HospitalInspections.org

Based on interview and record review, the hospital failed to protect and promote each patient's rights when:

1. Signed consents were not obtained in a language the patient (Pt) could understand for Pt 13, Pt 17 and Pt 29 according to hospital policy and procedure (P&P) titled "Consents" and "Conditions of Admissions & Consent to Outpatient Care."

This failure denied Pt 13, Pt 17 and Pt 29 of their right to make informed consent about their care. (Refer to A-0131, item 1).

2. Pt 29 and Pt 40 received patient care and services that 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, "Interpreters/Translation: Non-English/Limited English Proficient & Deaf/Hearing Impaired" (Refer to A-0131, item 2).

These failures denied Pt 29 and Pt 40 to participate in their daily care and had the potential to affect all non-English speaking patients treated at the hospital. (Refer to A-0131, item 2).

The cumulative effect of these systemic problems resulted in failure to ensure patients were cared for in a safe manner, and their rights were protected and promoted at all.

Based on observation, interview and record review, the hospital failed to have an organized nursing service for nine of 52 sampled patients (Patient [Pt] 14, Pt 19, Pt 23, Pt 27, Pt 28, Pt 30, Pt 40, Pt 53 and Pt 56) when:

1. Licensed Nurses (LNs) did not follow the hospital's Policies and Procedures (P&P) titled, "Pain Assessment and Management -Patients 14 and Older", dated 1/15/25, and "Provider Orders", dated 8/25/23, for five of 52 patients (Pt 19, Pt 23, Pt 28, Pt 40, and Pt 53) (Refer to A-0398, item 1).


2. LNs failed to follow the hospital's P&P titled, "Medications - Orders, Administration, Storage, Documentation", dated 12/19/23 for one of 11 patients (Pt 14) (Refer to A-0398, item 2).

3. Licensed Vocational Nurses (LVNs) and Patient Care Technicians (PCTs) failed to document an incident involving skin tears (traumatic wound when skin separates) to the chest caused by the removal of electrode stickers (small sticky patches that attach to the skin), for one of 56 patients (Pt 56) in accordance with the hospital P&P titled, "Documentation in the Health Record", dated 6/14/18, (Refer to A-0398, item 3).

4. LVNs and PCTs failed to report an incident of patient harm through the hospital's incident reporting system for one of 56 patients (Pt 56), after causing a skin tear wound to Pt 56's chest when removing the telemetry (remote monitoring of heart rate and rhythm) electrodes, in accordance with the hospital's P&P titled, "Incident Reporting Intranet System (IRIS)", dated 1/13/22, (Refer to A-0398, item 4).

5. LNs and PCTs failed to follow the hospital's policies and procedures titled, "Documentation in the Health Record", and "Interdisciplinary Plan of Care", dated 10/12/23, for two of five sampled patients (Pt 27 and Pt 30), and "Pressure Injury Risk Assessment, Prevention, Staging and Treatment", dated 9/13/24, for one of five sampled patients (Pt 30) (Refer to A-0398, item 5).

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

Based on observation, interview and record review, the hospital failed to ensure that safe pharmaceutical services had been provided to meet the needs of each patient as evidenced by:

1. For two of two patients (PT 5, PT 49), staff pharmacist did not clarify benzocaine 20% oral solution (medication used to relieve mouth pain) medication order when instructions for use were not clear; staff pharmacist did not provide accurate medication-related information to Registered Nurse (RN) 5 who administered benzocaine 20% solution to PT 5. As a result, PT 5 experienced dizziness, tachycardia (increased heart rate), tachypnea (abnormal rapid breathing), cyanosis (bluish-purple discoloration of skin due to lack of oxygen), was diagnosed with methemoglobinemia (rare condition where red blood cells cannot carry oxygen and can result in death), which required hospitalization in the Intensive Care Unit (ICU), and treatment with methylene blue (medicine used to treat methemoglobinemia) and hemodialysis (medical procedure that filters waste products and excess fluid from the blood when the kidneys are no longer functioning properly). (Refer to A 500)

2. The hospital failed to ensure unusable medications were not available for patient use when an intravenous (IV, in the vein) fluid bag was out of its protective overwrap against professional standards in the medication room (a room where medications are stored and prepared) on 2nd floor East. (Refer to A 505)

The cumulative effect of this systemic problem resulted in the facility's inability to ensure the provision of quality health care, in compliance with the Condition of Pharmaceutical Services.

Based on interview and record review, the hospital failed to ensure patients (Pts) were informed of their rights to make decisions about care for four of 13 patients (Pt 13, 17, 29 and 40) when:

1.Signed consents were not obtained in a language the patient could understand for Pt 13, Pt 17 and Pt 29 according to hospital P&P titled "Consents" and "Conditions of Admissions & Consent to Outpatient Care."

This failure denied Pt 13, Pt 17 and Pt 29 of their right to make informed consent about their care.

2. Pt 29 and Pt 40 received patient care and services that 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, "Interpreters/Translation: Non-English/Limited English Proficient & Deaf/Hearing Impaired"

These failures denied Pt 29 and Pt 40 to participate in their daily care and had the potential to affect all non-English speaking patients treated at the hospital.

Findings:

1. During an interview on 2/25/25 at 10:02 a.m. with Pt 13, at bedside in the short stay pre-operative unit (the area or department in a hospital or clinic where patients receive care and preparation before undergoing a surgical procedure) , Pt 13 explained she did not speak English. Pt 13 stated Spanish is her primary language. Pt 13 stated she was at the short stay (where simple procedures or day surgery happens) unit today for a revision of her malfunctioning AV fistula (a connection that's made between an artery and a vein for dialysis (a procedure to remove waste products and excess fluid from the blood when the kidneys stop working properly) access. Pt 13 voiced no concerns with her care at time of interview.

During a concurrent interview and record review on 2/26/25 at 9:29 a.m. with Clinical Supervisor (CS) 3, and Imaging Manager (IM) 1, Pt 13's Electronic Health Record (EHR- digital version of the medical record) was reviewed. Pt 13's Face Sheet (FS-a document that contains a summary of a patient's personal and demographic (all the non-clinical data about a patient (name, date of birth , address, etc.) information), the FS indicated, "...P[t 13], a 66-year-old...Admit Source: Home, work...Admit Event Date/Time: 2/25/25, 08:53 (a.m.)..."

During a review of Pt 13's EHR on 2/26/25 at 9:29 a.m. with CS 3 and IM 1, Pt 13's "Short Form History and Physical (H&P- a formal assessment of a patient's health that includes a medical history and physical exam)" dated 2/25/25, was reviewed. The H&P indicated Pt 13 "... Reason for visit: Poorly functional hemodialysis access...history of anemia (when there is not enough healthy red blood cells), dialysis, End-Stage Renal Disease (ESRD - It refers to a severe and irreversible loss of kidney function that requires ongoing treatment to maintain life), and hypertension (high blood pressure)..."

During a review of Pt 13's EHR on 2/26/25 at 9:39 a.m. with CS 3 and IM 1 , Pt 13's "Authorization for and Verification of Consent to Surgery, Administration of anesthetics and Rendering of Other Medical Services (Informed Consent Form- permission granted in the knowledge of the possible consequences, given by a patient to a doctor for treatment with full knowledge of the possible risks and benefits)" dated 2/25/25, was reviewed. The Informed Consent form reviewed was in English, with Pt 13's signature affixed to page 1 of 2 authorizing the provider to perform "...Right upper extremity fistula gram (an X-ray procedure that examines a fistula, which is an abnormal passage between two parts of the body), possible intervention, possible dialysis catheter placement with procedural sedation..." CS 3 stated the witness signature affixed to the Informed Consent form was that of an Interventional Radiology department's "tiered" Registered Nurse (RN). CS 3 explained the tiered language staff process included testing and certification of the level of ability to interpret in a language other than English. CS 3 stated RN 13, who obtained and witnessed the patient signature is a "Tier 2" level Spanish interpreter. CS 3 stated as a Tier 2 interpreter, RN 13 was not certified to read or write in Spanish, so the process used in the IR is that an English form is used to ensure RN 13 understands the form they are using to provide verbal interpretation to the patient.

During a review of a document, undated, certifying RN 13's level of interpreting proficiency...the Document indicated RN 13 "...has tested proficient to serve as a Tier 2 Bilingual Patient Care Communicator Using the language of: Spanish as of this date: 03/20/2021...In this role, clinical information can be provided to patients and families to enhance care and conversation..."

During record review on 2/27/25 at 10:00 a.m. with the Director of Emergency Department (DED) , Pt 17's "Electronic Health Record [EHR], "FS," dated 2/23/25, Pt 17's "H&P" dated 2/23/25, and the "Emergency Department Patient Care Timeline Interpreter Services Flowsheet [EDPCT]", dated 2/23/25 to 2/26/25 were reviewed. The "FS" indicated Pt 17 arrived at the ED on 2/23/25 at 12:21 a.m. for hypoglycemia (is a condition where the blood glucose level drops below normal) and Pt 17's preferred spoken language was Spanish, and an interpreter was needed. The "EDPCT" indicated, Pt 17 presented to the ED on2/23/25 at 12:21 am and stayed in the ED to 2/26/25 at 7:49 p.m. The "EDPCT" indicated Pt 17 was transported to Interventional Radiology (medical specialty that uses minimally invasive procedures to diagnose and treat conditions) on 2/24/25 at 3:05 p.m. and returned at 4:26 p.m. The "EHR" indicated Pt 17's "Authorization for and Verification of Consent to Surgery, Administration of Anesthetics and Rendering of Other Medical Services [AVCSAAROMS-legal document that signifies a patient's informed agreement to undergo a surgical procedure, including the administration of anesthesia and any related medical interventions, after fully understanding the risks, benefits, and alternatives involved]" was in English and signed. The "AVCSAAROMS" did not include the second page where staff document if an interpreter was used.

During a concurrent interview and record review on 2/28/25 at 9:34 a.m. with Clinical Supervisor (CS) 3 and Registered Nurse (RN) 10, Pt 17's AVCSAAROMS, dated 2/24/25 was reviewed. RN 10 stated her signature was on the AVCSAAROMS and she witnessed the patient consent the form. RN 10 stated she does not remember if interpreter services was used, or a tiered (facility approved interpreter) interpreter was used with Pt 17. RN 10 stated she uses an English document instead of Spanish document for a Spanish speaking patient because, "We always do this".

During an interview on 2/28/25 at 10:30 a.m. with Nurse Practitioner (NP) 1, NP1 stated she was the provider who performed the procedure on 2/24/25 on Pt 17. NP 1 stated she does not remember if Pt 17 consented the AVCSAAROMS using interpreter services or a tiered interpreter. NP 1 stated when a tiered interpreter is used, she speaks in English and the tiered interpreter translates into the native language, then the tiered interpreter signs the consent form as does the patient. NP 1 states she does not document anything regarding consent forms. NP 1 stated she has not seen a Spanish consent form, only English.

During a record review on 2/28/25 at 1:30 p.m. with CS 3, Pt 17's AVCSAAROMS, dated 2/24/25 was reviewed. CS 3 stated they have Spanish Consent forms but don't use them very often. CS 3 stated they use the Spanish Consent forms for Spanish Reading patients and if are unsure if the patients read Spanish, they use the English consent forms. CS 3 stated, "Our practice to Spanish speaking patients is to interpret in Spanish and sign the consent form in English". CS 3 stated this practice has been in place before he was the supervisor which has been 5 years.

During a concurrent interview and record review on 2/26/25 at 10:57 a.m. with Nurse Director (ND) 1, Pt 29's "Face Sheet [FS- a document that contains a summary of a patients' personal information]," dated 2/11/25, Pt 29's "History & Physical [H&P- an assessment from physician including medical history and exam]," dated 2/11/25, and the "Interpreter Services Flowsheet [ISF]", dated 2/11/25 and 2/12/25 were reviewed. The "FS" indicated Pt 29 was admitted on 2/11/25 at 4:52 a.m. for osteosarcoma (a type of bone cancer) Pt 29's preferred spoken language was Panjabi (Punjabi), and an interpreter was needed. The "H&P" indicated, Pt 29 presented to the surgical department on 2/11/25 for scheduled right maxillectomy (surgical procedure to remove part or all the upper jaw) with reconstruction of right fibula free flap (using part of the smaller of the two leg bones to rebuild the upper jaw).

During a concurrent interview and record review on 2/26/25 at 11:15 a.m. with ND 1 Pt 29's "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 2/11/25 at 4:55 a.m. was reviewed. Pt 29's "COA" was signed on 2/11/25 at 4:55 a.m. and witnessed by hospital staff. ND 1 stated the Interpreter Statement area, and the Interpreter signature area on Pt 29's "COA" were blank. ND 1 stated an interpreter should have been provided to Pt 29 to interpret the "COA". ND 1 stated the interpreter would then sign the form. ND 1 stated no family member signed the form indicating a family member interpreted the "COA".

During a concurrent interview and record review on 2/27/25 at 3:38 p.m. with the Director of Patient Access (DPA) and the Manager of Registration and Admitting (MRA), Pt 29's "COA," dated 2/11/25 and "FS" were reviewed. The DPA and MRA verified Pt 29's "FS" indicated a preferred language of Punjabi. The DPA and the MRA verified Pt 29 signed the "COA" on 2/11/25 at 4:55 a.m. and a registration staff member signed the form as a witness on 2/11/25 at 4:55 a.m. The DPA stated a patient's preferred language needed to be the language used to communicate with patients during the "COA" process. The DPA and the MRA verified the interpreter area on Pt 29's "COA" was blank. The MRA stated, patient registration staff should have used an interpreter for Pt 29 to communicate the "COA" information, to ensure understanding of the form. The DPA stated, when an interpreter was used the interpreter services area was completed on the "COA". The DPA stated, when a staff member was tiered and interpreted the "COA", the staff would complete the interpreter area on the "COA" and enter the tier number on the "COA". The DPA stated registration staff should have contacted interpreter services for Pt 29 and interpreter services should have signed the "COA".

