HospitalInspections.org

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Based on observation, interview, and document review, the hospital failed to protect and promote patients' rights related to care in a safe setting.

Failure to protect and promote each patient's rights by providing for care in a safe setting risked patient harm.

Findings included:

1. Failure to ensure the implementation of a process to provide prompt resolutions of patient grievances.

Cross Reference: A0118

2. Failure to ensure that once the patient grievances are resolved, the hospital provides the patient with a written notice of its decision and steps taken during the investigation.

Cross Reference: A0123

3. Failure to ensure the development and implementation of policies and procedures for the administration of emergency medications, when used as chemical restraints during emergency crises.

Cross Reference: A0167

4. Failed to ensure that orders for emergency medications, when used as chemical restraints, were never written on an as needed basis (PRN),

Cross Reference: A0169

5. Failed to ensure patients were monitored after receiving a chemical restraint.

Cross Reference: A0175

6. Failure to develop and implement an effective system to ensure that all patients placed in physical/chemical restraints or seclusion receive one-hour face-to-face evaluations by a physician or qualified trained registered nurse (RN).

Cross Reference: A0179

7. Failure to develop and implement an effective system to ensure that when the one-hour face-to-face evaluation is performed by a qualified trained RN, the RN consults with the physician who is responsible for the care of the patient as soon as possible after the evaluation.

Cross Reference: A0182

Due to the severity of deficiency under 42 CFR 482.13, the Condition of Participation for Patient Rights was NOT MET.

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Based on interviews, document review, and review of the policies and procedures, the hospital failed to ensure that staff implemented the complaint and grievance policy to establish a mechanism to receive, investigate, review, process, and provide prompt resolutions of patient grievances.

Failure to follow the hospital's policy and procedure implementing a grievance reporting and investigation process violates patient rights and puts the patient at risk for harm or abuse from unresolved concerns.

Findings included:

1. Document review of the hospital's policy and procedure titled, "General Grievances and Patient Advocacy (Inpatient (IP), Partial Hospitalization Program (PHP), and Intensive Outpatient (IOP)," policy number 14962780, last revised 01/24, showed the following:

a. The purpose of the policy is to establish a mechanism by which to impartially receive, investigate, review, and process patient complaints, patient grievances, and/or any issues regarding Patient Rights.

b. A patient complaint is a verbal complaint regarding patient care and/or services that can be resolved at the point of service/contact by staff present. Typically, minor issues, such as but not limited to housekeeping or food preferences, do not require an investigation, or involve a restriction of the patient's rights.

c. A patient grievance is a formal or informal written or verbal complaint that is made by the patient, or the patient's representative, regarding the patient's care (when a verbal complaint about a patient's care is not resolved at the time of the complaint by staff present), abuse or neglect, issues related to the hospital's compliance with the Centers for Medicare and Medicaid Services (CMS) Hospital Conditions of Participation (CoP), or a Medicaid beneficiary billing complaint related to rights and limitations provided by 42 CFR § 489.

d. The Patient Advocate is the designee who is available to assist in hearing, investigating, and resolving patient complaints and/or patient grievances. The Patient Advocate's role is to monitor the protection of patient rights or to act as an individual advocate on behalf of a particular patient in the facility. The Patient Advocacy Program is available 24 hours a day, 7 days a week. The Patient Advocate will be appropriately trained and knowledgeable in the fundamental, civil, constitutional, and statutory rights of psychiatric patients.

e. When a patient complaint is received, any staff will attempt to resolve it within their scope and authority. Information regarding the complaint and the resolution must be forwarded to the Patient Advocate for tracking purposes.

f. When a patient grievance is received, the Patient Advocate or Patient Advocate Designee will do the following:

i. Acknowledge receipt of the patient grievance within 24 business hours.

ii. Provide the patient, family member, or patient representative with the opportunity to voice their concerns.

ii. Investigate the identified patient grievance and determine the resolution within 7 business days. If unable to complete within 7 business days, the patient, family member, or representative will be notified in writing that the investigation is ongoing.

iii. The Patient Advocate will notify the patient, family members, or patient representative of the results in writing.

g. A log of all documentation of all patient complaints, patient grievances, and patient communications regarding the complaint or grievance will be maintained by the Patient Advocate in a centralized file, with oversight by the facility Director of Quality and Risk.

2. On 02/02/24, Investigator #15 requested a list of patient grievances for the last two months, December 2023 and January 2024. On 02/05/24 at 4:07 PM, the Investigator received email correspondence from the Chief Executive Officer (Staff #1503) stating that the hospital did not have any grievances on record for the months of December 2023 and January 2024.

