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Based on observation interview and record review the facility failed to protect and promote each patient's rights when:

1. Patient (Pt) 1 was not secured by safety straps on an operating room (OR) table, without a transfer bed (a bed next to the bed the patient is currently in, that the patient will be moved in too after surgery) when transferring or staff member by her side and subsequently, fell off of the table while waking up from anesthesia (the use of medicines to prevent pain during surgery and other procedures) breaking her left humerus (upper arm bone). (Refer to A144 finding 1).

2. Pt 4 had an emergent laparoscopic cholecystectomy (a procedure where a surgeon makes small incisions in your abdomen and a tube with a tiny video camera goes through those incisions. The surgeon watches a video monitor in the operating room while using tools inserted through the other incisions to remove your gallbladder [a small, pear-shaped organ that is located in a persons' upper right abdomen]) and the gall bladder was never removed due to the surgeon leaving it in Pt 4's abdominal cavity (the cavity within the abdomen, the space between the abdominal wall and the spine). (Refer to A144 finding 2).

3. The facility did not respond to grievances in accordance with hospital policy for one of three patients (Pt) 1 when the Patient Safety Officer (PSO) did not communicate what events occurred during the procedure that caused her to fall from the OR table and subsequently break her left humerus (upper arm) denying Pt 1 the right to voice concerns, be informed of, and participate in resolving the grievance. (Refer to A118).

The cumulative effect of these systemic problems resulted in failure to ensure patients were cared for in a safe manner, and their rights were protected and promoted at all times.

Based on observation, interview and record review, the hospital failed to provide anesthesia services in a well-organized manner when:

1. The hospital failed to ensure anesthesia (use of medicines to prevent pain during surgery and other procedures) services were appropriate to the scope of the services provided, for one of one sampled Patient (Patient 1), when Certified Registered Nurse Anesthetist (CRNA- a Registered Nurse who has specialized training in anesthesia) 1 ordered diagnostics in the post-anesthesia care unit (PACU- a unit where patients go directly after a surgical procedure to recover from the effects of anesthesia) after Patient (Pt) 1 fell off the Operating Room (OR) table and the Anesthesia in Charge (AIC) that day was a CRNA (CRNA 2). (Refer to A 1001)

2. The hospital failed to ensure the safety and well-being of one of one patients (Pt 1), when Pt 1 was under the direct care of the Certified Registered Nurse Anesthetist (CRNA) 1 and fell off of the operating room table while emerging from Anesthesia (the use of medicines to prevent pain during surgery and other procedures). (Refer to A 1002)

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality healthcare in a safe and responsible manner.

Based on interview and record review, the facility failed to ensure the rights of one of three patients (Pt 1) were conserved when the facility did not provide Pt 1 and her family with a satisfactory explanation of the events which lead to the patient 1's fall from the Operating Room (OR) table, action the hospital took to investigate the grievance, resolve the grievance, other actions taken by the hospital as required by facility policy and procedure (P&P) and state and federal regulations.

These failures resulted in actual patient physical harm, associated with the adverse event, and an unresolved patient 1's grievance.

Findings:

During an interview on 4/23/24 at 11:00 a.m., with Pt 1, Pt 1 stated, "She received a registered letter from the facility five (5) days after the fact. Hospital did an investigation. That is all it said. After all this happened, [it] felt like a slap in the face, extremely cold the hospital. I wanted out before they hurt me some more. Hospital doesn't seem very concerned about me with just this letter."

During an interview on 6/17/24 at 8:45 a.m., with the Public Safety Officer (PSO), PSO explained any staff member of the hospital can submit a report of an unusual or unexpected occurrence. PSO stated the report was routed to his office for review, investigation, and resolution. PSO stated he was familiar with the adverse event involving Pt 1 who suffered a fall to the OR floor with subsequent injury due to not being secured by safety straps on an OR table; without a transfer bed or staff member by her side; while waking up from anesthesia (the use of medicines to prevent pain during surgery and other procedures) resulting in a fracture of her left humerus (broken upper arm bone). PSO stated for this adverse incident, he responded personally by immediately meeting with the patient stated his process for responding to a report of an adverse event or patient/patient representative complaint or grievance was to meet with the individuals involved in the report and to formulate an investigation plan. spouse to inform him that the patient had fallen from the OR table. PSO stated he informed the spouse he would be starting an investigation into the adverse event. PSO stated he normally includes department managers for their assistance in investigating events such as this one and he did consult with OR department leaders as needed.

During a concurrent interview and record review on 6/17/24 at 8:55 a.m., with the PSO and review of the facility patient complaint resolution letter dated 4/12/24, the PSO stated after his investigation was complete, he sent a generic form letter to the patient/patient family informing them "As of the date of this letter, the Grievance Committee has completed its review of your concerns and consider this matter to be resolved ..." PSO stated he communicated the progress of his investigation, via telephone and that he met with the patient while in the facility, however he did not maintain a record of dates and times he telephoned or met face-to-face with the patient/patient family. PSO stated that in his discussions with the patient/patient family, he had not provided the patient/patient family with an explanation of the events, nor did the investigation completion notification letter explain specifically, how the injury occurred (fall from the OR table) to the patient/patient family. PSO stated he saw now the letter was "too generic" and should have been drafted to address the patient/patient family specific questions of the/action taken of this adverse event. PSO stated at minimum he should have documented telephone calls and other meetings with patient/patient family, provided details to meet the patient/patient family rights to be informed of how it came to be that she went in for an elective procedure on her hip and ended up with a left arm fracture after hip surgery.

During an interview on 6/18/24 3:00 p.m. with the Chief Nursing Officer (CNO) and Chief Executive Officer, (CEO), the CEO acknowledged there were opportunities to improve upon the grievance and adverse event reporting process.

During a review of P&P titled, "Patient Complaints/Grievances" dated12/22, the policy indicated, " ...II. Purpose: ...This policy provides a mechanism for initiation, review, and when possible, prompt resolution of patient complaints concerning the quality of care of service(s) received ... V. Procedure: ...C. Patient Grievance ...4. Each grievance will be followed up with a written notice of decision ...within 30 days. The written response will contain the following elements: Date of receipt of grievance. Name of the Hospital contact person for patient follow up if needed. Steps taken to investigate. Results of investigation. Date of investigation completion ...5. A grievance is considered resolved when the patient is satisfied with the actions taken on his/her behalf ..."

Based on interview and record review, the hospital failed to ensure patients (Pt) received care in a safe setting for 2 of 2 sampled Pts (Pt 1 and Pt 4) when,

1. Pt 1 was not secured by safety straps on an operating room (OR) table, without a transfer bed (a bed next to the bed the patient is currently in, that the patient will be moved in too after surgery) when transferring or staff member by her side and subsequently, fell off of the table while waking up from anesthesia (the use of medicines to prevent pain during surgery and other procedures) breaking her left humerus (upper arm bone).

2. Pt 4 had an emergent laparoscopic cholecystectomy (a procedure where a surgeon makes small incisions in your abdomen and a tube with a tiny video camera goes through those incisions. The surgeon watches a video monitor in the operating room while using tools inserted through the other incisions to remove your gallbladder [a small, pear-shaped organ that is located in a persons' upper right abdomen]) and the gall bladder was never removed due to the surgeon forgetting it in Pt 4's abdomen cavity (The cavity within the abdomen, the space between the abdominal wall and the spine).

These failures resulted in actual harm to Pt 1 and Pt 4. These safety errors caused Pt 1 to break her left upper arm, which resulted in a same-day second surgical procedure and Pt 4 had to incur the risk of a new emergent surgical procedure and anesthesia due to the gall bladder being left behind . Pt 4's second surgical procedure was 90 minutes after the first one ended.

Findings:

1. During a review of Pt 1's "Pre-operative History and Physical (H&P)", dated 4/2/24, the H&P indicated, " ...75-year-old, Female ... Chief Complaint: ... right hip hurts ... Focused Examination: ... The patient does have a bit of a pannus (an apron of excess skin and fat hanging from the abdomen below the waistline) overlapping the proximal (nearer to the center of the body) portion ... deep hip pain ... pain with external and internal rotation ... She has an antalgic gait (limp) ... Impression: Arthritis right hip (a condition in which there is loss of the cartilage [strong, flexible connective tissue that protects your joints and bones] of the head of the thighbone and of the cup-shaped socket of the pelvis where the thighbone fits into the join) ... Diagnosis: Arthritis of right hip, Abdominal pannus ... Recommendation/Plan: ... Proceed with surgical interview involving right total hip arthroplasty (a surgical procedure in which an orthopedic surgeon removes the diseased parts of the hip joint and replaces them with new, artificial parts) ... The potential risks, benefits, complications, outcomes were discussed with the patient who understood, agreed and consented to proceed ... Signature: [Medical Doctor (MD) 7] ... Reviewed Problems: Graves Disease (an immune system [cells that defend the body against infection] condition that affects the thyroid gland [produces hormones for the human body]) - onset 2/1/20, Myasthenia gravis (a chronic autoimmune disorder [A condition in which the body's immune system mistakes its own healthy tissues as foreign and attacks them] in which antibodies [proteins that protect you when an unwanted substance enters your body] destroy the communication between nerves [a bunch of wires or cables that send signals to and from the brain] and muscle, resulting in weakness of the skeletal muscles), Essential Hypertension (high blood pressure), Coronary Arteriosclerosis (the buildup of fats, cholesterol and other substances in and on the blood vessels causing vessels to narrow blocking blood flow) ..."

During a review of Pt 1's "Operative Note (ON- from MD 7) EMR (Electronic medical record)", dated 4/8/24, the ON indicated, " ...Correction to note. Prior to transfer the patient to PACU (Post-anesthesia care unit- a unit where patients go directly after a surgical procedure to recover from the effects of anesthesia), the Pt fell off the bed landing on her left upper extremity and complaining of shoulder pain. She is subsequent to that, was sent to radiology for evaluation and it appeared to have had a fracture of the humeral shaft at the distal third (a break in the lower end of the upper arm bone). I discussed that with family ... will reevaluate when more awake to discuss surgical treatment ... patient ... complaining of left upper extremity pain, the right hip appears to be having no pain ..."

During a review of Pt 1's "Surgical Documentation (SD)", dated 4/8/24, the SD indicated, " ...Last modified by: Registered Nurse (RN) 10 [RN 8 note] ... General Comments: Once procedure was complete dressings were placed on incision ted hose (compression stockings that are designed for the lower legs to help reduce risk of blood clot formation) placed on patient. Left arm was freed and placed on chest in order to bring bed to side of table. I turned to move suction and Bovie Electrocauterization [or electrocautery- A procedure that uses heat from an electric current to destroy abnormal tissue] is often used during surgery to remove unwanted or harmful tissue. It can also be used to burn and thus seal blood vessels. This helps reduce or stop bleeding during surgery) out of the way and patient had rolled off of surgical table to the right side. I ran to patient and saw her in a prone position on floor. I asked her if she was okay or hurt and she asked what happened. I then positioned her on her back supporting her head. I placed a pillow under head and covered her with blankets. I did a quick scan assessment checking for abrasions or obvious injuries, I saw no apparent skin injuries ... other staff had come into the room by then and a lift team was called. I was sent to a lunch break and did not witness the lift team placed the patient in bed ... General Comments: (Last modified by RN 8) ... 11:10 a.m. patient fell from bed (post removed) witnessed by RN 8, Certified Registered Nurse Anesthetist (CRNA- is an advanced practice registered nurse who administers anesthesia for procedures and surgeries.) 1, Scrub Technician (ST-is a college-educated operating room assistant who performs multiple job duties, including providing the surgeon with the instruments needed to perform surgery.) 4, patient stabilized while on floor, kept warm inform charge nurse lifting called for patient on bed. MD (Medical Doctor) 7 informed of incident ... 11:30 a.m. patient (1) on bed by lift team ... transferred to PACU ... "

During a review of Pt 1's "Diagnostic Radiology (DR- a field of medicine that uses non-invasive imaging to diagnose patients)", dated 4/8/24 at 12:26 p.m., the DR indicated, " ... Ordering Provider: CRNA 1. Report: XR Humerus Minimum 2 Views Left ... Clinical Information: fall ... Impression: Comminuted angulated fracture (broken bone in at least three places) of the distal humeral (Upper arm) ... Final Report: Dictated by MD 8 ... Signed by: MD 8 ..."

