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Based on observation, interview, and record review, the facility failed to ensure the Condition of Participation for Patient Rights was met as evidenced by:

1. The facility failed to provide a safe environment to implement standard procedures and processes to ensure the correct identification and appropriate consent of patients for procedures, particularly in the outpatient Urology (branch of medicine and physiology concerned with the function and disorders of the urinary system) Clinic (which serves approximately180 patients daily), for four (4) of thirty (30) sampled patients (Patient 1, Patient 5, Patient 21, and Patient 24). Patient 1 was misidentified and was subjected to an unnecessary procedure when License Vocational Nurse (LVN) 1 inserted a catheter (a tube inserted through a narrow opening into a body cavity) into the urethra (the tube through which urine leaves the body) and anus (the opening in a person's bottom through which solid waste leaves the body) of Patient 1 to initiate a procedure not intended for Patient 1. The Urology Clinic's staff did not utilize an interpreter service to communicate with Patient 1 on 10/17/23 (the day when Patient 1 underwent the incorrect procedure). Patient 1's preferred language, Vietnamese is documented. Consent was not completed in accordance with the facility's policy and procedure for Patient 1, Patient 5, Patient 21, and Patient 24. The Urology Clinic does not adhere to the facility's "Patient Identification" policy and procedure when the clinic fails to place an identification arm band on patients scheduled to receive medications or undergo procedures during their appointments.

These deficient practices resulted in Patient 1 being subjected to discomfort, risked damage to the urinary sphincter (a muscular structure that regulates the outflow of urine from the bladder to the tube where urine leave the body), and increased the likelihood of allergic reactions (the immune system overreacts to a substance that may cause minor itch and swelling or severe life-threatening symptoms such as chest pain, pulmonary edema [fluid built up in the lungs], and hypotension [drop in blood pressure]) to iodine contrast (ICM, are drugs containing iodine that are given to patients to enhance the ability to see blood vessels and organs on medical images). Such practices also pose a risk of misidentifying of patients among the 180 patients seen daily, potentially resulting in errors during medication administration or procedures. (Refer to A 0144)

2. The facility failed to ensure four (4) of thirty (30) sampled patients' consent for procedures was verified and obtained (for Patient 1, Patient 5, Patient 21, and Patient 24) in accordance with the facility's policy and procedures.

This deficient practice resulted in Patient 1 being subjected to a procedure not intended for Patient 1. Patient 5's preference language was not the dialogue written on the consent; Patient 21's and Patient 24's consent was incomplete, jeopardizing patient safety and violating patients' right to be appropriately informed prior to consenting to the procedure. (Refer to A 0131)
The cumulative effect of these deficient practices resulted in the facility's inability to provide quality healthcare in a safe environment and potentially placing patients at risk of not receiving necessary care and treatments.

Based on observation, interview, and record review, the facility failed to ensure four (4) of thirty (30) sampled patients' consent for procedures was verified and obtained (for Patient 1, Patient 5, Patient 21 and Patient 24) in accordance with the facility's policy and procedures.
This deficient practice resulted in Patient 1 being subjected to a procedure not intended for Patient 1. Patient 5's preference language was not the dialogue written on the consent; Patient 21's and Patient 24's consent was incomplete, jeopardizing patient safety and violating patients' right to be appropriately informed prior to consenting to the procedure.

Findings:

a. During a review of Patient 1's "Urology (branch of medicine and physiology concerned with the function and disorders of the urinary system) Procedure Note" dated 1/19/2023, the note indicated, Patient 1 "now returns to see me 12 months after he was last seen and he is now 37 months out from implantation of an artificial urinary sphincter (a device which is implanted to treat severe urinary incontinence, the cuff is filled with fluid and gently squeezed the urethra closed to keep urine in the bladder.) The patient comes in today very well. He is happy with the performance of the AUS (artificial urinary sphincter). Plan: I am very happy with how (Patient 1's name) has appeared. We will see him again in 12 months to make sure he is doing well as part of normal surveillance. "

During a concurrent interview and record review on 4/3/24 at 2:23 p.m. with the Assistance Manager of Hematology (MH) Patient 1 electronic medical record (EMR) was reviewed. Patient 1 returned to the clinic on 10/17/23 for follow up appointment, status post Robotic Radical Prostatectomy, for prostate-specific antigen surveillance testing. Patient 1's preferred language is Vietnamese and LVN 1 does not speak Vietnamese and no interpreter service was used when Patient 1 was called from the waiting room. LVN 1 proceeded to bring back Patient 1 to the procedure room. The MH confirmed that LVN 1 did not verify if Patient 1 had been consented for the procedure prior to prepping Patient 1 for the fluoroscopic urodynamics procedure. MH acknowledge that if LVN 1 had look in the Patient 1 medical record for a consent for fluoroscopic urodynamics procedure and discover that there is no consent, it will alarm her that this may be the wrong patient and this will stop LVN 1 from proceeding to insert catheters into Patient 1.