3. On 02/06/24, Investigator #15 requested a list of patient grievances for the last six months, from July of 2023 to January of 2024. On 02/08/24 the interim Director of Quality/Human Resource Business Partner (Staff #1507) provided the Investigator with a list of patient grievances and complaints between 07/07/23 to 11/07/23. The grievance list included the date reported, the involved party, a description of the incident/complaint, the actions taken, the date of the communication to the patient, the method of communication (written or verbal), and categorization of the grievance type (such as patient rights or quality). Investigator #15 noted discrepancies in the documented dates for the communication to the patients. These dates were documented between 2021 and 2022, not 2023 when the complaints were initiated.

4. On 02/02/24 at 1:15 PM, during an interview with Investigator #15, Staff #1507 stated that the grievances were sent to the corporate office. Some are handled locally by the Patient Advocate who responds to the grievance, determines the level of severity, and tracks the hospital's response. The grievances are reported to the hospital's Quality committee, which meets monthly. Staff #1507 verified that there was no job description created or individualized training for the position of Patient Advocate.

5. On 02/07/24 at 11:52 AM, during an interview with Investigator #15 and Investigator #7, the Patient Advocate (Staff #1508) reported that she had been in the position for approximately 2 months. Staff #1508 stated that the training for the position was minimal. The Patient Advocate stated that since she had worked for the hospital for a year and a half in different roles, she already knew what the Patient Advocate did, and the role was straightforward and simple. She was told where to find the forms required to perform her role, such as the Patient Advocate Report Form. Staff #1508 shared the log that she created to track all incoming grievances and complaints. The log contained three columns, the date/time of the complaint/grievance, a summary of the complaint/grievance, and the actions taken by the Patient Advocate, including referral to another person or discipline within the hospital. If complaints come in from the corporate office, they are referred to the Patient Advocate. Staff #1508 stated she works with the Director of Quality (Staff #1507) and the CEO (Staff #1503) when they receive complaints sent directly to leadership. Staff #1508 stated that she was not asked to share the grievance log with the CEO, Quality Committee, or the Governing Board. She stated that she will often include the hospital leadership in communications regarding a specific complaint or grievance when indicated. The Patient Advocate noted that she was aware of the time frame requirements of responding to the complainant within 24 hours and resolution within 7 days. The grievance log contains documentation of when she talks to the patient or family member. The communication is usually verbal, and not written. If an investigation is required, the outcome or resolution is sometimes made verbally or noted on the Patient Advocate Report Form. In some cases, Staff #1508 sends the form to the complainant. In reviewing the grievance log for December 2023 and January 2024, Staff #1508 stated that there were approximately 200 incoming complaints or grievances logged. The Patient Advocate stated that not all the complaints received were grievances, maybe 50% or less of them were. Staff #1508 was not aware that the CEO had reported to the Investigator that there were no grievances for December 2023 and January 2024.

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Based on interviews, document review, and review of the policies and procedures, the hospital failed to ensure that staff followed the grievance policy by providing patients, family members, or the patient representative, a written response to the investigation results for their identified patient grievance.

Failure to follow the hospital's policy and procedure by providing patients with a written response of the results of the grievance violates patients' rights to be informed of the investigation and resolution of their grievance and puts the patient at risk for harm or abuse from unresolved concerns.

Findings included:

1. Document review of the hospital's policy and procedure titled, "General Grievances and Patient Advocacy (Inpatient (IP), Partial Hospitalization Program (PHP), and Intensive Outpatient (IOP)," policy number 14962780, last revised 01/24, showed the following:

a. The purpose of the policy is to establish a mechanism by which to impartially receive, investigate, review, and process patient complaints, patient grievances, and/or any issues regarding Patient Rights.

b. A patient complaint is a verbal complaint regarding patient care and/or services that can be resolved at the point of service/contact by staff present. Typically, minor issues, such as but not limited to housekeeping or food preferences, do not require an investigation, or involve a restriction of the patient's rights.

c. A patient grievance is a formal or informal written or verbal complaint that is made by the patient, or the patient's representative, regarding the patient's care (when a verbal complaint about a patient's care is not resolved at the time of the complaint by staff present), abuse or neglect, issues related to the hospital's compliance with the Centers for Medicare and Medicaid Services (CMS) Hospital Conditions of Participation (CoP), or a Medicaid beneficiary billing complaint related to rights and limitations provided by 42 CFR § 489.

d. The Patient Advocate is the designee who is available to assist in hearing, investigating, and resolving patient complaints and/or patient grievances.

e. The Patient Advocate will investigate the identified patient grievance and determine the resolution within 7 business days. The Patient Advocate will notify the patient, family members, or patient representative of the results in writing. The written response will address each of the following areas:

i. Written notice of decision.

ii. The name of the facility contact.

iii. The steps taken on behalf of the individual to investigate the patient's grievance.

iv. The results of the patient grievance process.

v. The date of the completion of the patient grievance process.

f. If unable to complete the investigation within 7 business days, the patient, family member, or representative will be notified in writing that the investigation is ongoing.

