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Tag No.: A0119
Based on medical record (MR) review, document review and interview the hospital did not adequately investigate a complainant's concerns. Specifically, a review completed by Staff A, Physician, Interim Executive Medical Director for Mohawk Valley Health Services Medical Group made recommendations; these were not followed. This could lead to unresolved patient complaints.
Findings include:
-- Per MR review, a patient (Patient # 1) a 36-year-old male was brought to the Emergency Department (ED) by ambulance after a motor vehicle accident. A CT scan of the head revealed massive head trauma. The patient was taken emergently to the operating room (OR) for a craniotomy (opening of the skull). After the surgery, Patient #1 remained in a coma. His prognosis was grave for return to the community or return to self-activities of daily living. The patient was made a DNR (do not resuscitate) and care was withdrawn. The patient expired.
-- Per review of a complaint received by the hospital, allegations included, that a physician and Organ Procurement Organization (OPO) representative (from Center for Donation and Transplant [CDT]) aggressively and repeatedly badgered the patient's mother about donating Patient #1's organs, even after she repeatedly told them no. Also the complainant had concerns about the quality of medical care provided and that after the patient was extubated, he could hear his mother and when she asked him to squeeze her hand, he did and raised his arm. She was questioning if she did the right thing by withdrawing medical care.
-- This complaint was reviewed by Staff A. The review indicated the following: Staff B, Trauma Surgeon, reviewed the CT scan with the family, with a nurse present showing the extensive traumatic brain injury. He/she discussed with the family that the patient still had a gag reflex and some breathing. He/she is a Trauma Surgeon and is qualified to make the determination of brain death. Also, Staff B did request a neurology consultation, however, terminal extubation was done prior to the neurology consultant arriving to the floor. The investigation also revealed that Staff B indicated the CDT person was called and came to the hospital to discuss organ donation with the family. He/she stated the CDT person, along with the mother, the mother's boyfriend, daughter-in-law, himself/herself and a hospital nurse were all in the room for the organ donation discussion. He/she explained the discussion was done by the CDT. Staff B told the family organ donation was up to them, he/she did not have any direct talk about organ donation.
Staff A's investigation summary indicated due to conflicting stories (regarding organ donation) this would require further investigation into other members present at the meeting including the nurse and the CDT person as to what conversation took place. The reviewer also indicated the quality of care would depend on an independent peer review being done.
-- Per interview of Staff D, Supervisor of Quality Management, on 8/16/22 at 12:24 pm, Staff A did mention an independent review, but the hospital didn't get one. The case was discussed at a Trauma Meeting and there were no concerns with the clinical care that was provided.
-- Review of the Trauma Performance Improvement Patient Safety Committee Meeting minutes dated 3/17/2022 revealed a mortality review was done and no findings were identified. The concerns identified in the complaint were not discussed.
-- Review of email from Staff C, Director of Risk Management (former), dated 3/21/2022 at 8:45 am to Staff D stated: Staff A was assigned the primary investigator, however, he/she has not investigated the concerns fully. The concerns noted above inquiring to other staff members involved in conversations regarding organ donation. Staff C then questioned who should be looking into these questions. Also, was a quality review being completed? If so, maybe that would be the the answer. Staff C indicated he/she would like to wrap this up by the end of next week as a new Risk Manager was starting.
-- Review of email from Staff D to Staff E, Hospital Liaison for Organ Procurement on 3/29/2022 at 3:37 pm, asked if the CDT personnel keeps records of who is in the room during organ donation discussion.
-- Review of email from Staff E to Staff D on 3/30/2022 at 1:36 pm, stated the mother and daughter-in-law were present during the initial organ procurement approach and then the boyfriend (of the mother) joined.
No further documentation was provided. No additional interviews were conducted and no independent peer review was completed.
-- During interview of Staff D and Staff F, Director of Quality Management on 8/19/22 at 11:20 am, they acknowledged these findings.
Tag No.: A0131
Based on document review, medical record (MR) review, and interview, in 1 of 7 MRs reviewed, the hospital lacked an Informed Consent form for blood administration for a patient (Patient #2). This may affect a patient or designee's right to make informed decisions regarding their care.
Findings include:
-- Review of the hospital's policy and procedure (P&P) titled "Blood and Blood Products Transfusion," last revised 5/2022, indicated the Registered Nurse shall obtain the appropriate Informed Consent and it must be signed by the patient or other designee prior to transfusion.
-- Review of the hospital's mandatory inservice and competency titled "Blood Administration," undated, indicated written Informed Consent (for blood administration) must be obtained from the patient or their designee prior to transfusion.
-- Per review of Patient #2's MR, she was admitted to the hospital on 8/15/2022 with altered mental status, abnormal heart rate and dialysis. She had a physician's order dated 8/16/2022 at 12:01 pm to "Prepare RBC (red blood cell) - 1 unit. Transfusion indications included hypovolemia/decreased O2 (oxygen) carrying capacity due to surgery, trauma, or hemorrhage, renal failure treated by dialysis, symptomatic chronic anemia, maintenance of perfusion ... . Has consent been obtained: No." The patient received a blood transfusion on 8/16/2022 at 3:35 pm.