During an interview on 2/28/25 at 3:36 p.m. with the Chief Nursing Officer (CNO), the CNO stated, when patients have a preferred language other than English and consents are needed, it should be in the patient's preferred language, otherwise the patient doesn't know what they are signing. The CNO stated it is hospital policy to have non-English-speaking patients sign documents their native language and be attested by an interpreter.

During a review of the hospital's P&P titled, "Conditions of Admissions & Consent to Outpatient Care [COPC]," dated 12/1/20, indicated, " ...All [Hospital Name] patients have the right to self-determination over his or her body and property ... A signed verification of the COA/COPC provides legal authorization for treatment or services. ...If a patient or the patient's representative cannot communicate with the [Hospital Name] personnel because of language or communication barriers, [Hospital Name] personnel shall arrange for interpreter services ... If available, a
copy of the COA or COPC should be provided to the patient or patient's representative in their preferred language. ...If the COA or COPC is not available in the patient's primary language the interpreter should orally translate the form for the patient and ask the patient to sign the English form if the patient agrees to the terms and conditions that the interpreter orally stated. If the patient or the legal representative agrees, the interpreter should be signing the "Interpreter Signature is Applicable" section on the COA or COPC. ...When an interpreter is used, it must be documented in the "Interpreter Signature if Applicable" section on the COA or COPC. ...Family member /friends of the patient can interpret for the patient; however, the family member/friend should not sign the COA or COPC for the patient. ...The person who interpreted the COA or COPC to the patient must sign and state their relationship to patient under the "Interpreter Signature if Applicable" section of the COA or COPC. ...If [Hospital Name] personnel registering the patient is a tiered interpreter (at least level 1) in the same language as the patient preferred language, he/she may translate the document, provide the document in the patient's preferred language and fills out the "Interpreter Signature if Applicable" section of the COA or COPC...".

During a review of hospital P&P titled "Consents," dated 4/13/23, the P&P indicated "...I. PURPOSE: A. To describe the principles of consent, protect the rights of patients, ...B. To clarify the responsibilities of the hospital for consent to services and verification of informed consent...III. POLICY: A. the [hospital] patient has the right of self-determination over his or her body and property...B. A signed verification of consent provides legal authorization for treatment or services... [the hospital' is responsible for obtaining the patient's or legal representative's consent for hospital services or activities...IV. PROCEDURE: A. Determine who is authorized to sign the consent form...6. Obtaining Consent a. Consent to hospital services should be obtained in writing on appropriate consent forms and in appropriate language as applicable, by appropriate personnel as follows...ii. Surgical procedures, blood transfusion, special invasive and non-invasive, such as a radiologic test using dye procedure that put the patient at risk and require consent...b. Informed Consent is to be given for all invasive, complex, medical procedures such as the following...ii. All non-emergency invasive procedures requiring procedural sedation... e. Verification of consent takes place once the physician has ordered the appropriate medical treatment. It is the responsibility of licensed personnel to verbally verify with the patient or the patient's legal representative that a discussion has taken place between the physician/Advanced Practice Provider (APP) about the procedure including the risks, benefits and alternatives. If the patient or representative still has significant questions about the nature of the procedure or did not understand the information, hospital personnel must contact the patient's physician to allow him or her to answer the patient's questions. If the patient or legal representative does not verify that they provided informed consent to the physician, the procedure shall not begin (refer to the Informed Consent Flow Process document). Once the verification is complete, the patient will be asked to read and sign one of the following forms, as applicable: ... NOTE: If an interpreter is used to assist with the informed consent process, he/she will document on the consent form, if it includes the interpreter's attestation or on the Interpreter Attestation During Informed Consent form per the Interpreters - Use for Limited English (LEP) and Deaf /Hard Of Hearing Patients policy...."

According to the "Safety First: The Importance of Interpreters & Translated Documents in Preventing Patient Harm" column electronically retrieved on 3/5/25 from https://wmc.wa.gov/sites/default/files/public/Newsletter/4.SafetyFirst.pdf the column indicated "...Ensure Translation of Patient Education and Vital Clinical Documents Written communication with patients is just as important as verbal communication. Providers should make sure patient education materials, after visit or discharge summaries, and legal forms, such as informed consent, are translated in the top three or five languages in their service area. It is critical that... patients understand all the information necessary to make informed decisions about their care and know how to care for themselves when they return home to reduce the chances of hospital or ED (Emergency Department) readmissions and poor health outcomes..."

2. 2. During a concurrent interview and record review on 2/26/25 at 10:57 a.m. with Nurse Director (ND) 1, Pt 29's "Interpreter Services Flowsheet [ISF]", dated 2/11/25 and 2/12/25 was reviewed. ND 1 stated Pt 29's "ISF" indicated, an interpreter was used on 2/26/25 two times and on 2/27/25 one times while Pt 29 was in the Surgical Services Department. ND 1 stated no other "ISF" entries were entered into Pt 29's Electronic Health Record (EHR). ND 1 stated Pt 29 was still admitted to the hospital as of 2/26/25. ND 1 stated, RNs should have used an interpreter to communicate with Pt 29, and the information should have been documented in the "ISF". ND 1 stated RNs should be using an interpreter to interpret Pt 29's POC, assessments, pain, medications, and general communication. ND 1 stated speaking to Pt 29 in his preferred language was important for him to understand what was happening to him. ND 1 stated RNs should document interpreter use in the "ISF."

During a concurrent interview and record review on 2/27/25 with Clinical Supervisor (CS) 1 and Registered Nurse (RN) 8, Pt 29's "Admission Preferred Language [APL]", dated 2/11/25 and the "ISF" dated 2/11/25 through 2/27/25 were reviewed. RN 8 stated Pt 29 spoke English and Punjabi. RN 8 verified in the "APL" Pt 29's preferred language was Punjabi and needs interpreter was indicated. RN 8 stated, RNs must use certified language interpreters if the patient's preferred language was other than English. RN 8 verified in the "ISF" only three entries were documented, and all were from surgical services from Pt 29's day of admission. RN 8 stated, she communicated with Pt 29 in English and Punjabi. RN 8 stated she did not document in the nurses note or in the interpreter flowsheet speaking to Pt 29 in Punjabi, and she should have. RN 8 stated she had been tiered (tested-to interpret) but had not received the sticker for her badge yet. RN 8 stated, she should use an interpreter to communicate with Pt 29 since she did not have the tier sticker. RN 8 stated documenting interpreter use in the EHR was important, so the entire care team knew what Pt 29 had been educated about and Pt 29's understanding of the POC. CS 1 stated, RNs should use an interpreter to communicate with patients in their preferred language, when the language is other than English. CS 1 stated, RNs should document in the EMR when using an interpreter. CS 1 stated, if the RN was a tiered interpreter they should still document the information interpreted in the nursing note or in the "ISF". CS 1 stated, interpreting in the preferred language was important for patient understanding.

During a concurrent interview and record review on 2/7/25 at 12:00 p.m. with the Director of Emergency Department (DED), Pt 40's "EHR", "FS", dated 2/23/25, Pt 40's "H&P," undated, and the "EDPCT", dated 2/22/25 through 2/25/25 were reviewed. The "FS" indicated Pt 40 arrived at the ED on 2/22/25 at 11:08 a.m. for fall from tree. Pt 40's "FS" indicated his preferred spoken language was Spanish, and an interpreter was needed. The "EDPCT" indicated, Pt 40 presented to the ED on 2/22/25 at 11:08 a.m. and stayed in the ED to 2/25/25 at 2:08 p.m. The "EDPCT" indicated during Pt 40's stay in the ED, hospital staff documented interpreter services/tiered interpreter use was five times, on 2/23/25 at 7:45 a.m., 2/23/25 at 3:57 p.m., 2/25/25 at 4:30 a.m., 8:40 a.m. and at 12:00 p.m. The DED stated every time staff touch a patient, they should be using an interpreter service or a tiered interpreter. The DED stated not only should staff be using some sort of interpreter services, but the staff should also be documenting it in the EHR. The DED stated staff did not follow policy for interpreter services.

During an interview on 2/28/25 at 3:36 p.m. with the Chief Nursing Officer (CNO), the CNO stated, when patients have a preferred language other than English, hospital staff should be using an interpreter to communicate with the patient. The CNO stated, hospital staff should be documenting in the EMR communication with the patient in their preferred language using one of the approved methods per policy.

During a review of the hospital's P&P titled, "Interpreters/Translation: Non-English/Limited English Proficient & Deaf/Hearing Impaired," dated 6/14/24, indicated, " ...Purpose ...To define the communication system that is used for patients who have Limited English Proficiency (LEP) ... Definitions ...Any staff member who communicates in languages other than English when caring for patients is referred to as a Care and Conversation Communicator ... Upon testing and training, such a staff member is assigned a Tier 1 or 2 badge buddy [a small card attached to the identification badge], depending on their scope of competency in the given targeted language. ...Courtesy Language Resources/In-house Language Resources (Tier 1).: Such a bilingual staff member is fluent in English and in the necessary second language. The staff member can speak and readily interpret general patient communication in the necessary second language. ( ...excluding medical information). ...Professionals (Tier 2): ...Such an individual has knowledge of anatomy, symptom description, common diseases/ailments, etc. and wishes to provide service to non-English speaking patients/clients/customers without the aid of an interpreter; he/she wishes to communicate directly with the patient. ...Certified Healthcare Interpreter (Tier 3): A certified professional whose exclusive job description is "INTERPRETER - 1, 2 or 3 - Health care" and who is fluent in both English and another language. Certified Healthcare Interpreters communicate critical medical information, such as informed consents, goals of care, end of life discussions, etc. ...Policy ...A certified health care interpreter (Tier 3) or badged bilingual staff (Tier 2) shall be used - telephonically, videoconferencing or in-person, as required - in any situation were clear and effective communication of medical information is necessary. ...presence of an interpreter for deaf, hearing impaired, or limited English-speaking patients is necessary to ensure thorough and accurate communication including "critical medical information" ...but are not limited to: 1. Explaining a medical procedure or intervention(s). 2. When Informed Consent is required for treatment. 3. When explaining and describing medical conditions, tests, treatment options, medications, surgery and other procedures. 4. When providing a diagnosis, prognosis, and recommendation for treatment during treatment and testing procedures. 5. When providing instructions for medications, post-treatment activities, and follow-up treatments. ...In the event that the patient prefers to use a friend or a family member to interpret on their behalf, one of the following waivers must be signed and scanned into the patient's EHR. ...Documentation ...Staff member documents in the patient's EHR if an interpreter or device(s) is/was used ...Name of the interpreter, including i. Interpreter used (first and last name) ii. Interpreter agency, as appropriate iii. Time iv. Date ...The staff member documents the following information in the EHR upon concluding the interpreter session including when interpretation was provided by a family member: 1. Start date 2. Start time 3. End time 4. Language Spoken 5. Interpreter Session type ...".

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, surveillance video review and record review, the hospital failed to ensure nurses followed policies and procedures (P & P) when:

1. Licensed Nurses (LNs) did not follow the hospital's P&P titled, "Pain Assessment and Management -Patients 14 and Older", and "Provider Orders," for five of 52 patients (Pt 19, Pt 23, Pt 28, Pt 40, and Pt 53). For four of 52 Pts licensed nurses did not complete a pain assessment (Pt 19, Pt 23, Pt 40, and Pt 53). For three of 52 Pts (Pt 19, Pt 28, and Pt 40) licensed nurses did not reassess pain after administration of pain medications within the expected timeframe. For two of 52 Patients (Pt 28, and Pt 53) licensed nurses did not administer adequate pain medications to address or re-address severe pain in accordance with physician orders and hospital P&P.
These failures placed patients at risk to receive inadequate pain management and had the potential for LNs to not recognize a change in condition timely.

2. LNs failed to clarify an incomplete physician's order (missing goal parameter -must state what the medication is for and specifically when, how much and how often the medication may be administered) for propofol (an intravenous (IV- administered into a vein) anesthetic medication used to help you relax or sleep before and during surgery or other medical procedures) for one (1) of eleven (11) patients sampled, Patient (Pt) 14, in accordance with hospital policy and procedure (P&P) titled "Medications - Orders, Administration, Storage, Documentation," dated 12/19/23.
This failure had the potential to result in a medication administration error, and avoidable harm to Pt 14 from over or under sedation (administering of a drug to produce a state of calm or sleep).

3. Licensed Vocational Nurses (LVNs) and Patient Care Technicians (PCTs) failed to document an incident involving skin tears (traumatic wound when skin separates) to the chest caused by the removal of electrode stickers (small sticky patches that attach to the skin), for one of 56 patients (Pt 56). Pt 56's Electronic Medical Record (EMR) did not include an entry documenting a skin assessment after the skin tear was discovered, or documentation about applying a dressing (bandage) to the skin tear. Pt 56's EMR also did not have documentation about reporting the incident to Pt 56's family or reporting the incident to Pt 56's physician prior to Pt 56's discharge on 1/19/25 according to the LVN and PCT "Job Descriptions" and the hospital P&P titled "Documentation in the Health Record".

This failure resulted in Pt 56 sustaining a skin tear to the chest and was discharged without a plan of care for treatment to the skin tear wound which could lead to an infection of the wound.