2. On 02/07/24, the Investigator reviewed the complaint and grievance log provided by the Patient Advocate (Staff #1508). The log contained a list of complaints and grievances received between 12/01/23 through 02/07/24. The log contained three columns, the date/time of the complaint/grievance, a summary of the complaint/grievance, and the actions taken by the Patient Advocate, including referral to another person or discipline within the hospital. The log included 117 complaint/grievances for December 2023, 141 complaints/grievances for January 2024, and 37 complaints/grievances between 02/01/24 to 02/07/24. The log did not identify if the call or referral was a complaint or a grievance.

3. On 02/02/24 at 1:15 PM, during an interview with Investigator #15, the interim Director of Quality/Human Resource Business Partner (Staff #1507) Staff #1507 stated that the grievances were sent to the corporate office. Some are handled locally by the Patient Advocate who responds to the grievance, determines the level of severity, and tracks the hospital's response.

4. On 02/07/24 at 11:52 AM, during an interview with Investigator #15, the Patient Advocate (Staff #1508) stated that she was aware of the time frame requirements of responding to the complainant within 24 hours and resolution within 7 days. The grievance log contains documentation of when she talks to the patient or family member. The communication is usually verbal, and not written. If an investigation is required, the outcome or resolution is sometimes made verbally or noted on the Patient Advocate Report Form. In some cases, Staff #1508 reported that she sends the form to the complainant. Staff #1508 was not familiar with the hospital's grievance policy protocol to notify the patient, family member, or patient representative of the results of all grievance investigations in writing, or the requirements to be addressed within each written response.

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Based on interviews, record review, and review of policies and procedures, the hospital failed to develop and implement policies and procedures for the administration of emergency medications during emergency crises, including documenting the implementation, assessment, and monitoring of the chemical restraint incident, as demonstrated by 3 of 7 records reviewed (Patient #1501, #1503, and #1505).

Failure to develop and implement policies and procedures for the administration, monitoring, and documentation of emergency medications during emergency crises, puts patients at risk for violation of their rights, risk of psychological harm, and loss of personal dignity.

Reference:


Findings included:

1. Document review of the hospital's training document titled, "Seclusion and Restraint," published by Articulate Storyline, not dated, showed the following:

a. An emergency crisis is a violent or aggressive event requiring immediate interventions.

b. Emergency medications are used to treat patients in acute crisis.

c. The hospital does allow this practice as a therapeutic intervention with a provider order.

d. A chemical restraint is a form of medical restraint in which a drug is used to restrict the freedom of movement of a patient.

e. The hospital does not practice the use of chemical restraints.

Document review of the hospital's policy titled, "Informed Consent for Psychotropic Medications," policy number 13555811, last revised 06/23, showed the following:

a. Emergency Situation - A situation in which it is immediately necessary to administer medication to a patient to prevent:

i. Imminent probable death or substantial bodily harm to the patient who is overtly or continually threatening or attempting to commit serious bodily harm.

ii. Imminent physical or emotional harm to others because of threats, attempts, or other acts the patient overtly or continually makes or commits.

b. Refusal to consent to the administration of psychotropic medication may include the patient's refusal to submit to hypodermic injection or psychotropic medication.

Document review of the hospital's document titled, "Patient Bill of Rights - Federal," not dated, last revised 06/21, showed the following:

Centers for Medicare and Medicaid Services, § 482.13 Condition of Participation: Patient Rights

(e) Standard: Restraint or seclusion.

(e) (1) (i) (B) A restraint is a drug or medication when it is used as a restriction to manage the patient's behavior or restrict the patient's freedom of movement and is not a standard treatment or dosage for the patient's condition.

Document review of the hospital's policy titled, "Seclusion and Restraint," policy number 15084525, last revised 01/24, showed the the hospital does not practice the use of chemical restraints.

Document review of the hospital's policy titled, "Medicating Patients in Emergencies," policy number 13809269, effective 06/23, showed the following:

a. Both voluntary and involuntary patients can be given antipsychotic medication over their objection if an emergency exists.

b. Emergency is defined as a situation in which action over the patient's objection is immediately necessary for the preservation of life or the preservation of serious bodily harm to the patient or others.

c. Emergencies are not indefinite. An emergency allows for the administration of medication only to the degree and duration needed to address the emergency.

d. Occasionally standing orders for IM (intramuscular) medications, such as "100 mg Thorazine as needed (PRN) oral (PO) or IM if PO refused." To the extent that IM connotes forcible administration of the medication, these orders violate the statute.

e. The treating physician should be consulted each time an emergent situation arises for "IM medication in an emergency."

