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Based on observations, interviews, and record review, that facility failed to have a well-organized and effective nursing service when:

1. Licensed Nurses (LN) did not follow the hospital's P&Ps for "Pain Management", Licensed Provider Orders: Receiving, Transcribing, Reviewing" and "Medication Administration" for eight of 14 Pts (Pts 1, 3, 7, 8, 12, 15, 19, 21). For six of 14 Pts (Pts 1, 3, 12, 15, 19, 21), LNs did not complete a pain assessment. For three of 14 Pts (Pts 1, 15, 19), LNs did not reassess pain after administration of pain medication within the expected timeframe. LNs did not administer adequate pain medications to address 10/10 pain experienced by Pt 3 and instead inappropriately administered Acetaminophen. LNs did not follow the Pt 7's physician's order to titrate (slowly increasing the dose of a medicine by very small amounts to find the right dose that is effective) the pain medication. (Refer to A-0398 Finding 1)

2. Licensed Nurses (LNs) did not monitor the patient while administering a high-risk/high-alert medications (Medications that have a heightened risk of causing significant patient harm when they are used in error) in accordance with their policies for "Medication Administration" and "High Risk/High Alert Medications" for one of one sampled patient (Pt 10). (Refer to A-0398 Finding 2)

3. Licensed nurses (LNs) did not clarify an order of "ventilator compliance" for a medication used for sedation in accordance with their policy for "Medication Administration" for one of one sampled patient (Pt 5). (Refer to A-0398 Finding 3)

4. LNs did not follow the physician order (PO) for two of three patients (Pt 1 and Pt 20), when the ordered neurological assessment (a physical exam that helps identify disorders of the brain, spinal cords, and nerves) was completed by LNs without the pupil measurement, according to hospital policy and procedure (P&P) "Neurological Assessment and Flow Sheet". (Refer to A-0398 Finding 4)

5. LNs did not document a change of condition assessment for one of 17 patients (Pt 1) after Pt 1 had an unexplained injury, in accordance with the hospital P&P titled, "Assessment: Admission and Reassessment." (Refer to A-0398 Finding 5)

6. LNs failed to document discharge instructions were to two of 36 patients (Pt 1 and Pt 20) according to hospital P&P titled "Discharge Planning Services". (Refer to A-0398 Finding 6)

7. LNs failed to review one of four sampled patients (Pt 5) discharge medications with the patient and family prior to discharge on 11/22/24, which resulted in Pt 5 being prescribed the wrong dose of Coreg (medication used to treat high blood pressure and heart failure (chronic condition in which the heart does not pump blood as well as it should)) causing Pt 5 to be readmitted on 11/26/24 with low blood pressure (hypotension) and low heart rate (bradycardia- below 60 heart rate). (Refer to A-0398 Finding 7)

8. LNs did not develop and keep current nursing care plans for two of 14 patients (Pt 4 and Pt 20). (Refer to A-0396)

9. The hospital failed to monitor and keep current one of two Monitor Technician (MT- staff member who monitors heart rhythms and reports to nurse if there are irregular rhythms)/ Nursing Assistant (NA) required annual and biannual skills validation training (process of assessing, verifying, and documenting an individual's competencies in a specific area) for Basic Life Support (BLS - a course designed to equip healthcare providers with basic skills and knowledge needed to respond effectively to breathing and cardiac emergencies in adults, children and infants) and Monitor Technician Electrocardiograph (EKG- test that measures the heart's electrical activity) Exam. (Refer to A-0397)

The cumulative effect of these system problems resulted in the hospital's inability to provide quality nursing care in a safe setting.

Based on observation, interview and record review, the hospital failed to ensure pharmaceutical services met the needs of patients when:

1. The appropriateness of Patient 5's medication regimen prior to discharge was not reconciled. Patient 5's carvedilol (medication to lower blood pressure and strengthens heart to pump blood) dose was inappropriately increased prior to discharge. This failure resulted in Patient 5's return to the hospital's emergency department four days after discharge with hypotension (low blood pressure) and bradycardia (slow heart rate) and potential beta blocker (medication like carvedilol that lowers prssure) overdose. (Refer to A500)

2. An effective system to monitor high controlled substance (CS, medications with high probability of addiction and are controlled by the federal government) usages was not implemented and accurately reconcile controlled drugs losses for three of four sampled patients (Patients 57, 58, 59). These failures increased the potential to result in unaccounted controlled drug loss and for hospital staff to divert controlled drugs, which could place patients at risk for potential adverse outcomes including inadequate pain relief, as well as the potential for hospital staff to abuse controlled drugs. (Refer to A494)

3. Controlled substance (CS medications with high probability of addiction and are controlled by the federal government) medications were not stored according to hospital policy and procedures (P&P) for three of three sampled patients (Patients 56, 54, 55). These failures had the potential for CS medication diversion (illegal use of prescription medication or use for purposes not intended by the prescriber) and unauthorized access to medications. (Refer to A503)

4. The hospital failed to follow its policy titled, "Labeling of Medications" when three of 10 medications were observed to be unlabeled and left in a patient's (Pt 8) drawer in a medication cart on the Oncology (a branch of medicine that specializes in the diagnosis and treatment of cancer) unit and were available for patient use. (Refer to 505)

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure quality patient care in a safe setting.

Based on interview and record review, the hospital failed to consider the right of patients to receive communication in preferred language for four of sixteen patients (Pt 6, Pt 16, Pt 17 and 21) whose preferred language was not English, patient care and services were not communicated in the preferred language, and interpreter services (help people communicate with each other when they speak different languages) were not used, in accordance with the hospital policies and procedures (P&P) titled, "Language Assistance Services Policy" and "Conditions of Admission and/or Registration Form".

These failures had the potential for ineffective communication, misunderstandings, and possible patient harm.

Findings:

During a concurrent interview and record review on 12/3/24 at 3:40 p.m. with Registered Nurse (RN) 2, Pt 21's "Electronic Medical Record [EMR]" was reviewed. RN 2 stated she was Pt 21's primary nurse for the day shift on 12/3/24. RN 2 stated Pt 21 understood some English. RN 2 stated, Pt 21's "Admission Navigator Admit Information [ANAA]," dated 12/1/24 indicated Pt 21's preferred language was Pashto, and an interpreter was needed for communication. RN 2 stated Pt 21's brother had been at bedside during her beginning of shift assessment, and he interpreted for Pt 21. RN 2 reviewed Pt 21's "Interpreter Services Flowsheet [ISF]," dated 12/3/24 and no interpreter information was documented. RN 2 stated she had not documented in the interpreter flowsheet for the morning assessment yet. RN 2 stated she should document on the "ISF" when Pt 21's brother interprets. RN 2 stated Pt 21 should have signed a consent form indicating his brother could interpret for him, but none was scanned into the "EMR". RN 2 stated the interpreter line should have used for Pt 21 when family was not at bedside for any new information and to ensure Pt 21 understood his plan of care, so "nothing gets lost in translation."

During an observation and interview on 12/3/24 at 3:48 p.m. with Pt 21 in his hospital room, Pt 21 was observed lying in bed with his eyes open. Pt 21 had no family at bedside. Pt 21 had bruising to right eye, with bandages to the cheekbone by right eye. Pt 21 stated he understood a little English, but he preferred Pashto was spoken to him. Pt 21 stated his brother was there sometimes and interpreted.

During an interview on 12/3/24 at 3:53 p.m. with Director (DIR) 3, DIR 3 stated, common practice was to use an interpreter for non-English speaking patients for medical treatment. DIR 3 stated patients could designate family to interpret for them, and the hospital designated family interpreter form was signed by the patient and scanned into the medical record. DIR 3 stated LNs must document who interpreted in the medical record. DIR 3 stated the expectation was for LNs to follow the hospital's interpreter policy and procedure.

During a concurrent interview and record review on 12/5/24 at 1:30 p.m. with Nurse Educator (NE) 1 Pt 21's "ISF," dated 12/1/24 was reviewed. NE 1 stated on 12/1/24 no LN documentation was entered on the "ISF". NE 1 stated LNs should have used an interpreter when communicating Pt 21's plan of care, for any consents, and any new medications. NE 1 stated an interpreter should have been used and the information documented on the "ISF".

During an interview on 12/11/24 at 2:50 p.m. with the Chief Nursing Officer (CNO) the CNO stated, LNs should follow the hospital's policy and procedure for interpreters.

During a review of Pt 17's "H&P" dated 11/23/24, the "H&P" indicated, Pt 17 was brought into the Emergency Department (ED) on 11/9/24 with Altered Mental Status (AMS - change in a person's mental function, including their level of consciousness, awareness, cognition, or behavior) after being found in a parked car. Pt 17 was admitted to the hospital as an inpatient on 11/9/24 for acute respiratory failure (lungs cannot get enough oxygen for the body to survive) and Fournier's gangrene (a type of flesh-eating disease that effects the genital area) and was moved to the ICU. The H&P indicated Pt 17 was in the Intensive Care Unit (ICU) from 11/9/24 to 11/22/24 and Pt 17 was moved to the Cardiac Telemetry (patient's heart rhythm and rate, respiratory rate and oxygen are continuously monitored) Unit on 11/23/24 for intensive medical and surgical management due to the complexity and severity of his health issues.

During an observation on 12/4/24 at 10:04 a.m. in Pt 17's hospital room, Pt 17 was observed lying in bed at a 30-degree angle watching television with a sitter and Licensed Nurse (LN) at bedside. Pt 17 was heard speaking Spanish to his LN, and safety sitter.
During an interview on 12/4/24 at 10:25 a.m. with Registered Nurse (RN) 10, RN 10 stated she was Pt 17's primary nurse. RN 10 stated Pt 17 was a Spanish speaking patient who could be "belligerent [hostile and aggressive]" and "combative [ready to fight]" with the LNs and Certified Nursing Assistants (CNAs) when receiving care. RN 10 stated she used interpreter services for Pt 17 when communicating new medical information, and any consents.

During a concurrent interview and record review on 12/5/24 at 9:35 a.m. with NE 2 Pt 17's, "Interpreter Tab" documents dated 11/23/24 to 11/25/24 were reviewed. The "ADA [American with Disabilities Act] Accommodations Provided [ADAP]" under the "Interpreter Tab," indicated, Pt 17's, preferred language was Spanish and language assistance was needed. The "ISF" documentation was blank on 11/23/24, 11/24/24, and the a.m. shift of 11/25/24 indicating an interpreter was not used to communicate with Pt 17. NE 2 stated on 11/23/24 at 1:30 p.m. and 11/25/24 at 9:10 a.m. LNs documented in the "ADAP" Pt 17 needed language assistance in Spanish, but the "ISF" was blank. NE 2 stated on 11/24/24 no documentation was in the medical record for Interpreter Services. NE 2 stated LNs should have used an interpreter to communicate with Pt 17. NE 2 stated using an interpreter was important when communicating things such as, education, medications, and plans of care, so that Pt 17 could understand what was being done to him and for him. NE 2 stated LNs should be providing "patient centered care".