4. LVNs and PCTs failed to report an incident of patient harm through the hospital's incident reporting system for one of 56 patients (Pt 56), after causing a skin tear wound to Pt 56's chest when removing the telemetry (remote monitoring of heart rate and rhythm) electrodes, in accordance with the hospital's P&P titled, "Incident Reporting Intranet System (IRIS)".

This failure prevented hospital investigation into the incident from occurring timely, potentially preventing a reoccurrence of the incident in other areas of the hospital.

5. Nurses and PCTs failed to follow hospital P&P regarding nutrition for two of five sampled patients (Pt 27 and Pt 30) by not documenting and tracking the nutritional intake in the medical record for patients who had a care plan in place for a nutrition deficit according to hospital P&Ps titled, Documentation in the Health Record", and "Interdisciplinary Plan of Care [IPOC-interdisciplinary care plans are detailed plans of care created by representatives from several medical disciplines or specialties, each focused on a specific patient's condition, treatment goals, and methods for improving outcomes]." Nurses also failed to obtain a dietary consult for Pt 30 when she was eating an average of 25% of her meals and had significant weight loss of 10.68%, according to hospital P&P titled, "Pressure Injury Risk Assessment, Prevention, Staging and Treatment" (involves identifying individuals at risk, implementing preventative measures, classifying injury severity, and providing appropriate care to promote healing).

These failures resulted in Pt 30 to experience a significant weight loss due to not tracking/addressing her nutritional intake and deficiency, a dietary consult was not obtained and placed Pt 30 at an increased risk for skin breakdown, slow wound healing and a longer hospital admission.

Findings:

1. During an observation and interview on 2/24/25 at 11:35 with Pt 23 in her hospital room on the Post Partum Unit, (a hospital ward where mothers and their newborns receive care and support immediately after childbirth, focusing on the mother's recovery and the baby's initial needs). Pt 23 was observed lying in her hospital bed with her eyes opened. Pt 23 stated she had a baby three weeks ago by Cesarean Section (C/S - a surgical procedure used to deliver a baby through a cut in the mother's stomach and womb (a simple, everyday term for the uterus, the hollow, pear-shaped organ in a woman's pelvis where a fetus develops before birth) and was readmitted because of an infection to the incision (surgical cut) from the C/S. Pt 23 stated she had a lot of pain around her incision area when she was first admitted to the hospital. Pt 23 stated, her pain was getting better with the medications she was receiving.

During a review of Pt 23's "History & Physical [H&P- an assessment from physician including medical history and exam]," dated 2/23/25, and "Admission Discharge Transfer Events [ADT]," dated 2/23/25 to 2/24/25, the "H&P" indicated, Pt 23 presented to the Emergency Department (ED) for an infection of her cesarean section incision. The "H&P" indicated, Pt 23 reported the pain over the incision started worsening, and the incision started leaking fluid. The "H&P" indicated; Pt 23 was admitted to the hospital as an inpatient for intravenous (IV- medical technique that administers fluids, medications and nutrients directly into a person's vein through a thin flexible tube) antibiotics (medications used to treat bacterial infections). The "ADT" indicated, Pt 23 arrived in the ED on 2/23/25 at 9:48 a.m., and was admitted as an inpatient on 2/23/25 at 2:33 p.m. Pt 23 was moved to the Postpartum (PP -a dedicated area within a hospital where new mothers stay after giving birth) Unit on 2/23/25 at 6:15 p.m.

During a concurrent interview and record review on 2/25/25 at 2:55 p.m. with Nurse Director (ND) 4, Pt 23's "Physician Medication Order [PMO] 1," dated 2/23/25 at 10:10 a.m. was reviewed. "PMO 1" indicated, " ...acetaminophen [mild pain medication] ... tablet 1,000 mg [milligram - a unit of measurement] ...Oral ... Once...".

During a concurrent interview and record review on 2/25/25 at 2:58 p.m. with Nurse Director (ND) 4, Pt 23's "Physician Medication Order [PMO] 2," dated 2/23/25 at 1:54 p.m. was reviewed. "PMO 2" indicated," ...fentanyl [strong pain medication] ... Injection 50 mcg [micrograms - a unit of measurement] ...intravenous [IV]... EVERY 2 HOURS PRN [as needed] for SEVERE pain...".

During a concurrent interview and record review on 2/25/25 at 3 p.m. with Nurse Director (ND) 4, Pt 23's "Pain Monitoring Flowsheet [PMF]," dated 2/23/25 to 2/24/25, was reviewed. The "PMF" indicated, on 2/23/25 at 10:14 a.m. Pt 23 was administered 1,000 mg acetaminophen. ND 4 stated, Pt 23's "PMF" pain documentation was blank at the date and time of medication administration and no earlier pain assessment was in the "PMF". ND 4 stated, Pt 23's nurse should have assessed for pain prior to administering the medication, to ensure the administered medication was appropriate to the patient's stated level of pain. The "PMF" indicated on 2/23/25 at 11:14 a.m. a reassessment pain score of 8 (severe). ND 4 stated, Pt 23's nurse should have contacted the physician if Pt 23 was still in pain after pain medication reassessment if Pt 23 had no other pain medication orders. ND 4 stated, no additional pain medications were administered until 2:08 p.m. on 2/23/25. The "PMF" indicated, on 2/23/25 at 2:08 p.m. Pt 23's nurse administered 50 mcg fentanyl through the IV. ND 4 stated, Pt 23's "PMF" pain documentation was blank during the associated medication administration time. ND 4 stated, Pt 23's nurse should have assessed Pt 23's pain prior to administering fentanyl, because the previous pain score was three hours before.

During a review of Pt 28's "Face Sheet [FS - a document that contains a summary of a patients' personal information]," dated 2/21/25, Pt 28 was admitted on 2/21/25 at 5:26 p.m. The "FS" indicated; Pt 28 was a transfer from one distinct unit of the hospital to a different distinct unit. The "FS" indicated Pt 28's admit reason was, STEMI (ST Elevation Myocardial Infarction- [a life-threatening heart attack that occurs when a coronary artery (the blood vessels that supply the heart muscle with oxygen and nutrients) is completely blocked], and Acute Hypoxic Respiratory Failure (lungs cannot get enough oxygen for the body to survive).

During a review of Pt 28's "H&P," dated 2/21/25, the "H&P" indicated, Pt 28 was brought in by ambulance to the ED on 1/14/25 for shortness of breath for four to five days. The "H&P" indicated; Pt 28 was admitted to the hospital as an inpatient on 1/14/25 for acute hypoxic respiratory failure. The "H&P" indicated Pt 28 had a coronary artery bypass graft [CABG - also called heart bypass surgery, is a medical procedure to improve blood flow to the heart) and tracheostomy (a surgical procedure that creates an opening in the windpipe to allow air to enter the lungs) placement during the hospital admission of 1/14/25 to 2/21/25. The "H&P" indicated Pt 28 was moved to the hospital's inpatient Rehabilitation (Rehab-a specialized area where patients receive intensive therapy to regain physical, cognitive [thinking], or functional abilities lost due to an injury, illness, or surgery) Unit on 2/21/25.

During a concurrent interview and record review on 2/26/25 at 10:38 a.m. with ND 1, Pt 28's "PMO," dated 2/21/25 at 5:38 p.m. was reviewed. The "PMO" indicated, " ...acetaminophen... tablet 650 mg... Oral ... Every 6 Hours PRN for MILD Pain...".

During a concurrent interview and record review on 2/26/25 at 10:40 a.m. with ND 1, Pt 28's "PMF," dated 2/25/25 to 2/26/25, was reviewed. The "PMF" indicated, on 2/25/25 at 8:37 p.m. a pain score of 10 (the worst pain) in Pt 28's shoulder. The "PMF" indicated 650 mg acetaminophen was administered. ND 1 stated RNs administered a mild pain (1-3) medication for a severe pain (7-10) score. ND 1 stated, RNs should have contacted the physician for a pain medication for severe pain. ND 1 stated, if Pt 28 preferred mild pain medication for severe pain, RNs should have documented the refusal of stronger pain medication on the "PMF" and reported to the physician so the order could be updated. ND 1 stated, the "PMF" did not have another pain score documented until 2/26/25 at 9 a.m., 11 hours after medication administration. ND 1 stated Pt 28's RN should have reassessed Pt 28's pain within an hour of medication administration to make sure Pt 28's pain was adequately controlled. ND 1 stated reassessment of pain was important to ensure adequate pain control for patients.

During a review of Pt 53's "H&P," dated 1/20/25, the "H&P" indicated, Pt 53 presented to the ED with a complaint of abdominal pain, nausea, vomiting and constipation for two days. Pt 53 was admitted to the hospital as an inpatient on 1/20/25 at 3:27 p.m. for a small bowel obstruction (SBO-a blockage in the digestive system preventing normal passage of food, fluids, and gas), hydronephrosis (urine builds in kidney causing swelling), and adenocarcinoma (type of cancer that originates in cells that produce secreting substances-hormones, enzymes (help speed up chemical reactions in the body), mucus) of the rectum (part of large intestine between colon and anus) that had spread to the liver. Pt 53 was transferred to the Oncology (special unit where patients diagnosed with cancer receive treatment) Unit on 1/22/25 at 6:44 p.m.

During a concurrent interview and record review on 2/28/25 at 9:05 a.m. with ND 1, Pt 53's "PMO 1," dated 1/20/25 at 2:17 p.m. was reviewed. "PMO 1" indicated, " ... oxycodone immediate release tablet [strong pain medication] 5 mg ... Oral ... ONCE...".

During a concurrent interview and record review on 2/28/25 at 9:08 a.m. with ND 1, Pt 53's "PMO 2," dated 1/20/25 at 3:40 p.m. was reviewed. "PMO 2" indicated, " ... oxycodone immediate release tablet 5 mg ... Oral ... Every 6 HOURS PRN for Moderate pain (pain score 4-6) ...".

During a concurrent interview and record review on 2/28/25 at 9:11 a.m. with ND 1, Pt 53's "PMO 3," dated 1/20/25 at 3:40 p.m. was reviewed. "PMO 2" indicated, " ... oxycodone immediate release tablet 10 mg ... Oral ... Every 6 HOURS PRN for SEVERE pain ... (pain score 7-10) ...".

During a concurrent interview and record review on 2/28/25 at 9:15 a.m. with ND 1, Pt 53's "PMF," dated 1/20/25 to 1/22/25 was reviewed. The "PMF" indicated, on 1/20/25 at 3:52 p.m. Pt 53 was administered a 5 mg tablet of oxycodone, no pain score was associated with the medication administration. The "PMF" indicated, on 1/20/25 at 4:52 a pain reassessment of 9 (severe), no additional medications were administered at the time of reassessment. The "PMF" indicated, on 1/22/25 at 4:19 a.m. a pain reassessment of 8 (severe), no additional medications were administered at the time of reassessment. ND 1 stated, on 1/22/25 at 9:36 a.m. Pt 53 was administered a 10 mg tablet of oxycodone with no associated pain score. Pt 53 did not have a pain assessment or pain medication for six hours after scoring her pain 8 at 4:19 a.m. ND 1 stated nursing staff should have assessed Pt 53's pain prior to administering medication and a pain assessment should be completed again after administration to assure the patient had pain relief. ND 1 stated, nurses should have assessed Pt 53 prior to medication administration to know if the appropriate level of pain medications were given according to reported pain and physician order, or if the patient even needed pain medication. ND 1 stated, nurses should document declination of pain medications in the EMR if Pt declines. ND 1 stated when a Pt did not have adequate pain control nurses should report to the physician for a different pain medication order.

During an interview on 2/28/25 at 3:44 p.m. with the Chief Nursing Officer (CNO), the CNO stated pain should be assessed before and after pain medications were administered, to ensure patients were getting effective pain control.

During a review of Pt 19's "History and Physical (H&P-patient's medical history and a physical examination. It is a comprehensive assessment that provides a detailed overview of the patient's health status)," dated 2/22/25, the "H&P" indicated, Pt 19 chief complaint (primary reason for coming to the emergency department) for chest pain, shortness of breath (SOB) for days. Pt 19 was discharged on 2/15/25 but returned to the ER (emergency Room) on 2/16/25 for uncontrolled pain.

During a review of Pt 19's "Medication Administration Record (MAR- an electronic record of medications that were given)," dated 2/21/25-2/27/27, the "MAR" indicated, "... fentanyl (opioid pain medication to treat severe pain) injection 50 mcg [microgram-unit of measure], Dose: 50 mcg, Freq: ONCE, Route: IV (intravenous). Start: 2/24/25 10:50 p.m., End: 2/24/25 11:10 p.m. ...".

During a review of Pt 19's "MAR," dated 2/21/25-2/27/27, the "MAR" indicated, "... Hydromorphone (narcotic to treat moderate to severe pain. injection 0.25 mg [milligram-unit of measure], Dose: 0.25mg, Freq: Every 4 hours PRN [as needed], Route: IV, PRN Reason: Severe Pain, Start: 2/25/24 12:52 a.m., End: 2/25/25 7:55 a.m. ...".

During a concurrent interview and record review on 2/26/25 at 10:00 a.m. with the Director of Emergency Department (DED), Pt 19's "MAR" and "Pain Monitoring Flowsheet (PMF-documentation for charting specific pain interventions and pain levels)" dated 2/21/25 to 2/27/25 was reviewed. The "MAR" on 2/24/25 indicated, Pt 19 was administered fentanyl 50 mcg at 11:10 p.m. on 2/24/25 and hydromorphone 0.25 mg at 1:56 a.m. on 2/25/25. The "PMF" indicates no pain assessment was charted prior to administration of both medications. The DED stated Pt 19's pain assessment was not complete prior to administration of medications. The DED states Pt 19's pain should have been assessed prior to administration of pain medication.