2. During the investigation, the Investigator reviewed seven medical records for patients admitted to the hospital between December 2023 through January 2024. The Investigator's review focused on patients who exhibited aggressive or assaultive behaviors during their admission and were administered IM medications as interventions to address the emergency crisis. Of the sample chosen, Patients #1504, #1506, and #1507, were not administered an emergency IM medication during their admission. The remaining 4 of 7 patients, however, did receive an IM medication due to an emergency crisis during their admission. The medical record review for these patients showed the following:

Patient #1501

3. Investigator #15 reviewed the medical record for Patient #1501, a 44-year-old female admitted voluntarily on 01/29/24, after a reported suicide attempt by overdose and increased suicidal ideation. A review of the Patient's medical record showed the following:

a. On the Seclusion and Restraint Clinical Assessment Progress note dated 01/31/24, nursing staff documented that Patient #1501 was standing at the nursing station making verbal threats and cursing at staff. The nurse contacted the provider to advise them of the situation.

b. On 01/31/24 at 1:01 PM, nursing staff received an order from the provider for emergency medication of Ativan 2 mg, Benadryl 50 mg, and Haldol 10 mg. An additional order was initiated for a 3-minute physical hold for the medication administration which was administered via intramuscular injection (IM). The indication for the chemical restraint is documented by the provider as "psychosis."

c. Due to the 3-minute physical hold (or restraint), nursing staff completed the seclusion and restraint documents for the incident, which documented the Patient's response to the physical hold, communication with the provider, and a patient debrief after the incident.

d. However, based on the hospital's policies, the IM emergency medication was not considered a chemical restraint and therefore did not require or include the seclusion and restraint documentation for continued assessment and monitoring of the patient after the IM medication administration, communication with the provider notifying them of the patient's status, or the patient's response to the emergency medications.

Patient #1503

4. The Investigator reviewed the medical record for Patient #1503, an 18-year-old female admitted voluntarily on 12/05/23, after a reported suicide attempt by overdose and increased depression. The Patient had severe symptoms of impulsivity and had been self-harming at home. A review of the Patient's medical record showed the following:

a. On the Seclusion and Restraint Clinical Assessment Progress note, nursing staff documented that on 12/08/23, Patient #1503 was slamming her door and screaming at staff. When the door opened, the Patient lunged at staff. Staff placed the Patient on a physical hold. The Patient then agreed to take oral medications, so the staff released the hold. When released, Patient #1503 kicked a staff member in the abdomen, fracturing her rib. The Patient was then placed in a 4-person hold. When the Patient appeared calm and agreed to be safe, she was released from the second hold. The Patient then refused the oral medication offered, throwing the cup and medication at a staff member. The nursing staff then ordered that a third hold be initiated and administered an IM medication of Haldol, Ativan, and Benadryl. The nursing staff failed to document that the provider was notified of the incident in the seclusion and restraint documentation for the incident on 12/08/23.

b. On 12/08/23 at 8:10 PM, the psychiatric provider initiated an order for an emergency medication administration of Ativan 2 mg, Benadryl 50 mg, and Haldol 5 mg. An additional order for restraint and seclusion was initiated with an 8:00 PM start time and no stop time indicated.

c. Due to the physical holds (or restraint), nursing staff completed the one set of seclusion and restraint documents for the entire incident that occurred between 8:00 PM to 8:15 PM. Due to the nursing staff's involvement in another patient's restraint incident, there was no assessment completed after the Patient's release.

d. The medical record did not contain documentation of an assessment and monitoring of the patient after the chemical restraint, communication with the provider notifying them of the patient's status, or the patient's response to the emergency medications.

Patient #1505

5. The Investigator reviewed the medical record for Patient #1505, a 39-year-old female admitted voluntarily on 01/27/24, with paranoid delusions, mania, and psychosis. A review of the Patient's medical record showed the following:

a. During the assessment process, while the Patient was still in the intake area, the nursing staff documented that on 01/27/24 at 9:35 PM, the assessment nurse and the house supervisor administered the following emergency medications: Haldol 5 mg IM now, Ativan 2 mg IM Now, and Benadryl 50 mg IM now. The indication for the chemical restraint is documented by the provider as "unspecific psychosis," which is the Patient's admission diagnosis, not the behaviors exhibited requiring the emergency medication.

b. A seclusion and restraint packet was not completed by the staff. The review of the medical record found that nursing staff failed to document the indication for the emergency medication or communication with the psychiatric provider regarding the situation. A review of the nursing progress notes found that staff failed to assess or monitor the patient after the chemical restraint administration. The only reference to the incident that occurred on 01/27/24 was documented by nursing staff on 01/28/24 at 3:10 AM when the patient reported pain related to the injection received earlier.

5. On 02/01/24 at 1:30 PM, during an interview with Investigator #15, a Registered Nurse (RN) (Staff #1505), stated that when a code is called, or a patient is escalating, the provider will be notified of the incident and to request orders. When the patient does not respond to efforts to de-escalate and the offer of oral medications, the provider may order emergency medications, usually Haldol, Ativan, and Benadryl, and order a therapeutic hold for the administration of the IM. These emergency medications are not considered chemical restraints, so when the seclusion and restraint documents are completed, they assess, monitor, and document communications with the provider based on the therapeutic hold intervention only. Staff #1505 stated that she was not aware of any protocols or policies requiring assessment and monitoring after emergency medications and/or IMs.

