HospitalInspections.org

Based on record review and interview, the facility failed to protect the patient's right to make informed decisions on their care in 1 (#1) of 26 emergency room patient's records reviewed. The facility failed to ensure that patient or their representatives were provided with risks and benefits prior to the sedation for the procedure performed. Also, the facility failed to follow their own policy and procedures on the "Procedural Sedation" Informed consent.

Refer to Tag: A0131

Based on record review and interview, the facility failed to protect the patient's right to make informed decisions on their care in 1 (#1) of 26 emergency room patient's records reviewed. The facility failed to ensure that patient or their representatives were provided with risks and benefits prior to the sedation for the procedure performed. Also, the facility failed to follow their own policy and procedures on the "Procedural Sedation" Informed consent.

This deficient practice had the likelihood to cause harm to all patients receiving sedation for procedures in the emergency room.

Findings included :

A review of Patient #1's record revealed:

The patient was admitted to the Emergency Room (ER) on 9/5/2022 at 2:14 PM following an All-Terrain Vehicle (ATV) accident with a head injury, bruising to his right chest, and a facial/scalp laceration. Patient #1 received Ketamine Intravenous push for sedation during the repair of a scalp laceration.

There was no informed consent found on record for procedural sedation signed by Patient #1's parents.

A review of the facility's policy titled; "Procedural Sedation in the Emergency Department" dated 03/18 revealed the following:

"PURPOSE: To provide for safe effective administration of medication for the purpose of procedural sedation during interventional procedures in the Emergency Department.

2. The Licensed Independent Practitioner completes the 'Sedation/Plan Orders' in the 'Procedural Sedation Record', which includes the airway assessment, ASA score, and indication for procedure plan for sedation. informed consent for the procedure sedation must be obtained prior to the initiation of procedural sedation."

An interview with Staff RN #3 on 11/30/2022 at 4:00 PM confirmed there was no informed consent for procedural sedation using the medication Ketamine for a scalp laceration found in the medical record.

Based on record review and interview, the facility failed to ensure the registered nurse provided assessment and monitoring during a procedural sedation of a pediatric patient receiving ketamine in the emergency department for 1 of 26 records reviewed. Also, the facility failed to follow their own policy and procedures for "Procedural Sedation in the Emergency Department".

Refer to Tag A 0392

Based on record review and interview, the facility failed to ensure the registered nurse provided assessment and monitoring during a procedural sedation of a pediatric patient receiving ketamine in the emergency department for 1 of 26 records reviewed. Also, the facility failed to follow their own policy and procedures for "Procedural Sedation in the Emergency Department".

This deficient practice had the likelihood to cause respiratory depression and loss of airway to the pediatric patient.

Findings include:

A review of Patient #1's record revealed:

Patient #1 was admitted to the Emergency Room (ER) on 9/5/2022 at 2:10 PM following an unhelmet All-Terrain Vehicle (ATV) accident with a head injury, bruising to his right chest, and a facial/scalp laceration 25 cm.

Patient #1 received Ketamine Intravenous push 86 mg for sedation for a repair of a scalp laceration at 3:51 PM (1551) by Staff RN #7.

Patient #1 received Ketamine Intravenous push 43 mg for sedation for a repair of a scalp laceration at 4:11 PM (1611) by Staff RN #11.

Vital signs were documented on the "Trauma Nursing Assessment" record.

3:14 PM (1514) B/P 108/57, pulse 69, respirations 14, O2 sat 97%, temp 98

3:46 PM (1546) B/P 107/59, pulse 103, respirations 22, O2 sat 98%, no temp

3:54 PM (1554) B/P 115/69, pulse 99, respirations 14, O2 sat 98%, no temp

4:13 PM (1613) B/P 122/68, pulse 100, respirations 19, O2 sat 98%, no temp

5:05 PM (1705) B/P 114/63, pulse 100, respirations 18, O2 sat 100%, temp 98.1

Patient #1 was discharged home at 5:38 PM (1738) with parents.