During an interview on 12/11/24 at 2:50 p.m. with the Chief Nursing Officer (CNO) the CNO stated, LNs should follow the hospital's policy and procedure for interpreters.

During a concurrent interview and record review on 12/5/24 at 1:40 p.m. with Nurse Educator (NE) 2, Pt 16's "H&P," dated 12/1/24, "Conditions of Admission [COA-consent to the general terms and condition for receiving care from hospital. Authorizes general medical and nursing to be provided and financial responsibility for payment of hospital charges for services rendered]," dated 12/1/24 at 2:50 p.m. and "ISF" dated 12/1/24 p.m. was reviewed. The "H&P" indicated Pt 16 was "Cambodian Speaking". NE 2 stated Pt 16's "COA" was in English, Pt 16 signed the form, and two staff members witnessed the form but the area on the form indicating an interpreter was used was left blank. NE 2 stated Patient Access Staff completed the "COA" form with patients upon admission to the hospital. NE 2 stated Pt 16's "ISF" had no documentation an interpreter was used for the "COA". NE 2 stated hospital staff were supposed to document in the "ISF" when an interpreter was used.

During an interview on 12/9/24 at 8:40 a.m. with the Manager of Patient Access (MPA) and the Patient Access Lead (PAL), the PAL stated Pt 16's preferred language (Cambodian) was not available (in written form) in the facility's "COA" so Patient Access Staff should have used an interpreter. The PAL stated when an interpreter was used, registration staff were supposed to document the interpreter's name, ID number, and if interpreter was by phone, video, or in person. The PAL stated Patient Access Staff could also document in the "ISF" when an interpreter was used. The PAL stated using an interpreter for non-English speaking patients was important to ensure understanding of the document before signing.

During a concurrent interview and record review on 12/6/24 at 10:25 a.m. with Registered Nurse (RN) 6, Pt 6's "Electronic Medical Record [EMR] was reviewed. Pt 6's "Admission Navigator Admit Information [ANAA]," dated 12/2/24 indicated Pt 6's preferred language was Spanish, and an interpreter was needed for communication. Pt 6's "COA," dated 12/2/24 at 7:28 a.m. was in English, signed by Pt 6 and Patient Access Staff, and the interpreter field was blank. RN 6 stated the "COA" should have been given to the patient in Spanish or the interpreter field should have been completed if an interpreter was used to translate the form. RN 6 stated PT 6's "ISF" had no documentation from Patient Access Staff.

During a concurrent interview and record review on 12/9/24 at 8:45 a.m. with the MPA and the PAL, Pt 6's, "ANAA" and "ISF," dated 12/2/24, and the "COA," dated 12/2/24 at 7:28 a.m. were reviewed. The PAL verified on the "ANAA" Pt 6 indicated her preferred language was Spanish, and she requested an interpreter. The PAL verified Pt 6's "COA" was written in English and no interpreter information was documented on the "COA" or on the "ISF". The PAL stated the "COA" should have been written in Pt 6's preferred language and/or an interpreter should have been used to interpret the form.

During a review of the hospital's P&P titled, "Language Assistance Services Policy," dated 1/8/24, indicated, " ... To ensure that Limited English Proficient (LEP) persons and persons with hearing or visual impairments have equal access as well as awareness as to possible options for all services offered by [hospital] ... [hospital] will promptly identify the language and communication needs of the LEP person ... The interpreter's responsibilities will include translating the information regarding the recommended medical treatment that the patient or the patient's legal representative needs to receive before deciding whether to give consent, as well as instructions regarding medical care ... The patient has the right to appoint someone to interpret for themselves. In these cases, the patient MUST sign the [hospital] "Patient Appointed Language and Sign Language Consent" Form ... Use of family members or companions as interpreters is discouraged, except for the most extraordinary circumstances, such as medical emergencies ... Staff will be utilized only for simple interpretations such as those dealing with Activities of Daily Living (ADLs) and simple patient care related issues ... Staff will not translate for conversations dealing with medical issues, i.e. [such as] diagnosis and/or treatment, risks and benefits, informed consents, etc. ... Vital documents, including consent forms, presented by hospital staff to a patient will be written in a language that the patient can understand or translated into such a language ... [hospital] will conduct a nursing admission assessment of the communication needs of each patient served and record the patient's needs in the medical record ... The assessment will include: ... Preferred language ... Need for interpreter services (e.g., LEP, hearing impairment, sight impairment) Any subsequent use of any interpreter services will be documented in the medical record ... Reason for service ... Agency Used ... Name/and or ID number of the interpreter ..."


During a review of the hospital's P&P titled, "Conditions of Admission and/or Registration Form," dated 3/27/24, indicated, " ... A Conditions of Admission (COA) and/or Conditions of Registration (COR) Consent Form must be signed by each patient or patient's representative upon admission to [hospital name] or as soon thereafter as possible. It is the responsibility of the representative to clearly define each aspect of the conditions of admission to the patient/patient representative ... If a patient is identified as having Limited English proficiency (LEP), language assistance will be provided through use of language identification cards, proficient bilingual staff, telephone language interpretation vendor services, and/or other arrangements. A patient, after being informed of the availability of the interpreter service, may choose to use a family member/friend instead ..."


During a review of professional reference titled, "Clinicians' Obligations to Use Qualified Medical Interpreters When Caring for Patients with Limited English Proficiency," dated 3/2017, (retrieved from https://journalofethics.ama assn.org/article/clinicians obligations use qualified medical interpreters when caring patients limited English/2017 03) indicated, " ... Access to language services is a required and foundational component of care for patients with limited English proficiency (LEP) ... In the United States, patients with LEP have a legal right to access health care in their preferred language ..."

Based on observation, interview and record review, the hospital failed to ensure nursing staff developed and kept current a nursing care plan when:

1. Licensed Nurses (LNs) did not assess and develop a care plan for Pt 20's primary admitting diagnosis of seizures (a temporary episode of abnormal electrical activity in the brain that causes sudden change of behavior, movement, or consciousness) and alcohol withdrawal in accordance with hospital policy and procedure (P&P) titled, "Patient Plan of Care" and the hospital "Registered Nurse Job Description".

This failure had the potential to result in Pt 20's seizure and alcohol withdrawal care needs going unmet and could possibly lead to a decline in health status.

2. LNs did not assess and revise an individualized care plan for one of two sampled patients (Pt 4) for safety and smoking cessation in accordance with their policy and procedure titled "Patient Plan of Care".

This failure had the potential to result in Pt 4's care needs going unmet and could possibly lead to a decline in health status.

Findings:

1. During a concurrent interview and record review on 12/5/24, at 2:40 p.m. with Nurse Educator (NE) 1, Pt 20's "History and Physical [H&P - the formal document that physicians produce through interview with the patient, physical exam, and the summary of testing either obtained or pending]", dated 12/2/24, was reviewed. The "H&P" indicated, Pt 20 had a past medical history of hypertension (high blood pressure), seizure disorder (a chronic brain condition that causes recurring temporary episodes of abnormal electrical activity in the brain that cause sudden change of behavior, movement, or consciousness), and alcohol abuse, who presented to the ED (Emergency Department) after three unwitnessed seizures the day before. NE 1 stated Pt 20 was admitted to the hospital as an inpatient on 12/2/24 for alcohol withdrawal seizures. NE 1 stated Pt 20 was moved to the Medical Surgical (MS) unit on 12/2/24 at 5:51 a.m.

During a concurrent interview and record review on 12/5/24, at 2:48 p.m. with NE 1, Pt 20's "Care Plan Event Log [CPEL]", dated 12/2/24 to 12/4/24 was reviewed. Pt 20's "CPEL" addressed issues for impaired skin integrity, and falls. NE 1 stated Pt 20's alcohol withdrawal and history of seizures were not addressed in the care plan. NE 1 stated there should have been a nursing care plan to address Pt 20's seizures and alcohol withdrawal. NE 1 stated LNs were expected to develop care plans that matched and guided the care needs of the patient and ensured individualized care was provided.

During an interview on 12/6/24 at 9:03 a.m. with Nurse Manager (NM) 3, NM 3 stated, nurses were expected to initiate and revise care plans for patient's care needs.

During a concurrent interview and record review with the Chief Nursing Officer (CNO), on 12/11/24, at 2:40 p.m., Pt 20's primary diagnosis and past medical history were reviewed. The CNO stated Pt 20's primary diagnosis and any chronic diseases should have been addressed by LNs in the care plan. The CNO stated, LNs were expected to follow hospital policy and procedure to develop, document and update the care plan to meet the patients' care needs.

During a review of the facility P&P titled, "Patient Plan of Care", dated 10/19/23, the P&P indicated, " ... The plan is individualized/revised based on ongoing assessment findings, the patient's response to treatment/interventions and evaluation of progress toward outcomes. Care planning ends at discharge/ transition of care ... Patient Plan of Care: Patient-centric documented plan for care, treatment and services that reflects his/ her specific needs and preferences. It may include individualized goals and services required to meet those goals in the designated setting of care. It is maintained/revised based on the patient's condition, preferences, response to interventions. It is the patient's plan - the centralized plan that drives the priorities and professional processes of care for the inter-professional team to prevent/manage/minimize potential problems and outcomes ...Reviewing and updating the plan of care occurs on an ongoing basis throughout the patient's hospitalization. Each shift the registered nurse is responsible for reviewing and updating the plan of care after assessing the patient. Additionally, other members of the inter-professional care team will review and update the plan of care as necessary ..."

During a review of the hospital's document titled, " Registered Nurse Job Description" dated 12/3/24, indicated, " ... Delivers holistic and individualized care to all patients in an assigned area. Develops, implements, and coordinates a plan of care that incorporates psychological, sociocultural, spiritual, economic, and life-style factors ... Collaborates and communicates with physicians and other members of the healthcare team to interpret, adjust, and coordinate daily patient care plan to ensure a plan of care that is patient centric [centered] with continuity of care [consistent and seamless provision of ongoing healthcare management to a patient over time] ...".

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 ..."

2. During a concurrent interview, on 12/6/24, at 8:15 a.m., with Director of Accreditation (DA) and Director, Quality and Patient Safety (DQPS), dated 12/3/2024, was reviewed. DQPS stated, Pt 4 had come to the hospital for chest pain, cough, and shortness of breath. DQPS stated, Pt 4 had been smoking in his room and was found with burn to chin and bedding. DQPS stated, Pt 4 has been treated and no other patients have been harmed. DA stated, Pt 4 was still in the hospital.

During a concurrent observation and interview on 12/6/24, at 8:45 a.m., with Pt 4, Pt 4 was observed sitting in bed and watching television. Pt 4 observed with uneven beard and white cream substance in strands of his beard. Pt 4 stated he had some pain but very minimal as he rubbed his chin. Pt 4 stated, he did not remember how fire started in his room or what happened. Pt 4 denied being a smoker and stated he did not know anything about the fire. Pt 4 stated he was in bed and fire was there and did not remember how big the fire was.

