HospitalInspections.org

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Based on observation, interview, and document review, the Critical Access Hospital failed to meet the requirements for the Condition of Participation for Provision of Services.

Failure to establish and implement policies and procedures for hospital services provided to all patients admitted to the hospital risks substandard and inconsistent care which can lead to negative patient outcomes.

Findings included:

1. Failure to adopt and implement policies and procedures for identifying, investigating, and reporting allegations of abuse and inappropriate use of chemical restraints.

2. Failed to ensure that staff followed the hospital's complaint and grievance policy and ensure timely complaint resolution.

3. Failure to ensure that a provider correctly ordered restraints upon application of the restraint or immediately thereafter and that restraints were reordered every 2 hours for children and youth ages 9-17.

Cross Reference: C 1006

4. Failure to ensure that staff assess and monitor vital signs and oxygen saturations following the administration of chemical restraints as required by hospital policy.

Cross Reference: C 1046

5. Failure to perform a two-person check before administering weight-based medications to pediatric patients places patients at risk for over sedation, decreased respiratory drive, and death.

6. Failure to ensure that all decisions to administer emergency antipsychotic medications to minor patients are reviewed by non-attending physicians within 24-hours.

Cross Reference: C 1049

Due to the cumulative effect of these findings, the Condition of Participation at 42 CFR 485.635 Provision of Services was NOT MET.
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Item #1 Investigation of Abuse Allegations

Based on interview and review of hospital documents the hospital failed to immediately address allegations of patient abuse by a staff member for 1 of 1 records reviewed (Patient #1).

Failure to immediately address allegations of abuse places patients at risk for serious physical and/or psychological harm.

Findings included:

1. Document review of the hospital document titled, "Protecting Patients from Abuse and Neglect Policy," no policy ID, no approved date, showed the following:

a. For allegations of patient abuse by staff, the staff member in question will be reassigned to non-patient care duties and have no contact with patients until the investigation is concluded. A representative of the organization will meet with the patient and/or family and, to the extent permitted by hospital policy and law, keep the patient informed as to the status/outcome of the investigation.

b. Any potential incident of abuse or neglect will be investigated by the organization and reported to the appropriate State authorities immediately in accordance with hospital policy. Allegations of abuse or neglect inflicted on a patient by staff are to be promptly investigated and the following completed if possible:

i. Event report created by the staff member receiving the complaint.

ii. Notification of appropriate Director(s) and Human Resources, who will interview staff.

iii. Patient Safety and Risk Mitigation Manager may assist with gathering information from the patient or eyewitnesses.

iv. Documentation that the patient was examined properly for injury and the results of the examination.

v. Steps taken to protect the patient from further abuse.

vi. Corrective action taken and documented to prevent further abuse.

vii. Notification of licensing agencies by the Director of Human Resources.

2. Review of hospital documents showed that on 07/07/22, the mother of Patient #1, a 13 year-old adolescent brought into the hospital on 05/31/22 for suicide ideation and self-harming behavior, submitted a 7-page grievance by email detailing patient care concerns, including excessive use of a chemical restraint and allegations of physical and mental abuse of Patient #1.

The email included allegations that 07/02/22 at 10:16 PM, a nurse (Staff #5) grabbed Patient #1 under the armpits, picked the patient up, forcibly dragged the patient from the bathroom to the ED treatment room, and tossed the child onto the bed. Patient #1 immediately got out of bed and began slamming their head into the wall. Staff #5 again picked up the patient and slammed the patient onto the bed, causing the child to hit their knees and face on the bed. After multiple staff members restrained Patient #1 to the bed, Staff #5 grabbed the patient's face, placing one finger against each cheekbone, his thumbs behind the ears, and the remaining fingers down toward the neck. As another nurse attempted to inform the patient of what was needed to avoid further restraint, Staff #5 stated that Patient #1 would be medicated, "no matter what." Patient #1, no longer resisting the physical hold, began to cry and informed Staff #5 that his actions were causing facial pain. Staff #5 leaned down close to Patient #1's face and replied, "good, it's supposed to hurt."

The grievance alleged that even as Patient #1 remained calm, at 10:21 PM hospital staff administered ketamine, a chemical restraint. As staff prepared the medication, the nurse was unsure of the dose, and asked the other nurses in the room if 300mg sounded right. The nurse administered the ketamine, and at 10:38 PM, Patient #1 began to have difficulty breathing. Patient #1 would not respond to sternal rubs or take deep breaths as instructed. After supplemental oxygen was applied, Patient #1's oxygen saturations increased from the 70s to her baseline in the 90s (normal 92 - 100). The family discussed the ketamine overdose with the provider, but the provider minimized the dosing error and attributed the incident to the nurse's unfamiliarity with the drug.

