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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 communicate with Patient (Pt) 1's representative when obtaining an informed consent (when a healthcare provider explains a medical treatment to a patient before the patient agrees to it. This type of communication lets the patient/representative ask questions and accept or deny treatment.) for a paracentesis (procedure where fluid from the stomach is removed through a needle) when Pt 1 did not have the capacity to make health care decisions.

This failure resulted in Pt 1 to undergo a paracentesis without obtaining an informed consent from Pt 1's representative which would allow him/her to agree to the procedure.

Findings:

During a review of Pt 1's "Skilled Nursing Facility (SNF) History and Physical (H&P)," dated 5/6/20, the "SNF H&P" indicated "...Resident does not have capacity to make health care decisions..."

During a review of Pt 1's "Condition of Agreement (COA) [a contract between the hospital and the patient. COAs typically outline the patient's obligations with respect to the hospital services they receive, which may include the duty to pay for services rendered per the hospital]," dated 6/9/20, the "COA" indicated a phone consent was obtained from Pt 1's family member (FM 1).

During a concurrent interview and record review on 6/29/20 at 10 a.m. with the Director of Admitting (DOA), Pt 1's "COA" dated 6/9/20 was reviewed. The DOA stated the COA was completed and witnessed by Registration Employee (RE) 1 and Registration Employee (RE) 2 on 6/9/20. The DOA stated RE 1 notified her Pt 1 was not being cooperative and did not answer questions on the COA. The DOA stated Pt 1 did not sign the COA form. The DOA stated RE 1 did not feel Pt 1 had the capacity to sign the COA and stopped the registration process and notified RE 2. The DOA stated RE 2 called FM 1 from Pt 1's emergency contacts and obtained consent for Pt 1's COA. The DOA stated RE 1 and RE 2 should have notified the registered nurse caring for Pt 1 to update him/her on Pt 1's mental status and Pt 1 he was unable to sign the COA. The DOA stated RE 1 did not inform Pt 1's nurse of Pt 1's mental state, but should have.

During an interview on 7/1/20 at 9:35 a.m., with the Nurse Practitioner (NP), the NP stated he worked in the Radiology Department (RD). The NP stated he performed Pt 1's paracentesis on 6/9/20. The NP stated he reviewed the risks and benefits of the paracentesis procedure with Pt 1. The NP stated Pt 1 consented to the procedure. The NP stated Pt 1 did not ask questions. The NP stated he was unaware of Pt 1's inability to make healthcare decisions. The NP stated he was not informed Pt 1 was unable to sign the COA in the emergency department (ED). The NP stated the RD should have been made aware Pt 1 did not have the mental capacity to sign an informed consent for a procedure.

During a concurrent interview and record review on 7/1/20, at 9:56 a.m., with the Sonographer, Pt 1's "Authorization for and Verification of Consent to Surgery, Administration of Anesthetics and Rendering of Other Medical Services," dated 6/9/20 was reviewed. The "Authorization for and Verification of Consent to Surgery" indicated, on 6/9/20, the Sonographer signed her name. The Sonographer stated she witnessed Pt 1 sign the informed consent form for a paracentesis. The Sonographer verified her signature on the informed consent.

During a review of the hospital's policy and procedure (P&P) titled, "Consents", dated 6/21/2017, the P&P indicated, "...Capacity: Patient is able to understand the nature and consequences of proposed health care, including its significant benefits, risks, and alternatives and make and communicate a decision...the hospital is responsible for obtaining ...consent for hospital services or activities...consent for these activities is included in the 'Conditions of Admission' form...INFORMED CONSENT for SURGERY or SPECIAL DIAGNOSTIC and THERAPEUTIC PROCEDURES...the treating physician is responsible for providing...an incompetent patient's surrogate decision-maker with the information that is necessary to allow an 'informed decision' to be made. OBTAINING CONSENT...difficulty obtaining patient's signature on the consent form...should be referred promptly to the Manager/Clinical Supervisor/Registered Nurse on duty..."