During a concurrent interviews and record review on 12/6/24, at 8:55 a.m. and 9:20 a.m., with Registered Nurse (RN) 9, Pt 4's electronic health record (EHR- digital collection of medical information) and Pt 4's "H&P", dated 12/4/2024 at 2:16 a.m. were reviewed. Pt 4's H&P indicated Pt 4 was brought to the hospital with shortness of breath and a productive cough. Pt 4 was admitted with a diagnosis of pneumonia (infection of the lungs) and was prescribed intravenous (by the vein) antibiotics (medications to treat infections). Pt 4 denied smoking tobacco in the H&P. RN 9 stated, Pt 4 had attempted to smoke in his room on 12/4/2024 at 10:07 a.m. and burned his chin from the oxygen tubing that caught on fire. RN 9 stated, patient had denied smoking and illicit drug use, although a lighter was found in his belongings.

During an interview on 12/6/24 at 9:03 a.m. with Nurse Manager (NM) 3, NM 3 stated, nurses were expected to initiate and revise care plans for patient's care needs. NM 3 stated, nurses should have updated the care plan for Pt 4 to include safety with oxygen and smoking cessation.

During a concurrent interviews and record review on 12/6/24, at 9:20 a.m., with Registered Nurse (RN) 9, Pt 4's EHR and "Document in Plan [Nursing Care Plan]", dated 12/4/2024, were reviewed. RN 9 stated, had Pt 4's "Nursing Care Plan" indicated, " ... Diabetes (disorder characterized by difficulty in blood sugar control and poor wound healing), ... Respiratory Insufficiency (a medical condition that makes it difficult to breathe) ... Pain (Acute-sudden) ... Pressure Ulcer (localized area of skin damage caused by constant pressure on the skin) Risk ... Violence, Risk/Actual ... Fall Risk ... Patient Care Overview ... as the focused care problems for nursing interventions ...." RN 4 stated, the care plan did not address the issue of smoking cessation or safety. RN 4 stated, after the incident, she was unable to find any documentation from the nurses, educating Pt 4 about not smoking or safety in regard to use of oxygen. RN 4 stated, the care plan should be updated to include educating the patient about not smoking and safety with oxygen use. RN 4 stated, care plans were used to guide the care of the patient and ensured the continuity of the care of the patient.

During an interview on 12/11/2024 at 2:40 p.m., with the CNO, the CNO stated, the nursing care plan should have been revised to addressed Pt 4's primary needs for safety and smoking cessation. The CNO stated, nurses were expected to follow the policy to develop, document and update the care plan to meet the patient's care needs.

During a review of the facility P&P titled, "Patient Plan of Care", dated 10/19/2023, the P&P indicated, " ... The plan is individualized/revised based on ongoing assessment findings, the patient's response to treatment/interventions and evaluation of progress toward outcomes. Care planning ends at discharge/ transition of care ... Patient Plan of Care: Patient-centric documented plan for care, treatment and services that reflects his/ her specific needs and preferences. It may include individualized goals and services required to meet those goals in the designated setting of care. It is maintained/revised based on the patient's condition, preferences, response to interventions. It is the patient's plan - the centralized plan that drives the priorities and professional processes of care for the inter-professional team to prevent/manage/minimize potential problems and outcomes ...Reviewing and updating the plan of care occurs on an ongoing basis throughout the patient's hospitalization. Each shift the registered nurse is responsible for reviewing and updating the plan of care after assessing the patient. Additionally, other members of the inter-professional care team will review and update the plan of care as necessary ...".

During a review of the hospital's document titled, " Registered Nurse Job Description" dated 12/3/24, indicated, " ... Delivers holistic and individualized care to all patients in an assigned area. Develops, implements, and coordinates a plan of care that incorporates psychological, sociocultural, spiritual, economic, and life-style factors ... Collaborates and communicates with physicians and other members of the healthcare team to interpret, adjust, and coordinate daily patient care plan to ensure a plan of care that is patient centric [centered] with continuity of care [consistent and seamless provision of ongoing healthcare management to a patient over time] ..."

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 ensure staff received appropriate education and training to provide care for each patient in accordance with the individual needs of each patient according to job description, titled "Monitor Technician & Nurse Assistant" when one of two sampled Monitor Technician [MT] did not complete the required annual and biannual skills validation training (process of assessing, verifying, and documenting an individual's competencies in a specific area) for Basic Life Support (BLS - a course designed to equip healthcare providers with basic skills and knowledge needed to respond effectively to breathing and cardiac emergencies in adults, children and infants) and Monitor Technician Electrocardiograph (EKG- test that measures the heart's electrical activity) Exam.

These failures resulted in MT to be not trained to handle emergency situations and had the potential to result in patients' harm due to lack of staff training in the management of patients with medical emergencies.

Findings:

During a concurrent interview and record review on 12/6/2024 at12:30 p.m. with Director of Critical Care Services (DIR), MT's personnel file was reviewed. MT was hired June 2014 and had been oriented to his current position on July 2015. A document titled, "Basic Life Support", undated, indicated, MT's BLS certification was expired as of January 2024 and was not current. DIR 1 stated, MT had worked earlier in the week as a MT. DIR stated MT should have completed BLS training per hospital policy. A document titled, "Student and Group Transcript Report", undated, indicated, MT's annual competency for EKG was completed 4/17/2017 indicating it expired on 4/17/2018. There was no updated EKG competency completed since 4/17/2017. DIR 1 stated the MT Should have completed the annual competency per MT's job description. DIR stated, MT had been suspended until he had updated all trainings.

During an interview on 12/11/24 at 2:30 p.m. with the Chief Nursing Officer (CNO), the CNO stated MT was not in compliance with up-to-date EKG competencies or BLS Certification. The CNO stated MT not being in complianc was unacceptable. CNO stated MT should not have had expired EKG and BLS certification. The CNO stated the expectation was for all staff to be compliant with all training.

During a review of MT's personnel file, a document titled, "Monitor Technician and Nurse Assistant- Job Description", undated, indicated, "... COMPLIANCE ... Retains and completes mandated continuing education requirements to meet departmental and facility requirements ... CERTIFICATION AND LICENSURE: BLS-Basic Life Support Healthcare Provider EKG-Technician within 30 days ..."

Based on observation, interview, and record review, the hospital failed to follow their policies and procedures (P&P) for 11 of 36 sampled patients (Pt), Pt 1, Pt 3, Pt 5, Pt 7, Pt 8, Pt 10, Pt 12, Pt 15, Pt 19, Pt 20, Pt 21) when:

1.Licensed Nurses (LN) did not follow the hospital's P&Ps for "Pain Management", Licensed Provider Orders: Receiving, Transcribing, Reviewing" and "Medication Administration" for eight of 14 Pts (Pts 1, 3, 7, 8, 12, 15, 19, 21). For six of 14 Pts (Pts 1, 3, 12, 15, 19, 21), LNs did not complete a pain assessment. For three of 14 Pts (Pts 1, 15, 19), LNs did not reassess pain after administration of pain medication within the expected timeframe. LNs did not administer adequate pain medications to address 10/10 pain experienced by Pt 3 and instead inappropriately administered Acetaminophen. LNs did not follow the Pt 7's physician's order to titrate (slowly increasing the dose of a medicine by very small amounts to find the right dose that is effective) the pain medication.

These failures had the potential for patients to receive inadequate pain management and had the potential for LNs to miss a change in condition.

2. LNs did not monitor the patient while administering a high-risk/high-alert medications (Medications that have a heightened risk of causing significant patient harm when they are used in error) in accordance with their policies for "Medication Administration" and "High Risk/High Alert Medications" for one of one sampled patient (Pt 10).

This failure placed Pt 10 at risk for not receiving the desired patient therapeutic medication goals (meaningful outcome for patients).

3. LNs did not clarify an order of "ventilator [a machine for used to assist with breathing] compliance" for a medication used for sedation (administering of a medication that causes a state of calm or sleep) in accordance with their policy for "Medication Administration" for one of one sampled patient (Pt 5).

This failure had the potential to leave patients with under (to little sedation can cause a patient to be in pain or increase the patient's anxiety) or oversedation (causing excessive drowsiness, loss of response to verbal command, inappropriate movement, hearing and vision disturbances, etc.).

4. LNs did not follow the physician order (PO) for two of three patients (Pt 1 and Pt 20), when the ordered neurological assessment (a physical exam that helps identify disorders of the brain, spinal cords, and nerves) was completed by LNs without the required pupil measurement, according to hospital policy and procedure (P&P) "Neurological Assessment and Flow Sheet".

This failure had the potential to result in missing a change in condition in patients and a possible delay in implementing interventions to address the clinical needs of patients.

5. LNs did not document a change of condition assessment for one of 17 patients (Pt 1) after Pt 1 had an unexplained injury, in accordance with the hospital P&P titled, "Assessment: Admission and Reassessment."

This failure resulted in conflicting documentation about Pt 1's injury site and had the potential to result in a possible delay of needed treatment and services for Pt 1.


6. LNs failed to document discharge instructions for two of 36 patients (Pt 1 and Pt 20) according to hospital P&P titled "Discharge Planning Services".

These failures had the potential for Pt 1 and Pt 20 to be discharged without fully understanding discharge information, including any follow up appointments and new or changed medications which could lead to patient harm.

7. LNs did not follow the hospital policy "Medication Reconciliation" for one of four patients, Pt 5 upon discharge on 11/22/24.

This failure resulted in Pt 5 being discharged on 11/22/24 on the wrong dose of Coreg (medication used to treat high blood pressure and heart failure) and being readmitted on 11/26/24 with low blood pressure and low heart rate.

Findings:

1. During a review of Pt 1's "History and Physical [H&P - an assessment from physician including medical history and exam]," dated 9/23/24, the "H&P" indicated, Pt 1was brought in by ambulance to the Emergency Department (ED) after a motor vehicle accident (MVA). Pt 1 was admitted as an inpatient to the hospital on 9/23/24 at 9:37 a.m. for a scalp laceration (cut on the head), a closed dislocation of phalanx (finger bone) of right hand, a dislocation (joint if forced out of normal position) of tarsometatarsal (joints connecting mid-foot bones to hindfoot bones) joint of right foot, a right metatarsal (tubular bones in the middle of foot connecting ankle to toes) fracture, and a Subarachnoid hemorrhage (Bleeding in the space between the brain and the tissue covering the brain).

During a concurrent interview and record review on 12/4/24 at 1:30 p.m. with Nurse Educator (NE)2 Pt 1's "Physician Medication Order [PMO]," dated 9/23/24 at 7:01 a.m. was reviewed. The "PMO" indicated, " ...fentanyl [strong pain medication] ... Inj [injection] 50 mcg [micrograms - a unit of measurement] ... intravenous (into the vein) ... EVERY 30 MINUTES PRN [as needed] ... IV push [pushed into the intravenous line with a syringe] over 1 to 2 min [minutes].

