:10 p.m., during an interview, Pharmacist 3 (Pharm 3) stated the process for identification of patient's home medications involved calling the nursing unit and trusting the information nurses gave them regarding the patient's home medications. Pharm 3 stated, "The pharmacist did not independently identify the home medication." Pharm 3 stated "... We do not leave (the pharmacy) and go to the (patient care) units to look at it (patient home intravenous medications) ourselves..."

On 7/11/14 at 12:32 p.m., during an interview, the CNM 2 stated, "On 7/1/14 at 3:22 a.m., through 7/2/14 at 8:57 a.m., [Patient 5] received home Dilaudid without staff identifying the medication, the concentration, or the rate of infusion." CNM 2 stated she had never seen a pharmacist come to a nursing unit to look at a patient's home medications and/or equipment.

The hospital's policy and procedure titled, "Physician (Licensed Independent Practitioner) Orders," implemented 7/2012, indicated, "When receiving a LIP's (Licensed Independent Practitioner) order that is questionable or that deviates from standard patient care practices(s), the nurse will contact the ordering LIP and discuss it with him/her. Following this discussion, if a question remains, the nurse will: 1. Contact the attending LIP (if other than the LIP who wrote the order) and, attempt clarification with him/her. 2. If no resolution occurs, contact the Department Director, or the Administrative House Supervisor (AHS) depending on availability and time of day. If further intervention is necessary, the AHS/Director will contact: a) Chief Nurse Executive or Administrator on-Call; b) Medical Staff Department Chairperson; c) Chief of Medical Staff; d) Vice President of Medical Affairs..."

Based on observations, staff interview, clinical record and administrative document review, the hospital failed to ensure the provision of pharmaceutical services was safe and effective and met the needs of patients evidenced by the following:

1. Policies and procedures were not implemented for safe administration and monitoring of drugs. (Refer to A 0405)

2. Lorazepam (medication used for anxiety) vials were not stored in a refrigerator in accordance with manufacturer storage requirements. (Refer to A 491)

3. Facility failed to maintain accurate records of scheduled or controlled (drugs which have strict prescribing and availability because of their potential for addiction or abuse) drugs when patient's home drugs were stored in the pharmacy and documented as destroyed. (Refer to A 494)

4. Policies and procedures were not developed and implemented for distribution and control of drugs to ensure patient safety. (Refer to A 0500, findings 1, 2, 3 and 4)

For A 500 finding 1: On 7/10/14 at 12:20 p.m., an Immediate Jeopardy (IJ) was called with the hospital Administration due to the failure of the hospital to ensure safe administration and distribution of Patient 5's personal (own) medication. The hospital submitted an approved Action Plan and monitoring occurred on 7/11/14, 7/12/14, 7/13/14, 7/14/14 and 7/15/14 to determine whether the hospital implemented all elements of the Action Plan. The IJ was abated on 7/15/14 at 2:38 p.m.

The cumulative effects of these systemic problems resulted in the facility's inability to provide pharmaceutical services and care in a safe and effective manner in accordance with the Conditions of Participation: Pharmaceutical Services.

Based on observation, staff interview and administrative document review, the hospital failed to follow manufacturer storage requirements when eight lorazepam (medication for anxiety) injection vials were not stored in the refrigerator. This failure had the potential of exposing patients to ineffective treatment or infections due to potentially deteriorated or contaminated drugs.
Findings:
During a tour of the Intensive Care Unit (ICU) with the Director of Pharmacy (DOP) on 7/7/14 at 3:20 p.m., an automated dispensing cabinet (ADC) was observed in the medication storage room. Inspection of the ADC showed seven vials of lorazepam 2 milligrams (mg)/milliliter (ml) in a drawer, at room temperature. The vials were placed in two clear plastic bags with dates of 7/26/14 and 8/5/14. The bag dated 7/26/14 had two vials in it, and the bag dated 8/5/14 had five vials in it. Review of the label on the lorazepam vial indicated "Refrigerate." The DOP stated the dates on the bags indicated how long the lorazepam vials can be stored out of the refrigerator. DOP stated that the vials of lorazepam were stored up to 30 days out of the refrigerator.

On 7/7/14 at 3:40 p.m. one vial of lorazepam was observed in an ADC stored at room temperature in the Labor and delivery department.

