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Based on interview and record review, the hospital failed to have an organized nursing service for five of fifteen sampled patients (Patient 1, Patient 8, Patient 9, Patient 10 and Patient 11) when:

1. Patient 1 was found unresponsive (not responding to stimuli) after nursing staff administered Hydromorphone (strong opioid pain medication) intravenously (in the vein). Patient 1 was not assessed or re-assessed in accordance with the policy and procedure titled "Pain Assessment & Management- Patients 14 and Older" for pain, before or after that administration of Hydromorphone.(refer to A398)


2. Nursing staff did not conduct 14 pain reassessments for 3 of 3 admitted patients (Patient 8, 9 and 10) in the Emergency Department in accordance with the policy and procedure titled, "Pain Assessment & Management- Patients 14 and Older". (refer to A398)


3. Patient 10 reported severe pain and was given the pain medication for moderate pain 10 separate times without staff contacting the attending provider or charting the reason for giving the lesser pain medication in accordance with physician order and the policy and procedures titled, "Pain Assessment & Management- Patients 14 and Older and Provider Orders". (refer to A398)


4. Patient 8, 10 and 11 reported a moderate or severe pain score and subsequently, did not receive pain medication 14 times in total for all three patients, in accordance with the policy and procedures titled "Patient's Rights and Responsibilities, Pain Assessment & Management- Patients 14 and Older and Provider Orders". (refer to A398)

5. The hospital failed to follow their policy for "Pain Assessment & Management -Patients 14 and older" for Pt 1 when nurses did not assess and develop a care plan that met the primary care needs of the patient related to safety. (refer to A396)

The cumulative effect of these deficient practices resulted in the facility's inability to provide quality health care by the nursing staff.

Based on observation, interview, and record review, the hospital failed to provide pharmaceutical services that meet the needs of the patients as evidenced by:

1. The hospital failed to develop and implement systems to ensure the safe use of medications to minimize adverse drug events. Patient 1 received multiple doses of intravenous (IV, into the vein) opioids, a class of medication identified as high-risk/high-alert medications, exceeding the manufacturer's recommended dose for the patient's medical conditions, and suffered respiratory and cardiac arrest (stopping of the heart and breathing) leading to anoxic brain injury (death of brain cells due to oxygen deprivation to the brain) and subsequently expired 10 days later. (Refer to A 500)

2. The hospital failed to implement its Policy & Procedure (P&P) on high-risk/high-alert medications to incorporate external alerts and internal respective review to identify opioids, including hydromorphone, as high-risk/high-alert medications and develop safeguards to reduce the risk of errors. The hospital also did not take appropriate actions to prevent future adverse drug events after one patient, Patient 1, suffered anoxic brain injury and died in October 2023 as a result of unsafe opioid use. (Refer to A 491)

3. The hospital failed to consistently implement its Black Box Warning (BBW, the highest safety-related warning that medications can have assigned by the Food and Drug Administration) P&P and take precautions to address the warning and recommendations issued by external alerts and the FDA (U.S. Food and Drug Administration) pertaining to the heightened risks associated with the use of opioids.

The cumulative effect of the systemic problems resulted in the hospital's failure to ensure the provision of pharmaceutical services in a safe environment that met the needs of the patients.

Based on interview and record review the hospital failed to follow their policy for "Pain Assessment & Management -Patients 14 and older" for one of 15 sampled patients (Patient (Pt) 1)) when nurses did not assess and develop a care plan that met the primary care needs of the patient related to safety.

This failure had the potential to result in Patient 1's care needs going unmet.

Findings:

During a concurrent interview and record review of Pt 1's electronic health record (EHR- digital collection of medical information) on 5/18/24, at 12:40 p.m., Pt 1's "History and Physical (H&P -- the formal document that physicians produce through the interview with the patient, the physical exam, and the summary of the testing either obtained or pending)", dated 10/11/23, and "Education [Nursing Care Plan]", dated 10/13/2024, were reviewed with the Emergency Department Director (EDD), Emergency Department Clinical Supervisor (EDCS) and Emergency Department Educator (EDed). Pt 1's H&P indicated Pt 1 was brought to the hospital "with a past medical history of ESRD [End Stage Renal (kidney) Disease] on dialysis [a procedure to remove waste products and excess fluid from the blood when the kidneys stop working properly], diabetes [chronic disease that occurs when the body does not produce enough insulin or cannot effectively use the insulin it produces], and MI [Myocardial infarction - heart attack] s/p [status post -after] bypass [heart surgery], and stroke [brain attack] with left-sided residual weakness, hypertension [high blood pressure] who presents to the ED [Emergency Department] for significant pain, redness and abscess [an enclosed collected of infection and pus in/on the body] like masses on abdominal wall. Patient states she developed it 3 weeks ago and was admitted at ...[another] Hospital where she received IV [intravenous - by the vein into the blood stream] antibiotic for 4 days and was discharged on p.o. [oral] doxycycline [antibiotic medication] for 10 days which she has finished. Patient said even after taking antibiotic as prescribed, it continued to get worse to the point where she has significant pain on movement and getting up. ...". EDD stated, Pt 1's care plan addressed issues for skin integrity, nutrition, dialysis, gas exchange and potential for falling as the focused care problems for nursing interventions. EDD stated, pain was not included in the care plan. EDD stated, the care plan does not address pain as it was a reason for the admission. EDD stated, there should be a focus in the nursing care plan that addresses the patient's pain. EDD stated, nurses are expected to develop a care plan that matches and guides the care of the patient.

During an interview on 5/17/24, at 10:00 a.m., with the Chief Nursing Officer (CNO) and the Director of Inpatient Services (DIS), Pt 1's care was reviewed. The CNO stated, the nursing care plan should address Pt 1's main complaint for admission. The DIS stated, the nursing care plan should address the main care needs of the patient. The DIS stated, the nurses are expected to follow the policy to documenting and updating the care plan.

During a review of the facility P&P "Pain Assessment & Management -Patients 14 and older", dated 10/12/2023, the P&P indicated, " ... provide safe and effective pain treatment for all patients, including safe opioid [medication] prescribing and, when appropriate, family preferences and cultural, spiritual, and / or ethnic beliefs/practices for pain management. This will be implemented in the pain management plan of care ... The patient's care plan will reflect an active plan for the treatment of pain. ... A. The patient/family member/ caregiver will be provided with the following education: ... 1. Information regarding pain and the importance of effective pain management upon entry into the health care setting, prior to admission, or as soon as patient is stable enough to receive information. 2. The patient's pain and the effective treatment is an important part of the treatment plan. ... "

The "Lippincott Manual of Nursing Practice 10th Edition," dated 2014, page 16-17 indicated, " Standards of practice General Principles... 1. The practice of professional nursing has standards of practice setting minimum levels of acceptable performance for which its practitioners are accountable ...b. These standards provide patients with a means of measuring the quality of care they receive ...5. A deviation from the protocol should be documented in the patient's chart with clear, concise statements of the nurse's decisions, actions, and reasons for the care provided, including any apparent deviation ... Legal claims most commonly made against professional nurses include the following departures from appropriate care: failure to assess the patient properly or in a timely fashion, follow physician orders, follow appropriate nursing measures, communicate information about the patient, adhere to facility policy or procedure, document appropriate information in the medical record ... Failure to formulate or follow the nursing care plan ..."

