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Based on interview and record review, the hospital failed to ensure the physician's order for the use of restraint was renewed each calendar day for one of eight sampled patients (Patient 17) as required by the hospital's policy and procedure (P&P). This failure resulted in the continued use of soft restraints without renewal orders from the physician.

Findings:

Review of Patient 17's History and Physical (H&P) dated 6/8/24, indicated Patient 17 presented to the Emergency Department (ED) and was admitted to the hospital with a diagnosis of Pulmonary Hypertension (a type of high blood pressure that affects arteries in the lungs and in the heart).

During a record review on 9/27/24 at 11:00 a.m., with Nursing Quality Coordinator (NQC) I, a Non-Violent Restraints order was placed on 6/22/24 at 6:11 p.m. with restraint criteria of pulling at lines, and removing tubes.

During a concurrent interview and record review on 9/27/24 at 12:57 p.m., with NQC I, NQC I stated there was no order for the soft restraints documented applied in the Non-Violent Restraints flowsheet on 6/23/24 from 6:15 p.m. to 6/24/24 at 4:14 p.m., 6/26/24 from 6:45 p.m. to 6/27/24 at 2:29 a.m., 7/7/24 from 6:15 p.m. to 7/8/24 at 10:29 a.m., 7/11/24 from 4:15 p.m. to 7/12/24 at 12:44 a.m., 7/16/24 from 8:30 p.m. to 7/17/24 at 1:14 a.m., and 7/20/24 from 11:15 a.m. to 7/21/24 at 6:44 a.m.

During an interview on 10/1/24 at 1:48 p.m., with Registered Nurse (RN) J, RN J stated "when its (restraint) applied they have to have an order".

During a review of the hospital's policy and procedure (P&P), titled "Restraint and Seclusion", last approved date 2/24, indicated "The continuing need for non-violent restraints must be documented by the LIP/APP and a new order written each calendar day".

Based on interview and record review, the hospital failed to ensure a wound care plan was implemented for one out of 30 sampled patients (Patient 18) when there was no documentation indicating wound treatment was implemented as ordered. This failure had the potential for Patient 18's needs not being met and worsening conditions of skin abnormalities.

Findings:

Review of Patient 18's inpatient history and physical, dated 7/08/24, indicated the patient visited the emergency department (ED) with a chief complaint of worsening cough productive of blood-tinged sputum (a mixture of saliva and mucus coughed up from the respiratory tract), N/V (nausea/vomiting), decreased appetite, and fatigue (a feeling of extreme tiredness).

Review of Patient 18's Wound Ostomy Continence Nurse (WOCN) note, dated 7/13/24, indicated: sacrum/coccyx (bones at the base of the spine): patient with congenital dimple (a small depression in the flesh inborn), skin blanching (the skin appears whitish due to restricted blood flow) and intact (not damaged); cover clean dry skin with upside down large sacral Allevyn (foam dressing used for wound management), assess skin every shift, change dressing MWF (Monday, Wednesday, and Friday) and PRN (as needed).

Review of Patient 18's Encounter Problems included intervention to prevent skin injury was to relieve, redistribute pressure, protect bony prominences, (condition of standing out by physically projecting) and skin at risk for injury. The intervention to implement measures was based on patient-specific risk factors.

Review of Patient 18's order, dated 7/13/24, indicated: cover clean dry skin with upside down large sacral Allevyn, assess skin every shift, change dressing MWF (Monday, Wednesday and Friday) and PRN.

Review of Patient 18's WOCN note, dated 8/09/24, indicated: sacrum/coccyx: increase in wound size; agree with colleague from 7/13/24 that sacrum exhibits a congenital dimple, however area was now open.

Review of Patient 18's WOCN note, dated 8/12/24, indicated: sacrum/coccyx: multiple superficial open areas noted.

Review of Patient 18's WOCN note, dated 8/16/24, indicated: sacrum/coccyx: wound WOCN verified-pressure injury, stage 2 (partial-thickness skin loss with exposed dermis [the inner layer of the skin]).