b. During a review of Patient 5's "Face Sheet (document that contains a summary of a patient's personal and demographic information)," dated 4/3/24, the face sheet indicated, Patient 5 registered at the Urology and Genitourinary Oncology (GU Oncology, focuses on research and treatment of urinary system cancers in both genders) Clinic to undergo MRI () fusion guided transrectal biopsy (A biopsy procedure that combines the pictures from an MRI scan and an ultrasound to create a detailed 3-D image personal and demographic information)," dated 4/3/24, the face sheet indicated, Patient 5 registered at the Urology and Genitourinary Oncology (GU Oncology, focuses on research and treatment of urinary system cancers in both genders) Clinic to undergo MRI (Magnetic resonance imaging, a test that uses powerful magnets, radio waves, and a computer to make detailed pictures ) fusion guided biopsy (A biopsy procedure that combines the pictures from an MRI scan and an ultrasound to create a detailed 3-D image ).


During a review of Patient 5's "Procedure Note (document that contains a summary of a patient's surgical information)," dated 4/3/24, the note indicated, Patient 5 with a history of elevated prostate-specific antigen was referred for a MRI/ultrasound guided fusion biopsy.

During a concurrent interview and record review on 4/3/24 at 2:15 p.m. with Assistant Manager Hematology (MH), Patient 5's EMR, titled, "General Information," was reviewed. The document indicated, "The language in which the patient prefers to receive Health Care Information is Armenian." The document also indicated under "Translator/Interpreter," "Yes" was selected. There were no other selections indicating English was also an acceptable language of communication for Patient 5.

During a concurrent interview and record review on 4/3/24 at 2:15 p.m. with Assistant Manager Hematology (MH), Patient 5's surgical consent form for prostate biopsy (procedure to remove samples of suspicious tissue from the prostate, a gland surrounding the neck of the bladder in male) titled "Surgery, Treatment, or Special Procedure-Related information," dated 4/3/24 was reviewed. The consent form is written in English. There was no documentation indicating an interpreter service was use. The MH stated if the patient refused to have an interpreter service for any reason, it should be documented. MH further confirmed that there is no documentation indicating Patient 5 refuse to have interpreter or that she did not require and interpreter services.

During a review of the facility's policy and procedure (P&P) titled, "Impair Communication, Interpreter Services," d ate last revised 7/11/23, the P&P indicated, "To outline the organization's process of providing interpreter services and/or communication assistance to patients that is following federal and state regulations, thus ensuring a patient's right to participate in health care decisions in their preferred language. This will advance effective communication, cultural competence, and patient and family-centered care ... Personnel must consider engaging interpreter services at all stages across the continuum of care to ensure that patient needs are addressed and met. Personnel assess patient communication needs at point of entry and indicate on electronic health record patient's preferred language. The hospitals will provide language interpreting options, which include qualified staff interpreters as well as contract interpreting services, in person, via OPI or video. The hospitals will provide interpreter services to ensure effective situational communication. This policy includes but is not limited to the following instances of communication ... Obtaining patient medical history. Obtaining informed consent and permission for treatment. Explaining diagnosis, treatment and prognosis of illness. Communicating during preparation for surgery and recovery after surgery..."

During a review of Patient 21s medical record, patient had an urgent outpatient visit on 4/1/24 due to swelling and pain at groin area. Patient 21's "Face Sheet (document that contains a summary of a patient's personal and demographic information)," dated 4/1/24, the face sheet indicated, Patient 21 registered at the Urology Clinic at the Pasadena location.

During a concurrent interview and record review on 4/3/24 at 9:45 a.m. with Clinical Manager of Oncology Service (CMOS), Patient 21's surgical or special procedure consent form for incision and drainage (procedure to release pus or pressure built up under the skin) of the scrotum/testes titled "Informed consent to surgery or special procedure," dated 4/1/24 was reviewed. The consent form was written in English. There was no documentation of time when the consent was signed by the patient 21 and provider. The CMOS stated the consent should be completed with patient signature, provider's signatures, date, and time when they signed the consent; the consent is incomplete.

During a review of the facility's policy and procedure (P&P) titled, "Consents: Obtaining and Verifying," da te revised 11/29/23, the P&P indicated: "... Informed Consent: It is the provider's responsibility to obtain the patient's informed consent, or the consent of the patient's legal representative, for a procedure or medical treatment. The elements of the informed consent must be explained in terms the patient can understand. Informed consent includes the following elements: The nature of the procedure, the facility where the surgical procedure or intervention is taking place, the risks, complications, and expected benefits or effects of the procedure including the possible risks of not receiving care, treatment or surgery, any alternatives to the treatment and their risks and benefits, potential problems during recuperation, any potentially conflicting interest the provider may have (such as research or financial interest), a discussion regarding the attending provider's presence and participation in the key /critical portions of the procedure and that he / she may not be present to the entire procedure, if applicable... d. The date and time on the form should be the date and time that the patient or patient's legal representative signs the form, not the date and time of the procedure or operation..."