Based on interview and record review, the hospital failed to follow nursing standards of practice, facility policies and procedures for pain assessments and reassessments for five of fifteen sampled patients (Patient 1, Patient 8, Patient 9, Patient 10 and Patient 11), when:

1. Patient 1 was found unresponsive (not responding to stimuli) after nursing staff administered Hydromorphone (strong opioid pain medication) intravenously (in the vein). Patient 1 was not assessed or re-assessed in accordance with the policy and procedure titled "Pain Assessment & Management- Patients 14 and Older" for pain, before or after that administration of Hydromorphone.

2. Nursing staff did not conduct 14 pain reassessments for 3 of 3 admitted patients (Patient 8, 9 and 10) in the Emergency Department in accordance with the policy and procedure titled, "Pain Assessment & Management- Patients 14 and Older".

3. Patient 10 reported severe pain and was given the pain medication for moderate pain 10 separate times without staff contacting the attending provider or charting the reason for giving the lesser pain medication in accordance with physician order and the policy and procedures titled, "Pain Assessment & Management- Patients 14 and Older and Provider Orders".

4. Patient 8, 10 and 11 reported a moderate or severe pain score and subsequently, did not receive pain medication 14 times in total for all three patients, in accordance with the policy and procedures titled, "Patient's Rights and Responsibilities, Pain Assessment & Management- Patients 14 and Older and Provider Orders".

These failures resulted in Patient 1 being found unresponsive and suffering avoidable pain. These failures resulted in Patient 8, 9,10 and 11 suffering avoidable pain and that could have negatively affected their well-being and had the potential to negatively affect treatment of pain for all patients by not adequately addressing patients' pain, improper monitoring and missed reassessments. These patients were potentially placed at risk of harm and possible death.

Findings:

1. During a review of Pt 1's,"Hospitalist History & Physical [H&P]," dated 10/11/23, the "H&P" indicated, Pt 1 was admitted on 10/11/23, " ... past medical history of ESRD [End Stage Renal (kidney) Disease] on dialysis [a mechanical procedure to remove waste products and excess fluid from the blood when the kidneys stop working properly], diabetes [chronic disease that occurs when the body does not produce enough insulin or cannot effectively use the insulin it produces], and MI [Myocardial infarction - heart attack] s/p [status post -after] bypass [heart surgery], and stroke [brain attack] with left-sided residual weakness, hypertension [high blood pressure]. Pt 1 presented to the ED [Emergency Department] for significant pain, redness and abscess [an enclosed collected of infection and pus in/on the body] like masses on abdominal wall. Patient stated she developed it 3 weeks ago and was admitted at ...[another] Hospital where she received IV [intravenous - by the vein into the blood stream] antibiotic for 4 days and was discharged on p.o. [oral] doxycycline [antibiotic medication] for 10 days which she has finished. Patient said even after taking antibiotic as prescribed, it continued to get worse to the point where she has significant pain on movement and getting up. ..."

During a concurrent interview and record review on 5/14/24, at 4:15 p.m., with the Emergency Department Director (EDD), Emergency Department Clinical Supervisor (EDCS) and Emergency Department Educator (EDed), Pt 1's "Face sheet" (provides demographics of the patient, name, date of birth, admission date, chief complaint), "Pain Monitoring Flowsheet [PMF]", and "electronic health records" (EHR), were reviewed for Pt 1's admission dated 10/11/2023. The EDD stated, Pt 1 had an order for Hydromorphone IV (intravenous (IV) strong opioid pain medication) 1 mg (unit of measurement- milligrams) every four hours as need for severe pain of 8 out of 10 (Pain management scales utilizing the 0-10 descriptors, will be assessed as a pain rating of 0=no pain, 1-3=mild pain, 4-6=moderate pain and 7-10=severe pain). The PMF indicated, Pt 1 received 1 mg of Hydromorphone on 10/12/23 at 11:49 p.m. for severe pain of 8 out 10. The PMF indicated, at 10/13/24 at 12:05 a.m., no pain reassessment number was documented but Pt 1 was "sleeping". The PMF indicated a Richmond Agitation and Sedation Scale (RASS) [a tool used to rank sedation and agitation], "Alert and calm." The EDD validated no pain assessment was documented. The PMF indicated, Pt 1 received 1 mg of Hydromorphone on 10/13/23 at 5:29 a.m., no pain assessment or reassessment was documented. The EDD validated the pain assessments and reassessments were not documented for administered medication. The EDD stated, the pain medications should be reassessed within 15 minutes for IV medications, if not sooner for medications affecting respiratory efforts, and 1 hour with medications by mouth. The EDD stated nurses are expected to follow the hospital policies and monitor patients for adverse reactions to pain medications.

During a concurrent interview and record review on 5/15/24, at 10:45 a.m., with the Float Pool Registered Nurse 1 (RN 1) and Float Pool Nurse Manager (NM 1), Pt 1's "Face sheet" (provides demographics of the patient, name, date of birth, admission date, chief complaint), "Pain Monitoring Flowsheet [PMF]", "Hydromorphone -Black Box Warning" and "electronic health records" (EHR), were reviewed for Pt 1's admission dated 10/11/2023. RN 1 stated, Pt 1 had an order for Hydromorphone IV 1 mg every four hours as need for severe pain of 8 out of 10 and she had given Hydromorphone 1mg IV at 10/12/23 at 11:49 p.m. and 10/13/23 at 5:29 a.m. for pain. RN 1 stated, she did not document the pain score for the Hydromorphone at 10/12/23 at 11:49 p.m. but stated she recalls she was sleeping although she also documented she was "alert and calm". RN 1 did not comment when asked if Pt 1 was "sleeping" or "alert and calm". RN 1 stated, she gave the Hydromorphone 1mg IV at 10/13/23 at 5:29 a.m. because Pt 1 requested the pain medication based on RN 1's recollection. RN 1 stated, nothing was documented about giving the medication or the pain reassessment. RN 1 stated, she did not know the term "black box warning" for medications. RN 1 read "Hydromorphone -Black Box Warning", which indicated, "Serious, life-threatening, or fatal respiratory depression may occur, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of Hydromorphone". RN 1 stated, Pt 1 should have been on a cardiac monitor and Pt 1's respirations should be monitored. RN 1 stated, she came back to Pt 1 at 6:10 a.m. do perform a fingerstick to check her blood glucose but the patient was unresponsive at that time. RN 1 stated, she was not aware of Pt 1's renal impairment or Pt 1 passing out on 10/11/2023 at 1:18 p.m. after receiving Fentanyl (strong opioid pain medication) 75 mcg (micrograms- unit of measurement) IV. NM 1 stated, nurses are expected to assess the pain of the patient and give medications for the pain. NM 1 stated, nurses should document what they are doing and reassess when giving opioids to the patient. NM 1 stated, if this is not done, then there could be bad outcomes for the patient.

