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Tag No.: A0144
Based on interview and record review, the facility failed to ensure Patient 8 was provided care in a safe environment, when a renal biopsy (procedure where a small sample of kidney tissue is removed for examination under a microscope) was performed on Patient 8 that was indicated for another patient.
This failure resulted in Patient 8 having a renal biopsy procedure performed, in which Patient 8 experienced a subcapsular perirenal hematoma (SPH, a collection of blood that forms beneath the kidney's outer layer and around the kidney), and had the potential for patient harm and/or death.
Findings:
On April 7, 2025, at 8 a.m., an unannounced visit was conducted at the facility for a complaint investigation survey.
On April 9, 2025, at 9:11 a.m., Patient 8's medical record was reviewed with the Chief Quality Officer (CQO). The record indicated, Patient 8 was admitted to the facility on March 8, 2025, for complaints of fatigue and weakness for one week, diagnosed with severe anemia (a condition where the body has a deficiency of red blood cells or hemoglobin, resulting in a decreased ability to carry oxygen) and thrombocytopenia (a condition that occurs when the platelet count in your blood is too low).
The facility document titled, "Final Report," electronically signed on March 12, 2025, at 11:06 p.m., was reviewed on April 9, 2025, at 9:20 a.m. It indicated, "Reason for Exam: abdominal pain s/p [status post, after a procedure] right kidney biopsy...Impression: Large right renal subcapsular hematoma with several foci [plural form of focus- a point or area of interest]...Findings are likely the sequela of recent renal biopsy..."
On April 9, 2025, at 10:01 a.m., a review of Patient 8's renal biopsy consent was reviewed with the Accreditation and Regulatory Manager (ARM). The consent was labeled with Patient 31's identification sticker, which included Patient 31's name, date of birth, and medical record number. The consent contained Patient 8's signature. The ARM stated the procedure was supposed to be performed on Patient 31, not Patient 8.
On April 9, 2025, at 9:15 a.m., an interview with the CQO was conducted. The CQO stated Patient 8 was being evaluated for abdominal pain and low hemoglobin. The CQO stated the hematologist (medical doctor specializing in the diagnosis, treatment, and prevention of blood disorders, including blood cancers) felt Patient 8 needed a bone biopsy. When the order was clarified, it was determined a bone biopsy should be done at (Name of hospital 2). The CQO stated Patient 8 was transferred to (Name of hospital 2) on March 11, 2025, for a bone biopsy, and transferred back to (Name of hospital 1) after the bone biopsy was completed. The CQO further stated, the morning after the procedure on March 12, 2025, Patient 8's name appeared on the Interventional Radiology (IR, a medical specialty that uses imaging techniques to guide minimally invasive procedures, to diagnose and treat various conditions) worklist. The CQO stated, the procedure was supposed to be manually deleted because it was already completed at an outside facility. The CQO stated, the "TICKET TO RIDE" (a request to pick up and transport a patient) was completed by the nurse and transporter. The transporter then took Patient 8 to IR. The CQO stated, while Patient 8 was in IR, they were expecting another patient (Patient 31) for a renal biopsy scheduled for the day. The CQO further stated the nurses, physician, and staff did a chart review for Patient 31 during the "TIMEOUT" (a brief pause by the entire medical team to confirm critical details before a procedure, like patient identity, the correct procedure, and surgical site) and there was a "presumptive assumption" that the patient inside the room was Patient 31. The CQO stated the Medical Doctor (MD) consented Patient 8 inside the procedural room in Spanish, and Patient 8 consented for a renal biopsy.
On April 9, 2025, at 11:10 a.m., the Physician Assistant (PA) was interviewed. The PA stated she was working with the primary team and was asked by the Charge Nurse (CN) to speak with the patient and family regarding the renal biopsy that was "inadvertently" done on the patient [Patient 8]. The PA further stated, "It [renal biopsy] was never ordered but was done inadvertently".
