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Based on interview and record review, the hospital failed to ensure medical staff's accountability to the governing body for the quality of medical care provided to the patients. This resulted in the following actual and potential patient outcomes.

For Patient 1, a physician ordered medical therapy based on an unfamiliar protocol and without first performing an assessment; another physician reduced sedative medication but not opioid pain medication when Patient 1 exhibited signs of oversedation, resulting in respiratory arrest for Patient 1.

For Patient 31, a physician failed to assess the patient's prior opiate history and ordered opiate pain administration via a PCA (Patient Controlled Anesthesia)pump with higher than recommended doses for opiate-naive patients, dropping her respirations, potentially putting her at risk for respiratory arrest.

For Patient 32, a physician ordered opiate pain administration via a PCA (Patient Controlled Anesthesia) pump with higher than recommended doses for opiate-naive patients, potentially putting her at risk for respiratory arrest.

Findings:

1. Medical record review on 9/29/10 showed that Patient 1 was admitted to the hospital on 8/17/10 for elective cervical spine surgery. After recovery in the post-anesthesia care unit (PACU), Patient 1 was transferred to the intensive care unit (ICU) where staff informed the surgeon that Patient 1 was exhibiting behaviors they believed was consistent with alcohol withdrawal. Patient 1 was ordered sedatives following a protocol for treatment, along with previously-ordered post-surgery intravenous opioid pain medication. Patient 1 exhibited signs of excessive sedation, developed respiratory depression, then went into respiratory arrest.

During an interview on 12/16/10 at 12:30 p.m., Patient 1's surgeon (Physician C) stated that an ICU nurse had informed him that Patient 1 was restless and acting inappropriately and she suspected that Patient 1 might be having alcohol withdrawal symptoms. Physician C said the nurse informed him that the hospital had an alcohol withdrawal protocol, "So, I just signed off on the orders." Physician C stated he was not familiar with the alcohol withdrawal protocol, nor did he assess the patient prior to signing the orders because another physician (Physician B) was assigned to care for Patient 1.

During a telephone interview on 10/8/10 at 2:30 p.m., Physician B said that all pain medication orders were managed by the surgeon, and dose adjustments to increase or decrease pain medication dosages were managed by the surgeon in conjunction with the nurses. On 8/19/10 at 8:30 p.m., Patient 1 was lethargic, a sign of oversedation. Physician B assessed Patient 1 and documented to decrease Librium and Ativan and pain medications on a progress note on 8/19/10 at 9 p.m. Physician B wrote orders to decrease the Librium and Ativan doses; however, Patient 1's opioid pain medications were not changed. Patient 1 received three mg of Dilaudid (a powerful narcotic medication) between 9 p.m. and 11:30 p.m., along with reduced doses of Librium and Ativan. Patient 1 coded on 8/20/10 at 1:24 a.m., and was in respiratory arrest.

Review of the Medical Staff Bylaws, revised 8/2010, indicated its Bylaws Committee's responsibilities, duties, and authority "Cause, through ongoing review, that the bylaws, rules and regulations reflect current practice, national standards of patient care, and an efficient organization of the Medical Staff to perform its functions."

The Chief of Medical Staff was interviewed on 12/17/10 at 10:20 a.m. He was asked how the Medical Staff was involved with hospital policies and procedures. He stated anything involving drugs, nursing, order sets went to the Pharmacy and Therapeutics Committee (P&T), then to the Medical Executive Committee (MEC) for approval. He stated the patient controlled anesthesia (PCA) order sets were reviewed by the Anesthesia/OR (operating room) committee. When questioned if the PCA order set should reflect doses for opiate naive patients. He stated that doses for opiate naive patients should have been considered.

The Chief of Medical Staff was asked if three different order sets for spinal surgery, including an order set reflecting a single surgeon's preferences and one reflecting a spine surgical practice preferences were approved by the P&T and MEC. He stated the three order sets were all approved, and acknowledged it was not ideal to have three different order sets for the same type of surgery.

The Chief of Medical Staff acknowledged there was a problem with polypharmacy (medications simultaneously ordered with similar actions and/or side effects). He stated it "...means we have to have pharmacy intervene and give alerts." He was asked if there had been hospital-wide physician education regarding incidents of opioid/sedation overdoses requiring rescue. He acknowledged review of each incident was during peer review with the individual involved physician and not systemically disseminated throughout the medical staff. He was asked if there been hospital-wide physician education for determining a patient's prior opioid use prior to ordering opioids whether by injection or PCA. He stated there had not. He stated that oversedation was not taken lightly, that there was a need to enhance monitoring of patient's respiratory status. He stated the MEC recommended that patients on PCA would be continuously monitored for oxygen saturation, a means of assessing respiratory status. He was informed the current PCA order set did not require the use of continuous pulse oximetry.

The Chief of Medical Staff was asked to comment on an order set generated for the neonatal intensive care unit (NICU) and approved for use on 7/15/10. For respiratory monitoring, an order box could be checked for "Continuous Pulse Oximetry: Notify MD of O2 Sat (oxygen saturation measured via a device) less than _____% (the physician had filled in 100) or greater than ____%. (The physician had filled in 92) The Chief of Medical Staff acknowledged the order did not make sense.

During an interview on 12/17/10 at 10:38 a.m., the DOP (Director of Pharmacy) stated that any patient on basal/continuous PCA should be on continuous oxygen saturation monitoring. The DOP stated that the PCA order set should have specified that continuous oxygen saturation monitoring should be done for patients ordered for basal or continuous PCA opioid drug delivery..

During an interview on 12/17/10 at 1:25 p.m. the assistant director of quality improvement and the Director of Clinical Process Improvement (DCPI) stated the PCA order set had been developed by anesthesia services. After reviewing the PCA order set, both directors acknowledged the order set did not call for continuous pulse oximetry, nevertheless, the assistant director stated continuous pulse oximetry was used in all nursing units with PCA pumps. She was informed continuous pulse oximetry was not used in the Medical-Surgical unit.

During a state complaint interview on 10/7/10 at 11:30 a.m., with the DOP and the DCPI in attendance, a staff pharmacist (Pharm 1) said prior to approving orders she would evaluate their appropriateness by reviewing the indication, dose and duplicate therapies. If orders were not clear or if she had concerns about medication use or dosage, Pharm 1 said she would contact the prescriber prior to approving the orders. Pharm 1 said she had approved Patient 1's post operative pain medication orders on 8/17/10. Pharm 1 and DOP said Dilaudid 1 mg IV is equivalent to Morphine 8 mg IV and should not be used as a starting dose for opiate naive patients. When asked about Patient 1's post op Dilaudid and Morphine orders, Pharm 1 said:
"The orders come from an order set that none of us like."
" It does not make sense to use Dilaudid 1 mg or Morphine 2 mg for the same level of pain."
" I did not contact the physician because in the past he did not want to change the orders."
"This is an ongoing problem with this physician and I entered the orders as is."

Pharm 1 stated she had discussed the order set with Physician C about six months ago and he had insisted on not changing the orders, "So I did not contact him again for this particular order."

Review of the hospital's policy and procedures titled, "Medication Systems and Processes for Inpatient, Medication Use Preparation & Dispensing ", last reviewed and revised on 12/07, indicated the following: " In situations involving a questionable drug dosage or quantity requiring consultation ....the pharmacist will contact the physician for clarification ...if the dosage of use of the medication is still questionable and considered inappropriate by the pharmacist, and the physician does not wish to change his order, the pharmacist shall consult with the medical department chair, chief of staff or designated representative for a final ruling. "

During the same interview, the DCPI stated the inappropriateness of the prior opioid order sets had been brought to the attention of the P&T chair and the medical department chair, who should have passed the message along to the individual physicians.

2. Record review showed Patient 32 was admitted to the facility on 12/10/10 with an obstructed small intestine and gallstones. The "Admission Medication Reconciliation" record dated 12/11/10 at 4:10 a.m. showed that Patient 32's only pre-admission medication was Melatonin, a non-prescription sleep aid.

On 12/13/10 Patient 32 underwent extensive abdominal surgery. Review of the post-operative pain control medication showed the physician had ordered Dilaudid (a potent narcotic medication, five to eight times stronger than morphine) via "Patient Controlled Analgesia". Patient 32's PCA orders were as follows:

Dilaudid 0.2 mg/ml (milligrams/milliliter) concentration
Loading dose (Bolus): 2 mg (milligrams)
PCA mode dose: 0.3 mg
Basal rate/continuous : 0.1 mg/hr
Delay/interval between doses: 10 minutes
One hour limit: 1.5 mg

The PCA order set had three different dosage recommendations for patient doses, first dosage was considered the "Usual Dose", the second was for patients older than 64 or had sleep apnea (persons who stop breathing in their sleep), and the third for opioid-tolerant patients. Opioid tolerant patients are by definition those patients who have been taking for more than seven days 60 mg of oral morphine, or 30 mg of oral oxycodone, or 8 mg of oral Dilaudid or an equianalgesic dose of another opioid.

The Patient Controlled Analgesia order set had as the maximum recommended loading (bolus) dosage of 1 mg for opioid tolerant patients, Patient 32's dose was 2 mg. The maximum dosage for one hour limit for opioid tolerant patients was 1.5 mg per hour, Patient 32's dose was 1.5 mg per hour. According to the PCA order set, non-opioid tolerant patients a basal rate was not to be ordered.

LexiComp, a drug/medication reference, recommends opiate-naive patients receive Dilaudid lV in the lower dose range of 0.2-0.6 mg every 2-3 hours as needed for pain (http://online.lexicom/crlsql/servlet/crlonline?a=doc&bc=patch_f&mn=&id=7053&mid=).

On 12/17/10 at 9:30 a.m. RN L (Assistant Nurse Manager) reviewed Patient 32's record and agreed that Patient 32 was not an opiate-tolerant patient. RN L was asked if she thought Patient 32's PCA orders were appropriate; she stated the 2 mg loading dose of Dilaudid was a, "Heavy dose". RN L stated she was concerned about the one hour limit of 1.5 mg per hour and also of an non opiate-tolerant patient being on a basal/continuous dose.

Pharm 4 on 12/16/10 at 2:44 p.m. stated that an opiate-tolerant patient was one who had opioid therapy on regular basis. In hospitalized patients it would be patients who have had seven days of consistent opiate pain medication therapy. The opiate therapy would have to be equivalent to 60 mg of morphine per day if the patient if the had been on opiate medication for chronic pain at home. Pharm 4 was asked if a non opiate-tolerant patient would still have a PCA basal/continuous rate ordered, she stated yes, but with oxygen saturation monitoring. Pharm 4 stated the patient's physician would be contacted and would be asked for justification on the continuous dosing. During the interview Pharm 4 reviewed Patient 32's electronic record and determined that Patient 32 was not opiate-tolerant. Pharm 4 stated after a pharmacist has reviewed the PCA orders and found that they are out of the recommended range for a non opiate tolerant patient the ordering physician should be contacted. Pharm 4 was unable to locate documentation in the pharmacy record that Patient 32's physician or nurse caring for the patient at that time had been contacted concerning the PCA orders.

3. Record review on 12/14/10 showed that Patient 31 had extensive lower abdominal surgery on 12/13/10. The Anesthesiology Service History and Physical Exam, dated 12/10/10, showed that Patient 31 was taking only multivitamins prior to admission.

Review of the Patient Control Analgesia (PCA) order set dated 12/13/10, at 8:30 a.m. showed Dilaudid was ordered by the surgeon for pain control after surgery. The Dilaudid loading dose was 0.4 mg, PCA dose mode was 0.2 mg with six minute interval and one hour limit of 2 mg., a very high dose. Further review of the physician's PCA orders showed that if Patient 31's respiratory rate dropped below eight per minute, nurses were to give Narcan lV (intravenous), then call the physician.

Review of the nurses' notes, "GYN Flowsheet" dated 12/13/10 showed the following:

- Patient 31 had arrived on the nursing unit at 10:20 a.m. at which point Patient 31 was "very sleepy" and complaining of 'a lot' of pain, and her respirations were 16 per minute.
- At 10:30 a.m. Patient 31's pain was 'better', still sleeping, respirations were 12 per minute and her heart rate was 56 beats per minute.
- The next nursing notes entry was at 11:35 a.m., one hour later, with Patient 31's respirations now 7 per minute, on oxygen at three liters per minute, there was no heart rate documented, and Patient 31's medical record showed, "... sedated from PCA Dilaudid". RN C documented she had called and notified Patient 31's physician regarding "slow respiratory rate."
- At 11:45 a.m. Patient 31 "... continues to sleep...", respirations are still 7 per minute and heart rate was 78 per minute.

On 12/17/10 at 10:50 a.m. Physician A was asked how he determined Patient 31's PCA doses. He stated he based the dosage on how Patient 31 had responded to the pain medication given during surgery. There was no evidence in the medical record that Physician A had determined whether or not Patient 31 was opiate tolerant prior to ordering opiate tolerant doses of Dilaudid.

The Condition of Participation - for Nursing Services was not met.