During an interview on 7/8/14 at 10:10 a.m. the DOP stated that the manufacturer of the lorazepam vials did not allow for storage out of the refrigerator.

Review of the manufacturer's product information insert revised June 2011 for lorazepam indicated "...for IM (intramuscular) or IV (intravenous) injection store in a refrigerator..."

Based on observation, staff interview, and administrative document review, the hospital failed to ensure that policies and procedures (P&P) were implemented for accurate records of disposition of controlled substances (controlled drugs - for example opioids (pain reliever) and sedatives (tranquilizer) which are given a schedule by the Drug Enforcement Agency because of their risk for abuse) when patients' personal controlled drugs were stored in the pharmacy and documented as wasted. This failure created the potential risk of drug diversion (the use of prescription drugs for recreational purposes) and possible medication errors.

Findings:

On 7/7/14 at 2 p.m., a concurrent tour of the pharmacy with an observation of an automated dispensing cabinet (ADC) and interview with the Director of Pharmacy (DOP) was conducted. The bottom two shelves of the ADC had clear plastic bags with drug vials. One of the clear bags was dated 8/10/13. The contents of the bag included a vial of 65 tablets of alprazolam (a controlled medication for anxiety) 1 milligram (mg), and 31.5 tablets of Norco (a controlled opioid pain medication) 10/325 mg for Patient 31. The DOP stated the clear bags contained a discharged patient's own controlled medications and were awaiting destruction by the pharmacist.

Review of "Patients Medication Storage" (PMS) sheet, dated 8/10/13, for Patient 31 indicated, "Meds destroyed by: [initials of staff] Date: 9/19." The medications listed on the sheet included alprazolam 1 mg and Norco 10/325 mg.

On 7/7/14 at 2 p.m., during an interview, the DOP acknowledged the PMS indicated the medications were destroyed. The DOP stated the initials were probably for the non-controlled medications on the document but there were no separate entries on the form for controlled and non-controlled medications.

Inspection of the remaining clear plastic bags revealed four bags with controlled medications waiting to be destroyed, which dated back to December 2013.

Review of hospital P&P titled, "Patient medication storage while admitted," dated 10/13 indicated, "Medications not claimed will be stored for at least 30 days after discharge. After at least 30 days the medications will be destroyed according to regulations. Destruction will be documented on the POM (Patient own medication) log by listing the date destroyed and the initials of the person destroying.

The facility policy did not address who was responsible for destruction of controlled drugs.

Based on observation, interviews, clinical record and administrative document review, the hospital failed to develop and implement policies and procedures (P&P) for the distribution and control of drugs to ensure patient safety when:
1. Patient 5's own home medication of high potency (higher concentration than supplied by the hospital) Dilaudid (hydromorphone, opioid narcotic pain medication) intravenous (IV- injected through the vein) infusion pump was not identified by a pharmacist and the dose of Dilaudid administered was not evaluated or documented in the clinical record. This failure led to over sedation of Patient 5 and had the potential of causing severe respiratory depression (inadequate breathing, less than 10 breaths per minute) and death.

On 7/10/14 at 12:20 p.m., an Immediate Jeopardy (IJ) was called with the hospital Administration due to the failure of the hospital to ensure safe administration and distribution of Patient 5's personal (own) medication. The hospital submitted an approved Action Plan and monitoring occurred on 7/11/14, 7/12/14, 7/13/14, 7/14/14 and 7/15/14 to determine whether the hospital implemented all elements of the Action Plan. The IJ was abated on 7/15/14 at 2:38 p.m.

2. Patient 5's change in rate of infusion of IV (intravenous - within the vein) Dilaudid was not documented in the clinical record. This failure had the potential of exposing Patient 5 to medication errors resulting in over sedation.

3. Multi dose vials of injections were accessed in patient treatment areas in the emergency and operating rooms and used on multiple patients. This failure had the potential of exposing patients to infections due to contamination.

4. Single use Intravenous (IV - within the vein) bags of sodium chloride (salt water solution) for injection were used to prepare syringes for multiple patients for use up to 24 hours with a potential of exposing patients to infections due to contamination.