Vital signs were not documented every 1-2 minutes at the beginning of the sedation and vitals were not documented every 5 minutes during the sedation and procedure. There was no procedural sedation record found in the medical record. The only vital signs found in the medical record were on the "Trauma Nursing Assessment" record. The last dose of ketamine was given at 4:11 PM and the procedure was completed at 5:00 PM. Patient #1 was discharged home at 5:38 PM. Last set of vital signs was taken at 5:05 PM. There was no documentation about how the patient tolerated the procedure, the patients condition post-procedure, and the condition at discharge.

A review of the facility's policy titled; "Procedural Sedation in the Emergency Department" dated 03/18 revealed the following:

"PURPOSE: To provide for safe effective administration of medication for the purpose of procedural sedation during interventional procedures in the Emergency Department.

Clinical applications involving analgesia

A. Prior to Sedation: The nurse completes the nurse portion of the
Procedural Sedation Record'. Assessment may include but is not limited to:

1. Pre-sedation nursing assessment
a) Vital Signs
b) Analgesia & sedation score
c) Review of pre -procedural history and physical exam

2. The Licensed Independent Practitioner completes the 'Sedation/Plan Orders' in the 'Procedural Sedation Record', which includes the airway assessment, ASA score, and indication for procedure plan for sedation. informed consent for the procedure sedation must be obtained prior to the
initiation of procedural sedation."

3. The nurse ensures appropriate care and resuscitation equipment is
available at the patient bedside. Equipment should include but is
not limited to:
a) Appropriate equipment for the monitoring of vital signs and SaO2 level
b) Supplemental Oxygen delivery
c) Suction apparatus with catheters
d) Code cart/defibrillator; airway kit
e) Reversal agents
f) EKG/Cardiac monitoring device
9) ETCO2 monitoring, unless precluded or invalidated by
the nature of the patient, procedure or equipment.

B. lntra-Procedure: A reassessment is done immediately prior to beginning the procedure to assure the patient is still a candidate for the proposed procedure and sedation.

1. The patient is continuously monitored throughout the procedure and is at a level consistent with the potential effect of the procedure and/or sedation given.
2. The patient's response to care provided is documented in the "Procedural
Sedation Record".

Vital signs and level of consciousness should be assessed every, I -2 minutes during the onset of sedation and whenever medications are being titrated and every 5 minutes during the procedure. Key elements of physiological status and mental status are monitored and documented and include:

Pre sedation evaluation.
A pre-procedural history and physical exam

At a minimum, procedural or dissociative sedation in the ED requires one practitioner (the emergency physician) to perform the procedure, one practitioner (typically the ED nurse) to assist in the procedure and a third practitioner (ED RN or Respiratory Therapist) who is not involved in the procedure and whose sole responsibility is to monitor the patient throughout the procedure.

Recovery. Patients should be monitored until they are no longer at risk for respiratory depression, their vital signs are stable, and they are alert and at age-appropriate baseline level of consciousness. The ED record should reflect how well the patient tolerated the procedure, the patient's condition post-procedure, and when transfer or discharge took place."

An interview with Staff RN #3 on 11/30/2022 at 4:00 PM confirmed there was no "Procedural Sedation Record" found in the medical record and that Ketamine was given for a scalp laceration procedure.

A review of the drug information for Ketamine (Ketalar) on the FDA.com website, Reference ID: 4089409 revealed the following:

"Emergence reactions have occurred in approximately 12 percent of patients.
The physiological manifestations vary in severity between pleasant dream-like states, vivid imagery, hallucinations, and emergence delirium. In some cases, these states have been accompanied with confusion, delirium, excitement, and irrational behavior.

When Ketalar is used on an outpatient basis, the patient should not be released until recovery from anesthesia is complete and then should be accompanied by a responsible adult.

Warnings
Cardiac function should be continually monitored. Respiratory depression may occur with over dosage or too rapid a rate of administration of Ketalar, in which case supportive ventilation should be employed. Mechanical support of respiration is preferred to administration of analeptics.


Risk of Drowsiness
The patients should be cautioned that driving an automobile, operating hazardous machinery, or engaging in hazardous activities should not be undertaken for 24 hours or more (depending upon the dosage of Ketalar and consideration of other drugs employed) after anesthesia ..."

Ketalar (Ketamine) is a CIII non-barbiturate general anesthetic.

Based on observation, record review, and interview, the facility failed to ensure practices
and process were in place to prevent and control infections in the Emergency Department (ED) Supply rooms, ED patient treatment rooms, ED Patient kitchen, and ED medication refrigerators for infection control.