Based on observations, interviews, and record/document reviews, the hospital failed to ensure safe and effective nursing care and services that met the needs of patients as evidenced by:

1. Patient 1 was not screened for alcohol use, was not assessed per hospital protocol for alcohol withdrawal symptoms or sedation, and nurse to nurse communication lacked detail about Patient 1's current medications, pain medication efficacy and increasing respiratory depression, factors contributing to Patient's over-sedation and respiratory arrest. (Refer to A 395)

2. Patients 1, 33, and 42 were not consistently assessed for their use of incentive spirometry to help inflate their lungs after surgery, increasing risk for pulmonary complications like shortness of breath and pneumonia. (Refer to A 395)

3. Patient 32 was transferred from surgery and not assessed for potential complications by the receiving nurse. Patient 32 on continuous patient-controlled analgesia (PCA) was not placed on oxygen saturation monitoring when her opioid dose was increased. (Refer to A 395)

4. Patient 21 on a continuous opioid epidural therapy, was not assessed every two hours for changes in her neuro status, a potential sign of oversedation. (Refer to A 395)

5. Patient 23 on a PCA and pulse oximetry as a respiratory monitor, did not have the correct low oxygen alarm that would alert her nurse that Patient 23 was experiencing respiratory difficulties. (Refer to A 395)

6. Patient 1 received excessive doses of opiates and unnecessary doses of benzodiazepines, contrary to physician's orders and developed respiratory depression, hypoxemia (low blood oxygen) and consequently went into cardiopulmonary arrest (heart and/or lungs stopped functioning), suffered irreversible brain injury and never regained consciousness. (Refer to A 404)

7. Patient 2 did not receive pain medications in a timely manner and in accordance with physician's orders. This failure contributed to Patient 2's prolonged suffering from severe pain unnecessarily. Additionally, Patient 2 received duplicate pain medications, which had the potential to increase his risk of adverse reactions. (Refer to A 404)

8. Patient 3 did not receive Patient Controlled Analgesia (PCA), in accordance with physician's orders, when hospital staff did not reduce the continuous intravenous (IV) infusion rate when his respiratory rate decreased below 12. This failure had the potential to expose Patient 3 to adverse reactions, such as respiratory depression and hypoxemia. (Refer to A 404)

9. Patient 31 received Dilaudid (potent narcotic medication) loading dose that was 0.4 mg, PCA dose mode was 0.2 mg with six minute interval and one hour limit of 2 mg, a very high dose. Patient 31's respiratory rate dropped below eight per minute, a low respiratory rate indicating respiratory depression, resulting in the patient requiring IV Narcan in order to reverse the effects of the Dilaudid. (Refer to A 404)

10. Patient 32 was administered a loading dose and basal rate of IV Dilaudid by PCA in a dose higher than recommended for patients that are not opiate tolerant. This failure had the potential to expose Patient 32 to adverse reactions, such as respiratory depression and hypoxemia. (Refer to A 404)

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of safe and effective nursing care to patients in a safe environment.

Based on observation, interview and record review, the hospital failed to ensure that nursing staff evaluated and provided care within nursing standards of practice and facility policies for six (Patients 1, 21, 23, 32, 33, 42) of 24 sampled patients.

Patient 1 was not screened for alcohol use, was not accessed per hospital protocol for alcohol withdrawal symptoms or sedation, and nurse to nurse communication lacked detail about Patient 1's current medications, pain medication efficacy and increasing respiratory depression, factors contributing to Patient's over-sedation and respiratory arrest.

Patients 1, 33, and 42 were not consistently assessed for their use of incentive spirometry to help inflate their lungs after surgery, increasing risk for pulmonary complications like shortness of breath and pneumonia.

Patient 32 was transferred from surgery and not assessed for potential complications by the receiving nurse. Patient 32 on continuous patient-controlled analgesia (PCA) was not placed on oxygen saturation monitoring when her opioid dose was increased.

Patient 21 on a continuous opioid epidural therapy, was not assessed every two hours for changes in her neuro status, a potential sign of oversedation.

Patient 23 on a PCA and pulse oximetry as a respiratory monitor, did not have the correct low oxygen alarm that would alert her nurse that Patient 23 was experiencing respiratory difficulties.

Findings:

1. Review of Patient 1's medical record on 9/29/10 (initiated during a complaint investigation) showed that the hospital admitted Patient 1 on 8/17/10 for an elective spinal surgery procedure to relieve neck and right hand pain, weakness and numbness. An anesthesiology services history and physical exam dated 8/17/10 indicated that Patient 1 occasionally drank alcohol and an anesthesia record indicated that Patient 1 drank 24 ounces of beer daily, a moderate amount. An operative report, dated 8/17/10, indicated that Patient 1 tolerated the procedure well and had no complications.

During interview on 9/29/10 at 10:30 a.m., the Director of Clinical Process Improvement (DCPI) said Patient 1 was agitated in the recovery room and the intensive care unit (ICU), making multiple attempts to get out of bed and pulling and removing catheters and wires. The hospital staff suspected that Patient 1 may have been withdrawing from alcohol.

The hospital's policy and procedures titled, "Nursing Assessment for Patients at Risk for Alcohol Withdrawal ", effective date 4/09, indicated the following,
"If there is a history of alcohol consumption noted on admission, utilize the CAGE screening tool for alcohol withdrawal."
"If 2 or more questions on the CAGE screening tool are answered, "yes", obtain a physician order to initiate the protocol for alcohol withdrawal."

During interview on 12/14/10 at 1:15 p.m., the director of education (DE) said a CAGE screening is used to help identify patients at risk for developing alcohol withdrawal symptoms during hospitalization. DE said a CAGE screening should be performed on every patient with a history of alcohol consumption in order to determine whether orders for the alcohol withdrawal prophylaxis protocol should be initiated. For Patient 1, a pre-operative nurse should have completed a CAGE questionnaire when Patient 1 disclosed that he occasionally consumed alcohol on the anesthesiology services history and physical exam.

During interview on 12/15/10 at 9:30 a.m., the assistant director of quality said Patient 1's record did not contain any evidence that a CAGE screening was conducted.

On 8/18/10 at 8:30 a.m., an ICU nurse obtained verbal orders to initiate the hospital's Alcohol Withdrawal Prophylaxis and Treatment Protocol for Patient 1 a.m. The Protocol directed nurses to use the Alcohol Withdrawal Assessment Flow sheet / Clinical Institute Withdrawal Assessment of Alcohol Scale (CIWA) to assess and score Patient 1's alcohol withdrawal symptoms, such as anxiety, agitation, tremors, nausea, sweats and hallucinations. Nurses would then medicate patients with benzodiazepines (tranquilizers/sedatives) based on their CIWA score and corresponding orders.

Patient 1's CIWA score on 8/18/10 at 8:00 a.m. was "7", a low score, indicating that he was not in active withdrawal but would require prophylactic treatment. The protocol directed nurses to assess Patient 1's alcohol withdrawal symptoms and sedation every 4 hours and to medicate to prevent alcohol withdrawal symptoms with Librium (benzodiazepine) 50 milligrams (mg) by mouth or if unable to take medications by mouth, Ativan 0.5 mg intravenously (IV) every 4 hours while awake for 72 hours. Additionally, the hospital's policy titled, "Nursing Assessment for Patients at Risk for Alcohol Withdrawal", effective 4/09 and the alcohol withdrawal flowsheet directed nurses to assess sedation one hour after each oral dose and 15 minutes after each IV dose of benzodiazepines.

During interview on 12/14/10 at 1:30 p.m., DE explained that nurses are expected to conduct and obtain a CIWA score and then administer medications. According to the DE, this was important because patient's status may change, requiring more medication if symptoms increase or less medication if patients become sedated.

Review of Patient 1's ICU vital signs and alcohol withdrawal flow sheets, for 8/18/10 and 8/19/10, showed that nursing staff did not assess and score Patient 1's alcohol withdrawal symptoms every four hours and then administer medications. Additionally, there was no documented evidence that nursing staff assessed Patient 1's sedation, as required.
8/18/10
8 a.m.: CIWA 7; Librium 50 mg at 10:30 a.m.
12 p.m.: CIWA 7; Librium 50 mg at 3:15 p.m.
4 p.m.: No documented CIWA score; Librium 50 mg at 6:45 p.m.

On 8/18/10 at 7 p.m., Patient 1's CIWA score was 8. According to the hospital's policy titled, "Nursing Assessment for Patients at Risk for Alcohol Withdrawal", effective 4/09, a score between 8-25 required hourly assessments for eight hours until stable. The hospital staff did not assess Patient 1 every hour. A CIWA score between 8-25 indicated mild to moderate withdrawal. Patient 1 did not have any medication orders for the treatment of mild to moderate alcohol withdrawal. Patient 1's CIWA scores continued to increase. At 9 p.m. and 11 p.m., Patient 1's CIWA score was 10. Patient 1 received Librium 50 mg at 10:34 p.m.

According to the DE, when Patient 1's CIWA score increased to 8, indicating worsening symptoms, his alcohol withdrawal symptoms/CIWA should have been assessed hourly. The physicians should have been notified and medications should have been changed. DE said if patients are sleeping, nurses are expected to wake them up to perform CIWA assessments, because symptoms may worsen during sleep.

During interview on 12/15/10 at 2:30 p.m., RN G said she did not assess Patient 1's alcohol withdrawal symptoms hourly and was not aware that the protocol required increased monitoring and different medications for a CIWA score greater than 8. RN G did not notify the physician and continued to treat Patient 1 with the same medications prescribed for milder symptoms.

On 8/19/10 at 10:30 a.m., the hospital transferred Patient 1 to the Definitive Observation Unit (DOU), a nursing unit providing telemetry (heart rhythm) monitoring for medical-surgical patients. Patient 1's orders for the alcohol withdrawal protocol, assessments and medications were continued without any change. At 11 a.m., Patient 1 received both Librium by mouth and Ativan IV, contrary to physician's orders. Patient 1's record did not contain any evidence of a sedation assessment, 15 minutes after the administration of IV Ativan or one hour after the administration of oral Librium, as required. At 3 p.m., Patient again received both Librium by mouth and Ativan IV, again contrary to physician's orders. Patient 1's record did not contain a CIWA assessment and score prior to the 3 p.m. double dose of benzodiazepines or a sedation assessment after the doses of benzodiazepines.

During interview on 10/6/10 at 10:40 a.m., the DOU nurse (RN D) who cared for Patient 1 during the day shift on 8/19/10 confirmed he did not conduct the CIWA assessments as required.

During interview on 10/6/10 at 1:40 p.m., DCPI said the hospital staff had not followed the alcohol withdrawal protocol and physicians orders in accordance with hospital policies.

Review of the hospital's policy and procedures, titled, "Hand Off Communication", reviewed on 2/09, showed that hospital staff must communicate pertinent information regarding care, treatment and current status accurately when transferring care of a patient between or among providers. During interview on 9/29/10 at 10:30 a.m., DCPI said hospital staff did not follow the policy when information regarding Patient 1's episodes of apnea, decreased oxygen saturation and accurate medication use history was not passed on to the next nurse.

On 8/18/10 at 1 p.m. in ICU, Patient 1 received Dilaudid 1 mg IV. At 1:30 p.m.,
an ICU nurse's note indicated that Patient 1's oxygen saturation dropped to 88-89%, a possible indication of respiratory depression indicative of oversedation. Patient 1's oxygen saturation levels had been 96-97% on room air (normal). The note indicated that Patient 1 was placed on 2 liters of oxygen and his oxygen saturation increased to 96%. Administering additional oxygen can increase the oxygen saturations, but does not correct oversedation or respiratory depression.

On 8/18/10 during the night shift, another ICU nurse (RN G) administered Dilaudid 2 mg IV and benzodiazepines to Patient 1. Opiates and benzodiazepines together can increase respiratory depression. Patient 1 experienced additional episodes of decreased oxygen saturations, as follows:

7:45 p.m.: Dilaudid 2 mg IV
7 - 8 p.m.: On room air, oxygen saturation was 92%
8 p.m.: On 2 liters of oxygen, oxygen saturation increased to 96%
10:15 p.m. : Restoril 15 mg (benzodiazepine/sedative used for sleep)
10:34 p.m.: Librium 50 mg
11 p.m.: Dilaudid 2 mg IV
12 a.m.: Sleeping, on 2 liters of Oxygen, periods of apnea (cessation of breathing).
2 a.m.: Dilaudid 2 mg IV
2:30 a.m.: A nurse's note indicated that Patient 1's oxygen was increased to 4 liters and he was placed on a 10 liter oxygen mask in order to increase his oxygen saturation, low at 91%.

During interview on 12/15/10 at 2:30 p.m., RN G said she thought that based on report from the previous nurse; Patient 1 had been receiving Dilaudid 2 mg for pain. RN G said she did not know that Patient 1 had not received any Dilaudid 2 mg during previous shifts and that the nurse from the previous shift had documented "0" pain following the administration of Dilaudid 1 mg. RN G could not recall whether she had checked the EMAR to review Patient 1's pain medication history. When asked, RN G said she was not aware that Patient 1's oxygen saturation levels had dropped during the previous shift.