3. Nursing note documentation dated 07/02/22 at 10:30 PM showed that 3 staff observed Patient #1 in the bathroom, banging her head against the wall and floor. At 10:34 PM, Staff #5 documented that the patient was picked up and carried to her room where she fought with staff and attempted to bite Staff #5 and the Nursing Supervisor. Staff #5 documented that the patient was chemically sedated for her and staff safety and was resting in bed on (cardiac) monitor. At 10:43 PM, document review showed a technician entered Patient #1's room to assist with a reaction to sedation.

4. Provider note documentation dated 07/04/22 at 9:48 AM, showed the following:

a. On 07/02/22 at approximately 10:21 PM, the provider was called to evaluate Patient #1 at bedside. Patient #1 was physically restrained by staff to prevent self-harming behaviors. Patient #1 attempted to bite multiple staff members and "required her head to be held down." Shortly after the patient received an injection of (IM) ketamine, the patient's oxygen saturations dropped. The patient was repositioned, and the provider opened her airway using a jaw thrust with immediate improvement in oxygenation. An oral-pharyngeal airway was used briefly, and after the patient spat it out, she was transitioned to supplemental oxygen and continued to improve.

b. On 07/03/22 at 1:15 AM, parents requested that the provider examine Patient #1's face. Document review showed that the patient complained of facial pain and tenderness over the right cheek and minor scratches following a physical hold by staff, but the patient's face was otherwise normal, and the patient and family were advised to continue to monitor the pain and swelling.

5. On 05/04/23 between 10:00 AM and 11:55 AM, Investigators #1 and #2 interviewed the Executive Director of Quality and Compliance (Staff #1), the Executive Director of Nursing (Staff #2), and the ED Nurse Manager (Staff #3) about the hospital's abuse investigation process following the family grievance. During the interview, Staff #1 and Staff #3 confirmed that the hospital did not notify Human Resources of the abuse allegations, did not conduct staff interviews with potential witnesses or Staff #5, and failed to take steps to protect the patient from further abuse, including removing Staff #5 from patient-care duties until an investigation was performed as required by hospital policy. When asked about the ketamine administration, Staff #3 stated that staff should have entered an Event Report when the patient required assistance with her airway and oxygen after the ketamine administration, but they did not. Staff #1 and Staff #3 stated that the hospital did not follow up on the grievance regarding the inappropriate and excessive use of a chemical restraint of Patient #1 according to hospital policy.

Item #2 Grievance Resolution

Based on record review, interview, and review of hospital policies and procedures, the hospital failed to follow its policy for investigating, resolving, and responding to patient grievances for 1 of 1 documents reviewed.

Failure to promptly manage or resolve grievances or complaints can lead to poor patient outcomes and failure to meet patients' right to a timely complaint resolution.

Findings included:

1. Document review of the hospital's policy titled, "Complaints & Grievances," no policy ID, no approval date, showed the following:

a. A patient grievance is a formal or informal written or verbal complaint by a patient, family member or patient representative regarding patient care, abuse or neglect, issues related to the hospital's compliance with the Centers for Medicare and Medicaid (CMS) Conditions of Participation, and a Medicare beneficiary with specified complaints.

b. During the course of a grievance investigation, the Department Manager/Supervisor or designee is responsible for investigating, resolving, and providing written explanation (by the Patient Experience Coordinator) to the patient or representative, that the grievance was received within 7 business days. Resolution letters (by the Patient Experience Coordinator) will be sent within 45 business days from receipt of the initial grievance and will include the following:

The name of the hospital contact person
The steps taken on behalf of the individual to investigate the complaint
The date of the final investigation/review
The results of the process
The date of the completion of the complaint process

c. Regardless of the nature of the grievance, the hospital should make sure that it is responding to the substance of each grievance while identifying, investigating, and resolving any deeper, systemic problems indicated by the grievance.

2. Review of hospital documents showed that on 07/07/22, the mother of Patient #1, 13 year-old adolescent hospitalized in the emergency department (ED) between 05/31/22 and 07/12/22 for suicide ideation and self-harming behavior, emailed the hospital a 7-page grievance. The grievance included allegations of physical, verbal, and mental staff-to-patient abuse, inappropriate use of chemical restraints, failure to produce medical records, failure to provide appropriate emergency medical and mental health provider treatment, inadequate nursing care, and multiple attempts to discharge without an adequate discharge plan in place.