Findings include:

During a tour of the Emergency Department with Staff #3 on 11/30/2022 beginning at 12:23 PM, the following infection control issues were observed:

Patient Treatment Room #13 was supposed to have been a "clean" room per Staff #4. A visibly dirty counter was noted with a pink substance, yellow substance, and an opened betadine wipe with betadine staining on the counter. Disinfectant wipes were not readily available. Also, noted was an opened bottle of Normal Saline in the cabinet with no date.

Storage Room 1, referred to by Staff #4 as the "small storage room", was found to have the following expired supplies:

1 -Oro/naso Tracheal Tube size 3.0 cm that expired on 5/24/2022. The expiration date was circled by an unknown staff.
1 -Oro/naso Tracheal Tube size 2.0 cm that expired on 11/12/2022.
1 -Oro/naso Tracheal Tube size 2.5 cm that expired on 03/29/2022.
1 -Oro/naso Tracheal Tube size 4.0 cm that expired on 05/24/2022.
1 -Oro/naso Tracheal Tube size 5.0 cm that expired on 03/23/2022.
1 -Oro/naso Tracheal Tube size 5.5 cm that expired on 06/05/2022.
2 -Oro/naso Tracheal Tubes size 6.5 cm that expired on 05/30/2022.
1 -Oro/naso Tracheal Tube size 7.0 cm that expired on 06/11/2022.
1 - #6.4 Shiley Endotracheal tube that expired on 10/24/2022
1 - #6.4 Shiley Endotracheal tube that expired on 11/25/2022

Storage Room 2, referred to by Staff #4 as the "large storage room", was found to have the following the following expired supplies:

1 -Urology Set that expired on 06/14/2022
1 -Suprapubic Foley Set, size 16 fr, that expired on 11/28/2022
9 -Heimlich Valve that expired on 08/31/2022
An opened pair of Magill forceps
1 -Endo Tracheal Tube that expired on 09/30/2022.
2 -Foley catheter tubes, size 8fr that expired on 04/30/2022.

A container that holds wire cutting scissors had a very large bundle of dust, hair, and lint on top of the packaged scissors.

A cardboard box of Nitrile exam gloves sitting directly on the floor.

Trauma Room 3, used for emergent deliveries of babies, was found to have the following in the Neonatal Crash Cart:

1 -bottle of sterile water that expired on 11/11/2022
1 -Pediatric Calorimetric CO2 Detector that expired on 01/10/2022

The cabinets in Trauma Room 3 contained the following:

1 -Oro/naso Tracheal Tube size 9.0 mm that expired on 11/12/2022.
1 -Oro/naso Tracheal Tube size 6.0 mm that expired on 11/12/2022.

The Pharmacy refrigerators (there were 2 of them) were noted to have the following:

Both of the freezers were in need of defrosting. This has the likelihood for varying temperatures in the refrigerator and a potential problem with accuracy for the temperatures of refrigerated medications.


The patient nutrition refrigerator in the medication room had dirty appearance. The refrigerator was noted to have the following:

Visible, sticky spills, and crumbs along the bottom edge
Visible sticky spills, and crumbs on all shelves
4 -containers of grape juice that expired on 11/25/2022
1 -container of yogurt that expired on 10/11/2022

Temperature Logs for the month of November 2022 for all 3 refrigerators in the Emergency department revealed that daily monitoring of the refrigerator and freezer temperatures were left blank.

During the tour of the emergency room department on 11/30/2022 at 12:30 PM with Staff #3 accompanying the Surveyors. Staff #4 stated, "You're killing me. I have tried to get the staff to stop this." Staff #3 accompanied the Surveyors in collecting the expired supplies of the various rooms in the Emergency department. Staff #4 confirmed the above findings of expired supplies and the infection control issues observed during the tour.

Based on record review and interview, the facility's emergency department physician failed to complete a medical screening and stabilize Patient #1's condition prior to being discharged home.

