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Tag No.: A0466
Based on interview and record review, the facility failed to properly obtain informed consent for a procedure for 1 (#2) of 12 sampled patients. This deficient practice had the potential to affect all patients requiring informed consent for procedures. Findings include:
Review of patient #2's electronic medical record showed patient #2 was brought to the facility via ambulance after being found down, and unresponsive at home. After being assessed in the ED (emergency department), patient #2 was found to have a Glasgow Coma Scale score of 6 (moderate to severe level of impairment in a patient's neurological function) and was intubated. Patient #2 was admitted to the ICU (intensive care unit) on 5/29/25 in diabetic ketoacidosis with a coma and probable aspiration. After medical management in the ICU, patient # 2 was extubated and downgraded to a lower level of care. On 6/7/25, patient #2 developed altered mental status and declined, requiring reintubation and transfer back to the ICU. An MRI (magnetic resonance image) of the brain was completed on 6/7/25 and showed, "No evidence of hemorrhage, acute infarction, mass or pathologic enhancement. General cerebral volume loss."
Review of a procedure note dated 6/8/25 at 9:34 am, showed: "Lumbar puncture.
-consent obtained: Verbal
-consent given by: [Family Member] via phone" ...
Review of patient #2's electronic medical record showed there was no consent form on file, signed by the physician or nursing staff.
During an interview on 8/13/25 at 1:45 p.m., staff member A stated if a procedure was needed for a patient, the provider would place an order in the patient's medical record. Staff member A stated the provider is the one who goes over the risks and benefits with the patient or the patient's representative. Staff member A stated verbal consent can be received for procedures, but the process required two signatures on the form to verify that the risks and benefits were discussed prior to the procedure. Staff member A stated the expectation was for the policy to be followed in obtaining informed consent.
Review of a facility policy titled, "Informed Consent," with an approved date of 9/2024, showed:
" ... I. Provider:
... B. Obtains informed consent according to Medical Staff Rules and Regulations Section A: Surgery and Procedures: Article v, and documents in the patient's chart ...
II. Nurse or Respective Department Personnel
A. Completes the information required on the Authorization for Surgery or Special Procedures form.
B. Witnesses the patient's or next of kin/legal representative's signature ...
... 2. In the event the patient is unable to give consent and the legal representative or next of kin is not immediately available, consent may be received via phone with a second witness verifying their agreement."
Review of a Facility document titled, "Medical Staff Rules and Regulations, showed:
" ... 5. Informed consent: There shall be documentation within the medical record that the Hospital's policy pertaining to informed consent has been followed by documenting the process."
Tag No.: A0749
Based on observation, interview, and record review, the facility failed to adhere to infection prevention standards by not performing proper hand hygiene; not donning gloves prior to performing patient care or doffing gloves after performing patient care going from a dirty area to a clean area, for 2 (#s 6 and 11); and failed to clean medical equipment prior to entering or exiting a patient room for 2 (#'s 6 and 9) of 12 sampled patients. This deficient practice had the potential to affect all patients receiving care in the facility. Findings include:
1. Review of patient #11's electronic medical record showed, patient #11 was admitted to the facility on 7/29/25 with diagnoses of acute respiratory failure, acute on chronic encephalopathy, and hyponatremia. Patient #11 required admission to the ICU (intensive care unit) and mechanical ventilation. A bronchoscopy was completed, and on 8/6/25 it was determined patient #11 had acquired MSSA (Methicillin Susceptible Staphylococcus Aureus) from ventilator use.
During an observation and interview on 8/12/25 at 8:40 a.m., patient #11 was lying in bed. Patient #11 was attached to a mechanical ventilator, had an indwelling foley catheter, a nasogastric tube, and an intravenous line with multiple secondary lines inserted in the left antecubital area. Patient #11 appeared agitated and restless. Staff member K stated patient #11 was agitated because she had tried to wean patient #11 off the mechanical ventilator and patient #11 had become tachycardic and could not maintain respirations on her own. Staff member K stated patient #11 had failed the trial.
During an observation on 8/12/25 at 8:45 a.m., staff member K doffed a pair of gloves and walked over to the computer located next to patient #11's bed and began to document in patient #11's chart. At 8:47 a.m., staff member K turned away from the computer and walked over to the right side of patient #11's bed. Staff member K leaned over the rail of the bed and touched the mechanical ventilator tubing, which was close to patient #11's mouth, with her hands. No hand hygiene was performed after touching the computer or prior to touching the mechanical ventilator tubing, and staff member K did not don a pair of gloves prior to touching the mechanical ventilator tubing. At 8:49 a.m., staff member K walked back to the computer located at the bedside of patient #11 and began to document. No hand hygiene was performed. At 8:52 a.m., staff member K stopped documenting, walked about ten feet, and grabbed a pair of gloves from the container on the wall. Staff member K donned the gloves. No hand hygiene was performed prior to donning the gloves. Staff member K walked back to the right side of patient #11's bed and began to touch the mechanical ventilator tubing again. Staff member K stated, "I was just checking the placement of the endotracheal tube by looking at the centimeters."