Findings:

1. Review of a list of patients, provided by the hospital, who had Narcan (used to reverse adverse effects of opioid drugs including over sedation and respiratory depression) 0.4 milligram (mg)/ milliliter (ml) injection removed from the automated dispensing cabinet from 6/9/14 to 7/9/14 indicated that Patient 5 was on the list.

On 7/9/14 at 2:15 p.m., a review of Patient 5's clinical record was conducted. A physician order dated 7/1/14 at 1:30 a.m., indicated she was admitted to the facility with colon cancer, a urinary tract infection, and altered level of consciousness. A physician order dated 7/1/14 at 1:50 a.m., indicated a telephone order for Dilaudid (hydromorphone, opioid for pain) IV (intravenous, injected through the vein) infusion 1000 mg (Dilaudid)/100 ml (normal saline - solution of salt and water) "1-7 mg/hr" with "a bolus (extra dose of medication) of 1 mg IV q (every) 10 min (minutes) prn (as needed) pain."

Review of Patient 5's electronic medical record (eMAR) indicated an entry on 7/2/14 for "Dilaudid 10 mg/ml PUMP" with dose instructions indicating, "See MD's order." There was no entry on the eMAR to indicate Dilaudid 10 mg/ml Pump was being administered to Patient 5.

Review of Patient 5's nurses' notes indicated the following entries: On 7/1/14 for occurrence at 6:53 a.m., "Called pharmacy and talked to [Pharm 2] regarding Dilaudid drip. Stated pharmacy does not prepare this product [high potency Dilaudid concentration of 1000 mg/100 ml]. Stated will follow up with the chief pharmacist. [That's] why it is not in the EMAR."
On 7/2/14 for occurrence at 7:55 a.m., "RN at bedside, Pt [Patient 5] not responding verbally, breathing regular, eyes wide open [with] flat affect [no emotions or facial expression when spoken to]..."
On 7/2/14 for occurrence at 11 a.m., "RN able to talk to Dr ...All meds not given po [orally] d/t [due to] lethargy [lack of energy] not safe. MD will call our pharmacy if we have to give this patient Dilaudid IV x [multiplied by] 1 dose still working with Dilaudid drip."

On 7/9/14 at 3:35 p.m., during an interview, RN 3 stated Patient 5 was admitted with a Dilaudid pump from home. RN 3 stated Patient 5 had become very drowsy and "We did not know how to work it [the pump]." .

On 7/10/14 at 10:30 a.m., during an interview, Patient 5's daughter (RP 5) stated that she was called by the hospital mid-morning on 7/2/14 (more than 24 hours after admission) to come in and shut off the infusion pump. The RP 5 stated when she arrived at the hospital, midmorning on 7/2/14, she observed Patient 5 as being "spacey". The RP 5 stated Patient 5 was not able to talk and was not alert. The RP 5 stated she was told by the nurse her mother (Patient 5) was over medicated. The nurse had paused the pump and RP 5 had to show her how to shut the pump off. RP 5 stated the nursing staff did not know how to change the dose or rate of the Dilaudid pump.

On 7/10/14 at 2 p.m., in order to confirm the Dilaudid home infusion, an interview was conducted with a pharmacist (Pharm A) who was employed by the pharmacy that had dispensed Patient 5's at home use Dilaudid pump. Pharm A stated Patient 5's pump was set to administer a continuous dose of 8 mg/hour of Dilaudid. An additional patient-controlled dose of 3 mg Dilaudid was available every 15 minutes as needed for break-through pain (total potential dose of 20 mg/hour). Pharm A stated that the Dilaudid bag had a concentration of 10 mg/ml and a total volume of 400 ml. Pharm A stated the pump had a display which showed the amount of drug infused hourly.

On 7/10/14 at 9:25 a.m., during an interview with the Chief Nursing Officer (CNO) and the DOP, the CNO confirmed that no documentation existed in the clinical record of the pump name, drug verification by a pharmacist, or the dose of Dilaudid being administered to Patient 5. The CNO acknowledged the physician order dated 7/1/14, for Patient 5's at home Dilaudid pump was not complete. The physician prescribed a dose of 1-7 mg/hour which was not what Patient 5's home Dilaudid pump was set at; which was 8 mg/hour. The DOP stated, "The pharmacy did not identify the home Dilaudid drip being administered to Patient 5 until after 6 a.m. on 7/2/14. The pharmacy had previously phoned the physician on 7/1/14, to clarify an order which could not be implemented. The physician said don't worry about it; he was sending the patient out. The pharmacist put the order on hold and the phone call to the physician was not documented."