The review showed a grievance resolution letter dated 08/22/22 stating, "you have a right to obtain copies of your medical records at any time." The letter failed to respond to the substance of each patient care concern and abuse allegation addressed in the grievance, include any steps taken to investigate the complaint, and include the date of the final investigation/review process as required by hospital policy.

3. On 05/04/23 between 10:00 AM and 11:55 AM, Investigators #1 and #2 interviewed the Executive Director of Quality and Compliance (Staff #1), the Executive Director of Nursing (Staff #2), and the ED Nurse Manager (Staff #3) about the hospital's response to the grievance reviewed above. Staff #1 stated that the family was asked where they would like clarity, but they did not provide the hospital with any specific information. Staff #2 stated that he and Staff #3 communicated with the family daily, and any family complaints were addressed in the administrative notes. Staff #2 and Staff #3 were unable to describe any investigative processes and confirmed there were no documents showing that the department conducted any complaint reviews about the care and treatment of Patient #1. Staff #1, Staff #2, and Staff #3 confirmed the Investigators' findings that the hospital did not follow its grievance resolution process.

Item #3 Restraint Orders

Based on record review, interview, and review of hospital policy and procedures, the hospital failed to ensure that violent/self-destructive restraint orders were limited to 2 hours for children and youth ages 9 to 17 for 1 of 1 patient records reviewed (Patient #1).

Failure to ensure that violent/self-destructive restraint orders are limited to 2 hours in children and youth ages 9-17 places patients at risk for physical and psychological harm, loss of dignity, and violation of patient rights.

Findings included:

1. Document review of the hospital's policy titled, "Restraint and Seclusion" no policy ID, no approved date, showed an order for violent/self-destructive restraints is limited to 2 hours for children and youth ages 9 to 17.

2. On 05/09/23, Investigator #1, the Manager of Applications and Informatics (Staff #4), and the Emergency Department (ED) Nurse Manager (Staff #3) reviewed the medical record for Patient #1, a 13-year old ED patient treated between 05/31/22 and 07/12/22. The review showed the following restraint orders:

a. On 06/02/22 at 11:00 PM - violent restraints with 1:1 observation every 4 hours.

b. On 06/03/22 at 01:32 AM - violent restraints with 1:1 observation every 4 hours. Start at 03:00 AM.

c. On 06/03/22 at 01:32 AM - violent restraints with 1:1 observation every 4 hours. Start at 07:00 AM.

d. On 06/03/22 at 01:32 AM - violent restraints with 1:1 observation every 4 hours. Start at 11:00 AM.

e. On 06/03/22 at 01:32 AM - violent restraints with 1:1 observation every 4 hours. Start at 15:00 PM.

f. On 06/03/22 at 01:32 AM - violent restraints with 1:1 observation every 4 hours. Start at 19:00 PM.

g. On 06/03/22 at 01:32 AM - violent restraints with 1:1 observation every 4 hours. Start at 23:00 PM.

h. On 06/30/22 at 8:45 PM - violent restraints with 1:1 observation every 4 hours.

i. On 07/04/22 at 9:35 PM - violent restraints with 1:1 observation every 4 hours.

3. At the time of the review, Staff #3 and Staff #4 confirmed the investigator's findings that Patient #1's restraint orders were entered incorrectly and should have been limited to 2 hours.

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Based on record review, interview, and review of hospital policies and procedures, the hospital failed to ensure that staff members assessed and monitored patient vital signs and oxygen saturation following the administration of chemical restraint medications according to hospital policy for 2 of 2 records reviewed (Patient #1 and Patient #2).

Failure to monitor patient vital signs and oxygen saturation following the administration of chemical restraint medications places patients at risk for serious harm from medication side effects, including death.

Findings included:

1. Document review of the hospital's policy and procedure titled, "Restraint and Seclusion," no policy number, last reviewed 12/21/22, showed that patients receiving chemical restraints shall have vital signs and oxygen saturations monitored at 15 minutes, 30 minutes, and, at a minimum, every 2 hours thereafter until no longer sedated. Patients who receive chemical restraint shall have continuous cardiac and respiratory monitoring or documentation explaining why it is contraindicated.