During a review of Pt 1's "Progress Note (PN- from CRNA 1)", dated 4/8/24, the PN indicated, " ... I told (Pt 1), surgery is now over. Stay still and don't move. We are getting you ready to be moved to your bed. (RN 5) removed the tape from the patient's right arm which was taped over the patient's chest. I removed the arm strap from the Pt's left arm which was strapped to an arm board connected to the bed. Patient was still groggy so I reminded the patient to not move ... Pt raised her left arm and rolled over to the right side. Pt fell off of the OR bed and was on the ground face-down with her left arm shielding her face ... I told her not to move and try to stay still while we were getting more help to move her back to the bed ... Pt was unable to move or feel her legs due to the spinal block I had placed earlier for the surgery ... Pt stated that she felt pain in her shoulders. I noted that the Pt's left-hand squeeze was weaker than the right hand, so I lifted the Pt's left gown sleeve and observed a suspected fracture in her left upper arm ..."

During a review of Pt 1's "Operative/Procedure Reports (OPR)", dated 4/9/24, the OPR indicated, " ...Surgeon: MD 7 ... Anesthesiologist (a medical doctor who specializes in administering anesthesia): MD 9 ... Post-operative diagnosis: Left comminuted and displaced closed distal third humeral shaft fracture ... Indications for Procedure: This is a 74-year-old woman who fell off the operative table after surgical intervention for her right hip today causing her to develop a displaced fracture of the left distal humerus for which require surgical intervention. After discussing this with the staff, the family and the patient herself, we deemed important and necessary to fix this as soon as possible so that we can allow her to be able to ambulate after her hip arthroplasty ... consented to proceed ... Findings: Displaced comminuted humeral shaft fracture ... Implants/Explants: ... humerus plate with ... screws ... Patient Condition: good ..."

During an interview on 6/13/24 at 2 p.m., with ST 4, ST 4 stated she was in the room when Pt 1 fell off of the OR table. ST 4 stated she turned her back to push away her surgical instrumentation table and in that moment Pt 1 fell off of the OR table. ST 4 stated the patient did not have any safety belts or arm boards on at the time of the fall.

During an interview on 6/13/24 at 3 p.m., with CRNA 1, CRNA 1 stated she was at the head of Pt 1's OR table when the fall occurred. CRNA 1 stated she was focused on the airway of Pt 1 and did not know where the other members of the OR team were. CRNA 1 stated Pt 1 was "groggy (stunned or confused and slow to react)" but waking up answering questions appropriately. CRNA 1 stated she removed the left arm strap for Pt 1 to make her more comfortable while waking up. CRNA stated Pt 1 than raised up her left arm and rolled off the OR bed to her right side. CRNA 1 stated she thought Pt 1 initiated and was the cause of the fall. CRNA 1 stated "I told her not to move and she moved when I told her don't move." CRNA 1 stated the transfer bed was not in the room at the time of the fall. CRNA 1 stated she was not responsible for the transfer bed not being there. CRNA 1 stated she "wished" there were two staff on each side of the patient and "wished" the patient would not have fallen. CRNA 1 stated she would not have done anything differently.

During an interview on 6/13/24 at 3:50 p.m., with MD 5 (Anesthesia in Charge), MD 5 stated that he did not think CRNA 1 could have done anything differently.

During an interview on 6/14/24 at 8:45 a.m., with RN 8, RN 8 stated he was in the room and was the circulating nurse (works outside the sterile field. Responsible for managing the Pt's nursing care within the OR) at the time of Pt 1's fall. RN 8 stated the other people in the room with him were CRNA 1 and ST 4. RN 8 stated he made a call to an intercom system (a communication system within the surgical unit that allows the caller to announce to the entire department what they need) to ask for a transfer bed because the surgical procedure was finished. RN 8 stated while he was waiting for the transfer bed, he removed the perineal post (a post under the bottom region of your pelvic cavity that is used for additional stability and holds patient in place without the need for the patient going Trendelenburg [patient is supine (lying flat on back) on the table with their head declined below their feet]) of the Hana Orthopedic (an area of medicine that focuses on the diagnosis, treatment, prevention, and rehabilitation of injuries and diseases within the musculoskeletal system) Surgical Table (a special orthopedic surgical table designed for total hip replacement surgeries), both safety straps on the arms and placed the patients hands on her chest. RN 8 stated he never put on a safety strap over Pt 1's abdomen that comes with the Hana Surgical Table. RN 8 stated the Hana Surgical Table was "short and narrow". RN 8 stated he was on the left side of the patient when he noticed he needed to move the Bovie machine (is a surgical device used to remove unwanted tissue and/or stop bleeding) and suction machine. RN 8 stated Pt 1 was lying comfortably so he turned his back to move those and "she was on the floor next". RN 8 stated the Pt should have had her safety straps on and the perineal pole in place until the transfer bed was next to the patient in a locked position. RN 8 stated ST 4 and himself had their backs turned to the patient, were not at the bedside and all of Pt 1's safety straps were off. RN 8 stated due to the lack of communication, all of the staff in that room put Pt 1's safety at-risk.

During an interview on 6/18/24 at 9:55 a.m., with the OR Director (ORD), the ORD stated Pt 1's safety was put at-risk due to staff having a "lack of awareness" and actual harm occurred. The ORD stated Pt 1's right to care in safe setting was violated.. The ORD stated the surgical department used Association of Perioperative (the entire patient experience from the beginning of the surgical process until the end) Registered Nurses (AORN) guidelines as their professional reference.

During an interview on 6/18/24 at 12:15 p.m., with MD 7, MD 7 stated he was not in the room when Pt 1 fell off of the OR table. MD 7 stated that once the "main part" of the surgery was complete he left the room and his surgical assist finished the case by suturing (a medical provider stitch or stitches; sutures are a medical device used to hold body tissues together and approximate wound edges after an injury or surgery) Pt 1's wound closed. MD 7stated he left to dictate (process of speaking medical information into a recorder), talk to the family and prepare for his next case. MD 7 stated his surgical assistant told him Pt 1 had fallen off of the table. MD 7 stated he immediately went and told Pt 1's Husband and he was "devastated and upset". MD 7 stated Pt 1's safety was all staff's responsibility including himself. MD 7 stated the expectation for Pt 1 was to have the surgery and recover with no further injury. MD 7 stated Pt 1's safety was put at-risk, which resulted in actual Pt harm.

During an interview on 6/18/24 at 2 p.m., with the Chief of Anesthesia (COA), the COA stated the role of anesthesia would be to be the "team leader at that moment". The COA stated when a Pt was coming out of anesthetic, Pt 1 would not be capable of making "rational decisions". The COA stated it would be "unfair" to expect Pt 1 to follow commands by the CRNA.

During an interview on 6/18/24 at 2:40 p.m., with the Chief Executive Officer (CEO), the CEO stated the expectation for Pt 1's care would be that she would not have been left unsecured on the OR table without staff standing by or a transfer bed in place and locked next to her. The CEO stated Pt 1 should have never been left unsupervised on the OR table. The CEO stated Pt 1 safety was compromised by staff. The CEO stated Hospital policy and procedures were not followed in this case. The CEO stated Pt 1's rights were violated because she did not receive care in a safe setting.

During a review of the facility's policy and procedure (P&P) titled, "Patient Safety", dated 1/14/22, the P&P indicated, " ...PURPOSE: to identify and eliminate potential safety hazards thereby reducing risk to patients, personnel and visitors... POLICY: Patient safety refers to a systematic hospital wide program to minimize preventable physical injuries, accidents and undo psychological stress during hospitalization ... B. PATIENT OBSERVATION: 1. Patients on operating tables are never left unattended. Side rails and/or safety straps are utilized ..."

During a review of the facility's policy and procedure (P&P) titled, "Transferring Patients from Gurney/Bed to Operating Room Table", dated 1/12/23, the P&P indicated, " ...PURPOSE: A. To prevent ... patient injuries during the handling, repositioning and transferring of patients ... II. POLICY: A. All employees are responsible to perform in a safe manner and are expected to identify and report potentially unsafe work practices and conditions. B. Patients will be transferred from gurneys/bed to the OR table in a safe manner ..."

Review of AORNguidelines.org Professional Reference titled, "Guideline for Positioning the Patient" dated 5/17/22, (found at https://aornguidelines.org/guidelines/content?sectionid=173734066&view=book&expand=true) indicated, " ... 3.1. Identify potential hazards associated with positioning activities and establish safe practices. Positioning patients and using positioning equipment and devices during perioperative care is a high-risk task that can result in injury to patients or personnel. Identifying potential hazards and establishing safe practices may reduce the risk for patient and personnel injury ... 3.2. Perioperative team members should proactively determine who is responsible for attending to the patient (for example, remaining present at the patient's side) while the patient is on the OR bed. Patients are at risk for falls in the perioperative setting. It is the responsibility of the entire perioperative team to proactively discuss patient observation responsibilities for all phases of the intraoperative period and consider crucial periods, such as induction (putting the patient to sleep with Anesthesia medications) and emergence (waking up) from anesthesia and periods of sedation during which patients are not yet positioned or restrained in their final positions. To minimize or eliminate the risk of patient injuries from falls, perioperative team members must remain vigilant (paying attention) to the infrequent but potentially devastating consequences of a patient's fall from the OR bed. A lack of clear communication about who is responsible for attending the patient after the safety straps are removed or before the patient is transferred to the OR bed has been reported as a contributing factor for patient falls in the perioperative setting ... 3.21. Apply safety restraints in a manner that safely secures the patient. Applying safety restraints reduces the patient's risk of falling off the OR bed ..."

During a review of the "Owner's Manual- Hana Orthopedic Surgery Table (OM)", dated 2017, the OM indicated, " ...Standard Components ... Patient Safety Strap: The patient safety strap secures the patient in place when positioned on the table the 90-inch strap slides around the foot-end of the table ... Anterior (in the front of) Total Hip Arthroplasty ... Table Setup for ... Right Total Hip Arthroplasty ... 7. Slide the Patient Safety Strap in Place (picture of safety strap fastened over the belly-button area of patient) ..."

2. During a review of Pt 4's "Admission History and Physical (H&P)", dated 4/5/23, the H&P indicated, " ...CHIEF COMPLAINT: Complaint of abdominal pain, has gallstones (hard, pebble-like pieces of material, usually made of cholesterol or bilirubin (yellowish pigment that is made during the breakdown of red blood cells), that form in your gallbladder. Gallstones can range in size from a grain of sand to a golf ball), needs to have cholecystectomy but has had it cancelled in the past. HISTORY OF PRESENT ILLNESS: 42-year-old female with known cholelithiasis (gallstones) for years, came in with acutely worsening abdominal pain few hours ago today, described as sharp located in the right upper quadrant with radiation to the back. Associated with nausea and vomiting. Admits to some vague urinary symptoms for the last two days like difficulty voiding (urinating) but patient not able to specify any further. Says it was painful urination ... PHYSICIAL EXAM: ... Abdomen: ... right-sided tenderness ... ASSESSMENT/PLAN: 1. Acute cholecystitis (is inflammation of the gallbladder that occurs due to occlusion [a complete or partial blockage of a blood vessel] or impaired emptying of the gallbladder) ..."

