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Based on interview with key staff from Risk Management and review of the hospital's "Master List Query" and review of the policy, "Complaint and Grievance Resolution Policy" on January 27, 2016, it was determined that the hospital failed to follow its established process for prompt resolution of patient grievances.
The findings are as follows:
The hospital policy, "Complaint and Grievance Resolution", specifies that:
"A Patient Grievance is a written or verbal complaint ... by a patient or the patient's representative, regarding the patient's care, abuse or neglect, patient harm or hospital compliance with CMS requirements."
On October 23, 2015, a family member of a patient complained to the Manager of Risk Management that the patient, who had surgical intervention for a fractured hip at the hospital and was discharged to a rehabilitation unit and returned to the Emergency Room 2 days after discharge, was found to have 2 Fentanyl patches in place. The patient received Narcan for the overdose in the Emergency Department.
An interview on January 27, 2016 at approximately 12:30 PM was conducted with the Manager of Risk Management who stated that although an investigation was completed the verbal complaint was never logged as a grievance.
This information was further corroborated with review of the hospital's Master List Query for October to November 2015, which documented that the family member had complained to staff at the hospital regarding potential patient harm and it was not identified as a Grievance, necessitating an investigation and written follow up letter to the complainant per policy.

Based on record review and interviews with key personnel on January 27-28, 2016, it was determined that the Condition of Participation: Quality Assessment and Performance Improvement (QAPI) was not met due to the facility's failure to take action to analyze, track and reduce medical errors following a suspected adverse patient event. The information obtained during this investigation indicated that the facility failed to conduct a thorough internal investigation or root cause analysis of the factors contributing to the suspected adverse event and that thus failed to identify a lack of a systematic approach or policy/procedure that ensures patient's being transferred to other health facilities have their medical needs met prior to and during the transfer.


The findings include:

1. Patient A was discharged from the hospital on October 19, 2015, was returned to the emergency department (ED) on October 22, 2015 at 3:41 PM. Patient A was at a rehabilitation facility and returned to the hospital due to complaint of "General weakness". Under section "notes" in the ED record the following was entered: October 22, 2015 at 4:00 PM: "Upon head to toe exam, two fentanyl patches were discovered one on right hip area and one on right deltoid." The next note entered on October 22, 2015 at 4:15 PM states, "reviewed MAR from [rehabilitation facility] it appears no fentanyl patches are ordered for this pt., RN removed both patches, both patches are 12mcg/hour dose. [Rehabilitation facility] called spoke to a RN caring for pt., MAR at [Rehabilitation facility] was reviewed it also appears no orders for fentanyl 12mcg/hr patches." A complete medication list was provided by the rehabilitation facility; however no fentanyl patch was identified on the medication list.
The patient record from the previous admission indicated that a "Fentanyl patch 12 mcg/hr 1 patch TOP/Q72H" was ordered for the patient on 10/15/15 at 10:10 PM. An additional order was added at the same time to "Remove controlled patch 1 ea miscellaneous, not specified XX/Q72H". The Medication Administration Record (MAR) indicated that a Duragesic (fentanyl) Patch was applied to the patient's right arm at 11:29 PM. Nursing documentation dated "10/19/15 0611 10/19/15 0614" states "During night shift, this RN was due to remove the pt's fentanyl patch that was placed 72 hours prior in order to place new fentanyl patch. The patch was supposed to be on the right hip, but could not be found. [Another RN] assisted this RN in looking for the patch on the pt., but with no success." Reported another Duragesic Patch was applied at that time.
The patient was discharged on October 19, 2015 to a rehabilitation facility. The discharge summary form the hospital did not list any Fentanyl Patches in the "Discharge Medications" nor did the discharge summary report the use of any Fentanyl Patches during the hospitalization. The rehabilitation facility reported that they were unaware of the patient being on a fentanyl patch.
On October 23, 2015, a patient family member requested to speak with the Director of Risk Management regarding concerns related to the condition of the patient. Hospital reported that they, "would conduct an investigation to learn more about the issue, and to identify what happened." The hospital reportedly interviewed the nurses involved in looking for the initial fentanyl patch, and applying a new patch after the initial patch was not able to be located. The Pharmacy was reportedly involved to determine, "the effects of two patches in place."
The Director of Risk Management reported that she discussed the case with the VP of Quality and Patient Safety. The case was reportedly reviewed to determine if it was a reportable event and a determination was made that, "...this did not meet the definition of a reportable event." Reported that follow-up included discussion of the case, "...in a blinded fashion at the departmental huddle so that all staff could learn from it and [Nurse Manager] reinforced the policy around medication patch removal." The Vice President of Quality stated on January 22, 2016 at approximately 1:11 PM, that information regarding this event was not presented to the Pharmacy and Therapeutics Committee as a medication error as the severity/harm level had not been determined. Additionally it was reported that no medication error was reported in the occurrence reporting system.
This finding was confirmed with the Manager of Risk Management on January 22, 2016 at approximately 2:45 PM and with the Vice President of Quality on January 28, 2016 at approximately 3:00 PM, who agreed that the incident identified by the State Survey Agency had not been reported out as a medication error and that no process was put in place to determine potential causes and means to prevent reduce similar errors.
2. On January 27, 2016 at approximately 3:05 PM, the surveyor reviewed the medical record for Patient B who had been transferred from an in-patient bed within this facility to another acute care hospital for specialized surgery and inpatient status there. There was a physician's order to discharge the patient with a note to transfer to a hospital 19 miles away to the care of Dr. B. The medical record contained a physician's discharge summary that included a list of medications at the time of transfer, including an intravenous solution (IV), and a Southern Maine Medical Transfer Form that was titled "EMTALA Transfer Form." There were no orders or documents that indicated what the physician/provider had ordered for care and services to be performed by the nurse either prior to, or during transfer to ensure the patient's medical needs were met for a safe medical transfer. On January 27, 2016 at approximately 3:10 PM, the surveyor was informed in an interview with the charge nurse, that whatever medications and treatments that are in place during the patient's inpatient stay remain and continue throughout the transfer unless the physician orders otherwise. When asked how that information is communicated to the nurse, the surveyor was informed that the nurse follows what he/she is told verbally by the physician or what is written on the physician discharge summary for medications at the time of transfer. On January 27, 2016 at approximately 3:15 PM, the surveyor interviewed the nurse who conducted the transfer of patient B. In this interview, the surveyor was informed that the patient was a discharge and that the nurse discontinued the running IV and that the EMS unit transported this patient with a saline lock in place and no running fluid. The surveyor asked the nurse what was the process used to safely transfer patients to other healthcare facilities, including the communication of the patient's condition and the process used for the physician to communicate what a patient being transferred would need for nursing interventions prior to (or during) the transfer, the nurse responded that she would look at the discharge summary as these patients were handled as discharges. The nurse who conducted the transfer advised that she did not call the receiving facility and that no communication with the receiving facility occurred to coordinate care and services other than between the sending provider and the receiving provider. When asked about why no nurse to nurse conversation occurred, she stated that she was told by the provider who ordered the transfer that the patient was going to the ER and then direct to surgery and she didn't need to do any verbal report to the receiving facility. This finding was reviewed with the nurse manager on January 28, 20/16 who advised that there was no specific policy or procedure for non-EMTALA (Emergency Medical Treatment and Labor Act) patient transfers. The nurse manager advised that the sending nurse did send a printed hand off communication report with the patient to the receiving facility as is the practice for transfer patients.
The surveyor reviewed the facility policy titled, "Hand-Off Communications Policy" This policy included a requirement that a "Hand-off communication" occurs when "Transfer or discharge of a patient from the ED [Emergency Department] or hospital unit to another hospital, healthcare organization, nursing home, or home health agency." The policy further requires, "Interactive communication is expected between the care providers involved. There should be an opportunity for questions to be answered." The nurse involved in this in-patient transfer confirmed that there was no interactive communication with the receiving facility.
3. On January 28, 2016 at 2:00 PM, this finding was reviewed with the Director of Risk Management and an additional 3 medical records for transferred patients were reviewed. In all 3 records, there was no documentation of physician orders to nursing to ensure each patient's medical needs were met for a safe transfer immediately prior to or during the transfer to another acute care hospital. One of the three additional records reviewed contained nursing documentation that a cardiac patient being transferred to a cardiac catheterization lab had his/her IV access discontinued and removed prior to the transfer which is inconsistent with the standard of care for cardiac patients. There was no evidence of a physician order to discontinue the IV access. The surveyor did note that the discharge summary signed by the physician for this transfer stated that the patient had elevated Troponin levels (a protein released by heart muscle which is indicative of heart muscle damage). This discharge summary indicated that the patient was being transferred to a cardiac center, yet it only included a list of oral medications that this patient was on and did not identify that this patient was receiving IV fluids at the time of transfer. The surveyor also noted that there was no documentation in the medical record being reviewed at the time of the survey to indicate that the sending nurse had communicated with the receiving facility nurse regarding this patient.
On January 28, 2016 at approximately 2:25 PM, the surveyor confirmed the findings regarding a lack of a systematic process for non-EMTALA transfer situations with the Director of Risk Management and the nurse manager of the Special Care Unit. The surveyor reviewed the facility policy titled, "Hand-Off Communications Policy" with the Director of Risk Management. This policy included a requirement that a "Hand-off communication" occurs when "Transfer or discharge of a patient from the ED [Emergency Department] or hospital unit to another hospital, healthcare organization, nursing home, or home health agency." The policy further requires, "Interactive communication is expected between the care providers involved. There should be an opportunity for questions to be answered." There was no evidence in the cases reviewed that interactive communication had occurred by nursing.