During a review of Patient 24's medical record, patient came to outpatient visit for a scheduled pain medicine appointment. Per Patient 24's Face Sheet (document that contains a summary of a patient's personal and demographic information)," dated 3/24/24, the face sheet indicated, Patient 24 registered at the Pain Medicine Clinic at the Arcadia location.

During a concurrent interview and record review on 4/3/24 at 11:45 a.m. with CMOS, Patient 24's surgical or special procedure consent form for Injection at Joint with Corticosteroid (injection of cortisone in a specific area of the body for pain relieve) at Right sternoclavicular joint titled "Informed consent to surgery or special procedure," dated 3/25/24 was reviewed. The consent from is written in English. There was no documentation of time when the consent was signed by the patient 24 and provider. The CMOS stated the consent should be completed with patient signature, provider's signatures, date, and time when they signed the consent; the consent is incomplete.

During a review of the facility's policy and procedure (P&P) titled, "Consents: Obtaining and Verifying," da te revised 11/29/23, the P&P indicated the following. General Consent Information:
a. Every competent adult has the fundamental right of self-determination over his or her body and property. Consent to surgery or special diagnostic or therapeutic procedures must be freely given and must not be obtained through the exercise of duress or coercion. Individuals who are unable to exercise this right, such as minors and adults lacking capacity to consent, have the right to be represented by another person who will protect their interests and preserve their basic rights.
b. Title 22, California Administrative Code provides that a patient has the right to "receive as much information about any proposed treatment or procedure as the patient may need in order to give informed consent or to refuse this course of treatment." A competent adult patient must consent to his / her treatment. (22 C.C.R § 70707(b)(5))
c. A provider has both a legal and an ethical duty to obtain the patient's consent, or the consent of the patient's legal representative, to medical treatment. Therefore, the provider, not the hospital, has the responsibility to obtain consent. The role of the hospital in this process shall be limited to verifying that the patient's informed consent has been obtained by the provider before the provider is permitted to perform the medical procedure. This verification is documented on the "Authorization and Informed Consent to Surgery or Special Diagnostic or Therapeutic Procedures" form (hospital consent form) ...Consent to Procedures: It is the responsibility of the provider to obtain and document informed consent. It is recommended that the provider document in the medical record that a discussion was held with the patient and that informed consent was obtained. During the Time Out the nurse should verify that the consent form signed by the patient is consistent with the planned procedure and the correct patient. Any discrepancies must be brought to the attention of the provider performing the procedure and support staff. To be effective, consent must be made knowingly and given freely. The patient must be conscious and competent to understand the purpose and effect of the decision to be made and the form to be signed ... Informed Consent: It is the provider's responsibility to obtain the patient's informed consent, or the consent of the patient's legal representative, for a procedure or medical treatment. The elements of the informed consent must be explained in terms the patient can understand. Informed consent includes the following elements: The nature of the procedure, the facility where the surgical procedure or intervention is taking place, the risks, complications, and expected benefits or effects of the procedure including the possible risks of not receiving care, treatment or surgery, any alternatives to the treatment and their risks and benefits, potential problems during recuperation, any potentially conflicting interest the provider may have (such as research or financial interest), a discussion regarding the attending provider's presence and participation in the key /critical portions of the procedure and that he / she may not be present to the entire procedure, if applicable ...Recommendations for Completing a Consent From:
a. The medical terminology describing the procedure should be entered into the space provided on the form. No abbreviations should be used in describing the operation or procedure.
b. A description of the operation or procedure in lay terminology should be entered by the provider in the space provided.
c. The provider should complete the spaces provided for the expected benefits or effects, significant risks, alternatives, the potential problems during recuperation, and benefits and risks of the alternatives unless the provider has documented elsewhere in the medical record.
d. The date and time on the form should be the date and time that the patient or patient's legal representative signs the form, not the date and time of the procedure or operation..."

During a review of the facility's policy and procedure (P&P) titled, "Impair Communication, Interpreter Services," date last revised 7/11/23, the P&P indicated, "To outline the organization's process of providing interpreter services and/or communication assistance to patients that is following federal and state regulations, thus ensuring a patient's right to participate in health care decisions in their preferred language. This will advance effective communication, cultural competence, and patient and family-centered care ... Personnel must consider engaging interpreter services at all stages across the continuum of care to ensure that patient needs are addressed and met. Personnel assess patient communication needs at point of entry and indicate on electronic health record patient's preferred language. The hospitals will provide language interpreting options, which include qualified staff interpreters as well as contract interpreting services, in person, via OPI or video. The hospitals will provide interpreter services to ensure effective situational communication. This policy includes but is not limited to the following instances of communication ... Obtaining patient medical history. Obtaining informed consent and permission for treatment. Explaining diagnosis, treatment and prognosis of illness. Communicating during preparation for surgery and recovery after surgery.. ..."