During a review of Pt 4's "Consult Note (CN)", dated 4/5/23, the CN indicated, " ... Reason for Hospital Consultation: Acute Cholecystitis, right upper quadrant pain (abdominal pain), nausea and vomiting ... RECOMMENDATION: the patient was given informed consent (A process in which patients are given important information, including possible risks and benefits, about a medical procedure) and explained the option for a laparoscopic cholecystectomy The patient will be added to the OR schedule ..."

During a review of Pt 4's "Intra-op Record (IR)", dated 4/5/23 at 9:38 p.m., the IR indicated, " ... Intra-op Specimens/Cultures ... Description: gall bladder ... Specimen number: 1 ... Specimen Site: Abdomen ... Last modified by RN 10 ...". The gall bladder was retained during this surgical procedure and RN 10 never obtained a specimen.

During a review of Pt 4's "Operative Note (ON)", dated 4/5/23 at 10:18 p.m., the ON indicated, "OPERATIVE REPORT: ... POSTOPERATIVE DIAGNOSIS: Acute on Chronic Cholecystitis ... OPERATIVE PROCEDURE: Laparoscopic cholecystectomy ... SURGEON: MD 6 ... DESCRIPTION OF PROCEDURE: ... the patient was given informed consent regarding the operation. The patient understood all the risk, alternatives and benefits associated with the operation and agreed to proceed with the operation ... gallbladder was bluntly dissected (surgical separation of tissue layers by means of an instrument) and electrocauterized away from the gallbladder fossa (location of gallbladder in the human body). No bleeding occurred at the gallbladder fossa. The entire gallbladder was then removed from the umbilical port (a small surgical incision on the belly button, frequently used for surgical instrumentation to enter and extend to retrieve the surgical specimen) using an endoscopic catch bag (a pouch that consists of a long cylindrical tube and pouch that minimizes spillage and intraoperative contamination by isolating and containing specimens) the rest of the abdomen was then inspected, no bleeding occurred anywhere at the gallbladder fossa site ... the patient was returned to the recovery room in stable condition..."

During a review of Pt 4's "Operative Note (ON)", dated 4/6/23 at 12:02 a.m., the ON indicated, " ...OPERATIVE REPORT: ... PREOPERATIVE DIAGNOSIS: post operative retained intra-abdominal gallbladder ... POSTOPERATIVE DIAGNOSIS: Same ... OPERATION: 1. Diagnostic laparoscopy (A procedure that uses a laparoscope, inserted through the abdominal wall, to examine the inside of the abdomen) 2. Laparoscopic removal of retained postoperative intra-abdominal gallbladder. SURGEON: MD 6 ... INDICATIONS: The patient is a 42-year-old female who is in PACU after a laparoscopic cholecystectomy. It was discovered during the post operative. That the gallbladder was normal in the specimen container [documentation error- gallbladder was not in the specimen container] and that the endoscopic catch bag from the prior operation was not used at this point the decision was made to perform a diagnostic laparoscopy for retrieval of retained post operative intra-abdominal gallbladder the consent was obtained by two physician and the patient in the post operative PACU ... DESCRIPTION OF THE OPERATION: ... Upon entering the abdominal cavity, the gallbladder specimen was seen on top of the omentum (thin tissue that lines the abdomen that surrounds the stomach and other organs in the abdomen). The gallbladder was retrieved with an endoscopic catch bag ... the gallbladder was then removed with the endoscopic catch bag ... the gallbladder specimen was passed off to the back table ..."

During an interview on 6/14/24 at 2:50 p.m., with MD 6, MD 6 stated he was the surgeon for Pt 4 and it was "difficult" to remove her gallbladder. MD 6 stated as he was moving the gallbladder through Pt 4's abdomen she had a bleed on the liver he needed to get under control. MD 6 stated after he stopped the bleed, he forgot he had not removed the gall bladder. MD 6 stated he deflated Pt 4's abdomen and "closed" her up. MD 6 stated he was contacted by RN 10 when the case was completed and Pt 4 was already in the PACU. MD 6 stated RN 10 told him staff did not have the specimen in the OR and could not find it. MD 6 stated that he told RN 10 the gallbladder must be in the patient still. MD 6 stated he never put the "catch bag" into the patient during the procedure to obtain the gallbladder and it "must have slipped his mind". MD 6 stated when Pt 4 went back for the second surgery, he saw the gallbladder in the right lower quadrant of the abdomen. MD 6 stated the expected outcome for Pt 4 was to have a successful first surgery and that was not the case. MD 6 stated Pt 4's safety was put at-risk due to needing a second surgery due to the retained gallbladder. MD 6 stated Pt 4 could have had an anesthesia complication that could have resulted in a heart attack, or stroke. MD 6 stated Hospital protocols and procedures were not followed for safety and specimen collection. MD 6 stated he was "to blame" for Pt 4 needing a second operation for the retained gallbladder.

During an interview on 6/18/24 at 8:45 a.m., with ST 5, ST 5 stated she was the ST during Pt 4's retained gallbladder surgery. ST 5 stated MD 6 asked for the catch-bag at the end of the procedure and she placed on MD 6's mayo stand (a small, movable stand or table that is designed to hold sterile instruments and supplies during surgeries). ST 5 stated she never noticed that MD 6 did not use the catch bag and never removed the gallbladder. ST 5 stated she did not notice because she was getting supplies ready for the closure of the procedure. ST 5 stated her and the MD 6 never did a "read-back" in regard to specimen collection. ST 5 stated she should have worried about the specimen and not the closing portion of the procedure. ST 5 stated "we absolutely" put the patient's safety at-risk by leaving the gallbladder inside Pt 4. ST 5 stated "a patient should not have to come back for a second surgery." ST 5 stated the procedure should have been done correctly the first time. ST 5 stated we should have been "100 percent focused" and we were not. ST 5 stated Pt 4's rights were violated by not having care in a safe setting. ST 5 stated the P&P for Specimen care and handling was not followed.

During an interview on 6/18/24 at 9:55 a.m., with the OR Director (ORD), the ORD stated the expectation for the Pt 4 was to have surgery and the procedure "Is done as it should be and they recover and go forward." The ORD stated Pt 4 rights were violated as she had the right to care in a safe setting. The ORD stated because Pt 4 had to go back for a second surgery, she had an increased risk for infection. The ORD stated staff did not follow the P&P for Care and Handling of Specimens.

During an interview on 6/18/24 at 11:11 a.m., with RN 10, RN 10 stated he was the circulator during the Pt 4's retained gall bladder surgical case. RN 10 stated he did not hear a "read-back" of the specimen collection between ST 5 and MD 6. RN 10 stated he never saw the specimen throughout the case. RN 10 stated he took Pt 4 to the PACU and asked RN 9 to get the specimen for him. RN 10 stated RN 9 could not find the specimen in the OR. RN 10 stated he told MD 6 they could not find the specimen and he completed an incident report. RN 10 stated the OR team put the patient safety at-risk. RN 10 stated Pt 4 was put at "extra risk" because of the additional surgery. RN 10 stated he did not follow the P&P for specimen collection and did not document the specimen correctly.

During an interview on 6/18/24 at 2:40 p.m., with the CEO, the CEO stated MD 6 placed the gallbladder aside in the abdomen to address bleeding and "forgot" to remove the gallbladder. The CEO stated the expectation was for MD 6 to remove the gallbladder prior to closure. The CEO stated Pt 4's rights were violated in terms of care in safe setting due to "reoperation".

During a review of the facility's policy and procedure (P&P) titled, "Care and Handling of Specimens", dated 4/13/23, the P&P indicated, " ... I. PURPOSE: A. To establish a guideline for proper appropriate care and handling of specimens used in determining or confirming a diagnosis ... III. OUTCOME: A. They're not care and handling of the specimen will include proper identification of the patient, the item/tissue removed, use of the correct preservative, as well as complete and accurate specimen documentation ... IV. PROCEDURE: A. Care and Handling of Specimens ... 3. Specimens Requiring Special Handling ... 1. The specimen is handed off the sterile field and placed in a properly labeled, dry specimen container, or an appropriate labeled and sealed plastic bag. 2. RN Circulator will order specimen exam in electronic health record (EHR) per surgeon's verbal order ... C. The RN Circulator is responsible for: Completely and accurately documenting all specimens in Perioperative Documentation in EHR. 2. Correctly caring for and handling of all specimens per policy ...".

Review of AORNguidelines.org Professional Reference titled, "Guideline for Specimen Management. In: Guidelines for Perioperative Practice", dated 9/28/20, (found at https://aornguidelines.org/faq/content?gbosid=403556) indicated, " ... What is the process for verifying patient and specimen information before transferring a specimen off the sterile field? The process should include using a read-back method to verify the patient and specimen identification on the label, pathology requisition form, and patient health record with the surgeon. The label should not be placed on the specimen container until after the specimen is placed in the container ..."

Based on interview and record review, the hospital failed to track adverse patient events and analyze their causes to implement effective preventive actions for two of two sampled patients, Patient (Pt) 1 and Patient 4, when:

1. An effective root cause analysis was not conducted to determine all factors that could have led to Patient 1's fall from the Operating Room (OR) table. Pt 1 had a surgical procedure on 4/8/2024 dated and in the process of transferring the Patient 1 from the Operating Room (OR) table to the patient gurney, Patient 1 fell to the floor fracturing her arm.

2. Required reporting for adverse events to the California Department of Public Health was not done for Pt 1's avoidable fall with injury and a situation with Pt 4 where Pt 4's gall bladder was unintentionally left inside Pt 4 for a procedure meant to remove the gall bladder.

These failures resulted in the potential harm of not implementing effective quality improvement actions to keep patients safe.

Findings:

1. During a review of the clinical record for Pt 1 indicated, Pt 1 was not secured by safety straps on an operating room (OR) table, without a transfer bed or staff member by her side and subsequently fell off of the table while waking up from anesthesia (the use of medicines to prevent pain during surgery and other procedures) breaking her left humerus (upper arm bone). Pt 1 had to return to the OR for surgery for her broken arm. Registered Nurse (RN) 8, Certified Registered Nurse Anesthetist (CRNA-is an advanced practice registered nurse who administers anesthesia for procedures and surgeries.) 1, Scrub Technician (ST- is a college-educated operating room assistant who performs multiple job duties, including providing the surgeon with the instruments needed to perform surgery.) 4 witnessed the fall of Pt 1.