Based on observation, record review and interviews with key personnel on January 22, 2016 at approximately 2:00 PM, it was determined that the Condition of Participation: Pharmacy was not met due to the facility's failure to have appropriate systems in place to address Black Box Warnings (please refer to A-491) and failure to ensure adherence to facility processes for notification and review of medication errors in order to prevent reoccurrence of errors.

The finding includes:
· On October 22, 2015, patient A returned to the hospital and was found to have two (2) Fentanyl patches applied to his/her skin. The patient was displaying symptoms consistent with an overdose of an opioid medication. The patient reportedly was discharged from the facility two days earlier with no order for Fentanyl patches to be continued outside of the hospital. Additionally, the use of this medication was contrary to the FDA "Black Box Warning" for this medication.
· Hospital policy MM.07.01.03 adverse drug reactions and medication errors. The document defines medication error as: any incorrect a wrongful administration of a medication, such as a mistake and dosage or rule of administration, failure to prescribe are administered the cracked drug or formulation for a particular disease or condition, use of outdated drugs, failure to observe the correct time for administration of the drug, or lack of awareness of adverse effects of certain drug combinations. Causes of medication error may include difficulty in reading in written orders, confusion about different drugs with similar names, and lack of information about a patient's drug allergies or sensitivities.
· Under the section titled PROCEDURE it states: "b. For medication error:... i. If the medication error has reached the patient, notify the Physician. ii. Complete the Medication Error Pharmacist Review or create a Medication Error report in Quantros. iii. All Medication Errors will be presented in a quarterly review to the Pharmacy and Therapeutics Committee."
· The Associate Vice President of Quality was asked to provide information regarding reporting of the medication error through the aforementioned reporting channels, and indication that the information was reported through the Pharmacy and Therapeutics Committee. The Associate Vice President of Quality indicated on January 22, 2016 at approximately 2:00 PM that those reports were not done.

Based on observation, record review and interviews with key personnel on January 27, 2016 at approximately 10:45 AM, it was determined that the facility failed to address "Black Box warnings" by the Food and Drug Administration (FDA).

The finding includes:

The pharmacy or drug storage area must be administered in accordance with accepted professional principles, including compliance with applicable Federal and State laws, regulations, guidelines governing pharmaceutical services, as well as, standards or recommendations promoted by nationally recognized professional organizations.

The FDA "Black Box" warning for Duragesic is as follows: "DURAGESIC® should ONLY be used in patients who are already receiving opioid therapy, who have demonstrated opioid tolerance, and who require a total daily dose at least equivalent to DURAGESIC® 25 mcg/h. Patients who are considered opioid-tolerant are those who have been taking, for a week or longer, at least 60 mg of morphine daily, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid. Because serious or life-threatening hypoventilation could occur, DURAGESIC® (fentanyl transdermal system) is contraindicated: in patients who are not opioid-tolerant ..."

A review of patient "A" medical record on January 27, 2016 at approximately 10:00 AM, indicated that on October 15, 2015, the patient was prescribed a Duragesic 12 mcg/hr Patch which was administered to the patient. The patient record did not indicate that the patient had been determined to be opioid tolerant as described in the Duragesic Full Prescribing Information, provided by the manufacturer.

This finding was confirmed by the Director of Pharmacy, Pharmacy Manager and a staff Pharmacist on January 27, 2016 at approximately 11:00 AM.

Based on observation, record review and interviews with key personnel on January 27, 2016 at approximately 10:45 AM, it was determined that the facility failed to follow accepted professional pharmacy principals.
The finding includes:
All drugs and biologicals must be controlled and distributed in accordance with applicable standards of practice. This requires a monitoring process is in place to assure medication therapy is appropriate and minimizes the occurrence of adverse events.
There was no current policy or process in place to decrease medication errors/adverse events per national organizations recommendations such as the Institute of Safe Medication Practices (ISMP).
This finding was confirmed by the Director of Pharmacy, Pharmacy Manager and a staff Pharmacist on January 27, 2016, at approximately 11:00 AM.