On 7/11/14 at 12:10 p.m., during an interview, the hospital pharmacist (Pharm) 3 stated the process for identification of patient's home medications involved calling the nursing unit and trusting the information nurses gave them regarding the patient's home medication. The patient's home medications were allowed to continue infusing without pharmacist identifying the product.

On 7/11/14 at 12:32 p.m., during an interview, CNM 2, the 4th floor Manager, confirmed Pharm 3's statements. She stated she had seen patients come in with their own medications and infusions pumps from home. She stated she had not ever seen pharmacy come to verify a patient's home medications and/or equipment.

On 7/11/14 at 2:05 p.m., during a concurrent interview and clinical record review, the 4th floor Clinical Nurse Manager (CNM) 2 stated nursing did not identify or keep track of the amount of Dilaudid Patient 5 received via her home infusion pump. The CNM 2 stated there was no documentation of the Dilaudid home infusion on the eMAR, nursing narrative or assessment notes; and it should have been in at least one of those records. She stated Patient 5 received her home Dilaudid infusion from the time of admission on 7/1/14 at 3:22 a.m., until 7/2/14 at 8:57 a.m.; for a total infusion time of over 29 hours. Review of Patient 5's physician orders indicated the following: On 7/2/14 at 8:50 a.m., "Narcan 0.4 mg IV x 1 now. Turn off Dilaudid pump x 1 hour, then restart with a reduced dose of 5 mg/hour." The CNM 2 stated Patient 5's order for Narcan was to reverse the over sedation effect of Dilaudid.

Patient 5's home Dilaudid would have been administered for a total of 29 hours, minus the hour the physician ordered the pump to be turned off, which equals 28 hours. Patient 5's dose of 8 mg/hr multiplied by 28 hours equals 224 mg of Dilaudid. This does not include the additional 3 mg of Dilaudid, every 15 minutes, available to Patient 5 as needed for pain; which had the potential of an additional 336 mg in the same 28 hours.

Dilaudid is a narcotic used for pain and carries a boxed warning which is the strongest warning the Food and Drug Administration (FDA) requires a manufacturer to put on a drug: [U.S. Boxed Warning] "May cause potentially life-threatening respiratory depression even with therapeutic use..."

Review of facility policy titled, "Hydromorphone (Dilaudid), intravenous dosing of", dated 8/13, indicated, "Due to the potential adverse outcomes associated with the use of hydromorphone (Dilaudid) ...staff will assure that the appropriate dose is administered and appropriate monitoring is performed for all patients who require hydromorphone for pain control."

Review of hospital policy titled "Medication/Device, use of patients own", dated 12/13, indicated, "Medications from home may not be administered to the patient or self administered by the patient before a pharmacist has verified the supply." The policy further indicated, "Medications administered via the device may only be given to the patient following review by the pharmacy and with the written order of the attending physician."

Because of the findings detailed in item 1, an imminent danger to the health and safety of patients related to unsafe administration of medications, Immediate Jeopardy (IJ) was called with the hospital Administration on 7/10/14 at 12:20 p.m. The following hospital staff were present when the IJ was called: RC 1, DOP, DRS, DOM, HP, VP/COO, and the CNO. The hospital submitted an approved Action Plan on 7/11/14 at 4:15 p.m. The Action Plan revolved around modifications to the hospital's policy and procedure (P&P) on Medication Management titled, "Medication/Device, use of patients own," which included:
1. Nursing was to notify Pharmacy when a patient was admitted with home medications being administered intravenously.
2. Pharmacists were required to personally visualize and verify the medication and dose being administered.
3. Pharmacist were given the responsibility to contact the physician for a valid medication order for the same medication to furnished by the hospital, or for a substitute medication to be furnished by the hospital.
3. All licensed staff were to sign off that they had read and reviewed the new P&P before the start of their next shift.
The hospital had not fully addressed or implemented the items on the approved Action Plan by the exit of 7/11/14. Monitoring for implementation of the approved Action Plan occurred on 7/11/14, 7/12/14, 7/13/14, 7/14/14 and 7/15/14 to determine whether the hospital implemented all elements of the Action Plan. The IJ was abated on 7/15/14 at 2:38 p.m.

