HospitalInspections.org

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Based on observation, interview, record review, and review of hospital policies and procedures, the hospital failed to ensure that patient safety events, such as medication errors were identified, entered into the hospital's incident reporting system, and evaluated for further action when indicated for 1 of 1 medical record reviewed (Patient #1).

Failure to ensure the identification and reporting of patient safety events, such as medication errors, limits the hospital's ability to analyze events and implement measures that would prevent or mitigate future patient harm or death.

Reference:

Suboxone Medication Guide - Approved by the U.S. Food and Drug Administration, dated 06/22.

Suboxone may cause serious and life-threatening breathing problems. Get emergency help right away if you are feeling faint, dizzy, confused, sleepy, or uncoordinated. Side effects can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.

Findings included:

1. Document review of the hospital's policy and procedure titled, "Adverse Drug Events (ADE) - Medication Errors Policy #38," policy number 14980123, effective 0/12/24, showed the following:

a. A medication error is a preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in control of the health care professional, patient, or consumer. Such events may be related to professional practice, healthcare products, procedures, and systems, including prescribing; order communication; product labeling, packaging, and nomenclature; compounding; dispensing; distribution; administration; education; and monitoring and use.

b. A significant medication error is a medication error that reached the individual and required monitoring to confirm that it resulted in no harm to the individual, and/or that required intervention to preclude or mitigate harm.

c. It is the policy of the hospital that medication errors and adverse drug events are reported immediately to the attending physician and reported to the organization-wide quality assessment and performance improvement (QAPI) program.

d. It is the responsibility of all clinical staff involved in the medication management process to report known or suspected medication errors and adverse drug events using the organization-wide event reporting system/process.

e. Medication error monitoring is a component of the QAPI program.

f. Medication error events include, but are not limited to errors in prescribing, transcribing, dispensing, administering, and monitoring of medication and wrong dose.

Document review of the hospital's policy and procedure titled, "Healthcare Peer Review - Incident Reporting System Policy," policy number 14605171, effective 12/04/23, showed the following:

a. An incident/occurrence is defined as an outcome that is not consistent with the routine care of a patient and/or the desired operations of the facility.

b. Serious Injuries/Events include medication error and/or adverse drug events, serious physical and/or psychiatric residuals, and/or death.

c. Level III (serious) incidents are defined when the potential for litigation could be initiated at any time. Worst negative patient, visitor, or employee outcome (for example permanent disability, coma, or death).

2. Patient #1, a 49-year-old female was admitted on 08/29/23. The Patient had a history of Polysubstance Use but had not used illicit drugs since her incarceration from May 2023 through August 2023. Before the Patient's admission to Inland Northwest Behavioral Hospital, she was admitted to an inpatient rehabilitation facility between 08/25/23 through 08/28/23 and an acute care hospital for medical clearance from 08/28/23 through 08/29/23. A review of the Patient's medical record showed the following:

a. Medication reconciliations from the inpatient rehabilitation facility and the sending acute care hospital showed that the Patient's current medications included one buprenorphine-naloxone (Suboxone) 8mg-2mg sublingual tablet daily (between 08/25/23 through 08/28/23).

b. On the clinical information obtained from the sending acute care hospital dated 08/28/23, the hospital's pharmacy review of medications noted that before admission, the Patient was taking one buprenorphine-naloxone (Suboxone) 8mg-2mg sublingual tablet daily. The pharmacy technician noted in the pharmacy findings that this dosage was a change from a "2.5 mg film every day."

c. On 08/30/23, the psychiatric provider initiated an order to place the Patient on 2.5 Suboxone 8mg-2mg sublingual films daily. This is two and a half times the patient's previous dose reported by the inpatient rehabilitation facility and the acute care hospital.

d. On 09/04/23 at 8:30 AM, staff found Patient #1 unresponsive in her bed. A Rapid Response code was initiated and 911 was called. The Patient was transported to the acute care hospital by ambulance at 8:50 AM. The patient remained intubated at the hospital until 09/13/23 when she passed away.