During a review of Pt 40's "History and Physical (H&P)," dated 2/22/25, the "H&P" indicated, "... Pt 40's Chief Complaint was a fall approximately 50 feet from a tree, and Pt 40 does not remember if he lost consciousness. The "H&P" indicated the plan was to admit Pt 40 to the TICU (Trauma Intensive Care Unit) and control his pain using multimodal pain control (multiple interventions to achieve effective pain relief)

During a review of Pt 40's "Medication Order," dated 2/22/25, the "MO" indicated, " ... fentanyl injection 50 mcg, Ordered Dose: 50 mcg, Route: Intravenous, Frequency: Once, Admin Dose: 50 mcg ...". acetaminophen 325 mg Tab ... 650 mg 2 tab ... Oral, [every four hours as needed for] PAIN ..."

During a review of Pt 40's "MO", dated 2/22/25, the "MO" indicated, " ... fentanyl injection 25 mcg, Ordered Dose: 25 mcg, Route: Intravenous, Frequency: Once, Admin Dose: 25 mcg, Scheduled Start Date/Time: 2/22/25 3:50 p.m., End Date/Time: 2/23/25 11:05 a.m. ..."

During a review of Pt 40's "MO", dated 2/22/25, the "MO" indicated, " ... oxycodone (narcotic pain medication used to treat moderate to severe pain) immediate release tablet 5 mg, Ordered Dose: 5 mg, Route: Oral, Frequency: Ever 4 hours PRN for MODERATE Pain, Admin Dose: 5 mg, Scheduled Start Date/Time: 2/22/25 3:49 p.m., End Date/Time: 2/23/25 11:05 a.m. ...".

During a review of Pt 40's "MO", dated 2/22/25, the "MO" indicated, " ... oxycodone immediate release tablet 5 mg, Ordered Dose: 5 mg, Route: Oral, Frequency: Ever 4 hours, Admin Dose: 5 mg, Scheduled Start Date/Time: 2/22/25 3: 49 p.m. (Original Order) Start Date/Time (After Last Modification) 2/23/25 11:21 a.m., End Date/Time: 2/25/25 7:22 a.m. ...".

During a review of Pt 40's "MO", dated 2/23/25, the "MO" indicated, " ... acetaminophen (pain medication used to treat minor pain and fever reduction) tablet 1,000 mg, Ordered Dose: 1,000 mg, Route: Oral, Frequency: Every 6 hours, Admin Dose: 1,000 mg, Scheduled Start Date/Time: 2/23/25 1:00 p.m., End Date/Time: 2/23/25 -- ...".

During a concurrent interview and record review on 2/25/25 at 2:00 p.m. with the (DED), Pt 40's "MAR" and "PMF" dated 2/22/25 to 2/26/25 was reviewed. The "MAR" indicated, Pt 40 was administered fentanyl 50 mcg at 12:34 p.m., administered fentanyl 25 mcg at 4:49 p.m. on 2/22/25 and at 5:43 a.m. on 2/2/3/23, administered oxycodone 5 mg at 3:36 a.m. on 2/23/25 and at 11:48 a.m. on 2/23/25, and administered acetaminophen 1,000 mg at 1:22 p.m. on 2/23/25, 1:49 a.m. on 2/24/25, 2:38 a.m. and 7:05 p.m. on 2/26/25. The "PMF" indicates no pain assessment was charted prior and/or after administration of these medications. The DED stated Pt 40's pain assessment was incomplete, Pt 40 did not have pain assessments prior and/or after administration of pain medications. The DED stated the LNs did not follow hospitals pain policy.

During an interview on 2/28/25 at 3:36 p.m. with the Chief Nursing Officer (CNO), the CNO stated pain assessments prior to medication administration and after administration are mandatory and should always occur. The CNO stated without a pain assessment prior to or after administration of medication, nurses would not know if the pain medication was effective.

During a review of the hospital's P&P titled, "Pain Assessment and Management -Patients 14 and Older," dated 1/15/25, indicated, " ... Pain screen is used to determine if pain is present or absent by utilizing verbal acknowledgment of pain by a patient/family/caregiver or utilizing a pain measurement tool. ...Comprehensive pain assessment may include information from the patient/family about provoking factors, quality/characteristics, region/radiation, relieving factors, associated symptoms, timing, and pain intensity scores obtained with a pain measurement tool. ...analgesic (a drug that reduces pain) history, medical diagnosis, physical assessment ... Data Collection and Assessment ... Assess and reassess pain using one of the following scales as appropriate. a. 0-10 pain intensity scale (adolescents to adults who do not have cognitive (relating to the mental process involved in knowing, learning, and understanding things) disorders). The appropriate pain rating scale is used to determine an appropriate pain management modality ... Pain management scales utilizing the 0-10 descriptors, will be assessed as a pain rating of 0=no pain, 1-3=mild pain, 4-6=moderate pain and 7-10=severe pain. Patients' denial of pain will be interpreted as 0. ...Pain Management Plan ... Once a pain management plan is established, in agreement with the patient/family/caregiver and the health care team, the pain management care plan is administered as prescribed to achieve desired comfort level. ...Implementation 1. Medications will be administered based on the patient's pain scale level identified and as ordered by the provider. ...Monitor - Assessment/Reassessment of Pain Management and Adverse Effects 1. Assessment for pain is to be completed using the appropriate pain assessment tools during routine unit assessment times, prior to pain medication administration and as needed. 2. Reassessment for pain intensity and presence of adverse effects is to be completed following administration of pharmacological pain management. Reassessment parameters are based on route and typical timeframes needed to reach peak effect. a. IV Administration - within 30 minutes. b. Oral (by mouth)/Intramuscular (into a muscle)/Subcutaneous (beneath the skin) - within 60 minutes. c. This reassessment will be documented in the EHR using the appropriate pain and sedation scale as indicated. ... If the patient appears to be sleeping, the nurse will document objective observations in the EHR, and a pain intensity level will not be documented. ... Document the following in the appropriate section of the EHR: 1. If pain is identified as an issue, the initial assessment will include pain intensity (0-10), verbal pain descriptors, or the behavioral pain score and the patient's acceptable level of pain, location, quality, duration, and any associated symptoms. ...Subsequent reassessments should include the following: intensity, location, response to treatment modalities, and type of pain assessment scale used. ...Any interventions for pain management, such as analgesics on the Medication Administration Record according to policy. ...Any communication with the provider. ...The patient's care plan reflecting an active plan for the treatment of pain ...".

During a review of the hospital's P&P titled, "Provider Orders," dated 8/25/23, indicated, " ...The RN acknowledgment of orders indicates they assume responsibility for ensuring implementation of the order within the prescribed period. ... Questions and concerns regarding carrying out physician's orders. ... The RN, LVN and Licensed Psychiatric Technician (LPT) are health practitioners and must act prudently to deliver optimal patient care. Each licensed person is responsible for a knowledge base in his or her health care area. It is their responsibility to question inexact, illegible or potentially inappropriate physician's orders. This includes, but is not limited to, medication dosages and administration. ... The RN is to call the physician to clarify the order ...".

During a review of the professional reference 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 ...".

2. During a concurrent observation and interview with the ICU Nurse Director, (ND) 6 on 2/24/25 at 1:05 p.m., during a tour of the Burn Intensive Care Unit (ICU- a department of a hospital in which patients who are dangerously ill are kept under constant observation) Pt 14 was on a continuous IV administration of propofol.

During a review of Pt 14's Electronic Health Record (EHR- a digital version of a patient's medical history) on 2/26/25 at 2:31 p.m., with ND 6, Pt 14's Face Sheet (FS-a document that contains a summary of a patient's personal and demographic (all of the non-clinical data about a patient (name, date of birth , address, etc.) information), the FS indicated, "...Admit Reason (s): 2nd And 3rd Degree Burns to Abdomen, Legs And Genitals...ED Arrival Date/Time: 2/23/253 16:30 (4:30 p.m.)...Admit Source: Transfer from another acute care hospital...Date/Time First Inpatient: 2/23/25, 16:34 (4:34 p.m.)..."

During record review of Pt 14's EHR, on 2/6/25 at 2:31 p.m., with ND 6, Pt 14's "History and Physical (H&P- a formal assessment of a patient's health that includes a medical history and physical exam)" dated 2/23/25, was reviewed. The H&P indicated Pt 14 was an "...87-year-old...patient with a history of hypertension (high blood pressure) and pacemaker (a device used to control an irregular heart rhythm (heart beat(s)) ...transferred from a [local general acute care hospital (GACH)] for burns over bilateral lower extremities (both legs), genitals and buttocks...injury... [while] using a welding torch when his pants caught fire..."

During a concurrent interview and record review of Pt 14's EHR, on 2/28/25 at 9:00 a.m., with ND 6 and RN 12, Pt 14's "Propofol Order" dated 2/25/25, was reviewed. The order indicated "... propofol infusion 10 mg/ml (milligrams per milliliter- the amount of one substance dissolved in a specific volume of a liquid)... Admin Instructions: Goal sedation: Ventilator compliance/synchrony (a patient's breathing efforts are perfectly aligned with the breaths delivered by a mechanical ventilator (a type of therapy that helps you breathe or breathes for you when you can't breathe on your own)..." RN 12 stated she did not believe the order was incomplete and therefore did not seek to clarify the order with the ordering provider. RN 12 stated has administered this medication to other patients, under the same goal sedation instructions in the past. RN 12 explained that she titrated (the medication dose is either progressively increased or decreased in response to the patient's status) the propofol to ensure that Pt 14 was tolerating, but not fighting against the mechanical ventilator settings. ND 6 stated this goal sedation is used in a special population of patients, such as Pt 14, who require special administration considerations and are more difficult to sedate. ND 6 stated she agreed with RN 12's actions in administering the propofol as ordered and therefore, did not believe a clarification was needed.

During an interview on 2/28/25 at 3:38 p.m. with the Chief Nursing Officer (CNO) the CNO stated, nurses were expected to follow hospital P&Ps. CNO stated any incomplete order [such as Pt 14's propofol order] should be clarified with the provider. CNO stated the "ventilator compliance/synchrony" sedation goal is incomplete as it does not provide a specific goal for the nurse to follow.

During a review of hospital P&P) titled, "Medications - Orders, Administration, Storage, Documentation" dated 12/19/23, the "P&P" indicated " ...I. PURPOSE To provide guidelines for the safe and accurate ordering, transcribing, labeling, administration, storage and documentation of medications...III. POLICY... 3. A medication order must be clear, legible and include the following...g. For infusions, orders to titrate medications must indicate starting rate, titration parameters and maximum rate. These orders may include, but not limited to systolic blood pressure (the pressure in your arteries when your heart beats, pushing blood out to the body), respiratory rate, ...sedation scale, and pain scale...4. Any orders for medications that are illegible, incomplete, and/or unclear will require clarification. a. ...RN will contact the ordering prescriber and clarify using the telephone/verbal order process... V. PROCEDURE A. Acknowledge and verify that all orders are valid and contain all elements required in related [hospital] policies..."

According to the Joint Commission (JC- is the nation's oldest and largest standards-setting and accrediting body in health care) electronically retrieved on 3/5/25 from:
https://www.jointcommission.org/standards/standard-faqs/critical-access-hospital/medication-management-mm/000002114/?p=1 the JC defines the "Required elements for medication titration orders: Medication name, Medication route, Initial or starting rate of infusion (dose/min), Incremental units the rate can be increased or decreased, Frequency for incremental doses (how often does(rate) can be increased or decreased, Maximum rate (dose) of infusion, Objective clinical endpoint (RASS score (a medical scale used to measure the agitation or sedation level of a person), CAM score (a tool used by healthcare professionals to quickly and accurately identify delirium, a state of confusion), etc.... Goals when developing requirements for safe administration:...Nursing not placed in a position of making dosing/administration decisions that may conflict with their scope of practice..."

3. During a review of Pt 54's "H&P," dated 1/15/25, and "ADT," dated 1/15/25 to 1/19/25, the "H&P" indicated Pt 54 was a 78-year-old who was brought to the ED by family with a complaint of (C/O) dizziness, nausea and vomiting, slurred speech and difficulty walking. Pt 54 was admitted to the hospital as an inpatient on 1/15/25 at 5:59 p.m. for hypoglycemia (low blood sugar), near syncope (almost fainting), acute kidney injury (AKI- a sudden and often reversible decline in kidney function), abnormal ECG (heart test), and cirrhosis (disease where healthy liver tissue is replaced by scar tissue). The "ADT" indicated Pt 54 was discharged from the hospital on 1/19/25 at 2:56 p.m.

During a telephone interview on 2/27/25 at 1:50 p.m. with Family Member (FM) 1, FM 1 stated when Pt 54 was discharged from the hospital on 1/19/25 family members observed the staff "hurrying" to get Pt 54 out of the hospital room. FM 1 stated, his brother, and cousin watched the "nurse" pull the lines (IV lines) and "roughly" pull off all the chest electrode stickers. FM 1 stated, when Pt 54 got home, and family helped change Pt 54's clothing, gauze and tape were discovered on her chest over a skin tear where one of the electrodes was removed. FM 1 stated the wound was bleeding and family members bandaged the wound again. FM 1 stated nursing staff did not inform the family of the skin tear at the time of discharge. FM 1 stated, Pt 54's family did not see the skin tear at the hospital, or the bandaging of the wound, they just saw the "nurse" pulling off medical equipment quickly. FM 1 stated, his brother called the hospital and made a complaint about the incident on 1/20/25. FM 1 stated, if Pt 54's family did not see the wound when changing Pt 54, they would not have known, and it may have gotten infected. FM 1 stated, the "nurse" should have told the family when the incident occurred.