FORM AND RETENTION OF RECORDS

Tag No.: A0438

Based on interview and record review, the hospital failed to maintain a complete medical record for one of 62 sampled patients (Pt 1) when Pt 1's "Authorization for and Verification of Consent to Surgery, Administration of Anesthetics and Rendering of Other Medical Services" form for a paracentesis (procedure where fluid from the stomach is removed through a needle) was missing one of two pages (page 2).

This failure resulted in the potential harm of continuity of care and communication of the content of page 2 to staff.

Findings:

During a review of Pt 1's "Authorization for and Verification of Consent to Surgery, Administration of Anesthetics and Rendering of Other Medical Services," dated 5/18/20, the "Authorization for and Verification of Consent to Surgery, Administration of Anesthetics and Rendering of Other Medical Services" indicated, "Page 1 of 2." The "Authorization for and Verification of Consent to Surgery, Administration of Anesthetics and Rendering of Other Medical Services" did not include page 2.

During a concurrent interview and record review on 6/29/20 at 11:50 a.m., with Quality and Regulatory Staff (QRS), Pt 1's "Authorization for and Verification of Consent to Surgery, Administration of Anesthetics and Rendering of Other Medical Services," dated 5/18/20 was reviewed. The QRS stated page two of the consent was not scanned in the electronic medical record (EMR).

During a concurrent interview and record review on 7/1/20 at 10:01 a.m., with the Director of Medical Imaging (DMI), Pt 1's "Authorization for and Verification of Consent to Surgery, Administration of Anesthetics and Rendering of Other Medical Services," dated 5/18/20 was reviewed. The DMI stated the expectation of the staff was to ensure the form was filled out entirely. The DMI verified page 2 of the consent form was missing. The DMI stated she was unsure of why page two was not found in the medical record.

During a review of the hospital's policy and procedure (P&P) titled, "Medical Record Electronic Health Record" dated 9/12/19, the P&P indicated, "... Medical record/electronic health record must be maintained for all patients who receive treatment at the Hospital...Consent forms...Responsibility... any house staff member(s) working with him/her as assigned by the individual departments shall be responsible for the preparation of a complete medical record for each patient...COMPLETION OF THE RECORD... No medical record shall be filed until it is complete...OBTAINING CONSENT ...If an interpreter is used to assist with the informed consent process, he/she will document on the consent form..."

FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE

Tag No.: A0724

Based on observation, interview, and record review, the hospital failed to ensure facility equipment were inspected and maintained to an acceptable level of safety and quality when:

1. Crash carts (a cart stocked with emergency medical equipment, supplies, and drugs for use by medical personnel especially during a patient emergency) in patient care areas were not check daily per the hospital's policy and procedure titled, "Code Blue-Medications & Crash Carts"; and

2. Patient nutrition refrigerators were not checked daily per the hospital's policy and procedure titled, "Refrigerators in Patient Care Areas".

These failures had the potential for malfunctioning equipment to be used on patients during an emergency and for food to be stored at improper temperatures.

Findings:

1. During a concurrent observation and interview on 6/24/20, at 1 p.m., with Clinical Supervisor (CS) 5, CS 5 observed the crash cart on 10 West Neuro and reviewed the document titled, "Crash Cart Check Sheet ...Neuro 1..." dated June 2020. CS 5 confirmed on 6/20/20, there was no signature present which indicated the crash cart was not checked for the day. CS 5 stated, the expectation was for the crash cart to be checked daily by an assigned staff member and the clinical supervisor verifies to ensure it was done by the end of their shift. CS 5 stated, she did not know why it was missed.