During a review of Pt 1's "Pre-operative History and Physical (H&P)", dated 4/2/24, the H&P indicated, " ...75-year-old, Female ... Chief Complaint: ... right hip hurts ... Focused Examination: ... The patient does have a bit of a pannus (an apron of excess skin and fat hanging from the abdomen below the waistline) overlapping the proximal (nearer to the center of the body) portion ... deep hip pain ... pain with external and internal rotation ... She has an antalgic gait (limp) ... Impression: Arthritis right hip (a condition in which there is loss of the cartilage [strong, flexible connective tissue that protects your joints and bones] of the head of the thighbone and of the cup-shaped socket of the pelvis where the thighbone fits into the join) ... Diagnosis: Arthritis of right hip, Abdominal pannus ... Recommendation/Plan: ... Proceed with surgical interview involving right total hip arthroplasty (a surgical procedure in which an orthopedic surgeon removes the diseased parts of the hip joint and replaces them with new, artificial parts) ... The potential risks, benefits, complications, outcomes were discussed with the patient who understood, agreed and consented to proceed ... Signature: [Medical Doctor (MD) 7] ... Reviewed Problems: Graves Disease (an immune system condition that affects the thyroid gland) - onset 2/1/20, Myasthenia gravis (a chronic autoimmune disorder in which antibodies destroy the communication between nerves and muscle, resulting in weakness of the skeletal muscles), Essential Hypertension (high blood pressure), Coronary Arteriosclerosis (the buildup of fats, cholesterol and other substances in and on the blood vessels causing vessels to narrow blocking blood flow) ..."

During a review of Pt 1's "Surgical Documentation (SD)", dated 4/8/24, the SD indicated, " ...Last modified by: Registered Nurse (RN) 10 [RN 8 note] ... General Comments: Once procedure was complete dressings were placed on incision ted hose placed on patient. Left arm was freed and placed on chest in order to bring bed to side of table. I turned to move suction and Bovie out of the way and patient had rolled off of surgical table to the right side. I ran to patient and saw her in a prone position on floor. I asked her if she was okay or hurt and she asked what happened. I then positioned her on her back supporting her head. I placed a pillow under head and covered her with blankets. I did a quick scan assessment checking for abrasions or obvious injuries, I saw no apparent skin injuries ... other staff had come into the room by then and a lift team was called. I was sent to a lunch break and did not witness the lift team placed the patient in bed ... General Comments: (Last modified by RN 8) ... 11:10 a.m. patient fell from bed (post removed) witnessed by RN 8, Certified Registered Nurse Anesthetist (CRNA) 1, Scrub Technician (ST) 4, patient stabilized while on floor, kept warm inform charge nurse lifting called for patient on bed. MD 7 informed of incident ... 11:30 a.m. patient (1) on bed by lift team ... transferred to PACU ... "

During a review of Pt 1's "Diagnostic Radiology (DR)", dated 4/8/24 at 12:26 p.m., the DR indicated, " ... Ordering Provider: CRNA 1. Report: XR Humerus Minimum 2 Views Left ... Clinical Information: fall ... Impression: Comminuted, angulated fracture of the distal humeral (Upper arm bone broken in at least three places) ... Final Report: Dictated by MD 8 ... Signed by: MD 8 ..."

During a review of Pt 1's "Progress Note (PN- from CRNA 1)", dated 4/8/24, the PN indicated, " ... I told (Pt 1), surgery is now over. Stay still and don't move. We are getting you ready to be moved to your bed. (RN 5) removed the tape from the patient's right arm which was taped over the patient's chest. I removed the arm strap from the Pt's left arm which was strapped to an arm board connected to the bed. Patient was still groggy so I reminded the patient to not move ... Pt raised her left arm and rolled over to the right side. Pt fell off of the OR (Operating Room) bed and was on the ground face-down with her left arm shielding her face ... I told her not to move and try to stay still while we were getting more help to move her back to the bed ... Pt was unable to move or feel her legs due to the spinal block (a temporary loss of feeling in the abdomen and/or the lower part of the body) I had placed earlier for the surgery ... Pt stated that she felt pain in her shoulders. I noted that the Pt's left-hand squeeze was weaker than the right hand so I lifted the Pt's left gown sleeve and observed a suspected fracture in her left upper arm ..."

During a review of Pt 1's "Operative/Procedure Reports (OPR)", dated 4/9/24, the OPR indicated, " ...Surgeon: MD 7 ... Anesthesiologist: MD 9 ... Post-operative diagnosis: Left comminuted and displaced closed distal third humeral shaft fracture ... Indications for Procedure: This is a 74-year-old woman who fell off the operative table after surgical intervention for her right hip today causing her to develop a displaced fracture of the left distal humerus for which require surgical intervention. After discussing this with the staff, the family and the patient herself, we deemed important and necessary to fix this as soon as possible so that we can allow her to be able to ambulate after her hip arthroplasty ... consented to proceed ... Findings: Displaced comminuted humeral shaft fracture ... Implants/Explants: ... humerus plate with ... screws ... Patient Condition: good ..."

During a concurrent interview and record review on 6/11/24 at 4:35 p.m., with the Patient Safety Officer (PSO) and Designated Nurse Executive (DNE), the PSO and DNE provided information regarding the investigation after Pt 1 fell off the table in OR. The facility document titled, "Root Case Analysis" (RCA) was reviewed. The RCA described the event, and the root cause was determined to be "nurse error" and the plan for correction was, "disciplinary action was put into place" and "Education provided". The PSO did not have an answer to questions about possible systemic issues that may have contributed to the fall, including appropriate staffing, why the bed was not already in the room before the patient was released for surgical restraints, and if it was appropriate for the surgeon and surgical assistant to leave the room prior to the patient being transferred to the gurney, and whether actions or inactions from other team members may have contributed to the fall. These possible contributing factors were not explored in the RCA. The PSO stated the nurse "admitted that he shouldn't have left the patient's side to get the transfer bed." The PSO stated that looking back, it should have been considered a team responsibility.

During a review of the hospital document titled, "Quality Assurance and Performance Improvement Program," dated 5/23 2022, the document indicated, " ...Administration and Management: The Governing Board and the medical staff delegate the development, implementation, and evaluation of this program to the Medical Center Administration and Management team. Administration and Management are responsible for improving the quality of care, safety, and service provided by the Medical Center and its staff. The Administration and Management team have developed structures and processes to carry out this responsibility..."

During a review of the hospital policy and Procedure (P&P) titled, "Patient Safety Program" dated 4/13/23, the P&P indicated, " ...VIII. Sentinel Event Status. A sentinel event is an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof. Serious injury specifically includes loss of limb or function. The "risk thereof" includes any process variation for which a recurrence carries a significant chance of serious adverse outcomes..."

During a review of professional reference titled, "Root Cause Analysis and Medical Error Prevention" from www.nih.gov dated May 2, 2022, the reference indicated, " ...A root cause analysis can provide a beneficial resolution for healthcare professionals and patients to further understand and combat medical error and prevent future occurrences ... [the RCA] process highlights the interprofessional team's role in preventing medical errors and sentinel events within the healthcare organization..."

2. During an interview on 6/14/24 at 4:05 p.m. with the Director of Quality (DQ), the DQ stated that both Pt 1 and Pt 4 should have been reported to the California Department of Public Health (CDPH) because both Pt 1 and Pt 2 had to return to surgery because of errors made by the hospital. The DQ stated he was under the impression that because the incidents did not result in death, they did not need to be reported. The DQ stated he understood that unusual occurrences that result in patient harm, should be reported to appropriate regulatory agencies.

During a concurrent interview and record review on 6/17/24 at 8:45 a.m., with the PSO, the facility's P&P was reviewed. The PSO stated the incident resulting in serious bodily injury to a patient when the patient fell from the OR table met the criteria for reporting to CDPH, however, due to a misinterpretation of the facility's P&P, he did not submit a report to CDPH. The PSO reviewed the hospital policy titled, "Adverse Event Reporting to the California Department of Health Services," dated 8/4/22, P&P indicated, " ...(7) An adverse event or series of adverse events that cause the death or serious disability of a patient, personnel, or visitor. As used in the foregoing list of events the term "serious disability" means a physical or mental impairment that substantially limits one or more of the major life activities of an individual, or the loss of bodily function, if the impairment or loss lasts more than seven days or is still present at the time of discharge from an inpatient health care facility or the loss of a body part..." The PSO stated, after reviewing their facility P&P again, he should have reported the adverse event to CDPH.

During an interview on 6/18/24 3:00 p.m. with the Chief Nursing Officer (CNO) and Chief Executive Officer, (CEO), the CEO acknowledged opportunities to improve upon the adverse event reporting process.

Based on observation, interview and record review, the facility failed to ensure the Licensed Nurse (LN) identified and/or recognized the complex needs of one of two sampled patients (Pt 27), when the LN did not develop, revise, or implement interventions and goals for Pt 27's skin integrity (skin health) care plan (CP- a road map for the care of a patient and a necessary tool in following the nursing process) that reflected the nursing care to be provided to meet Pt 27's needs as required by facility policy and procedure (P&P).

These failures had the potential for harm due to delayed healing of a wound, formation of new wounds, infection including death.

Findings:

During a concurrent observation and interview on 6/12/24 at 11:31 a.m., on the Medical Surgical unit, at the bedside with Pt 27 and Wound Registered Nurse (WRN) 1 and WRN 2, WRN 1 stated Pt 27 was admitted from a local nursing home for a wound to her left coccyx (tail bone) area. WRN 1 stated she was responding to a wound nurse consultation request and would be changing Pt 27's dressing. After removal of the old dressing, WRN 1 stated the wound appeared to be old, slow healing, with a discharge of white/yellow colored fluid, possibly puss given the presentation of the wound, with deep tunneling (a wound that's progressed to form passageways underneath the surface of the skin). WRN 1 stated Pt 27 was at high risk for developing additional wounds and poor healing of existing wound due to her medical history and clinical presentation (the appearance in a patient of illness or disease-or signs or symptoms).

During a review of Pt 27's "Admission H&P (history and physical)," dated 6/11/24, indicated Pt 27's past medical history included: atrial fibrillation (A-fib- an irregular and often very rapid heart rhythm) with anticoagulation medication (blood thinner), breast cancer in remission, depression, diabetes (high blood sugar), hypertension (high blood pressure), hyperthyroidism (overactive thyroid gland), pacemaker (surgically inserted device that helps regulate irregular heart rhythm)."

During a review of Pt 27's "Wound Care Note (note)" dated 6/12/24, the note indicated the WRN recommended " ...3. Nutritional optimization as patient's medical condition allows. Registered Dietician (RD) consult may be warranted, if not already requested ..."

During a concurrent interview and record review on 6/13/24 at 9:40 a.m., of Pt 27's Electronic Medical Record (EMR) with Nurse Manager (NM) 3, the skin assessment and physician's order were reviewed, the skin assessment indicated, Pt 27's admission Braden Scale Score (a standardized tool used to help determine the risk of a patient developing a pressure injury risk scores can be categorized as low (19-23), mild (15-18), moderate (13-14, high (10-12), and severe (9) risk) was "15" indicating Pt 27 was at "mild risk" of developing a pressure wound. NM 3 stated the physician orders indicated Pt 27 had a "regular diet" ordered on 6/11/24, and a wound nurse consult ordered on 6/11/24 at 3:47 p.m. NM 3 stated the physician orders indicated there was no order for a nutrition consultation or nutrition supplements in the EMR. NM 3 stated it was her expectation that LNs would follow facility P&P's in preventing deterioration of wounds and the formation of any new wounds by documenting interventions that were planned and performed in the patient's care plan.