During interview on 10/6/10 at 10:40 a.m., the DOU nurse (RN D) who cared for Patient 1 during the day shift on 8/19/10, said ICU transferred Patient 1 on 8/19/10 in the morning. RN D received report from the ICU nurse that Patient 1 was on the alcohol withdrawal protocol. RN D said he thought he was told that Patient 1 had been receiving both Librium and Ativan. RN D said the electronic medication administration record (EMAR) showed that both medications were scheduled to be administered every 4 hours. RN D said he did not review Patient 1's Librium/Ativan medication administration history and did not realize that the IV Ativan should only be administered if Patient 1 was not able to take medications by mouth. RN D said he had not reviewed the original physician's orders because the transfer process was to review the last 12 hours of orders and review the EMAR for older orders. RN D administered both Librium and Ativan in DOU on 8/19/10 at 11 and 3 p.m., contrary to physician's orders.

During interview and computer demonstration on 12/15/10 at 10:44 a.m., RN D accessed Patient 2's EMAR. The EMAR displayed Patient 1's medications with instructions. The EMAR did not indicate that Ativan should only be administered if Patient 1 was not able to take medications by mouth. When RN D "right clicked" on the Ativan and Librium EMAR entries, a "Pop Up" window appeared with additional instructions to only administer Ativan if patient was not able to take medications by mouth. RN D said he could not remember whether he had seen the "Pop Up" window prior to administering Patient 1's benzodiazepines.

During interview on 10/7/10 at 1:15 p.m., the Chief Nursing Officer (CNO) said the receiving nurse should be reviewing the EMAR for medication use history and the nurse should question if two medications are used for the same indication and clarify with the prescriber.

Patient 1's postoperative orders dated 8/17/10 at 11:30 a.m. included, "Incentive spirometry use 10 times per hour while awake."

During interview on 12/15/10 at 9:30 a.m., the Assistant Director of Quality stated she could not find any documented evidence from nursing that Patient 1 performed incentive spirometry post operatively in ICU or DOU.

During interview on 12/15/10 at 2:30 p.m., an ICU nurse (RN G) who cared for Patient 1 on 8/18/10 during the night shift, said she did not ensure that Patient 1 performed incentive spirometry, "I did not do it, I did not think about it."

During interview on 12/14/10 at 10:44 a.m., a DOU nurse (RN D) who cared for Patient 1 on 8/19/10 during the day shift, said he could not remember whether Patient 1 had performed incentive spirometry. RN D said his usual practice would be to remind and observe patients performing incentive spirometry hourly and document during the every 4 hour shift assessment.

During interview on 12/16/10 at 12:30 p.m., Patient 1's surgeon (Physician C), stated that performing incentive spirometry is important to prevent atelectasis. Atelectasis is a collapse of lung tissue affecting part or all of one lung. This condition prevents normal oxygen absorption to healthy tissues.



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2. Record review on 12/15/10 showed that Patient 32 was admitted to the facility on 12/10/10 with small intestine and gallbladder problems. On 12/13/10 Patient 32 had abdominal surgery; and was returned to the nursing unit from the recovery room on 12/13/10 at 10 p.m. The only post operative documentation found was the vital signs (temperature, pulse, respiratory rate, blood pressure, and oxygen saturation) and pain level assessment and pain medication. There was no other assessment documented for Patient 32, a fresh surgical patient, until 12/14/10 at 12:15 a.m., over two hours later.

During an interview on 12/15/10 at 3 p.m. RN M stated Patient 32 had returned to the nursing unit from surgery at 10 p.m. and the night nurse (11 p.m.-7:30 a.m. shift) would be the one to do the assessment. RN M stated she had only assessed Patient 32's vital signs. RN M stated when patients arrive on the nursing unit at 10 p.m. or later, the off-going nurse settles the patient in and takes vital signs, puts up any intravenous fluids ordered and the on-coming shift would do the admission/assessment. RN M stated for surgery patients she would "settle them in". RN M stated this was what she had been told by her supervisor.

On 12/17/10 at 10 a.m., RN L (Assistant Manager of the nursing unit) stated that surgery patients on arrival to the unit should have a complete assessment done within 15-30 minutes of arrival. RN L agreed that a patient who returned to the nursing unit after surgery would have had a change in condition/diagnosis and would thus need to have a complete reassessment. For a surgical patient, complete assessment was considered a head to toe assessment with focus on the surgical procedure to rule out complications.

Review of the policy and procedure, "Multidisciplinary Patient Assessment and Reassessment (Prioritization of Care)" showed that patients were to have an initial assessment on admission to the unit. The assessment would be done by a registered nurse. The patient was to have a reassessment when there had been a significant change in condition or diagnosis and when there was a change in the level of care.

3. Record review on 12/15/10 showed that Patient 32 was admitted to the facility on 12/10/10 with small intestine and gallbladder problems. The "Admission Medication Reconciliation" record dated 12/11/10 at 4:10 a.m. showed that Patient 32's only pre-admission medication was Melatonin, a non-prescription sleep aid.

Review showed the physician ordered pain medication to be delivered via a PCA pump. The PCA order set, dated 12/13/10 at 10:30 p.m.. showed Patient 32's PCA orders were:

Dilaudid 0.2 mg/ml (milligrams per milliliter)concentration
Loading dose (Bolus): 2 mg.
PCA mode dose: 0.3 mg.
Basal rate/continuous : 0.1 mg/hr
Delay/interval between doses: 10 minutes
One hour limit: 1.5 mg.

On 12/15/10 at 10:20 a.m. observation showed Patient 32 connected to a PCA pump receiving Dilaudid both as a continuous rate (basal) and as needed "PCA" doses. Observation showed no pulse oximeter (a machine that measures oxygen saturation, a way to monitor a patient's respiratory status) in the room. The record showed that on 12/14/10 at 9:12 p.m. the PCA mode dose been increased to 0.4 mg. Review of the vital sign electronic record showed nursing did not document Patient 32's vital signs for this dose increase until 12/15/10 at 12:20 a.m., over three hours later. Review showed the next set of vital signs were not taken until 4 a.m., almost three hours later.

Review of the "Patient Controlled Analgesia" order set dated 12/13/10 showed that,"... and after each change in the pump setting..., record respiratory rate and pulse oximetry ..." every two hours for the first six hours.

4. Record review on 12/16/10 showed that Patient 33 was an elderly female who had been admitted to the facility on 12/9/10 with multiple medical diagnoses which included pneumonia (infection of the lungs), CHF (congestive heart failure), irregular rapid heart rate, and a low hemoglobin of 8.1 (The oxygen carrying protein found in the red blood cell, normal range 12-16).

On 12/16/10 at 9:33 a.m. observation showed Patient 33 using her incentive spirometer, a hand-held device used by patients to help inflate their lungs and avoid collapse of the air sacs, or atelectasis, which can lead to pneumonia. Patient 33 reached only half-way to the 500 milliliters volume mark on the air chamber of the incentive spirometer and failed to hold her breath briefly at the end of inhaling or exhale slowly.

On 12/16/10 at 11:10 a.m. RN L (nursing unit assistant manager) stated that the incentive spirometer was part of the clinical core measures/care plan for patients with the diagnosis of pneumonia. Record review showed that although nursing consistently documented most shifts that Patient 33's breath sounds were "diminished", indicating lower airways were not fully inflated, documentation was not consistent for Patient 33's incentive spirometer use or how effective it was. Documentation was noted only for 12/9/10 and 12/10/10 at 8 a.m. only, 12/12/10 at 8:20 a.m. only, 12/13/10 at 8:28 p.m., 12/15/10 at 7:51 a.m. and 9:06 a.m.


25632

5. Review of the medical record on 12/16/10 AT 10:15 a.m., showed that the hospital admitted Patient 42 for spine surgery on 12/14/10. Patient 42 was a 56 year old man with the diagnosis of degenerative spine disease; he had undergone surgery on his spine for decompression and fusion. Review of the Post Op Orders showed that the physician had ordered Incentive spirometry (An incentive spirometer is a medical device commonly used after surgery to help expand the lungs to open the alveoli [air sacs where oxygen and carbon dioxide are exchanged] to avoid the complications of pneumonia) 10 times per hour while awake. Further review of the record showed no documentation of incentive spirometry for 12/14/10 the first post operative day and only four times documented on 12/15/10 the second post operative day and none on 12/16/10 the third post operative day.

Review on 12/16/10 of the " Interdisciplinary Plan of Care " showed that the RN (registered nurse) did not include incentive spirometry in the respiratory care plan.

On 12/16/10, when asked about the lack of incentive spirometry for Patient 42 post operatively RN N provided no explanation.


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6. During the initial tour of the definitive observation unit (DOU) on 12/14/10, the unit's shift supervisor, RN T stated DOU did receive patients with patient-controlled analgesia (PCA) pumps as well as patients with epidural pain medication infusions. She stated those patients would be on continuous pulse oximetry via bedside machines to help staff identify potential patient oversedation from the narcotics used in PCAs and epidurals. She stated the default alarm setting for low oxygen saturation was at 92%, although patients with chronic obstructive pulmonary disease (COPD) might have a lower alarm setting such as 88%.

Record review on 12/15/10 showed Patient 23 was admitted to the hospital on 12/13/10. On 12/14/10 Patient 23 underwent intestinal surgery. After her surgery and recovery in the post-anesthesia care unit (PACU) Patient 23 was transferred to the DOU for telemetry monitoring. Her physician in his Postoperative Orders electronically signed 2/14/10 at 10:40 a.m., indicated Patient 23 would receive pain medication via a patient-controlled analgesia (PCA) pump. Vital sign orders indicated the physician was to be notified if "O2 (oxygen) sat(uration) less than 93%."

On 12/15/10 at 11:40 a.m., observation showed Patient 23's nurse, RN S at the central nurses's station. RN S confirmed patients on PCAs were always on pulse oximetry and she confirmed the order to call the physician if Patient 23's oxygen saturation dropped below 93%. She stated the pulse oximeters were set for 90% but "would consider" increasing this low alarm limit for Patient 23. She made no move toward Patient 23's room to adjust the alarm setting that would alert her if Patient 23's oxygen saturation dropped below 93%, a possible sign of oversedation. At 11:50 a.m., observation showed Patient 23 sitting up in bed. RN S was asked to display the oxygen saturation setting on Patient 23's bedside machine that would trigger the alarm for low oxygen saturation. Observation showed the alarm was set for 88%, although Patient 23 was not identified as having COPD. The assistant director for quality asked RN S to reset the alarm for a higher setting.

Review of the facility policy "Pulse oximetry" indicated "For continuous, prolong (sic) monitoring, the Hi/Low alarms, should to (sic) be appropriately set."

7. Record review of Patient 21 on 12/14/10 indicated she was admitted to the ICU following chest surgery on 12/13/10. Review of the physician orders dated 12/13/10, showed she was on an epidural continuous infusion consisting of a narcotic medication and an anesthetic for pain. An epidural infusion directly injects pain medications into a space around the spinal cord, allowing for better pain control.

Patient 21's nurse, RN R was interviewed on 12/14/10 at 10:45 a.m. She stated Patient 21 knew she was getting narcotic medication through her epidural, but was afraid of narcotics, so did not want anything in addition.

Observation on 12/14/10 at 11 a.m. showed Patient 21 sitting up in bed. She stated she knew she had an epidural for pain medication. She stated she had a previous bad reaction to the narcotic medication, morphine; "I had respiratory arrest", a dangerous, life-threatening condition caused by respiratory depression resulting from too much narcotic medication.

According to the assistant director of ICU, patients on a PCA or epidural infusion would have continuous pulse oximetry and close monitoring of their respiratory status as well as neurological assessments every two hours to assure patients were not over-sedated and experiencing respiratory depression.

Review of the online morning nursing assessment showed Patient 21's neuro assessment was "WNL", within normal limits. No sedation level was noted.

According to the assistant director of quality improvement, the online prompt for documenting a patient's sedation level was located on the "Analgesia Infusion Validation" screen which nurses accessed during shift change or change of infusion syringes. Review of the "Analgesia Infusion Validation" screen indicated nursing was to document "Pain location, Rating, Quality, LOS (level of sedation) Side Effects, Sensory Motor Function- every two hours.

Based on interview and record review the hospital failed to ensure that five (Patients 1, 2, 3, 31, 32) of 24 sampled patients received medications in accordance with physician's orders and hospital policies and procedures, increasing risk for adverse reactions for patients.

Patient 1 received excessive doses of opiates and unnecessary doses of benzodiazepines, contrary to physician's orders and developed respiratory depression, hypoxemia (low blood oxygen) and consequently went into cardiopulmonary arrest (heart and/or lungs stopped functioning), suffered irreversible brain injury and never regained consciousness.

Patient 2 did not receive pain medications in a timely manner and in accordance with physician's orders. This failure contributed to Patient 2's prolonged suffering from severe pain unnecessarily. Additionally, Patient 2 received duplicate pain medications, which had the potential to increase his risk of adverse reactions.

Patient 3 did not receive Patient Controlled Analgesia (PCA), in accordance with physician's orders, when hospital staff did not reduce the continuous intravenous (IV) infusion rate when his respiratory rate decreased below 12. This failure had the potential to expose Patient 3 to adverse reactions, such as respiratory depression and hypoxemia.

Patient 31 received Dilaudid (potent narcotic medication) loading dose that was 0.4 mg, PCA dose mode was 0.2 mg with six minute interval and one hour limit of 2 mg, a very high dose. Patient 31's respiratory rate dropped below eight per minute, a low respiratory rate indicating respiratory depression, resulting in the patient requiring IV Narcan in order to reverse the effects of the Dilaudid.

