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Based on review of medical record, hospital documents, policies/procedures, and interviews, it was determined that the hospital failed to measure, analyze, and track quality indicators, including adverse patient events, and other aspects of performance that assess processes of care, hospital service and operations for 1 of 1 patients (Pt #7).

Findings include:

Pt. #7 arrived at the Emergency Department (ED) on 10/9/09, at 1217 for evaluation of shortness of breath and chest pain. The ED record contained documentation: "...KNOWN ALLERGIES...Morphine Sulfate, Penicillins...PREVIOUS VISIT ALLERGIES: Amitriptyline Hydrochloride...Morphine Sulfate, Penicillins...." At 1336, an RN documented the patient's "Current Medications" in the ED record. This list did not include immediate release Morphine or extended release Morphine.

The medical record also contained a single page document titled "Emergency Information" for the patient, "...(As of 8/22/09)...." Review of this document revealed: "... allergic to Penicillin and Morphine Sulfate...." It also contained a list of the patient's current medications. This list did not include immediate release Morphine or extended release Morphine.

On 10/9/10 at 1645, an RN documented that the patient was admitted to the Telemetry Unit.

On 10/9/09, at 1830, a physician completed General Hospitalist Admission Orders: "...Admit to Telemetry...Allergies: PCN (Penicillin)...." At 1835, the same physician ordered several medications.The physician's orders did not contain either immediate release Morphine or extended release Morphine. The physician noted in his/her order: "...No narcotics or any other pain meds. pt cannot tolerate...."

On 10/10/09, another physician signed a form titled Admission Medication Reconciliation Orders. This form contained a list of medications with a heading "Home Medications." Instructions at the bottom of the form directed the prescriber to place a mark next to each medication to indicate whether to continue, discontinue, or change/clarify "...if medication dose, route or frequency is to be changed and document on Physician Order Form...." Additional instructions included: "...When Admission Medication Reconciliation Orders are signed, orders are to be faxed, or scanned to pharmacy and placed in the physician orders section of the chart...."

The Admission Medication Reconciliation Order form included: "...morphine extended release 120mg by mouth Q12H...morphine 15mg immediate release 1/2 tab up to 3 daily as needed...." A check mark was placed in the space indicating to continue both of these medications. The physician did not place a mark in the "change/clarify" space next to the Morphine. The physician signed the form and dated it 10/10/09. The form contained documentation that an RN noted the orders at 1059 and the form was scanned to the pharmacy at 1140.

The medical record contained documentation that the patient was given Morphine 120mg ER (Extended Release) by mouth on 10/10/09 at 2059. An RN recorded a physician's telephone order on 10/11/09 at 0050: "...Hold all po (oral) medication except Warfarin...."

Review of the medical record revealed nursing documentation regarding patient status as follows: "...10/11/09, 0614...drowsy; oriented to all...0800...Drowsy; oriented to all...1242...Alert...Drowsy...Disoriented & converses...1730...Alert...Disoriented & converses...."

On 10/11/09, at 1215, a physician documented: "...spoke with son regarding medication dose and frequency...seems sleepy...(not) in acute distress...sleepiness 2/2 (secondary to) morphine overdose/medlist error...will give narcan...morphine allergy was not notify until today, the medication list reviewed by her son and correct the list...the medication list was filled incorrectly with ? dose...asked nurse 10/10/09 to clarify dose meds & call me that it didn't happen unfortunately...."

On 10/11/09, at 1220, a physician ordered: "...Narcan 0.4mg IV (intravenous) slowly in 10 minutes...check v/s (vital signs) to report...Hold all (po) meds for now...."

At 1820, a physician documented: "...I asked pulmonary to evaluate pt. pt received 1 (one) amp (ampule) of narcan...pt was not in severe dyspnea but checked ABG (arterial blood gases)...stable...& received SVN (small volume nebulizer)/albuterol to confirm respiratory...will D/C (discharge) home at a.m ...drowsiness 2/2 drug overdose...d/w (discussed with) son that pt is intolerable to morphine instead of allergic...."

At 1830, a physician ordered: "...no narcotic...call MD with change in mental status to evaluate...."

On 10/12/09 at 1200 a.m., a physician ordered: "...add morphine to list of allergy/intolerance of pts...pt ok to D/C today...."

On 10/12/09, at 1550, an RN recorded a physician's telephone order: "...Hold discharge today...."

