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Based on observation, interview, record review, review of the Malignant Hyperthermia Association of the United States (MHAUS), review of the United States Pharmacopeia (USP) Chapter 797, and policy review, the hospital failed to ensure the required life-saving medication was readily accessible when administering Malignant Hyperthermia triggering medications.

Due to the potential risk and harm to all patients this resulted in the non-compliance with
§42 CFR 482.25 Condition of Participation: Pharmaceutical Services.

Please refer to A-500 for further details


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Based on observation, record review, interview and policy review, the hospital failed to:
- Verify two patient identifiers for medication administration for four patients (#9, #20, #23 and #53) of 11 reviewed;
- Provide appropriate bathing and repositioning for five patients, (#8, #9, #14, #15, and #23) out of 12 reviewed;
- Perform appropriate glove changes and hand hygiene when administering care to six patients (#6, #20, #23, #25, #34 and #35) of 22 reviewed; and
- Perform an appropriate dressing change for one patient (#23) of 8 reviewed.

These failures had the potential to lead to poor outcomes, increased risk of infection, impaired skin integrity, and overall increased risk of health status deterioration for every patient admitted to the hospital.

Review of the hospital's policy titled, "Two Patient Identifiers," dated 06/2022, showed Kindred hospitals and staff will utilize a standardized patient identification process to include the use of at least two patient identifiers to verify patient identity prior to administering medications, collecting blood samples and other specimens, clinical testing, providing treatments or procedures and at any other time as needed. A patient room number and/or location shall not be used as an identifier. Hospital specific identifiers recommended include the patient's full name and date of birth. The patient identification bracelet shall be utilized for patient identification.

Review of the hospital's policy titled, "Routine Bathing," dated 06/2023, showed the patient's mental status, mobility, level of cooperation, physical health, and bathing preferences are to be considered when preparing a patient for bathing. Standard precautions (also known as universal precautions, avoiding contact with patients' bodily fluids by means of wearing gloves, goggles and face shields) are to be followed during bathing unless the patient is on isolation. Pre-moistened disposable cloths that contain a no-rinse surfactant are used for daily bathing. The frequency of bathing is dependent on the patient's hemodynamic status, therapy schedule, preference, incontinence (inability to control urination or bowel movements) needs, and body odor.

Review of the hospital's policy titled, "Indwelling Urinary Catheter (a small flexible tube inserted into the bladder to provide continuous urinary drainage) Standards and Practice," dated 06/2022, showed hand hygiene should be done immediately before and after any manipulation of the catheter site or apparatus. The staff should maintain a sterile, continuously closed drainage system. Change gloves and practice good hand hygiene when emptying each patient's drainage system. Catheter care includes gently cleaning of the perineal area with soap and water or general bathing cloth at least once a shift.

Review of the hospital's policy titled "Clinical Guidelines for Pressure Injury," dated 06/2022, showed the following guidelines to prevent and treat pressure injuries (injury to the skin and/or underlying tissue, usually over a bony area):
- The skin and wound assessment is conducted per the RN on admission and each shift, including the day of discharge.
- All patients are considered at risk for pressure injuries. Therefore, patients are routinely screened to determine their Braden Scale (an assessment tool for predicting the risk of bed sores or pressure ulcers) risk level on admission and daily.
- Standard interventions for all patients can include, but are not limited to, a support surface, skin and wound assessments, repositioning orders (minimum turns every two hours), wound and nutritional consults, decrease or elimination of friction and shear (injury to the skin caused by friction) forces and incontinence management.
- Standard interventions also include the consideration of turning the patient every hour if the patient is unable to reposition themselves, has poor nutrition, multiple wounds, a recent change of condition (acute decline in hemodynamics), poor cognition, their skin is moist or at high risk for friction/shear injury.
- Based on the Braden Scale risk score and individual subscales, additional interventions may be required. Additional interventions for may include repositioning devices, active therapy support surfaces, preventative dressings, and heel offloading (relieve from pressure) devices. All devices are to be removed each shift to inspect the skin.
- The frequency of wound dressing changes depends upon various clinical indicators including, but not limited to, physician orders, dressing integrity, skin integrity (refers to skin health, to be free of wounds or irritation) and incontinence.

Observation on 11/13/24 at 2:38 PM, showed Staff H, Licensed Practical Nurse (LPN), contaminated Patient #6's drawer handle with a used glove during a wound dressing change.

Observation with concurrent interview on 11/13/24 at 9:10 AM, showed Patient #8's room had suction tubing, which was previously connected to the patient's external urinary draining device, lying on the floor. The tubing was connected to a suction canister that contained urine. She reported that she had only been bathed twice since she was admitted on 10/15/24.

During an interview on 11/13/24 at 9:50 AM, Patient #9 stated that:
- She was bathed that morning, but it had been four days since her last bath.
- Urinary catheter care was only completed when she was bathed.
- When she was bathed that morning, the towel used to clean between her legs looked like it was covered in mud.
- When medications were administered, the nurses did not verify her identity or verify that she received the correct medications.

Observation on 11/13/24 at 11:00 AM, showed Patient #9's bathroom contained heavily soiled towels that were used to bathe her.

During an interview on 11/13/24 at 11:15, Staff L, CNA, stated that Patient #9 was dirty and soiled before she bathed her.

Review of Patient #14's medical record dated 03/19/24 through 03/25/24, showed a bed bath and linen change were only completed twice, on 03/19/24 and 03/21/24, during her six-day hospitalization.

Review of Patient #15's medical record showed he was not repositioned every two hours as required by hospital policy. He acquired multiple pressure injury wounds during his admission.