During an interview on 8/12/25 at 8:56 a.m., staff member K stated, "Hands should be sanitized or washed with soap and water before and after patient care is performed, and before and after donning and doffing gloves. Staff member K stated she had been educated on infection prevention policies, including hand hygiene and donning and doffing gloves. Staff member K stated, "I should not have touched the ventilator tubing without doing hand hygiene or wearing gloves." Staff member K stated she understood how not performing hand hygiene and touching the mechanical ventilator without gloves could increase the risk of infection.
2. Review of patient # 6's electronic medical record showed he was admitted to the facility on 8/8/25 with diagnoses of exacerbation of congestive heart failure, atrial fibrillation, and rheumatoid arthritis. On 8/10/25, two days after admission, patient #6 was transferred to the ICU with a new diagnosis of metabolic encephalopathy (a condition where brain function is impaired due to a chemical or metabolic imbalance in the body) and was placed on mechanical ventilation.
During an observation on 8/12/25 at 9:06 a.m., patient #6 was lying in bed. Patient # 6 had an indwelling foley catheter, a nasogastric tube hooked up to suction, was on a mechanical ventilator, and had an intravenous line in the left antecubital area, with multiple secondary lines attached.
During an observation and interview on 8/12/25 at 9:10 a.m., staff member L was standing at a computer located next to the right side of patient #6's bed, and had documented a conversation with NF1, who was present in patient #6's room. Staff member L stated she was getting ready to do her nursing assessment and provide care to patient #6. Staff member L donned a pair of gloves. No hand hygiene was completed after touching the computer or before donning gloves. Staff member L walked over to the right side of patient #6's bed and placed her gloved hands on the side rail of the bed. As staff member L was standing next to the right side of patient #6's bed, she dropped a piece of paper on the floor. Staff member L stepped back from the bed, bent over, touched the floor with her glove, picked up the piece of paper, placed it back into the pocket of her scrub top, and placed her hands back on the side rail of the bed. Staff member L did not doff her gloves or perform hand hygiene after the gloves became contaminated. At 9:13 a.m., staff member L reached into the pocket of her scrub top and grabbed the Rover (handheld device) used for charting and documentation. Staff member L turned on the flashlight on the device and proceeded to do a neurological exam on patient #6. Staff member L completed the neurological exam with the handheld device and placed it back into her pocket. Staff member L did not clean the device prior to use or after use. Staff member L did not perform hand hygiene or doff her gloves after using the unclean, handheld device. Staff member L walked over to patient #6's intravenous lines and touched the intravenous access area near the left antecubital site. No hand hygiene or clean gloves were used prior to touching the intravenous lines. Staff member L then touched the nasogastric tube and unhooked it from suction. Staff member L placed her gloved thumb over the end of the suction tube, checked the suction, and then reconnected the suction tube to the nasogastric tube. The suction tube was not cleaned prior to reattaching it to the nasogastric tube. Gloves were not doffed, and no hand hygiene was completed after touching the end of the suction tube. With the same dirty gloves, staff member L began to touch patient #6's arms, hands, legs, and feet to check for edema. Staff member L picked up the indwelling foley catheter tubing to assess patency. Staff member L put the indwelling catheter tubing down and touched the dorsal aspect of patient #6's right foot to check for a pedal pulse. Gloves were not doffed when going from a dirty area to a clean area, and hand hygiene was not performed. Staff member L doffed her gloves, walked over to the computer at the right side of patient #6's bed, and began to document. No hand hygiene was completed after doffing her gloves or prior to touching the computer. At 9:24 a.m., staff member L left patient #6's room. No hand hygiene was completed.
During an interview on 8/12/25 at 9:25 a.m., staff member L stated hand hygiene was to be completed prior to entering and exiting a patient room, before and after touching a patient, and when going from a dirty area to a clean area. Staff member L stated, "I am just so used to touching the patient all the time for assessments and to provide care, that I did not pay attention to hand hygiene or putting on clean gloves, and I did not think about cleaning the Rover (handheld device)." Staff member L stated she had been educated on infection prevention practices, hand hygiene, and donning and doffing personal protective equipment.
3. Review of patient #9's electronic medical record showed she was admitted to the facility on 8/10/25 with pyelonephritis and a possible small bowel obstruction.