2. Investigator #1 reviewed the medical records of 2 patients who received chemical restraints for aggressive or violent behavior in the ED. The review showed the following:

a. Patient #1 was a 13-year-old brought to the ED by ambulance on 05/31/22 for a mental health evaluation after displaying self-harming behavior and verbalizing suicide ideation. Staff administered 13 doses of chemical restraints in the ED between 06/02/22 and 07/06/22. The investigator could find no documentation that a staff member documented the patient's vital signs and oxygen saturations at 15 minutes, 30 minutes and, at a minimum every 2 hours thereafter until no longer sedated for each chemical restraint administered, as required by hospital policy.

b. Patient #2 was a 69-year-old brought to the ED by ambulance on 04/24/23 for altered mental status. On 04/25/23, Patient #2 became aggressive with staff, was restrained chemically with ketamine 100 mg at 3:24 AM, olanzapine 10mg at 4:10 AM, and olanzapine 10mg at 5:33 AM, and was placed in 4-extremity locked restraints. The investigator could find no documentation that a staff member documented the patient's vital signs and oxygen saturations at 15 minutes, 30 minutes and, at a minimum every 2 hours thereafter until no longer sedated for each chemical restraint administered, as required by hospital policy.

3. On 05/09/23 between 10:00 AM and 12:00 PM, Investigator #1 interviewed the Executive Director of Nursing Services (Staff #2), the ED Nurse Manager (Staff #3), and the Manager of Applications and Informatics (Staff #4) about the patient assessment and monitoring process. Staff #2 and Staff #3 confirmed the investigator's findings that staff did not complete vital signs and oxygen saturations according to hospital policy or document if attempts were made.
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Based on interview and review of policies and procedures, the hospital failed to ensure that nursing staff performed a two-person check when administering a weight-based medication to a pediatric patient for 1 of 1 patient records reviewed (Patient #1).

Failure to perform a two-person check before administering weight-based medications to pediatric patients places patients at risk for over sedation, decreased respiratory drive, and death.

Item #1 Weight-Based Medication

Findings included:

1. Document review of the hospital's policy titled "Pediatric Medication Administration," no policy ID, no revised dates, showed that calculations for pediatric medications that need to be calculated for the pediatric patient must be done by the provider and/or RN and double-checked by a second registered nurse (RN), provider, or pharmacist.

2. Document review of Patient #1's medical record showed that on 05/31/22, the patient was brought to the emergency department (ED) by ambulance for a mental health evaluation for performing self-harming behaviors. Nursing note documentation showed that the patient was 13 years old, stood 5 feet tall, and weighed 53 kg. The review showed that multiple ED providers ordered ketamine (an individually dosed sedative approved for general anesthesia and procedural sedation in patients 16 years and older) on multiple occasions citing "aggressive behavior" as the indication for chemical restraint. Review of provider orders and the Medication Administration Record (MAR) for 05/31/22-07/12/22, showed the following:

a. On 06/02/22 at 11:30 PM, the provider ordered ketamine 191mg IM (intramuscularly) STAT.

b. On 06/03/22 at 1:34 AM, the provider ordered Ketamine 240mg IM STAT.

c. On 06/06/22 at 11:56 PM, the provider ordered Ketamine 240mg IM STAT.

d. On 06/30/22 at 8:55 PM, the provider ordered Ketamine 240mg IM STAT.

e. On 07/02/22at 10:21 PM, the provider ordered Ketamine 300mg IM STAT.

f. On 07/04/22 at 10:11 PM, the provider ordered Ketamine 150mg IM STAT.

g. On 07/06/22 at 8:25 PM, the provider ordered Ketamine 240 mg IM STAT.

The investigator found no documentation showing how the provider determined the pediatric medication dosing and no evidence that the medication calculations were double-checked by a second RN, provider, or pharmacist prior to administration.

3. On 05/09/23 at 4:07 PM, the investigator reviewed medical records and interviewed the Executive Director of Quality and Compliance (Staff #1), the Executive Director of Nursing Services (Staff #2), and the Emergency Department Nurse Manager (Staff #3). During the interview, Staff #3 stated that that the hospital does not have a specific policy for ketamine administration. Staff #3 stated that ketamine is considered a high-risk medication, and staff should be performing a double-check when administering the medication. Staff #3 confirmed the investigator's findings of the missing documentation of medication dosing calculations and staff-double checks.

Item #2 Non-Attending Physician Review

Based on interview and review of policies and procedures, the hospital failed to ensure that all emergency antipsychotic medications administered to minor patients were reviewed by a non-attending physician within 24-hours for 1 of 1 patient records reviewed (Patient #1).