Observation on 11/13/24 at 8:40 AM, showed Staff N, RN, enter Patient #20's room for a medication pass. The patient was given medications via percutaneous endoscopic gastrostomy (PEG, a tube inserted through a person's abdomen directly into the stomach to provide a means of feeding when oral intake is not possible) tube, one intravenous (IV, in the vein) medication, eye drops, and prescription powder to the patient's peri-area. Staff N failed to verify two patient identifiers. She did not change her gloves at any time and she did not pull a curtain, or close the door, to protect the patient's privacy when her peri-area was exposed.

Observation on 11/13/24 at 10:15 AM, showed Staff N, RN, enter Patient #23's room for medication administration. The patient was on contact precautions (precautions used to minimize the risk of infection spreading through touching an infected person or contaminated object). He was given four medications via PEG tube. Staff N did not change gloves in between documenting on the computer and administering the medications. She spoke to the patient by name, however, she did not verify his birth date or look at his ID bracelet. The patient's foley catheter drainage line popped loose from the catheter. She replaced the foley line and drainage bag, placing the old line and drainage bag containing urine in the trash can.

Observation on 11/13/24 at 3:44 PM, showed Staff N, RN, and Staff S, Certified Nursing Assistant (CNA), performed a dressing change on Patient #23's right upper leg and buttocks area. The wound was cleansed and wet gauze was applied to the wound. Staff N placed three padded dressings over the gauze. She dropped the second padded dressing onto a pile of soiled dressings on the bed, picked it back up and placed it on the wound. No glove changes were observed between removing the soiled dressing and applying new dressings. The patient had a foul body odor although hygiene had been documented.

Observation on 11/13/24 at 11:08 AM, showed Staff Q, RN, prepared for a procedure on a dirty bedside table for Patient #25. She placed a glucometer (used to measure the amount of glucose [sugar] in blood at patient bedside) on the patient's bedside table that had pooled and dried spills on the surface, without cleaning the surface. She touched multiple surfaces with gloves used during the procedure, she did not change gloves or perform hand hygiene.

Observation on 11/13/24, at 9:55AM, Staff Y, Wound Care RN, performed hand hygiene, applied gloves, and then proceeded to touch multiple surfaces in the patient's room such as the bed and bedding, tray side table, IV poles and assisted the patient to change positions. Staff Y did not change gloves or perform hand hygiene prior to performing wound care on Patient #34.

Observation on 11/13/24 at 10:22 AM, showed Staff JJ, RN, failed to perform hand hygiene prior to applying and after removing gloves when she provided care to Patient #35.

During an interview on 11/13/24 at 2:41 PM, Patient #53 stated that she didn't understand why Staff P, RN, was verifying her name and date of birth for her medication administration while observed by a surveyor. She stated that the staff never did that and wondered why it was happening that day. She also questioned why her room was being mopped that day when that rarely happened.





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Based on observation, interview, record review, review of the Malignant Hyperthermia Association of the United States (MHAUS) guidelines and policy review, the hospital failed to ensure the required life-saving antidote medication and additional emergency supplies per MHAUS guidelines were readily available and accessible to staff when succinylcholine (a muscle relaxant/paralytic used with anesthesia during intubation [a process where a healthcare provider inserts a tube through a person's mouth or nose down into their windpipe when a person is not breathing on their own], mechanical ventilation, and surgery) was administered during a bedside tracheostomy (an opening created in the neck in order to place a tube into a person's windpipe that allows air to enter the lungs) placement for one current patient (Patient #19). This failure had the likelihood of potential negative outcome resulting is serious harm or death due to the unavailability of the antidote and recommended supplies.

Findings included:

Review of the hospital's policy "Neuromuscular Blocking Agents (NMBA)," dated 06/2022, showed, when NMBA were available to be administered, the hospital must be aware of and be prepared to treat MH.

Review of, "MHAUS guidelines," dated 2016, showed to ensure that malignant hyperthermia (MH) deaths become a "never event," an adequate supply of dantrolene (a muscle relaxant used to treat malignant hyperthermia) should be available when an NMBA, such as succinylcholine, are administered. The minimum dantrolene dose of 10mg per kilogram (kg) of patient weight should be immediately available (within 10 minutes). There is a direct correlation between the length of time it takes to administer dantrolene and subsequent patient outcomes related to MH.

Review of the hospital's online procedure, "MH," dated 06/2022, showed there must be an internal communication plan for response to MH. A MH crisis box (containing medications, supplies, cooling equipment, monitoring equipment and laboratory testing supplies) must be appropriately stocked and readily available.

Review of the hospital's document, "Drug Usage Report for Succinylcholine," dated 08/01/23 through 11/22/24, showed succinylcholine was administered once. On 10/23/24 at 6:30 AM, Patient #19 received succinylcholine 80 mg intravenous (IV, in the vein).

Observation with concurrent interview on 11/19/24 at 8:50 AM, in the High Acuity Unit (HAU) with Staff QQ, Pharmacist, showed there was no dantrolene available to be administered if MH occurred after the use of succinylcholine. Staff QQ stated that succinylcholine was rarely used at the hospital and only used in small doses. Therefore, dantrolene was not needed and was not stocked. A patient would be transferred to an acute care hospital after succinylcholine was used for intubation.

During an interview on 11/12/24 at 3:20 PM, Staff E, House Supervisor, stated the hospital has had to use succinylcholine during intubation, in the past. She had not received any education on rapid sequence intubation (RSI, an airway management technique where administering anesthesia medications induces immediate unresponsiveness and muscle relaxation for the purpose of controlling an emergency airway) for the treatment of MH and was not aware of any education provided to the nursing staff. The nurses were required to complete Advance Cardiac Life Support (ACLS, specific life saving measures taken by certified health professionals when a patient's heartbeat or breathing stops). The hospital does not perform surgery or employ any anesthesia staff.



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