3. On 02/22/24 at 2:00 PM, during an interview with the Investigator, the Director of Risk (Staff #2) stated that when reviewing the adverse outcome that occurred for Patient #1, the hospital found that the Patient was prescribed a large dose of Suboxone. Staff #2 reported that the review found that the hospital's treatment team had reviewed the decision, however, the provider that prescribed the large Suboxone dose was no longer working at the hospital and was not available for an interview or to clarify the reasoning for the dosage.

4. On 02/28/24 at 11:50 AM, during an interview with the Investigator, a Medication Nurse (LPN) (Staff #10) stated that the dose that Patient #1 was prescribed, 2.5 Suboxone 8mg-2mg sublingual films daily, is a large dose and he would have called the pharmacist to verify the dose before administering the medication. Staff #10 reported that it's always best to do your due diligence and verify the dose with the pharmacy.

5. On 02/28/24 at 3:00 PM, during an interview with the Investigator, the Chief Medical Officer (Staff #7) stated that regarding the adverse incident with Patient #1, Suboxone does not increase respiratory depression. The Patient was given one dose of Narcan during the incident, with no response. The Narcan did not do anything, which means you can take Suboxone off the table as the cause for the Patient's change in condition.

6. On 03/13/24 at 10:45 AM, during an interview with the Investigator, the Staff Pharmacist (Staff #12) stated that when reconciling the Suboxone dose for Patient #1, the psychiatric provider reported to the pharmacist that he had not used the Provider Monitoring Program (PMP) to verify the dose, but he had verified the dose with the inpatient treatment facility. The Investigator reviewed the clinical information provided for the Patient upon admission. Staff #12 stated that the medication reconciliation from the acute care medical hospital dated 08/28/23, referencing a 2.5 mg film, appears to be the pharmacy tech's reference to a different dose of Suboxone (2 mg/0.5 mg Suboxone). It was not intended to prescribe the Patient with a dose two and a half times their previous dose (8mg/2mg). The pharmacist stated that this was probably a medication error. Staff #12 stated that the pharmacy would have caught this, but they do not have access to the patient's clinical information provided during the admission process.

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Based on observation, interview, and document review, the hospital and the director of nursing services failed to provide adequate supervision and evaluation of all nursing personnel to ensure that all staff provided care in a safe setting for patients who were prescribed Suboxone therapy for the management of opiate withdrawal symptoms.

Failure to provide patient care in a safe setting for patients requiring the management of opiate withdrawal symptoms, places patients at risk for serious adverse outcome, injury or death.

Findings included:

1. Failure to provide monitoring, including vital signs every 6 hours, and assessments for withdrawal symptoms for 3 of 3 patients who were prescribed Suboxone therapy for the management of withdrawal symptoms and complications..

Cross Reference: A0398

2. Failure to provide care in a safe setting by following the hospital's policies and procedures for medication reconciliation before prescribing and administering medications.

Cross Reference: A0405


Due to the scope and severity of deficiencies cited under 42 CFR 482.23, the Condition of Participation for Nursing Services was NOT MET

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Based on observation, interview, record review, and review of hospital policies and procedures, the hospital failed to ensure that nursing staff provided monitoring, including vital signs every 6 hours, and assessments for withdrawal symptoms, as demonstrated by record review for 6 of 6 records reviewed (Patient #1, #2, #3, #4, #5, and #6).

Failure to ensure that nursing personnel adhere to the hospital's policies and procedures regarding the monitoring and assessment of patients receiving Suboxone treatment for opiate withdrawal/maintenance places the patient at risk of experiencing a serious adverse outcome or death.


Findings included:

1. Document review of the hospital's policy and procedure titled, "Use of Detoxification Protocols in Inpatient Units," policy number 15112694, effective 02/02/24, showed the following:

a. It is the policy of the hospital to use prescribed protocols to monitor patients who are withdrawing from opiates, alcohol, and benzodiazepines. The purpose of the policy is to provide procedures for monitoring and effective management of withdrawal symptoms and complications.

b. When a patient has been chronically using opiates and presents in withdrawal, or is expected to be in withdrawal, the provider will (at their discretion), order the use of COWS (Clinical Opiate Withdrawal Scale) to monitor the severity of the symptoms. The results of the COWS will be communicated to the provider.

c. A patient who is in, or suspected to be in opiate withdrawal will be prescribed (at the provider's discretion), medications for symptomatic treatment (including clonidine, dicyclomine, baclofen, ondansetron, loperamide, and acetaminophen) and short-term opiate replacement using buprenorphine/naloxone (Suboxone) or buprenorphine alone (Subutex).