During a concurrent interview and record review on 2/28/25 at 9:39 a.m. with ND 1, Pt 54's "Wound Care Flowsheet [WFS]," dated 1/15/25 to 1/19/25 was reviewed. The "WFS" indicated from 1/15/25 to 1/19/25 Pt 54's skin was documented as intact during

Based on interview and record review, the hospital failed to ensure medication was distributed from pharmacy in accordance with standards of practice and hospital policy and procedures when for two of two patients (PT 5, PT 49):

1. For PT 5, staff pharmacist did not clarify benzocaine 20% oral solution (medication used to relieve mouth pain) medication order when instructions for use were not clear, and staff pharmacist did not verify benzocaine 20% oral solution medication order or product for PT 5 and provided inaccurate medication-related information to Registered Nurse (RN) 5.

2. For PT 49, staff pharmacist did not clarify benzocaine 20% oral solution medication order when instructions for use were not clear.

These failures resulted in RN 5 to incorrectly administer 30 milliliters (ml- unit of measure) of benzocaine 20% oral solution to Patient (PT) 5, and instructed PT 5 to swallow 30 ml of benzocaine 20% oral solution on 1/30/25. As a result, PT 5 experienced dizziness, tachycardia (increased heart rate), tachypnea (abnormal rapid breathing), cyanosis (bluish-purple discoloration of skin due to lack of oxygen), was transferred to Intensive Care Unit (ICU) , diagnosed with methemoglobinemia (rare condition where red blood cells cannot carry oxygen and can result in death), and treated with the antidote (medication taken to counteract poison) methylene blue (medicine used to treat methemoglobinemia) and hemodialysis (medical procedure that filters waste products and excess fluid from the blood when the kidneys are no longer functioning properly). PT 5 was discharged on 2/4/25.

Findings:

1. During a concurrent interview and record review on 2/24/25 at 1:16 p.m., with Medication Safety Coordinator (MSC) and Nurse Director of Pediatric Unit (ND) 3, PT 5's "History and Physical Exam (H&P)" dated 1/23/25 and "Medication Orders" dated 1/30/25 were reviewed. PT 5's H&P indicated PT 5, age 25, presented to the Emergency Department for a ruptured gangrenous (tissue that has died) appendix (a tube-shaped structure like a pouch, attached to and opening into the lower end of the large intestine in humans), and was eventually admitted to the pediatric unit after operation. MSC stated, a medication order for benzocaine 20% oral mouth solution was verified by RPH 2 on 1/30/25 at 3:13 pm. MSC stated Pharmacy Technician (PhT) printed a label for the benzocaine 20% oral solution medication order after nursing staff requested the medication on 1/30/25 at 3:17 p.m. and packaged the medication. MSC stated the medication was verified and signed by RPH 2, after which the medication was delivered to the pediatric unit. MSC acknowledged RN 5 administered 30 ml of benzocaine 20% oral solution to PT 5 on 1/30/25 at 4:49 p.m. and the order was discontinued by a medical doctor on 1/30/25 at 7:16 p.m. ND 3 stated PT 5 was admitted to a side of the pediatric unit where pediatric nursing staff provided care for small adults.

During a concurrent interview and record review on 2/24/25 at 2:23 p.m., with PhT and RPH 2, PT 5's "Medication Orders" dated 1/30/25 were reviewed. PT 5's medication order for benzocaine 20% oral solution ordered 1/30/25 at 3:05 p.m. indicated, benzocaine 20% oral solution, mouth/throat four times daily as needed for pain. PhT stated once a label was dispensed, a pharmacy technician would find medication, scan medication and label, put any auxiliary labels (provide extra information to ensure that medicine administration, use, and storage are done in the proper way) if needed and give to the pharmacist. PhT stated the label would usually indicate what auxiliary label was needed. RPH 2 acknowledged his pharmacist initials for checking PT 5's 20% benzocaine oral solution. RPH 2 stated when doing final check of a medication product, a pharmacist was expected to check the right product, right size, right dose, expiration date, make sure auxiliary labels are correct and that it has been prepped by a pharmacy technician. RPH 2 stated mouth/throat was a topical route where a nurse should dip an applicator into the bottle and apply to mouth sores, and for topical product, doses cannot be quantified easily. RPH 2 acknowledged that PT 5's benzocaine 20% oral solution medication label did not have any instructions. RPH stated mouth/throat meant topical administration to mucous membrane in the mouth, and orally meant swallowing.

During an interview on 2/24/25 at 2:41 p.m., with Director of Pharmacy (DOP) and MSC, DOP stated she did not know if the hospital had a policy that defined mouth/throat as a route of administration and could not answer as to why mouth/through was used in the hospital's order entry system. MSC stated there was a topical route in the hospital's medication order entry system. MSC stated topical could apply to the body, mouth and throat, and would hope end user would clarify if confused about the route. MSC acknowledged PT 5's benzocaine 20% oral solution medication label did not have administration instructions and stated there were opportunities to improve the instructions which had been done, including adding administration instructions for "do not swallow", "swish and spit", and removal of benzocaine 20% oral solution from the pharmacy inventory and hospital's medication order entry system. MSC acknowledge it was the responsibility of the pharmacist to clarify medication orders for clear directions or instructions to help prevent medication errors.

During an interview on 2/24/25 at 2:52 p.m., with ND 3, ND 3 stated she spoke with RN 5, and RN 5 did not recognize the form of benzocaine that was sent from pharmacy, so she called RPH 3 to ask how to administer the medication. RPH 3 directed RN 5 to instruct PT 5 to swish and swallow benzocaine 20% oral solution since PT 5 was having throat pain. ND 3 stated, as a result, RN 5 administered 30 ml of benzocaine 20% oral solution to PT 5, and instructed PT 5 to swish and swallow the medication. ND 5 stated if RN 5 would have had administration instructions that would have clarified what mouth/throat meant, instead of having just mouth/throat. ND 5 stated she had not seen mouth/throat as directions before.

During an interview on 2/24/25 at 2:57 p.m., with DOP and MSC, DOP stated she spoke with RPH 3 and his recollection was that he did not look at the medication product or medication order in the hospital's medication order system, and misinterpreted the medication RN 5 called about. MSC stated when a pharmacist receives a call, the expectation was to look at the medication order, check references, clarify medication order with provider if needed and give consultation. DOP stated pharmacists did not follow expectations on how to clarify medication orders. DOP acknowledge PT 5's benzocaine 20% oral solution medication label did not have sufficient information on how to use the product, and the expectation was to contact provider, get clarifying information, and make adjustment to the order accordingly. DOP acknowledged mouth/throat route was not defined in the hospital's medication administration policy and stated it was important for pharmacists, nursing staff and providers to know how route was to be used to reduce risk of incorrect medication administration.

During a concurrent interview and record review on 2/26/25 at 1:11 p.m., with DOP and RPH 2, PT 5's order for benzocaine 20% oral solution ordered 1/30/25 at 3:05 p.m., was reviewed. RPH 2 acknowledged she was the pharmacist who reviewed the order on 1/30/25 at 3:13 p.m. RPH 2 stated the expectation when reviewing a medication order was to review the key elements including dose, route, frequency, and sometimes end dated, and seek clarification if needed, with the doctor. RPH 2 stated, to her, mouth/throat meant topical, so swish and spit, gargle and spit, not swallow. RPH 2 acknowledged, the hospital did not have a definition for mouth/throat and stated her definition was based on her clinical judgement. RPH 5 acknowledged the benzocaine 20% oral solution medication order did not have cautionary instructions in the direction, and at the time thought it was clear that the medication should not be swallowed. RPH 2 stated she did not see any cautionary instructions printed on the label and acknowledged if cautionary instructions for benzocaine 20% oral solution were entered fin hospital medication order system, they would have printed on the medication label.

During a concurrent interview and record review on 2/26/25 at 1:34 p.m., with RPH 2, PT 50's medication order for lidocaine 2% mucosal oral solution (medication to relieve pain) was reviewed. PT 50's order for lidocaine 2% mucosal oral solution ordered on 2/21/25 at 1:30 p.m., indicated 15 ml every 15 minutes, mouth/throat, swish and swallow. RPH 2 acknowledged mouth/throat could also mean "swish and swallow" and was not only indicated for "swish and spit". RPH 2 stated if benzocaine 20% oral solution was swallowed, a patient could experience adverse effects including methemoglobinemia.

During an interview on 2/26/25 at 1:47 p.m. with RN 5 and RPH 3, RN 5 stated she received PT 5's benzocaine 20% oral solution bottle with a clear seal around the top, with a printed label on the bottle in a clear plastic zipped bag. RN 5 stated since she was unfamiliar with the medication, she asked her charge nurse about the medication, and the charge nurse directed her to ask RN 5 to consult RPH 3. RN 5 stated when she asked RPH 3 if PT 5 should "swish and swallow" or "swish and spit" the benzocaine 20% oral solution, RPH 3 told her PT 5 should "swish and swallow" the medication since PT 5 was experiencing pain in the throat. RN 5 stated she looked at the hospital's drug reference and scanned the bottle's manufacturer code for dosage information but was unable to find dosage information. RN 5 stated 30 ml was printed on PT 5's benzocaine 20% oral solution label so she administered 30 ml to PT 5 on 1/30/25 at 4:52 p.m.

During an interview on 2/26/25 at 2 p.m., with RPH 3, RPH 3 stated he did not review the medication order when RN 5 called to clarify directions for PT 5's medication and thought the medication was lidocaine viscous oral solution. RPH 3 stated RN 5 told him it was for throat pain, so he instructed RN 5 to administer as "swish and swallow" because the medication needed to touch the throat to be effective. RPH 3 stated that ideally a pharmacist is expected to pull the information for the specific patient, and it was important to ensure the five rights of the patient to make sure the information was accurate.

During a continued interview on 2/26/25 at 2:10 p.m., with RN 5, RN 5 stated PT 5 had already had surgery for his ruptured appendix and on 1/30/25, PT 5 was stable and medical staff was looking at his wound to make sure it wasn't infected. RN 5 stated after approximately 45 minutes after administering PT 5 30 ml of benzocaine 20% oral solution, RN 5 was notified that PT 5 was asking for a nurse. RN 5 stated she observed PT 5 sitting at the edge of bed, saying that he was feeling dizzy. PT 5 stated he was sitting on a chair eating dinner and had a sudden urge to have a bowel movement. PT 5 stated he had a bowel movement, started feeling dizzy and called for RN 5. RN 5 stated she immediately took a reading of PT 5's blood pressure, which was elevated and PT 5's oxygen saturation (measurement of oxygen in the blood, normal range is between 95 to 100%), which was 77%. RN 5 stated she grabbed and put on a nasal cannula (flexible tube that delivers oxygen through the nose) on PT 5, called the charge nurse and informed her about PT 5. RN 5 stated after putting on PT 5's nasal cannula, PT 5's oxygen saturation improved to 80% so she changed his oxygen delivery to a nonrebreather mask (a type of oxygen mask that is used to deliver high concentrations of oxygen to patients who can breathe on their own but need supplemental oxygen, preventing them from rebreathing their exhaled carbon dioxide). RN 5 stated charge nurse called the physician, house supervisor and other medical staff. RN 5 stated the physician assessed PT 5 and PT 5 was transferred to the ICU on 1/30/135 at 7:26 p.m.

During a concurrent interview and record review on 2/26/25 at 2:24 p.m., with RN 5, RN 5 stated PT 5's 30 ml bottle of benzocaine 20% oral solution bottle did not have instructions for use. A review of two photographs of PT 5's benzocaine 20% solution bottle provided by the hospital indicated the bottle did not contain instructions for use.

During a record review on 2/26/25, PT 5's "Physician Progress Note (PPN)", signed on 1/30/25 at 8:24 p.m., the PPN indicated, "Paged by RN at 5:56 RN that patient had sudden drop in oxygen to 75% with minimal improvement even on nonrebreather fac mask at 100%. Immediately wend to bedside and patient was pale, on nonrebreather, but had no increased work of breathing on the facemask. O2 [oxygen] hovering at 80% and heart rate was elevated at 120s-130s and blood pressure 150s/80s, afebrile [not having a fever]. [PT 5] states that just before he was having a bowel movement and suddenly felt dizzy and weak and short of breath. RN called to room and he was able to walk back to bed. [PT 5] had clear lung sounds, and did not appear to be struggling to breath. His fingertips and toes appeared pale/dusky and cold. .. further review of MAR [medication administration record] found [PT 5] given benzocaine mouth spray as an oral solution approximately 1 hr [hour] prior to this episode. This raised suspicion for methemoglobinemia. Given ongoing poor oxygen saturation patient transferred emergently to ICU for further work up and management."

During an interview on 2/27/25 at 9:04 a.m., with RN 6, RN 6 acknowledged he was one of the nursing staff who provided care for PT 5 in the ICU. RN 6 stated he started his shift on 1/30/25 at 7pm, and PT 5 was transferred to ICU under his care on 1/30/25 at 7:26 p.m. RN 6 stated once PT 5 arrived in ICU, he was assessed, toxicology was consulted and recommended methylene blue, PT 5 was intubated for safety, a vascular catheter (vascath- flexible plastic tube that is inserted into a vein located either in the neck or in the groin and used for exchange transfusion) was inserted and PT 5 was dialyzed (a medical treatment that removes waste products and excess fluid from the blood when the kidneys are not functioning properly) around 2 to 3 a.m. in the morning. RN 6 stated when he returned the next day on 1/31/25 at 7 p.m., PT 5 was alert, walking and had returned to baseline. RN 6 stated when PT 5 arrived in the ICU, PT 5 was experiencing labored breathing, elevated heart rate (HR) in the 130's, his extremities were more on the darker side and not the usual pale cooler, PT 5 was cool to touch.

