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Tag No.: A0119
Based on interview and record review, the hospital failed to ensure the patient representative's grievances were addressed as per the hospital's P&P for one of eight sampled patients (Patient 3), creating the risk of unaddressed grievances and ongoing substandard practices for the patients.
Findings:
Review of the hospital's P&P titled Patient Relations: Complaints and Grievances, Formal dated June 2022 showed the following:
* Any staff or physician in any area or department can receive inquires, suggestions for improvement, and feedback by telephone, in-person, or correspondence.
* Staff or physicians receiving the inquiry, suggestions for improvement or feedback may contact a member of the Office of the Patient Experience for assistance via phone or email.
* If it requires investigation and/or further actions to resolve, the concerns become grievances.
* The office of the Patient Experience will follow the standard grievance workflow process determined by the department.
On 1/29/25, Patient 3's closed medical record was reviewed with the Clinical Nurse Educator.
Review of Patient 3's closed medical record showed Patient 3 was admitted to the hospital on 12/11/24, and discharged on 12/15/24.
Review of the Current Summary Patient/Client Flow Event dated 12/14/24, showed Patient 3's representative voiced concerns including unacknowledged pain and unresponsive call button for 90 minutes.
On 1/29/25 at 1344 hours, an interview was conducted with the Manager of Patient Relations in the presence of the Assistant Director of Risk and Regulatory. When asked, the Manager of Patient Relations stated the concerns seemed like grievances. However, the Department of Patient Relations was not aware of the above concerns. When asked, the Assistant Director of Risk and Regulatory stated the author of the event did not task for the Patient Relations. The Assistant Director of Risk and Regulatory verified the above findings.
Tag No.: A0395
Based on interview and record review, the hospital failed to ensure the nursing staff supervised and evaluated the nursing care for three of eight sampled patients (Patients 3 and 4) as evidenced by:
1. The nursing staff failed to conduct the pain reassessment and management for Patient 3's as per the hospital's P&P.
2. The nursing staff failed to conduct the IV site assessments for Patient 3 as per the hospital's P&P.
3. The nursing staff failed to complete documentation of a blood transfusion for Patient 4 as per the hospital's P&P.
These failures had the potential for unsafe care to the patients.
Findings:
1. Review of the hospital's P&P titled Pain: Adult & Pediatric dated December 2023 showed reassessment should be completed in a timely manner, within approximately one hour, to determine if the intervention is working or if the patient is experiencing adverse effects.
On 1/29/25, Patient 3's closed medical record was reviewed with the Clinical Nurse Educator.
Review of Patient 3's closed medical record showed Patient 3 was admitted to the hospital on 12/11/24, and discharged on 12/15/24.
Review of the flowsheets for the pain scores and medication administration records showed the following:
* On 12/12/24 at 0015 hours, Patient 3 complained of pain eight out of 10 (on a 0 to 10 pain scale, 0 being no pain and 10 being the worst pain). Patient 3 received Dilaudid (a pain medication) 0.2 mg IVP at 0015 hours. However, there was no pain reassessment for the patient until at 0308 hours.
* On 12/12/24 at 0312 hours, Patient 3 complained of pain 10 out of 10. Patient 3 received Dilaudid 0.5 mg IVP at 0312 hours. However, there was no pain assessment for the patient until 0813 hours.
* On 12/12/24 at 2104 hours, Patient 3 complained of pain 10 out of 10. Patient 3 received Oxycodone (a pain medication) 10 mg by mouth at 2105 hours. However, there was no pain assessment until 12/13/24 at 0158 hours.
* On 12/13/24 at 0158 hours, Patient 3 complained of pain 8 out of 10. Patient 3 received Dilaudid 0.3 mg IVP 0158 hours. However, there was no pain assessment until 12/13/24 at 0513 hours.
2. Review of the hospital's P&P titled Adult Core Nursing Standards of Care dated March 2024 showed the peripheral IV site and dressing should be assessed every four hours.
On 1/29/25, Patient 3's closed medical record was reviewed with the Clinical Nurse Educator.
Review of Patient 3's closed medical record showed Patient 3 was admitted to the hospital on 12/11/24, and discharged on 12/15/24.
Review of the Peripheral IV to right hand flowsheet showed the infusing IV site was assessed on 12/11/24 at 1947 and 2218 hours; and 12/12/24 at 0813 hours. However, further review of Patient 3's closed medical record failed to show the IV site was assessed between 12/11/24 at 2218 hours and 12/12/24 at 0813 hours (for eight hours and 55 minutes), as per the hospital's P&P.
3. Review of the hospital's P&P titled Blood/Blood Component Transfusion dated September 2024 showed the following:
* Patients will be monitored for transfusion reaction. Vital signs will be taken within 30 minutes prior to starting the transfusion, 15 minutes after the start the transfusion, and at the end of the transfusion.
* If the transfusion duration is more than 2 hours, vital signs are taken hourly.
Review of the Attachment A: Blood Transfusion Guidelines showed to slow the rate of infusion during the first 15 minutes (1-2 ml/min) and observe for adverse effects.
On 1/29/25, Patient 4's medical record was reviewed with the Clinical Nurse Educator.
Review of Patient 4's medical record showed Patient 4 was admitted to the hospital on 1/20/25.
Review of the physician's order dated 1/28/25 at 1154 hours, showed to transfuse one pack of RBC for two hours.