Document review of the hospital's policy and procedure titled, "Vital Signs and Weights," policy number 15061877, effective 02/02/24, showed the following:

a. Vital signs are obtained and recorded to provide essential information for medical providers, nursing staff, and other treatment providers to ensure safe, reliable, and accurate assessment and care.

b. Vital signs consist of blood pressure (BP), pulse (P), temperature (T), respiration (R), and pulse oximetry (O2). Weights will be recorded in pounds.

c. Vital signs are obtained on every patient at the time of admission and daily unless providers order an alternative schedule.

Document review of the hospital's policy and procedure titled, "Suboxone (Buprenorphine-Naloxone) Subutex (Buprenorphine) Policy," no policy number, revised 03/14/24, showed the following:

a. Once the provider has confirmed the diagnosis of an opioid use disorder and determines that the patient is a candidate for Suboxone/Subutex treatment, the provider discusses the medication with the patient, obtains informed consent, and places the order for the medication and order set outlining the monitoring protocol.

b. The Registered Nurse (RN) will complete the COWS flowsheet, documenting the results in the electronic medical record medication administration record (MAR).

c. The RN will monitor vital signs at a minimum of every 6 hours, or more often if ordered by a provider while COWS protocol is active.

Patient #1

2. Patient #1, a 49-year-old female was initially sent from jail to court-ordered inpatient rehabilitation treatment on 08/25/23. On 08/28/23, the Patient became manic and aggressive to staff and was then transferred to an acute care hospital for medical clearance. After the Patient was medically cleared on 08/29/23, she was transferred to Inland Northwest Behavioral Hospital and admitted for involuntary treatment. A review of the Patient's medical record showed the following:

a. A review of the admission assessments showed that the Patient had a history of Polysubstance Use but had not used illicit drugs since May 2023. A review of the Patient's medications from the inpatient rehabilitation facility and the sending acute care hospital showed that the current medications included one buprenorphine-naloxone (Suboxone) 8-2mg sublingual tablet daily.

b. On 08/30/23 the psychiatric provider initiated an order to place the Patient on a daily dose of Suboxone for opiate maintenance and additionally placed an order for the vital signs to be obtained every 6 hours, as directed by hospital policy.

c. A document review found that staff failed to monitor the patient's vital signs 11 of 20 times between 08/30/23 through 09/04/23. The review found that the last set of vital signs recorded for Patient #1 was on 09/03/23 at 9:32 PM.

d. On 09/04/23 at 8:30 AM, staff found Patient #1 unresponsive in her bed. A Rapid Response code was initiated and 911 was called. The Patient was transported to the acute care hospital by ambulance at 8:50 AM. The patient remained intubated at the hospital until 09/13/23 when she passed away.

Patient #2

3. Patient #2, a 26-year-old female was admitted on 12/29/23 due to Major Depressive Disorder and Substance Use disorder. A review of the Patient's medical record showed the following:


a. On 01/18/24, the psychiatric provider initiated an order to place the Patient on Suboxone one 4-1mg sublingual film daily for opiate maintenance, and vital signs every 6 hours. On 02/15/24, the psychiatric provider increased the medication dose to one 8-2mg sublingual film daily.

b. A review of the vital signs between 01/18/24 through 02/16/24 found that staff failed to document the Patient's vital signs 58 of 116 times.

Patient #3

4. Patient #3, a 28-year-old female was admitted on 02/22/24 due to increased suicidal and homicidal ideation and substance abuse. A review of the Patient's medical record showed the following:

a. On 02/22/24, the provider wrote an order for Suboxone one 8mg-2mg sublingual film daily for opiate maintenance, and vital signs every 6 hours.

b. A review of the vital signs between 02/22/24 through 03/13/24 showed that staff failed to document the Patient's vital signs 35 of 80 times.