During a concurrent interview and record review on 5/17/24, at 10:00 a.m., with the Director of Inpatient Services (DIS), and Chief Nursing Officer (CNO), the facility policy and procedure (P&P) "Pain Assessment & Management -Patients 14 and older", dated 10/12/2023), and the care of Pt 1 were reviewed. The DIS stated, nurses should document pain reassessments within 60 minutes as per the policy and assess patients for oversedation according to the indication for each medication. The DIS stated, nurses should monitor patients for oversedation when giving opioid medications. The CNO stated, she expects the nurses to follow hospital policies about assessing and reassessing for pain and document their actions and assessments.

During a review of the facility P&P "Pain Assessment & Management -Patients 14 and older", dated 10/12/2023, the P&P indicated, " ... provide safe and effective pain treatment for all patients, including safe opioid [medication] prescribing and, when appropriate, family preferences and cultural, spiritual, and / or ethnic beliefs/practices for pain management. This will be implemented in the pain management plan of care. ... Pain management scales utilizing the 0-10 descriptors, will be assessed as a pain rating of 0=no pain, 1-3=mild pain, 4-6=moderate pain and 7-10=severe pain. Patients' denial of pain will be interpreted as 0.... Clinicians assess patients with pain as frequently as necessary to provide adequate pain relief and ensure patient safety. ... Pain intensity will be reassessed after each pharmacological [using medication] pain management intervention once a sufficient time has lapsed for the treatment to reach peak effect, ... , IV [using a vein into the blood stream] medication is effective within 30 minutes and PO [by mouth]/ IM [injection to a muscle] medication is effective within 60 minutes. This re-assessment will be documented in the patient medical record using the appropriate pain scale. ... Evaluate and reassess for side effects of treatment risk factors for adverse events caused by the treatment. ... Risk Assessment and Monitoring for Opioid-induced Respiratory Depression (OIRD) and Opioid-induced Sedation (OIS). ... 1. Patients at highest risk include. but are not limited to: ... a. Patients with obstructive sleep apnea [stop breathing] or snoring ... b. Body mass index [tool that estimates body fat based on height and weight] greater than 40 ... c. Age greater than 60: risk of OIRD/ OIS increase with age ... d. Heart failure ... e. Concomitant [using together] sedatives received within 2 hours of opioid administration ... f. Post-operative abdominal or thoracic surgery ... g. Anesthesia time greater than 3 hours ... h. Continuous infusion of opioids ... i. Opioid naïve [patients who have not used pain medications over the last 180 days] ... 2.. Monitor patients for OIRD and OIS using the Richmond Agitation and Sedation Scale [a tool used to rank sedation and agitation], respiratory rate and respiratory pattern. ... ".

During a review of the facility P&P "Black Box Warning (serious warning from the FDA for drugs that may cause serious harm or death)", dated 2/10/22, the P&P indicated, " PURPOSE: A. To identify medications having the Food and Drug Administration (FDA) designated Black Box Warning (BBW) applicable to "Hospital" facilities. B. To monitor and advocate the safe use of these medications. A. BBW- Refers to the most serious FDA warning. This is also known as a Boxed Warning. The warning provides safety details and may provide restrictions for use or distribution ... III. POLICY: A. All FDA releases of black box warning medications will be continuously reviewed and assessed ... E. Pharmacy Services will present, on an as-needed basis, the following to the P&T Committee contingent on the use of BBW medications: 1. The list ... identified BBW medications with risk reductions measures, the required elements for use and expected health care professional actions involving the identified medications. 2. Any revision of medication use guidelines. 3. Changes to monitoring procedures. 4. Use of alternative medication(s). 5. Deletion of the medication(s) from the formulary (a drug list). 6. Education plan for health care professionals ... 8. BBW notification will be placed in the electronic health record (EHR) to allow a view of the BBW for the pharmacist and nurse. In addition, the information will be placed in the appropriate field for the Automated Dispensing Cabinet (ADC) to reinforce the BBW for the user. 9. Health Care Professional Education ... b. Education will be provided ... v. The BBW designation will be placed into the EHR to alert the nurse of the use of the BBW medication on the medication administration record (MAR) and via the automated dispensing cabinet (computer-controlled systems that automate the dispensing of medications in hospitals) if applicable ...".

During a review of the drug manufacturer medication insert, "Hydromorphone", dated 4/2024, the insert indicated, " ... Serious, life-threatening, or fatal respiratory depression may occur, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] are essential. ... Concomitant use of opioids [medications used to treat pain] with benzodiazepines [medications used to relieve anxiety] or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. ... Renal Impairment: Initiate treatment with one-fourth to one-half the usual starting dose, depending on degree of renal impairment. ...Life-Threatening Respiratory Depression in Patients ... in Elderly, ... or Debilitated Patients: Monitor closely, particularly during initiation and titration. ... Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, even when used as recommended. Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death. ... "

During a review of the California Board of Registered Nursing Professional Reference titled, "California Code of Regulations" undated, (https://rn.ca.gov) indicated, "... A registered nurse shall directly provide ... Ongoing patient assessments as defined in the Business and Professions Code, Section 2725(d). Such assessments shall be performed, and the findings documented in the patient ' s medical record, for each shift and upon receipt of the patient when he/she is transferred to another patient care area ... RN is accountable for an ongoing comprehensive assessment that includes data collection, analysis, and drawing conclusions/making judgments in order to ... formulate diagnoses and update diagnoses formulate or change the plan of care ... decide on specific activities to implement the plan of care (immediate and long-term) ... prioritize and coordinate delivery of care delegate to nursing care competent staff to deliver required care ... anticipate discharge planning/teaching needs... advocate for the patient as needed ... RN uses scientific knowledge and experience to make clinical judgments about observed abnormalities and changes based on a series of complex, independent and collaborative decision making activities ... RN is responsible/accountable to see actual and potential patient needs/health problems are addressed and get recorded on the plan of care ...".

2. During a review of Patient 8's "ED (Emergency Department) Provider Note (EPN)" dated 5/10/24, the EPN indicated Patient 8 was admitted on 5/10/24 for " ... Chief Complaint: Influenza (highly contagious virus) signs and symptoms ... Patient brought in by ambulance for flu like symptoms, fever, chills, increased pain to right foot with fixator (an external frame device placed on the leg that is made of metal and keeps bones in place) noted ... Disposition: Admission ... Clinical Impression: 1. Diabetic ulcer (an open sore or wound) of the right foot associated with type 1 diabetes mellitus (a chronic (life-long) disease that prevents your pancreas from making insulin), with necrosis (death of your body tissue) of muscle, unspecified part of foot. 2. ESRD (End stage renal disease- the final, permanent stage of chronic kidney disease, where kidney function has declined to the point that the kidneys can no longer function on their own). 3. Fever, unspecified cause ...".