During a concurrent interview and record review on 6/14/24 at 8:48 a.m., with Registered Nurse (RN) 6, RN 6 stated Pt 27 was admitted to the hospital from a local nursing home for a non-healing wound to her coccyx area. RN 6 validated Pt 27's Braden Scale Score was 15. RN 6 stated not sure exactly what the score means but the patient is on a "brand name" low-air loss bed (a mattress designed to prevent and treat pressure wounds), heels are being floated (elevated with pillows so heels do not touch the mattress) to prevent formation of pressure wounds to heels, and turning and repositioning is being done every two hours to prevent new wounds and promote healing of the existing wound. RN 6 stated she did not believe that Pt 27 had a risk for nutrition deficit (a lack or shortage of something that the body needs to work properly ). RN 6 stated knowing today that Pt 27 had had poor oral intake the last several meals she may have considered adding nutrition as a concern on the CP. RN 6 stated nutrition was required for wound healing; if nutrition was inadequate wound healing would not be possible. RN 6 stated a nutrition consult should have been submitted for Pt 27 and it was not. RN 6 stated she would add nutrition risk to Pt 27's CP.RN 6 stated the purpose of the CP is it helps guide the care the nurse provides. RN 6 validated Pt 27's EMR did not show a nutrition risk CP had been initiated. RN 6 stated the potential harm in not having a patient's specific care plan was "the reason they are here [reason for admission] will not be resolved." RN 6 validated a CP had been established and it indicated the goal of nursing interventions was for Pt 27 to reach a "Braden Scale Score of 18 by the end of the shift." RN 6 stated that in reviewing the skin integrity care plan more closely, she did not believe the goal was realistic for Pt 27. RN 6 stated nursing CPs are revised and updated daily.
During an interview on 6/14/24 at 9:25 a.m., with Wound RN (WRN) 1, and WRN 3, WRN 1 stated with wounds, nutrition is very important, "You are treating the whole patient and not just the hole in the patient. Taste bud changes and poor appetite are all a part of the aging process; so you consider supplementation to give the wound the optimal healing environment."

During an interview on 6/14/24 at 9:10 a.m., with Nursing Director (ND) 1, ND 1 stated there are opportunities for the Medical Surgical RN staff education to the Braden Scale Scoring tool and the nursing interventions to be implemented based on the patient's risk score. ND 1 stated it was her expectation that nurses would be able to verbalize understanding of the Braden Scale Score and assign an appropriate and realistic patient goal on the CP. ND 1 stated given Pt 27's medical history, wound and nutritional intake she would expect the Braden Scale Score goal of 18 might be unattainable.

During a concurrent observation and interview on 6/14/24 at 9:57 a.m., with Certified Nurse Assistant (CNA) 1 via telephone, CNA 1 stated she assists with meal tray distribution, set up and collection when patients were done eating. CNA 1 stated Pt 27 "doesn't eat much, doesn't want what is offered." CNA 1 stated that if they [patients] don't eat much [she] offers a substitute. Sometimes tells the nurse if observe that the patient is not eating nothing." CNA 1 stated she knows Pt 27 had the wound on her left buttock because the nurses told her. CNA 1 stated she spoke with the patient's nurse yesterday (6/13/24). CNA 1 stated Pt 27 told her she likes "brand name" nutritional supplement drink in the chocolate flavor only. CNA 1 stated she was helping with the turning and repositioning every two hours, she does not document, the primary RN does.

During an interview on 6/17/24 at 9:55 a.m., with Registered Dietician (RD) 1, RD 1 stated the goal was to complete a nutrition consult within 48-hours of receipt. RD 1 stated that most referrals made to his department were "auto-generated, nurse/provider generated, or facility policy is, that all inpatients are evaluated by RD for any Length of Stay (LOS-the duration of a single episode of hospitalization.) of greater than or equal to seven (7) days. RD 1 stated other factors, such as Braden Scale Score of 16 or below was an auto-consult; MST- Malnutrition Screening Tool, decreased appetite, and weight loss (based on how much weight lost; it increases the number count) 2 criteria met generates a consult. RD 1 stated it was his practice to review the chart and speak with nurses regarding the patient when completing a nutrition assessment. RD 1 stated RD nutritional assessment was not done due to Pt 27's admission Braden scale of 15, a nutrition consultation should have been generated, but it did not.

During a concurrent interview and record review of Pt 27's EMR on 6/17/24 at 4:00 p.m., with RN 5, RN 5 stated in reviewing the Pt 27's EMR, an order for a nutrition consultation was entered on 6/13/24 at 12:16 p.m. and had not yet been done to her knowledge. RN 5 stated she spoke with the doctor and asked for a nutrition consult after her manager told her she might consider Pt 27's nutritional needs. RN 5 stated Pt 27's meal intake was "sometimes good and sometimes not so good." RN 5 stated Pt 27 was a "picky eater." RN 5 stated the goal for Pt 27 was to heal the existing wound and prevent any new ones from forming, so may need to add some supplements and foods that patient might prefer. RN 5 stated she had not done an assessment of the preferred foods with Pt 27, this was to be done by the RD. RN 5 stated she was aware there was a gap in the documentation of repositioning and turning on 6/12/24 at 3:00 p.m., 5:00 p.m., and 7:00 p.m. and stated the Pt 27 was turned, but she "didn't document [the turns] and dropped the ball on that." RN 5 stated the harm in not turning and repositioning was risk for further deterioration of Pt 27's skin and formation of new wounds. RN 5 stated it was important to track meal intake for proper nutrition and wound healing. RN 5 stated Pt 27's meals should have been documented because it gave us (caregivers) a picture of what was happening with the patient, and would allow for trending and nurse intervention. RN 5 stated she did not review the WRN's consultation note yesterday [6/16/24]. RN 5 stated that if she had reviewed the WRN consultation note she would have seen the WRN's recommendation for considering a nutrition consult and performed a nutrition assessment. RN 5 stated Pt 27's CP goal of a Braden Scale Score of 18 by the end of the shift was not a realistic goal.

During an interview on 6/18/24 3:00 p.m. with the Chief Nursing Officer (CNO) and Chief Executive Officer, (CEO) the CEO, the CEO stated he was aware of this case and had talked with nursing and medical providers, in addition to the dietician in this case as it is a team effort to understand why there was a delay in the ordering of a nutrition consult.

During a review of P&P titled, "Standard for Impaired Skin Integrity (Potential/Actual)" dated11/22/19, the P&P indicated, " ...I POLICY A. Using the nursing process, RN/LVNs [LNs] will organize, coordinate, and direct nursing care to prevent the development of pressure injuries, promote healing of pressure injuries, or prevent the deterioration of existing pressure injuries. B. Using the guidelines provided RN/LVNs will identify skin impairment issues and implement a plan of care appropriate for each wound. C. A multidisciplinary process will be use, with RN/LVNs collaborating with physicians the wound care team, the infection control nurse(s), dieticians ..." PURPOSE A. To identify patients at risk for development of pressure injuries. B. To prevent the development of pressure injuries in patients identified as at risk. C. To promote healing of existing pressure injuries by implementation of a consistent structured intervention process. D. To prevent the deterioration of existing pressure injuries. E. To promote healing of existing skin impairment issues ..."

Based on observation, interview, and record review, the facility failed to maintain a clean and sanitary environment to avoid sources and transmission of infection when:

1. Three of three sampled sinks in Intensive Care Unit Nutrition Room, Medical Unit Nutrition Room, and Labor & Delivery Nurses Station had residue on the countertops.

2. One of two "Brand Name" endoscope re-processors [machine that cleans and disinfects the (endoscope- a thin, tube-like instrument used to look at tissues inside the body)] had residue on the top of loading basin and front panel cabinet.

3. Certified Registered Nurse Anesthetist [CRNA- a Registered Nurse who has specialized training in (anesthesia-A loss of feeling or awareness caused by drugs or other substances.)] 1 was starting a spinal block (a temporary loss of feeling in the abdomen and/or the lower part of the body) on Patient (PT) 28 and did not do hand hygiene prior to putting on sterile gloves (gloves that are free from all microorganisms) for a spinal block procedure.

4. CRNA 1 disposed of her sharps (needles) from Pt 28's spinal block in a blue pharmaceutical waste (drug that may be expired, is unused, or left over after medical treatment or surgical procedure) container and not in a red sharps container.

These failures placed staff and patients at risk of cross contamination and infection, including the intensive care unit, the medical unit, the labor and delivery unit, the endoscopy unit and the operating rooms.

Findings:

1. During a concurrent observation and interview on 6/10/24 at 1:47 p.m. in the Intensive Care Unit (ICU) Nutrition Room with the Designated Nurse Executive (DNE), the countertop next to the ice machine was covered with a sticky residue, as if something had been taped on the counter previously and the adhesive had not been removed. The DNE stated she could feel the stickiness when she rubbed her hand across it. The DNE stated sticky surfaces can harbor (hold onto) organisms (An individual animal, plant, or single-celled life form) and could cause the spread of infection.

During a concurrent observation and interview on 6/10/24 at 3:10 p.m. in the Medical Unit nutrition room with a Nursing Director (ND),1 the sink where food was prepared, and hands were washed had a white residue around it. ND 1 felt the surface around the sink and stated it felt like mineral deposits. ND 1 stated the buildup causes a risk of infection because organisms can harbor on the surface.

During a concurrent observation and interview on 6/11/24 at 10:45 a.m. with ND 1 and the Director of Environmental Services (DES) in the labor and delivery unit at the nursing station, a white residue was surrounding the sink. The DES stated, "it's an infection control concern." The DES stated the textured surface can allow for the spread of bacteria.

During an interview on 6/18/24 3:00 p.m. with the Chief Nursing Officer (CNO) and Chief Executive Officer, (CEO) the CEO stated having sinks, equipment and fixtures that could not be cleaned thoroughly due to buildup of mineral deposits concerned him, because it would put patients at risk of infection.

During a review of policy and procedure (P&P) titled, "Cleaning of Clean Utility Room" dated 01/24, the P&P indicated, " ... B... While cleaning, use all-purpose cleaner to remove adhesives and tape ... E. Clean sinks with cream cleanser and scrubbing pad ..."

According to the Centers for Disease Control (CDC), undated, retrieved 6/21/24 from https://www.cdc.gov/infection-control/hcp/environmental-control/appendix-c-water.html, " ...Microorganisms (An organism that can be seen only through a microscope) have a tendency to associate with, and stick to surfaces ... These adherent organisms can initiate and develop biofilms (a thin layer of bacteria that adheres to the surface.)..."

2. During a concurrent observation and interview on 6/11/24 at 1:56 p.m. in the Endoscopy (a medical procedure where a doctor puts a tube-like instrument with a camera into the body to look inside) unit, with Surgical Tech (ST) 3 the "brand name" endoscope re-processor machine had visible, white-colored residue on edges around and between surfaces inside the top loading basin and on the front panel cabinet. ST3 stated despite following the facility's P&P and [brand name] instruction for use (IFU) for cleaning and maintaining the machine, the white residue remained. ST3 stated the residue may be hard water stains. ST3 stated it was important to ensure the machine was cleaned per manufacturer's instruction to prevent the spread of infection from one patient to the next.

During a concurrent observation and interview on 6/11/24 at 2:15 p.m. in the endoscope processing room, with the Out-Patient Surgery Nurse Manager (NM) 2, the top loading basin and front control panel were observed to have residue on the top of loading basin and front of the panel cabinet. NM 2 stated her expectation was that staff reprocessing dirty endoscopes follow the facility P&P and the manufacturer IFUs to ensure cleaning and maintenance of the endoscopes were safe to use on patients.