During a telephone interview on 9/27/24 at 10:48 a.m. with WOCN C, she stated there was a risk to the wound getting worsened if wound treatment was not implemented as ordered. WOCN C further stated licensed nurse should have implement the treatment as ordered by the physician and document on flowsheet when they implement treatment.

During a concurrent interview and record review on 9/27/24 at 11:00 a.m. with Nursing Quality Management Coordinator (NQMC) D, Patient 18's flowsheets dated from 7/13/24 to 8/09/24 were reviewed. The flowsheets dated from 7/15/24 to 7/20/24 indicated the licensed nurse did not implement the treatment to change Allevyn dressing on MWF and PRN as ordered for Patient 18. NQMC D confirmed there was no documentation indicating the treatment was implemented as ordered from 7/15/24 to 7/20/24 for Patient 18.

During a review of the hospital's policy and procedure (P&P) titled "Pressure Injury Prevention Protocol," dated 9/2014, the P&P indicated, "E. Care Plan: 7. Documentation should include the type of therapy bed the patient is on, any nursing treatments and/or interventions for the prevention of pressure injuries."

During a review of the hospital's policy and procedure (P&P) titled "Standard of Practice for Acute and Critical Care Nursing," dated 11/2021, the P&P indicated, "E. Implementation: 1. The nurse caring for the patient implements the plan of care. F. Documents implementation of the plan in the Care Plan system within the EHR (electronic hospital record) in a clear, timely manner."

Based on interview and record review, the hospital failed to comply with the Condition of Participation for Surgical Services as evidenced by:

1. Hospital staff failed to implement their policy titled "Universal Protocol" during a nerve block (a procedure that involves injecting medication into or around a nerve to block pain) when the wrong injection site was marked, and a patient received the medication on the wrong side of the body. (Refer to A951).

2. Hospital Staff failed to implement their Policy titled "Surgical Counts" during a surgical procedure. (Refer to A951).

3. Hospital failed to have a safety practice in place to inspect, measure, or observe ureteral catheter device after used in surgical procedures, ensure the device was intact and not retained in the body. (Refer to A951).

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.

Based on interview and record review, the hospital failed to implement surgical services policies for three of 30 sampled patients (Patient 20, Patient 21, & Patient 22) and to provide acceptable standards of medical practice for surgical patient care when:

1. Hospital staff failed to implement their policy titled "Universal Protocol" during a nerve block (a procedure that involves injecting medication into or around a nerve to block pain) when the wrong injection site was marked, and a patient received the medication on the wrong side of the body.

2. Hospital staff failed to implement their policy titled "Surgical Counts" during a surgical procedure for Patient 21.

3. The hospital failed to have a safety practice in place to inspect, measure, or observe ureteral catheter devices after used in surgical procedures, ensure the device was intact and not retained in the body for Patient 22.

These failures resulted in:
1. Patient 20 receiving unnecessary medication and had a "panic attack" after the incorrect administration of nerve block medication to wrong side of the body.

2. Patient 21 had multiple retained surgical items (a foreign surgical item that is not intended to remain in the patient at the end of surgery) after a surgical procedure.

3. Patient 22 had a retained surgical item after a surgical procedure.

Findings:

1. During a review of Patient 20's "Anesthesia Preprocedure Evaluation" dated 8/23/24, Evaluation indicated, "Procedure: Shoulder Total Arthroplasty [a surgical procedure that replaces a damaged joint with an artificial joint, or prosthesis](Right)". Evaluation indicated, "Pt[patient] reports anxiety during prior nerve block at [hospital] for LT [left] shoulder sx [surgery] on 12/21/23".

During a review of Patient 20's "Consent to Operation, Procedure and Administration of Anesthesia" dated 8/23/24, consent indicated, the procedure was "Right reverse total shoulder arthroplasty. Right".

During a review of Patient 20's "Anesthesia Procedure Note" dated 8/29/24, the note indicated, "Peripheral Nerve Block Date/Time start: 8/29/24 5:47 AM. . .Preanesthesia Checklist Patient identified, site marked, surgical consent reviewed, pre-op evaluation reviewed, timeout performed, IV checked. . .Additional peripheral nerve block details: First interscalene [a paired structure in the neck, the space between the scalene muscles] block was placed on L [left] side using same technique after verbal confirmation by patient. Dosed with 10cc 0.25% ropivacaine [local anesthetic used for local anesthesia during surgery and for short-term management of acute pain]. Following placement, block was noted to be on incorrect side" Signed by Medical Doctor (MD) A.

