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SAN DIEGO, CA 92123

PATIENT RIGHTS: CARE IN SAFE SETTING

Tag No.: A0144

Based on interview and record review, the hospital failed to ensure staff followed its policy and procedure related to monitoring patient with high risk for suicidal ideation (SI- taking own life) for one of 30 sampled patients (Patient 24).

This failure had the potential to cause Patient 24 to possibly harm herself.

Finding:

Review of Patient 24's admission record dated 9/16/24, indicated Patient 24 was in the Emergency Department (ED) with medical diagnoses including, SI, methamphetamine (drug that affects mood) abuse.

Review of Patient 24's Columbia Suicide Severity Rating Scale (assessment tool) dated 9/16/24, indicated Patient 24 was "high risk" for suicide.

During a concurrent interview and interview conducted with an observer staff (OS) on 11/4/24 at 11:10 A.M., The OS stated when an OS was assigned to a high-risk patient, the OS should monitor the patient continuously inside the room and wherever the patient was. The OS further stated this was done to provide a safe environment for the patient. The OS also stated, it was a requirement for them to fill out a form titled, SMH ED Observer Workflow Log (EDOWL) or to enter the activities in the patient's electronic medical record (EMR) under Patient Observation. The OS further stated the form would have to be filled out hourly by the OS who was assigned to that patient. The EDOWL will then have to be submitted to the charge nurse at the end of the shift.

During an interview with registered nurse (RN) 24 on 11/6/24 at 11:30 A.M., RN 24 stated high-risk patients were identified when patients in the ED who needed continuous monitoring. RN 24 further stated, the OS would have been assigned and should have been documenting patient with high risk at least hourly on the EDOWL or in the patient's observation section of the EMR.

During a concurrent interview and record review with the Clinical Nurse Specialist (CNS) 24 on 11/6/24 at 3:15 PM., CNS 24 stated, Patient 24 did not have an OS EDOWL on file and there was no documented evidence in the EMR charting indicating Patient 24 was observed hourly. CNS 24 further stated, the OS who was assigned to Patient 24 should have filled out the EDOWL form or entered Patient 24's activities in the EMR to indicate that Patient 24 was continuously monitored for safety. This was not done for Patient 24.

A review of the hospital's policy titled, Safety Observer Instructions, (undated), indicated, "...During Shift:..2. Note patient behaviors every 60 minutes and notify RN with any changes or concerns. 3. Document patient activity, ADL's, safety precautions at a minimum of every 2 hours in the EMR."

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0168

Based on interview and record review the hospital did not ensure the use of restraint for 1 of 1 patient (Patient 15) were in accordance with physician order when Patient 15's was placed on left upper extremities soft restraint on 2/18/24 and 2/19/24.
This failure had the potential risk for Patient 15's care and well-being.

Finding:

Patient 15 was admitted to the hospital on 2/11/24 for diagnoses which included intracranial hemorrhage (bleeding in the brain) and altered mental status (confusion) per history and physical (H&P) dated 2/11/24.

A review of Patient 15's Restraint Evaluation and Monitoring form dated 2/18/24 and 2/19/24 indicated that Patient 15 was on left upper extremities soft restraint from 2/18/24 at 12 A.M. until 2/19/24 at 11:59 P.M.

A review of Patient 15's Physician Orders on restraint indicated that Patient 19 did not have an order for left upper extremities soft restraint on 2/18/24 and 2/19/24.

A concurrent interview and record review of Patient 15's Restraint Evaluation and Monitoring, and Restraint orders were conducted on 11/7/24 at 8:30 A.M., with the Director of Critical Care (DCC). The DCC stated Patient 15 was placed on left upper extremities soft restraint from 2/18/24 at 12 A.M., until 2/19/24 at 11:59 P.M. The DCC further stated Patient 15 did not have a valid physician order for restraint on 2/18/24 and 2/19/24. The DCC stated it was important to ensure Patient 15 had an order for restraint to ensure appropriateness of restraint and patient safety. The DCC acknowledged that Patient 15 should have a physician order for restraint but did not.

A review of hospital's policy and procedure titled, Restraint and Seclusion Use last revised 7/8/22 indicated " ...III. Policy: ...G. The use of restraint and seclusion will be in accordance with the order of a physician or other LIP who is responsible for the care of the patient and authorized to order restraint or seclusion ..."

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0175

Based on interview and record review the hospital did not ensure that 1 of 30 patient (Patient 15) were consistently assessed and monitored while placed on soft restraint.
This failure had the potential risk for Patient 15's care and well-being.

Findings:

Patient 15 was admitted to the hospital on 2/11/24 for diagnoses which included intracranial hemorrhage (bleeding in the brain) and altered mental status (confusion) per history and physical (H&P) dated 2/11/24.

A review of Patient 15's Restraint Evaluation and Monitoring indicated that Patient 15 was placed on left upper extremities soft restraint from 2/12/24 at 7 A.M., until 3/16/24 at 8 A.M. Further review indicated there were no evidence of documentation that Patient 15 were consistently monitored and reassessed every 2 hours while on restraint per hospital policy.

A concurrent interview and record review of Patient 15's Restraint orders, and Monitoring/Assessment forms were conducted on 11/7/24 at 8:30 A.M., with the Director of Critical Care (DCC). The DCC stated Patient 15 had an order for left upper extremities soft restraint on 2/13, 2/28 and 2/29/24. The DCC stated Patient 15's Monitoring/Assessment forms did not indicate he was monitored/reassessed on these dates and times:

2/13/24 at 12 and 2 P.M.
2/28/24 at 12, 2, 4 and 6 A.M.
2/29/24 at 2, 4, and 6 P.M.