Patient #4

5. Patient #4, a 39-year-old male was admitted on 03/09/24 due to increased suicidal ideation with a plan and a history of chronic polysubstance use. A review of the Patient's medical record showed the following:

a. On 03/10/24, the provider wrote an order for Suboxone one 8mg-2mg sublingual film daily for opiate maintenance, and vital signs every 6 hours.

b. A review of the vital signs between 03/10/24 through 03/12/24 showed that staff failed to document the Patient's vital signs 4 of 9 times.

Patient #5

6. Patient #5, a 48-year-old male was admitted on 03/04/24 due to increased suicidal ideation with a plan and a history of methamphetamine use. A review of the Patient's medical record showed the following:

a. On 03/05/24, the provider wrote an order for Suboxone one 8mg-2mg sublingual film daily for opiate maintenance, and vital signs every 6 hours.

b. A review of the vital signs between 03/05/24 through 03/11/24 showed that staff failed to document the Patient's vital signs 14 of 25 times.

Patient #6

7. Patient #6, a 34-year-old female was admitted on 01/21/24 due to increased psychosis and a history of chronic polysubstance use. A review of the Patient's medical record showed the following:

a. On 01/22/24, the provider wrote an order for Suboxone one 8mg-2mg sublingual film daily for opiate maintenance, and vital signs every 6 hours.

b. A review of the vital signs between 01/22/24 through 03/07/24 showed that staff failed to document the Patient's vital signs 76 of 181 times.

8. On 02/22/24 at 2:00 PM, during an interview with the Investigator, the Director of Risk (Staff #2) verified that the provider's orders to obtain the vital signs every 6 hours for Suboxone patients were not consistently followed. Staff #2 verified that the last recorded vital sign for Patient #1 was at 09/03/23 at 9:32 PM before being found unresponsive by staff the next morning on 09/04/23 at 8:30 AM. The Director of Risk stated that in the electronic medication ordering and administration system (HCS) when an order for vital signs every 6 hours is initiated, the system will prompt the nursing staff to obtain and record the patient's vital signs every 6 hours.

9. On 03/07/24 at 3:15 PM, during an interview with the Investigator, an RN (Staff #11) stated that they were unclear if the hospital had a policy or protocol regarding patients who were administered Suboxone. Staff #11 stated that typically the nursing staff would assess the patient's respiratory status/rate, their blood pressure, and watch for any changes in mental status. The RN noted that there was a knowledge gap for staff when monitoring Suboxone patients.

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Based on observation, interview, record review, and review of hospital policies and procedures, the hospital failed to ensure that staff members followed its procedures for medication reconciliation before prescribing and administering medications, as demonstrated by record review for 3 of 6 records reviewed (Patient #1, #3, and #6).

Failure to ensure that staff follow the hospital's policies and procedures regarding medication reconciliation places the patients at risk for medication errors, patient harm, and/or death.

Findings included:

1. Document review of the hospital's policy and procedure titled, "Medication Reconciliation Information Policy #43," policy number 15054003, effective 02/02/24, showed the following:

a. Medication Reconciliation is the process of identifying the most accurate list of all medications that the patient is taking, including the name, dosage, frequency, and route by comparing the medical record to an external list of medication obtained from a patient, hospital, or other provider.

b. Medication reconciliation is a multidisciplinary process, performed upon entry to the hospital, following relevant encounters, or a transition of care upon discharge.

c. For Inpatient settings, medication information is obtained to include at a minimum, the medication name, dose, frequency, and route, the indication (or purpose) for use, and the date and time of the last dose.

d. During medication reconciliation, the list of medications the patient was taking is compared to the medications currently ordered at the hospital.

e. Discrepancies are identified and resolved by the contacting prescriber. Documentation explaining the discrepancies and resolution is recommended. The individual responsible for reconciling medications will document the process and include their signature and the date and time the medications were reconciled on the Medication Reconciliation Form in the medical record.

f. Medication reconciliation should be completed within 24 hours following admission. The prescribing physician is notified if there are any variances, discrepancies are resolved, and a new and/or changed medication order is written when indicated.