During a concurrent interview and record review on 12/4/24 at 1:35 p.m. with NE 2 Pt 1's "PMO," dated 9/23/24 at 9:41 a.m. was reviewed. The "PMO" indicated, " ... acetaminophen [mild pain medication] ... 1000 mg [milligram - a unit of measurement] ...intravenous ... Q8HR [every 8 hours] ...".

During a concurrent interview and record review on 12/4/24 at 2 p.m. with NE 2, Pt 1's "Pain Assessment Flowsheet [PAF], and "Medication Administration Record [MAR]" dated 9/23/24 were reviewed. The "PAF" and "MAR" indicated complete pain assessments were not documented with medication administration per P&P. The "PAF" indicated at 7:38 a.m. a pain score of 10 out of 10 "worst possible" and the "MAR" indicated administration of 50 mcg Fentanyl. The "PAF" had no additional pain assessment indicators documented. NE 2 stated LNs should have documented a complete pain assessment prior to administering pain medications, including the location of the pain, if pain was radiating (pain that travels from one body part to another) and a description of the type of pain. The "PAF" indicated at 3:14 p.m. a pain score of 9 and the "MAR" indicated administration of 1,000 mg acetaminophen. NE 2 stated no additional pain assessment indicators were documented. NE 2 stated her expectation was for the entire pain assessment flowsheet to be completed when LNs assessed pain. NE 2 stated controlling patient's pain promoted better healing.

During an interview on 12/9/24 at 10:05 a.m. with Registered Nurse (RN) 5, RN 5 stated he was an ED Trauma Nurse. RN 5 was Pt 1's primary nurse in the ED on 9/23/24. RN 5 stated when he assessed for pain, he talked with the patient about where the pain was located, the quality of the pain, what made it worse, and where the injury site was. RN 5 stated he did not always document the entire pain assessment on the "PAF", but he assessed pain fully. RN 5 stated he should document the entire pain assessment. RN 5 stated completing a full pain assessment was important because a pain score number did not "paint a full picture [give enough information]" of a patient's pain.

During an interview on 12/9/24 at 10:05 a.m. with Nurse Manager (NM) 6, NM 6 stated pain should be assessed completely and documented.

During an interview on 12/9/24 at 10:37 a.m. with Pt 1, Pt 1 stated, he had a lot of pain when he was first admitted to the hospital. Pt 1 stated he did not feel his pain was controlled very well the first day of admission. Pt 1 stated he felt LNs were always "behind the pain", so his pain was not controlled. Pt 1 stated medications were not administered until his pain was a nine or 10. Pt 1 stated he felt if LNs administered pain medications sooner his pain would have been more controlled.

During an interview on 12/11/24 at 2:36 p.m. with the Chief Nursing Officer (CNO), the CNO stated her expectation was for LNs to do a full pain assessment according to hospital P&P. The CNO stated LNs should complete a full pain assessment during the initial and shift assessment, when patient's had pain, and when pain medications were administered.

During a review of Pt 15's "H&P," dated 12/1/24, the "H&P" indicated, Pt 15 presented to the ED with a chief complaint of right hip pain. The "H&P" indicated Pt 15 had a past medical history (PMH) of type 2 diabetes (disorder characterized by difficulty in blood sugar control and poor wound healing) with peripheral neuropathy (disease or dysfunction of one or more nerves, typically causing numbness or weakness in the hands and feet). The "H&P" indicated Pt 15 was admitted to the hospital on 12/1/24 at 2:14 p.m. for closed fracture of the neck of right femur (top of the thigh bone breaks just below the hip joint).

During a concurrent interview and record review on 12/5/24 at 3:10 p.m. with NE 2 Pt 15's "PMO," dated 12/1/24 at 1:02 p.m. was reviewed. The "PMO" indicated, " ... acetaminophen [mild pain medication] ... 1000 mg [milligram - a unit of measurement] ...Oral ... Now ...".

During a concurrent interview and record review on 12/5/24 at 3:14 p.m. with NE 2 Pt 15's "PMO," dated 12/1/24 at 2:08 p.m. was reviewed. The "PMO" indicated, " ...fentanyl [strong pain medication] ... Inj ... 25 mcg ... intravenous ... NOW ... IV push [pushed into the intravenous line with a syringe] over 1 to 2 min [minutes].

During a concurrent interview and record review on 12/5/24 at 3:18 p.m. with NE 2 Pt 15's "PMO," dated 12/1/24 at 2:08 p.m. was reviewed. The "PMO" indicated, " ... tramadol (medication for moderate to moderately severe pain) ... tab [tablet] 50 mg ... Oral ... Q6H [every 6 hours] for moderate pain (4-6) ...".

During a concurrent interview and record review on 12/5/24 at 3:22 p.m. with NE 2, Pt 15's "PAF", and "MAR" dated 12/1/24 were reviewed. The "PAF" and "MAR" indicated complete pain assessments were not documented with medication administration and reassessments were not completed within two hours after medication administration. The "PAF" indicated at 1:02 p.m. a pain score of five out of 10 "moderate pain" with no additional pain assessment information documented, and the "MAR" indicated administration of 1000 mg acetaminophen. NE 2 stated LNs should have documented a complete pain assessment prior to administering pain medications, including the location of the pain, if pain was radiating and a description of the type of pain. The "PAF" indicated at 3:18 p.m. a pain score of five with no additional pain assessment information documented, and the "MAR" indicated administration of 25 mcg of fentanyl. The "PAF" indicated at 6:05 p.m. a pain score of 5. NE 2 stated a pain reassessment should have been documented at 5:18 p.m. NE 2 stated LNs should have reassessed Pt 15's pain within two hours of medication administration to ensure effectiveness.

During an interview on 12/11/24 at 2:36 p.m. with the Chief Nursing Officer (CNO), the CNO stated her expectation was for LNs to do a full pain assessment, and reassess pain according to hospital P&P.

During a review of Pt 19's "H&P," dated 11/18/24, the "H&P" indicated, Pt 19 was transferred from another hospital for bariatric (making changes to digestive system to lose weight) and gastroenterologist (GI -physician who specializes in digestive system) evaluation. The "H&P" indicated Pt 19 had a Previous Medical History (PMH) of Roux-en-Y (weight loss surgery that involves creating a small stomach pouch connected directly to the small intestine) surgery, who presented to the hospital with abdominal pain. The "H&P" indicated Pt 19 was a direct admit to the hospital on 11/18/24 at 8:32 a.m. for cholecystitis (inflammation of the gallbladder) with gangrene (body tissue dies due to a lack of blood supply) of gallbladder after bariatric surgery.

During a concurrent observation and interview on 12/4/24 at 10:19 a.m. with Pt 19 in Pt 19's hospital room, Pt 19 was lying in his hospital bed on his back with his eyes open at a 45-degree angle. Patient had several red and swollen areas on his abdomen. Pt 19's wounds were initially covered with a dressing (applied to wounds to protect from infection) and a surgical drain coming out of one of the wounds draining fluid to a collection bag attached to the railing of his hospital bed. Pt 19's LNs were performing a dressing change to his abdominal wound. Pt 19 stated he had an infection in his abdomen requiring surgical cleaning of the wound. Pt 19 stated he required twice a day dressing changes with packing (a method of filling a wound with dressing material to help healing) into the wound. Pt 19 stated his abdominal pain was "really bad" when he was first admitted to the hospital.

During a concurrent interview and record review on 12/5/24 at 3:52 p.m. with NE 2, Pt 19's "PMO," dated 11/18/24 at 9:23 a.m. were reviewed. The PMO indicated, " ... morphine lnj 2 mg ... Intravenous ... Q2H [every 2 hours] PRN [as needed] for Moderate Pain (4-6), Severe Pain (7-10) ...".

During a concurrent interview and record review on 12/5/24 at 3:57 p.m. with NE 2, Pt 19's "PAF", and "MAR" dated 11/18/24 were reviewed. The "PAF" and "MAR" indicated complete pain assessments were not documented with medication administration and reassessments were not completed within two hours after medication administration. The "PAF" indicated at 9:40 a.m. a pain score of eight (severe pain) out of 10 with no additional pain assessment information documented, and the "MAR" indicated administration of 2 mg morphine. NE 2 stated LNs should have documented a complete pain assessment prior to administering pain medications, including the location of the pain, if pain was radiating and a description of the type of pain. NE 2 stated Pt 19's "PAF" indicated at 1 p.m. a pain score of seven (severe) with no additional pain assessment information documented. NE 2 stated Pt 19's pain should have been reassessed at 11:40 a.m. within two hours of medication administration to ensure effectiveness.

During a review of Pt 21's "H&P," dated 11/30/24, the "H&P" indicated, Pt 21 was brought in by ambulance to the ED after an MVA. Pt 21 was admitted as an inpatient to the hospital on 11/30/24 at 10:45 p.m. for a compression fracture of T12 vertebra (a broken bone in the spine of the middle back), closed fracture (broken bone where skin remains intact) of right sided and left sided mandibular body (lower jaw), and closed fracture of maxilla (bone that forms the upper jaw).

During a concurrent observation and Interview with on 12/3/24 at 3:48 p.m. in Pt 21's hospital room, Pt 21 was observed lying in bed at a 45-degree angle with his eyes open. Pt 21 had bruising to his face around his right eye, with scrapes along his cheekbone near his eye. Pt 21 had no family with him at bedside. Pt 21 had a non-English preferred language but stated he understood some English. When Pt 21 was asked if he had pain from his injuries, Pt 21 stated sometimes his injuries hurt "a lot".

During a concurrent interview and record review on 12/5/24 at 1:38 p.m. with NE 1, Pt 21's "PMO," dated 11/30/24 at 11:42 p.m. was reviewed. The "PMO" indicated, " ... HYDROcodone/acetaminophen [medication for moderate to severe pain]5mg/325mg [5 mg hydrocodone with 325 mg acetaminophen] ... 1 tab [tablet] ... Oral ... Q4H PRN for Severe Pain (7-10) ...".

During a concurrent interview and record review on 12/5/24 at 1:43 p.m. with NE 1 Pt 21's "PAF" and "MAR," dated 12/4/24 was reviewed. The "PAF" and "MAR" indicated Pt 21 was administered pain medication and was discharged from the hospital without a pain reassessment. The "PAF" indicated on 12/4/24 at 2:15 a.m. a pain assessment score of eight out of 10 and the "MAR" indicated administration of one tablet hydrocodone/acetaminophen. NE 1 stated the "PAF" had no documentation of a pain reassessment for Pt 21. NE 1 stated Pt 21 was discharged from the hospital on 12/4/24 at 2:32 a.m. NE 1 stated Pt 21 was discharged with a documented pain score of eight. NE 1 stated LNs should have reassessed Pt 21 prior to discharge to ensure he had relief from pain.