2. Review of Patient 5's clinical record indicated that she was admitted to the facility on 7/1/14 with diagnoses including urinary tract infection and altered level of consciousness.

Review of Patient 5's physician orders included the following: on 7/2/14 at 10:49 a.m., Dilaudid infusion at 6 mg/hour; on 7/3/14 at 7:53 a.m., decrease Dilaudid infusion to 4 mg/hour.

On 7/9/14 at 3:15 p.m., during an interview, the Director of Pharmacy (DOP) stated the Dilaudid infusion was ordered on 7/2/14 at 6 mg/hour and the rate was changed to 4 mg/hour on 7/3/14 at 7:59 a.m. per physician order. The DOP acknowledged that the eMAR reflected a rate of 4 mg/hour (not 6 mg/hour) for 7/2/14.

The DOP showed the surveyor the history on the eMAR for 7/2/14 that indicated pharmacy edited the Dilaudid infusion rate at 7:59 a.m. from 6 ml/hour to 4 ml/hour per physician order.

There was no documentation on the eMAR showing that nurses changed the rate of Dilaudid infusion on 7/3/14 at 7:59 a.m. from 6 mg/hour to 4 mg/hour. The next documentation was during the Dilaudid bag change on 7/4/14 at 6:50 a.m. showing a rate of 4 mg/hour was being administered.

On 7/10/14 at 8:30 a.m., during an interview, the DOP confirmed that on 7/3/14 the Dilaudid bag was changed prior to the rate change and therefore there was no documentation or double check (two licensed nurses verifying and documenting correct medication dose)noting the rate change. The DOP acknowledged there was no way of identifying on Patient 5's clinical record whether Patient 5 received 6 mg/hour or 4 mg/hour from 7/3/14 at 7:59 a.m. to 7/4/14 at 6:50 a.m. (nearly 24 hours later).

Review of facility policy "Medication "high Alert", Administration of", dated 5/14, indicated "High-Alert" medications are those medications involved in a high percentage of errors and/or sentinel events (A sentinel event is an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof), as well as medications that carry a higher risk for abuse or other adverse outcomes. Medications considered to be "High Alert" are: Narcotic drips ...All "High-Alert" medications will have an independent double check performed and documented prior to initial administration, during dosage adjustment ..."

On 7/10/14 at 9:27 a.m., during a group interview, with the Chief Nursing Officer (CNO), the DOP, and informatics (specialization in computer and electronic records) nurse (INFO 1), the DOP stated the hospital was unaware that rate change edits on IV infusions were not showing on the nurses' status board (electronic notification board that flags patient order changes to alert nurses). The CNO, the DOP and the INFO 1 acknowledged that Patient 5's eMAR did not reflect the actual amount of high dose Dilaudid administered.

3a. On 7/8/14 at 9:20 a.m., during a tour of the emergency department, two open vials of Humulin R (insulin to control blood sugars) were observed in a refrigerator. The vials did not have a patient specific label.

In a concurrent interview, Registered Nurse (RN) 6 stated that when a patient needed insulin it was retrieved from the refrigerator and taken to the patient's bedside. RN 6 stated the insulin was drawn up at patient bedside and verified by another nurse. RN 6 further stated after the insulin was administered it was returned to the refrigerator. RN 6 confirmed that the same vial of insulin could be used on a different patient.

On 7/8/14 at 2:30 p.m., during a concurrent observation and interview, an open vial of Humulin R was observed in the refrigerator in the Peri-Operative Department (surgical area of the hospital). The open vial of Humulin did not have a patient specific label. The Clinical Nurse Manager (CNM) 3 stated the opened vial of Humulin R was used in the operating rooms and then returned to the refrigerator to be used for another patient if needed.

On 7/10/14 at 8:42 a.m., during an interview, the DOP acknowledged that the pharmacy was aware of the use of multi dose vials accessed in patient treatment areas and used in multiple patients.