The MR lacked an Informed Consent form signed by the patient or her designee for the transfusion administration.
-- During interview of Staff G, Director of Nursing Quality on 8/17/2022 at 11:30 am, he/she confirmed that an Informed Consent form for blood administration was lacking from Patient #2's MR.
Tag No.: A0286
Based on document review and interview the hospital lacked a process to ensure that all correctives actions identified in 3 of 4 Patient Safety Event investigations/Root Cause Analysis (RCA) were completed. This could lead to repeat safety events occuring
Findings include:
-- Review of a Patient Safety Event revealed on 3/21/2022, staff heard a noise in a patient's room, they responded and found the patient on the floor next to her bed. She sustained significant injury, a subdural hematoma that required neurosurgical intervention.
The hospital's investigation identified that the new patient beds recently placed in patient rooms were a contributing factor to this Safety Event. The nurse providing care to the patient at the time of the fall thought the patient's bed alarm was on, but it was not. The process for operating bed alarms on the new beds was different than the previous beds. When the new beds were implemented, on the spot education occurred by the bed company's representative. It was determined that the on the spot education was inconsistent between units and shifts and did not always include bed alarm education. Actions to address this included re-education to ensure all nursing staff learned how to correctly set the bed alarm. The education occurred on 3/29/2022 and 4/4/2022. Additionally nursing leadership educated staff, in-person through rounds, huddles and at shift changes. A net learning module was created for nurisng and ancillary staff. The net learning was meant to emphasize the in-person education, not replace and was required to be completed by 5/6/2022. The investigation also stated "extensive consistent bed alarm education has occurred and random spot checks with immediate re-education is occurring on the nursing units."
Per review of another Patient Safety Event that occurred on 6/5/2022, a patient fell and required surgical repair of a left hip dislocation. The investigation identified again that the involved nurse had documented that the bed alarm was on, however it was not on. Through interview of other staff on the involved unit, they all thought the bed alarm was on as well. It was determined the bed alarm was functioning properly. The conclusion stated "bed alarm education had previously occurred on the unit. Due to staff insistence that the bed alarm was turned on, yet the alarm did not sound (and equipment malfunction was ruled out), it was decided that individual education will occur with each RN and nurse tech to include review of the Fall Protection and Prevention Program ... and return demonstration on how to use the bed scale on the bed in conjunction with the bed alarm. All face to face education will be completed by 7/31/2022."
-- Per interview of Staff D, Supervisor Quality Management on 8/17/2022 at 9:35 am and at various other days and times during the survey, after the first Patient Safety Event it was identified that staff did not know how to use the new beds. The bed alarms were built into the new beds. For the bed alarm to work correctly, the bed scale had to be zeroed, then the patient weighed. The weight had to be accurate for the bed alarm to function properly. In both Patient Safety Events, the bed alarms did not go off. The beds were determined to be functioning correctly.
Staff D indicated that when a Patient Safety Event is reviewed and a RCA conducted, responsible individuals are assigned to ensure the preventative actions planned to address the causes and contributing factors are carried out. It is expected that these responsible people carry out their actions. Sometimes, a couple of weeks after the initial RCA meeting, the team will meet again to monitor progress of the preventative actions. However, there is no documentation returned to Quality Management Department that indicates the actions are completed.
-- Per interview of Staff H, Manager of Staff Education on 8/18/2022 at 9:00 am, after the first Patient Safety Event, steps were taken to educate staff (nursing, environmental services, rehabilitation therapies) about the new beds. Staff H acknowledged there was no formalized tracking to ensure all staff completed the education and attended live bed demonstrations. After the second Patient Safety Event event occurred, as of 8/18/2022, Staff H could not provide documented evidence that all staff had been educated regarding the new beds.
-- Review of a Patient Safety Event revealed on 3/11/2022 a patient presented to Emergency Department (ED) with severe sepsis and a history of seizure disorder. He was admitted to the hospital. Valproic acid and phenobarbital (anti-seizure medications) were ordered. Additionally the patient was placed on a Carbapenem antibiotic. The patient had seizure activity while hospitalized.
The RCA identified one of the contributing factors to the patient's break through seizures was the interaction of valproic acid with the Carbapenem antibiotic the patient was on. The second factor identified was that phenobarbital fell off the medication administration record (MAR) so it was not administered to the patient. It was found that phenobarbital orders are automatically discontinued after 7 days in the electronic medical record. A discontinuation alert, which appears 24 hours prior to the medication dropping off the MAR, was apparently not seen by providers.
The process was started to determine who would be responsible to ensure that medication orders that are set to automatically discontinue are addressed (i.e., providers or pharmacists). As of 8/17/2022, the hospital had not resolved this question.
-- During interview of Staff D and Staff F on 8/19/2022 at 11:20 am, they acknowledged these findings.