During an observation and interview on 8/12/25 at 9:40 a.m., staff member N was in the medication room with staff member M. Staff member N took the Rover (handheld charting device) out of her pocket and placed it on the counter near a sink and walked over to the medication dispensing system and pulled up patient #9's physician orders. Staff member N reviewed patient #9's medication orders and pulled out five milligrams of baclofen and a vial of fentanyl. Staff member N stated she was going to give 50 micrograms of fentanyl and waste the remainder with staff member M. At 9:43 a.m., staff member N picked up the Rover (handheld device) and placed it in the front pocket of her scrub top. Staff member N walked down the hallway to patient #9's room and entered the room. No hand hygiene was completed prior to entering patient #9's room. Staff member N reached into her front scrub pocket and took out the Rover and placed it on a shelf near patient #9's bed. The Rover was not cleaned after being removed from staff member N's pocket. Staff member N donned a pair of gloves. No hand hygiene was performed prior to donning gloves. Staff member N picked up the Rover with her gloved hands and picked up patient #9's left hand and scanned her identification bracelet. Staff member N placed the Rover on the shelf. Staff member N did not doff her gloves or perform hand hygiene after touching the dirty Rover. Staff member N took an alcohol wipe from her front scrub pocket, opened the alcohol wipe, and cleaned patient #9's intravenous port. Clean gloves were not donned, and hand hygiene was not completed prior to touching patient #9's intravenous port. Staff member N administered five milliliters of normal saline through the intravenous line, picked up the syringe of 50 micrograms of fentanyl, administered the fentanyl over two to three minutes, and flushed the intravenous line with the remaining five milliliters of normal saline. Staff member N doffed her gloves, picked up the Rover, and left the room. No hand hygiene was completed after doffing her gloves, picking up the dirty Rover, or upon exiting patient #9's room. Staff member N did not clean the Rover after leaving patient #9's room and placed the Rover in her pocket.
During an interview on 8/12/25 at 8:48 a.m., staff member N stated she had been educated on infection prevention practices, but did not recall ever having education on cleaning the Rover after its use.
During an interview on 8/13/25 at 10:00 a.m., staff members C and Q stated all staff were educated on infection prevention, including hand hygiene, donning and doffing personal protective equipment, and cleaning medical devices. Staff member Q stated when she performs infection prevention audits, she utilized the "in the moment teaching," but did not document any of the findings as she found them to be punitive. Staff member Q stated she had not completed any recent education on infection prevention with staff. Staff member Q stated equipment that entered patient rooms was required to be cleaned prior to and after use, and the Rover was to be cleaned with purple-topped sani-wipes. Staff members C and Q stated if staff had any questions about infection prevention, they should look at the facility policies. Staff members C and Q stated infection prevention education was completed upon hire and with mandatory annual education.
Review of a facility policy titled, "Hand Hygiene," with an effective date of 6/2025, showed:
... "Hand hygiene is expected of all employees before and after all patient/resident contacts, after glove use, before any clean or sterile procedure ... when hands are visibly soiled ... Staff education is provided during new employee orientation and annually regarding proper hand hygiene techniques.
Procedure:
... D. Decontaminate hands with alcohol based waterless antiseptic agent or with soap and water if intolerant of alcohol-based product:
1. Before having direct contact with patients
2. After contact with a patient's intact skin (as in taking a pulse or blood pressure ...)
3. After removing gloves
4. After contact with body fluids or excretions, mucous membranes, non-intact skin ...
5. When moving from a contaminated body site to a clean body site during patient care.
6. After contact with inanimate objects (including medical equipment) in the immediate vicinity of the patient.
7. Before preparing/administering medications, manipulating IV's or other equipment.
VI. Other aspects of Hand Hygiene
... E. Change gloves during patient care if moving from a contaminated body site to a clean body site.
Review of a facility policy titled, "Infection Prevention and Control Plan," with an effective date of 6/2025, showed:
... "XIII. Employees-Are responsible for complying with corporate and department specific infection prevention policies and attending infection prevention education programs ..." [sic]
Review of a facility document titled, "Learner Transcript," showed, staff member K completed the mandatory annual education, which included infection prevention, on 6/24/25. Staff member L completed the mandatory annual education, which included infection prevention, on 7/29/25. Staff member N completed the mandatory annual education, which included infection prevention, on 7/29/25.
Review of a facility policy titled, "Guidelines for Isolation Precautions," with an effective date of 1/2025, showed:
... "D. Patient Care Equipment
1. Reusable equipment is not used for the care of another patient/resident until cleaned and appropriately reprocessed.
2. Reusable equipment must be cleaned before and after each encounter with a patient/resident."
Review of an email provided by the facility, sent by staff member Q on 5/21/25, showed:
... "The purple wipes will now be outside of patient rooms to clean equipment and surfaces ..."
Review of a facility document titled, "NPC Notes," dated 1/21/25, showed:
... "Rovers can be cleaned with purple wipes."