6. On 02/02/24 at 11:15 AM, during an interview with Investigator #15, the House Supervisor (RN) (Staff #1506) reported that when the staff initiates a physical hold or therapeutic hold, the seclusion and restraint documents must be completed. Seclusion and restraint documentation is not required for IMs or emergency medications. Staff #1506 stated that at the hospital, IM emergency medications are not considered chemical restraints.
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Based on interview, record review, and review of hospital policies and procedures, the hospital failed to ensure that orders for emergency medications, when used as chemical restraints, were never written on an as needed basis (PRN), as demonstrated by 3 of 8 records reviewed. (Patients #706, #707, and #1001).

Failure to adhere to policies and procedures for the administration of emergency medications places patients at risk for violation of their right to refuse antipsychotic medications, risk of psychological harm, loss of personal dignity, personal freedom.

Reference:

FDA
https://www.fda.gov/safety/medical-product-safety-information/benadryl-diphenhydramine-drug-safety-communication-serious-problems-high-doses-allergy-medicine#:~:text=BACKGROUND%3A%20Diphenhydramine%20is%20an%20antihistamine,as%20runny%20nose%20and%20sneezing.
"BACKGROUND: Diphenhydramine is an antihistamine used to temporarily relieve symptoms due to hay fever, upper respiratory allergies, or the common cold, such as runny nose and sneezing."

FDA
https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/haloperidol-marketed-haldol-haldol-decanoate-and-haldol-lactate-information.
Haloperidol (marketed as Haldol) is an antipsychotic medication.

FDA
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018140s028lbl.pdf
Lorazepam, a benzodiazepine with antianxiety, sedative, and anticonvulsant effects.

Findings included:

1. Document review of the hospital policy titled, "Seclusion and Restraint", PolicyStat #15084526, last approved 01/24, showed the following:

a. "This hospital does not practice the use of chemical restraints".

Document review of the hospital policy titled, "Medicating Patients in Emergencies", PolicyStat #13809269, last approved 06/23, showed "Occasionally standing orders for intramuscular (IM) medication are found in the medical record, such as "Haldol 10mg PRN PO/IM for agitation" or "100 mg Thorazine PRN PO or IM if refused". To the extent that "IM" connotes forcible administration of the medication, these orders are in violation of statute. The treating physician should be consulted each time an emergent situation arises to request orders for "IM medication in an emergency."

Document review of a hospital document provided to patients upon admission titled, "Patient Bill of Rights Federal Patient's Copy", revised 06/21, showed the text of 482.13 Condition of Participation: Patient's Rights, including:

a. 482.13(e) Standard: Restraint or Seclusion.

i. Definitions: A restraint is a drug or medication when it is used as a restriction to manage the patient's behavior or restrict the patient's freedom of movement and is not a standard treatment or dosage for the patient's condition.

ii. Orders for the use of restraint or seclusion must never be written as a standing order or on an as needed basis (PRN).

2. On 01/23/24 at 8:56 AM, Investigator #7 and the Nurse Manager reviewed the medical record for Patient #706. The review showed the following:

a. Patient #706 received IM injection of 50mg diphenhydramine (Benadryl), 10mg haloperidol (Haldol) and 2mg lorazepam (Ativan) on 06/06/23 at 5:10 PM.

b. Orders on 06/06/23:

i. "Diphenhydramine 50mg Intramuscular give now for unspecified psychosis due to substance or known physiol cond", start 06/06/23 at 5:00 PM, stop 06/06/23 at 7:32 PM."

ii. "Haloperidol 10mg Intramuscular give now to give 10mg use 2ml of 5 mg/ml for unspecified psychosis due to substance or known physiol cond", start 06/06/23 at 5:00 PM, stop 06/06/23 at 7:32 PM."

iii. "Lorazepam 2mg Intramuscular give now for unspecified psychosis due to substance or known physiol cond", start 06/06/23 at 5:00 PM, stop 06/06/23 at 7:32 PM."

iv. "Diphenhydramine oral give every 6 hours as needed PRN for psychotic agitation may provide IM with refusal and aggression max daily doses: 4."

v. "Haloperidol oral give every 6 hours as needed PRN for psychotic agitation may provide IM with refusal and aggression max daily doses: 4."

vi. "Lorazepam oral give every 6 hours as needed PRN for psychotic agitation may provide IM with refusal and aggression max daily doses: 4."

3. At the time of the review, Staff #701 verified Patient #706 had PRN orders for IM Benadryl, Haldol and Ativan and that it is not an approved practice.