During a review of Patient 8's "Medication List (ML)" dated 5/10/24 to 5/17/24, the ML indicated, " ...Acetaminophen for mild pain, Fentanyl (strong opioid pain medication ) 25 mcg (micrograms- unit of measurement) every 6 hours for breakthrough pain (sudden increase in pain), Fentanyl 50 mcg every 6 hours for breakthrough pain, Hydromorphone (strong opioid pain medication ) .25 mg (milligrams- unit of measurement) PRN every 4 hours for breakthrough pain, Hydromorphone .25 mg every 4 hours for severe pain, Morphine (Strong opioid pain medication) 1 mg for severe pain, Hydrocodone (Strong opioid pain medication) 5 mg every 6 hours for severe pain ...".

On 5/17/24 at 8:30 a.m., Patient 8's MAR was requested from facility but was not provided. Patient 8 chart was received but the MAR was not included.

During a review of Patient 8's "ED Care Timeline (ECT)", dated 5/10/24 to 5/13/24, the ECT indicated, Patient 8 received pain medication without a pain reassessment on " ... 5/10/24 at 11:11 p.m., Medication given: Fentanyl (Pain medication) 50 mcg (microgram- unit of measurement), (no pain assessment) Route: Intravenous (in the vein); no reassessment documented ...". The ECT indicated, on " ... 5/11/24 at 2:03 a.m., Medication given: Fentanyl 50 mcg (no pain assessment); no reassessment documented ... 5:51 a.m., Medication given: Fentanyl 50 mcg (no pain assessment); no reassessment documented ...". The ECT indicated, on " ... 5/12/24 at 5:18 a.m., Medication given: Fentanyl 25 mcg (no pain assessment); no reassessment documented ... 9:11 a.m., Medication given: Oxycodone (Pain medication) 5 mg (milligrams- unit of measurement), route: Oral (by mouth). Pain assessment: 10 severe. Pain type: Acute pain. Pain location: foot; no reassessment documented ... 12:39 p.m., Medication given: Fentanyl 25 mcg, route: Intravenous: Pain Assessment: 10 severe; no reassessment documented ...". The ECT indicated, on " ... 5/13/24 at 6:46 a.m., Medication given: Oxycodone 5 mg, route: oral. Pain assessment: 10 severe; no reassessment documented ....".

During a review of Patient 10's "ED (Emergency Department) Provider Note (EPN)" dated 5/6/24, the EPN indicated Patient 10 was admitted on 5/5/24 for " ... Chief Complaint: Respiratory short of breath ... from skilled nursing home ... more difficulty breathing than normal ... associated cough ... Disposition: Admission ... Clinical Impression: 1. Acute Dyspnea (shortness of breath) ... 2. Interstitial lung disease (disease that causes scarring of the lungs) ...".

During a review of Patient 10's "Medication Administration Report (MAR)", dated 5/7/24 to 5/16/24, the MAR indicated, " ...Hydrocodone-acetaminophen (Brand name- pain medication) 5-325 mg (milligrams- unit of measurement), 1 tablet ... Frequency: every 6 hours PRN (as needed) Route: oral. PRN reason: Moderate Pain ... Start: 5/6/24 at 9:26 a.m. ... Hydromorphone (Brand name- pain medication) injection .5 mg ... Frequency: every 4 hours PRN. Route IV (intravenous- in the vein). PRN reason: Severe Pain ...Start: 5/9/24 at 1:47 p.m. ...".

During a review of Patient 10's "ED Care Timeline (ECT)", dated 5/6/24 to 5/8/24, the ECT indicated, Patient 10 received pain medication without a pain reassessment on " ... 5/6/24 at 11:55 p.m., Medication given Hydrocodone-acetaminophen (Pain medication), route oral. Pain Assessment: 7 Severe; no reassessment documented ...". The ECT indicated, " ...5/8/24 at 9:59 a.m., Medication given Hydrocodone-acetaminophen, route oral. Pain Assessment: 10 Severe; no reassessment documented ... 3:58 p.m., Hydrocodone-acetaminophen, route oral. Pain Assessment: Pain Assessment: 6 moderate; no reassessment documented...".

During a review of Patient 9's "ED Provider Note (EPN)", dated, 5/5/24, the EPN indicated Patient 9 was admitted on 5/5/24 for " ...Chief Complaint: swelling groin ...history of diabetes mellitus (a disease that affects how the body uses blood sugar), anasarca (severe generalized swelling of the body) and chronic kidney disease (CKD- a long-term condition where the kidneys do not work as well as they should) ... Disposition: Admission ... Clinical impression: 1. acute kidney injury superimposed (a secondary issue) by CKD. 2. Hypervolemia (fluid overload) ...".

During a review of Patient 9's "Medication Administration Report (MAR)", dated 5/7/24 to 5/16/24, the MAR indicated, " ...Hydromorphone (Brand name- pain medication) injection 1 mg ... Frequency: every 4 hours PRN. Route IV (intravenous- in the vein). PRN reason: Moderate Pain, Severe Pain ...Start: 5/5/24 at 1:47 p.m. ... Oxycodone-acetaminophen (Brand name- pain medication 10-325 mg, Dose: 1 tablet. Frequency: every 4 hours PRN. Route: oral. PRN reason: Severe Pain. Start: 5/6/24 at 12:54 p.m. ...".

During a review of Patient 9's "ED Care Timeline (ECT)", dated 5/5/24 to 5/7/24, the ECT indicated, Patient 9 received pain medication without a pain reassessment on " ... 5/5/24 at 10:56 p.m., Medication given Hydromorphone 1 mg, route Intravenous. Pain Assessment: 9 Severe; no reassessment documented ...". The ECT indicated, on " ... 5/6/24 at 3:54 a.m., Medication given Hydromorphone 1 mg, route Intravenous. Pain Assessment: 10 Severe; no reassessment documented ...". The ECT indicated, " ... 5/7/24 at 4:16 a.m., Medication given: Oxycodone-acetaminophen (Pain medication) 10-325 mg, route: oral. Pain assessment: 9 severe; no reassessment documented ... 9:52 p.m., Medication given: Hydromorphone 1 mg, route Intravenous. No Initial Pain Assessment: no reassessment documented ...".

During an interview on 5/17/24 at 8:45 a.m., with the Emergency Department Director (EDD), the EDD stated every patient that received pain medication needed to have a pain reassessment. The EDD stated pain reassessment are important because a patient could have respiratory issues or an allergic reaction after medication administration. The EDD stated pain not being reassessed was a patient safety issue and inadequate patient care. The EDD stated nursing staff did not follow the policy and procedure, "Pain Assessment and Management- Patients 14 and Older".

During a concurrent interview and record review on 5/17/24, at 10:00 a.m., with the Director of Inpatient Services (DIS), and Chief Nursing Officer (CNO), the facility policy and procedure (P&P) "Pain Assessment & Management -Patients 14 and Older", dated 10/12/2023, was reviewed. The DIS stated, nurses should document pain reassessments within 90 minutes as per the policy and assess patients for oversedation according to the indication for each medication. The DIS stated, nurses should monitor patients for oversedation when giving opioid medications. The CNO stated, she expects the nurses to follow hospital policies about assessing and reassessing for pain and document their actions and assessments.