During a concurrent observation and interview on 6/24/20, at 1 p.m., with CS 5, CS 5 observed the Crash Cart on 10 West Neuro 2 and reviewed the document titled, "Crash Cart Check Sheet...Neuro 2..." dated June 2020. CS 5 confirmed on 6/5/20, there was no signature present which indicated the crash cart was not checked for the day. CS 5 stated, the expectation was for the crash cart to be check daily by an assigned staff member and the clinical supervisor verifies to ensure it was done by the end of their shift. CS 5 stated, she did not know why it was missed.

During a concurrent observation and interview on 6/24/20, at 2:33 p.m., with the Clinical Educator (CE) 3, CE 3 observed the Crash Cart on 7 West Station B and reviewed the document titled, "Crash Cart Check Sheet...Station B..." dated June 2020. CE 3 confirmed on 6/23/20, there was no signature present which indicated the crash cart was not checked for the day. CE 3 stated, the expectation was for the crash cart to be checked daily. CE 3 stated, she did not know why it was missed.

During a concurrent observation and interview on 6/24/20, at 2:40 p.m., with CE 3, CE 3 observed the Crash Cart on 7 West Oncology and reviewed the document titled, "Crash Cart Check Sheet...Oncology..." dated June 2020. CE 3 confirmed on 6/23/20, there was no signature present which indicated the crash cart was not checked for the day. CE 3 stated, the expectation was for the crash cart to be check daily. CE 3 stated, she did not know why it was missed.

During a review of the hospital's policy and procedure (P&P) titled, "Code Blue-Medications & Crash Carts" dated 7/6/2018, indicated, "...C. External crash cart checks, including defibrillator (an apparatus used to control heart fibrillation by application of an electric current to the chest wall or heart) battery tests...are to be completed at least every 24 hours by staff competent to do so..."

2. During a concurrent observation and interview on 6/24/20, at 12:47 p.m., with the CE 1, CE 1 observed the patient refrigerator on 10 West Stepdown Unit and reviewed the document titled, "Refrigerator/Freezer Temperature Log...Unit: 10 W [west] Stepdown" dated June 2020. CE 1 stated, the temperature of the refrigerator should be checked daily. CE 1 validated the form was incomplete, temperature checks were missing for nine days during the month of June (June 1, 2, 4, 5, 9, 15, 16, 21, & 23). CE 1 stated, when the temperature of the refrigerator is not checked, it can cause food to spoil.

During a concurrent observation and interview on 6/24/20, at 12:55 p.m., with CE 1, CE 1 observed the patient refrigerator on 10 West Neuro (name of unit) and reviewed the document titled, "Refrigerator/Freezer Temperature Log...Unit: 10 W [west] Neuro" dated June 2020. CE 1 stated, the temperature of the refrigerator should be checked daily. CE 1 validated the form was incomplete, temperature checks were missing for five days during the month of June (June 1,5,9,17, & 23).

During a concurrent observation and interview on 6/24/20, at 1:51 p.m., with CE 2, CE 2 observed the Patient Refrigerator on 8 West Station A and reviewed the document titled, "Refrigerator/Freezer Temperature Log ...Unit: 8 West A" dated June 2020. CE 2 validated the form was incomplete, temperature checks were missing for four days during the month of June (June 6, 12, 16, & 17). CE 2 stated, the temperature of the refrigerator should be checked daily. CE 2 stated, when the temperature of the refrigerator is not checked, it can cause food to spoil.

During a concurrent observation and interview on 6/24/20, at 1:58 p.m., with CE 2, CE 2 observed the Patient Refrigerator on 8 West Station C and reviewed the document titled, "Refrigerator/Freezer Temperature Log ...Unit: 8 West C" dated June 2020. CE 2 validated the form was incomplete, temperature checks were missing for two days during the month of June (June 6 & 12). CE 2 stated the temperature of the refrigerator should be checked daily. CE 2 stated when the temperature of the refrigerator is not checked, it can cause food to spoil.

During a review of the hospital's P&P titled, "Refrigerators in Patient Care Areas," dated 11/26/2018, indicated, "...Check refrigerator temperatures daily..."