On April 9, 2025, at 11:28 a.m., the Interim Director of Quality (IDQ) was interviewed. The IDQ stated, "Next time, ensure time out is completed for the right patient, right procedure, and right time". The IDQ further stated, "The wrong procedure can cause harm to the patient and on extreme case may result in permanent disability".
On April 9, 2025, at 1:15 p.m., the Interventional Radiology Medical Doctor 1 (IRMD) was interviewed. The IRMD 1 stated, "It was a disaster". The IRMD 1 further stated, the "TIMEOUT" was done for Patient 31. The Information was read for Patient 31. Patient 31 had a normal platelet count. Patient 8's platelet count was 41. The IRMD 1 stated, "I would not have done the renal biopsy if I had known".
IRMD 1 stated, "I assumed verification was done". They read the name of Patient 31, read his labs and not Patient 8's. The IRMD 1 stated, "Everybody agreed the patient in the room was [Name of Patient 31]." The IRMD 1 stated, the patient in the room was not included in the "Timeout", and the patient in the room was not asked his name.
A review of facility policy titled, "SUMMARY OF STATE REPORTING REQUIREMENTS", dated, April 25, 2014, indicated, "An Adverse Event means... Surgery performed on a wrong body part that is inconsistent with the documented informed consent for that patient...Surgery performed on the wrong patient...The wrong surgical procedure performed on a patient, which is a surgical procedure performed on a patient that is inconsistent with the documented informed consent for that patient..."
Tag No.: A0175
Based on interview and record review, the facility failed to implement their restraint (device that limits a patient's movement to keep them safe and prevent them from harming themselves or another person) policy, when restraint assessments and documentation was not performed, for one of 31 sampled patients (Patient 23).
This failure had the potential to result in serious patient harm and/or death.
Findings:
On April 8, 2025, at 1:50 p.m., a review of Patient 23's medical record was conducted with the Operating Room Charge Nurse (ORCN).
The facility's undated, and untitled, document was reviewed. The document indicated Patient 23 was admitted to the facility on January 31, 2025, for seizures (a condition caused by uncoordinated changes to electrical signals in the brain that results in uncontrollable body twitching).
A facility document untitled, dated February 9, 2025, at 9:25 a.m., was reviewed. The document indicated, "...Patient Rounding Comment: Pt [patient] pulled out NG [Naso-Gastric] tube (a thin, flexible tube inserted through the nose and into the stomach)...Date/Time: February 09, 2025, 09:25 [9:25 a.m.] Verify by [Name of Registered Nurse (RN) 2]..."
A facility document untitled, dated February 9, 2025, at 9:40 a.m., was reviewed. The document indicated, "...Patient Rounding Comment: MD [Medical Doctor] notified of tube removal...Date/Time: February 09, 2025 09:40 [9:40 a.m.] Verify by [Name of RN 2]..."
A facility document untitled, dated February 9, 2025, at 2:20 p.m., was reviewed. The document indicated, "...Patient Rounding Comment: New NG tube order and (sic) restraint order...Date/Time: February 09, 2025 1420 [2:20 p.m.] Verify by [Name of RN 2]..."
An undated facility document titled, "Order Sheet," was reviewed. The document indicated, "...Order entry D/T [Date/Time]: 02/09/25 [February 9, 2025] 18:56 [6:56 p.m.]...Ordering Doctor: [Name of MD] Restraint Initiation Non-violent...interferes with medical device...soft limb restraints...bilateral upper extremity [both upper arms]..."
During the record review there was incomplete documentation of restraints assessment from February 12, 2025, 8 a.m., to February 13, 2025, at 6 p.m. There was no documented evidence of restraint removal and restraint assessment after restraints were removed.
On April 8, 2025, at 2:43 p.m., an interview with the ORCN was conducted. The ORCN stated there were incomplete restraint assessments for Patient 23 from February 12, 2025, 8 a.m., to February 13, 2025, 6 p.m. The ORCN stated there was no documentation of restraint removal, and assessment after restraint removal. The ORCN stated RN 2 should have assessed Patient 23 for difficulty breathing, skin assessment, range of motion, Nutrition/hydration, hygiene/elimination, discontinuation are you OK Readiness attempts, pain restraints, and patient safety from February 12, 2025, 8 a.m. to February 13, 2025, 6 p.m. The ORCN stated an RN should have documented removal of restraints and performed an assessment of Patient 23 after removal of the restraints. The ORCN stated it is done for patient safety.