Patient 32 was administered a loading dose and basal rate of IV Dilaudid by PCA in a dose higher than recommended for patients that are not opiate tolerant. This failure had the potential to expose Patient 32 to adverse reactions, such as respiratory depression and hypoxemia.

Findings

1. Review of Patient 1's medical record on 9/29/10 (during a complaint investigation) showed the hospital admitted Patient 1 on 8/17/10 for elective spinal surgery to relieve neck and right hand pain, weakness and numbness. According to two pre-operative history and physical (H &P) exams (dated 8/5/10 and 8/13/10), Patient 1 was 60 years old and did not have any chronic medical illnesses. Pain medications used by Patient 1 at home included an unknown amount of Norco (an opioid medication) and Motrin (a non-opioid pain medication). An operative report, dated 8/17/10, showed that Patient 1 tolerated the surgery well and had no complications. Patient 1 was moved to the recovery room in good condition and subsequently moved to the intensive care unit (ICU). Patient 1's Post Operative pain medication orders, dated 8/17/10 at 11:30 a.m., included the following:

For severe pain: Dilaudid 1 milligram (mg) intravenously (IV) every two hours. If ineffective use 2 mg Dilaudid every 2 hours as needed or Morphine Sulfate 2 mg IV every 2 hours as needed

For moderate pain: Morphine 1 mg IV every 3 hours as needed.

According to the hospital's policy and procedures, entitled, "Pain Assessment and Management", revised and reviewed 8/10, a numerical "0-10" pain rating scale will be used to assess pain, "0" being no pain and "10" being the worst pain ever experienced. The policy defined that 1-2= mild; 3-6 = moderate; 7-10 = severe pain. The policy further indicated that pain medication orders will specify the dose for mild, moderate or severe pain and frequency and route of administration and nurses will administer pain medications as ordered by physician.

During interview on 12/14/10 at 1:15 p.m., the Director of Education (DE) said nurses are required to assess and document patient's pain, using the pain score and to medicate patients based on the pain score and in accordance with physician's orders

Patient 1's vital signs flow sheet and electronic medication administration record (EMAR) for 8/17/10 showed contradictory and inconsistent documentation of pain assessments and scores. Patient 1 received pain medications contrary to physicians' orders and hospital policy as follows:

8/17/10 1:50 p.m.: Morphine 1 mg IV; Registered nurse (RN J) documented on the EMAR the reason for medication was "moderate pain". Patient 1's vital signs flow sheet dated 8/17/10, between 1 p.m. and 2 p.m., indicated that Patient 1's pain score was "10" (severe pain). RN J documented that Patient 1's pain score was "0" upon reassessment, 1 hour after morphine administration indicating Morphine 1 mg provided effective pain relief.

8/17/10 3:50 p.m.: Dilaudid 1 mg IV, RN J documented on the EMAR the reason for medication was "severe pain" without a pain score. Patient 1's vital signs flow sheet dated 8/17/10, between 2 p.m. and 8 p.m., indicated that every hour, including between 3 p.m. and 4 p.m., Patient 1's pain score was "0" indicating Patient 1 was not experiencing pain. The nurse's notes did not contain any additional information regarding the nature of Patient 1's pain or explanations regarding the use of Dilaudid instead of Morphine, since the prior Morphine dose had resulted in complete pain relief.

During interview on 9/29/10 at 10:30 a.m., the Director of Clinical Process Improvement (DCPI) confirmed nursing staff did not consistently assess and document Patient 1's pain on the EMAR or using pain scores.

During interview on 10/7/10 at 11 a.m., the director of the intensive care unit/definitive observation unit (ICU & DOU) could not explain nursing's inconsistent documentation of pain and the use of Dilaudid to relieve pain when Morphine was effective. In a follow up Email communication, dated 10/8/10, the director indicated that RN J said "It is my recollection that morphine did not work and I was looking for something to work."

On 8/18/10, Patient 1's EMAR documented pain scores and reasons for medications were contradictory and inconsistent. Patient 1 received two more doses of Dilaudid 1 mg IV for the treatment of moderate pain, contrary to physician's orders, at 12:13 a.m. (pain score "6") and 5:26 a.m. (Pain score "5" ). The EMAR indicated that the reason for medication was severe pain both times.

According to Lexi-Comp On line, Dilaudid is indicated for the relief of moderate-to-severe pain in opioid-tolerant patients who require larger than usual doses of opioids to provide adequate pain relief. Initial IV Dilaudid dosing for opiate-naive patients is 0.2-0.6 mg every 2-3 hours as needed. Patients with prior opiate exposure may tolerate higher initial doses. Compared to Morphine, Dilaudid is much faster acting and is 8 to 10 times stronger. Opiate naive patients are at increased risk of adverse events including: apnea (transient cessation of breathing) and respiratory depression leading to decreased oxygen saturation (measure of the amount of oxygen in the blood, normal value for healthy adults 96-100%) and respiratory arrest.

When asked whether nurses were familiar with Dilaudid and Morphine conversion, DCPI said the hospital had recently started an educational campaign. Patient 1's record did not contain any evidence that a nurse had clarified the use of Dilaudid 1-2 mg IV or Morphine 2 mg for the same level of pain. Review of the hospital ' s policy and procedures, titled, "Pain Assessment and Management", revised and reviewed 8/10, showed, "If opiates are ordered, RN verifies that the dosage is within recommended dosing guidelines for the drug." The policy directed staff to use an attached conversion table to ensure equivalency when switching analgesics (opiates). According to the table, by administering Dilaudid 1 mg, the nurse actually administered seven times the morphine dose.

ICU nurses' notes on 8/18/10, starting at 7 a.m., indicated that Patient 1 was agitated, made multiple attempts to get out of bed and pulled on his catheters and wires. During interview on 9/29/10 at 10:30 a.m., DCPI said when Patient 1 continued to be agitated in the ICU, the nursing staff suspected that Patient 1 may have been withdrawing from alcohol.

On 8/18/10 8:30 a.m., an ICU nurse (RN F) obtained telephone physicians orders for initiation of the hospital's Alcohol Withdrawal Prophylaxis and Treatment Protocol. The Protocol directed nurses to assess Patient 1's alcohol withdrawal symptoms and sedation every 4 hours and medicate to prevent alcohol withdrawal symptoms with Librium (a long acting benzodiazepine/sedative) 50 mg by mouth or if unable to take medications by mouth, Ativan 0.5 mg IV every 4 hours while awake for 72 hours. Patient 1 received three doses of Librium 50 mg on 8/18/10, during the day shift, at 10:30 a.m., 3:15 p.m. and 6:45 p.m.

The hospital staff continued to treat Patient 1's moderate pain with medication prescribed to treat severe pain, contrary to physician's orders. Patient 1 received Dilaudid 1 mg IV at 1 p.m. for moderate pain (pain score 5). At 1:30 p.m., RN F's note indicated that Patient 1's oxygen saturation dropped to 88-89%. Patient 1's oxygen saturation levels had been 96-97% on room air. The note indicated that Patient 1 was placed on 2 liters of oxygen and his oxygen saturation increased to 96%. Decreasing oxygen saturation levels can indicate over-sedation. Giving supplemental oxygen can increase oxygen saturation levels, but do not correct over sedation or respiratory depression.

During interview on 10/7/10 at 10:10 a.m., RN F who cared for Patient 1 on 8/18/10, during the day shift, stated that a pain score of "3-6" was considered moderate and that Dilaudid was ordered to treat severe pain. However, RN F said she administered Dilaudid for moderate pain because, "I went by what the previous nurses said worked for him before."

The 8/18/10, ICU night shift nurse's (RN G) assessments indicated that Patient 1's alcohol withdrawal symptoms were worsening. During interview and review of the hospital's Alcohol Withdrawal Prophylaxis and Treatment Protocol on 12/14/10 at 1:15 p.m., DE said Patient 1's symptoms should have been assessed hourly when they worsened and the physician should have been notified and the medications changed to reflect the new level of alcohol withdrawal. During interview on 12/15/10 at 2:30 p.m., RN G said she did not assess Patient 1's alcohol withdrawal symptoms hourly and had not been aware that the protocol required increased monitoring and different medications for more severe symptoms. RN G did not notify the physician and continued to treat Patient 1 with the same medications prescribed for milder symptoms.

On 8/18/10 during the night shift, the hospital staff treated Patient 1's reported severe pain with Dilaudid 2 mg instead of 1 mg. According to the physician's orders, Patient 1 should have received Dilaudid 2 mg only if Dilaudid 1 mg was not effective for severe pain. Patient 1 experienced additional episodes of decreased oxygen saturations, as follows:

7:45 p.m.: Dilaudid 2 mg IV; 7 - 8 p.m.: On room air; oxygen saturation was 92%
8 p.m.: On 2 liters of oxygen; oxygen saturation increased to 96%
10:15: Restoril 15 mg (benzodiazepine/sedative used for sleep)
10:34 p.m.: Librium 50 mg; 11 p.m.: Dilaudid 2 mg IV
12 a.m.: Sleeping, on 2 liters of Oxygen, periods of apnea (cessation of breathing).
2 a.m.: Dilaudid 2 mg IV
2:30 a.m.: A nurse's note indicated that Patient 1's oxygen was increased to 4 liters and he was placed on a 10 liter oxygen mask. Patient 1's oxygen saturation improved from 91% to 100%.

During the same interview, RN G said she thought that based on report from the previous nurse, Patient 1 had been receiving Dilaudid 2 mg, "Because he had a history of alcoholism, 1 mg wasn't doing it, so give him 2 mg". RN G said she did not know that Patient 1 had not received any Dilaudid 2 mg during previous shifts and that the nurse from the previous shift had documented "0" pain following the administration of Dilaudid 1 mg. RN G could not recall whether she had checked the EMAR to review Patient 1's pain medication history. RN G said she was not aware that Patient 1's oxygen saturation levels had dropped during the previous shift. RN G said she thought Patient 1's decreased oxygen saturations could be due to sleep apnea or pain medications. RN G did not inform the physician of Patient 1's episodes of apnea and dropping oxygen saturations because she thought she could " fix it " by increasing oxygen. RN G said during the night and in the morning, Patient 1 was lethargic.

During interview on 12/16/10 at 12:30 p.m., the physician (Physician C) who prescribed Patient 1's post op pain medication orders and alcohol withdrawal protocol said he was not aware that Patient 1 had periods of apnea and oxygen desaturation. Physician C said the nurse should have notified a physician if she thought Patient 1 was having a reaction to the medications.

The hospital's policy and procedures, titled, "Pain Assessment and Management", revised and reviewed 8/10, directed nursing staff to monitor for side effects of pain relieving agents such as sedation, decreased respiratory drive and confusion and to notify physicians of serious side effects

According to the package insert, respiratory depression is the chief hazard of Dilaudid. Dilaudid should be used with extreme caution since even the usual therapeutic doses of opioids may decrease respiratory drive while simultaneously increasing airway resistance to the point of apnea (cessation of breathing) and that Dilaudid should be employed only under careful medical supervision at the lowest effective dose.

For patients with apnea, the respiratory depressant effect of benzodiazepines may further suppress their respiratory drive and put them at risk for respiratory depression and death. The combined use of benzodiazepines and opiates can exert a combined effect, larger than either exerts alone, which would relax the throat and tongue muscles to prevent the flow of air, suppress wakening which would otherwise allow breathing, and reduce the body's physiologic breathing reflex reducing the effort to breath.

On 8/19/10 at 10:30 a.m., the hospital transferred Patient 1 to the Definitive Observation Unit (DOU: a unit providing care intermediate between that of an intensive care unit and a normally-staffed in-patient division). Patient 1's pain medications and alcohol withdrawal protocol assessments and medications were continued without changes. According to Patient 1's vital signs flow sheet, Patient 1 continued to receive 4 liters of Oxygen via on 8/19/10 until 8 p.m. Patient 1's oxygen saturations ranged between 97-100% while on oxygen.

On 8/19/10 at 11 a.m. and 3 p.m., contrary to physician's orders, Patient 1 received both Librium 50 mg by mouth and Ativan 0.5 mg IV. Additionally, Patient 1 was not assessed for alcohol withdrawal symptoms or sedation prior to the administration of the 3 p.m. doses of benzodiazepines.

During interview on 12/15/10 at 1:30 p.m., DE explained that nurses are expected to conduct the alcohol withdrawal symptoms assessments and then administer medications. This is important because patient's status may change, requiring more medication if symptoms increase or less medication if patients become sedated.

During interview on 10/6/10 at 10:40 a.m., the DOU nurse (RN D) who cared for Patient 1 during the day shift on 8/19/10, said ICU transferred Patient 1 on 8/19/10 in the morning. RN D received report from the ICU nurse that Patient 1 was on the alcohol withdrawal protocol. RN D said he thought he was told that Patient 1 had been receiving both Librium and Ativan. RN D said the EMAR showed that both medications were scheduled to be administered every 4 hours. RN D said he did not review Patient 1's Librium/Ativan medication administration history and did not realize that the IV Ativan should only be administered if Patient 1 was not able to take medications by mouth. RN D did not question why Patient 1 would require both Ativan and Librium. RN D said he did not conduct the alcohol withdrawal assessments every 4 hours as required by physician's orders.