Based on observation, interview, and record review, the facility failed to implement standard procedures and processes to ensure the correct identification and appropriate consent of patients for procedures, especially in the outpatient Urology (branch of medicine and physiology concerned with the function and disorders of the urinary system) Clinic (which serves approximately180 patients daily), for four (4) of thirty (30) sampled patients (Patient 1, Patient 5, Patient 21, and Patient 24), as evidence by:

1. LVN 1 misidentified patient 1 and performed an unnecessary procedure by inserting a catheter (a tube inserted through a narrow opening into a body cavity) into the urethra (the tube through which urine leaves the body) and anus (the opening in a person's bottom through which solid waste leaves the body) of Patient 1, initiating a procedure that was not intended for Patient 1.

2. The Urology Clinic's staff did not utilize an interpreter service to communicate with Patient 1 on 10/17/23 (the day when Patient 1 underwent the incorrect procedure). Patient 1's preferred language, Vietnamese is documented.

3. The Urology Clinic does not adhere to the facility's "Patient Identification" policy and procedure when the clinic fails to place an identification arm band on patients scheduled to receive medications or undergo procedures during their appointments.

These deficient practices resulted in Patient 1 being subjected to discomfort, risked damage to the urinary sphincter (a muscular structure that regulates the outflow of urine from the bladder to the tube where urine leave the body), and increased the likelihood of allergic reactions (the immune system overreacts to a substance that may cause minor itch and swelling or severe life-threatening symptoms such as chest pain, pulmonary edema [fluid built up in the lungs], and hypotension [drop in blood pressure]) to iodine contrast (ICM, are drugs containing iodine that are given to patients to enhance the ability to see blood vessels and organs on medical images). Such practices also pose a risk of misidentifying of patients among the 180 patients seen daily, potentially resulting in errors during medication administration or procedures.

On 4/5/2024 at 11:34 a.m., the survey team called an Immediate Jeopardy (IJ, a situation in which the facility ' s noncompliance with one or more requirements has caused, or is likely to cause, a serious injury, harm, impairment, or death to a patient) in the presence of the Chief Medical Officer (CMO), Chief Nursing Executive Officer (CNEO), Chief Nursing Officer (CNO), Chief Ambulatory Officer, Chief Pharmacy Officer (CPO), Deputy Director of Cancer Services, Assistance Administrator, Interim Executive Administrator, and Manager of Regulatory and Patient Safety. The facility failed to implement standard procedures and processes to ensure the correct identification and appropriate consent of patients for procedures, particularly in the outpatient Urology (branch of medicine and physiology concerned with the function and disorders of the urinary system) Clinic (which serves approximately180 patients daily), for four (4) of thirty (30) sampled patients (Patient 1, Patient 5, Patient 21, and Patient 24), as evidence by: Patient 1 was misidentified and was subjected to an unnecessary procedure when License Vocational Nurse (LVN) 1 inserted a catheter (a tube inserted through a narrow opening into a body cavity) into the urethra (the tube through which urine leaves the body) and anus (the opening in a person's bottom through which solid waste leaves the body) of Patient 1 to initiate a procedure not intended for Patient 1. The Urology Clinic's staff did not utilize an interpreter service to communicate with Patient 1 on 10/17/23 (the day when Patient 1 underwent the incorrect procedure). Patient 1's preferred language, Vietnamese is documented. Consent was not completed in accordance with the facility's policy and procedure for Patient 1, Patient 5, Patient 21, and Patient 24. The Urology Clinic does not adhere to the facility's "Patient Identification" policy and procedure when the clinic fails to place an identification arm band on patients scheduled to receive medications or undergo procedures during their appointments. These deficient practices resulted in Patient 1 being subjected to discomfort, risked damage to the urinary sphincter (a muscular structure that regulates the outflow of urine from the bladder to the tube where urine leave the body), and increased the likelihood of allergic reactions (the immune system overreacts to a substance that may cause minor itch and swelling or severe life-threatening symptoms such as chest pain, pulmonary edema [fluid built up in the lungs], and hypotension [drop in blood pressure]) to iodine contrast (ICM, are drugs containing iodine that are given to patients to enhance the ability to see blood vessels and organs on medical images). Such practices also pose a risk of misidentifying of patients among the 180 patients seen daily, potentially resulting in errors during medication administration or procedures.

On 4/5/2024 at 6:45 p.m., the IJ was removed in the presence of the CMO, CNEO, CNO, Chief of Operations Officer, Deputy Director of Cancer Services, Chief Pharmacy Officer, and Chief Ambulatory Officer the facility submitted an acceptable IJ Removal Plan (interventions to correct the deficient practice). The elements of the IJ Removal Plan were verified and confirmed through observations, interviews, and record review. The IJ Removal Plan indicated the CMO, CEO, Chief of Operations, CNO, Chief of Ambulatory Operations, Executive Administrator of Risk Management, Chief Regional Oncology Officer and other clinical and administrative staff convened to review and analyze current policies for Patient Identification, Informed Consent, and Interpreter Services were reviewed and confirmed existing policies meet current medical standards and applicable laws. The CEO called an emergency town hall meeting on April 5, 2024, at 3:00 pm that included administrative, operational and clinical staff to communicate the following mandatory standards: Effective Immediately and without exception all (name of the facility) licensed hospital environments, including hospital licensed clinics will fully comply with facility policies-specifically: Patient Identification, Informed Consent, and Interpreter Services ...The Chief of Ambulatory services, in collaboration with key stakeholders will implement the capability in each of the of the licensed (name of facility) ambulatory clinics to print patient ID bands. Directors and managers will train each clinic staff member on the required steps as outlined in the Patient Identification policy to ensure compliance. All patients who present to the clinic will have a patient identification armband placed at the time of registration. As an interim action, check lists instructing staff on the key steps for patient identification posted at registration stations and in exam rooms to guide staff on following the expected identification process.