Findings include:

Patient #1 was an 8-year-old male admitted to the Emergency Room (ER) on 9/5/2022 at 2:13 PM following an All-Terrain Vehicle (ATV) accident with a head injury, bruising to his right chest, and a facial/scalp laceration. The patient was not wearing a helmet. The patient denies any loss of consciousness, has associated symptoms of headache and chest pain. Denies nausea. Patient #1 was first seen by the treating emergency Physician #5, at 2:13 PM. Physician #5 documented that Patient #1 had a "large longitudinal laceration to the left forehead with degloving to the scalp." Physician #5 documented the laceration was 25 cm in length.

A review of the record revealed the Registered Nurse #7 documented child was crying on admission complaining of pain and nausea while in the CT room at 2:41 PM.

Patient #1's chest x-ray obtained in the ER showed no fracture and no apparent pneumothorax.

Patient #1's Cat scan (CT) of the abdomen and pelvis showed no abnormality of the liver, gall bladder, spleen, or pancreas.

Patient #1's CT of the head showed
1. Soft tissue injury,
2. Small amount of air in the right orbit.
3. Negative exam of the brain"
4. Recommend clinical follow-up as warranted.

Patient #1's CT of the cervical spine showed no fracture or dislocation, pulmonary apices clear, and "no acute abnormality."

Patient #1's liver enzymes were noted to be elevated as follows: AST 100, ALT 87, total protein 8.1, and Lipase was not obtained.

The suturing of laceration took almost 1 hour and required moderate sedation, or "Procedural Sedation" per the facility's terminology. Ketamine was given at 2 different times at 3:51 PM and 4:11 PM during the procedure.
The treating physician, Staff #5's "differential diagnosis" was written, "No serious injury warranting admission, patient remains well and stable, parents comfortable with home supportive care and primary medical doctor follow-up this week." Staff #5 documented a "normal inspection of eyes, no apparent dental trauma, contusion to right chest wall, no crepitus or flail, normal gait." Patient #1's discharge diagnosis by Staff #5 was "laceration without foreign body or fracture post ATV accident, given antibiotics" Patient #1 was discharged home on antibiotics and his condition was noted to be "stable" on 9/5/2022 at 5:03 PM.

An interview with Physician #17 on 11/30/2022 at 5:00 PM reported air seen in the orbital socket on the CT report should have been acted upon by Staff #5. Staff #17 stated, "Air in the orbital socket indicates the need for a facial CT to rule out a fracture. This was not done." Physician #17 indicates that a full and appropriate medical screening was not obtained by Staff #5. The extremities were not assessed, and no x-rays of the extremities were obtained.

Patient #1 was taken to a children's facility in the Woodlands by private car by his parents, which was 122 miles from the facility that patient had been discharged from and then transferred by ambulance to Children's facility in Houston.

A review of the medical record at the second facility Woodlands hospital revealed the following:

This is an 8-year-old male who presents after he was injured after the ATV rolled over on him after hitting a bump. Pt sustained a laceration to his scalp, swelling to the right eye, abrasions to the chest and abdomen. Pt complains of a headache and felt dizzy. He has been more emotional. At the outside hospital he had his laceration sutured, and had a head CT, neck CT and abdominal CT that were read as normal. Pt was discharged, parents were still concerned and came to the Emergency room. Pt vomited once after he arrived. Pt remembers the episode and has no LOC.

A review of the medical record for patient #1 from a Children's Hospital Woodlands revealed the following:

The Emergency Room (ER) Physician's Note on 9/5/22 Patient #1 was brought in on 9/5/2022 at 11:07 PM. The ER physician's note states that the mother stated, "He is more swollen". The Physician note indicated Patient #1 had, "no neuro deficits, denies c-spine [cervical spine] tenderness." Patient #1 presented to this ER with a large laceration to forehead that extends to right parietal area that has been repaired. The ER physician documented that Patient #1 had "swelling to the right eye, abrasions to the chest and abdomen and that Patient #1 "complains of a headache and felt dizzy and feeling more emotional." The ER physician documented that the outside hospital had sutured his laceration, and that his head Cat Scan (CT), neck CT, and abdominal CT that were read as normal. Patient #1 was noted to have vomited once after he arrived at Children's Hospital Woodlands but had no loss of consciousness.

Patient #1's liver enzymes were noted to still be elevated as follows: AST 112, ALT 101, and Lipase 24.