On April 8, 2025, at 3:14 p.m., an interview with the Interim Director Of Quality (IDQ) was conducted. The IDQ stated it is important to complete restraint assessments for patients as it is for "the well-being of the patients."
A review of the facility policy titled, "Restraints Violent/Non-Violent," dated, August 19, 2009, indicated, "...the purpose of this policy is to define the hospital's approach to the application of restraints for patients in a way that protects the patient's health and safety, and preserves his or her dignity [self-respect], rights and well-being...monitoring must include but is not limited to...Ability to clear airway...Circulation...Heart rate...Respirations...Skin integrity [condition of the skin]...Sensation..."
Tag No.: A0749
Based on observation, interview, and record review, the facility failed to implement their Infection Prevention Policy for two of 31 sampled patients (Patients 24, and 25) when hand hygiene was not performed.
This failure had the potential for the transmission of infections to be spread to Patient 25.
Findings:
On April 7, 2025, at 9:32 a.m., a tour of facility was conducted with the Emergency Department Director (EDD), the Operating Room Charge Nurse (ORCN), and the Interim Quality Director (IQD).
On April 7, 2025, at 11:07 a.m., during the tour of the Emergency Department, Registered Nurse (RN) 1 was observed coming out of Isolation Room 1 (Patient 25's room) and did not perform hand hygiene. RN 1 was observed going back into Isolation Room 1 without performing hand hygiene.
On April 7, 2025, at 11:08 a.m., during the tour of the Emergency Department, Emergency Room Medical Doctor (ERMD) was observed coming out of Isolation Room 1 (Patient 25's room), and going into Isolation Room 2 (Patient 24's room), without performing hand hygiene. The ERMD was observed coming out of Isolation Room 2, and going back into Isolation Room 1, without performing hand hygiene.
On April 9, 2025, at 11:11 a.m., a review of Patient 24's medical record was conducted with the ORCN. It indicated Patient 24 was admitted on April 7, 2025, for diarrhea.
An undated facility document titled, "Order Sheet," was reviewed. The document indicated, "...Isolation...04/07/2025 [April 7, 2025] 9:56 [9:56 a.m.]...Continuous, enteric precautions...Pt name: [Name of Patient 24]..."
On April 7, 2025, at 11:12 a.m., an interview was conducted with the ERMD. The ERMD stated she did not perform hand hygiene when she came out of Isolation Room 1 (Patient 25's room) and went into Isolation Room 2 (Patient 24's Room), and before going back into Isolation Room 1 after coming out of Isolation Room 2, because she was busy. The ERMD stated she should have performed hand hygiene before and after going into the isolation rooms. The ERMD stated she broke infection control.
On April 7, 2025, at 11:18 a.m., an interview was conducted with the EDD. The EDD stated the ERMD and RN 1 should have performed hand hygiene before entering patient rooms, and after leaving patient rooms. The EDD stated it is important to do this for infection control.
On April 10, 2025, at 11:23 a.m., an interview was conducted with IP 2. IP 2 stated infection control practices should be followed to prevent and control Hospital Acquired Infection (HAI -infections that patients develop while receiving care in a hospital).
The facility's undated, policy titled, "isolation procedures," was reviewed. The facility policy indicated, "...This policy is designed to prevent the transmission of infectious [likely to be passed to people] agents...These measures are to be used when providing care to all patients...hand hygiene...Placing a patient in isolation...order is placed in the electronic medical record with the type of isolation precaution...an appropriate isolation sign must be placed outside patient's room so the sign is visible to staff and visitors..."
Tag No.: A0750
Based on interview and record review, the facility failed to follow its Infection Surveillance Prevention Program and Plan when:
1. An Infection Preventionist (a trained personnel that focuses on preventing and controlling the spread of infection) was not physically present to conduct observations on infection prevention control practices in the facility from November 4, 2024, through April 10, 2025.