During a concurrent observation and interview on 6/11/24 at 2:30 p.m. with ST 3 and NM 2 expired sterile and reusable equipment labeled "misc-inst GI[Gastrointestinal- of, relating to, affecting, or including both stomach and intestine]" was found in the endoscope reprocessing room in an overhead cabinet. ST3 stated he was not sure what the equipment was used for, but the date on the sticker "23822" was "expired." NM2 stated the date could be year 2022 or year 2023, regardless the reusable equipment should have been removed and sent to the Sterile Processing Department (SPD-comprises that service within the hospital in which medical/surgical supplies and equipment, both sterile and, are cleaned, prepared, processed, stored, and issued for patient care) for [re]-sterilization.) NM2 stated her expectation was that staff would not use expired equipment on a patient because using SPD equipment beyond the expiration date could affect equipment's performance.

During an interview on 6/12/24 at 4:11p.m. with the Infection Prevention nurse (IP), the IP stated, "We try to minimize the buildup (the deposits on the wet sinks) on equipment and fixtures. If it is close to the work area, it could be a source of infection. It have been addressed previously and corrected after reports to leaders. It is fixable." The IP stated it was a housekeeping issue, and that EVS needs to be more diligent in cleaning the areas around the sinks to help prevent the spread of infection.

During an interview on 6/18/24 3:00 p.m. with the Chief Nursing Officer (CNO) and Chief Executive Officer, (CEO), the CEO stated having sinks, equipment and fixtures that could not be cleaned thoroughly due to buildup of mineral deposits concerned him, because it would put patients at risk of infection.

During a review of policy titled, "Cleaning of Clean Utility Room" last reviewed 01/24, the policy indicated, " ... B... While cleaning, use all-purpose cleaner to remove adhesives and tape ... E. Clean sinks with cream cleanser and scrubbing pad ..."

According to the professional reference titled, "Using the Health Care Physical Environment to Prevent and Control Infection, a project conducted by The Health Research & Educational Trust of the American Hospital Association, undated, retrieved 6/21/24 from:
https://www.ashe.org/sites/default/files/ashe/CDCfullbookDIGITAL.pdf, " ...Health care facility design can contribute either in a positive way by contributing to prevention of infection or negatively by contributing to transmission ... An example of a negative impact would be handwashing sinks not designed ... to minimize risk of splashing onto nearby countertops where staff prepare food, medications, or dressings, resulting in surface contamination that may lead to infection ..."

According to the professional reference titled, "Using the Health Care Physical Environment to Prevent and Control Infection," a project conducted by The Health Research & Educational Trust of the American Hospital Association, undated, retrieved 6/21/24 from:
https://www.ashe.org/sites/default/files/ashe/CDCfullbookDIGITAL.pdf, " ...Areas in a hospital where sterilization and high-level disinfection are performed should be designed to permit effective workflow and maintain maximum cleanliness ..."

According to the Centers for Disease Control (CDC), undated, retrieved 6/21/24 from https://www.cdc.gov/infection-control/hcp/environmental-control/appendix-c-water.html, " Microorganisms have a tendency to associate with, and stick to surfaces ... These adherent organisms can initiate and develop biofilms (a thin layer of bacteria that adheres to the surface.)"

According to the "[Brand Name] Endoscope Re-processor Operation Manual (OM)," undated, the "OM" indicated " ...Chapter 5 Endo-of-Day Checks," page 149, " ...Using a clean cloth moistened with neutral detergent, clean every part of the device including the front and back of the lid, the lid packaging, the edge and inside of the reprocessing basin and the control panel, then wipe with a dry clean cloth. To prevent growth of microorganisms, it is also recommended to wipe every part of the equipment with a cloth moistened with 70% ethyl alcohol or isopropyl alcohol figure 5.1...Chapter 7 Routine Maintenance," page 186, "To ensure safe operation of the device, it should be cleaned and inspected regularly ... WARNING ... Be sure to perform all the inspections, cleaning, replacement of consumables and other tasks as described in this chapter. Otherwise, this equipment may not continue to operate and perform as expected..."


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3. During an observation on 6/12/24 at 9:45 a.m., in Operating Room (OR) 4, CRNA 1 did not complete hand hygiene right before she put on the sterile gloves for the procedure. CRNA 1 was observed touching IV tubing, OR bed sheets and the spinal block tray (includes devices used for the procedure) prior to putting on the sterile gloves.

During an interview on 6/12/24 at 4:10 p.m., with the Infection Preventionist (IP), the IP stated the expectation for CRNA 1 was to do hand hygiene, let it dry and then put on the sterile gloves prior to the procedure. The IP stated this was "very basic" and hand hygiene was the "number one" prevention of the spread of infection. The IP stated because the CRNA did not do hand hygiene properly, Pt 28 could have been potentially cross-contaminated (the physical movement or transfer of harmful bacteria from one person, object or place to another) and could develop an infection.

During an interview on 6/13/24 at 3 p.m., with CRNA 1, CRNA 1 stated she did not sanitize (get rid of germs) her hands right before she put on the sterile gloves. CRNA 1 stated the expectation was for her to do hand hygiene right before she put on the gloves. CRNA 1 stated by not completing the hand hygiene she could have given the patient an infection.
During an interview on 6/18/24 at 9:55 a.m., with the OR Director (ORD), the ORD stated the CRNA should have done hand hygiene right before she put her sterile gloves on. The ORD stated Pt 28's safety was put at-risk by not doing hand hygiene properly. The ORD stated Pt 28 would have an increased infection risk. The ORD stated the CRNA `1 did not follow hospital's policies.

During an interview on 6/18/24 at 2:40 p.m., with the Chief Executive Officer (CEO), the CEO stated infection control was a "foundational" and "critical component" of patient safety at the hospital. The CEO stated hospital leadership already spoke to the CRNA 1 and reinforced the importance of hand hygiene.

During a review of the facility's policy and procedure (P&P) titled, "Prevention and Surgical Infections and Complications", dated 6/28/18, the P&P indicated, " ...I. POLICY: [Hospital] implements national standards of surgical care and best practices for surgical site infection prevention. II. PURPOSE: to implement processes that scientific based evidence associates with reduced surgical site infections and other potential complications of surgery. III. PROCEDURE: ... 6. Hand Hygiene: ... b. Strict adherence to hand hygiene for staff between each point of contact with the patient, required also between patient tasks and/or contact with equipment or surfaces ..."

During a review of facility's P&P titled, "Hand Hygiene", dated 6/18/21, the P&P indicated, " ...I. POLICY: [Hospital] promotes excellence in hand hygiene practice. II. PURPOSE: excellence in hand hygiene is known to reduce the transmission of pathogenic organisms between patients and health care workers ... V. Healthcare personnel should use an alcohol-based hand rub or wash with soap and water for the following clinical indications: ... 2. Moment 2: Before performing a clean/aseptic procedure ..."

During a review of facility's P&P titled, "Infection Control Responsibilities for Anesthesia", dated 2/28/19, the P&P indicated, " ... I. PURPOSE: to prevent cross contamination of patients during the administration of anesthesia. II. POLICY: A. Anesthesia personnel will follow all appropriate infection control measures for the OR ... III. RESPONSIBILITIES: A. Anesthesia personnel responsible for abiding by infection control policies and procedures of the OR ... B. All OR ... personnel will perform patient care activities in a manner that decreases the possibility of cross contamination. C. Strict hand washing will be observed at all times between different patient contacts ..."

4. During an observation on 6/12/24 at 9: 50 a.m., in Operating Room (OR) 4, CRNA 1 threw away three sharps/needles that were used in Patient 28's spinal block in a blue waste container. Two of the needles are attached to syringes without labels, and one 18-gauge (size of the hole in the needle) needle was by itself. Directly above the blue waste container was a document labeled "EMC Pharmaceutical Waste Management" that distinguished what waste should be discarded (thrown away) and what container should be used.

During a review of the facilities "EMC Pharmaceutical Waste Management Document (PWD) (located on the wall directly above the blue waste container the sharps were discarded in)", the PWD indicated, " ...[Blue waste container] Non-RCRA (Resource Conservation and Recovery Act- established the framework for proper management of hazardous wastes) Pharmaceutical Waste ... Examples: Pills & Tablets, Full or Partial Vials, Full or Partial IV's (intravenous tubing) with Medication Instilled [keep tubing attached and place in re closable bag] Lotions, Creams and Ointments must be capped ... [Red Waste Container] Sharps, Infectious Waste ... Sharp waste capable of inflicting puncture or cuts ... Objects that are contaminated with an infectious substance ... Examples: Needles, Broken Glass, Vials/Ampules (a small sealed vial which is used to contain and preserve a sample, usually a solid or liquid) Blood/Syringe, Scalpels/Blades/Lancets, Razors, Staples, Guidewire ..."

During an interview on 6/12/24 at 4:10 p.m., with the Infection Preventionist (IP), the IP stated the expectation for CRNA 1 was to discard of the two needles she used in the spinal block procedure into a red sharps container. The IP stated there were red sharps containers available in every OR room. The IP stated there were "no exceptions" in the OR, sharps would go into the red sharps containers. The IP stated a staff member could have had a sharps injury due to not disposing into the correct container. The IP stated cross-contamination to the patient could occur and a subsequent infection.

During an interview on 6/13/24 at 3 p.m., with CRNA 1, CRNA 1 stated she threw her sharps from the spinal block away in the blue waste container. CRNA 1 stated "she thought the container said sharps". CRNA 1 stated she was unsure on what other container she could have used. CRNA 1 stated that container was "what is there" so "I threw it all in there". CRNA 1 stated the PWD says needles go in red "but I think we can put in blue".
During an interview on 6/18/24 at 9:55 a.m., with the Operating Room Director (ORD), the ORD stated any sharp needed to go in an approved sharps container. The ORD stated she needed to confer with hospital leadership if the blue waste container was appropriate.

During a review of a facility document (provided by ORD) titled "Pharmaceutical Waste Management", undated, the document indicated, " ...Blue Non-RCRA Pharmaceutical Waste ... 2 Gallon Sharps Container: syringes, ampules or sharps with residual non-RCRA medication. No controlled substance ...". [This document was different than the PWD directly above the blue waste container in OR 4 that was observed].

During an interview on 6/18/24 at 2 p.m., with the Chief of Anesthesia (COA), the COA stated there is a "big red sharps container" in every OR. The COA stated needles always go in a sharps container. The COA stated that can be "red or blue". The COA stated that if the spinal tray has "bloody stuff" on it than he would put it in the red container.

During an interview on 6/18/24 at 2:40 p.m., with the Chief Executive Officer (CEO), the CEO stated he was taught for the proceduralist (practitioner completing the procedure) to sort the sharps and medications and put them in the appropriate bin. The CEO stated that sharps could be in the "larger blue bin".

During a review of the facility's P&P titled, "Biohazardous (waste contaminated with potentially infectious agents or other materials that are deemed a threat to public health or the environment) Waste Management Plan (BWMP)", dated 1/2/24, the BWMP indicated, " ... I. PURPOSE: the biohazardous waste management plan has been developed to ensure the health and safety of employees, patients and visitors. Information regarding medical waste will be provided by the proper identification, labeling, containment and handling of biohazardous waste ... IV. CONTAINMENT AND LABELING: all biohazardous waste is contained separately from other waste ... biohazardous waste shall be contained in red biohazard bags or rigid puncture-resistant containers as appropriate ... any container used shall be labeled with biohazardous waste and/or the international biohazard symbol. Containers must be labeled on all sides notifying container is for biohazard product ... Sharps waste shall be contained in "sharps container" which are rigid, puncture resistant when sealed, labeled "Sharps Waste" or "Biohazardous Waste" with the international biohazard symbol ... Facility areas containing biohazard containers ... OR (Operating Room) Surgical Units (Main OR ...): Rigid Biohazard Container, Rigid Pharmaceutical Container, Rigid Control Substance Container ...".
During a review of United States Environmental Protection Agency (EPA) Professional Reference titled, "A 10-Step Blueprint for Managing Pharmaceutical Waste in US Healthcare Facilities", dated 2022, (found at https://hercenter.org/10_step_blueprint_guide_final_9-22.pdf) indicated, " ...The purpose of this document is to provide a practical guide to help healthcare facilities, including hospitals ... STEP NINE: Training Programs ... Other departments ... such as ... surgery ... can use the nursing training material and apply it to their specific situation ... Figure 9: Model #3: Full Sorting of Hazardous and Non-hazardous in ... Nursing ... Non-Hazardous Pharmaceutical Waste [Blue color] ... All non-RCRA, Non-antineoplastic (waste that could kill cancerous cells or inhibit their growth), NO NEEDLES ... Red Sharps [Red color] ... Bio-hazardous drugs, Empty syringes with needles, NO OTHER DRUGS ..."

