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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 ensure the Notice of Patient Rights (a document that informs patients of their rights and responsibilities in the healthcare system such as how patients can participate in decisions about their healthcare) included the correct contact information of the regulatory agency for 30 of 30 sampled patients or patient representatives to call to make a complaint.

This deficient practice had the potential for the inability of patients or patient representatives to contact the regulatory agency to make a complaint which may result in inaccurate or delayed diagnosis, and preventable harm or injury to the patient. (Refer to A-0117)

2. The facility failed to use an interpreter (facilitates communication between healthcare providers and non?English speaking patients to provide the best possible quality of care) when obtaining informed consent (the process in which a healthcare provider educates a patient about the risks, benefits and alternatives, of a given procedure or intervention) for one of 30 sampled patients (Patient 11), in accordance with the facility's policy and procedure regarding informed consent.

This deficient practice had the potential for Patient 11 not receiving accurate and current information in the language Patient 11 could understand which may result in Patient 11 not understanding information regarding her (Patient 11) health status and treatment and may delay recovery from illness. (Refer to A-0131)

3. The facility failed to provide information about the condition of admission (COA - a contract between the hospital and patient regarding treatment, payment for services rendered by the facility, etc.) and responsibilities upon admission, including the patient's right to make informed decisions regarding their care for three of 30 sampled patients (Patient 16, Patient 15, and Patient 13, who are considered as minors [a patient younger than 18 years old except individuals from 16 to 18 years old who have been emancipated by court]) or patient representatives, in accordance with the facility's policy and procedure regarding admitting patients into the facility, when:

3.a. A documented blood transfusion informed consent provided in the patient's and patient representative's preferred language of Spanish was not completed for Patient 16.
3.b. A documented COA provided in the patient's and patient representative's preferred language of Mandarin was not completed for Patient 15.
3.c. A documented COA was not completed for Patient 13.

These deficient practices resulted in Patient 13, Patient 15, and Patient 16, including their representatives (patient representatives) not being able to fully understand and exercise their rights as patients, as well as their responsibilities regarding billing and financial responsibility during hospitalization, which could have negatively affected the patients' right to be involved in their own care and treatment in the facility. (Refer to A-0131)

4. The facility failed to ensure safety for patients at risk for fall (an unintentional event that results in the person coming to rest on the ground or another lower level), when using a highchair, for one of 30 sampled patients (Patient 23), per manufacturer's instructions regarding highchair use, when Patient 23 was left unattended in a highchair (a seat raised a far distance from the ground). This deficient practice had the potential to result in Patient 23 falling off from the highchair and sustain injury such as fracture (broken bone). (Refer to A-0144)

5. The facility failed to ensure two of five sampled emergency crash carts (carts that store emergency medical equipment and medications) were inspected and verified for readiness, according to the facility's protocol on emergency carts' maintenance and readiness. This deficient practice had the potential to delay emergency patient care during an unexpected event requiring emergency crash cart use, due to the emergency crash cart equipment not being inspected and verified for availability and proper function, which could result in patient harm and/or death. (Refer to A-0144)

6. The facility failed to ensure patient protected health information (PHI - private identifiable patient information) was safeguarded and secured against unauthorized use for two of 30 sampled patients (Patient 18 and Patient 20), when Patient 18's and Patient 20's individual identification sticker labels containing their PHI were left affixed onto a workstation on wheels (WOW - a mobile computer workstation used for clinical record documentation), accessible and visible to anyone accessing the unit hallway, including visitors and staff members.

This deficient practice had the potential for unauthorized individuals to access and misuse these patients' PHI and compromise the confidentiality that was expected for these patients as they received care in the facility. (Refer to A-0146)

7. The facility failed to ensure nursing staff initiated and developed a restraint (any method, physical or chemical, or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move or access any part of his/her body) care plan (provides a framework for evaluating and providing patient care needs related to the nursing process) upon restraints initiation, in accordance with the facility's policy and procedure regarding restraints, for three of 30 sampled patients (Patients 21, 23 and 28) when the restraint care plan was initiated:

1. on 7/27/2024, two (2) days after Patient 21 was placed on mitten (a soft, padded gloves that covers a patient's hands and fingers to prevent them from grabbing or dislodging tubes, catheters, or other medical equipment) restraints)
2. on 8/14/2024, 14 days after Patient 23 was placed in an enclosed bed (tent-like enclosure entirely covering a hospital bed. Someone on the outside of the bed must unzip one of the tent flaps before an individual can exit the bed)
3. on 8/18/2024, four (4) days after Patient 28 was placed in an enclosed bed

This deficient practice had the potential to result in unnecessary restraints use for Patients 21, 23 and 28 as there was no care plan developed for nursing staff to monitor progress and evaluate restraints use. This deficient practice also had the potential to result in complications of restraints use such as skin integrity issues, etc. (Refer to A-0166)

8. The facility failed to ensure there was a restraints (any method, physical or chemical, or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move or access any part of his/her body) renewal order from the qualified licensed practitioner (QLP, any individual permitted by state law and organization policy to order restraints and seclusion for patients), in accordance with the facility's policy and procedures regarding restraints, for two of 30 sampled patients (Patients 21 and 23), who were both placed in restraints when:

1. Patient 21 had mitten (a soft, padded gloves that covers a patient's hands and fingers to prevent them from grabbing or dislodging tubes, catheters, or other medical equipment) restraints.
2. Patient 23 was placed in an enclosed bed (tent-like enclosure entirely covering a hospital bed. Someone on the outside of the bed must unzip one of the tent flaps before an individual can exit the bed).

This deficient practice had the potential to result in unnecessary restraints use as Patients 21 and Patient 23 were not being evaluated by the providers for the need of continued use of restraints. This deficient practice also had the potential to result in complications regarding restraints use such as skin breakdown (damage to the skin), etc. (Refer to A-0168)

9. The facility failed to ensure staff performed ongoing assessment, monitoring and documentation of restraints (any method, physical or chemical, or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move or access any part of his/her body) use, every two (2) hours for 14 hours, for one of 30 sampled patients (Patient 28), in accordance with the facility's policy and procedure regarding restraints, when Patient 28 was placed in an enclosed bed (tent-like enclosure entirely covering a hospital bed. Someone on the outside of the bed must unzip one of the tent flaps before an individual can exit the bed).

This deficient practice had the potential to result in Patient 28's needs not being met and not being monitored while in the enclosed bed. (Refer to A-0175)

10. The facility failed to ensure nursing staff demonstrated satisfactory restraints (any method, physical or chemical, or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move or access any part of his/her body) application competency (ability to perform skilled learned) during onboarding in accordance with the facility's policy and procedure regarding restraints training, when one of one sampled Registered Nurse competency record (RN 8), did not have a restraints competency record.

This deficient practice had the potential to result in RN 8 not being monitored and evaluated for restraints application skills, monitoring and assessment of patients while on restraints, which may put patients at risk for harm due to improper restraints use. (Refer to A-0196)

The cumulative effect of these deficient practices resulted in the facility's inability to provide quality healthcare in a safe environment and placing patients for patient's rights violations, such as right to confidentiality, right to be informed of patient's health status, and right to be free from restraints.

Based on observation, interview, and record review, the facility failed to ensure the Notice of Patient Rights (a document that informs patients of their rights and responsibilities in the healthcare system such as how patients can participate in decisions about their healthcare) included the correct contact information of the regulatory agency for 30 of 30 sampled patients or patient representatives to call to make a complaint.

This deficient practice had the potential for the inability of patients or patient representatives to contact the regulatory agency to make a complaint which may result in inaccurate or delayed diagnosis, and preventable harm or injury to the patient.

Findings:

During a tour on 8/19/2024 at 1:17 p.m. with the Quality Coordinator (QC 2), the Patient Rights (a subset of human rights such as the right to considerate and respectful care) posting was observed in the Admitting Area (area of the hospital where patients are admitted). The Patient Rights posting indicated a telephone number to contact the regulatory agency (responsible for protecting the public's health and safety). The telephone number was dialed in the presence of QC 2. The telephone number was not working.

During a concurrent interview on 8/19/2024 at 1:17 p.m., QC 2 verified that the telephone number to the regulatory agency was incorrect and not working. QC 2 stated the facility would check and ensure to include the correct number.

During an interview on 8/19/2024 at 3:25 p.m. with the Interim Manager of the Nursing Office (IMNO), the IMNO stated that the correct telephone of the regulatory agency should be available in case patients or patient representatives wish to make a complaint.