General Surgery - Trauma, Emergency Room Consultation:
Assessment:
"Patient #1 was a 8 year old male who sustained a head injury and blunt abdominal trauma today after crashing his ATV. Initially seen at outside hospital where workup was unremarkable per family and head laceration sutured. Patient #1 presents for additional evaluation. significant for large laceration to scalp s/p repair, facial swelling, and superficial abrasion w/ tenderness to right upper quadrant. Lethargic but arousal and answers appropriately. CXR and pelvis XR unremarkable. Labs w/ elevated AST 112, ALT 101. Lipase 24. FAST exam performed by EC attending with no obvious free fluid. Physician requires transfer to Children's Houston for further evaluation."


A review of the medical record of patient #1 from Children's Hospital Houston (9/6/2022 to 9/7/2022) was reviewed and the findings were as followed:

Patient #1 was transferred via Emergency Medical Services (EMS) from Woodland's hospital after the transfer Team was notified at 3:52 AM upon his arrival and arrived at Patient #1's bedside at 4:05 on 09/06/2022. The Transfer Note states, "8-year-old male presented to the Emergency Center from another hospital for headache, dizziness and altered mental status after being involved in ATV accident with no helmet. CT head and abdomen done at the other hospital. Has abrasions on chest and abdomen with 25 cm laceration on scalp that has been repaired. Chest x-ray clear. Pelvic x-ray normal. LFT's elevated. Being transferred for trauma evaluation.

Fellow Transfer Update 09/06/2022 revealed the following:

The physician's assessment revealed the following:
"Pupils 5 --> 3 on left, right side eye swollen shut. Obvious scalp laceration extending from nasal bridge up and around right parietal region and ending on left parietal region. Diffuse TTP (Thrombotic thrombocytopenic purpura) of forehead, obvious crepitus to scalp R>L. No facial tenderness to palpation of maxilla, jaw, nose. Diffuse edema and TTP concerning for orbital fracture. Dry blood at nares. + sternal tenderness to palpation. Liver not palpable below right costal margin. Spleen not palpable below left costal margin. Alert and responsive. Intact distal sensation to light touch. 5/5 strength all extremities. No focal neurological deficits observed. Normal rectal tone."

A review of the imaging thus far shows, "Acute fracture of the right medial orbital wall with depression of the lamina papyracea. No retrobulbar hematoma. There is focal enlargement of the right orbital medial rectus muscle. Incidental note is made of multiple dental caries and a periapical lucency of the right maxillary premolar tooth felt to represent a periapical Abscess.

Normal CXR and L spine XR, done at Woodlands normal. Bowing fracture of left radius.

Pending outside hospital CT abdomen/pelvis to be obtained by family member.

A review of the medical record indicated the plan is to admit and consult with plastic surgery for the facial fracture and to consult with orthopedics due to a concern for entrapment of the radial fracture, provide pain control, and to provide intravenous (IV) fluids

A review of the Pediatric Trauma History and Physical at Houston on 09/06/2022 revealed the following:
Previous interventions include c-spine immobilization, and scalp laceration repair.
The initial assessment notes that there has been no loss of consciousness, no seizures, and Patient #1 remained stable in route with no changes in hemodynamics. Patient #1's initial Glasgow Coma Score (GCS) was 15. The assessment notes that Patient #1 complains of nausea and abdominal pain. Upon arrival to trauma bay A, "TLS Protocol" was initiated.

A review of the secondary assessment notes, "Significant right face/periorbital edema and ecchymosis, sutured curved laceration from forehead to parietal scalp with underlying bogginess, crepitus and tenderness to touch, right eye swollen shut, left eye pupil 4mm and reactive, EOMI (eye movements), dried blood at nares without septal hematoma, tenderness to palpation over inferior sternum, superficial abrasions to right torso, no respiratory distress, unlabored breathing, lungs clear to auscultation bilaterally, abdomen soft, nondistended, no guarding, no peritonitis, superficial abrasions to right abdomen and flank, mildly diffusely TTP [tenderness to palpation] midline cervical and down spine, moves all extremities, compartments soft and compressible, pain to bilateral wrists without obvious deformities, alert, awake, appropriately responsive for age, GCS 15, no focal deficits .... wounds as above."

An x-ray of the pelvis on 9/6/2022 shows, "Normal exam.

A 2-view chest x-ray on 9/6/2022 shows, "Normal chest radiographs.