Review of the hospital's Policy/Procedure titled Banner Health Medication Reconciliation Policy, effective 1/28/09, revealed: "...Purpose...to reconcile medication orders for patients and ensure continuity of care, decrease errors, and decrease complications of the patient's health related to changing medications...Definition...Medication reconciliation: a process of obtaining a complete and accurate list of each patient's current home medications...then comparing the physician's orders to that list...The process involves...Verification (collection of medication history)...Clarification (ensuring that the medications and doses are appropriate)...Reconciliation (document of changes in the orders)...Policy...Performed by nursing, pharmacy and/or medical staff...On admission, with the patient's involvement, a current home medication list is created...Once admission medication orders are obtained, they will be compared with the medication list...Admission medication reconciliation will be completed within 24 hours of admission...Medications recorded on the medication list which corresponds to the admission medication orders are considered to be reconciled. Those medications which do not correspond to these orders will require clarification...Any discrepancies will be reconciled with the physician...."

Employee #1 was unable to identify the source of the information on the medication reconciliation order form in the patient's medical record. However, s/he was able to confirm that Morphine was last documented on a 5/4/08 inpatient admission, for this patient and that it was incorrectly listed on the 10/9/09 admission, under home medications on the reconciliation form. S/he confirmed that the admitting physician documented in his/her orders on 10/9/09, that the patient was not to receive narcotics due to an intolerance and that the attending physician ordered Morphine for the patient on the next morning.

On 11/12/10, Employee #7, a Quality Specialist, provided documentation, via an E-mail dated 10/14/10, that the attending physician reported the fact to Quality Management that s/he had signed the medication reconciliation form and ordered Morphine for the patient, thinking that the reconciliation form was current. The physician also reported that the patient became very somnolent and required Narcan. In addition, the physician reported that when s/he realized the error, s/he held the meds but the meds were still on the electronic medical record the next day. The documentation included information that an incident report had been completed. Review of the Incident Report revealed that the incident reported was that the pt. was given po medications when the medical record contained an order to hold all po medications.

Review of hospital policy/procedure titled Incident Reporting, Serious and Sentinel Event Reporting revealed: "...Purpose/Expected Outcome: A. To promote a culture of safety that supports reporting of errors and near misses...B. To optimize the quality and safety of patient care. C. To prevent/reduce potential recurrence of similar incidents. D. To identify patient care processes and services which have opportunities for performance improvement. E. To provide timely response to patient incidents...Policy: A. Any employee/medical staff member who becomes aware of a patient safety issue or incident is responsible for reporting the incident...Procedure/Interventions:...B Report Incident (Health Care Staff)...5. Submit the incident...C. Assign incident to appropriate departments for investigation. (QM) (Quality Management)...D. Investigation and Closing Case (Director/Designee)...1. Review the incident within 72 hours from date of initial entry...3. Investigate and enter follow up information in Department follow Up section under column titled: Quality Management Investigation. The Summary of Findings field is mandatory...4. Assign a severity level based on investigation...5. Investigate and close case within ten (10) days from the initial entry...6. Close case within thirty (30) days from date of initial entry for incidents requiring further investigation...."

The hospital was unable to provide an incident report for the administration of Morphine when the medical record contained documentation that the patient was allergic to and/or intolerant of Morphine.

Review of the hospital policy/procedure titled Adverse Drug Events revealed: "...Purpose/Expected Outcome: A. To insure prompt measures in reporting and dealing with Adverse Drug Events...B. To accumulate, trend, and report Adverse Drug Event data with the goal of preventing future occurrences...Definitions: A. Adverse Drug Event (ADE) is defined as any unexpected, unintended, undesired, or excessive response to a drug that: 1. Requires discontinuation of the medication; or 2. Requires alteration of medication therapy...Consistent with the definition...an allergic event (an immunologic hypersensitivity) and an idiosyncratic event (abnormal susceptibility to a medication by an individual) are also considered adverse drug events...Policy: A. Banner Health...ADE...reporting system includes the following: 1. An ongoing and concurrent surveillance system based on the reporting of suspected ADEs by pharmacists, physicians, nurses, ancillary department personnel, and quality resource management personnel using the adverse drug event reporting form or by any other means available (telephone/ADE hotlines, or verbally)...2. A concurrent system that monitors for designated alert orders for medications that are used to treat common adverse drug events (...naloxone...) the abrupt discontinuation or dosage reduction of a medication...4. A method of ranking adverse drug events by severity (see severity ranking under procedure)...5. Findings from the ADE monitoring and reporting program will be incorporated into ongoing quality improvement activities...Procedure/Interventions: A. If a drug reaction/allergy is suspected: Patient care staff will:...e. Notify pharmacy in the following manner (or use the Soft Med Incident Reporting System where available). i. BBMC (Banner Baywood Medical Center)...pink ADE card...2. Pharmacy will: a. Gather pertinent information regarding the potential ADE. b. Evaluate to determine probability of being an actual adverse drug event. c. Determine severity of adverse drug event...Catastrophic...Major...Moderate...Minor...d. Classify adverse drug reactions as follows:...Type B: Idiosyncratic or allergic reactions...f. Review and evaluate adverse event reports and present to the Pharmacy and Therapeutics Committee...."