During an interview on 9/27/24, at 9:45 a.m., with Patient 20, Patient 20 stated, "It was a big mistake that happened, they put the nerve block on the wrong side which was the left side. I don't know which Doctor gave the nerve block, but they never told me they were putting it on the left side. I didn't notice they were doing it on the wrong side until they told me, they put on the wrong side. I felt like I couldn't breath and was panicking". Patient 20 stated, the doctors gave her something in her IV(intravenous catheter) to make her calm, so she didn't realize what was going on.

During an interview on 9/30/24 at 8 a.m., with MD A, MD A stated, he assisted with the nerve block procedure for Patient 20 on 8/29/24 along with MD B. MD A stated, himself and MD B were present during the checklist and they reviewed the patients informed consent from a computer used by another staff member. MD A stated, "The patient identifiers and surgery site do not appear on the screen at the same time due to size so we scrolled down to confirmed the surgery site".

During an interview on 9/30/24, at 1:30 p.m., with MD B, MD B stated, "generally the trainee resident preps the patient" prior to nerve block. MD B stated he prepped Patient 20 on 8/29/24. MD B stated the anesthesia team preps the patient by positioning them and marking the injection site prior to doing the anesthesia checklist. MD B stated, he could not remember if he or MD A marked the injection site on the left side, prior to marking we looked at the patient chart. MD B stated, "I think the challenge was walking from the work station and to the computer and it was easy to get distracted. We did not have a printed consent. Myself and [MD A] performed the nerve block on the left side". MD B stated, he recognized the error after the nerve block was administered to the left side, when he went to chart in Patient 20's medical record. MD B stated, "The most likely cause [of incorrect administration of nerve block on left side] was the cognitive overload, I am a trainee it happens where you prep the wrong side, you just proceed without taking a minute. . .you can read a form then see the opposite arm when you are busy".

During a review of the hospitals Policy and Procedure (P&P) titled, "Universal Protocol", dated 2022, the P&P indicated, "the purpose of this policy was to provide a process to reduce the risk of wrong patient, wrong procedure, and or wrong site surgery and procedures. . . Pre-procedure verification: the process by which relevant documents, information, and equipment are available prior to the procedure and are correctly identified, labeled, and match to the patients identifiers prior to the patient receiving anesthesia".

2. During a review of Patient 21's "Operative Report" dated 8/2/24, report indicated, "Date of operation 8/2/24. Surgeons [MD E]. . .Procedures: 1. Bilateral neck exploration and washout 2. Control of hemorrhage 3. Right pectoralis major rotational flap [a surgical technique that uses the pectoralis major muscle to cover defects and wounds] 4. Flexible tracheoscopy [a procedure that allows a doctor to examine the inside of the trachea] and bronchoscopy [a procedure that allows a doctor to examine the inside of the lungs using a thin, flexible tube with a light and camera]. . .Findings: 2 pinpoint areas of bleeding were found at the right common carotid artery at the level of the stomal dehiscence [a complication that occurs when the skin around a stoma breaks down]. . .We applied pressure [to the bleeding artery] and called our vascular surgery colleagues for an intraoperative consultation". Signed by MD E (Ear, Nose and Throat- ENT Physician)

During a review of Patient 21's "Operative Report" dated 8/2/24, report indicated, Date of operation 8/2/24. . . Operation performed: 1. Open exploration right common carotid artery. . . Surgeon: [MD F]. . . Findings: 1. Hemorrhage from right common carotid artery . . . At the time we joined the case a neck expiration had been performed by the head and neck team, with bleeding originating from the right common carotid artery just superior to the level of the clavicle. And approximate 2 milimeters (mm, unit of measurement) defect was visualized in the medial right common carotid artery. . . Manual pressure was held for hemostasis [stopping bleeding] and we discussed transition to endovascular [minimally invasive procedures that are done inside the blood vessels] approach for control of hemorrhage. Quick clot [type of gauze used to stop bleeding] was packed into the wound for temporary packing and secured with loban [temporary dressing]". Signed by MD F.