Findings:

1. During a review of Patient 1's "Urology (branch of medicine and physiology concerned with the function and disorders of the urinary system) Procedure Note" dated 1/19/2023, the note indicated, Patient 1 "now returns to see me 12 months after he was last seen and he is now 37 months out from implantation of an artificial urinary sphincter (a device which is implanted to treat severe urinary incontinence, the cuff is filled with fluid and gently squeezed the urethra closed to keep urine in the bladder.) The patient comes in today very well. He is happy with the performance of the AUS (artificial urinary sphincter). Plan: I am very happy with how (Patient 1's name) has appeared. We will see him again in 12 months to make sure he is doing well as part of normal surveillance."

During a concurrent interview and record review on 4/3/24 at 10:00 a.m. with the Manager of Operation of the Urology Services (MAS), Patient 1's electronic medical record was reviewed. Patient 1, a Vietnamese speaking patient, was scheduled on 10/17/23 for a follow up appointment for S/P Robot Assisted Laparoscopic Prostatectomy (surgery that uses a computer-assisted mechanical device to remove the entire prostate), which does not involve any invasive procedure. Patient 1 has a history of artificial urinary sphincter which was opened (correctly) prior to follow up schedule date (10/17/23). On this day 10/17/23, Patient 1 should have been brought to an exam room, instead he was brought to a procedure room. The MAS stated the clinic sees about 180 patients daily.

During the interview on 4/3/24 at 11:36 a.m. with the Radiology Technician (RT 1), who was the C-ARM (an advanced medical imaging device based) operator that was supposed to start the procedure for a Fluoroscopic Urodynamics (FUDS, is a test of bladder and urethral function that shows organs, tissues, or other internal structures moving in real time with the use of iodine contrast) on Patient 1. Patient 1 had 2 catheters already inserted. RT 1stated he entered the procedure room, looked at the patient and asked him to say his name. RT 1 looked in the system and did not see Patient 1's name. Then RT 1 asked Patient 1 to spell his name. RT1 stated that he was not able to find Patient 1's name in the system. RT 1 then saw a printout of a sticker label with a different patient name on the computer. RT 1 alerted the MD 1 and LVN 1 that this may be the wrong patient. The catheters were removed, and Patient 1 was sent back to the waiting room.

During record review of Patient 1 provider notes titled "Office/Clinic Notes," signed by MD 1 dated 10/19/23 at 2:45 p.m. indicated, "I was alerted that this patient had been prepared for a fluoroscopic urodynamics procedure incorrectly after he was brought into the procedure room by the nurse. I entered the room where our clinic manager and fellow were speaking to the patient. I was told that the patient had identified themselves to the nurse incorrectly and that the nurse proceeded to prepare him for the urodynamics by placing the urethral and rectal catheters. He has a history of artificial urinary sphincter which was opened (correctly) prior to urethral catheterization. At this point it apparently became evident that he was in fact the wrong patient and the two catheters were removed. He was understandably upset but was reassured by our team and brought over to the correct clinic location. He was given a dose of antibiotic for prophylaxis. This event took place October 17th, 2023 at 1:30 p.m."

During a review of the facility's policy and procedure (P&P) titled, "Patient's Rights and Responsibilities," date revised 11/22/2022, the P&P indicated, "To provide an updated and accurate list of patient rights to every patient receiving treatment at the facility ...Patient Rights: Considerate and respectful care, and to be made comfortable. Patients have the right to respect for their cultural, psychosocial, spiritual, and personal values, beliefs and preferences ... Make decisions regarding medical care, and receive as much information about any proposed treatment or procedure as he/she may need in order to give informed consent or to refuse a course of treatment. Except in emergencies, this information shall include a description of the procedure or treatment, the medically significant risks involved, alternate courses of treatment or non-treatment and the risks involved in each, and the name of the person who will carry out the procedure or treatment...Receive care in a safe setting ..."

2. During a review of Patient 1's "Urology (branch of medicine and physiology concerned with the function and disorders of the urinary system) Procedure Note" dated 1/19/2023, the note indicated, Patient 1 "now returns to see me 12 months after he was last seen and he is now 37 months out from implantation of an artificial urinary sphincter (a device which is implanted to treat severe urinary incontinence, the cuff is filled with fluid and gently squeezed the urethra closed to keep urine in the bladder.) The patient comes in today very well. He is happy with the performance of the AUS (artificial urinary sphincter). Plan: I am very happy with how (Patient 1's name) has appeared. We will see him again in 12 months to make sure he is doing well as part of normal surveillance."