During an interview on 5/17/24 at 2:30 p.m., with ED Registered Nurse (RN) 3, RN 3 stated he was the nurse for Patient 8 in the ED on 5/13/24. RN 3 stated Patient 8 was in pain and he gave him Oxycodone. RN 3 stated he was "supposed" to do a pain scale before he gave the Oxycodone and a pain reassessment after he gave Patient 8 the medication. RN 3 stated he did not do either and they were not charted.

During a review of the facility's Policy and Procedure (P&P) titled, "Pain Assessment & Management- Patients 14 and Older", dated 10/12/23, the P&P indicated, "PURPOSE: A. To demonstrate [Hospital Name] commitment to a patient's right to effective pain management. B. To establish standards of nursing care and practice that defines the role and responsibilities of the RN to provide pain management at all facilities ... III. POLICY: A. It is the policy ... to provide safe and effective pain treatment for all patients ... B. Pain is whatever the person experiencing says it is ... Pain is always subjective ... E. Pain management tool is a reliable and validated tool used to measure clinical pain intensity and approved for use ...IV. PROCEDURE: ... 5. Assess and reassess pain using one of the following scales as appropriate. a. 0-10 pain intensity scale ... The appropriate pain rating scale is used to determine an appropriate pain management modality ... C. Implementation ... 2. Medications will be administered based on the patient's pain scale level identified and as ordered by the provider ... D. Evaluation/Reassessment of Pain Management ...2. Pain intensity will be reassessed after each pharmacological pain management intervention once a sufficient time has lapsed for the treatment to reach peak effect, but no longer than 90 minutes after intervention. Generally, intravenous (IV- in the vein) medication is effective within 30 minutes and by mouth or intramuscular medication is effective within 60 minutes. This re-assessment will be documented in the patient medical record using the appropriate pain scale ... 5. Evaluate and reassess for side effects of treatment and risk factors for adverse events caused by treatment ... V. DOCUMENTATION: ... 2. Subsequent reassessments should include the following: intensity, location, response to treatment, modalities (the way in which something happens or is experienced) and type of pain assessment scaled used ...VI. PATIENT EDUCATION: ... 2. The patient's pain and the effective treatment is an important part of the treatment plan ...".

Review of Nursing World.org Professional Reference titled, "The American Nurses Association- Nursing: Scope and Standards of Practice, Third Edition", dated July 2015, (found at https://www.nursingworld.org/~4af71a/globalassets/catalog/book-toc/nssp3e-sample-chapter.pdf) indicated, " ...Standards of Practice The Standards of Practice describe a competent level of nursing care as demonstrated by the critical thinking model known as the nursing process. The nursing process includes the components of assessment, diagnosis, outcomes identification, planning, implementation, and evaluation. Accordingly, the nursing process encompasses significant actions taken by registered nurses and forms the foundation of the nurse's decision-making ... Standard 1. Assessment The registered nurse collects pertinent data and information relative to the healthcare consumer's health or the situation ...".

3. During a review of Patient 10's "ED (Emergency Department) Provider Note (EPN)" dated 5/6/24, the EPN indicated Patient 10 was admitted on 5/5/24 for " ... Chief Complaint: Respiratory short of breath ... from skilled nursing home ... more difficulty breathing than normal ... associated cough ... Disposition: Admission ... Clinical Impression: 1. Acute Dyspnea (shortness of breath) ... 2. Interstitial lung disease (disease that causes scarring of the lungs) ...".

During a review of Patient 10's "ED notes (EDN)", dated 5/8/24 at 4:36 p.m., the EDN indicated, " ...Patient states he feels anxious and upset and requesting anxiety medication. Visibly agitated and verbally aggressive towards staff. Patient also requesting pain med, 6/10 generalized pain ... 3:58 p.m.: Medication given for anxiety, patient still upset and requesting to speak with supervisor. Notified. ...4:33 p.m.: Patient is still agitated and angry ... Patient noted to be argumentative and irritated ... MD (Medical Doctor) contacted for additional anxiety medications. Pending response ...".

During a review of Patient 10's "Physician Orders (PO)", dated 5/6/24 to 5/16/24, the PO indicated:

" ...Hydrocodone-acetaminophen (Brand name- strong opioid pain medication) 5-325 mg (milligrams- unit of measurement) ... ordered dose: 1 tablet ... Route: Oral (by mouth) ... Frequency: Every 6 hours PRN (as needed) for Moderate pain ... Scheduled start date/time 5/6/24 at 9:26 a.m. ... End Date/Time: (still active order) ...".

" ...Hydromorphone (Brand name- strong opioid pain medication) ... Ordered dose: .5 mg ... Route: Intravenous ... Frequency: Every 4 hours PRN for Severe pain, please give only if unable to tolerate oral medications ... Scheduled Start Date/Time: 5/9/24 at 1:47 p.m. ... Admin Instructions: ... If oral and IV medications are both ordered: Oral PRN pain medications are to be given if patient tolerating oral intake ...".

Patient 10 did not have an oral medication ordered for severe pain; IV Hydromorphone injection .5 mg was given seven times since the scheduled start date/time of 5/9/24.

During review of Patient 10's "Pain flowsheet (PF)" dated 5/17/24, the PF indicated, on " ...5/11/24 at 9:01 a.m., Pain Assessment: 8 severe. Medication given: 1 tab Hydrocodone-acetaminophen 5-325 mg by mouth ... 3:35 p.m., Pain Assessment: 8 severe. Medication given: 1 tab Hydrocodone-acetaminophen 5-325 mg by mouth ...". The PF indicated, on " ... 5/13/24 at 6:12 a.m., Pain Assessment: 8 severe. Medication given: 1 tab Hydrocodone-acetaminophen 5-325 mg ...". The PF indicated, on " ... 5/14/24 at 3:04 p.m., Pain Assessment: 8 severe. Medication given: 1 tab Hydrocodone-acetaminophen 5-325 mg ...". The PF indicated, on " ... 5/15/24 at 8:31 a.m., Pain Assessment: 9 severe. Medication given: 1 tab Hydrocodone-acetaminophen 5-325 mg ... 6:41 p.m., Pain Assessment: 8 severe. Medication given: 1 tab Hydrocodone-acetaminophen 5-325 mg...".

Patient 10's pain flowsheet was requested on 5/17/24 at 8:30 a.m. but was not provided.

During an interview on 5/17/24, at 10:00 a.m., with the Chief Nursing Officer (CNO), the CNO stated, she expects the nurses to follow hospital policies and procedures in relation to patient pain and their medications.

During an interview on 5/17/24 at 1:20 p.m., with RN 4, RN 4 stated she was the nurse for Patient 10 on 5/11/24 on the step-down unit of the hospital. RN 4 stated the point of the patient pain scale assessment was to give the appropriate medication to the patient for pain control. RN 4 stated Patient 10 did state his pain was severe but wanted Hydrocodone-acetaminophen instead of the Hydromorphone. RN 4 stated Patient 10 would say he had severe pain of an 8, "but looking at him he is just sitting there calm". RN 4 stated to her, Patient 10 did not "look like" he was in severe pain. RN 4 stated she never contacted the physician and Patient 10 did not have anything ordered by mouth for severe pain.