Review of the transfuse flowsheet dated 1/28/25, showed the RBC was transfused at 1156 hours at the rate of 200 ml/hr. Further review of Patient 4's medical record failed to show the completion time of the transfusion and total amount of the blood transfused. In addition, there was no documented evidence of slowing rate of infusion during first 15 minutes.
On 1/29/25 at 1315 hours, the Clinical Nurse Educator verified the above findings.
Tag No.: A0397
Based on interview and record review, the hospital failed to develop a standardized acuity tool for the infusion center to accurately reflect clinical patient characteristics and workload ensuring appropriate care levels are staffed according to the patient's needs. This failure increased the risk for substandard outcomes to the patients receiving care at the infusion center.
Findings:
a. On 1/30/25 at 1153 hours, an interview with the Director of Oncology Services and the Interim Manager for Infusion Center was conducted.
The Director of Oncology Services stated establishing a standardized acuity system in the outpatient infusion clinic was a challenge. Accordingly, current academic studies did not have adequate data to support one method over another in acuity and staffing ratios for outpatient infusion clinic; therefore, the hospital was still receiving input and making changes from the nursing staff and leadership in focus groups through the live environment. The Director of Oncology Services stated the current acuity system integrated an EMR-based scheduling program with a separate acuity tool derived from similar research studies. However, the process remained manual, requiring nurses to update both the acuity tool and EMR scheduling system in real time for patients who failed to meet predefined criteria.
When asked, the Interim Manager for Infusion Center stated there was no P&P for the acuity tool at the infusion center, but the hospital was actively trying to develop a standardized method to utilize the acuity tool.
When asked how long the current acuity system was trialing, the Director of Oncology Services stated it was an ongoing project since November 2024.
b. Review of the acuity tool reference the infusion clinic was using showed the following levels of acuity:
- Level 1 (Green): one IV drug with or without PO pre-medications, hydration and/or electrolyte replacement.
- Level 2 (Yellow): two IV drugs, one drug with IV pre-medication, CADD pump hook up, one to two units of blood product alone, level one acuity and isolation, single agent immunotherapy, single agent chemotherapy.
- Level 3 (Pink): three or more drugs, two drugs with pre and post hydration, CADD pump with two or more IV drugs, drug requiring three or more titrations, IV push vesicant therapy, CD1D1 newly diagnosed patient with one to two drugs, clinical trial not meeting level 4, three or more blood products, one to two blood products with IV drug, Level 2 acuity with isolation, procedures, an auto-increase to level 3 is needing full assistance with mobility, add on for infectious work up, coordination of unplanned admission, or infusion reaction.
- Level 4 (Orange): C1D1 (cycle 1, day 1) clinical trial with three or more ECG/PK/vital sign, any cycle of clinical trial with eight or more ECG/PK/vital signs, C1D1 newly diagnosed/standard of care with three or more drugs, Level 3 acuity an isolation, C1D1 level 3 acuity clinical trial and SW.
On 1/30/25 at 0920 hours, Patient 8's closed medical record review was conducted with the Infusion Supervisor, Director of Oncology Services, and Professional of Risk and Regulatory.
Patient 8's closed medical record showed the patient came to the infusion clinic on 1/28/25. Patient 8 was designated as a research patient.
Review of Patient 8's physician's order showed the patient would receive a clinical trial of chemotherapy INV MER-XMT-1660 D1/8 every 28 days. Further review of the physician's order showed there was no additional chemotherapy, testing or close monitoring required for this clinical trial.
Review of the staffing assignment showed Patient 8 was scored an acuity of "2".
Further review of the acuity reference tool showed level 2 failed to identify any level of clinical trial patients, although there was mention of single-agent chemotherapy. When asked, the Infusion Supervisor stated that although the patient was on a clinical trial, the acuity was downgraded to a level 2 instead of 3 as the chemotherapy was a one-dose treatment with no further work-up or close monitoring required.
On 1/30/25 at 1020 ours, the above findings were shared and acknowledged by the Director of Oncology Services and Professional of Risk and Regulatory.
Tag No.: A0405
Based on interview and record review, the hospital failed to ensure the medication was administered to one of eight sampled patients (Patient 8) as ordered. This failure had the potential for unsafe care to the patient.
Findings:
On 1/29/25 at 1428 hours, Patient 8's closed medical record was reviewed with the Interim Manager for Infusion Center, Director of Oncology Services, and Infusion Supervisor.
Review of Patient 8's closed medical record showed Patient 8 was treated at the hospital's infusion clinic on 1/18/25.
Review of the physician's order dated 1/18/25 at 1032 hours, showed to administer a test dose of iron dextran (a medication used to treat iron deficiencies) 25 mg in sodium chloride 0.9% (an IV solution) 50 ml IVPB one time over 10 minutes.
Review of the physician's order dated 1/18/25 at 1032 hours, showed to administer 975 mg iron dextran in sodium chloride 0.9% 500 ml IVPB if there was no adverse reaction within 60 minutes of administering the test dose.
Review of the MAR Scheduling History showed the iron dextran 975 mg IVPB was edited and administered on 1/18/25 at 1212 hours. The infusion was stopped by RN 7 at 1721 hours.
The Infusion Supervisor stated the pharmacy overfilled the iron dextran IVPB. However, the infusion was discontinued after five hours rather than upon complete administration of the overfilled IVPB and the patient did not receive the full dose of 975 mg of iron dextran as ordered.
The above findings were acknowledged by the Director of Oncology Services, and Infusion Supervisor.