During an interview on 12/11/24 at 2:36 p.m. with the CNO, the CNO stated Pt 21's pain should have been reassessed prior to discharge. The CNO stated her expectation was for LNs to follow hospital P&P and reassess for pain after pain medications were administered.

During a concurrent interview and record review on 12/5/24, at 3:34 p.m., with the NE 6, Pt 12's "Face sheet" (provides demographics of the patient, name, date of birth, admission date, chief complaint), "PMF", and "electronic health records" (EHR), were reviewed for Pt 12's admission dated 11/23/2024. NE 6 stated Pt 12 had an order for Hydrocodone/acetaminophen 5mg /325 mg one tablet ordered every 4 hours for pain. The PMF indicated, Pt 12 received 1 table of Hydrocodone/acetaminophen 5mg /325 mg on 12/4/24 at 11:06 a.m., for a pain level of 7 but no reassessment was documented. NE 6 validated the missing reassessment and interventions for the elevated pain assessment after the medication was given. NE 6 stated the pain medication should be reassessed up to 2 hours after medications administration per policy. NE 6 stated she expected nurses to treat patients' pain and try to control the patients' level of pain to what is acceptable to the patient. NE 6 stated nurses were expected to monitor patients for adverse affects to pain medications.

During a review of Pt 12's,"HOSPITALISTS H&P," dated 11/23/24, the "H&P" indicated, Pt 12 was admitted on 11/23/24 for " ...Chief Complaint: dark stool ... with PMH significant for esrd [end stage renal disease] HD [hemodialysis - a machine used to filter blood when kidneys no longer function] since 11/01/24, urine retention, chronic foley [a catheter in the bladder to drain urine], ... HFpEF [Heart Failure with Preserved Ejection Fraction - a type of heart failure where the heart does not pump the blood efficiently], RLE DVTs [Right Lower Extremity Deep Vein Thrombosis - blood clots in the leg] on coumadin [a medication to prolong the clotting time of blood and prevent clots], who presents for evaluation of dark stool. ... the patient developed blood in her stool, however she is unsure which color ... She unchanged back pain which has been occurring for the past 2 weeks, she has multiple black lesions in skin abd [abdomen] ..."

During an interview on 12/11/24, at 2:35 p.m. with the Chief Nursing Officer (CNO), the CNO stated, a complete assessment should be completed at least once a shift. The CNO stated, pain reassessments should have been done as per the policy. The CNO stated, nurses were expected to assess patient pain levels to help determine the effectiveness of the pain medications no longer than two hours or based on the intervention as per policy.

During a review of Pt 3's H&P dated 8/15/24 at 7:03 p.m., the H&P indicated Pt 3 was a 65 year old male with a chief complaint of left (Lt) lower extremity (LE) weakness, with a past history of hypertension (HTN- high blood pressure), Type 2 Diabetes (DM- a chronic disease that occurs when the body doesn't produce enough insulin or doesn't use insulin properly) with neuropathy (Weakness, numbness, and pain from nerve damage, usually in the hands and feet), sciatica (pain affecting the back, hip, and outer side of the leg, caused by compression of a spinal nerve root in the lower back), chronic back pain, history of chronic opioid (class of drug that is addictive) dependence, tobacco abuse and atrial fibrillation (Afib- irregular heart rhythm). Pt 3 presented with numbness and weakness in his left lower extremity (interior medial thigh) that started around 2 p.m. this afternoon.

During a concurrent interview and record review on 12/4/24 at 1:40 p.m., with Register Nurse Manager (NM) 5, Pt 3's Electronic Health Record (EHR- medical records in electronic form) for his admission from 8/15/24 - 8/30/24 were reviewed. Pt 3's PAF indicated on 8/30/24 at 12:14 p.m. Pt 3's pain score was 10 out of 10 described as right abdominal aching pain, intervention was medication given; at 12:59 p.m. Pt 3's pain score was still a 10 out of 10 with no description of the pain and no pain interventions documented at this time.

During a review of Pt 3's Medication Administration Record (MAR) dated 8/15/24-8/30/24 indicated, Pt 3 had the following as needed (PRN) medications: Oxycodone (strong pain medication) 10 mg (milligram- unit of measurement) oral every 6 hours (Q6H) for Severe Pain (7-10) order start dated 8/24/24 at 2:03 p.m. and ended 8/30/24 at 7:24 p.m. Last given: Oxycodone 10 mg on 8/30/24 at 12:14 p.m.; Oxycodone 5 mg oral Q6H for Moderate Pain (4-6); Acetaminophen (Tylenol- medication used for fever and pain) 650 mg oral Q6H PRN fever greater than 37.5 degrees Celsius (C) order start dated 8/15/24 at 6:57 p.m. and ended 8/30/24 at 7:23 p.m. Last given: Acetaminophen 650 mg given on 8/30/24 12:59 p.m.

During a concurrent interview and record review on 12/4/24, at 5:10 p.m., with RN 8, Pt 3's Progress Note dated 8/30/24 at 1:47 p.m. written by RN 8 was reviewed. RN 8 stated she remembered caring for Pt 3 and discharging him on 8/30/24. Pt 3's Progress Note indicated, "End of Day Shift Summary Mentation: Alert and oriented x 4 [alert to person, place, time, and event] Pain: has complaint(s) of abd [abdomen] pain ... Significant events: Report called to nurse [name] at [name of skilled nursing facility] at 13:56 [1:56 p.m.]. All questions answered ... Pt medicated with PRN pain medication Tylenol 650 mg po [by mouth] x1, oxycodone 10mg PO x 1. Discharge information explained to patient with no questions. Pt received milk of mag [medication used to help with constipation] 60 ml with large BM [bowel movement] resulted. Transport arrived at 1600 [4 p.m.]. Pt leaving via gurney to [name of skilled nursing facility] at 1618 [4:18 p.m.] ..." RN 8 reviewed Pt 3's Pain flowsheet for 8/30/24 and stated that Pt 3 had pain score of 10 out of 10 and she gave oxycodone and reassessed Pt 3's pain less than an hour later and Pt 3's was still reporting a pain score of 10 out of 10. RN 8 stated there was no other documentation and she stated, "I would not have discharged him with a 10 out of 10 pains ... I probably gave something [to Pt 3] and just didn't document a reassessment".

During a concurrent interview and record review on 12/6/24 at 8:40 a.m. with NM 1, Pt 3's EHR for his admission 8/15/24-8/30/24 were reviewed. NM 1 stated, "No" the acetaminophen order was not for pain it was indicated for fever. NM 1 stated the RN 8 should not have given the acetaminophen for Pt 3's pain since it was indicated for fever. NM 1 stated she would have expected "[name of RN 8] to document a reassessment of the patient's [referring to Pt 3] pain level after it was given and if it was not helping, I would have expected the nurse to escalate to the physician if medications ordered were not effective".

During an interview on 12/11/24, at 2:40 p.m. with the CNO, the CNO stated, "We [referring to hospital staff] need to adhere to what the order is, and we need to follow the policy." The CNO stated a complete assessment of the patient's pain should be done every four hours, and the reassessment can just be the number the patient states for their pain level. The CNO stated after pain medication is given per the policy a reassessment should be done within two hours. The CNO stated if acetaminophen was written for fever, it should not be given for pain and the nurse should not have given a pain medication less affective if the pain was still a 10 out of 10. The CNO stated, "We should have notified the doctor and attempted to improve the patient's pain before considering discharging the patient and hold or delay the discharge if needed."

During a record review on 12/4/24 at 1:48pm with NE 4, Pt 8's EMR was reviewed. The H&P dated 11/27/24 at 12:59 p.m., indicated, Pt 8 had a history of kidney and pancreatic transplants (a surgical procedure where both a kidney and a pancreas from a deceased donor are transplanted into a living patient), pancreatic cancer which spread and on chemotherapy (a cancer treatment that uses drugs to kill or stop the growth of cancer cells). Pt 8 chief complaint was blood in stool. Pt 8's MAR, dated 3/25/24-12/4/24, indicated, " ...Morphine [opioid medicine for severe pain] 2 mg [milligrams, unit of measure] Injection. Dose: 2mg. Frequency: Q4H [every 4 hours] PRN, Route: IV [Into the vein] PRN Reason: pain ...". The EMR indicated morphine was administered on 12/3/24 at 10:26 p.m., 12/4/24 at 5:53 a.m., and 12/4/24 at 3:18 p.m. The EMR PFS did not have documentation of pain reassessment 30 minutes after medication was administered. NE 4 stated there should be pain reassessment documentation 30 minutes after each medication was administered.

During an interview on 12/10/24 at 7:45 a.m. with NM 7, NM 7 stated pain reassessment should be done within 30 minutes after administration. Peak effectiveness of morphine is 15 minutes therefore 30 minutes is enough time to determine if medication worked or not.

During a record review on 12/4/24 at 1:42 p.m. with Nurse Educator (NE) 4, NE 4 opened the Electronic Medical Record (EMR) for Pt 7. The document titled, "History and Physical [H&P]," dated 11/24/24 at 4:43 p.m., the "H&P" indicated, Pt 7 tripped over his dog yesterday, went to urgent care and found to be with left ninth rib fracture. Pain worsened over time and not relieved with medication or ice. Patient then presented to Emergency Department and found to be hypotensive (the pressure of blood circulating around the body is lower than normal or lower than expected) and diagnosed with "hemothorax [a serious condition that occurs when blood accumulates in the space between the chest wall and the lung making hard to breathe] and Traumatic Hemorrhagic Shock [a life-threatening condition when severe blood loss from trauma impairs the body's ability to deliver oxygen to the organs of the body] ...Plan and Recommendations: Admit to ICU, NEURO: PO [by mouth]/IV pain medication ...". Pt 7's "Medication Administration Record" (MAR), dated 12/1/24-12-3/24, indicated, " ...Morphine [opioid medicine for severe pain or well-controlled and regularly titrated can help ease respiratory distress] 1mg [milligrams, unit of measure]/ml [milliter- unit of measure] IV Bolus from drip 1-8 mg, Dose: 1-8mg, Freq: Every 15 minutes PRN [Latin phrase pro re nata, which means "as the need arises"], Route: IV ... Give initial dose of 1mg. After each 15-minute interval, reassess pain for a total of 4 additional assessments. For pain scale 0-3, give no bolus. For pain scaled 4-6, give same as previous dose administer. For pain scale 7-10, increase previous dose administer by 2mg ...". Pt 7's EMR indicated boluses of morphine were administered on 12/2/24 at 7:53 p.m., 12/2/24 at 8:52 p.m., 12/3/24 at 12:16 a.m., 12/3/24 at 2:00 a.m., 12/3/24 at 3:53 a.m., and 12/3/24 at 5:01 a.m. Pt 7's EMR "Pain Flowsheet" (PFS) did not have documentation of pain reassessment 15 minutes after boluses were administered or the additional assessments. NE 4 stated there should be pain reassessment documentation 15 minutes after each bolus was administered and a total of 4 pain assessments. NE 4 stated pain assessments were not done according to the orders written.