Document review of the hospital's policy and procedure titled, "Methadone/Suboxone Verification Policy #65," policy number 15025310, effective 01/12/24, showed the following:

a. It is the responsibility of the prescriber to check the Washington State Prescriptions Monitoring Program (PMP) to verify the patient's current dose/usage before prescribing.

b. The provider can request that a background check history with the outpatient provider is conducted before accepting the patient to ensure the patient is in good standing with the outpatient services.

c. Pharmacy must be notified to ensure the product is available and at the unit where the patient will reside.

Document review of the hospital's policy and procedure titled, "Suboxone (Buprenorphine-Naloxone) - Subutex (Buprenorphine) - Function: Care," no policy number, revised 03/14/24, showed the following:

a. The purpose of this policy is to provide effective and evidence-based acute withdrawal and maintenance treatment to patients identified with substance use disorders.

b. During the initial evaluation, the psychiatrist will screen the patient for substance use disorder. The provider will gather information about the type of substances, duration of use, quantity of use, and time of last dose.

c. Once the diagnosis of an opioid use disorder is confirmed and the psychiatrist has determined that the patient is a continued candidate for buprenorphine treatment, he/she discusses the medication and obtains informed consent.

d. Procedure for patients admitted on buprenorphine - Before any buprenorphine dose is dispensed or administered, confirmation of the buprenorphine dose from the outpatient prescriber or the outpatient pharmacy must be obtained. This can be completed by the psychiatrist/provider by accessing the PMP. The psychiatrist/provider must document the confirmation information to include at a minimum, the source of the information and the date of the last dose.

e. Once the dose is confirmed, the physician writes the dose confirmation information in the notes.

f. The pharmacist will review and evaluate to approve the buprenorphine order.

2. During the investigation, the Investigator reviewed six medical records for patients who were prescribed Suboxone for opiate maintenance during their admission, between September 2023 through March 2024. The Investigator's review focused on the hospital's medication reconciliation process used to verify the dose from the outpatient provider or the community pharmacy, document confirmation of this information, and initiate the order for the Suboxone. The review showed the following:

3. Patient #1, a 49-year-old female was initially sent from jail to court-ordered inpatient rehabilitation treatment on 08/25/23. On 08/28/23, the Patient became manic and aggressive to staff and was then transferred to an acute care hospital for medical clearance. After the Patient was medically cleared on 08/28/23, she was transferred to Inland Northwest Behavioral Hospital and admitted on 08/29/23. A review of the Patient's medical record showed the following:

a. A review of the admission assessments showed that the Patient had a history of Polysubstance Use but had not used illicit drugs since May 2023. During the Patient's incarceration (between May 2023 and August 2023, the Patient reported that she had not received her previously prescribed buprenorphine (Subutex).

b. On the clinical information obtained from the sending acute care hospital dated 08/28/23, the hospital's pharmacy review of medications noted that before admission, the Patient was taking one buprenorphine-naloxone (Suboxone) 8mg-2mg sublingual tablet daily. The pharmacy technician noted in the pharmacy findings that this dosage was a change from 2.5 mg film every day.

b. A review of the Patient's medications from the inpatient rehabilitation facility and the sending acute care hospital showed that the current medications included one buprenorphine-naloxone (Suboxone) 8mg-2mg sublingual tablet daily (between 08/25/23 through 08/28/23).

c. On the History and Physical Evaluation dated 08/30/23 at 8:30 AM, the medical provider from Inland Northwest Behavioral Health documented that the Patient had previously been on Suboxone 8mg-2mg 2.5 films daily, but the Patient stated not recently. The provider noted that the hospital would refrain from restarting this medication currently and recommended that the Patient follow up with her regular treatment team upon discharge.