During a review of the facility's policy and procedure titled, "Patient and Family Rights and Responsibilities," dated 2/27/2024, the P&P indicated the following: Patients have a right to ...File a complaint with the California Department of Public Health (regulatory agency) regardless of whether the hospital's grievance (a formal or informal complaint about a patient's care, treatment or mistreatment) process was used.

Based on interview and record review, the facility failed to:

1. Use an interpreter (facilitates communication between healthcare providers and non?English speaking patients to provide the best possible quality of care) when obtaining informed consent (the process in which a healthcare provider educates a patient about the risks, benefits and alternatives, of a given procedure or intervention) for one of 30 sampled patients (Patient 11), in accordance with the facility's policy and procedure regarding informed consent.

This deficient practice had the potential for Patient 11 not receiving accurate and current information in the language Patient 11 could understand which may result in Patient 11 not understanding information regarding her (Patient 11) health status and treatment and may delay recovery from illness.

2. Provide information about the condition of admission (COA - a contract between the hospital and patient regarding treatment, payment for services rendered by the facility, etc.) and responsibilities upon admission, including the patient's right to make informed decisions regarding their care for three of 30 sampled patients (Patient 16, Patient 15, and Patient 13, who are considered as minors [a patient younger than 18 years old except individuals from 16 to 18 years old who have been emancipated by court]) or patient representatives, in accordance with the facility's policy and procedure regarding admitting patients into the facility, when:

2.a. A documented blood transfusion (the process of receiving blood or blood products intravenously [through the vein]) informed consent provided in the patient's and patient representative's preferred language of Spanish was not completed for Patient 16.
2.b. A documented COA provided in the patient's and patient representative's preferred language of Mandarin was not completed for Patient 15.
2.c. A documented COA was not completed for Patient 13.

These deficient practices resulted in Patient 13, Patient 15, and Patient 16, including their representatives (patient representatives) not being able to fully understand and exercise their rights as patients, as well as their responsibilities regarding billing and financial responsibility during hospitalization, which could have negatively affected the patients' right to be involved in their own care and treatment in the facility.


Findings:

1. During a review of Patient 11's History and Physical (H&P, a formal and complete assessment of the patient and the problem), dated 8/11/2024 at 1:14 p.m., the H&P indicated the following: Patient 11 had a past medical history (PMH) of Pre-B-cell acute lymphoblastic leukemia (ALL, a fast growing blood cancer that occurs when the bone marrow [a soft, spongy tissue in the center of the bone] produces too many immature white blood cells [helps the body fight infection]). Patient had diagnosis of Pre-B-cell acute lymphoblastic leukemia, fever, and a viral infection (an illness caused by a virus, a small germ that uses a body's cells to reproduce).

During a review of Patient 11's Face Sheet, the Face Sheet indicated Patient 11 was admitted to the facility on 8/11/2024 at 12:13 p.m.

During a review of Patient 11's medical record titled, "Learning Care Needs Assessment," dated 8/11/2024 at 1:22 p.m., the medical record indicated, Patient 11's preferred language was Spanish.

During a review of Patient 11's medical record titled, "Verification of Consent for Blood Transfusion (the process of receiving blood or blood products intravenously [through the vein])," dated 8/12/2024, the medical record indicated, Patient 11's Mother signed the informed consent (the process in which a healthcare provider educates a patient about the risks, benefits and alternatives, of a given procedure or intervention) for blood transfusion on 8/12/2024 at 8:41 a.m., but there was no documentation for use of an interpreter (facilitates communication between healthcare providers and non?English speaking patients to provide the best possible quality of care) when the informed consent was obtained.

During a review of Patient 11's medical record titled, "Practitioner's Statement for Informed Consent," dated 8/12/2024 at 8:43 a.m., the medical record indicated, Patient 11's Practitioner signed that risks for the blood transfusion were discussed, but there was no documentation for use of an interpreter (facilitates communication between healthcare providers and non?English speaking patients to provide the best possible quality of care).