During an interview on 4/3/24 at 10:44 a.m. with LVN2, LVN2 stated Patient 1 came to the clinic for a follow up visit and stayed in the waiting room. When LVN 1 called out a last name for a patient in the waiting room, Patient 1 responded to the call from LVN 1. LVN 1 ushered Patient 1 to one of five procedure rooms instead to the exam room. LVN 2 stated while she was looking for Patient 1 from the waiting room, Patient 1 was already ushered to the procedure room by LVN 1. LVN 2 stated she thought Patient 1 was late and called Patient 1 on the phone but no answer. LVN 2 stated later she went out to the waiting room again and found Patient 1 already in the waiting room after being brought to the wrong procedure room and after the two (2) catheters were inserted one on the urethra the urethra (the tube through which urine leaves the body) and on one on the anus (the opening in a person's bottom through which solid waste leaves the body), and removed. Patient 1 expressed "he was feeling uncomfortable." Patient 1 spoke very little English but preferred Vietnamese. LVN 2 stated she did not use an interpreter service to clarify what Patient 1 expressed as being uncomfortable.

During a concurrent interview and record review on 4/3/24 at 11:20 a.m. with the MAS, Patient 1's electronic medical record was reviewed. The MAS stated Patient 1's electronic medical record indicated the language preference is Vietnamese. An interpreter was not used during his visits on 10/17/23. LVN 1 preceded to insert one catheter to the urethra and another to the "bottom" (referring to the anus). The MAS stated patient 1's preferred language should be the language use via interpreter services by LVN 1 to check and verify Patient 1's first and last name and date of birth prior to inserting the catheters.

During a review of the facility's policy and procedure (P&P) titled, "Impair Communication, Interpreter Services," date revised 7/11/23, the P&P indicated the following.
Purpose: To outline the organization's process of providing interpreter services and/or communication assistance to patients that is in compliance with federal and state regulations, thus ensuring a patient's right to participate in health care decisions in their preferred language. This will advance effective communication, cultural competence, and patient and family-centered care.
1. The facility provides necessary Interpreting Services to our patient population in compliance with Section 504 of the 1973 Federal Rehabilitation Act; Title 22, California Code of Regulations, Section 51007, and other federal and state regulations.
2. Interpreting Services are available seven days a week, 24 hours per day, at no cost to patients or their legal representatives.
3. Personnel must consider engaging interpreter services at all stages across the continuum of care to ensure that patient needs are addressed and met.
4. Personnel assess patient communication needs at point of entry and indicate on electronic health record patient's preferred language
5. The hospitals will provide language interpreting options, which include qualified staff interpreters as well as contract interpreting services, in person, via OPI or video.
6. The hospitals will provide interpreter services to ensure effective situational communication. This policy allows allied health members who have passed the Interpreter Skill Test of the medical staff who are proficient in given languages to perform interpretation. This policy includes but is not limited to the following instances of communication:
a. Obtaining patient medical history.
b. Obtaining informed consent and permission for treatment.
c. Explaining diagnosis, treatment and prognosis of illness.
d. Communicating during preparation for surgery and recovery after surgery.
e. Explaining of first dose medications including dosage, side effects, and rationale for use.
f. Explaining discharge instructions.

3a. During a review of Patient 1's "Urology (branch of medicine and physiology concerned with the function and disorders of the urinary system) Procedure Note" dated 1/19/2023, the note indicated, Patient 1 "now returns to see me 12 months after he was last seen and he is now 37 months out from implantation of an artificial urinary sphincter (a device which is implanted to treat severe urinary incontinence, the cuff is filled with fluid and gently squeezed the urethra closed to keep urine in the bladder.) The patient comes in today very well. He is happy with the performance of the AUS (artificial urinary sphincter). Plan: I am very happy with how (Patient 1's name) has appeared. We will see him again in 12 months to make sure he is doing well as part of normal surveillance."

During a concurrent interview and record review on 4/3/24 at 2:23 p.m. with the Assistance Manager of Hematology (MH) Patient 1 electronic medical record (EMR) was reviewed. The MH confirmed that LVN 1 did not verify if Patient 1 had been consented for the procedure prior to prepping Patient 1 for the fluoroscopic urodynamics procedure.

3b. During a review of Patient 5's "Face Sheet (document that contains a summary of a patient's personal and demographic information)," dated 4/3/24, the face sheet indicated, Patient 5 registered at the Urology and Genitourinary Oncology (GU Oncology, focuses on research and treatment of urinary system cancers in both genders) Clinic.

During a concurrent interview and record review on 4/3/24 at 2:15 p.m. with Assistant Manager Hematology (MH), Patient 5's EMR, titled, "General Information," was reviewed. The document indicated, "The language in which the patient prefers to receive Health Care Information is Armenian."