During a review of "Operative Report" dated 8/9/24, Report indicated, "Date of operation 8/8/24 . . . Preoperative diagnosis" Pharyngeal leak [a complication that occurs when saliva leaks from the throat through a defect in the pharyngeal mucosa], concern for retained foreign body in neck. . .Attending surgeon: MD G, assistant surgeon MD E. . .Findings: 'Quick clot' gauze removed from right central neck. . .specimens removed: Right foreign neck bodies. . .Procedure in detail: . . .We then examined the right central neck and removed several pieces of 'quick clot' gauze". Signed by MD G.

During an interview on 9/25/24, at 10 a.m., with Assistant Patient Care Manager (APCM) H, APCM H stated, regarding the reason Patient 21 had retained gauze after his procedure on 8/2/24, there were multiple factors, staff were not aware the gauze was opened and cut into pieces, the hand off from vascular team back to primary team was not well communicated regarding how much gauze was cut, the primary surgeon (MD E) knew quick clot was used prior to closing the patient up.

During an interview on 9/27/24, at 9:30 a.m., with MD E, MD E stated, Patient 21 was transferred to the hospital for coughing up blood, after scanning the patient we could not identify where the bleed was coming from, so we did a neck exploration. During the exploration we consulted our on call vascular surgeon (MD F) to assist. MD F tried to repair the holes in the carotid artery and was unable to because the artery was too fragile, she decided to hold pressure while we made a plan for other equipment needed for the repair. MD F requested quick clot gauze to pack the wound. Any countable item is added to the count when they are placed onto the sterile field (a designated area in an operating room or clinical setting that is free of bacteria and particles to reduce the risk of infection), I don't know if anyone requested the gauze be added to the countable items, we removed what we thought was all the quick clot gauze before we closed the patient up. After surgery the patient developed a fever and his tube feedings were refluxing into the neck, we had cause for a retained surgical item. We scheduled to the patient for surgery on 8/8/24. We then explored the neck again and found pieces of quick clot gauze in his neck. MD E stated, "Retained foreign objects are not a common complication from this procedure. We did not know how many pieces of the quick clot there were, if things are cut it is typically notated and communicated to the team". MD E stated, "I don't remember [MD F] telling us how many pieces there were in the body before closing".

During an interview on 9/27/24, at 11:30 a.m., with MD F, MD F stated, she was the vascular on call surgeon on 8/2/24, and was consulted for assistance with Patient 21 who needed a repair to his carotid artery. MD F stated, she saw a hole in the common carotid artery and the tissue of the artery was very fragile and falling apart. MD F stated, they started the process of getting the correct equipment needed for the repair, and in the meantime, she was holding pressure on the artery with her finger. MD F stated, she asked for hemostatic agents (substances used to stop or prevent bleeding during surgery). MD F stated, "they opened the quick clot it was the first available, it was a 3 foot long section. I cut it into pieces to pack into the wound then placed temporary dressing to hold the incision closed". MD F stated, "When they opened the quick clot, I asked if there was smaller size but the team was not aware, there was a lot of chaos of people running around. I told [MD E] we need to remove the quick clot, they stated they were comfortable to remove. I left the room". MD F stated, "I didn't know the quick clot was supposed to be part of the count, I don't know if the count included it. The circulator nurse [CN K] placed gauze on the sterile field. I did not count the pieces I cut".
During an interview on 9/30/24 at 10 a.m., with CN K, CN K stated, she was a circulator nurse and her role is to help set up surgical rooms, advocate for patients, and make sure consent is in order prior to surgery. CN K stated, she was assigned as an additional nurse to Patient 21 on 8/2/24. CN K stated she was asked to assist with Patient 21's surgical team after someone in the surgery room pressed the call button for help. CN K stated they asked for quick clot gauze, she stated herself and another circulator nurse went to get the quick clot. CN K stated, she explained to the other nurse that quick clot gauze is a countable item, and we have to track its use to make sure its counted and the end of surgery. CN K stated, she could not remember who placed the gauze on the sterile field to the surgeon, but she explained it needed to be added to the count, and she saw the nurse add it to the count. CN K stated, "We gave them what they requested, generally if anything was cut, we will state it was cut into multiple pieces and stated that one count. They generally don't cut quick clot, I didn't know you could". CN K stated, the count was correct because the quick clot gauze was added as one item and counted as one item.