On 7/10/14 at 8:42 a.m., during an interview, the Infection Control Nurse (ICN) 1 stated that it was not a good practice to use multiple dose vials in multiple patients. ICN 1 stated the hospital followed CDC (Centers for Disease Control) guidelines.

Review of the CDC 2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings page 83 indicated: "
IV.H.7. Do not keep multi dose vials in the immediate patient treatment area."

Review of CDC injection safety facts on; dated 5/2/12, indicated: "Can multi-dose vials be used for more than one patient? How? ... Multi-dose vials should be dedicated to a single patient whenever possible. If multi-dose vials must be used for more than one patient, they should not be kept or accessed in the immediate patient treatment area. This is to prevent inadvertent contamination of the vial through direct or indirect contact with potentially contaminated surfaces or equipment that could then lead to infections in subsequent patients. If a multi-dose vial enters the immediate patient treatment area, it should be dedicated to that patient only and discarded after use."

"What are examples of the immediate patient treatment area? ...Examples of the immediate patient treatment area include patient rooms or bays, and operating rooms."


3b. On 7/8/14 at 2:20 p.m., during a concurrent interview and tour of operating room 2, an anesthesia cart (cart that contains drugs and supplies needed during surgery) was observed. An opened and used single dose vial of furosemide (diuretic) 40 mg/4 ml and the following opened multiple dose vials were observed:-Lidocaine (anesthetic: numbing agent) 2% 20 ml vial; Enlon (to reverse effects of neuromuscular blockers after surgery) 150 mg/15 ml vial; Neostigmine (to reverse effects of neuromuscular blockers after surgery) 10 mg/10 ml vial. The Clinical Nurse Manager (CNM) 3 acknowledged the opened single dose and multi dose vials in the anesthesia cart.

Review of facility policy, "Multi-Dose Vials" dated 11/10 indicated, "Single unit-dose vials will be used whenever feasible and will be discarded after use." The policy did not address use of multi-dose vials in patient treatment areas.

On 7/10/14 at 8:42 a.m., during concurrent interviews, the ICN 1 stated it was the expectation to use single dose vial for single use and multi-dose vial for single patient only if accessed in patient treatment area. The DOP stated the policy does not address the use of multi-use vials in multiple patients. The DOP stated he was aware that Humulin R was used in the Emergency Department for multiple patients.

4. On 7/8/14 at 10:15 a.m., during a concurrent tour of the Computerized Tomography (CT - a specialized three dimensional x-ray) room and group interview, an opened spiked 1000 milliliter (ml) bag of Sodium Chloride 0.9% injection was observed. The manufacturer label on the bag indicated "single dose container." The label on the bag indicated, "Exp (expired) 7/8 time 22:20 (10:20 p.m.)".

The CT technician (CT Tech 1) stated the sodium chloride bag was used to fill 60 ml syringes, which were then loaded into an injection system that injects the contents of the syringe into the patient. CT Tech 1 stated that the bag of sodium chloride was opened and used to fill multiple syringes during the day for up to 24 hours.

The DOP acknowledged that the preservative free single use bag of sodium chloride should only be used to fill a syringe for immediate use (The United States Pharmacopeia Chapter 797, copyright 2014, for pharmaceutical sterile compounding indicates that immediate use is when administration begins no later than 1 hour following the start of the preparation and is not intended for batch use). The DOP stated monthly inspections were conducted in the CT department, however, pharmacy was not aware that the single use sodium chloride injection bag was used to fill syringes for multiple patients up to 24 hours after initial entry into the bag.

On 7/10/14 at 8:42 a.m., during an interview, the infection control nurse (ICN 1) stated her expectation was that a single use bag of sodium chloride injections should be for single use for a single patient. ICN 1 stated that the hospital followed CDC (Centers for Disease Control and Prevention) guidelines.

Review of the CDC 2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings page 83 indicated, "IV.H.5. Do not administer medications from single-dose vials or ampules to multiple patients or combine leftover contents for later use."

Review of CDC website www.cdc.gov dated 5/2/12, indicated, "CDC's Position - Protect Patients Against Preventable Harm from Improper Use of Single-dose/Single-use Vials: The Centers for Disease Control and Prevention's guidelines call for medications labeled as "single dose" or "single use" to be used for only one patient. This practice protects patients from life-threatening infections that occur when medications get contaminated from unsafe use."