During a concurrent interview and record review on 4/3/24 at 2:15 p.m. with Assistant Manager Hematology (MH), Patient 5's surgical consent form for prostate biopsy (procedure to remove samples of suspicious tissue from the prostate, a gland surrounding the neck of the bladder in male) titled "Surgery, Treatment, or Special Procedure-Related information," dated 4/3/24 was reviewed. The consent from is written in English. There was no documentation indicating an interpreter service was use. The MH stated if the patient refused to have an interpreter service for any reason, it should be documented. MH further confirmed that there is no documentation indicating Patient 5 refuse to have interpreter or that she did not require and interpreter services.

During a review of Patient 21's medical record, patient had an urgent outpatient visit on 4/1/24 due to swelling and pain at groin area. Patient 21's "Face Sheet (document that contains a summary of a patient's personal and demographic information)," dated 4/1/24, the face sheet indicated, Patient 21 registered at the Urology Clinic at Pasadena location.

During a concurrent interview and record review on 4/3/24 at 9:45 a.m. with Clinical Manager of Oncology Service (CMOS), Patient 21's surgical or special procedure consent form for incision and drainage (procedure to release pus or pressure built up under the skin) of the scrotum/testes titled "Informed consent to surgery or special procedure," dated 4/1/24 was reviewed.

During a review of Patient 24's medical record, patient came to outpatient visit for a scheduled pain medicine appointment. Per Patient 24's Face Sheet (document that contains a summary of a patient's personal and demographic information)," dated 3/24/24, the face sheet indicated, Patient 24 registered at the Pain Medicine Clinic at Arcadia location.
During a review of Patient 24's, "Pain Management Clinic Note," dated 3/25/24, the note indicated under "Intervention: Given the signs and symptoms of right sternoclavicular joint pain, we will proceed with right sternoclavicular joint injection today."
During a concurrent interview and record review on 4/3/24 at 11:45 a.m. with CMOS, Patient 24's surgical or special procedure consent form for Injection at Joint with Corticosteroid (injection of cortisone in a specific area of the body for pain relieve) at Right sternoclavicular joint titled "Informed consent to surgery or special procedure," dated 3/25/24 was reviewed. The consent from is written in English. There was no documentation of time when the consent was signed by the patient 24 and provider. The CMOS stated the consent should be completed with patient signature, provider's signatures, date, and time when they signed the consent; the consent is incomplete.

During a review of the facility's policy and procedure (P&P) titled, "Consents: Obtaining and Verifying," date revised 11/29/23, the P&P indicated the following. The purpose of this policy is:
1. To delineate the hospital's role in verifying that informed consent has been obtained.
2. To delineate the provider's role in obtaining an informed consent for medical treatment or procedure.
3. To outline the methodology by which consent is obtained for adult and minor patients.
General Consent Information:
a. Every competent adult has the fundamental right of self-determination over his or her body and property. Consent to surgery or special diagnostic or therapeutic procedures must be freely given and must not be obtained through the exercise of duress or coercion. Individuals who are unable to exercise this right, such as minors and adults lacking capacity to consent, have the right to be represented by another person who will protect their interests and preserve their basic rights.
b. Title 22, California Administrative Code provides that a patient has the right to "receive as much information about any proposed treatment or procedure as the patient may need in order to give informed consent or to refuse this course of treatment." A competent adult patient must consent to his / her treatment. (22 C.C.R § 70707(b)(5))
c. A provider has both a legal and an ethical duty to obtain the patient's consent, or the consent of the patient's legal representative, to medical treatment. Therefore, the provider, not the hospital, has the responsibility to obtain consent. The role of the hospital in this process shall be limited to verifying that the patient's informed consent has been obtained by the provider before the provider is permitted to perform the medical procedure. This verification is documented on the "Authorization and Informed Consent to Surgery or Special Diagnostic or Therapeutic Procedures" form (hospital consent form) ...Consent to Procedures: It is the responsibility of the provider to obtain and document informed consent. It is recommended that the provider document in the medical record that a discussion was held with the patient and that informed consent was obtained. During the Time Out the nurse should verify that the consent form signed by the patient is consistent with the planned procedure and the correct patient. Any discrepancies must be brought to the attention of the provider performing the procedure and support staff. To be effective, consent must be made knowingly and given freely. The patient must be conscious and competent to understand the purpose and effect of the decision to be made and the form to be signed ... Informed Consent: It is the provider's responsibility to obtain the patient's informed consent, or the consent of the patient's legal representative, for a procedure or medical treatment. The elements of the informed consent must be explained in terms the patient can understand. Informed consent includes the following elements: The nature of the procedure, the facility where the surgical procedure or intervention is taking place, the risks, complications, and expected benefits or effects of the procedure including the possible risks of not receiving care, treatment or surgery, any alternatives to the treatment and their risks and benefits, potential problems during recuperation, any potentially conflicting interest the provider may have (such as research or financial interest), a discussion regarding the attending provider's presence and participation in the key /critical portions of the procedure and that he / she may not be present to the entire procedure, if applicable...Recommendations for Completing a Consent Form:
a. The medical terminology describing the procedure should be entered into the space provided on the form. No abbreviations should be used in describing the operation or procedure.
b. A description of the operation or procedure in lay terminology should be entered by the provider in the space provided.
c. The provider should complete the spaces provided for the expected benefits or effects, significant risks, alternatives, the potential problems during recuperation, and benefits and risks of the alternatives unless the provider has documented elsewhere in the medical record.
d. The date and time on the form should be the date and time that the patient or patient's legal representative signs the form, not the date and time of the procedure or operation."