d. On the Psychiatric Evaluation dated 08/30/23 at 9:45 AM, the psychiatric provider documented that the Patient admitted to active cravings for methamphetamines. The provider noted that the Patient's current medications included "Suboxone 2.5 films daily" and the Patient's Initial Plan of Care included Suboxone 8mg-2mg 2.5 films sublingual daily for medication-assisted treatment (MAT).

e. On 08/30/23, the psychiatric provider initiated an order to place the Patient on 2.5 Suboxone 8mg-2mg sublingual films daily. This is two and a half times the patient's previous dose reported by the inpatient rehabilitation facility and the acute care hospital. The provider failed to document the indication for increasing the Patient's previously reported dose by two and a half times in the medical record.

f. On a Pharmacy Notification Form dated 08/30/23, the pharmacist documented in the electronic medication administration system (HCS) that when questioned about the large dose, the psychiatric provider reported that he did not look at the PMP but verified the dose with the inpatient rehabilitation facility.

g. The Investigator's review of Patient #1's medical record found that the documentation from the psychiatric provider that noted that the dose was verified with the inpatient treatment facility was incongruent with the dose found in the clinical records provided by the inpatient treatment facility. The review found that the psychiatric provider and the medical provider had differing plans of care for the Patient, however, the medical record did not contain evidence documenting communication between the psychiatric and medical providers clarifying the indications for the initiation of Suboxone treatment for the Patient.

4. Patient #3, a 28-year-old female was admitted on 02/22/24 due to increased suicidal and homicidal ideation and substance abuse. A review of the Patient's medical record showed the following:

a. On the Psychiatric Evaluation dated 02/22/24, the provider documented that the Patient reported that she was currently taking Suboxone and gave the provider the name of the clinic where she was receiving outpatient treatment. The provider did not document that the dose was verified with the outpatient clinic.

b. On 02/22/24, the pharmacist entered an order for Suboxone one 8mg-2mg sublingual film daily for substance use disorder. The order did not contain documentation of how the Suboxone dose was verified by the hospital staff.

c. A review of the provider's daily progress notes between 02/24/24 through 03/12/24 found that the psychiatric provider did not document how the Patient's previous Suboxone dose was verified with the outpatient/community provider or through the PMP system.

5. Patient #6, a 34-year-old female was admitted on 01/21/24 due to an LRA (least restrictive alternative) revocation, delusional, and substance use disorder. A review of the Patient's medical record showed the following:

a. On the Psychiatric Evaluation dated 01/21/24, the psychiatric provider documented that the Patient's current medications included Suboxone one 8mg-2mg sublingual film daily.

b. On 01/22/24, the provider initiated an order for Suboxone one 8mg-2mg sublingual film daily. The provider did not note on the order that the dose was verified with the outpatient/community provider.

c. A review of the provider's daily progress notes on 01/27/24 and 01/29/24 found that the psychiatric provider did not document how the Patient's previous Suboxone dose was verified with the outpatient/community provider or through the PMP system.

5. On 02/22/24 at 2:00 PM, during an interview with the Investigator, the Director of Risk (Staff #2) verified that when the hospital conducted their root cause analysis (RCA) for Patient #1's change in condition and transfer to the medical hospital, the RCA team found the conflicting plans of care regarding Suboxone administration between the psychiatric and medical provider.

6. On 03/13/24 at 10:10 AM, during an interview with the Investigator, the Chief Medical Officer (Staff #7) stated that when the hospital has a patient on Suboxone, the pharmacy always checks PMP. Staff #7 stated that the providers can check the monitoring systems, but usually, the pharmacist will do that.

7. On 03/13/24 at 10:45 AM, during an interview with the Investigator, the Staff Pharmacists (Staff #12) stated that during the medication reconciliation process, the admission/intake nurses will compare the medication list obtained through the hospital's electronic medication administration system (HCS) of the patient's outpatient/community medications with the information provided by the patient upon admission. The pharmacist and intake RN will clean up the list and send it to the provider for review. If a patient is on Suboxone, Staff #12 stated that all the providers have agreed to check PMP to verify the outpatient/community treatment and dose. The Pharmacists stated that they will document in HCS, however the providers will document in the patient's medical record.

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