During an interview on 5/17/24 at 1:45 p.m., with the Step-down Nurse Manager (SDNM), the SDNM stated the RN should have documented that the Patient was having severe pain but was requesting a less potent medication. The SDNM stated a nurse should believe what the patient said their pain level to be and not go off of how they "look". The SDNM stated the physician should have been notified of the patient repeated request for Hydrocodone-acetaminophen with a severe pain score. The SDNM stated that Hydromorphone was what Patient 10 had ordered for severe pain and if staff needed a severe pain medication by mouth the physician should have been notified as well. The SDNM stated there was no note in Patient 10's electronic health record that showed the physician was contacted or the patient requested a less potent pain medication. The SDNM stated staff did not follow the facilities policy and procedure ""Pain Assessment & Management- Patients 14 and Older".

During a review of the facility's Policy and Procedure (P&P) titled, "Pain Assessment & Management- Patients 14 and Older", dated 10/12/23, the P&P indicated, "PURPOSE: A. To demonstrate [Hospital Name] commitment to a patient's right to effective pain management. B. To establish standards of nursing care and practice that defines the role and responsibilities of the RN to provide pain management at all facilities ... III. POLICY: A. It is the policy ... to provide safe and effective pain treatment for all patients ... B. Pain is whatever the person experiencing says it is ... Pain is always subjective ... 2. As prescribed by the provider, the RN may use their clinical judgment to: a. Determine the analgesic and dose to administer based on the scale of pain intensity. Upon patients request a nurse may administer a less potent analgesic ... and document the alteration from the scale of pain intensity and the electronic health record (EHR) ... C. Implementation: ... 2. Medications will be administered based on the patient's pain scale level identified and as ordered by the provider. A. Exception: A patient may request or agree upon a less potent medication (if ordered) or a lower dose of medication; however, this must be documented in the EHR as to the variance to order ... E. Pain management tool is a reliable and validated tool used to measure clinical pain intensity and approved for use ...IV. PROCEDURE: ... 5. Assess and reassess pain using one of the following scales as appropriate. a. 0-10 pain intensity scale ...

Based on interviews and record and document reviews, the hospital failed to ensure the safe and appropriate use of medications with heightened risk of patient harm as evidenced by:

1. The hospital failed to implement its policy on high-risk/high-alert medications to incorporate external alerts and internal respective review to identify opioids, including hydromorphone and morphine, as high-risk/high-alert medications and develop safeguards to reduce the risk of errors. The hospital also did not take appropriate actions to prevent future adverse drug events after one patient, Patient 1, suffered anoxic brain injury (death of brain cells due to oxygen deprivation to the brain) and died in October 2023 as a result of unsafe opioid use.

2. The hospital failed to consistently implement its Black Box Warning (BBW, the highest safety-related warning that medications can have assigned by the Food and Drug Administration) policy and procedure (P&P) and take precautions to address the warning and recommendations issued by external alerts and the FDA (U.S. Food and Drug Administration) pertaining to the heightened risks associated with the use of opioids.

This failure compromised the hospital's ability to prevent serious patient harm from medication errors involving known high-risk medications.

Findings:

1. During a concurrent interview and record review on 5/9/24 at 1:34 p.m. with Pharmacy Medication Safety Coordinator (PMSC), Patient 1's physician's orders were reviewed. PMSC confirmed Patient 1 had the following medication orders approved by the pharmacist without any clinical interventions:

- Morphine 4 milligrams (mg, a unit of measurement) IV: 4 mg intravenous (IV, into the vein) once, ordered 10/11/23 at 6:52 p.m.
- Hydromorphone 1 mg IV: 1 mg every 4 hours as needed for severe pain, ordered 10/11/23 to 10/12/23 at 1:51 p.m.
- Hydromorphone 1 mg IV: 1 mg every 4 hours as needed for severe pain and breakthrough pain, ordered 10/12/23 at 1:50 p.m.

Patient 1's Medication Administration Record (MAR) indicated Patient 1 was administered IV morphine 4 mg on 10/11/23 at 6:59 p.m., hydromorphone 1 mg IV on 10/12/23 at 11:49 p.m. and 10/13/23 at 5:29 a.m. Patient 1 was found pulseless on 10/13/23 at 6:20 a.m. and a Code Blue (a code used in hospitals to indicate the need for immediate medical attention most often because of respiratory or cardiac arrest) was called. Patient 1 had to be intubated, admitted to the Intensive Care Unit (ICU, a hospital ward that provides specialized care to patients who are critically injured or ill), and subsequently died on 10/23/23.

Patient 1's Discharge Summary, dated 10/24/23, indicated, "Problems and Discharge Diagnoses ... respiratory arrest due to narcotics (opioids) ... Summary ... 10/15 ... MRI [magnetic resonance imaging, imaging test that produces detailed images of internal structures in the body] of the head suggests anoxic brain injury [death of brain cells after a complete oxygen deprivation to the brain]... Downtime unknown..."

Hydromorphone and morphine belong to a class of drugs called opioids. IV opioids work in the brain to produce a variety of effects including pain relief. IV opioids are potent and potentially dangerous medications due to their potential to cause adverse events, such as over sedation, respiratory depression, and death in some cases.

Institute for Safe Medication Practices (ISMP), a recognized nonprofit organization in the USA devoted to the prevention of medication errors, has identified opioids/narcotics as high-alert medications since 2014 to alert health care providers of the patient safety risks associated with their use. Based on error reports submitted to the ISMP National Medication Errors Reporting Program (ISMP MERP), reports of harmful errors in the literature, studies that identify the drugs most often involved in harmful errors, and input from practitioners and safety experts, ISMP created and periodically updates a list of potential high-alert medications. Practitioners responded to an ISMP survey designed to identify which medications were most frequently considered high-alert medications. High-alert medications are drugs that bear a heightened risk of causing significant patient harm when they are used in error. Although mistakes may or may not be more common with these drugs, the consequences of an error are clearly more devastating to patients.

During a review of the hospital's P&P titled, "Medications- High Alert & High Risk for Patients 14 and Older," dated 1/9/24, the P&P indicated that the hospital defined high-risk/high-alert drugs as, "Medications ... that have been shown to actually or potentially cause significant harm to patients, even when used as intended. This may be determined through retrospective review or practice; recommendations from organizations, such as the Institute for Safe Medication Practices (ISMP); or prospective analysis." The purpose of the policy was, "To provide guidelines to ensure patient safety for the safe selection, storage, ordering, transcribing, preparation, monitoring, administration, use and medication system evaluation of medications which have been identified as 'High-Alert/High-Risk.'" Morphine and hydromorphone were not identified as high-risk/high-alert medications on the policy.

A review of Patient 1's Discharge Summary, dated 10/24/23, indicated, "Problems and Discharge Diagnoses: respiratory arrest due to narcotics (opioids).