4. On 01/24/24 at 12:43 PM, Investigator #7 and Staff #701 reviewed the medical record for Patient #707. The review showed the following:

a. Patient #707 received multiple IM administrations of Benadryl, Haldol and Ativan during her stay.

b. Orders on 08/11/23:

i. "Benadryl 50mg IM give now for psychotic agitation."

ii. "Haldol IM give now to give 10mg use 2ml of 5mg/ml for psychotic agitation."

iii. "Lorazepam oral give now for psychotic agitation."

iv. "Lorazepam IM give now for psychotic agitation."

v. "Benadryl give every 6 hours as needed PRN for psychosis not due to substance or known physiol cond."

vi. "Benadryl IM give now PRN for dystonia (a state of abnormal muscle tone resulting in muscular spasm and abnormal posture, typically due to neurological disease or a side effect of drug therapy) prevention."

vii. "Haldol oral give q (every) 6 hours PRN for unspecified psychosis not due to substance or known physiol cond."

viii. "Lorazepam oral q6 hours PRN for unspecified psychosis not due to substance or known physiol cond."

ix. "Lorazapam oral give now PRN psychotic agitation."

x. "Lorazapam IM give PRN psychotic agitation."

xi. "Lorazapam IM give PRN psychotic agitation."

xii. "Lorazapam oral give now PRN psychotic agitation."

5. At the time of the review Staff #701 verified Patient #707 had PRN orders for IM Benadryl, Haldol and Ativan and that it is not an approved practice.

6. On 02/01/24 at 9:18 AM, Investigator #10 received the medication administration record for Patient #1001, who was admitted on 01/01/23 for psychosis. The record showed the following medication orders that started on 01/25/24 at 1:00 AM and stopped on 01/25/24 at 2:02 PM:

a. "Diphenhydramine 50mg IM every 6 hours PRN for dystonia prevention."

b. "Haloperidol 10mg IM every 6 hours PRN for psychotic agitation."

c. "Lorazepam 2mg IM every 6 hours PRN for psychotic agitation."
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Based on record review, interviews, and review of the hospital policies, the hospital failed to ensure patients were monitored after receiving a chemical restraint.

Failure to monitor patients after administering a chemical restraint places the patient at risk for a decrease in functional and cognitive performance, falls and fractures, excess sedation, and respiratory depression.

Findings included:

1. Document review of the hospital policy titled, "Seclusion and Restraint", PolicyStat #15084526, last approved 01/24, showed the following that pertains to monitoring after restraint:

a. This hospital does not practice the use of Chemical restraints.

b. This hospital does not practice the use of Mechanical restraint.

c. Monitoring activities:

i. Removes all potentially dangerous personal items such as jewelry, neckties, and glasses, if indicated prior to intervening with a patient.

2. Investigator #7 interviewed the Nurse Manager (Staff #701) regarding restraint and seclusion monitoring. Staff #701 Advised this facility does not use mechanical or chemical restraints, only Physical Holds, to be able to administer emergency intramuscular (IM) medications, and there is no monitoring done after that other than the rounding sheets that PCA document on every patient. Patients in seclusion have a staff member there with them for the entirety of the seclusion.

3. On 01/24/24 at 8:56 AM, Investigator #7 and the Nurse Manager (Staff #701) reviewed the medical record for Patient #706. The review showed Patient #706 received IM medications on 06/06/23 at 5:10 PM. A nursing note shows after receiving the IM medications Patient #706 "requested to go to her room".

4. Investigator #7 found no monitoring documented after the patient received a chemical restraint.

5. At the time of the review Staff #701 verified there was no monitoring and reiterated the facility policy is to not administer chemical restraints.

6. On 01/24/24 at 12:43 PM, Investigator #7 and Staff #701 reviewed the medical record for Patient #707. The review showed the following:

a. On 08/11/23 a nursing note, time 6:55 PM, detailed the administration of a chemical restraint (Benadryl, Haldol and Ativan) Patient #707 received IM.

b. After receiving the chemical restraint the patient was provided with her stuffed animal and helped to her room, music was played, and water provided. The patient showered, socialized, and laid down (no timeframes were provided).

7. Investigator #7 found no monitoring documented after the patient received a chemical restraint.

8. At the time of the review, Staff #701 verified there was no monitoring and reiterated the facility policy is to not administer chemical restraints.
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Based on interviews, medical record review, and review of policies and procedures, the hospital failed to ensure that patients placed in physical/chemical restraints and/or seclusion received a face-to-face assessment within one hour by a physician or qualified trained registered nurse (RN) as directed by hospital policy, as demonstrated by 7 of 10 records reviewed (Patients #703, #706, #1501, #1502, #1503, #1504, and #1505).

Failure to perform the required one-hour face-to-face evaluation when physical/chemical restraints and/or seclusion is used to manage violent or self-destructive behaviors to evaluate the patient's immediate situation, the response to the intervention, the medical and behavioral condition, and the need to continue or terminate the restraint and/or seclusion, places patients at risk of physical and/or psychological harm.