Employees #14 (Pharmacy Director) & #12 (Pharmacy Senior Manager) confirmed, on 11/10/10, that the patient's reaction to the administration of Morphine would have been considered an adverse drug event. It would have been reported on Pink Cards or Soft Med. They confirmed that this event was not investigated by Pharmacy as an adverse drug event and did not get reported through the Pharmacy and Therapeutics Committee. Both employees also confirmed that the pharmacy was not reviewing 100% of Narcan (naloxone) administrations previously or currently.

Employee #14 stated that the nurse on the unit or the Clinical Pharmacist on the unit, could have completed the Pink Card; or that the Pharmacist (in pharmacy) could have alerted the Clinical Pharmacist on the unit of the Adverse Drug Event when processing the patient's orders. This could have been done by placing the order in the Clinical Pharmacist's "box" or by calling the Clinical Pharmacist. Employee #14 could find no documentation that this was done, or that a Pharmacy investigation of an Adverse Drug Event was completed. Employee #14 also stated that the current processes for reporting of Adverse Drug Events is the same process that was used at the time of the patient's hospitalization.

Review of the Pharmacy & Therapeutics Committee Meeting Minutes, dated November 18,2 009, revealed: "...Quarterly Reports 3rd QTR 2009 ADR...There were 27 adverse drug reactions for the first quarter of 2009...The drugs were anticoagulants with the exception of a morphine overdose...." It is unclear if the Morphine overdose referred to in the minutes was this patient's or not. However, Employee #14 confirmed that the pharmacy had no documentation that an adverse drug event investigation was completed.

The hospital did not follow the policy/procedure for adverse drug events.

Employee # 7, Quality Specialist, stated, on 11/10/10, that the hospital's internal investigation of the event was initiated by the physician's report to the Quality Specialist, documented in the E-mail, described above. Employee #13, Quality Specialist, described, during interview on 11/10/10, how s/he had reviewed the medical record, after receiving the E-mail, and referred the issue to Medical Staff Peer Review.

Review of hospital documents and interview with Employee #13 on 11/10/10, revealed that after the peer review process, communication was sent to pharmacy and nursing committees. However, no report was received from pharmacy or nursing regarding follow-up or further investigation.

Employee #7 confirmed, on 11/10/10, that s/he provided (to the surveyor) all of the information that the hospital reviewed and actions taken by the hospital to correct the problems which were identified as the cause for the patient receiving the Morphine.

These actions focused on the correction of problems with the medication reconciliation process and with the identification of patient allergies/intolerance to medications in the electronic medical record. However, the fact that the procedures for reporting and investigating adverse drug events and reporting and investigating incidents not being followed were not identified as problems in need of correction in the documents provided during survey. In addition, the failure of the attending physician to document conferring or clarifying with the admitting physician regarding the no narcotics order was not identified as a problem in need of correction.

Based on review of medical record, policy/procedure and interviews, it was determined that the hospital failed to report the adverse drug reaction as required in the hospital's policy/procedure for 1 of 1 patient (Pt #7).

Findings include:

Cross reference TAG (267) for information regarding Pt #7, review of the medical record, policy/procedure titled Adverse Drug Events and interviews with Employees #14 and #12.

The patient's reaction to the administration of Morphine would have been considered an adverse drug event and this event was not investigated by Pharmacy as an adverse drug event per procedure. There was no documented evidence that this adverse drug event was referred through the Quality Management Program.