During a concurrent interview and record review on 12/10/24 at 7:30 a.m. with Registered Nurse (RN) 7, Pt 7's EMR was reviewed. RN 7 stated nurses are expected to follow all Physician orders and document accordingly. RN 7 verified orders for Pt 7 and read aloud order for Pt 7 Morphine bolus order. RN 7 was asked to show documentation of pain assessment after each bolus with a total of 4 pain assessments. RN 7 stated she forgot to document after each bolus and did not document any additional pain assessments regarding boluses. RN 7 stated she did not follow Physician orders.

During an interview on 12/10/24 at 7:45 a.m. with Nurse Manager (NM) 7, NM 7 stated all staff including nurses are expected to follow all physician orders without deviation. NM 7 stated the hospital policy is to follow physician orders. NM 7 stated RN 7 did not follow physician orders regarding Pt 7's morphine bolus order.

During an interview on 12/11/24 at 2:30 p.m. with the Chief Nursing Officer (CNO), the CNO stated the hospital policy is to follow physician order. All staff should always follow physician orders and policies and protocol are in place to protect patients. The CNO stated RN 7 did not follow hospital policy regarding following physician orders.

In a professional article retrieved from https://www.ncbi.nlm.nih.gov/books/NBK2658/#:~:text=Assessment%20of%20effect%20should%20be,45%E2%80%9360%20minutes%20after%20administration. on 12/17/24 titled, "Patient Safety and Quality: An Evidence-Based Handbook for Nurses," indicates, " ...Based upon evidence and clinical practice, there are several principles of analgesic management to meet the objective of preventing moderate to severe pain: ... Assessment of effect should be based upon the onset of action of the drug administered; for example, IV opioids are reassessed in 15-30 minutes, whereas oral opioids and nonopioids are reassessed 45-60 minutes after administration ..."

During a review of the hospital's P&P titled, "Pain Management," dated 4/9/24, indicated, " ... Initial Pain Assessment ... Upon admission to a patient care setting, including Emergency Department visits, patients will be assessed for pain using an appropriate scale ... Patients experiencing pain will have a comprehensive assessment of pain completed by a Registered Nurse (RN) or Licensed Independent Practitioner (LIP) ... This assessment may include pain score, type, location, stated pain goal, and pain interventions ... Pain should be assessed using an appropriate pain scale ... The use of a pain scale involving self-reporting of pain is preferred, when possible ... The patient is assessed for pain/presence of pain: at least once each shift ... Upon new reports of pain ... Prior to and/or during procedures or activities that are anticipated to cause pain ... Reassessment following pain intervention ... Occurs within a time frame sufficient for the intervention to reach effectiveness ... Should not exceed 2 hours following the intervention ... Reassessment of pain is demonstrated through evaluation and documentation of responses to pain intervention(s) ..."

During a professional reference review titled, "Acute Pain Management Pearls: A Focused Review for the Hospital Clinician [health care professional]," dated 12/22/22, (found at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9818465/) indicated, " ... Uncontrolled pain worsens patient outcomes ... Uncontrolled acute pain triggers a complex neurohormonal cascade [a series of coordinated responses where hormones produced by neurons [make up brain and nervous system] that are released in succession to body responses] that is toxic to nearly every organ system, as evidenced by increased rates of renal [kidney] and gastrointestinal [stomach and intestine] dysfunction, infection, cardiopulmonary [heart and lungs] and thrombotic [blood clot] complications, impaired wound healing, adverse psychological effects, and poorer functional recovery and quality of life ... Acute pain management in hospitalized patients should therefore be a clinician and institutional [facility] priority as a key driver of patient outcomes ..."

During a review of the hospital's P&P titled, "Licensed Provider Orders: Receiving, Transcribing, Reviewing," dated 10/11/2023, the P&P indicated, " ...3. Communication orders may include, but are not limited to: ... h. On-going patient assessments ...F. The Nurse will acknowledge ALL medication and standard communication orders and document care provided. G. Every Shift Order Review: 1. The assigned nurse is responsible to review entered/active orders for each patient assigned each shift. 2. The nurse will confirm that the orders are being carried out as entered. 3. The nurse will confirm appropriateness of orders bases on scope of service for that unit, and policy and procedure, as appropriate. A. This will include use of the MAR (Medication Administration Record) and any other EHR (Electronic Health Record) areas to confirm information. 4. Once the review is completed, the RN will incorporate in the end of shift care plan note a statement that the orders where completed. 5. The Licensed Practitioner (L

Based on interview and record review, the hospital failed to ensure an effective system to monitor high controlled substance (CS, medications with high probability of addiction and are controlled by the federal government) usages for providers and accurately reconcile controlled drugs losses for three of four sampled patients (Patients 57, 58, 59).

This failure increased the potential to result in unaccounted controlled drug loss and for hospital staff to divert controlled drugs, which could place patients at risk for potential adverse outcomes including inadequate pain relief, as well as the potential for hospital staff to abuse controlled drugs.

Findings:

During a concurrent interview and record review on 12/11/24 at 9:24 a.m., with Medication Safety Pharmacist (MSP), an electronic hospital document titled, "Unreconciled Incidents Closed October November Anesthesia [loss of feeling or awareness caused by a drug] (UIC)" was reviewed. The UIC document indicated patients including Patients 57, 58, 59 had CS medication transaction incidents that had been documented as resolved by pharmacy staff. MSP stated that for Patient 57, an anesthesia provider dispensed a hydromorphone (a CS medication for pain) 2 milligrams (mg- unit of measure) per milliliter (ml- unit of measure) vial from an automated dispensing unit (ADU- machine that stores medication and uses passcode for access) on 11/12/24 at 10:52 a.m. MSP stated a notification for a partially missing 1.25 mg hydromorphone dose was received, with Patient 57's medication administration record (MAR) indicating 0.75 mg hydromorphone was administered. MSP stated pharmacy staff was unable to find documentation for administration or wastage of hydromorphone 1.25 mg. The UIC document indicated an email was sent to the anesthesia provider, and on 11/21/24, the anesthesia provider stated the documentation had been fixed. MSP stated the fixing process was for anesthesia providers to back chart by going back in the patient's record as documenting the missing doses as administered.
MSP stated that for Patient 58, an anesthesia provider dispensed a fentanyl (a CS medication for pain) 100mcg (microgram- unit of measure) per 2 ml vial from an ADU on 11/12/24 at 11:53 a.m. MSP stated a notification for a partially missing 50 mcg fentanyl dose was received, with Patient 58's MAR indicating 50 mcg fentanyl was administered. MSP stated pharmacy was unable to find documentation for administration or wastage of fentanyl 50 mcg. The UIC document indicated, "[anesthesia provider] updated patient MAR to reflect a total of 100 mcg of fentanyl given. Back charted on 11/25/24 at 1036".

MSP stated that for patient 59, an anesthesia provider dispensed a midazolam (a CS medication for anxiety) 5 mg per ml vial from an ADU on 11/14/24 at 3:27 p.m. MSP stated a notification for a missing 5 mg midazolam was received. MSP stated pharmacy staff was unable to find documentation for administration or wastage of midazolam 5 mg. The UIC document indicated an email was sent to the anesthesia provider, and on 12/2/24, the anesthesia provider indicated the charting has been completed.
During an interview on 12/11/24 at 3:31 p.m. with MSP, MSP acknowledged the use of back charting for reconciling CS medication could be a potential for diversion. MSP stated the diversion prevention committee had a list, but it was not specific to back charting and only reported numbers and did not have a process in place for tracking and trending providers who back charted for potential diversion.

During an interview on 12/11/24 at 3:38 p.m. with Pharmacy Manager (PM), PM acknowledged the use of back charting for reconciling CS medication could be a potential for diversion.

During an interview on 12/11/24 at 3:45 p.m. with Director of Pharmacy (DIR 5), DIR 5 stated there was no effective system to reconcile controlled drugs related to back charting, as pharmacy did not track and trend back charting alone. DIR 5 stated back charting was potentially bad because somebody could falsely document that a CS medication was administered.

During a review of the hospital's Policy and Procedure (P&P) titled, "Controlled Drug Management and Diversion Prevention", dated 4/15/22, the P&P indicated, "Anesthesia Providers Administration of controlled substances removed from a Pyxis machine will be documented in the EHR [electronic health record]. Waste will be documented in the Pyxis [automated dispensing machine storing medications] with a co-signer/witness ... Waste will be documented in the Pyxis with a cosigner/witness. Controlled substances discrepancies will be resolved as soon as possible (ASAP) or by the shift end by the Anesthesiologist."

Based on interview and record review, the hospital failed to ensure dose appropriateness of a patient's medication regimen prior to discharge when Patient 5's carvedilol (medication to lower blood pressure and strengthens heart to pump blood) dose was inappropriately increased prior to discharge.

This failure resulted in Patient 5 presenting to the Emergency Department 4 days after discharge with hypotension (low blood pressure) and bradycardia (slow heartbeat) and potential beta blocker (medication like carvedilol that lowers blood pressure) overdose.

Findings:

During a concurrent interview and record review on 12/9/24 at 11:09 a.m. with Transition of Care Pharmacist (TCP) 1, Patient 5's medical record was reviewed. TCP 1 stated TCPs were involved in discharge medication reconciliation and bedside education for high-risk patients including heart failure patients. TCP 1 stated once a patient was discharged by a provider, a TCP would review the discharge orders for completeness, accuracy, check for discrepancies, verify correct pharmacy for medication to be dispensed, and provide bedside education to the patient. A review of Patient 5's Discharge Summary dated 12/5/24, indicated Patient 5 had diagnoses including hypertension (high blood pressure) and heart failure (condition where the heart is unable to pump enough blood and oxygen to the heart and organs), was admitted to the hospital on 11/17/24 for shortness of breath and discharged on 11/22/24. Patient 5's Medication Administration Record (MAR), dated 12/9/24, indicated Patient 5 was administered carvedilol 3.125 milligrams (mg- unit of measure) twice daily ( 11/ 18/24 at 10:15 a.m., 6:53 p.m.;11/19/24 at 8:42 a.m., 7:25 p.m.;11/20/24 at 8:08 a.m., 5:15 p.m.; 11/21/24 at 7:45 a.m.), and carvedilol 6.25 mg twice daily (11/21/24 5:36 p.m.; 11/22/24 9:04 a.m.) while admitted.

A review of TCP 2's "Discharge Progress Notes (DPN)" for Patient 5, dated 11/22/24 at 2 p.m., the DPN indicated, "In discussion with the provider [Physician 2], Coreg [carvedilol] 25 mg bid [twice daily] was escalated to Coreg 25 mg 2 tablets po [by mouth] bid to achieve a HF [heart failure] target dose." TCP 1 stated Patient 5's discharge medication list was reviewed and changed by TCP 2 on 11/22/24.