During an interview with PMSC on 5/14/24 at 1:38 p.m. (7 months after Patient 1 suffered respiratory arrest from opioid use), PMSC stated the hospital identified certain medications used within the hospital as high-risk/high-alert that required special safeguards in place well beyond most other medications, but IV opioids including hydromorphone and morphine were not included on the hospital's high-risk/high-alert medication list.

2. During a review of the hospital's P&P titled, "Black Box Warning," dated 2/10/22, indicated the purpose was, "To identify medications having the Food and Drug Administration (FDA) designated Black Box Warning applicable to [the hospital's medical centers]." The policy also indicated the following: "A. All FDA releases of black box warning medications will be continuously reviewed and assessed. B. Pharmacy services, working in conjunction with the [hospital medication management committee], will identify those agents with objective risk reduction measures which require specific actions by the healthcare professional. C. The medication(s) will be evaluated by pharmacy services based on formulary status, relative risk, significance, site specific utilization and the patient population involved. The BBW medication list may be revised by pharmacy services as needed based on parameters including but not limited to increased use, revised indication for use, revisions to the BBW and results of new evidence from external sources ..."

During a review of the hospital's Emergency Department IV Opioid Prescribing Patterns, dated April 2024, the report indicated the hospital utilized hydromorphone 18.9% and morphine 47.7% of the time whenever IV opioids were administered.

Hydromorphone and morphine are potent and potentially dangerous IV opioid medications due to their potential to cause serious, and potentially life-threatening adverse events. Given the high-risk nature of IV opioids, the manufacturer's labeling includes a Black Box Warning that warns of the risk of respiratory depression and death when used in combination with other opioids.

During an interview on 5/10/24 at 11:54 a.m. with PMSC, PMSC confirmed the hospital had a Black Box Warning medication list but hydromorphone and morphine were not included.

A review of the manufacturer's PI for IV Dilaudid (brand name for hydromorphone) indicated a Black Box Warning at the top of the Package Insert as follow: "WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS ... Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase." Under section 5.2, "Life-Threatening Respiratory Depression: Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, even when used as recommended. Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death. Management of respiratory depression may include close observation, supportive measures, and use of opioid antagonists, depending on the patient's clinical status. While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of DILAUDID INJECTION, the risk is greatest during the initiation of 2 therapy or following a dosage increase. Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy with and following dosage increases of DILAUDID INJECTION. To reduce the risk of respiratory depression, proper dosing and titration of DILAUDID INJECTION is essential."

A review of the hospital's Black Box Warning list, revised and approved by the Pharmacy and Therapeutics Committee on 8/25/21, indicated that intravenous and oral opioids, including morphine and hydromorphone, were not included on the list.

On 5/9/24 at approximately 5 p.m., a request was made for hospital to provide a policy for the safe use of narcotics/IV opioids. On 5/10/24 Risk Coordinator (RC) confirmed the hospital did not have a policy pertaining specifically to the use of opioids in the hospital.

American Society of Health-System Pharmacists (ASHP), the largest professional association of pharmacists in the United States, has published minimum standard guidelines intended to serve as a basic guide for the provision of pharmacy services in hospitals. The "ASHP Guidelines: Minimum Standard for Pharmacies in Hospitals," dated 4/13/12, indicated pharmacists and other appropriate hospital personnel shall establish and regularly revise policies and procedures regarding medication error and adverse event prevention and reporting to ensure that patient care services provided by pharmacists and other pharmacy personnel are delivered in adherence to applicable state and federal laws and regulations, hospital privileging requirements, and national practice standards. Pharmacy management should actively work with or as a part of hospital or health-system leadership to develop and implement policies and procedures that provide safe and effective medication use for the patients served by the institution."

Based on interviews and record reviews, the hospital failed to develop and implement systems to ensure the safe use of medications. Patient 1 received multiple doses of intravenous (IV, into the vein) opioids, a class of medication identified as high-risk/high-alert medications, exceeding the manufacturer's recommended dose for the patient's medical conditions, and suffered respiratory and cardiac arrest (stopping of the heart and breathing) leading to anoxic brain injury (death of brain cells due to oxygen deprivation to the brain) and subsequently expired 10 days later.

Findings:

A review of Patient 1's medical record indicated she was seen in the Emergency Department (ED) on 10/11/23 with diagnoses including abdominal wall cellulitis (A deep infection of the skin caused by bacteria), left abdominal, flank and upper leg pain and swelling, and end stage renal disease (ESRD, the final, permanent stage of chronic kidney disease, where kidney function has declined to the point that the kidneys can no longer function on their own) who received hemodialysis (a procedure where a dialysis machine and a special filter called an artificial kidney, or a dialyzer, are used to clean the blood) three times a week.

During a concurrent interview and record review on 5/9/24 at 1:34 p.m. with Pharmacy Medication Safety Coordinator (PMSC), Patient 1's physician's orders were reviewed. PMSC confirmed Patient 1 had the following medication orders approved by the pharmacist without any clinical interventions:

- Morphine 4 milligrams (mg, a unit of measurement) IV: 4 mg IV once, ordered 10/11/23 at 6:52 p.m.
- Hydromorphone 1 mg IV: 1 mg every 4 hours as needed for severe pain, ordered 10/11/23 to 10/12/23 at 1:51 p.m.
- Hydromorphone 1 mg IV: 1 mg every 4 hours as needed for severe pain and breakthrough pain, ordered 10/12/23 at 1:50 p.m.

Hydromorphone and morphine belong to a class of drugs called opioids. IV opioids work in the brain to produce a variety of effects including pain relief. IV opioids are potent and potentially dangerous medications due to their potential to cause adverse events, such as over sedation, respiratory depression, and death in some cases.

Patient 1's Medication Administration Record (MAR) indicated Patient 1 was administered IV morphine 4 mg on 10/11/23 at 6:59 p.m., hydromorphone 1 mg on 10/12/23 at 11:49 p.m. and 10/13/23 at 5:29 a.m. Patient 1 was found unresponsive and pulseless on 10/13/23 at 6:20 a.m. and a Code Blue (a code used in hospitals to indicate the need for immediate medical attention most often because of respiratory or cardiac arrest) was called. Patient 1 had to be intubated, admitted to the Intensive Care Unit (ICU, a hospital ward that provides specialized care to patients who are critically injured or ill), and subsequently died on 10/23/23.

Patient 1's Discharge Summary, dated 10/24/23, indicated, "Problems and Discharge Diagnoses ... respiratory arrest due to narcotics (opioids) ... Summary ... 10/15 ... MRI [magnetic resonance imaging, imaging test that produces detailed images of internal structures in the body] of the head suggests anoxic brain injury [death of brain cells after a complete oxygen deprivation to the brain]... Downtime unknown ..."