During a concurrent interview and record review on 2/27/25 at 10:14 a.m., PT 5's "Flowsheet History (FH)" dated 1/30/25 to 1/31/25, the FH indicated PT 5 readings for 1/30/25 at 1 a.m., heart rate (HR) 99 and blood pressure (BP) 132/80; 1/30/25 at 11:48 a.m., HR 96 and BP 144/83; 1/30/25 at 5:55 p.m., HR 129 and BP 158/87; 1/30/25 at 6:25 p.m., HR 125 and BP 153/90; 1/30/25 at 7:45 p.m., HR 136 and BP 153/86; 1/30/25 at 10 p.m., HR 144 and BP 181/125; 1/30/25 at 10:20 p.m., HR 140 and BP 175/107; 1/30/25 at 11 p.m., HR 108 and BP 149/86; 1/31/25 at 1 a.m., HR 84 and BP 112/70; 1/31/25 at 4 a.m., HR 69 and BP 103/59; 1/31/25 at 7 a.m., HR 86 and BP 129/86; 1/31/25 at 4 p.m., HR 88 and BP 123/72; 1/31/25 at 10 p.m., HR 85 and BP 129/71; 1/31/25 at 11:31 p.m., HR 86 and BP 119/65.

During a record review on 2/27/25 at 10:14 am, PT 5's FH dated 1/30/25 to 1/31/25 indicated PT 5's oxygen saturation readings on 1/30/25 at 8:10 a.m., 96%; 1/30/25 at 11:48 a.m., 97%; 1/30/25 at 5:55 p.m., 77%; 1/30/25 at 6:29 p.m., 82%; 1/30/25 at 7:45 p.m., 73%; 1/30/25 10 p.m., 87%; 1/30/25 at 11 p.m., 87%; 1/31/25 12 a.m., 88%; 1/31/25 at 1 a.m., 89%; 1/31/25 at 4 a.m., 95%; 1/31/25 at 6 a.m., 93%; 1/31/25 at 8 a.m., 90%; 1/31/25 at 12 p.m., 93%; 1/31/25 at 4 p.m., 95%; 1/31/25 at 7 p.m., 96%; 1/31/25 at 10 p.m., 96%; 1/31/25 at 11:31 p.m., 97%

During a continued interview and record review on 2/27/25 at 10:40 a.m., with RN 6 and Nurse Manager (NM) 4, PT 5's "Laboratory Results" dated 1/30/25, MAR dated 1/29/25 through 2/4/25, and "Nursing Note" dated 1/31/25 at 3:43 a.m., were reviewed. RN 6 stated methemoglobinemia was a rare reaction from ingesting benzocaine solution where the blood cannot bind oxygen and worst-case scenario, a patient needed to be dialyzed. NM 4 stated a diagnosis for methemoglobinemia was confirmed on 1/30/25 at 7:55 p.m., with a positive laboratory result value of 50.9 for methemoglobin. RN 6 stated PT 5 was administered 4 doses of methylene blue on 1/30/25 at 7:37 p.m., 7:57 p.m., 8:11 p.m., and 8:33 p.m., to treat methemoglobinemia. RN 6 stated PT 5 received dialysis treatment during the early morning of 1/31/25 for 82 minutes. NM 4 acknowledged PT 5's signs and symptoms experienced was likely due to benzocaine intoxication, and if not caught in time, there was risk for death, cardiac arrest ( medical emergency where the heart suddenly stops beating, preventing blood from being pumped to the body), and loss of life and limb.

During a record review on 2/26/25, PT 5's PPN, signed on 1 /30/25 at 10:59 p.m., the PPN indicated, "discussed concerns for possible methemoglobinemia with on call toxicologist [name]. [MD 6] recommended STAT [immediate] dosing of methylene blue [dose] and may repeat this up to 3 total doses at 10-minute intervals if no response to first dose ... First dose finished at 1944. Saturations remained in 70's. Second dose finished at 2002. Saturations remained in 70s-80s. Third dose began and discussed with Dr. [name] again at 1015 to let him know the third dose is being administered ... Discussed with hematology [study of blood diseases] @ [at] 2029, who will plan for exchange transfusion [a medical procedure where a patient's blood or blood components are removed and replaced] tonight. Vascath consent obtained, see separate note. [MD 6] recommending endotracheal intubation [medical procedure that involves inserting a flexible tube into the windpipe to keep the airway open], consent obtained; see separate note."

2. During a concurrent interview and record review on 2/26/25 at 9:33 a.m. with Nursing Manager (NM) 4 and RN 4, PT 49's H&P dated 1/16/25 and "Medication Orders" dated 1/19/25 were reviewed. PT 49's H&P indicated, PT 49, age 24, presented to the Emergency Department on 1/16/25 for altered mental status (a change in how well the brain is working), combative, and with a positive laboratory result for methamphetamines (powerful addictive drug that can cause depression, hallucinations, and violent rages), and was admitted to the ICU. PT 49's order for benzocaine 20% oral solution, ordered 1/19/25 at 5:33 a.m., indicated benzocaine 20% solution, mouth/throat, four times daily as needed for pain. RN 4 stated PT 49 needed medication to soothe his throat so benzocaine 20% oral solution was ordered by the physician. RN 4 acknowledged the medication label for benzocaine 20% oral solution did not have administration instructions, and stated he had previous experience administering benzocaine 20% oral solution. RN 4 stated he knew the medication should not be swallowed, so he poured some of benzocaine 20% oral solution in a medication cut and instructed PT 49 to gargle and spit out the medication.

During an interview on 2/26/25 at 1:11 p.m. with DOP, DOP stated staff pharmacists who verified PT 49's benzocaine 20% oral solution order were unavailable because pharmacist who verified PT 49's benzocaine 20% oral solution medication order was no longer employed at the hospital and pharmacist who verified packaging of Pt 49's benzocaine 20% oral solution was not scheduled to work during survey period.

During an interview on 2/27/25 at 2:21 p.m., with DOP, DOP stated mouth/throat was an ambiguous indication for a route of administration. DOP stated the expectation was for pharmacists clarify how the mediation was intended to be used, and for any medication, clear instructions to prevent medication error are important. DOP acknowledged mouth/throat route of administration was ambiguous and need to be clarified because it could be "swish and swallow" or "swish and spit". DOP stated RPH 2 who received medication order should have identified the instructions for use were unclear and need to clarify directions with prescriber. DOP stated for medications that are given orally not swallowed, or swish and spit, instructions would be in the administration instructions of the medication order. DOP acknowledged PT 5's benzocaine 20% oral solution bottle did not have instructions and was delivered to RN 5 with the manufacturer box containing instructions. DOP acknowledged a pharmacist role is to serve as a drug subject matter expert and provide accurate drug information to nurses and healthcare providers. DOP stated before providing drug information, the expectation was for a pharmacist to look at medication order and/or product directly to confirm that they are talking about the correct product or order. DOP stated this was important to ensure there was no miscommunication about the question or order to prevent medication error or potential patient harm. DOP stated methemoglobinemia was a known potential adverse event to benzocaine ingestion and even in small doses. DOP stated this was a serious adverse event because it prevents proper oxygen carrying by the red blood cell and could potentially lead to patient death. DOP stated PT 49's benzocaine 20% oral solution medication order should have been verified by a pharmacist.

During a continued interview on 2/27/25 at 2:36 p.m., with DOP and PM, DOP stated that on the day pharmacy leadership was made aware of PT 5's benzocaine 20% oral solution medication incident, pharmacy leadership reviewed all benzocaine products in the hospital's medication order entry system and removed all benzocaine products except single dose benzocaine applicator spray, and pharmacy staff was notified. DOP stated education was also provided to pharmacy staff for expectation that orders needing doses or instructions for administration be clarified before verification and dispensing, and when asked about questions regarding a medication order or product, to look at medication order and product before answering the question. PM stated an in-service presentation on the methemoglobinemia was also provided to all pharmacists.

During a review of the hospital's Policy and Procedures (P&P), titled, "Medications- Orders, Administration, Storage, Documentation", dated 12/19/23, the P&P indicated, "A medication order must be clear, legible and include the following ... d. dosage and method of administration ... Any orders for medication that are illegible, incomplete, and/or unclear will require clarification .... If an illegible, incomplete, and/or unclear order is received in the pharmacy, the pharmacist will contact the ordering prescriber and will clarify using the telephone/verbal order process ...Pharmacy will communicate the changes to the patient's RN ..."

During a review of the hospital's P&P, titled "Provider Orders", dated 8/25/23, the P&P indicated, "If an RN or LVN [licensed vocational nurse]/LPT [licensed psychiatric technician] receives a physician's order and believes it should not be carried out because of the above-mentioned reasons, the following actions are to be taken: a. If it is a medication order, utilized the Hospital Formulary, Physician Desk Reference (PDR), Care Notes PDR, or pharmacist to confirm correct dosage, administration route, and side effect."

Based on observation, interviews, and record review, the facility failed to ensure unusable medications were not available for patient use when an intravenous (IV, in the vein) fluid bag was out of its protective overwrap against professional standards in the medication room (a room where medications are stored and prepared) on 2nd floor East.

This failure had the potential for patients to receive altered, ineffective, and contaminated medications.

Findings:

During a concurrent observation and interview on 2/24/25 at 11:35 a.m. in 2nd floor East medication room with Registered Nurse (RN) 1, an IV fluid bag missing its protective overwrap was in the stock of IV fluids available for patient use. RN 1 stated an IV fluid bag that did not have a protective overwrap could not be used for a patient. RN 1 stated the IV fluid bag could have been tampered with and should have had a date and time on the bag once the overwrap had been removed. RN 1 stated the exposed IV bag needed to be disposed of.

During a review of a professional reference titled, "Working up a sweat (WUS)", dated 10/2002, the "WUS" indicated, " ... The purpose of the overwrap [for IV bags] is to improve shelf life and to stabilize the drug concentration. What happens then if a bag is removed from its overwrap and remains unused for days or weeks? Over time, the fluid volume inside the bag decreases and the drug concentration per milliliter [ml, a unit of measure] increases ... Don't remove the overwrap from any I.V. bag stored in your unit until you're ready to use the solution ...".

During a review of a professional reference titled, "Expiration dates and removal of i.v. bag overwrap (EDR)", dated 9/1/95, the "EDR" indicated, " ... The overwrap protects against evaporation of the solution, desiccation [removal of moisture] of the container, drug oxidation [common way of degrading a drug], and photochemical [with light] inactivation of the drug. Without a barrier, substantial moisture loss may occur, increasing the drug concentration ... Manufacturers of these products recommend ... removing the overwrap just before the drug or solution is administered ...".

Based on observations, interviews and record review, the hospital failed to maintain a clean and sanitary environment in accordance with hospital policy and procedures and clinical standards of practice for infection control when:

1. Ice was found in six open plastic cups in the patient nutrition freezer in the 2nd floor patient nutrition room and six plastic pitchers in 4th floor patient nutrition room.

2. One package of self-adherent wrap bandage (a stretchy, tape-like bandage that sticks to itself, not to skin or clothing) was observed on the floor of the clean supply room on the 8th floor Cardiovascular (heart) Medical Surgical (MS) Unit. One new unused electrocardiogram (ECG) (a record or display of a person's heartbeat) electrode (sticker) was observed on the floor of the clean supply room on the 7th floor MS Oncology (cancer treatment) Unit. Four packages containing individual 18-guage (G-inner diameter of needle opening measurement) hypodermic needles (thin sharp hollow needle) were observed on the floor of the clean supply room on the 4 South Unit at the Surgery Center. Two packages containing needleless cannulas (a medical device designed to access intravenous (into the vein) systems without the use of a traditional needle), and one unused blood collection tube were observed on the floor of the clean supply room on the 2nd floor Cardiovascular Intensive Care Unit (CVICU-specialized heart care) at the Surgery Center.

3. Intravenous line (IV) infusing medication did not have alcohol-impregnated caps (caps disinfect and protect IV access points, reducing the risk of infection) for one of ten patients (Patient 40).

These failures had the potential to place patients at risk for cross contamination (process by which bacteria or other microorganisms are unintentionally transferred from one substance or object to another, with harmful effect) and the spread of infection.

Findings:

1. During a concurrent observation and interview on 2/24/25 at 11:20 a.m. on the 2nd floor patient nutrition room with Registered Nurse (RN) 1, six uncovered plastic cups were filled with ice in the freezer and the ice pieces were fused together. RN 1 stated the ice was probably placed in the freezer when the ice machine was out of order several days ago. RN 1 stated she did not recall the date the ice machine was out of order.

During a concurrent observation and interview on 2/24/25 at 1:15 p.m. on the 4th floor patient nutrition room with RN 11, six plastic ice pitchers were filled with ice in the freezer. RN 11 stated the ice was placed in the freezer when the ice machine's filter was replaced on 2/21/25.

During an interview with the Infection Prevention Director (IPD) on 2/28/25 at 2:30 p.m., the IPD stated it was not the hospital's practice to store ice in the patient's nutrition freezer.

During a professional reference tiled, "Why the ice cubes in my ice container stick together? (WIC)", dated 3/22/18, the "WIC" indicated, " ... If ice cubes have not been used for a long period of time, the cubes melt into each other during the defrost cycles and stick together ...".
During a professional reference titled, "Preventing Ice contamination with Safe Practices (PIC)", dated 4/15/20, the "PIC" indicated, " ... The FDA [Food and Drug Administration] defines ice as food ... Since ice contamination starts with the user, you need to make sure your employees are handling the ice properly ... never throw unused ice back into the ice bin. If a server accidently fills an extra glass with ice, they should toss that ice into a sink ...".