During a telephone interview on 12/9/24 at 2:35 p.m., with Physician (PHY) 1, Patient 5's admitting physician, PHY 1 stated Patient 5 had worsening symptoms of heart failure upon admission on 11/17/24. PHY 1 stated although Patient 5's home medication list showed carvedilol 25 mg twice daily, Patient 5 was not compliant with taking medications, so she initiated Patient 5 on a low carvedilol dose at 3.125 mg twice daily. PHY 1 stated with heart failure, it was important to start patient at low dose and titrate slowly, and not have patient on too many antihypertensive medications.

During a telephone interview on 12/9/24 at 3:10 p.m., with Patient 5's wife (FM 2), FM 2 stated Patient 5 was discharged on 11/22/24 with a bottle of carvedilol 25 mg tablets after the pharmacist went over the directions. FM 2 stated Patient 5 was home for 4 days and had to call the ambulance to take him to the hospital, because he was weak, and his heart rate was in the forties. FM 2 stated she had followed the directions on the medication bottle and had administered approximately 2 carvedilol 25 mg tablets twice daily to Patient 5 for a total of approximately 16 tabs.

During an interview with Outpatient Pharmacy Manager (OPM) on 12/9/24 at 3:58 p.m., OPM acknowledged an order for carvedilol 25 mg, 2 tablets twice daily was processed and dispensed for Patient 5 on 11/22/24. OPM stated once Patient 5's carvedilol medication was processed, it was taken to a TCP.

A review of Patient 5's carvedilol order printed 12/9/24 indicated, a telephone order for carvedilol 25 mg, 2 tablets twice daily for quantity 120 tabs was created by TCP 2 on 11/22/24 at 10:36 a.m., electronically confirmed by the hospital's outpatient pharmacy on 1/22/24 at 10:37 a.m., and signed by PHY 2 on 11/22/24 at 11:42 a.m.

During a telephone interview on 12/9/24 at 4:18 p.m., with PHY 2, PHY 2 stated she received a call from TCP 2 on 11/22/24 regarding two other medications but not regarding carvedilol. PHY 2 stated her concern was that she ordered carvedilol 25 mg twice daily and did not know why TCP 2 changed the carvedilol dose. PHY 2 stated she ordered carvedilol 25 mg twice daily for Patient 5 because Patient 5 had been taking the dosage prior to hospitalization. PHY 2 acknowledged she signed TCP 2's order for carvedilol 25 mg, 2 tablets twice daily and did not recognize the order as a high dose or odd dose.

A review of Patient 5's carvedilol 25 mg tablet order printed 12/9/24, indicated carvedilol 50 mg twice daily, written date 11/22/24 by TCP 2. The order indicated, "Filtered Medication Warnings ...drug-disease ... stabilize patients on heart failure regimen prior to initiation or titration of beta-blocker. Beta-blocker therapy should be initiated at very low doses with gradual and careful titration. Worsening heart failure or fluid retention may occur during upward titration; dose reduction and/or slower titration may be necessary."

During a review of Patient 5's "Hospital Critical Care Notes (HCCN)" dated 11/26/24, the HCCN indicated, " ... recent hospitalization 11/17-11/22/2024 for hypoxic respiratory failure [not enough oxygen in blood] from pulmonary edema [too much fluid in lungs, making it difficult to breathe] and fluid overload who presents to [hospital] 11/26/2024 for evaluation of weakness x [for] 5 days and shortness of breath for 10 days ... The patient reports he has been compliant with his medications, noting that he was recently prescribed 80mg Lasix [medication that helps lower blood pressure and remove excess water from the body] BID and 50mg carvedilol BID ... The patient was given glucagon for possible beta blocker overdose .... Admitted to ICU [intensive care unit] for further management ... assessment/plan ... bradycardia; beta blocker overdose ..."

During an interview on 12/11/24 at 2:54 p.m. with TCP 1, TCP 1 acknowledged it was not standard of practice to increase carvedilol from 6.25 mg twice daily to 50 mg twice daily. TCP 1 stated if patient's heart rate was elevated and dose increase was warranted, a recommendation would be to increase to 12.5 mg twice daily and titrate up as tolerated.

During an interview on 12/11/24 at 3:57 p.m. with Director of Pharmacy (DIR 5), DIR 5 stated he would not go from carvedilol 6.25 mg twice daily to 50 mg twice daily due to possibility for low heart rate, low blood pressure and heart block in extreme cases.

During a review of DailyMed, a nationally recognized database, the manufacturer for carvedilol indicated, "DOSAGE MUST BE INDIVIDUALIZED AND CLOSELY MONITORED BY A PHYSICIAN DURING UP-TITRATION. Prior to initiation of COREG [carvedilol], it is recommended that fluid retention be minimized. The recommended starting dose of COREG is 3.125 mg twice daily for 2 weeks. If tolerated, patients may have their dose increased to 6.25, 12.5, and 25 mg twice daily over successive intervals of at least 2 weeks. Patients should be maintained on lower doses if higher doses are not tolerated. A maximum dose of 50 mg twice daily has been administered to patients with mild-to-moderate heart failure weighing over 85 kg (187 lbs.) ... Overdosage may cause severe hypotension, bradycardia, cardiac insufficiency [heart cannot pump enough blood], cardiogenic shock [ life-threatening condition that occurs when the heart is unable to pump enough blood and oxygen to the body's organs], and cardiac arrest [medical emergency that occurs when the heart suddenly stop beating]. Respiratory problems, bronchospasms [difficulty breathing], vomiting, lapses of consciousness, and generalized seizures may also occur ... To support cardiovascular function: Glucagon, 5 to 10 mg IV rapidly over 30 seconds, followed by a continuous infusion of 5 mg per hour; sympathomimetics [drugs to help increase heart rate and breathing] (dobutamine, isoprenaline, adrenaline) at doses according to body weight and effect.

Based on observation, interview and record review, the hospital failed to ensure controlled substance (CS medications with high probability of addiction and are controlled by the federal government) medications were stored according to hospital policy and procedures (P&P) for three of three sampled patients (Patients 56, 54, 55).

These failures had the potential for CS medication diversion (illegal use of prescription medication or use for purposes not intended by the prescriber) and unauthorized access to medications.

Findings:

During a tour of the hospital's pharmacy on 12/9/24 at 9:45 a.m., with the Pharmacy Supervisor (PS) and Pharmacy Manager (PM), an inspection of clear bags containing patient own medications hanging on a pole against the pharmacy wall, was conducted.
During the inspection, Patient 56's medication brought from home were identified as 29 tramadol (CS medication used for pain) 50 milligrams (mg- unit of measure) tablets inside a clear bag, Patient 54's medication brought from home were identified as oxycodone-acetaminophen (CS medication used for pain) tablets inside a clear bag, and Patient 55's medication brought from home were identified as hydrocodone-acetaminophen 10 (CS medication used for pain) tablets inside a clear bag hanging against the pharmacy wall near the entrance of the pharmacy, unsecured.

During a concurrent interview and document review on 12/9/24 at 9:50 a.m. with PM and PS, Patients 56, 54 and 55 patient own medication (POM) bags were reviewed. Patients 54 and 55's POM bags did not indicate the strength or quantity of the CS medications. PM stated POM were brought to the pharmacy by nursing staff with a completed form, and pharmacy staff filed the forms and placed the POM in clear bags and stored them against the wall in the pharmacy. PM acknowledged nursing staff did not accurately document the strength or quantity of Patients 54 and 55's medications brought from home. PM acknowledged pharmacy staff would not be able to accurately reconcile the CS medications if the CS medications were destroyed and the quantity and strength of each patient own CS medications brought to the pharmacy were not accurately identified. PS acknowledged the POM CS medications were stored with non-controlled POM on the wall. PS stated it was important to track storage and destruction of all CS medications because not accurately tracking storage and destruction could lead to an opportunity for diversion.

During an interview on 12/11/24 at 3:43 p.m., with Director of Pharmacy (DIR 5), DIR 5 acknowledged POM CS medications were not stored securely in the pharmacy and stated all CS medications received by pharmacy should be stored in the CS safe (secured storage system accessible only by passcode).

During a review of the hospital's P&P titled, "Medication Procurement, Storage, and Inspection", dated 6/16/21, the P&P indicated, "Controlled Substances ... Medications are stored in a secure manner to prevent diversion, in accordance with law and regulation ... Controlled substances will be kept secured at all times in automated dispensing machines [machine used to stored medications accessible only by passcode] (e.g., Pyxis) throughout the facility. "

Based on observation, interview, and record review, the hospital failed to follow its policy titled, "Labeling of Medications" when three of 10 medications were observed to be unlabeled and left in a patient's (Pt 8) drawer in a medication cart on the Oncology (a branch of medicine that specializes in the diagnosis and treatment of cancer) unit and were available for patient use .
This failure had the potential for the patient to receive the wrong medication and cause harm or even death.

Findings:

During a concurrent observation and interview on 12/3/24 at 2:00 p.m. with Nurse Educator (NE) 5 and Nurse Manager (NM) 9 on the Oncology Unit in the Medication Room, two pills (Sevelamer-medication for high blood levels of phosphorus in people with chronic kidney disease) and one transdermal (Lidocaine-to relieve nerve pain, it attaches to skin and contains medication) patch in manufacturer packaging were observed loose in Pt 8's drawer in a medication cart in the medication room with no patient identifiers. NE 5 stated all medications in the medication cart should have patient identifiers and be stored in a bag. NE 5 stated if a medication was not labeled properly, it might be given to wrong patient causing harm. NM 9 stated all medications should be labeled completely and properly. NM 9 stated nurses should discard medications that were not properly labeled.

During an interview on 12/9/24 at 8:00 a.m. with the Pharmacy Supervisor (PS), the PS stated all medications should be properly labeled which included but not limited to patient name, time of administration, dosage, and route. PS stated if medication did not have proper labeling, it should be returned to pharmacy. PS stated if wrong medication was given, it could harm patient to the point of death.

During an interview on 12/9/24 at 8:15 a.m. with Director of Pharmacy (DIR) 5, DIR 5 stated all medications without exception should be properly and completely labeled. DIR 5 stated medications in a medication cart should be stored in a bag and not loose. DIR 5 stated if medication is not labeled correctly and given to the wrong patient, the medication can cause harm or death for that patient. DIR 5 stated medication that did not have proper labeling should be returned to pharmacy.

During an interview on 12/11/24 at 2:30 p.m. with the Chief Nursing Officer (CNO), the CNO stated medications for all patients should be labeled correctly and placed together, not separated or loose in a container. The CNO stated if medications are not properly labeled, they have the potential to cause harm to the patient.

During a review of the facility's policy and procedure (P&P) titled, "Labeling of Medications," dated 10/15/2020, the P&P indicated, "PURPOSE: A. To provide guidelines for the correct labeling of medications dispensed ... D. Labels shall be printed by computer and firmly affixed to the prescription container or dose."

