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2823 FRESNO STREET

FRESNO, CA 93721

PATIENT RIGHTS: INFORMED CONSENT

Tag No.: A0131

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 ...".