2. During a concurrent observation and interview on 2/24/25 at 1:25 p.m. with Nurse Manager (NM 5), on the 8th floor MS Cardiovascular Progressive Care Unit, in the Clean Supply Room, one package of self-adherent wrap bandage was observed on the on the floor. NM 7 stated, supplies should not be used on patients after being on the floor, due to cross contamination. NM 5 stated if supplies fall on the floor, they should be thrown away. NM 5 discarded the package into the trash.

During a concurrent observation and interview on 2/24/25 at 1:49 p.m. with Clinical Supervisor (CS) 2, on the 7th floor MS Oncology Unit, in the Clean Supply Room, one new unused ECG electrode was observed on the floor. CS 2 stated, the electrode should not be on the floor and should not be used on patients after being on the floor. CS 2 stated supplies should not be used on patients after being on the floor due to cause cross contamination. CS 2 stated the electrode should be thrown away. CS 2 discarded the electrode in the trash.

During a concurrent observation and interview on 2/25/25 at 10:44 a.m. with Nurse Director (ND) 5, on the Surgery Center's 4 South Unit, in the Clean Supply Room, four packages containing individual 18-G hypodermic needles were observed on the floor. ND 5 stated using the needles on a patient would be an infection control concern, due to cross contamination. ND 5 stated, the floor was considered dirty, and patient supplies should not be on the floor. ND 5 stated supplies on the floor should be discarded. ND 5 discarded the needles into the container for sharps disposal.

During a concurrent observation and interview on 2/25/25 at 10:58 a.m. with ND 5, on the Surgery Center's 2nd floor CVICU, in the Clean Supply Room, two packages containing needleless cannulas, and one unused blood collection tube were observed on the floor of the clean supply room. ND 5 stated, the supplies should not be on the floor due to infection control. ND 5 discarded the supplies into the trash.

During an interview on 2/28/25 at 2:36 p.m. with the IPD, the IPD stated, anything on the floor needed to be thrown away. The IPD stated, the standard of practice was to use clean patient supplies, and not use patient supplies dropped on the floor, because the floor was dirty.

During an interview on 2/28/25 at 3:42 p.m. with the Chief Nursing Officer (CNO), the CNO stated, supplies for patients should not be on the floor in the clean supply room. The CNO stated when supplies were found on the floor they should not be used on patients and should go back to the central supply department, or in the trash.

During a review of the professional reference titled, "The role of the surface environment in healthcare-associated infections", dated August 2013, the professional reference indicated, " ...Hospital surfaces are frequently contaminated with important healthcare-associated pathogens (bacteria). Contact with the contaminated environment by healthcare personnel is equally as likely as direct contact with a patient to lead to contamination of the healthcare provider's hands or gloves that may result in patient-to-patient transmission of nosocomial (originating from the hospital) pathogens ...".

During a review of the professional reference titled, "Good Storage and Distribution Practices for Medical Products", (retrieved from https://www.who.int/publications/m/item/trs-1025-annex-7) dated 6/17/20, the professional reference indicated, " ...Storage and distribution are important activities in the supply chain management of medical products ... Storage areas should be of sufficient capacity to allow orderly storage of the various categories of medical products ... Storage areas should be appropriately designed, constructed, maintained or adapted. They should be kept clean and there should be sufficient space and lighting ... Materials and medical products should be stored off the floor, away from walls and ceilings, protected from direct sunlight and suitably spaced, to permit ventilation, cleaning and inspection ... Materials and medical products should be handled and stored in such a manner as to prevent contamination, mix-ups and cross-contamination ...".

During a review of the professional reference titled, "Keeping it Sterile: Fundamentals of Sterile Storage," (retrieved from https://www.ormanager.com/keeping-it-sterile-fundamentals-of-sterile-storage/) dated 7/20/23, the professional reference indicated, " ... Using sterile items in surgery is a fundamental practice, not a rudimentary one that can or should be taken for granted. Put simply, using unsterile items can result in a patient infection. If sterile storage conditions are not appropriate, the items can become contaminated. Such contamination may go undetected, rendering items unsafe and unusable. Therefore, healthcare facilities must take action to create an environment that properly protects sterile packages. This includes securing a proper sterile storage environment and developing policies and procedures to help ensure sterile packages are safely stored and handled ... Sterile packages should be handled with care and positioned so they are not crushed, bent, compressed, or punctured. Sterile items should never be stored on floors ...".

3. During a concurrent observation and interview on 2/24/25 at 11:37 a.m. with the Director of Emergency Department (DED), NM 6 and NM 7 in the Green zone in the Emergency Department, Pt 40 had an antibiotic (medications used to treat and prevent bacterial infections) infusing (method of putting fluids, including drugs, into the bloodstream) via IV tubing (flexible plastic tube that delivers fluids and medications into a patient's bloodstream) without alcohol-impregnated caps (is a cap or cover that is infused with alcohol, designed to be placed on the implanted port of IV tubing to disinfect the access point and prevent contamination) on the IV tubing port (NM 6 stated since the IV tubing was a one-time use for an antibiotic he was unsure if it needed any alcohol-impregnated caps on it. NM 6 stated he was not sure if the facility had a policy for one-time (designed to be used once and then thrown away) or multi-use (designed to be used repeatedly) IV tubing. The DED stated all IV tubing ports should have alcohol-impregnated caps on them. The DED stated the nurse should have put the alcohol-impregnated caps on the IV tubing port. The DED stated the alcohol-impregnated caps help prevent infection.

During an interview on 2/28/25 at 2:30 p.m. with the IPD, the IPD stated that the expectation is for all nurses to put alcohol-impregnated caps on all IV tubing, regardless of single use or multi-use. The IPD stated it is common practice to have caps on IV tubing's. The IPD stated the caps help mitigate infections and are to be used on all IV tubing's to help protect the patient from possible infections.

During an interview on 2/28 at 3:36 with the CNO, the CNO stated it is the facility policy to have an alcohol-impregnated cap on every IV tubing both single and multi-use IV. The CNO stated the caps help with infection prevention and keeps the patients from getting sicker than they already are.

During a review of the hospital's P&P titled, "Intravenous Tubing Changes, Intermittent Infusion Devices & IV Sites," dated 6/14/24, the P&P indicated, "I. PURPOSE. To establish the standard for maintaining asepsis by preventing the use of potentially contaminated intravenous (IV) tubing. II. DEFINITIONS. A. Disinfecting Port Protector (brand name): A single use passive disinfection device that luer-locks securely onto needless IV ports and provides a physical barrier to contamination between accesses. Disinfects in 1 minute ...Policy ... D. Aseptic technique and standard precautions are to be followed when performing this procedure. 1. A disinfecting port protector should be aseptically attached to each needleless accessible port (brand name) and at the end of the IV tubing (brand name) after each intermittent use ...V. Procedure ...I. Remove disinfecting port protector and scrub the needless connector with alcohol swab for at least 15 seconds ...".

Based on interview and record review, the hospital failed to ensure staff adhered to interventions meant to support the effectiveness of the policy and procedure (P&P) titled "Universal Protocol - Procedural Areas" for one (1) of eleven (11) sampled patients when on 2/18/25, the hospital self-reported to the California Department of Public Health (CDPH), a wrong side orthopedic (branch of medicine dealing with the treatment of bones, joints and muscles) procedure after surgery on Patient (Pt) 2 on 2/13/25.

This failure resulted in an unnecessary procedure for Pt 2, and had the potential for Pt 2 and future patients to suffer, needlessly, from the effects of wrong side surgery such as pain, injury, and additional surgery.

Findings:

During record review on 2/26/25 at 8:45 a.m., with Nurse Director (ND) 6, Pt 2's Electronic Health Record Electronic Health Record (EHR- a digital version of a patient's medical history) was reviewed.

During record review of Pt 2's History and Physical (H&P- a formal assessment of a patient's health that includes a medical history and physical exam) dated 12/13/25, indicated "...CHIEF COMPLAINT: ... Pedestrian vs Vehicle...reportedly struck by vehicle traveling approximately 45 miles per hour (mph)...42 y.o. (year old)...GCS 13 (Glasgow Coma Scale score- is a number that describes how responsive a patient is. It's used to assess a patient's level of consciousness and the severity of brain injuries. A score of 13 to 15 indicates mild traumatic brain injury (TBI), also known as a concussion). trauma (injury) noted to face, open deformity of left lower leg (a bone in the leg has broken through the skin, leading to an open wound and potential infection, and a possible need for surgery to fix the fracture and any accompanying damage), and closed deformity of left wrist (a deformity that doesn't involve an open wound or fracture), obvious open left tib-fib (tibia-fibula- a fracture of both the tibia (shinbone) and fibula (calf bone) where the bone has pierced through the skin, requiring immediate medical attention and potentially surgery) and appears to have right acetabulum (a break in the socket-shaped bone (acetabulum) on the right side of the hip joint) fracture on pelvis (bones between the lower abdomen and upper thighs that connect the spine to the legs) x-ray. Initially hemodynamically (how your blood flows through your arteries and veins and the forces that affect your blood flow) stable (enough to go to CT where Pt 2 was found to have fluid around the liver and possibly down to the pelvis. Patient BP (blood pressure) began to drop after CT down into the 80's, MTP (rapid administration of large amounts of blood products) activated and patient taken emergently to the OR (operating room)...... Patient reports taking a blood thinner, but doesn't know what...No past medical history on file...unable to assess history at this time...Assessment & Plan...to OR, Plan films and orthopedic consult for orthopedic injuries after OR..."

During record review of Pt 2's "ADT Events" undated, the record indicated Pt 2 was taken to the OR on "...2/13/25 at 0705 (7:05 a.m.)..." then to the Post-Anesthesia Care Unit (PACU)- a specialized recovery room in a hospital or surgery center where patients are closely monitored after undergoing surgery or procedures that require anesthesia (use of medicines to prevent pain during surgery and other procedures) on "...2/13/25 at 1121 (11:21 a.m.)..." remaining in the PACU Overflow area from "...2/13/25 at 1319 (1:19 p.m.) to 1629 (4:29 p.m.)..."

During record review of Pt 2's "Treatment Plan (TP)" dated 2/13/25 at 4:22 p.m., the TR indicated, "...Patient's acetabulum (s a cup-shaped socket in the pelvis that forms the hip joint.) fracture requires femoral traction (a technique using devices and weights to gently pull and realign a fractured or dislocated leg (or thighbone, or femur) to restore proper alignment and stabilize the fracture for healing, either as a standalone treatment or before surgery). Will proceed under implied consent as below. Implied Consent: Patient unable to provide informed consent; unable to contact family or next of kin. It is believed that the benefits from the procedure(s) would outweigh the associated risks of the procedure(s). Furthermore, it is inferred that the patient or patient's surrogate would consent to the procedure if the patient was not incapacitated or patient's surrogate was available. Procedure: right femoral skeletal traction pin (a medical procedure where a pin is surgically inserted into the femur bone, typically at the distal end, to facilitate skeletal traction for fracture management or temporary stabilization)..."

During an interview on 2/27/25 at 9:05 a.m., with Director Peri-Operative, Surgery Scheduling and Revenue (DOR), DOR stated did not witness event, reported event via [hospital event reporting system]. DOR stated a preliminary investigative indicated Pt 2 was hemodynamically unstable with the RN at head of bed monitoring Pt 2 (who just arrived from the OR to PACU). DOR stated there were 3 teams [of surgeons] OMFS (Oral Maxillofacial Surgery- a dental specialist, surgically trained in a hospital-based residency, who specializes in the diagnosis and surgical treatment of diseases, injuries, and defects involving the face, mouth, and jaw), Trauma Team, at the head of bed near the center of Pt 2's bedside, Ortho closer to foot of the bed. DOR stated a time out (a short, planned pause before an invasive procedure or surgery to ensure the right patient, procedure, and site are being addressed, promoting patient safety and preventing errors) was not performed prior to the orthopedic surgery. DOR stated the Residents (a medical school graduate who is undergoing postgraduate training in a specific medical specialty) determined the left leg had been pinned (an orthopedic surgeon (bone doctor) pushes a metal pin or wire through the skin and into the bone) at time of completion of the procedure, but prior to traction initiation. DOR stated the orthopedic surgeons (Residents) performed the procedure under implied consent (implied consent allows healthcare providers to act in the best interest of the patient's well-being when time-sensitive decisions are necessary) due to their determining the injury to be of an urgent nature. DOR stated her understanding of implied consent is when there is danger to life or limb, don't delay care to get consent from next of kin (refers to the closest living relative of a patient who is authorized to make medical decisions on their behalf if they are unable to do so themselves). DOR stated once the event was detected, a huddle (a brief, informal meeting among healthcare team members to discuss patient care, safety, and operational issues) was conducted with MD 3. DOR stated a debrief with the involved parties was on 2/18/25. With a root cause analysis (RCA- is a tool to help healthcare organizations retrospectively study events where patient harm or undesired outcomes occurred to identify and address the root causes) initiated by Risk Management on 2/21/25.