Failure to ensure that all emergency antipsychotic medications administered to minor patients were reviewed by a non-attending physician within 24-hours places patients at risk for physical and psychological harm, loss of dignity, and violation of patient rights.

Findings included:

1. Document review of the hospital's policy titled, "Rights of Minor Patients" no policy ID, no approved date, showed that minors boarding in the emergency department (ED) and awaiting placement in an approved treatment facility have the right not to consent to the administration of antipsychotic medications. Antipsychotic medications may be administered without consent when an emergency exists, provided there is a review of this decision by a non-attending physician within 24 hours.

2. Document review of Patient #1's medical record showed that on 05/31/22, the patient was brought to the emergency department (ED) by ambulance for a mental health evaluation for performing self-harming behaviors. Nursing note documentation showed that the patient was 13 years old, stood 5 feet tall, and weighed 53 kg. The review showed that multiple ED providers ordered ketamine (an individually dosed sedative approved for general anesthesia and procedural sedation in patients 16 years and older) on multiple occasions citing "aggressive behavior" as the indication for chemical restraint. Review of provider orders and the Medication Administration Record (MAR) for 05/31/22-07/12/22, showed the following:

a. On 06/02/22 at 11:30 PM, the provider ordered ketamine 191mg IM (intramuscularly) STAT, , and the medication was administered by nursing staff. The investigator found no documentation showing that a second, non-attending provider completed a review of the ordering provider's decision for the use of a chemical restraint.

b. On 06/03/22 at 1:34 AM, the provider ordered ketamine 240mg IM STAT, and the medication was administered by nursing staff. The investigator found no documentation showing that a second, non-attending provider completed a review of the ordering provider's decision for the use of a chemical restraint.

c. On 06/06/22 at 10:56 PM, the provider ordered ketamine 240mg IM STAT, and the medication was administered by nursing staff. The investigator found no documentation showing that a second, non-attending provider completed a review of the ordering provider's decision for the use of a chemical restraint.

d. On 06/18/22 at 8:16 PM, the provider ordered olanzapine 10 mg IM STAT, and the medication was administered by nursing staff. The investigator found no documentation showing that a second, non-attending provider completed a review of the ordering provider's decision for the use of a chemical restraint.

e. On 06/23/22 at 10:30 PM, the provider ordered olanzapine 10 mg IM STAT, and the medication was administered by nursing staff. The investigator found no documentation showing that a second, non-attending provider completed a review of the ordering provider's decision for the use of a chemical restraint.

f. On 06/25/22 at 9:00 PM, the provider ordered olanzapine 10 mg IM STAT, and the medication was administered by nursing staff. The investigator found no documentation showing that a second, non-attending provider completed a review of the ordering provider's decision for the use of a chemical restraint.

g. On 06/30/22 at 8:43 PM, the provider ordered olanzapine 10MG IM STAT, and at 8:55 PM, the provider ordered ketamine 240mg IM STAT. Both medications were administered by nursing staff as ordered. The investigator found no documentation showing that a second, non-attending provider completed a review of the ordering provider's decision for the use of chemical restraints.

h. On 07/02/22 at 10:21 PM, the provider ordered ketamine 300mg IM STAT, and the medication was administered by nursing staff. The investigator found no documentation showing that a second, non-attending provider completed a review of the ordering provider's decision for the use of a chemical restraint.

i. On 07/04/22 at 9:37 PM, the provider ordered olanzapine 5MG IM STAT, and at 10:11 PM, the provider ordered ketamine 240mg IM STAT. Both medications were administered by nursing staff as ordered. The investigator found no documentation showing that a second, non-attending provider completed a review of the ordering provider's decision for the use of chemical restraints.

j. On 07/06/22 at 8:25 PM, the provider ordered ketamine 240 mg IM STAT, and the medication was administered by nursing staff. The investigator found no documentation showing that a second, non-attending provider completed a review of the ordering provider's decision for the use of a chemical restraint.

3. On 05/04/23 at 4:00 PM, Investigator #1 interviewed the Executive Director of Quality and Compliance (Staff #1), the Executive Director of Nursing Services (Staff #2), and the ED Nurse Manager (Staff #3). Staff #1, Staff #2, and Staff #3 confirmed the Investigator's findings that a non-attending provider failed to review the ED providers' decisions to order the medications to chemically restrain Patient #1.
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