During a review of the hospital's P&P titled, "Surgical Count", dated 2021, the P&P Indicated, "Purpose: to ensure an environment of maximum patient safety and quality care and to protect against unintended foreign object retention within the body. . .Retained Surgical Item (RSI): A foreign surgical item that was not intended to remain in the patient at the end of surgery that remains in the patient after the patient has left the room. Also called retained foreign body (RFO). . .Count: accounting of all counted items including instruments, sponges, sharps, and miscellaneous items. . . cutting counted items: before an item that may be cut by the surgeon , the scrub person will lay it out on the back of the table drape and mark drape to indicate length or size. When the item was retrieved, scrub person will match item to table marking to determine that the item was retrieved in its entirety. Each time an item is cut, a notation must be made on the count board".

3. During a review of Patient 22's "Operative Report" dated 8/29/24, the report indicated, "Date of Operation 8/29/24 . . .Procedure: Cystoscopy and bilateral ureteral catheterization [a procedure that involves examining the bladder and urethra with a cystoscope, and then passing a catheter up into the kidneys]. . . Surgeon: [MD L]. . . Indication: this patient is a 60 [year old] male with recurrent diverticulitis [disease that occurs when small pouches in the large intestine become inflamed or infected] s/p [status post-after] colostomy undergoing colostomy takedown [a surgical procedure that reattaches the colon to the rectum]. Ureteral identification and catheterization was requested by the primary team". Report indicated, bilateral ureteral catheters were placed and left for the remainder or the abdominal surgery and planned.

During a review of Patient 22's "Operative Note" dated 8/29/24, note indicated, "Date of operation: August 29, 2024. . . Surgeon: [MD M]. Operative note indicated, no indication of the removal of the bilateral ureteral catheter post abdominal surgery.
During an interview on 9/27/24, at 1:30 p.m., with MD L, MD L stated he assisted with the procedure on 8/29/24 for Patient 22. MD L stated, the purpose of the procedure of ureteral catheter insertion is so the primary surgeon can find the ureter and don't inadvertently damage them. MD L stated, his team inserted the catheters without issue and the primary surgeon is supposed to remove them after finishing their procedure. MD L stated, "2 days later the on call Physician stated they found the catheter inside cut off through the ureter and catheter. It was definitely cut off. It looks like the original surgeon [MD M] cut through the ureter, there was no other explanation". MD L stated, It had been identified the cause of ureteral dissection (cutting through the ureter) was technical error on part of the surgeon, despite having urology perform the catheterization to minimize risks of damage to ureter, through technical error the surgeon damaged the ureter, it was not identified prior to closure.

During an interview on 9/30/24, at 9:30 a.m., with MD M, MD M stated, he was the general surgeon for Patient 22 on 8/29/24. MD M stated, the reason the urology team placed ureteral catheters are to minimize risk of damage to the ureter during the abdominal surgeon we performed. MD M stated, we (general surgery) remove the catheters after closure they are taken out at the end of the surgery. MD M stated, We removed the catheters at the end of the surgery, but that is not something we normally put in the operative note. MD M stated, the cause of the ureter to be cut "was almost certainly the ligasure [a vessel sealing system that uses radiofrequency energy and mechanical compression to seal vessels and tissue bundles], it was me who cause the damage. . .It was a technical error on my part". MD M stated normally if you inadvertently cut the ureter, you would see the catheter, but in this situation, it sealed the ureter which is why we didn't see the stent. MD M stated, the normal procedure for removing the catheters is to just remove them, we do not measure, or inspect them, it should have been noticed during the removal that the catheters were two different lengths, at the time we did not notice a piece was left behind.