On 8/19/10 at 8 p.m., a DOU nurse's (RN E) note indicated that Patient 1 was "too lethargic, Librium and Ativan held". During telephone interview on 10/8/10 at 2:15 p.m., Patient 1's hospital physician (Physician B) said she examined Patient 1 around 8:30 p.m. on 8/19/10. Physician B said Patient 1 was arousal and a little confused. Physician B said she decreased the Librium dose from 50 mg every 4 hours to 25 mg every 8 hours and discontinued Ativan 0.5 mg IV every 4 hours.

During interview on 10/6/10 at 11:25 a.m., RN E said Patient 1 was still agitated after the administration of Librium 25 mg at 10 p.m., and pulled out his Hemovac (a drain that removes blood and fluids that accumulate in the surgical area). RN E administered IV Ativan 0.5 mg IV at 10:56 p.m. using an older active order (originally dated 8/17/10, prior to initiation of the alcohol withdrawal protocol). RN E was aware that the physician had discontinued the every 4 hours Ativan IV orders because Patient 1 became lethargic. RN E did not notify a physician prior to administering IV Ativan. RN E was asked to comment on her use of Dilaudid 1 mg. at 9 p.m. followed by Dilaudid 2 mg. at 11:35 p.m. when Patient 6 had reported a pain level of "6", meaning moderate pain. RN stated Patient 1 should not have received Dilaudid for moderate pain, but she used Dilaudid because it had been used before and she increased the dose to 2 mg. Dilaudid when Patient 1 still complained of pain.

During telephone interview on 10/8/10 at 2:15 p.m., Physician B said her intention was to decrease benzodiazepine doses and sedation. Physician B was not sure if she had seen the older active order for Ativan. Physician B said she should have received a phone call when Patient 1 became agitated again and prior to using IV Ativan. Physician B said Patient 1 should have been on only one benzodiazepine while on the alcohol withdrawal protocol. Because of the cumulative effects, all other benzodiazepines should have been discontinued.

During interview on 12/16/10 at 12:30 p.m., Physician C said Patient 1 suffered an adverse outcome due to Ativan and "Polypharmacy". Polypharmacy is defined as the administration of many and excessive drugs together.

During interview on 10/6/10 at 12:55 p.m., RN E said Patient 1 appeared to be sleeping on 8/20/10 at 12 a.m. and 1 a.m. His heart rate was 78 at 11 p.m. and dropped to 61 at 11:40 p.m.; oxygen saturation on room air was 95% between 11 p.m. and 12 a.m. Oxygen saturation was checked every 4 hours in DOU. At 1:24 a.m., the monitor at the nurse's station alarmed that Patient 1's heart rate was 40, a dangerously low rate.

Patient 1 had stopped breathing and his pulse heart rate could not be felt. Cardiopulmonary resuscitation (CPR) was started immediately. A Code Blue Physician ' s progress note, dated 8/20/10, indicated that Patient 1's diagnosis was Pulseless Electrical Activity (a heart rhythm observed on an electrocardiogram that should be producing a pulse, but is not). Patient 1 could not breathe on his own and was intubated (a tube is placed into the mouth and then into the airway so that a patient can be placed on a ventilator to assist with breathing).
Over the next several days, Patient 1's condition deteriorated. He was unresponsive and unable to follow commands. A neurologist's consultation note, dated 8/23/10, showed: "Brain CT scan shows diffuse cerebral edema with loss of gray-white matter junction and bilateral basal ganglia infarct, which is clearly secondary to his anoxic (lack of oxygen) insult that happened on the 20th..., anoxic brain injury with severe anoxic encephalopathy (brain dysfunction), possible cortical brain (responsible for higher function such as thought and action) death ...significant brain injury as a result of the event ...marked cerebral dysfunction clinically with brain stem (responsible for basic vital life functions such as breathing, heart beat and blood pressure) compromise ..."
Anoxic brain damage occurs when the brain receives inadequate oxygen for several minutes or longer. Brain cells begin to die and after five minutes permanent anoxic brain injury can occur. This is a serious and life-threatening injury and can cause permanent damage. Patient 1 never regained consciousness. Several notes showed that physicians and social workers had explained to Patient 1's family that he was brain dead and unable to breathe or sustain life on his own. On 8/25/10 Patient 1's family decided to withdraw life support and Patient 1 was pronounced dead at 5:20 p.m.
According to the Autopsy Final Report, dated 9/17/10, "The anatomic findings underlying the cause of death were: anoxic encephalopathy due to hypoxemia (low blood oxygen) and elevated desialated transferring (a chronic alcohol consumption marker), in the range associated with heavy alcohol use ... Anatomic evidence indicates the patient experienced a severe hypoxemic event with anoxic encephalopathy while observed to be sleeping. The severe hypoxia appears to have resulted in cardiac electromechanical dissociation with cessation of pump function with preserved rhythm, which was detected when the cardiac rate reached the bradycardia threshold for the monitor and the patient was discovered in pulseless electrical activity. Cardiac activity was restored with resuscitation; however hypoxic encephalopathy was irreversible ..."

Physician B 's discharge summary, dated 9/28/10, indicated the following,"Most likely the cause of death is anoxic encephalopathy, most likely from sedative induced and complicated by underlying heavy alcohol abuse and alcohol withdrawal syndrome."

2. Review of Patient 2's medical record on 12/15/10 showed the hospital had admitted patient 2 on 12/13/10 for elective spinal surgery to relieve lower back and leg pain. An operative report, dated 12/13/10, indicated that Patient 2 tolerated the surgical procedural well and no complications were encountered. The hospital transferred Patient 2 to the DOU. Patient 2's post operative pain orders were not effective, as Patient 2 continued to complain of severe pain. On 12/13/10 at 8:15 p.m. Patient 2 complained of severe pain (pain score=9) and received morphine 2 mg. Patient 2's documented acceptable pain score goal was 5 (moderate pain). At 8:40 p.m., Patient 2's pain score was 7.

On 12/13/10 at 8:50 p.m., a different nurse obtained physician's telephone orders for pain medications, which included:

Morphine 6 mg IV for one dose, now
Morphine 4 mg IV every hour for severe pain
Morphine 2 mg IV every hour for moderate pain

On 12/16/10 at 11 a.m., review of Patient 2's medication administration record with the DOU charge nurse (RN H) and DICU/DOU showed that hospital staff did not administer the Morphine 6 mg IV Now order, with a notation "not given duplication". Patient 2 did not receive any additional pain medications until 10:31 p.m., when his pain score reached 9. RN H suggested that nursing staff may have been reluctant to administer Morphine 6 mg in addition to the Morphine 2 mg administered at 8:15 p.m. RN H could not say whether the nurse who had received the verbal order had communicated to the physician Patient 2's pain medication administration history prior to obtaining the "now" orders or whether she had communicated the new orders to the nurse administering Patient 2's pain medications. RN H and DICU/DOU could not find any documented evidence of discussions with the ordering physician to clarify the order or to cancel the "now" morphine order.

Review of nurse's pain assessments between 12/13/10 at 10:31 p.m. and 12/14/10 at 6 p.m., showed that Patient 2 complained of severe pain almost every hour. The hospital staff did not administer Morphine 4 mg IV every hour for severe pain, as ordered. Additionally, contrary to physician's orders, hospital staff administered medications ordered for moderate pain, Morphine 2 mg IV and Norco (a combination opioid analgesic containing Hydrocodone 10 mg and acetaminophen 325 mg), for Patient 2's severe pain. Patient 2's post op orders, dated 8/13/10, included Norco 2 tablets by mouth every 4 hours for moderate pain (4-6); do not administer an oral narcotic within 3 hours from when an injectable narcotic was given.

12/13/10 10:31 p.m., pain score 9, Morphine 4 mg IV given at 10:31 p.m.
12/13/10 11:44 p.m., pain score 8, Morphine 2 mg IV given at 11:44 p.m.
12/14/10 12:47 a.m., pain score 8, Morphine 4 mg IV given at 12:47 a.m.
12/14/10 1:44 a.m., pain score 7, Norco 2 tablets by mouth given at 1:44 a.m.
12/14/10 2:31 a.m., pain score 8, Morphine 4 mg IV given at 2:31 a.m.
12/14/10 3:46 a.m., 4:55 a.m., 6:03 a.m.: severe pain, no medications until morphine 4 mg IV given at 7:09 a.m.
12/14/10 8:47 a.m., pain score 9, Morphine 4 mg IV given at 8:47 a.m.
12/14/10 10:11 a.m., pain score 7, Norco 2 tablets by mouth given at 10:11 a.m.
12/14/10 11:01 a.m., pain score 8, Morphine 4 mg IV given at 11:01 a.m.
12/14/10 12:50 p.m., pain score 8, Morphine 4 mg IV given at 12:50 a.m.
12/14/10 1:11 p.m., pain score 7, Morphine 4 mg IV given at 2:38 p.m.
12/14/10 3:40 p.m., pain score 7, Morphine 4 mg IV and Norco 2 tablets by mouth given at 4:09 p.m.
12/14/10 5:09 p.m., pain score 7, Morphine 4 mg IV given at 6:05 p.m.

During interview and record review, RN H said that Patient 2's pain was severe and difficult to manage. RN H said Patient 2 should not have received both injectable Morphine and Norco by mouth. RN H could not provide an explanation or the use of Norco to treat severe pain and for not following physician's orders to medicate Patient 2 with Morphine 4 mg every hour for severe pain.

During interview on 12/16/10 at 12:30 p.m., Physician C (the physician who had prescribed Patient 2's post op pain medications) said that Patient 2 was suffering from severe pain and was probably not receiving enough pain medications. When asked about the use of Norco along with IV Morphine, Physician C said the purpose of the presence of the Norco on the order set was to transition the patient to oral pain medication and not to co administer or alternate with IV pain medication.

On 12/14/10 at 9 p.m., a pain specialist physician ordered sustained release oral morphine 30 mg by mouth three times daily, with the first dose to be administered "now". Sustained release morphine would provide Patient 2 with baseline and longer acting pain relief. Patient 2's pain score was 7 (severe pain) on 12/14/10 at 9:39 p.m. Review of Patient 2's medication administration record showed that the hospital staff administered 2 tablets of Norco by mouth at 9:39 p.m., not the sustained release oral morphine. Patient 2's record did not show any communication with the physician regarding the delay in the administration of "Now" pain medication orders. Between 12/14/10 10 p.m. and 12/15/10 at 1:25 a.m. Patient 2 continued to suffer from severe pain. The hospital staff administered the first dose of sustained release morphine 30 mg on 12/15/10 at 1:24 a.m., more than four hours' delay. Patient 2's pain score at the time was "9".

When asked about the hospital's time frame for administering "now" medication orders, RN H and DICU/DOU said the hospital did not have a specific time frame. Review of the hospital's policy and procedures titled, "Medication Use Administration, revised and reviewed on 8/10" indicated, "STAT or NOW medication orders will be given the highest priority and will be administered immediately"

Patient 2 continued to suffer from severe pain until 12/16/10 in the morning, when his pain scores became more moderate.

3. Review of Patient 3's medical record on 12/17/10 showed the hospital had admitted patient 3 on 12/10/10 for a total colectomy (removal of the large intestines). Patient 3 was 69 years old and had a complicated medical history that included heart failure, irregular heart beats, coronary artery disease, and a history of sleep apnea. After surgery, on 12/10/10, while in the recovery room, Patient 3 was delayed in waking and had an episode of very low heart rate and blood pressure. The hospital staff treated Patient 3 with multiple medications including medications to restore the heart rate and blood pressure and medications (Narcan) to reverse the effects of opiates (sedation and respiratory depression) administered during surgery. The hospital transferred Patient 3 to the ICU.

Patient 3's ICU pain medication orders, dated 12/10/10, included Dilaudid Patient Controlled Analgesia (PCA) with a Dilaudid continuous infusion of 0.2 mg/hr on a hospital Pharmacy and Therapeutics Committee approved order set (7/08). The PCA orders instructions directed staff to decrease the basal rate by 0.1 mg/hr if the respiratory rate falls below 12 respirations per minute.

Interview and review of Patient 3's record on 12/17/10 at 12 p.m. with DICU/DOU and a relief charge nurse medical/surgical unit (RN B) showed the following respiratory rates per minute:

12/11/10 6 a.m., 11
12/11/10 10 a.m., 10
12/11/10 11 a.m., 11
12/11/10 5 p.m., 11
12/11/10 10 p.m., 11
12/12/10 3 a.m., 11

Contrary to physician's orders, Patient 3's Dilaudid continuous infusion rate was not decreased in response to the multiple episodes of respiratory rates below 12 and remained at 0.2 mg/hr.

The director of the ICU said it could be that the respiratory rate was below 12 for a short period of time and it adjusted quickly above 12, so staff would not adjust the PCA continuous infusion rate. RN B and the director could not say for how long Patient 3's respiratory rates had remained below 12 for each respiratory measurement.

During interview on 12/17/10 at 12:15 p.m., when asked about PCA continuous rates adjustments for respiratory rates below 12 and shown the order set, an ICU nurse (RN O) said, "I'd call the physician and adjust or does it mean adjust the rate and then call the physician."

The order set did not contain any directions regarding how long the respiratory rate had to stay below 12 prior to adjusting the rate. Patient 3's record did not contain any documented evidence that hospital staff had contacted a physician regarding the episodes of respiratory rate below 12.