2. An Infection Preventionist was not physically present to complete Hospital Acquired Infection/ Conditions (HAI/HAC -infections that patients develop while receiving care in a hospital) reports for February and March 2025.
These failures resulted in inadequate surveillance and monitoring of infection control practices and data which can potentially hinder efforts to reduce HAIs and improve patient safety.
Findings:
1. On April 7, 2025, at 9:32 a.m., a tour of facility was conducted with the Emergency Department Director (EDD), the Operating Room Charge Nurse (ORCN), and the Interim Director of Quality (IDQ). The IDQ stated the Infection Preventionist (IP) 1, is currently on leave since November 4, 2024. The IDQ further stated IP 2 is covering for IP 1 and is assisted by the Quality/Performance Improvement Analyst (QPIA).
On April 10, 2025, at 11:12 a.m., an interview was conducted with the QPIA. The QPIA stated her primary responsibility is physician peer review. The QPIA stated she did not do observations on infection prevention and control practices in the facility from November 4, 2024, to present. The QPIA stated she did not conduct any inspections in the OR to ensure medical equipment cleaning, disinfecting and sterilizing guidelines were being followed.
On April 4, 2025, at 11:20 a.m., an interview was conducted with the IDQ. The IDQ stated observations on infection prevention control practices in the facility from November 4, 2024, to present, should have been conducted. The IDQ stated inspections in the OR should have been conducted to ensure sterilizing (to kill all bacteria and viruses) guidelines were being followed. The IDQ further stated it is important to do observations and surveillance to provide adequate patient care and prevent hospital acquired infection.
On April 10, 2025, at 11:33 a.m., an interview was conducted with the IP 2. The IP 2 stated she is an IP consultant for the facility. The IP 2 stated she can not do observations on infection prevention and control practices because she is not present onsite. The IP 2 stated it should be done to prevent and control HAIs.
2. On April 7, 2025, at 9:32 a.m., a tour of facility was conducted with the Emergency Department Director (EDD), the Operating Room Charge Nurse (ORCN), and the Interim Director of Quality (IDQ). The IDQ stated the Infection Preventionist (IP) 1, is currently on leave since November 4, 2024. The IDQ further stated IP 2 is covering for IP 1 and is assisted by the Quality/Performance Improvement Analyst (QPIA).
The facility HAC report dated January 2025, was reviewed with the IDQ and QPIA. There was no documented reports for February 2025, and March 2025.
On April 10, 2025, at 1: 38 p.m., an interview was conducted with the QPIA. The QPIA stated her primary responsibility is physician peer review. The QPIA stated she only completed the January 2025, HAC report, and did not complete the February and March 2025, HAC reports. The QPIA further stated she should have completed the February and March 2025, reports, however, it was only her "doing everything".
On April 10, 2025, at 2:07 p.m., an interview was conducted with the IDQ. The IDQ stated it was important the facility do their due diligence in ensuring that preventing and treating infections promptly were done "to keep patients and staff safe."
A review of the facility infection prevention policy titled, "Infection Prevention Program and Plan, dated January 22, 2009, indicated, "...the aim of our program is to deliver safe, cost effective care to our patients...the program is designed to prevent and reduce hospital associated infections...the IP is responsible for implementing this plan...the facility's IP will conduct daily infection prevention rounds with follow up required by the survey department...ensuring medical equipment cleaning, disinfecting [to kill bacteria] and sterilizing [to kill all bacteria and viruses]of medical equipment..."
A review of the facility infection prevention policy titled, "Post Discharge [after the patient left the hospital] Hospital Acquired Infection Surveillance," dated October 20, 2005, indicated, "...efforts shall be made to determine the infection rate for discharged patients presenting with an infection within thirty (30) and ninety (90) days of surgery...To document that infection and maintain a retrievable (capable of being regained) form of record keeping to be used in preparing the Monthly Surveillance Report..."