The DCC further stated it was important to ensure restraint monitoring and reassessment were conducted every 2 hours for patient safety. The DCC acknowledged that Patient 15 should have been monitored and assessed every 2 hours while on restraint but was not.

A review of hospital's policy and procedure titled, Restraint and Seclusion Use last revised 7/8/22 indicated " ...IV. Procedure: ...G. Monitoring/Reassessment 1. Monitor and document the patient's physical, psychological, and comfort status at least every two (2) hours ..."

OPERATING ROOM POLICIES

Tag No.: A0951

Based on interview and record review the hospital staff did not ensure the policies and procedures (P&P) were followed for 2 of 30 patients (Patient 8 and Patient 9) when:
1. Patient 8's surgical specimen was not sent from Operating room (OR) to Pathology.
2. Patient 9's miscellaneous surgical device was retained after the surgery.

These failures had the potential to affect Patient 8 and Patient 9 health and well-being.

Findings:

1. Patient 1 was admitted to the hospital on 10/23/24 for diagnoses which included Intrauterine fetal demise (IUFD) and for procedure which included Dilation and Evacuation (D&E - removal of products of conception) per history and physical (H&P).

An interview was conducted on 11/4/24 at 10:46 A.M., with the Director of Perioperative and Obstetrics and Gynecology Services (DPOBS). The DPOBS stated Patient 8 had a D&E procedure and Patient 8's products of conception specimen were not transported or directed from OR to pathology. The DPOBS further stated, the specimen went to Post Anesthesia Care Unit (PACU) instead.

An interview and record review were conducted on 11/6/24 at 2:05 P.M., with the Manager of Perioperative Services (MPS). The MPS stated the hospital policy on handling of surgical specimen indicated, "all anatomical parts, tissue and foreign objects removed in the operating room shall be sent to the pathologist for examination ..." The MPS stated the policy was not followed when he transported and directed Patient 8's product of conception specimen from the OR to PACU. The MPS stated the staff followed his instructions and opened Patient 8's product of conception specimen container. The MPS acknowledged that it was important to ensure the interpretation of the policy and procedure was clarified to protect everyone including the staff.

A review of the hospital's policy and procedure titled, Specimen - Handling of - Surgical Care last revised 7/7/2021 indicated " ...III. Text. A. ALL anatomical parts, tissue and foreign objects removed in the operating room shall be sent to the pathologist for examination ..."


50175

2. A review of Patient 9's Admission Record indicated Patient 9 was in the hospital on 4/22/24 with a diagnosis of a left ovarian cyst (a fluid filled sac on or inside the left ovary, a part of a woman's reproductive system).

A review of Patient 9's Authorization for and Consent to Surgery, signed by Surgeon 8 and Patient 9 on 4/22/24 at 11:22 A.M., indicated Patient 9 agreed to a robotic assisted left cystectomy (removal of part of the bladder), possible left oophorectomy (removal of ovarian tissue using surgical tools).

A review of the progress note written by Surgeon 8, dated 4/22/24, indicated after removal of the cyst, " ...The speculum (an instrument inserted into the vaginal cavity to help visualize the cervix, the birth canal) was then reinserted, the uterine manipulator (a device used during surgery to help reposition the uterus, the organ where the baby develops inside a woman's body) was removed from the cervix ..."

A review of the progress note written by Surgeon 8, dated 5/1/24, indicated Surgeon 8 had a discussion with Patient 9 "regarding ...the tip of the acorn manipulator was inadvertently left inside during the surgery ..."

An interview was conducted with Licensed Nurse (LN) 8 on 11/5/24 at 9:13 A.M. LN 8 demonstrated the use of the [Brand] uterine manipulator device. The uterine manipulator came in a package sealed with a clear film so the instrument and its parts can be seen. There were two different sized "acorns" (cone shaped device) and a probe (surgical instrument) in the package. The surgeon would choose which acorn to use and screw it onto the probe. The surgeon would then use a speculum to visualize the cervix and complete the procedure. LN 8 stated the acorn could get loosened from the instrument during the procedure because the instrument was moved in many different directions during the procedure. LN 8 stated the acorns should have been counted before and after the procedure to make sure all parts of the device was removed from Patient 9.

An interview was conducted with the Director of Perioperative and Obstetrics Services (DPO) on 11/6/24 at 9:02 A.M. The DPO stated she was aware of the situation indicated in the progress note written by Surgeon 8 on 5/1/24. The DPO stated the acorns were miscellaneous surgical items and should have been counted before and after the procedure. The DPO stated there was no itemized list in the packaging of the [Brand] uterine manipulator device. It was the responsibility of both the surgeon and surgical technician (assistant during surgeries) and/or circulating nurse (a registered nurse who works in the operating room) to count the acorns before and after the procedure to confirm all instruments and parts used during the procedure were removed from Patient 9.

A review of the policy titled, Intraoperative Counts, revised 10/29/24, " ...I. Purpose. To provide a method to systematically and accurately account for the items placed on the sterile field for use on a surgical procedure; when the depth and location of the wound is such that the item could be lost or left in the patient ...C. Other Miscellaneous Items includes items that ...have the potential for being retained in the surgical wound ...D. Instruments - surgical tools or devices ...E. Incorrect Counts - Any intraoperative count that reveals a number inconsistent ...on the running count on the whiteboard or instrument sheet ...A. Dual Responsibilities ...1 ...miscellaneous item and instrument counts are the dual responsibility of the scrub person and the RN Circulator with full accountability for the process. 2. The RN Circulator and scrub person will conduct a systematic and accurate accounting of all counted items. This is important to help prevent patient injury as a result of a foreign body ...5. When adding items to the sterile field both team members shall verbally verify and visually verify the count and white board documentation ..."