During interview on 12/17/10 at 1:30 p.m., the director of pharmacy said she would immediately decrease the continuous Dilaudid rate if respirations fall below 12.

During interview on 12/17/10 at 2:21 p.m., a critical care and pulmonary specialist (Physician E) said he would decrease the PCA continuous rate if respirations fell below 12 for 10 to 15 minutes. Physician E said he has had to intubate many patients who had difficulty breathing while on a continuous rate PCA.



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4. Record review on 12/15/10 showed Patient 32 was admitted to the facility on 12/10/10 with an obstructed small intestine and gallstones. The "Admission Medication Reconciliation" record dated 12/11/10 at 4:10 a.m. showed that Patient 32's only pre-admission medication was Melatonin, a non-prescription sleep aid.

On 12/13/10 Patient 32 underwent extensive abdominal surgery. Review of the post-operative pain control medication showed the physician had ordered Dilaudid (a potent opiate, five to eight times stronger than morphine) via "Patient Controlled Analgesia (PCA)". Patient 32's PCA orders were:

Dilaudid 0.2 mg/ml (milligrams/milliliter) concentration
Loading dose (Bolus): 2 mg (milligrams)
PCA mode dose: 0.3 mg
Basal rate/continuous : 0.1 mg/hr
Delay/interval between doses: 10 minutes
One hour limit: 1.5 mg
In addition Patient 32 could have a supplemental Dilaudid loading (bolus of 2 mg, a very large dose) dose administered by the nurse every four hours as needed.

The PCA order form had three different dosage recommendations for patient doses, first dosage was considered the "Usual Dose", the second was for patients older than 64 or had sleep apnea (persons who stop breathing in their sleep), and the third for opioid-tolerant patients. Opioid tolerant patients are by definition those patients who have been taking for more than seven days 60 mg of oral morphine, or 30 mg of oral oxycodone, or 8 mg of oral Dilaudid or an equianalgesic dose of another opioid.

The Patient Controlled Analgesia order form had as the maximum recommended loading (bolus) dosage of 1 mg for opioid tolerant patients, Patient 32's dose was 2 mg. The maximum dosage for one hour limit for opioid tolerant patients was 1.5 mg per hour, Patient 32's dose was 1.5 mg per hour, although she was not opioid tolerant. A

The Condition fo Participation - for Pharmaceutical Services was not met.

Based on observations, interviews, and record/document reviews, the hospital failed to ensure that pharmaceutical services met the needs of patients as evidenced by failure to:

1. Ensure that a pharmacist clarified and ensured the appropriateness of Patient 1's pain and duplicate sedative medication orders prior to making them available for use, in accordance with hospital policy. Patient 1 received excessive doses of pain and sedative medications, which likely contributed to his cardiopulmonary arrest and subsequent brain death. (Refer to A 500)

2. Clarify duplicate and as needed pain medication orders without indication for Patient 2, prior to making them available for patient use, in accordance with hospital policy, thereby exposing Patient 2 to inconsistent and possibly inadequate pain management while potentially exposing Patient 2 to additive adverse effects due to duplication of therapy. (Refer to A 500)

3. Ensure that 36 vials of Dantrolene were immediately available in areas where triggering agents were used such as in the Ambulatory Surgery Center, in accordance with accepted standards of practice. This failure had the potential to expose patients,with a life threatening medical emergency, to delays in treatment and possibly death. (Refer to A 500)

4. Ensure the pharmacy and therapeutics committee approved written policies and procedures to determine the contents, use and process for maintaining emergency drugs and supplies, in accordance with state laws and standards of care. This failure had the potential to expose patients with life threatening emergencies to inconsistent medication availabilities and delays in life saving treatments. (Refer to A 500)

5. Ensure that hospital policies and procedures provided appropriate safeguards and guidance to promote the safe use of medications with boxed warnings such as Amiodarone and Levaquin. This failure exposed Patient 3 to serious and adverse consequences related to the use of Amiodarone without addressing the various warnings associated with its use. (Refer to A 500)

6. Ensure that hospital staff completed sterile compounding tests (media fills) annually as required by hospital policy and state law. This failure had the potential to expose patients receiving sterile compounded products to contaminated products. (Refer to A 500)

7. Ensure that outdated or unusable drugs and solutions were not available for patient use as evidenced by presence, in patient care areas, of undated and opened inhalers in one unit's medication room and undated irrigation and intravenous solutions in warmer cabinets in the operating room area. The hospital's failure to follow manufacturer's storage instructions and its medication storage policies and procedures, potentially exposed patients to contaminated and/or ineffective medications. (Refer to A 505)

8. Ensure that a potential adverse drug reaction was accurately and legibly documented in Patient 3's record and reported to the hospital wide quality assurance program, in accordance with hospital policies and procedures. This failure had the potential to expose Patient 3 to additional similar adverse drug reactions. (Refer to A 508)

9. Ensure that information relating to drug therapy, side effects and boxed warnings was available to nursing staff. This failure had the potential to expose patients to dangerous side effects without appropriate monitoring or knowledge of the nursing staff (Refer to A 510)

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

Based on observations, record reviews and staff interviews the hospital failed to control, distribute and use drugs and biologicals in accordance with hospital policies, applicable standards of care and state regulations, in order to ensure patient safety and the safe and effective use of medications as evidenced by:

The failure to ensure that a pharmacist clarified and ensured the appropriateness of Patient 1's pain and duplicate sedative medication orders prior to making them available for use, in accordance with hospital policy. Patient 1 received excessive doses of pain and sedative medications, which likely contributed to his cardiopulmonary arrest and subsequent brain death.

The failure to clarify duplicate and as needed pain medication orders without an indication for Patient 2, prior to making the medications available for patient use, in accordance with hospital policy, thereby exposing Patient 2 to inconsistent and possibly inadequate of pain medications, as well as an increased risk for developing adverse effects due to duplication of therapy.

The failure to ensure that 36 vials of Dantrolene were immediately available in areas where triggering agents were used such as in the Ambulatory Surgery Center, in accordance with accepted standards of practice. This failure had the potential to expose patients with a life threatening medical emergency to delays in treatment and possibly death.

The lack of pharmacy and therapeutics committee approved, written policies and procedures to determine the contents, use and process for maintaining emergency drugs and supplies, in accordance with state laws and standards of care. This failure had the potential to expose patients with life threatening emergencies to inconsistent medication availabilities and delays in life saving treatments.

The failure to ensure that hospital policies and procedure provided appropriate safeguards and guidance to promote the safe use of medications with boxed warnings such as Amiodarone and Levaquin. This failure potentially exposed Patient 3 to serious and adverse consequences related to the use of Amiodarone without addressing the various warnings associated with its use.

The failure to ensure that hospital staff completed sterile compounding tests (media fills) annually as required by hospital policy and state law. This failure had the potential to expose patients receiving sterile compounded products to contaminated products.

Findings:

1. Review of Patient 1's medical record on 9/29/10 (initiated during a complaint investigation) showed that the hospital admitted Patient 1 on 8/ 17/10 for an elective spinal surgery procedure to relieve neck and hand pain, weakness and numbness. Pre operative history and physical exams indicated that Patient 1 occasionally used Norco and Motrin for pain. An operative report, dated 8/17/10, indicated that Patient 1 tolerated the procedure well and had no complications. Patient 1 was awakened and moved to the recovery room in good condition and subsequently moved to the intensive care unit (ICU).

Patient 1's post operative pain medication orders, dated 8/17/10 at 11:30 a.m., included:

For severe pain: Dilaudid 1 milligram (mg) intravenously (IV) every two hours. If ineffective use 2 mg Dilaudid every 2 hours as needed or Morphine Sulfate 2 mg IV every 2 hours as needed

For moderate pain: Morphine 1 mg IV every 3 hours as needed.

According to Online Lexicomp, a nationally recognized drug reference source, Dilaudid is indicated for the relief of moderate-to-severe pain in opioid-tolerant patients who require larger than usual doses of opioids to provide adequate pain relief. Compared to Morphine, Dilaudid is much faster acting and is 8 to 10 times stronger. Dilaudid 2 mg IV is equivalent to Morphine 16-20 mg IV.

According to the package insert, respiratory depression is the chief hazard of Dilaudid. It occurs most frequently in the elderly and debilitated. Dilaudid should be used with extreme caution in those patients since even the usual therapeutic doses of opioids may decrease respiratory drive while simultaneously increasing airway resistance to the point of apnea (cessation of breathing) ....Dilaudid should be employed only under careful medical supervision at the lowest effective dose.

Review of the hospital's policy and procedures titled, "Medication Systems and Processes for Inpatient, Medication Use Preparation & Dispensing", last reviewed and revised on 12/07, indicated the following, "Prior to entering a new order into the pharmacy computer system, the pharmacist will screen for the following: Appropriateness of the drug, dose, frequency and route of administration; therapeutic duplication; ...real or potential interactions between the medication order, food and medications that the patient are currently taking ...." Additionally, the policy required the following, "All concerns, issues or questions about the medication order are clarified with the individual prescriber prior to dispensing."

During interview on 10/7/10 at 11:30 a.m., in the company of the director of pharmacy (DOP) and the Director of Clinical Quality (DCPI), a staff pharmacist (Pharm 3) said she had approved and entered Patient 1's post operative pain medication orders on 8/17/10. Pharm 3 said prior to approving orders she would evaluate their appropriateness by reviewing the indication, dose and duplicate therapies. If orders were not clear or if she had concerns about medication use of dosage, Pharm 3 said she would contact the prescriber prior to approving the orders. Pharm 3 and DOP said Dilaudid 1 mg IV is equivalent to Morphine 8 mg IV and should not be used as a starting dose for opiate naive patients. A Pre Admit medication list showed that Patient 1 had orders for Norco (Hydrocodone 10 mg/Acetaminophen 325 mg) two tablets every four hours as needed. The list did not specify how much Norco Patient 1 had actually been using. DOP could not provide any documented evidence of the pharmacist's assessment of the appropriateness of using Dilaudid 1 mg IV for Patient 1 based on his previous opiate usage.

When asked about Patient 1's Dilaudid and Morphine orders, Pharm 3 said:
"The orders come from an order set that none of us like"
"It does not make sense to use Dilaudid 1 mg or Morphine 2 mg for the same level of pain"
"I did not contact the physician because in the past he did not want to change the orders"
"This is an ongoing problem with this physician and I entered the orders as is"

Pharm 3 said she had discussed the order set with Physician C about six months ago and he had insisted on not changing the orders, so she did not contact him again for this particular order.

Review of the hospital's policy and procedures titled, "Medication Systems and Processes for Inpatient, Medication Use Preparation & Dispensing", last reviewed and revised on 12/07, indicated the following, "In situations involving a questionable drug dosage or quantity requiring consultation ....the pharmacist will contact the physician for clarification ...if the dosage of use of the medication is still questionable and considered inappropriate by the pharmacist, and the physician does not wish to change his order, the pharmacist shall consult with the medical department chair, chief of staff or designated representative for a final ruling"

During the same interview, DCPI said this has to do with the entire medical group. The inappropriateness of the order sets had been brought to the attention of the P&T chair and the department chair, who should have passed the message along to the individual physicians.

On 8/17/10, contrary to physician's orders, Patient 1 received Dilaudid 1 mg doses for the treatment of moderate pain, as defined in the hospital's policy and procedures. (Cross reference A 404)

ICU nurses' notes on 8/18/10, starting at 7 a.m., indicated that Patient 1 was agitated, made multiple attempts to get out of bed and pulled on his catheters and wires. During interview on 9/29/10 at 10:30 a.m., DCPI said when Patient 1 continued to be agitated in the ICU, the hospital suspected that Patient 1 may have been withdrawing from alcohol.

On 8/18/10 8:30 a.m., an ICU nurse obtained telephone physicians orders for initiation of the hospital's Alcohol Withdrawal Prophylaxis and Treatment Protocol. The Protocol directed nurses to assess Patient 1's alcohol withdrawal symptoms and sedation every 4 hours and medicate to prevent alcohol withdrawal symptoms with Librium (a long acting benzodiazepine/sedative) 50 mg by mouth or if unable to take medications by mouth, Ativan 0.5 mg IV every 4 hours while awake for 72 hours.

Patient 1 had older active orders from 8/17/10 for other benzodiazepines: Ativan 0.5 mg every 4 hours as needed for anxiety and Restoril 15 mg at bedtime as needed for insomnia, may repeat once. Pharm 3 did not discontinue either order prior to approving Patient 1's Alcohol Withdrawal Prophylaxis and Treatment Protocol benzodiazepine orders (Librium and Ativan).

During the same interview, Pharm 3 said she saw the 8/17/10 orders for Ativan and did not discontinue the order because, "I did not think that such a small amount of Ativan would be something I would have to discontinue. I thought the patient would be constantly assessed when on the alcohol withdrawal protocol and I did not think the nurse would administer the medications without a thorough assessment." Pharm 3 said she did not discontinue the Restoril because it had a different indication, sleep.

During interview on 12/14/10 at 1:15 p.m., the director of education said patients on the alcohol withdrawal protocol should be on only one benzodiazepine at a time.