During a review of the facility's policy and procedure (P&P) titled, "Medication Procurement, Storage, and Inspection" dated 6/16/21, the P&P indicated, "PURPOSE: A. To establish guidelines and processes for medication procurement, storage, and inspection ... F. Storage 3. Drugs are stored under condition of sanitation, temperature, light, moisture, ventilation, segregation, and security ... 9. Drugs and antiseptics designated for external use shall be stored separately from internal and injectable medications ..."

Based on observation, interview, and record review, the facility failed to maintain a clean and sanitary environment to avoid sources transmission of infection according to hospital's policy and procedures, and the Center's for Disease Control and Prevention's (CDC) standards of practice for infection when:

1. One of three sampled rooms (Clean storage rooms), clean patient care supplies were found on shelves on the bottom shelf 2 inches from the contaminated floor.

2. One of one sampled clean vital sign machines (measures the basic medical indicators of health - temperature, pulse, breathing, and blood pressure), was found in a clean equipment room connected to a contaminated disposable pulse oximeter (a medical device that measures the oxygen levels in the blood).

3. Registered Nurse (RN) 1 failed to follow hospital policy and procedure (P&P) for one of one sampled patient (Pt 23) when RN 1 was observed in the Neonatal Intensive Care Unit (NICU-a hospital area that provides specialized care for newborn babies who are sick or premature) not performing hand hygiene (practice of cleaning hands to remove germs, dirt, or other harmful substances) and donning (putting on) new non-sterile gloves before and after touching Pt 23.

4. Six of six bottles of expired baby formula and one container of expired blood capillary collection tubes (very thin blood collection tubes) were found in the NICU supply room.

These failures placed all patients and staff at risk for transmission of infections (an infectious agent is transferred from a reservoir to a susceptible host) and cross contamination (the process by which bacteria or other microorganisms are unintentionally transferred from one substance or object to another, with harmful effect) and increased the potential for hospital acquired infections and illnesses.

Findings:

1. During a concurrent observation and interview, on 12/3/24, at 3:25 p.m., with the Director of Critical Care Services (Dir 1), in intensive care unit, clean storage room, the bottom shelf of a shelving unit for clean medical supplies was observed to be less than two inches from the floor. The Dir 1 stated, a mop could not fit under the shelving unit to clean underneath. The Dir 1 stated, the floors should be swept and mopped daily and as needed, including under the shelving units. The Dir 1 stated, supplies could become contaminated from the debris on the floor and possible infections could result.

During an interview, on 12/10/24, at 11:00 a.m., with the Infection Prevention Manager (IPM), the IPM stated, items should be stored 6 inches from the floor and 18 inches from the ceiling. IPM stated, this was important because staff needed to be able to clean and mop under the shelves, or otherwise, dust and debris will accumulate, and the environment would not be clean and safe for the supplies.

During a review of the facility's policy and procedure (P&P) titled, "Storage Requirements", dated 5/2022, the P&P indicated, "... To insure that all supplies and durable medical equipment are stored in a safe and uniform manner. ... 4. All sterile and non-sterile supplies, durable medical equipment, and materials will be stored 8-10 inches from the floor and 18-20 inches from the ceiling. ..."

During a professional reference review retrieved from https://www.cdc.gov/infectioncontrol/pdf/guidelines/environmental-guidelines-P.pdf titled, "Guidelines for Environmental Infection Control in Health-Care Facilities," dated 7/2019, the professional reference indicated, " ... Infection-control strategies and engineering controls, when consistently implemented, are effective in preventing opportunistic, environmentally-related infections in immunocompromised populations..."

2. During a concurrent observation and interview, on 12/3/24, at 4:15 p.m., with the Dir 1, on the third floor of the intensive care unit, in the clean equipment room, a vital sign machine was observed to be marked, "clean for use"; however, a disposable pulse oximeter with used foam tape was attached to the machine. The Dir 1 stated, the pulse oximeter should not be attached to the machine as it appeared to be used and was not reusable between patients. The Dir 1 stated, only clean equipment should be stored in the room to be ready for use with patients. The Dir 1 stated, it was important to use clean equipment with patients to prevent the spread of infections and ensure safe patient care.

During an interview, on 12/10/24, at 11:00 a.m., with the IPM, the IPM stated, disposable pulse oximetry units should not be reused and was for one patient only. IPM stated, disposable pulse oximetry units should be disposed of after used and not use with multiple patients. The IPM stated, reusing a disposable pulse oximetry unit multiple patients could cause transmission of organisms and a risk of infection.

During a review of the pulse oximetry manual titled, "[NAME BRAND] Single-Patient-Use Cloth and Foam SpO2 [oxygen saturation - amount of oxygen in the blood] Sensors", not dated, the manual indicated, "... sensors are for single-patient-use ... Dispose of sensor after use. Do not use the same sensor on another patient. ... "

During a review of the document titled, "CDC's Core Infection Prevention and Control Practices for Safe Healthcare Delivery in All Settings" retrieved from, https://www.cdc.gov/infection-control/hcp/core-practices/index.html dated 4/12/24, " ...standard precautions (basic level of infection control that is used in patient care) include: ...hand hygiene ...environmental cleaning and disinfection .. Reprocessing of reusable medical equipment between each patient or when soiled..."

3. During an observation and interview on 12/3/23 at 2:25 p.m. with Registered Nurse (RN) 1 in the NICU, RN 1 was observed providing care to Pt 23 with contaminated gloves. Pt 23 was lying in the radiant warmer (baby bed used in hospitals to provide heat to the body) quietly, on her back. RN 1 was observed listening to Pt 23's chest with a stethoscope (a medical device to listen to sounds inside the body). RN 1 set the stethoscope down on the radiant warmer's rail, touching multiple areas of the radiant warmer, turned to the side counter picking up her pen and writing on a clipboard. RN 1 then picked up a thermometer (device used to measure temperature) and took Pt 23's axillary (under arm) temperature. RN 1 set down the thermometer and proceeded to change Pt 23's diaper after which, she again picked up her pen and wrote on the same clipboard. RN 1 completed all tasks without removing contaminated gloves or performing hand hygiene. RN 1 stated she should have changed gloves between tasks and performed hand hygiene. RN 1 stated by not changing gloves, and cleaning her hands after touching the environment, pathogens (a disease-causing organisms) could transfer from her hands to the baby.

During an interview on 12/3/24 at 2:41 p.m. with Director (DIR) 3, DIR 3 stated her expectation was that LNs followed the hospital's hand hygiene policy and procedure exactly.

During a review of the hospital's policy and procedure (P&P) titled, "Hand Hygiene," dated 5/20/22, indicated, " ... Hand hygiene is performed by all healthcare workers (HCW) and hospital staff/employees. Hand hygiene is performed: ... immediately before touching a patient ... Before performing an aseptic task [free from contamination] ... or handling invasive [enters the body] medical devices ... Before moving from work on a soiled body site to a clan body site on the same patient ... after touching a patient or the patient's immediate environment ... after contact with blood, body fluids, or contaminated surface3s ... Before donning [putting on] gloves, after glove removal, and in between, glove changes ..."

During a review of professional reference from the CDC titled, "Clinical Safety: Hand Hygiene for Healthcare Workers, dated 2/27/24, the professional reference indicated, " ... Hand hygiene protects both healthcare personnel and patients. Hand hygiene means cleaning your hands with Handwashing with water and soap (e.g., plain soap or with an antiseptic). Antiseptic hand rub (alcohol-based foam or gel hand sanitizer) ... Cleaning your hands reduces: The potential spread of deadly germs to patients. The spread of germs, including those resistant to antibiotics ... Know when to clean your hands ... Immediately before touching a patient ... Before performing an aseptic task such as placing an indwelling device or handling invasive medical devices ... Before moving from work on a soiled body site to a clean body site on the same patient ... After touching a patient or patient's surroundings ... After contact with blood, body fluids, or contaminated surfaces ... Immediately after glove removal ..."

4. During a concurrent observation and interview on 12/3/24 at 2:38 p.m. with DIR 3 in the NICU clean storage area, six 2-ounce (oz-a unit of fluid measurement) bottles of [brand name] infant formula with the expiration date of 12/1/24 and one container of expired blood capillary collection tubes (a thin tube used to collect and analyze small amounts of blood) with the expiration date of 10/31/24. DIR 3 stated the six bottles of infant formula were expired and expired formula should not be used to feed babies. DIR 3 stated the potential for harm would be exposing pathogens to the baby and, "the baby is already immunocompromised [lower defenses against infections and diseases]". DIR 3 stated the blood capillary collection tubes were also expired and LNs should not use expired medical products because the product may no longer work as designed. DIR 3 stated Central Supply stocked supplies and checked the expiration dates on the supplies, but LNs should also check expiration dates and not use expired products. DIR 3 stated LNs should remove expired product from circulation and contact Central Supply for new unexpired products.

During an interview on 12/10/24 at 10:55 a.m. with the IPM, the IPM stated expired products should not be used on any patients. The IPM stated using expired products could cause infections and allergic reactions.

During an interview on 12/11/24 at 2:55 p.m. with the Chief Nursing Officer (CNO), the CNO stated, the hospital should not have any expired supplies in the supply rooms, especially expired baby formula. The CNO stated LNs should know to check expiration dates and take the products out of circulation. The CNO stated using expired formula had the potential for food poisoning to the baby.

During a review of the hospital's P&P titled, "Outdated, Expired, Defective and Event Related Sterile or Non-Sterile Manufactured Supplies," dated 5/31/22, indicated, " ... All Central Supply Distribution personnel shall insure that all sterile supplies are monitored for out dates, expiration dates, and defects. No outdated, expired, or defective medical supply (sterile or non-sterile) shall be maintained in the main inventory, or unit supply areas. Event- Related supplies should be monitored for packaging integrity and serviceability. Appropriate measures shall be taken to [ensure] that these supplies are removed from all supply areas, hospital-wide ... If sterile or non-sterile supplies are found to be outdated, expired, defective or damaged upon receipt into the Main Central Supply Inventory the department supervisors or lead should be notified so that a product failure may be reported ..."

During a review of the professional reference titled, "Handling Infant Formula Safely ...", dated April 2024, the professional reference indicated, " ... "Use By" Date-Don't use a package or container of infant formula after this date. The manufacturer guarantees the nutrient content and quality of the formula only up to the "use by" date. FDA [Food and Drug Administration] rules require a "use by" date on every container of infant formula ..."

During a professional reference review retrieved from https://www.cdc.gov/infectioncontrol/pdf/guidelines/environmental-guidelines-P.pdf titled, "Guidelines for Environmental Infection Control in Health-Care Facilities," dated 7/2019, the professional reference indicated, " ... Infection-control strategies and engineering controls [physical changes to a work area or process that reduce or eliminate the risk of workers coming into contact with hazards], when consistently implemented, are effective in preventing opportunistic [exploiting chances offered by immediate circumstances], environmentally related infections in immunocompromised populations..."