Based on interview and record review, the hospital failed to ensure anesthesia (use of medicines to prevent pain during surgery and other procedures) services were appropriate to the scope of the services provided, for one of one Patient (Patient 1), when Certified Registered Nurse Anesthetist (CRNA- a Registered Nurse who has specialized training in anesthesia) 1 ordered diagnostics in the post-anesthesia care unit (PACU- a unit where patients go directly after a surgical procedure to recover from the effects of anesthesia) after Patient (Pt) 1 fell off the Operating Room (OR) table. The Anesthesia in Charge (AIC) that day was a CRNA (CRNA 2).

These failures resulted in CRNA's working out of their scope and the patient not receiving the benefit of having care provided by an Anesthesiologist.

Findings:

During a review of Pt 1's "Pre-operative History and Physical (H&P)", dated 4/2/24, the H&P indicated, " ...75-year-old, Female ... Chief Complaint: ... right hip hurts ... Focused Examination: ... The patient does have a bit of a pannus (an apron of excess skin and fat hanging from the abdomen below the waistline) overlapping the proximal (nearer to the center of the body) portion ... deep hip pain ... pain with external and internal rotation ... She has an antalgic gait (limp) ... Impression: Arthritis right hip (a condition in which there is loss of the cartilage [strong, flexible connective tissue that protects your joints and bones] of the head of the thighbone and of the cup-shaped socket of the pelvis where the thighbone fits into the join) ... Diagnosis: Arthritis of right hip, Abdominal pannus ... Recommendation/Plan: ... Proceed with surgical interview involving right total hip arthroplasty (a surgical procedure in which an orthopedic surgeon removes the diseased parts of the hip joint and replaces them with new, artificial parts) ... The potential risks, benefits, complications, outcomes were discussed with the patient who understood, agreed and consented to proceed ... Signature: [Medical Doctor (MD) 7] ... Reviewed Problems: Graves Disease (an immune system condition that affects the thyroid gland) - onset 2/1/20, Myasthenia gravis (a chronic autoimmune disorder in which antibodies destroy the communication between nerves and muscle, resulting in weakness of the skeletal muscles), Essential Hypertension (high blood pressure), Coronary Arteriosclerosis (the buildup of fats, cholesterol and other substances in and on the blood vessels causing vessels to narrow blocking blood flow) ..."

During a review of Pt 1's "Surgical Documentation (SD)", dated 4/8/24, the SD indicated, " ...Last modified by: Registered Nurse (RN) 10 [RN 8 note] ... General Comments: Once procedure was complete dressings were placed on incision ted hose placed on patient. Left arm was freed and placed on chest in order to bring bed to side of table. I turned to move suction and Bovie (Electrocauterization [or electrocautery- A procedure that uses heat from an electric current to destroy abnormal tissue] is often used during surgery to remove unwanted or harmful tissue. It can also be used to burn and thus seal blood vessels. This helps reduce or stop bleeding during surgery) out of the way and patient had rolled off of surgical table to the right side. I ran to patient and saw her in a prone position on floor. I asked her if she was okay or hurt and she asked what happened. I then positioned her on her back supporting her head. I placed a pillow under head and covered her with blankets. I did a quick scan assessment checking for abrasions or obvious injuries, I saw no apparent skin injuries ... other staff had come into the room by then and a lift team was called. I was sent to a lunch break and did not witness the lift team placed the patient in bed ... General Comments: (Last modified by RN 8) ... 11:10 a.m. patient fell from bed (post removed) witnessed by RN 8, Certified Registered Nurse Anesthetist (CRNA) 1, Scrub Technician (ST) 4, patient stabilized while on floor, kept warm inform charge nurse lifting called for patient on bed. MD 7 informed of incident ... 11:30 a.m. patient (1) on bed by lift team ... transferred to PACU ..."

During a review of Pt 1's "Progress Note (PN- from CRNA 1)", dated 4/8/24, the PN indicated, " ... I told (Pt 1), surgery is now over. Stay still and don't move. We are getting you ready to be moved to your bed. (RN 5) removed the tape from the patient's right arm which was taped over the patient's chest. I removed the arm strap from the Pt's left arm which was strapped to an arm board connected to the bed. Patient was still groggy so I reminded the patient to not move ... Pt raised her left arm and rolled over to the right side. Pt fell off of the OR (Operating Room) bed and was on the ground face-down with her left arm shielding her face ... I told her not to move and try to stay still while we were getting more help to move her back to the bed ... Pt was unable to move or feel her legs due to the spinal block (a temporary loss of feeling in the abdomen and/or the lower part of the body) I had placed earlier for the surgery ... Pt stated that she felt pain in her shoulders. I noted that the Pt's left-hand squeeze was weaker than the right hand so I lifted the Pt's left gown sleeve and observed a suspected fracture in her left upper arm ... in the PACU I placed orders for a head/neck CT and X-ray of bilateral shoulders and arms ..."

During a review of Pt 1's "Diagnostic Radiology (DR)", dated 4/8/24 at 12:26 p.m., the DR indicated, " ... Ordering Provider: CRNA 1. Report: XR (x-ray Humerus (upper arm bone) Minimum 2 Views Left ... Clinical Information: fall ... Impression: Comminuted, angulated fracture of the distal humeral (Upper arm bone broken in at least three places) ... Final Report: Dictated by MD 8 ... Signed by: MD 8 ...".

During a review of Pt 1's "DR", dated 4/8/24 at 12:26 p.m., the DR indicated, " ...Procedure: XR Forearm 2 Views Right ... Ordering Provider: CRNA 1 ... Impression: No evidence of fracture ... Final Report: Dictated by MD 8 ... Signed by: MD 8 ..."

During a review of Pt 1's "DR", dated 4/8/24 at 12:26 p.m., the DR indicated, " ...Procedure: XR Forearm 2 Views Right ... Ordering Provider: CRNA 1 ... Impression: No evidence of fracture ... Final Report: Dictated by MD 8 ... Signed by: MD 8 ..."

During a review of Pt 1's "Computed Tomography (CT- A procedure that uses a computer linked to an x-ray machine to make a series of detailed pictures of areas inside the body)", dated 4/8/24 at 1:14 p.m., the CT indicated, " ...Procedure: CT Spine Cervical (top of the spine) without contrast ... Ordering Provider: CRNA 1 ... Clinical Information: Trauma-Acute Intracranial Injury/Pain ... Impression: No evidence of acute cervical spine osseous pathology ... Final Report: Dictated by MD 8 ... Signed by: MD 8 ..."

During a review of Pt 1's "CT", dated 4/8/24 at 1:14 p.m., the CT indicated, " ...Procedure: CT Head or Brain without contrast ... Ordering Provider: CRNA 1 ... Clinical Information: Trauma-Acute Intracranial Injury/Pain (Head injury or blow to the head) ... Impression: No evidence of acute cervical spine osseous pathology ... Final Report: Dictated by MD 8 ... Signed by: MD 8 ..."

During a review of "Valley Regional Anesthesia Associates- [Hospital] Schedule", dated 4/8/24 to 4/19/24, the Schedule indicated, a CRNA was assigned to be the AIC for 4/8/24 (date of Pt 1 fall), 4/10/24, 4/11/24, 4/16/24 and 4/19/24.

During an interview on 6/13/24 at 3 p.m., with CRNA 1, CRNA 1 stated the AIC was always an Anesthesiologist. CRNA 1 stated she would consult the AIC if had questions or needed guidance on a "difficult" case. CRNA 1 stated she did not have questions prior to the fall and this was a "normal" surgery with no issues prior to Pt 1's fall. CRNA 1 stated she did not order diagnostics in Pt 1's case, but according to her scope she could if needed. According to Pt 1's Electronic Medical Record (EMR) she ordered three XR's and two CT's without a documented order form with MD 7 or another physician.

During an interview on 6/13/24 at 3:50 p.m., with MD 5 (Anesthesia in Charge), MD 5 stated in the last month changes have been made to the role of the CRNA. MD 5 stated the AIC or physician available writes all orders in the pre-operative and post-operative phase since the change. MD 5 stated that before CRNA orders used to "roll-over" into the post-operative phase, but as of today they did not.

During an interview on 6/17/24 at 12:06 p.m., with CRNA 3, CRNA 3 stated the hospital requested a physician co-sign on CRNA orders that started in May or June of 2024. CRNA 3 stated the AIC could suggest changes to the anesthesia plan developed for a patient and the practice was collaborative.

During an interview on 6/18/24 at 2 p.m., with the Chief of Anesthesia (COA), the COA stated a CRNA ordering diagnostics "could be borderline". The COA stated CRNA can "interpret those things" and that if a Pt aspirated (accidental breathing in of fluid into the lungs. This can cause serious problems, such as pneumonia and other lung problems) under their care, they should be able to order an x-ray. The COA stated the "MD's" are the AIC's and not CRNA's. The COA stated the role of the AIC was to make clinical decisions, interact with consultants and other MD's.

During an interview on 6/18/24 at 2:40 p.m., with the Chief Executive Officer (CEO), the CEO stated the scope of the CRNA was to assess the Pt intraoperatively (during the surgical procedure), put together a plan of anesthesia for them with consultation (when someone ask someone for their advice or guidance) from an MD and know when to ask for assistance.

During a review of the Board of Registered Nursing (BRN) definition of a Nurse Anesthetist, indicated a " ...nurse anesthetist is a registered nurse who provides anesthesia services ordered by a physician ... and is certified by the BRN in this specialty". https://www.rn.ca.gov, accessed 1/12/2024 ..."

During a review of California's Business and Professions Code, "BPC, 2725(b)(2)- Practice of Nursing", the BPC indicated, " ...Direct and indirect patient care services, including, but not limited to, the administration of medications and therapeutic agents (treating a disease), necessary to implement a treatment, disease prevention, or rehabilitative regimen (schedule) ordered by and within the scope of licensure of a physician ..."

During a review of BPC, "2833.5. Practice of Nurse Anesthetist to Not Confer Authority to Practice Medicine or Surgery Except as provided in Section 2725", the BPC indicated, " ... in this section, the practice of nurse anesthetist does not confer authority to practice medicine or surgery. (Added by Stats. 1983, c. 696, § 7. and as defined by Section 1316.5 of the Health and Safety Code ) ...".

During a review of BPC "2051 Medical (Doctor) Licensing", the BPC indicated, " ...authorizes the physician to "diagnose" or "diagnosis" using any method, device, or procedure whatsoever, and whether gratuitous (free) or not, to ascertain (learn with certainty) or establish whether a person is suffering from any physical or mental disorder ..."