Between 8/18/10 at 10:30 a.m. and 8/19/10 at 7 a.m., in ICU, Patient 1 received multiple doses of Librium and Dilaudid 1 and 2 mg. Additionally, Patient 1 received Restoril and Librium within 15 minutes on the night of 8/19/10. During the same time period, Patient 1 had several episodes of decreased oxygen saturations and was noted to have periods of sleep apnea (cessation of breathing) requiring increased oxygen. Oxygen saturations reflect whether enough oxygen is carried in the blood to reach organs like the heart and brain. Organs that do not receive enough oxygen can become damaged. On the morning of 8/19/10, Patient 1 was noted to be lethargic.

On 8/19/10 Patient 1 received both Librium 50 mg orally and Ativan 0.5 mg IV at 11 a.m. and 3 p.m., contrary to physicians orders. The nurse who had administered the medications did not conduct the alcohol withdrawal and sedation assessments every 4 hours as required.

On 8/19/10 at 8 p.m., Patient 1 became lethargic and the Patient 1's internist (Physician B) reduced the Librium dose and discontinued the alcohol withdrawal protocol orders for Ativan. At 10 p.m., a nurse administered the reduced Librium dose. At 10:56 p.m., the same nurse administered Ativan 0.5 mg IV using the 8/17/10 orders, without consulting with the physician. Additionally, Patient 1 received a total of 3 mg Dilaudid between 9 p.m. and 11:35 p.m.

During a telephone interview on 10/8/10 at 2:15 p.m., Physician B said Patient 1 should have been on only one benzodiazepine while on the alcohol withdrawal protocol. Because of the cumulative effects, all other benzodiazepines should have been discontinued.

On 8/20//10 at 1:24 a.m., Patient 1 stopped breathing and his heart rate could not be felt. Patient 1 was in cardiopulmonary arrest. A Code Blue was called and cardiopulmonary resuscitation (CPR) was started. A Code Blue Physician ' s progress note, dated 8/20/10, indicated that Patient 1's diagnosis was Pulseless Electrical Activity (a heart rhythm observed on an electrocardiogram that should be producing a pulse, but is not). Patient 1 could not breathe on his own and was intubated (a tube is placed into the mouth and then into the airway so that a patient can be placed on a ventilator to assist with breathing). Patient 1 never regained consciousness and suffered anoxic (lack of oxygen) brain damage. On 8/25/10 Patient 1's family decided to withdraw life support and Patient 1 was pronounced dead at 5:20 p.m.

Benzodiazepines (Librium, Ativan and Restoril) are centrally acting depressants. They can cause respiratory depression, apnea, hypotension and sedation. Combining benzodiazepines with opiates (Dilaudid) may increase the likelihood of these adverse events. (www.drugs.com )

During interview on 12/6/10 at 12:30 p.m., Patient 1's physician who had prescribed the pain medications and the alcohol withdrawal protocol (Physician C) said Patient 1 suffered an adverse outcome due to Ativan and "Polypharmacy". Polypharmacy is defined as the administration of many and excessive drugs together.

During interview on 9/29/10 at 10:00 a.m., DCPI said the hospital had identified that Patient 1 had received multiple benzodiazepines, Librium, Ativan and Restoril. DCPI said Patient 1 should not have been on more than one benzodiazepine.

Physician B's discharge summary, dated 9/28/10, indicated the following, "Most likely the cause of death is anoxic encephalopathy, most likely from sedative induced and complicated by underlying heavy alcohol abuse and alcohol withdrawal syndrome."
(cross reference A 395 and A 404)

2. Review of Patient 2's medical record on 12/15/10 showed the hospital had admitted patient 2 on 12/13/10 for elective spinal surgery to relieve lower back and leg pain. An operative report, dated 12/13/10, indicated that Patient 2 tolerated the surgical procedural well and no complications were encountered.

Patient 2's post operative pain medication orders included Dilaudid 0.5 mg or Morphine 2 mg IV every two hours for severe pain and morphine 1 mg IV every three hours or Norco (a combination opioid analgesic containing Hydrocodone 10 mg and acetaminophen 325 mg), 2 tablets by mouth every four hours as needed for moderate pain. Patient 2's post operative medication orders for severe pain were not effective and Patient 2 continued to complain of severe pain. On 12/13/10 at 8:50 p.m., a nurse obtained physician's telephone orders to increase Patient 2's pain medications, which included,

Morphine 4 mg IV every hour for severe pain
Morphine 2 mg IV every hour for moderate pain

On 12/16/10 at 10 a.m., review of Patient 2's medication administration record with DOP showed that a pharmacist had approved and made available the above orders and did not discontinue the Norco orders for moderate pain. The medication administration record did not clarify when to use Norco by mouth or Morphine 2 mg IV, since both were indicated for moderate pain.

Further review of Patient 2's medication administration record showed that hospital staff had administered Norco in conjunction with morphine, contrary to physicians orders (Cross reference see A 404) as follows:

12/14/10 12:47 a.m., Morphine 4 mg IV
12/14/10 1:44 a.m., Norco 2 tablets by mouth
12/14/10 8:47 a.m., Morphine 4 mg IV
12/14/10 10:11 a.m., Norco 2 tablets by mouth
12/14/10 11:01 a.m., Morphine 4 mg IV
12/14/10 3:40 p.m., Morphine 4 mg IV and Norco 2 tablets by mouth

During interview on 12/16/10 at 10 a.m., DOP said the Norco and Morphine should not have been administered together. DOP could not provide any evidence that a pharmacist had clarified the duplicate pain medication orders with the prescriber, in accordance with hospital policy, to clarify when to use Norco 2 tablet by mouth or Morphine 2 mg IV, since both were ordered for the treatment of moderate pain.

On 12/14/10 at 9 p.m., a physician ordered new pain medications for Patient 2, which included, Morphine 4 mg IV every four hours as needed. Review of the medication administration record showed that a pharmacist had entered the orders without obtaining an indication and clarification for the type of pain, mild, moderate or severe. Review of the medication administration record, showed that hospital staff had administered Morphine 4 mg IV every four hours for both moderate and severe pain on 12/15/10 and 12/16/10.

During the same interview, DOP said that the orders should have been clarified to include an indication, specifying the type of pain.

According to the hospital's policy and procedures, titled, "Pain Assessment and Management", revised and reviewed 8/10, pain medication orders will specify the dose for mild, moderate or severe pain and frequency and route of administration and nurses will administer pain medications as ordered by physician.

3. On 12/14/10 at 12:15 p.m. inspection of the Malignant Hypothermia Cart, in the operating room/post anesthesia care room storage area, in the company of the operating room day shift supervisor (RN K), showed that the cart contained ten vials of Dantrolene. MH or malignant hyperthermia is a rare but potentially fatal reaction to certain medications used in anesthesiology. Dantrolene is the only specific and effective treatment for malignant hyperthermia. During interview on 12/14/10 at 12:15 p.m., RN K said the hospital follows MHAUS guidelines. MHAUS, the Malignant Hyperthermia Association of the United States, is a nationally recognized organization that sets standards of care for the treatment of this disorder. MHAUS has documented that all facilities, where MH triggering anesthetics are administered, should stock a minimum of 36 vials of Dantrolene, along with the other drugs and devices necessary to treat an MH reaction. MHAUS indicated that Dantrolene should be kept in or very close to the operating room, so that it is available immediately if MH occurs because minutes count in an MH emergency. The Professional Advisory Council of MHAUS strongly recommends that an adequate supply of Dantrolene be available wherever general anesthesia is administered. Responsibility for treatment rests with the facility where the surgery is performed. Sharing is not a good alternative. During the same interview, when asked about the number of vials of Dantrolene available in the cart, RN K said pharmacy stocks some Dantrolene. (www.mhaus.org)

On 12/14/10 12:30 p.m., in the company of DCPI, in the pharmacy, pharmacy personnel were asked for Dantrolene for an emergency. A pharmacy technician (Pharm Tek) said, "I never heard of it, no idea where it's at." Pharm Tek asked a pharmacist (Pharm 4) for Dantrolene. Pharm 4 located six vials on a shelf in the inpatient pharmacy and said, "I have to ask the buyer ". Pharm 4 led the surveyor and DCPI to the pharmacy office, across the hallway, where the pharmacy buyer and DOP located 20 vials of Dantrolene in two back up emergency MH drug supply kits. During interview on 12/14/10 at 12:40 p.m., DCPI said the hospital has another MH cart in the ambulatory surgery center (ASC), across the hospital's parking lot. When asked how long it would take to deliver the remainder of the Dantrolene vials to the ASC during an emergency, DCPI said, "Maybe five minutes, depending on who's taking it."

During a mock MH code conducted in the ASC's room 3, on 12/15/10 at 1:30 p.m., the surveyors presented hospital staff with the scenario of a 250 pound patient who developed MH during a surgical procedure. The anesthesiologist (Physician D), who was called to participate in the MH code by ASC nursing staff, said "I need as much Dantrolene as possible to reverse symptoms, 50 vials at least." When asked to define as soon as possible, Physician D said, "Within minutes".

The Dantrolene became available in the ASC's room 3, as follows,
1:30 p.m.: 10 vials from the MH cart in the ASC
1:43 p.m.: 10 more vials delivered from the operating room
1:52 p.m.: 10 more vials delivered
2:00 p.m.: 10 more vials delivered from pharmacy

It took hospital staff 30 minutes to make 40 vials of Dantrolene available in the ASC during a mock MH code.

MHAUS has documented, in a Frequently Asked Questions document (General FAQs) that the full 36 vials of Dantrolene should be available within five minutes of the diagnosis of MH.

Physician D said it was not unusual to have 250 pound patients. According the MHAUS, Dantrolene is dosed at 2.5 mg/kg, repeat as needed to control clinical signs of MH, may repeat up to cumulative doses of 10 mg/kg. For a 250 pound patient, up to 56 vials may be required to control an MH episode.

When asked about the consequences of the lack of timely administration of sufficient amounts of Dantrolene during an MH crisis, Physician D said the massive cellular breakdown could not be sustained and the patient would expire.

During an interview on 12/15/10 at 2 p.m., Physician D and the director of perioperative services (DPS) said the ASC and hospital had not conducted any MH mock codes in the past. When asked for the reason the hospital did not stock 36 vials of Dantrolene in the MH carts in areas where triggering agents are used, in accordance with MHAUS guidelines, Physician D said it was because of space issues and the MH cart only had room for ten vials.

4. The American Society of Health Systems Pharmacists, 1980, Technical Assistance Bulletin on Hospital Drug Distribution and Control, concerning the Emergency Medication Supplies section, indicated the following, "A policy to supply emergency drugs when the pharmacist is off the premises or when there is insufficient time to get to the pharmacy should exist. Emergency drugs should be limited in number to include only those whose prompt use and immediate availability are generally regarded by physicians as essential in the proper treatment of sudden and unforeseen patient emergencies. The emergency drug supply should not be a source for normal "stat" or "p.r.n." drug orders. The medications included should be primarily for the treatment of cardiac arrest, circulatory collapse, allergic reactions, convulsions, and bronchospasm. The P&T (pharmacy and therapeutics) committee should specify the drugs and supplies to be included in emergency stocks. Emergency drug supplies should be inspected by pharmacy personnel on a routine basis to determine if contents have become outdated and are maintained at adequate levels. Emergency kits should have a seal which visually indicates when they have been opened. The expiration date of the kit should be clearly indicated."

During medication storage inspection and interview on 12/14/10 at 12 p.m., in the company of RN K, a medication refrigerator, in the anesthesia work room, contained an unlabeled zip lock bag, which contained medications. RN K explained that the zip lock contained emergency medications to be used during a code by the anesthesiologists. RN K said the anesthesiologist would take this kit with them when called to respond to emergencies in other parts of the hospital such the emergency room and the cathlab. RN K did not know who had assembled the kit or whether it had been approved by the hospital's P&T committee. The kit contained the following injectable medications:

Succinylcholine and Rocuronium, 2 vials each (neuromuscular blockers, used for intubation and sedation)
Propofol, 2 vials (used for sedation)
Epinephrine, 3 vials (used for low heart rate and/or low blood pressure)
Atropine, 3 vials (used for low heart rate)

During interview on 12/17/10 at 11 a.m., DOP said she had not been aware of the presence of this kit in the anesthesia workroom refrigerator. DOP said a pharmacist should seal all emergency drug supplies.

When asked for P&T approved policies and lists of emergency drug supplies, the hospital staff provided two policies and procedures entitled, "Crash Cart Replacement and Maintenance". One was five pages long and was last reviewed and revised on 3/09 and the other was 11 pages long and revised on 11/10. Neither policy addressed the anesthesiologist emergency kit found in the anesthesia work room refrigerator. The policies contained lists of emergency supplies to be found in adult and pediatric crash carts. Neither policy contained P&T approved lists of the emergency drugs to be stocked in adult and pediatric crash carts. The policies referenced a rapid sequence intubation kit but did not include a list of approved emergency drugs to be contained within the kit.

The most recently reviewed and revised policy (11/10/10), did not indicate that a pharmacist had to perform the final check and seal the emergency drug supply.