During an interview on 2/27/25 at 1:08 p.m., with Director of Risk Management and Patient Relations (DRM), DRM stated the event was first detected Event occurred on 2/13 approx. 7:44 p.m. and was reported to CDPH on 2/18/25. DRM stated the RCA had been started with an RCA meeting held on 2/21 including the event staff. DRM stated since then, the DOR began conducting huddles with PACU staff on expectation regarding timeouts. DOR stated an outcome and any related recommendations will be provided to CDPH when it is available. DRM stated hospital has initiated immediate education to all residents and attending faculty as of 2/27. DRM stated this education included review of informed consent policy, highlighting the differences between simple and complex procedures and then universal protocol and time-out steps, and reviewed Universal Protocol policy with close attention to specific procedures done in procedural areas, which should be done the same as it is done in the OR suite. DRM stated the preliminary contributing factors were multiple procedures performed in tandem with many disciplines involved . DRM stated hospital has required signed attestations from residents, and attending faculty. DRM stated they are still working on other gaps identified and how to manage those.

During an interview on 2/27/25 at 3:42 p.m., via telephone, with Medical Doctor (MD) 4 and MD 2, MD 4 stated a consult for [Pt 2], a trauma patient, was requested while Pt 2 was in Emergency Department. MD 4 stated Pt 2 had been taken to the OR emergently. MD 4 stated he saw PT 2 in the PACU, after reviewing a CT angiogram images showed "run-off." MD 4 stated this is an exam that looks at vessels (a tube or canal that carries body fluids, such as blood or lymph, throughout the body) in lower extremity (leg) under contrast (A dye or other substance that helps show abnormal areas inside the body). MD 4 stated radiology images were reviewed in the team room with MD 2 and another Resident. MD 4 stated images reviewed. MD 4 stated during this review a hypothetical scenario (a situation that is imagined or proposed but may or may not be real) as it would require a different approach. MD 4 stated on his arrival to the PACU there were two (2) other teams present [MOFS and General (Trauma)] along with an X-ray Technologist (uses specialized equipment to take x-rays and other medical images to help doctors diagnose and treat illnesses and injuries) performing x-ray exams ordered before Pt 2 was taken to the OR emergently. MD 4 stated he approached Pt 2 at bedside. MD 4 stated he asked neighboring staff (RNs) to help with gathering supplies. MD 4 stated he irrigated and closed the wounds with nylon suture. MD 4 stated short leg splint (LT) traction supplies were prepared, the area marked and they proceeded w/application to L. MD 4 stated MD 2 (supervising faculty - a physician with a faculty appointment within a medical school who oversees the clinical activities and/or research projects of medical students, residents, or fellows to ensure patient safety, appropriate supervision, and professional development) presented to the PACU. MD 4 stated MD 2 notified them that the procedure should have been on right leg. MD 4 proceeded to prepare the right side. MD 4 stated the procedure was performed under "implied consent" Pt 2 was intubated and sedated and had been a trauma activation admitted under a trauma name (Doe), with no contact information to reach out to anyone to get consent. MD 4 stated general surgery were present overseeing x-ray procedure, OMFS was repairing laceration. MD 4 stated RN 14 was located at bottom left side of Pt 2's bedside. MD 4 stated he briefly interacted with RN 14, "she was one of the nurses to grab supplies" for the procedure and a neighboring RN also helped him gather the needed supplies for the procedure. MD 4 stated Lifesaving," probably not lifesaving, no." Recommended traction pin due to unstable acetabular.... concern for further subluxation or potential dislocation. MD 4 stated given Pt 2's instability, on (blood) pressure medications, telemetry monitoring, unstable vital signs (VS-measurements of the body's most basic functions) with labile (blood) pressures in the low 100's, it is usual to have the teams at the bedside in PACU. MD 4 stated he discussed with General Surgery (Resident), asked one of those residents asked for a bolus (a single dose of a drug or other medicinal preparation given all at once) of propofol [to sedate Pt 2]. MD 4 stated the general surgeon stated Pt 2 was likely able to tolerate the bolus and the procedure was started. MD 4 stated his understanding of implied consent is necessary for the betterment for the patient who is not able to consent/advocate for themselves and without an identified health care representative. MD 4 stated he received education about the consent process at the beginning of residency group in a lecture format in June 2024. MD 4 stated a time out had not been performed before starting the procedure which resulted in the incorrect side procedure. MD 4 stated a time out was done on the second procedure (to the correct leg).

During an interview on 2/28/25 at 8:30 a.m., with Registered Nurse (RN) 14, RN 14 stated she recalled the event involving Pt 2. RN 14 stated she had been relieved for a break by a resource (a registered nurse who supports other nurses by providing extra assistance with patient care tasks, such as admissions, discharges, and other nursing responsibilities, often helping to ensure the timely completion of tasks and improve overall patient care) RN, who reported Pt 2 was hemodynamically stable after leaving the OR for the IR intervention for possible pancreatic bleed. RN 14 stated upon assuming care of Pt 2, blood pressure had stabilized. RN 14 stated the surgical teams OMFS and Trauma/General were at Pt 2's bedside in the PACU. OMFS was concerned with facial laceration repair, Trauma/General Surgery team concerned with Pt 2's hemodynamic stability after multiple blood products, and exploratory laparotomy with closure of Pt 2's abdomen with an "brand name" (device used as -(a temporary abdominal closure system, designed to remove fluids from the abdominal cavity and draw wound edges together) and a trip to the Interventional Radiology (IR- the minimally invasive, image-guided treatment of medical conditions that once required open surgery). RN 14 described Pt 2's bedside as very busy with her actively monitoring vital signs, initiating vasopressor support along with managing pain and sedation medication drips. Added to this activity was the x-ray technologist moving about the patient positioning and shooting numerous x-rays ordered by the surgical teams. RN 14 stated she did not assist the orthopedic residents during their procedure. RN 14 stated she did not realize that the orthopedic residents had initiated a procedure until she overheard statements made, by whom she did not recall, that the wrong side had been pinned.

MD 5 stated he recalled the event. MD 5 stated shortly before he went to PACU MD 4 and MD 2 (Supervising Faculty) were in the team room MD 4 was going through the imaging with MD 2. MD 5 stated they reviewed Pt 2's CT images, which showed "runoff." MD 5 stated an x-ray of the pelvis, single view was pulled up with the CT scan pelvic imaging only around the right hip joint. Both saw the RT pelvis fracture with previous pelvic hardware located on Pt 2's left side. MD 5 stated it was easy to see where the facture was based on LT previous hardware. MD 5 stated he had received report that Pt 2 had been in general surgery to the abdomen, was unstable, intubated and sedated. MD 5 stated given the extent of the injuries Pt 2 suffered, when there is a fracture, where they would not be doing in a definitive surgery (a more permanent procedure), they could wash it out (clean), close [the wound(s)] and apply a supplemental immobilization device. MD 5 stated because of Pt 2s unstable condition, the pelvic fracture could not be addressed right away. MD 5 stated it was decided to place the leg in traction after reviewing the imaging which showed a right transverse acetabulum and LT tib fib. MD 5 stated it was agreed that a long leg splint foot to mid-thigh, to stabilize the fracture to take pressure off the acetabulum. MD 5 stated he did not participate in the theoretical/educational discussion had by MD 4 and MD 2. MD 4 stated MD 4 went to gather supplies needed for the washout and splinting. MD 5 stated he met up with MD 4 in the PACU where all needed supplies were already at Pt 2's bedside. MD 5 stated x-rays were being done, with general surgery residents supervising and working on the patient hemodynamics, MD 5 stated he and MD 4 spoke with a general surgeon about plan to apply a long leg splint for the tib fib and the traction. MD 5 stated a time out was not done for the first procedure. MD 5 stated they started with prepping washing and then splinted. MD 5 stated a time out was not necessary for the washing out and splint application. MD 5 stated a time out should have been done for application of a traction device. MD 5 explained shortly after placing the splint, MD 2 arrived and recognized the error. MD 5 stated weight had not been applied to the left leg. MD 2 ordered an immediate removal of the traction pin (one pin) to the left side- distal thigh/femur. MD 5 stated the left sided pin was removed and immediately irrigated and closed. MD 4 stated they then moved on to the right after getting new supplies. MD 5 stated he wrote the implied consent note after assessing the Pt 2's medical status (intubated, sedated, etc.). MD 5 stated the decision to treat by placing the right lower extremity was due to concern with prevention of morbidity [rate] (the state of being symptomatic or unhealthy for a disease or condition) with this type of fracture pattern. MD 5 stated putting in the pin was not emergent but had the potential to evolve (become more complicated).

During an interview on 2/28/25 at 3:38 p.m., with Chief Nursing Officer (CNO), the CNO stated, expectation is that this type of event, wrong side surgery, should not happen. CNO stated procedure should be with consent, procedure to be done with confirmation of which side is to be operated on and any x-rays/imaging reviewed before conducting a time out to ensure the correct site is agreed upon by the staff.

During a review of hospital P&P titled "Universal Protocol - Procedural Areas," dated 12/19/23, on 3/6/25, the P&P indicated, "...I. PURPOSE A. To provide guidance to peri-procedural personnel for verifying the correct patient, procedure, and site during operative or other invasive procedures. B. To provide guidance for improving team communication through a culture of safety in order to reduce the incidence of medical errors... III. POLICY A. The Universal Protocol must be followed on all procedures that require an informed consent. This includes all invasive/operative procedures, and all procedures done under Procedural Sedation whether invasive or non-invasive. B. The Universal Protocol must be followed in all areas of the organization where the procedure is performed (e.g., Operating Room (OR), Cardiac Catheterization Laboratory (CCL), Interventional Radiology (IR), Nuclear Medicine, Endoscopy, etc.). C. The Universal Protocol must be practiced whether the provider is doing the procedure alone (e.g., insertion of central line), or as part of a greater team (e.g., in the OR or CCL). D. The Universal Protocol is composed of the following elements: 1. Pre-Procedure verification. 2. Marking the site, when applicable 3. Procedural Briefing. 4. Time Out...E. The Universal Protocol is to be integrated with all other elements of patient safety, identification and preparation for a procedure as detailed in the following Patient Care policies: 1. Patient Identification. 2. Pre-Procedure & Post-Procedure Care 3. Procedural Sedation and Analgesia by Non-Anesthesia Professionals. F. Site marking is done by the provider who is credentialed and privileged by Community Medical Centers (CMC) Medical Staff to perform the intended invasive procedure and who will be present and directly involved in the procedure. Resident providers directly involved in the procedure and under the supervision of the faculty/attending provider may perform site marking. Site marking is done with the input of the patient, if possible, and should occur before the patient is moved to the procedural setting unless the pre-procedure and procedure areas are one and the same. G. The Universal Protocol verifications, pre-procedure/briefing, site marking, Time Out, and debriefings are to be documented in the electronic health record (EHR) when applicable. H. All staff whose role requires that they schedule or prepare patients for surgery or other procedures that require an informed consent, or who work as part of the procedural team, are to demonstrate competency in Universal Protocol... V. PROCEDURE ...A... 3. Verify and document all elements of the Universal Protocol beginning in the pre-procedure area and continuing into the procedural area for verification of all safety elements...b... iii. Pre-procedure verification must be completed prior to the start of the procedure, except in justifiably emergent situations... c. Time Out: Immediately before start of the procedure, verify and document all elements of the Time Out... D. 1. The Time Out is a standardized process that is performed with the healthcare team and used throughout the hospital before all operative/invasive procedures. The healthcare team involved in the procedure must pause to conduct a final verbal and audible verification of all safety elements listed below. This pause is referred to as a Time Out. 2. The Time Out involves the immediate members of the procedure team, including the individual performing the procedure and other active participants who will be participating in the procedure from the beginning....a. Conduct the Time Out immediately before the procedure begins with the patient properly positioned, prepped and draped. i. EXCEPTION: For both elective and STAT craniotomies, timeouts will occur after the patient marking and positioning, but before the drapes are applied. b. The provider (e.g., Surgeon) verbally initiates the verification process. For areas performing invasive procedures that do not require nursing support (e.g., Mammography, Nuclear Medicine, Ultrasound, etc.) the licensed technologist will initiate the verification process. i. The written consent will be utilized as a guide for the patient's identification and procedure. c. All activities are to be suspended for the duration of the Time Out, to the extent possible, without compromising the safety of the patient so that all members of the team are focused on elements of the Time Out. Each team member will play a role in the process. d. Time Out addresses and verbally confirms among all team members the following elements: i. Correct patient I. Confirmed with two identifiers (per Patient Identification policy). II. Correct procedure and laterality (when applicable) as consented. III. Site marked (when applicable). IV. Fire risk assessment score. A. Alcohol-based preps are dry prior to use of cautery (see also policy OR-Skin Prep of Surgical Patient) V. Ask question "are there any concerns identified in the procedural briefing/time out process". e. If there is a concern by any team member, or differences of opinion on any element of the Time Out, clarification is to be made by the primary Surgeon or provider before the procedure is allowed to begin. All members of the team must accept and be in agreement to continue. VI. DOCUMENTATION A. Document on the Universal Protocol in the EHR. 1. Begin with the Pre-Procedure Checklist, if patient's procedure is surgical. 2. Document Pre-Procedure Verification as prompted. Document if site marking is required. 3. Document the Time Out as prompted. Note the time the Time Out was performed..."

According to the Joint Commission's (JC- the nation's oldest and largest standards-setting and accrediting body in health care) website: Universal Protocol (UC) is one of nine (9), 2025 Critical Access Hospital National Patient Safety Goals concerned with preventing mistakes in surgery, electronically retrieved on 3/7/25 from: https://www.jointcommission.org/standards/national-patient-safety-goals/critical-access-hospital-national-patient-safety-goals/ , the Simplified version or the standards indicated "...Make sure that the correct surgery is done on the correct patient and at the correct place on the patient's body... Mark the correct place on the patient's body where the surgery is to be done... Pause before the surgery to make sure that a mistake is not being made..."