A CT of the maxillo-face and head was ordered and it was noted that the facility was still attempting to get outside hospital CT's sent.

The CT of the maxillofacial without contrast was later completed on 9/6/2022 and shows, "Acute fracture of the right medial orbital wall with depression of the lamina papyracea. No retrobulbar hematoma. There is focal enlargement of the right orbital medial rectus muscle. Recommend ophthalmology consultation to assess for entrapment. Incidental note is made of multiple dental caries and a periapical lucency of the right maxillary premolar tooth felt to represent a periapical abscess."

Patient #1 was admitted to the Floor. The facility will plan for tertiary survey within 24 hours and the plan of care was discussed with the pediatric surgery.

A review of the Plastic Surgery documentation revealed, "right periorbital edema and ecchymosis, EOMI (eye movements) in all directions, no entrapment, minimal pain with eye movement No double vision in any direction."

A review of the Pediatric Trauma Discharge Summary on 9/7/22 shows a "Final Diagnosis and Principal Problem: ATV accident-causing injury, initial encounter. Active Problems included scalp laceration, head injury, fracture of the lateral orbital wall on the right side for a closed fracture, and abrasions of multiple sites on the trunk.

A review of the hospital Course revealed the following:
Patient #1 presented to a children's in Houston as a code 2 trauma transfer from Woodland's hospital following an ATV accident on 9/5/2022. Upon initial evaluation at Houston, a primary survey was unremarkable, GCS 15. Secondary survey significant for repaired laceration from left medial eyebrow that extends superiorly before ending near the right parietal bone, TTP (Thrombotic thrombocytopenic purpura) and bogginess to the right scalp, TTP to the left parietal scalp, right eyelid swelling and ecchymosis, abrasions of the right chest wall and sternum, abrasions to right upper quadrant and left hip, diffuse abdominal TTP, bilateral wrist TTP, cervical and lumbar spine TTP. Outside hospital imaging was not immediately available upon arrival and family had family member bring imaging to Houston. Prior to arrival of outside hospital imaging, the following labs and imaging studies were obtained and reviewed: complete blood count, blood chemistry, AST, ALT, lipase, amylase, pro-time, partial thromboplastin time, CT of the head, CT maxillofacial, lumbar spine x-ray, bilateral wrist x-rays, left elbow x-ray, and SARS-CoV2 surveillance test. Outside hospital imaging became available 3 hours later. Pertinent findings included a left parietal scalp hematoma with scattered subcutaneous emphysema, acute fracture of the right medial orbital wall without retrobulbar hematoma, enlargement of right orbital medial rectus muscle, and a subtle grade I liver laceration. Orthopedic Surgery, Plastic Surgery and Ophthalmology were consulted. Patient #1 was admitted to the floor for further management.

On 09/07/2022 date of discharge, Patient #1 was deemed medically stable for discharge following trauma rounds and discussion with consulting services. Patient #1's condition at discharge was "good" per the providing physician's notes. Patient #1 was discharged home with his parents.

An interview with Physician #17 on 11/30/2022 at 5:00 PM confirmed that the emergency provider MD #5 on 9/05/2022 failed to complete an assessment for upper extremities, missed a right medial orbital wall fracture, and a bowing fracture of the Radius.

Based on record review and interview, the facility failed to ensure the physician documented the risks and benefits of patient transfers in writing in the signed physician certification section for 97 of 180 Memorandums of Transfer (MOTs) for the month of September 2022.

Findings include:

A review of the 180 Memorandums of Transfers (MOT) for the month of September 2022 revealed the following:

There were 165 adult (age 18 years and older) patients and 15 pediatric (under 18 years old) patients that were transferred from the facility to higher level of care. A review of the 165 Memorandums of Transfer for adult patients, 88 were missing the "Risks and Benefits" information for the physician's certification section. Also, a review 15 for Memorandums of Transfer for pediatric patients, 9 were missing the "Risks and Benefits" information for the physician's certification section.

An interview with Staff #3 and #13 on 11/30/2022 at 2:00 PM were unaware that in the Memorandums of Transfer section signed by the physician certifies that the risks and benefits of the transfer to another facility has been explained to the patient. The section was signed by the physician but the risk and benefit were left blank that explain the reason for the transfer.