Findings included:

1. Document review of the hospital's policy and procedure titled, "Seclusion and Restraint," policy number 15084525, effective 01/24, showed the following:

a. The physician or qualified trained RN conducts an in-person, face-to-face assessment of the seclusion and/or restraint patient within one hour of initiation and documents findings on the One Hour Face to Face Evaluation (in the seclusion and restraint packet). The face-to-face evaluation is performed even in those situations where the person is released early (before one hour).

b. The evaluation incorporates the following: the physical and psychological status of the patient, determination of the need for continued seclusion/restraint, and assists the patient in regaining control to promote discontinuation.

2. On 01/24/24 at 8:56 AM, Investigator #7 and the Nurse Manager (Staff #701) reviewed the medical record for Patient #706. The review showed Patient #706 was physically restrained on 06/06/23 from 5:09 PM to 5:18 PM. Investigator #7 was unable to locate any face-to-face documentation in the patient's chart.

3. At the time of the review, Staff #701 verified there was no face-to-face assessment documented in the patient's chart.

4. On 01/24/23 at 12:43 PM, Investigator #7 and Staff #701 reviewed the medical record for Patient #703 who was physically restrained on 01/23/24 at 11:28 AM. Investigator #7 was unable to locate any face-to-face documentation in the patient's chart.

5. At the time of the review Staff #701 verified there was no face-to-face assessment documented in the patient's chart.

6. On 01/24/24 at 4:10 PM during an interview with Investigator #7, the Registered Nurse (Staff #706) verified that no face-to face had been done because the hold lasted for such a short amount of time.

7. On 02/02/24, Investigator #15 reviewed the medical records for Patient #1501, a 44-year-old female admitted on 01/29/24. Document review showed the following:

a. On 01/31/24 at 1:19 PM, the nursing staff placed Patient #1501 on a 3-minute physical hold and administered the following emergency medications, Ativan 2 mg, Benadryl 50 mg, and Haldol 10 mg.

b. The nursing staff attempted to conduct the one-hour face-to-face assessment at 2:30 PM, however the Patient was sleeping and unrousable. Nursing staff failed to completed the one-hour face-to-face assessment for Patient #1501.

8. On 02/02/24, Investigator #15 reviewed the medical records of Patient #1502, a 44-year-old male admitted on 01/17/24. Document review showed the following:

a. On 01/23/24 at 11:25 AM, Patient #1502 was placed on a physical hold after he refused to take oral medication to administer an IM medication. The Patient agreed to take the medications orally, and the physical hold was released.

b. The one-hour face-to-face assessment was conducted at 8:15 PM, several hours after the interventions, and was incomplete. The RN failed to document the patient's vital signs, the physical/medical evaluation, and the psychological/emotional evaluation noting that they were "not applicable."

9. On 02/02/24, Investigator #15 reviewed the medical records of Patient #1503, an 18-year-old female admitted on 12/05/23. Document review showed the following:

a. On 12/08/23 Patient #1503 was placed on a physical hold from 8:00 PM to 8:15 PM, after becoming aggressive and assaultive to staff. During the incident, Patient #1503 kicked a staff member in the abdomen, fracturing her rib. After the refusal of oral medication, the nursing staff administered an IM medication of Haldol, Ativan, and Benadryl.

b. A review of the medical records found that the nursing staff completed the one-hour face-to-face evaluation on 12/09/23 at 3:38 AM, over 7 hours after the interventions. The nursing staff documented that the follow-up evaluation was not completed due to responding to another patient's escalation at the same time.

10. On 02/02/24, Investigator #15 reviewed the medical records of Patient #1504, a 24-year-old female admitted on 12/23/23. Document review showed the following:

a. On 12/27/23 at 4:30 PM, Patient #1504 was placed on a physical hold after she placed a metal tack in her mouth which she obtained during visitation. Patient #1504 was attempting to pierce her lip and refused to give the metal tack to staff. The Patient was physically restrained by staff from 4:30 PM to 4:38 PM. At 4:38 PM, the Patient spits the metal tack into a cup.

b. A review of the one-hour face-to-face assessment found that the evaluation was incomplete. The RN failed to document the patient's vital signs, the physical/medical evaluation, and the psychological/emotional evaluation noting that they were "not applicable."

11. On 02/02/24, Investigator #15 reviewed the medical records of Patient #1505, a 39-year-old female admitted on 01/27/24. Document review showed the following:

a. During the assessment process, while the Patient was still in the intake area, the nursing staff documented on 01/27/24 at 9:35 PM, that the assessment nurse and the house supervisor administered the following emergency medications: Haldol 5 mg IM now, Ativan 2 mg IM Now, and Benadryl 50 mg IM now. Staff failed to document if a physical hold was required to administer the medication or the duration of the hold.

b. A seclusion and restraint packet was not completed by the staff. Subsequently, there is no documentation of a one-hour face-to-face evaluation after the chemical restraint medication administration. A review of the medical record found that staff failed to document the indication for the interventions, the patient's reaction to the medication, and the patient's medical and behavioral condition.