California Code of regulations, Title 22, requires the following, with regards, to emergency medication supplies,
70263 (f) Supplies of drugs for use in medical emergencies only shall be immediately available at each nursing unit or service area as required.
(1) Written policies and procedures establishing the contents of the supply, procedures for use, restocking and sealing of the emergency drug supply shall be developed.
(2) The emergency drug supply shall be stored in a clearly marked portable container which is sealed by the pharmacist in such a manner that a seal must be broken to gain access to the drugs. The contents of the container shall be listed on the outside cover and shall include the earliest expiration date of any drugs within.
(3) The supply shall be inspected by a pharmacist at periodic intervals specified in written policies. Such inspections shall occur no less frequently than every 30 days. Records of such inspections shall be kept for at least three years

5. Review of Patient 3's medical record on 12/17/10 showed the hospital had admitted patient 3 on 12/10/10 for a surgical procedure. Patient 3 was 69 years old and had a complicated medical history, that included heart failure, irregular heart beats, coronary artery disease. Patient 3's medications prior to admission included Amiodarone. The hospital continued to treat Patient 3 with Amiodarone during his hospitalization. Amiodarone is a medication used to treat irregular heart beats (arrhythmia). Amiodarone has several boxed warnings.

The FDA can require a pharmaceutical company to place a boxed warning on the labeling of a prescription medication. It is the strongest warning that the FDA requires. When a medication's labeling includes a boxed warning, it means that medical studies indicate that the medication carries a significant risk of serious or even life-threatening adverse effects

The boxed warnings associated with Amiodarone include:

Lung damage (may occur without symptoms): monitor for pulmonary toxicity (chronic interstitial pneumonitis, organizing pneumonia, acute respiratory distress syndrome, solitary pulmonary mass). Evaluate new respiratory symptoms.

Hepatotoxicity: Liver toxicity is common, but usually mild with evidence of increased liver enzymes; severe liver toxicity can occur and has been fatal in a few cases

Proarrhythmic effect: can exacerbate arrhythmias, by making them more difficult to tolerate or reverse
Other non black box warnings for Amiodarone include:
Optic neuritis/neuropathy: May cause optic neuropathy and/or optic neuritis, usually resulting in visual impairment.
Thyroid disease: Use very cautiously and with close monitoring in patients with thyroid disease; may cause hyper- or hypothyroidism. Hyperthyroidism may result in thyrotoxicosis and may aggravate or cause breakthrough arrhythmias. If any new signs of arrhythmia appear, hyperthyroidism should be considered. Thyroid function should be monitored prior to treatment and periodically thereafter, particularly in the elderly and in patients with underlying thyroid dysfunction.
According to Lexicomp Online, monitoring parameters for patients on Amiodarone include: baseline pulmonary function tests and chest X-ray and then annually during therapy, liver function tests, monitoring electrolytes, baseline and periodic thyroid functions tests and regular ophthalmic exams.
During interview on 12/17/10 at 12:15 p.m., the pharmacy supervisor (Pharm 2) said the hospital did not have a specific policy or process for addressing the boxed warnings associated with Amiodarone therapy or for monitoring for other complications related to Amiodarone use. Pharm 2 said there was no documented evidence that a pharmacist had addressed the boxed warnings or various other warnings associated with Amiodarone use and assessed the appropriateness of Amiodarone therapy for Patient 3. Pharm 2 said she could not find any evidence that Patient 3's record had any pulmonary function tests or thyroid function tests.
On November 5, 2007, the California Department of Public Health (CDPH) released an All Facilities Letter (used to notify healthcare institutions licensed by the CDPH of recurring problems that had resulted in licensing and federal noncompliance determinations) entitled MEDICATION SAFETY: USE OF MEDICATIONS WITH "BOXED WARNINGS." This letter documented that: "It is the Department's expectation that appropriate safeguards for all medications are in place that acknowledge and manage each medication's inherent risks with its benefits. Medications that have a boxed warning pose an additional challenge to promote safe use in light of their potential for serious adverse consequences. We acknowledge that there may be occasions when a facility has the need to use medications in a manner that is not consistent with manufacturer's specifications, including those with boxed warnings. In those occurrences, documented evidence should be present of a deliberative, evidence-based process by your medical and pharmacy staff and appropriate hospital committees that support such use while ensuring patient safety."

The hospital's policy and procedures titled, "Black Box Drug Warning", last reviewed on 4/09, showed the following,
Black box warning issued by the FDA concerning medications shall be discussed at the Pharmacy and Therapeutics Committee in order to determine appropriate interventions.
When deemed appropriate by the Committee, the prescribing physician shall be alerted used written notifications from the Pharmacy Department.

During interview on 12/16/10 at 5:25 p.m., DOP said that P&T discusses new boxed warnings and determines whether any action should be taken. DOP could not explain how the P&T had addressed medications with existing boxed warnings. When asked about Amiodarone and Levaquin (an antibiotic), both with boxed warnings, DOP said both drugs were used commonly at the hospital, but the hospital did not have a specific plan to address the boxed warning for either drug. DOP could not provide any evidence that the P&T committee had discussed either drug's boxed warning during their meetings.

For Levaquin, the boxed warnings include the following,
There have been reports of tendon inflammation and/or rupture with quinolone antibiotics; risk may be increased with concurrent corticosteroids, organ transplant recipients, and in patients greater than 60 years of age.

6. Review of the California board of pharmacy requirements for sterile compounding (1751.7), applicable to all pharmacies that prepare sterile products in California, showed, "Each individual involved in the preparation of sterile injectable products must first successfully complete a validation process on technique before allowed to prepare sterile injectable products. The validation process shall be carried out in the same manner as normal production, except that an appropriate microbiological growth medium (media fill) is used in place of the actual product used during sterile preparation. The validation process shall be representative of all types of manipulations, products, and batch sizes the individual is expected to prepare. The same personnel, procedures, equipment, and materials must be involved. Completed medium samples must be incubated. If microbial growth is detected, the sterile preparation process must be evaluated, corrective action taken and the validation process repeated. Personnel competency must be revalidated at least every twelve months, whenever the quality assurance programs yield an unacceptable result, when the compounding process chances, equipment used in the compounding of sterile injectable drug products is repaired or replaced, the facility is modified a manner that affects airflow or traffic patterns, or whenever improper aseptic techniques are observed. Revalidation must be documented."

Review of the hospital's policy and procedures regarding sterile compounding on 12/15/10 at 4:40 p.m., titled "Injectable Admixture", in the company of DOP and the lead clinical pharmacist (Pharm 1) showed that all pharmacy staff will complete initially upon hire and annually an intravenous admixture competency validation. This would include a media fill, gloved fingertip tests and a written exam. The purpo

The hospital failed to ensure that outdated or unusable drugs and solutions were not available for patient use as evidenced by the presence, in patient care areas, of undated and opened inhalers in one unit's medication room and undated irrigation and intravenous solutions in warmer cabinets in the operating room area. The hospital's failure to follow manufacturer's storage instructions and its medication storage policies and procedures, potentially exposed patients to contaminated and/or ineffective medications.

Findings:

During observation on 12/14/10 at 12 p.m., in the company of the operating room day shift supervisor (RN K), the solution warmer cabinet contained the following solutions, without a date indicating when the solutions had been placed in the warmer:

Eight bottles of sterile water
Two bags of 3000 ml sodium chloride solution for irrigation
Seven bags of 1000 ml sodium chloride solution for injection

During interview on 12/14/10 at 12 p.m., RN K could not say when the solutions had been placed in the warmer. RN K said the solutions should have been labeled with the date they had been placed in the warmer. RN K removed all undated solutions from the warmer to discard.

Review of the hospital's policy and procedures titled, "Fluid Warming", revised on 10/08, showed that all solutions will be labeled with the date placed in the warmer. Also, warmed solutions can remain in the warmer for up to 14 days.

During observation on 12/15/10 at 10:15 a.m. in the Definitive Observation Unit (DOU) medication room in the company of the director of pharmacy (DOP) a patient's medication cassette contained an opened Advair Diskus 250/50 Inhaler, with 13 out of 14 doses remaining. Advair is an inhalation medication used to ease breathing. The manufacturer had a warning on the inhaler which indicated, "Discard the diskus 1 month after removal from the overwrap or when the indicator reads "0" whichever comes first." During interview on 12/15/10 at 10:15 a.m., DOP said that hospital staff should label Advair Inhalers with the open date upon removal from the overwrap. Without an open date, it would not be possible to determine if the inhaler had been opened longer than a month and therefore expired and not useable.

Further medication storage inspection in the DOU medication room, showed an automated dispensing cabinet, containing floorstock inhalation medication. One of the drawers contained eight Xopenex inhalation solution vials 1.25 mg/3 milliliters (ml) without a foil pouch. Xopenex is an inhalation medication used to ease breathing and open airways in the lungs. The vials did not have a date indicating when they had been removed from the foil pouch. The manufacturer's instructions indicated the following: "Unit dose vials should remain stored in the protective foil pouch at all times. Once the foil pouch is opened, the vials should be used within two weeks. Once removed from the foil pouch, the individual vials should be used within one week"

During the same interview, DOP said hospital staff should have labeled the Xopenex inhalation vials with the open date.

When asked if the hospital had a list of drugs that required labeling upon opening, DOP provided a list of medication stability titled, "Stability of Refrigerator Medications at Room Temperature and Stability of Some Medications Outside their Wrap". The list reiterated the manufacturer's instructions regarding the stability of Advair and Xopenex, once opened. However, the list did not direct hospital staff to date the medications upon opening.

Review of the hospital's policy titled, "Medication Systems and Processes", last reviewed on 10/10, indicated that medications will be stored following the guidelines set forth by the drug manufacturer in order to preserve its potency.

Based on interviews and record review the hospital failed to ensure that a potential adverse drug reaction was accurately and legibly documented for one
(Patient 3) of 24 sampled patient's record and reported to the hospital wide quality assurance program, in accordance with hospital policies and procedures. This failure had the potential to expose Patient 3 to additional similar adverse drug reactions.

Findings

Review of Patient 3's medical record on 12/17/10 showed the hospital had admitted patient 3 on 12/10/10 for a total colectomy (removal of the large intestines) to treat a long-standing history of severe constipation and impaction. Patient 3 was 69 years old and had a complicated medical history that included, heart failure, irregular heart beats, coronary artery disease, and a history of sleep apnea.

According to an anesthesiologist's difficult to read, hand written note on the side of the anesthesia record, after surgery, on 12/10/10, while in the recovery room, Patient 3 was delayed in waking and had an episode of very low heart rate and blood pressure. The hospital staff treated Patient 3 with multiple medications including medications to restore the heart rate and blood pressure and medications (Narcan) to reverse the effects of opiates (sedation and respiratory depression) administered during surgery. Patient 3 was subsequently transferred to the intensive care unit and received additional opiates.

During interview on 12/17/10 at 2:30 p.m., the director of clinical process improvement (DCPI) said Patient 3's record did not contain any additional documentation regarding Patient 3's potential adverse drug reaction (ADR). DCPI said normally, the anesthesiologist would have documented this event in the post operative report; however, this anesthesiologist was new. The hospital staff could not provide any documentation, besides the anesthesia record, from Patient 3's medical record regarding the ADR.

Review of the hospital's policy and procedures titled, "Adverse Drug Reactions", reviewed on 6/09, showed several definitions that apply to the reporting of ADRs including, "An ADR is any unexpected, unintended, undesired response to a drug that necessitates supportive treatment." The policy further indicated the following,
"Patient/family should be informed about the potential ADR"
"Document in the medical record assessment, interventions, evaluation and any other actions taken"
"Report event to pharmacy or to the facility's current safety risk management system"

When asked on 12/17/10 at 2:30 p.m. whether an adverse drug reaction report had been completed to report this potential ADR to the hospital wide quality assurance program, in accordance with hospital policies, DCPI said an ADR report had not been completed.

During interview on 12/17/10 at 1 p.m., the director of pharmacy (DOP) said the pharmacy would investigate this incident as a potential ADR. DOP said the pharmacy had not been informed of the potential ADR and had not investigated it yet.

Based on interviews and record review the hospital failed to ensure that information relating to drug therapy, side effects and boxed warnings was available to nursing staff. This failure had the potential to expose patients to dangerous side effects without appropriate monitoring.
Findings:
During interview and Patient 3's record review on 12/17/10 at 12:00 p.m., a relief charge nurse for the medical/surgical unit (RN B) said she commonly administered oral Amiodarone and Levaquin. When asked about the boxed warnings associated with both drugs, RN B said she was not familiar with the boxed warnings for these drugs.
The Food and Drug Administration (FDA) can require a pharmaceutical company to place a boxed warning on the labeling of a prescription medication. It is the strongest warning that the FDA requires. When a medication's labeling includes a boxed warning, it means that medical studies indicate that the medication carries a significant risk of serious or even life-threatening adverse effects

In the surveyor's presence, RN 4 clicked on the Amiodarone entry in Patient 3's electronic medication administration record (EMAR). The EMAR indicated that Amiodarone "has a Black Box Warning. Consult pharmacist, prescriber and/or prescribing information for guidance" RN B said she would usually access drug information online, using the hospital's online drug reference source. When RN B accessed the hospital's online drug reference, she could not locate the boxed warning for Amiodarone. RN B repeated the same process for Levaquin, and could not locate the boxed warning for Levaquin. Without adequate references to explain boxed warnings for commonly used drugs and expected monitoring parameters and actions, nursing staff would not be able to ensure proper monitoring of medications that can cause serious adverse effects. (Cross reference A 500 #5)