During a concurrent interview and record review on 5/9/23 at 11:02 a.m. with PMSC, the manufacturer's Package Insert (PI) for IV Dilaudid (brand name for hydromorphone) was reviewed. The PI indicated, under section 5.2, "Life-Threatening Respiratory Depression": Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, even when used as recommended. Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death. Management of respiratory depression may include close observation, supportive measures, and use of opioid antagonists, depending on the patient's clinical status. While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of DILAUDID INJECTION, the risk is greatest during the initiation of 2 therapy or following a dosage increase. Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy with and following dosage increases of DILAUDID INJECTION. To reduce the risk of respiratory depression, proper dosing and titration of DILAUDID INJECTION is essential. Under Section 2.1, "Dosing and Administration: The usual starting dose for intravenous administration is 0.2 mg to 1 mg every 2 to 3 hours. Patients with hepatic [liver] and renal [kidney] impairment should be started on a lower starting dose ... 8.6 Renal Impairment ... start patients with renal impairment on one-fourth to one-half the usual starting dose depending on the degree of impairment. Patients with renal impairment should be closely monitored during dose titration." PMSC stated the hydromorphone 1 mg dose (double the dose indicated by the manufacturer) did not seem like a high dose, despite the manufacturer's dosing guidelines for renally impaired patients.

During an interview on 5/9/24 at 1:40 p.m. with Director of Pharmacy (DOP), DOP stated the manufacturer's PIs were a starting place for determining a dose but that medications were often dosed off label. No evidence-based clinical justification was provided to support the appropriate dosing of hydromorphone and morphine for Patient 1.

During an interview on 5/10/24 at 11:05 a.m. with PMSC, PMSC stated morphine was a drug that should have been avoided in renal patients due to the dangerous buildup of metabolites (a substance made when the body breaks down drug) leading to respiratory depression, sedation, lowered blood pressure and slowing of the heart rate. He stated if he received an order for morphine for a renal patient, he would have called the doctor to ask for an alternative.

The Merck Manuals, medical references that cover a wide range of medical topics, including disorders, tests, diagnoses, and drugs, which have been published since 1899, indicates that many drugs, particularly water-soluble drugs and their metabolites, are eliminated largely by the kidneys in urine. Therefore, drug dosing depends largely on kidney function. In people whose kidney function has declined, the "normal" dosage of a drug that is eliminated primarily through the kidneys may be too much and may cause side effects. Therefore, health care practitioners sometimes must adjust the drug dosage based on the amount of decline in the person's kidney function. People with impaired kidney function require lower drug doses than those with normal kidney function. Health care practitioners have several ways to estimate the decline in kidney function. A more accurate estimate of kidney function by using the results of tests that measure the level of creatinine (a waste product) in the blood and sometimes also the urine. They use these results to calculate how effectively creatinine is removed from the body (called creatinine clearance, which reflects how well the kidneys are functioning.

A review of Patent 1's labs, dated 10/11/23, indicated she had a creatinine clearance (CrCl) of 21.77 milliliters/minute (mL/minute, a unit of measurement).

During an interview on 5/10/24 at 11:20 a.m., PMSC demonstrated the pharmacy order review process for patient with compromised kidney function by creating a "test patient" with a CrCl of 6 mL/min (indicating severe renal impairment) and an order for IV hydromorphone 10 mg administered as a single dose. PMSC confirmed the system generated an alert only for doses of 4 mg and above (Eight to 80 times the starting dose indicated by the manufacturer). PMSC stated the maximum dose allowed by the system should have been more conservative.

According to UpToDate Lexi-Drug, a drug information provider for health care professionals, IV morphine dosing for altered kidney function indicated, "As kidney function deteriorates ... patients may experience CNS (central nervous system) depression, sedation, and severe and prolonged respiratory depression, which may be delayed in presentation ... CrCl 15 to <30 mL/minute: Avoid use. If necessary, administer 25% to 50% of usual initial dose; may also consider extending dose interval. Titrate cautiously to response. CrCl <15 mL/minute: Avoid use."

During an interview on 5/14/24 at 9:59 a.m. with Pharmacist 1, Pharmacist 1 stated when medication orders were reviewed for appropriateness, the same process was followed for routine and one-time orders for all areas of the hospital. He stated the same verification process was used and steps were not bypassed for one-time orders. He stated a one-time dose of hydromorphone 1 mg from the ED was on the high end and would alert him to look further to see what was going on with a patient to warrant such a dose.

American Society of Health-System Pharmacists (ASHP), the largest professional association of pharmacists in the United States, has identified minimum standard guidelines intended to serve as a basic guide for the provision of pharmacy services in hospitals. The "ASHP Guidelines: Minimum Standard for Pharmacies in Hospitals," dated 4/13/12, indicated, "Medication therapy monitoring includes a proactive assessment of patient problems and an assessment of the following: a. The therapeutic appropriateness of the patient's medication regimen ... c. The appropriateness of the dose of the medication, as well as the route, method, and frequency of administration of the medication ... e. Medication-medication, medication-food, medication-dietary supplement, medication-laboratory test, and medication-disease interactions. f. Adverse drug reactions and other undesired effects ... h. Clinical and pharmacokinetic laboratory data to evaluate the efficacy and safety of medication therapy and to anticipate toxicity and adverse effects."

During a review of the hospital's Policy and Procedure (P&P) titled, "Medications- Orders, Administration, Storage, Documentation," dated 12/19/23, the P&P indicated, "V. Procedure ... B. Assess patient for factors that may place them at greater risk for adverse effects of the medication. Factors including, but not limited to, age, altered liver and kidney function ... may contribute to increased risk."

During a review of the hospital's P&P titled, "Medications Orders - Pharmacist Order Review Process," dated 1/8/24, the P&P indicated that the pharmacist would review all medication orders for appropriate medication prescribing, including medication dose, route of administration and drug selection, to ensure accuracy and patient safety. Under Section IV. Procedure ... D. "Pharmacists will apply appropriate clinical judgement in evaluating drug therapy. If there are questions or concerns with the medication prescribed, the physician will be contacted before administration to the patient. These concerns may include, but not limited to, the following ... 2. Appropriate drug selection and 4. Appropriate dosage and frequency ..."

A review of Patient 1 's clinical record indicated naloxone (an opioid antagonist, reversal agent for opioid overdose) was not administered during Code Blue despite the patient having had received a dose of hydromorphone IV 1 mg within one hour before the patient was found unresponsive.

During an interview on 5/9/24 at approximately 2 p.m. with PMSC, PMSC confirmed that naloxone was not administered during the Code Blue when Patient 1 was found unresponsive. When asked if there was any potential negative outcome associated with administering naloxone during the Cold Blue, PMSC responded that the risk would have been very low and the benefit would have surely outweighed the risk.

A review of the manufacturer's PI for hydromorphone IV indicated that for clinically significant respiratory or circulatory depression secondary to hydromorphone overdose, an opioid antagonist (naloxone) should be administered.

Institute for Safe Medication Practices (ISMP), a recognized nonprofit organization in the USA devoted to the prevention of medication errors, has identified opioids/narcotics as high-alert medications for over a decade to alert health care providers of the patient safety risks associated with their use. The "ISMP List of High-Alert Medications in Acute Care Settings," dated 1/10/24, indicated, "High-alert medications are drugs that bear a heightened risk of causing significant patient harm when they are used in error. Although mistakes may or may not be more common with these drugs, the consequences of an error are clearly more devastating to patients."