12. On 02/01/24 at 1:30 PM, during an interview with Investigator #15, an RN (Staff #1505) verified that the one-hour face-to-face evaluations should be done for all physical holds but were not always conducted. Staff #1505 stated that she was unable to complete the evaluation for Patient #1501 because she was sleeping after the intervention on 01/31/24 at 1:19 PM. The staff attempted to wake up Patient #1501 after the physical hold and chemical restraint, however she would not wake up. The Patient slept through a fire alarm at the facility and an attempted meeting with the Designated Crisis Responder (DCR) regarding the Patient's request to leave the hospital against medical advice (AMA). The Patient remained sleeping until 10:15 PM, when nursing staff administered her evening medications. At 12:20 AM, the nurse reported that the Patient stumbled out her room and fainted, losing consciousness. The Patient's heart rate was 45 bpm. The Patient was transferred to the medical hospital for evaluation.

13. On 02/02/24 at 11:15 AM, during an interview with Investigator #15, the House Supervisor (RN) (Staff #1506) stated that the house supervisor's role is to support the nurse who is running the code (emergency). If the patient is placed on an emergency hold, the seclusion and restraint documentation should be completed. The nurse is supposed to check in with the patient within one hour of the hold, to check their respiratory status and appearance, documenting the one-hour face-to-face assessment. Staff #1506 stated that she makes sure that the seclusion and restraint packet is completed after the incidents.

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Based on interviews, medical record reviews, and review of the policies and procedures, the hospital failed to ensure that after a seclusion and/or restraint incident, when a specially trained registered nurse (RN) completed a one-hour face-to-face assessment, the RN consulted the attending or on-call practitioner as soon as possible after the completion of the one-hour face-to-face evaluation, as demonstrated by 2 of 7 records reviewed (Patients #1503, and #1504).

Failure to ensure that a specially trained RN consults the attending physician or on-call practitioner who is responsible for the care of the patient, after the completion of the one-hour face-to-face evaluation risks serious physical harm, psychological harm, and violation of patient rights.

Findings included:

1. Document review of the hospital's policy and procedure titled, "Seclusion and Restraint," policy number 15084525, effective 01/24, showed the following:

a. The physician or qualified trained RN conducts an in-person, face-to-face assessment of the seclusion and/or restraint patient within one hour of initiation and documents findings on the one-hour face-to-face evaluation (in the seclusion and restraint packet). The face-to-face evaluation is performed even in those situations where the person is released early (before one hour).

b. If the one-hour face-to-face evaluation is conducted by a qualified trained RN, the RN will contact the attending physician or designee to review the one-hour face-to-face evaluation of the patient.

2. On 02/02/24, Investigator #15 reviewed the medical records of Patient #1503, an 18-year-old female admitted on 12/05/23. Document review showed the following:

a. On 12/08/23 Patient #1503 was placed on a physical hold from 8:00 PM to 8:15 PM and the nursing staff administered an intramuscular (IM) medication of Haldol, Ativan, and Benadryl.

b. The nursing staff documented the completion of the one-hour face-to-face evaluation on 12/09/23 at 3:38 AM, over 7 hours after the interventions. The nursing staff documented that the attending physician was not notified of the evaluation.

3. On 02/02/24, Investigator #15 reviewed the medical records of Patient #1504, a 24-year-old female admitted on 12/23/23. Document review showed the following:

a. On 12/27/23 at 4:30 PM, Patient #1504 was placed on a physical hold after she placed a metal tack in her mouth which she obtained during visitation. Patient #1504 was attempting to pierce her lip and refused to give the metal tack to staff. The Patient was physically restrained by staff from 4:30 PM to 4:38 PM. At 4:38 PM, the Patient spits the metal tack into a cup.

b. The nursing staff documented the completion of the one-hour face-to-face evaluation on 12/27/23 at 5:35 PM. Notification of the attending physician is dated 12/27/23 at 4:30 PM, at the time the incident began and before the one-hour face-to-face evaluation was conducted.

4. On 02/02/24 at 11:15 AM, during an interview with Investigator #15, the House Supervisor (RN) (Staff #1506) stated that after a seclusion and restraint incident, the nurse would usually monitor the patients for an hour, checking on them. The nurse is supposed to check on the patients within an hour to monitor their respiratory status and appearance, then document their findings on the seclusion and restraint one-hour face-to-face evaluation. Staff #1506 verified that some seclusion and restraint documentation was missing the notification of the provider because the nurse is only required to contact the provider if there is an issue or concern.

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