During a review of the facility's policy and procedure (P&P) titled, "Allied Health Professional Certified Registered Nurse Anesthetist Job Description/Protocol", dated 1/23/20, the P&P indicated, " ...Policy: With the overall anesthesia service being supervised by an anesthesiologist credentialed by the medical staff a CRNA ... may administer anesthesia and provide the following anesthesia-related care in the following general categories ordered by a physician ... who is a current member in good standing of the [Hospital] Medical Staff and has personally evaluated the patient ... General Scope or Services/Functions. A CRNA may perform the following functions: 1. Performing and documenting a pre-anesthetic assessment and evaluation of the patient including requesting consultations and diagnostic studies; selecting, obtaining, or administering pre anesthetic medications and fluids; and obtaining informed consent for anesthesia ... 11. CRNA's must contact the AOC (Anesthesiologist on call) or the AIC (Anesthesiologist in charge) as directed by departmental P&P, which includes ... as a direct by the AIC/AOC on a case-by-case basis ..."

Based on interview and record review the hospital failed to ensure the safety and well-being of one of one patients (Pt 1), when Pt 1 was under the direct care of the Certified Registered Nurse Anesthetist (CRNA- a Registered Nurse who has specialized training in anesthesia) 1 and fell off of the operating room table while emerging from Anesthesia (the use of medicines to prevent pain during surgery and other procedures).

This failure resulted in Pt 1 suffering a significant injury, breaking her left arm in multiple places.

Findings:

During a review of Pt 1's "Pre-operative History and Physical (H&P)", dated 4/2/24, the H&P indicated, " ...75-year-old, Female ... Chief Complaint: ... right hip hurts ... Focused Examination: ... The patient does have a bit of a pannus (an apron of excess skin and fat hanging from the abdomen below the waistline) overlapping the proximal (nearer to the center of the body) portion ... deep hip pain ... pain with external and internal rotation ... She has an antalgic gait (limp) ... Impression: Arthritis right hip (a condition in which there is loss of the cartilage [strong, flexible connective tissue that protects your joints and bones] of the head of the thighbone and of the cup-shaped socket of the pelvis where the thighbone fits into the join) ... Diagnosis: Arthritis of right hip, Abdominal pannus ... Recommendation/Plan: ... Proceed with surgical interview involving right total hip arthroplasty (a surgical procedure in which an orthopedic surgeon removes the diseased parts of the hip joint and replaces them with new, artificial parts) ... The potential risks, benefits, complications, outcomes were discussed with the patient who understood, agreed and consented to proceed ... Signature: [Medical Doctor (MD) 7] ... Reviewed Problems: Graves Disease (an immune system condition that affects the thyroid gland) - onset 2/1/20, Myasthenia gravis (a chronic autoimmune disorder in which antibodies destroy the communication between nerves and muscle, resulting in weakness of the skeletal muscles), Essential Hypertension (high blood pressure), Coronary Arteriosclerosis (the buildup of fats, cholesterol and other substances in and on the blood vessels causing vessels to narrow blocking blood flow) ..."

During a review of Pt 1's "Surgical Documentation (SD)", dated 4/8/24, the SD indicated, " ...Last modified by: Registered Nurse (RN) 10 [RN 8 note] ... General Comments: Once procedure was complete dressings were placed on incision ted hose placed on patient. Left arm was freed and placed on chest in order to bring bed to side of table. I turned to move suction and Bovie out of the way and patient had rolled off of surgical table to the right side. I ran to patient and saw her in a prone position on floor. I asked her if she was okay or hurt and she asked what happened. I then positioned her on her back supporting her head. I placed a pillow under head and covered her with blankets. I did a quick scan assessment checking for abrasions or obvious injuries, I saw no apparent skin injuries ... other staff had come into the room by then and a lift team was called. I was sent to a lunch break and did not witness the lift team placed the patient in bed ... General Comments: (Last modified by RN 8) ... 11:10 a.m. patient fell from bed (post removed) witnessed by RN 8, Certified Registered Nurse Anesthetist (CRNA) 1, Scrub Technician (ST) 4, patient stabilized while on floor, kept warm inform charge nurse lifting called for patient on bed. MD 7 informed of incident ... 11:30 a.m. patient (1) on bed by lift team ... transferred to PACU ... "

During a review of Pt 1's "Diagnostic Radiology (DR)", dated 4/8/24 at 12:26 p.m., the DR indicated, " ... Ordering Provider: CRNA 1. Report: XR Humerus Minimum 2 Views Left ... Clinical Information: fall ... Impression: Comminuted, angulated fracture of the distal humeral (Upper arm bone broken in at least three places) ... Final Report: Dictated by MD 8 ... Signed by: MD 8 ..."

During a review of Pt 1's "Progress Note (PN- from CRNA 1)", dated 4/8/24, the PN indicated, " ... I told (Pt 1), surgery is now over. Stay still and don't move. We are getting you ready to be moved to your bed. (RN 5) removed the tape from the patient's right arm which was taped over the patient's chest. I removed the arm strap from the Pt's left arm which was strapped to an arm board connected to the bed. Patient was still groggy so I reminded the patient to not move ... Pt raised her left arm and rolled over to the right side. Pt fell off of the OR (Operating Room) bed and was on the ground face-down with her left arm shielding her face ... I told her not to move and try to stay still while we were getting more help to move her back to the bed ... Pt was unable to move or feel her legs due to the spinal block (a temporary loss of feeling in the abdomen and/or the lower part of the body) I had placed earlier for the surgery ... Pt stated that she felt pain in her shoulders. I noted that the Pt's left-hand squeeze was weaker than the right hand so I lifted the Pt's left gown sleeve and observed a suspected fracture in her left upper arm ..."

During a review of Pt 1's "Operative/Procedure Reports (OPR)", dated 4/9/24, the OPR indicated, " ...Surgeon: MD 7 ... Anesthesiologist: MD 9 ... Post-operative diagnosis: Left comminuted and displaced closed distal third humeral shaft fracture ... Indications for Procedure: This is a 74-year-old woman who fell off the operative table after surgical intervention for her right hip today causing her to develop a displaced fracture of the left distal humerus for which require surgical intervention. After discussing this with the staff, the family and the patient herself, we deemed important and necessary to fix this as soon as possible so that we can allow her to be able to ambulate after her hip arthroplasty ... consented to proceed ... Findings: Displaced comminuted humeral shaft fracture ... Implants/Explants: ... humerus plate with ... screws ... Patient Condition: good ..."

During an interview on 6/13/24 at 3 p.m., with CRNA 1, CRNA 1 stated she was at the head of Pt 1 when the fall occurred. CRNA 1 stated she was focused on the airway of Pt 1 and did not know where the other members of the OR team were. CRNA 1 stated Pt 1 was "groggy (stunned or confused and slow to react)" but waking up answering questions appropriately. CRNA 1 stated she removed the left arm strap for Pt 1 to make her more comfortable while waking up. CRNA stated Pt 1 than raised up her left arm and rolled off the OR bed to her right side. CRNA 1 stated she thought Pt 1 initiated and was the cause of the fall. CRNA 1 stated "I told her not to move and she moved when I told her don't move". CRNA 1 stated the transfer bed was not in the room at the time of the fall. CRNA 1 stated she was not responsible for the transfer bed not being there. CRNA 1 stated she "wished" there were two staff on each side of the patient and "wished" the patient would not have fallen. CRNA 1 stated she would not have done anything differently.

During an interview on 6/13/24 at 3:50 p.m., with MD 5 (Anesthesia in Charge), MD 5 stated that he did not think CRNA 1 could have done anything differently.

During an interview on 6/18/24 at 9:55 a.m., with the OR Director (ORD), the ORD stated Pt 1's safety was put at-risk due to staff having a "lack of awareness" and actual harm occurred. The ORD stated Pt 1's right to care in safe setting was violated "unintentionally". The ORD stated the surgical department used Association of Perioperative Registered Nurses (AORN) guidelines as their professional reference.

During an interview on 6/18/24 at 2 p.m., with the Chief of Anesthesia (COA), the COA stated the role of anesthesia (CRNA 1) would be to be the "team leader at that moment". The COA stated when a Pt was coming out of anesthetic, Pt 1 would not be capable of making "rational decisions". The COA stated it would be "unfair" to expect Pt 1 to follow commands by the CRNA.

During an interview on 6/18/24 at 2:40 p.m., with the Chief Executive Officer (CEO), the CEO stated Pt 1 should have never been left unsupervised on the OR table. The CEO stated Pt 1's safety was compromised by staff. The CEO stated Hospital policy and procedures were not followed in this case. The CEO stated Pt 1's rights were violated because she did not receive care in a safe setting.

During a review of the facility's policy and procedure (P&P) for Anesthesia titled, "Patient Safety", dated 1/14/22, the P&P indicated, "...PURPOSE: to identify and eliminate potential safety hazards thereby reducing risk to patients, personnel and visitors... POLICY: Patient safety refers to a systematic hospital wide program to minimize preventable physical injuries, accidents and undo psychological stress during hospitalization ... B. PATIENT OBSERVATION: 1. Patients on operating tables are never left unattended. Side rails and/or safety straps are utilized ... 2. Special care is ensured by provision of an adequate number of personnel when moving patients to and from the operating table, or when positioning patients on the operating table..."

During a review of the facility's policy and procedure (P&P) titled, "Transferring Patients from Gurney/Bed to Operating Room Table", dated 1/12/23, the P&P indicated, "...PURPOSE: A. To prevent ... patient injuries during the handling, repositioning and transferring of patients ... II. POLICY: A. All employees are responsible to perform in a safe manner and are expected to identify and report potentially unsafe work practices and conditions. B. Patients will be transferred from gurney/bed to the OR table in a safe manner ..."

Review of AORNguidelines.org Professional Reference titled, "Guideline for Positioning the Patient" dated 5/17/22, (found at https://aornguidelines.org/guidelines/content?sectionid=173734066&view=book&expand=true) indicated, " ... 3.1. Identify potential hazards associated with positioning activities and establish safe practices. Positioning patients and using positioning equipment and devices during perioperative care is a high-risk task that can result in injury to patients or personnel. Identifying potential hazards and establishing safe practices may reduce the risk for patient and personnel injury ... 3.2. Perioperative team members should proactively determine who is responsible for attending to the patient (for example, remaining present at the patient's side) while the patient is on the OR bed. Patients are at risk for falls in the perioperative setting. It is the responsibility of the entire perioperative team to proactively discuss patient observation responsibilities for all phases of the intraoperative period and consider crucial periods, such as induction and emergence from anesthesia and periods of sedation during which patients are not yet positioned or restrained in their final positions. To minimize or eliminate the risk of patient injuries from falls, perioperative team members must remain vigilant to the infrequent but potentially devastating consequences of a patient's fall from the OR bed. A lack of clear communication about who is responsible for attending the patient after the safety straps are removed or before the patient is transferred to the OR bed has been reported as a contributing factor for patient falls in the perioperative setting ... 3.21. Apply safety restraints in a manner that safely secures the patient. Applying safety restraints reduces the patient's risk of falling off the OR bed ..."

During a review of the "Owner's Manual- Hana Orthopedic Surgery Table (OM)", dated 2017, the OM indicated, " ...Standard Components ... Patient Safety Strap: The patient safety strap secures the patient in place when positioned on the table the 90-inch strap slides around the foot-end of the table ... Anterior (in the front of) Approach Total Hip Arthroplasty ... Table Setup for ... Right Total Hip Arthroplasty ... 7. Slide the Patient Safety Strap in Place (picture of safety strap fastened over the belly-button area of patient) ..."