During a review of the facility's policy and procedure (P&P) titled, "Impair Communication, Interpreter Services," date last revised 7/11/23, the P&P indicated, "To outline the organization's process of providing interpreter services and/or communication assistance to patients that is following federal and state regulations, thus ensuring a patient's right to participate in health care decisions in their preferred language. This will advance effective communication, cultural competence, and patient and family-centered care ... Personnel must consider engaging interpreter services at all stages across the continuum of care to ensure that patient needs are addressed and met. Personnel assess patient communication needs at point of entry and indicate on electronic health record patient's preferred language. The hospitals will provide language interpreting options, which include qualified staff interpreters as well as contract interpreting services, in person, via OPI or video. The hospitals will provide interpreter services to ensure effective situational communication. This policy includes but is not limited to the following instances of communication ... Obtaining patient medical history. Obtaining informed consent and permission for treatment. Explaining diagnosis, treatment and prognosis of illness. Communicating during preparation for surgery and recovery after surgery. Explaining of first dose medications including dosage, side effects, and rationale for use. Explaining discharge instructions. Families and/or significant others are NOT considered qualified staff interpreters and cannot provide translation for the instances listed above. ..."

During a review of the facility's policy and procedure (P&P) titled, "Patient's Rights and Responsibilities," date revised 11/22/22, the P&P indicated, "To provide an updated and accurate list of patient rights to every patient receiving treatment at the facility ...Patient Rights: Considerate and respectful care, and to be made comfortable. Patients have the right to respect for their cultural, psychosocial, spiritual, and personal values, beliefs and preferences ... Make decisions regarding medical care, and receive as much information about any proposed treatment or procedure as he/she may need in order to give informed consent or to refuse a course of treatment. Except in emergencies, this information shall include a description of the procedure or treatment, the medically significant risks involved, alternate courses of treatment or non-treatment and the risks involved in each, and the name of the person who will carry out the procedure or treatment...Receive care in a safe setting ..."

3. During an interview on 4/3/24 at 11:20 a.m. with the Senior Manager Operation of Urology Clinic (SMOU), SMOU stated the clinic is not currently implementing armband identification for patients being seen in the Urology clinic.

During a concurrent interview and record review on 4/3/24 at 10:55 a.m. with the MAS, the MAS stated the Urology Clinic is working on establishing an armband identifier but is currently working on the process.

During a concurrent interview and record review on 4/4/24 at 11:30 a.m. with the Chief Medical Officer (CMO), the facility's policy and procedure (P&P) titled, "Patient Identification," date last revised 4/11/23 was reviewed. The P&P indicated, "The purpose of this policy is to outline the organization's standard for patient identification." The P&P further indicates the following.
1. The Admitting Department and any other department involving patient registration will make every attempt to ensure that the patient's identity has been properly verified.
2. All staff will identify patients using two approved patient identifiers; name and date of birth when providing care, treatment, or services.
3. Upon admission, staff will confirm patient identity by verbally asking the patient to state their name and date of birth. When a patient is unable to state their own name and date of birth, the following methods of confirmation are acceptable.
a. Government issued ID
b. Verbal confirmation by a parent, guardian, relative, surrogate or an interpreter
4. The patient's room number or physical location is NOT to be used as an identifier.
5. All inpatients and outpatients at (name of the hospital particular campus) Hospital, all inpatients at (name of hospital particular campus) Hospital, and all (name of the hospital particular campus, which include the Urology Clinic) Outpatients who will receive medications during their visit will have an identification band placed around either wrist at the time of admission. When the wrist location is not appropriate for a patient, the identification band will be placed around the ankle.
6. Minimum information on the identification band will include the
a. patient's name,
b. date of birth,
c. hospital medical record number,
d. FINancial Number
7. Prior to any inpatient or outpatient procedure including, but not limited to, administration of medications or blood products, collection of blood samples and other specimens for clinical testing, or providing other treatments or procedures, the healthcare provider will check the patient's identification band to verify the identification of the patient and, in addition, ask the patient to verbally identify himself/herself by name and date of birth. For additional patient identification related policies and procedures, refer to department ¿specific policy and procedure manuals. Procedure: Identification of patients upon arrival to the nursing unit or clinical area. The admitting clinician/provider/RN/ lab technician/ procedure will check the identification band and, ask the patient to verbally identify himself/herself by name and date of birth. When a patient is unable to state their own name and date of birth, a government issued ID, a parent/guardian/relative/surrogate, or an interpreter will be used to verify the patient's identity. The CMO stated, the Urology Clinic did not follow the facility's policy and procedure.