During a concurrent interview and record review on 8/11/2024 at 1:14 p.m. with the Manager of Patient Safety Team (MPS), Patient 11's medical records titled, " Verification of Consent for Blood Transfusion," dated 8/12/2024 and "Practitioner's Statement for Informed Consent," dated 8/12/2024, were reviewed. The medical record indicated, the Practitioner did not document using an interpreter for both medical records (Verification of Consent for Blood Transfusion and the Practitioner's Statement for Informed Consent). The MPS stated the Practitioner should have provided a Spanish interpreter for non?English speaking patients and the interpreter should have documented their name, signature, date & time on the blood consent or the name of the person who acted as the interpreter should have been documented in the patient's medical record, but this was not documented. The MPS verified the blood consent form was in English, instead of Spanish. The MPS stated the following: Consents should be obtained per policy. It is important to use an interpreter so the patient or parent/guardian can understand what they are consenting for. The consent form should also be provided in a language the patient or parent/guardian can read.

During a review of the facility's policy and procedure (P&P) titled, "Informed Consent," dated 10/4/2023, the P&P indicated the following: "Policy: I. When Informed Consent is Required: ...B. Procedures that Require Special Consents: Informed Consent will be obtained as required by law, and consistent with special legal requirements set forth in California or federal law, in situations including but not limited to: i. Blood transfusion ... III. Procedure for Obtaining and Documenting Informed Consent ... F. Interpreters: i. Patients and/ or their legal representatives must be able to understand what they are being asked to authorize, whether it is an agreement to general terms and conditions of hospitalization or to give Informed Consent for a surgical or other procedure. If there is a communication barrier [the facility] will arrange for communication in a language or mode that can be understood by the patient or surrogate decision-maker ... iii. A person providing interpretation services to assist with obtaining Informed Consent shall indicate the date and time the interpretation services were provided on the "Interpreter Certification" portion of the Verification Form for Consent to Surgery or Special Diagnostic or Therapeutic Procedures ..."

During a review of the facility's policy and procedure (P&P) titled, "Patient and Family Rights and Responsibilities," dated 2/27/2024, the P&P indicated the following: " ...Procedure: Patients have the right to: (4) Receive information about their health status, diagnosis, prognosis, course of treatment, prospects for recovery and outcomes of care (including unanticipated outcomes) in terms and in a language (including sign language for the hard of hearing) the patient can understand ..."

During a review of the facility's policy and procedure (P&P) titled, "Communication Assistance," dated 6/29/2023, the P&P indicated the following: "I. Oral Interpreting Services and/or Assistive Devices: A. All patients/ families with limited English proficiency (LEP) ...shall be advised of their right to receive healthcare information in a manner that meets the patient's needs, either directly in their primary spoken language, through a qualified interpreter ..."


2.a. During a review of Patient 16's "Face Sheet (a document containing a patient's medical and demographic information)," (undated), the "Face Sheet" indicated, Patient 16 was admitted to the facility on 8/2/2024 at 11:27 p.m., with a medical diagnosis of severe metabolic acidosis (a condition where there is too much acid in the body's fluid).

During a concurrent interview and record review on 8/20/2024 at 2:40 p.m. with the Registered Nurse Specialist (RNS), the Clinical Informatics/Kid Specialist (CKS), and the Senior Clinical Informatics (CSI), Patient 16's "Learning and Care Needs Assessment," collected from Patient 16's EHR (Electronic health Record, a digital version of paper chart), dated 8/2/2024 through 8/20/2024, was reviewed. The "Learning and Care Needs Assessment" indicated, Patient 16's preferred parents' language was Spanish. Patient 16's "Verification of Consent for Blood Transfusion (the process of receiving blood or blood products intravenously [through the vein])," dated 8/3/2024, was also reviewed. The "Verification of Consent for Blood Transfusion" document was printed in English (Patient 11's parents' preferred language was Spanish), with the name and identification number of the interpreter documented. Upon requesting a copy of the informed consent printed in Spanish within Patient 16's EHR, the RNS and the CKS stated they were unable to locate one for Patient 16. The RNS and the CKS further stated, they were not aware of an informed consent policy regarding patients being provided with informed consents in their own language.

During an interview on 8/21/2024 at 9:20 a.m. with the Registered Nurse Supervisor of the Clinical Neonatal Intensive Care Unit (RNCN), regarding the facility's process of obtaining informed consent from a non-English speaking patient, the RNCN stated, the physician usually used an iPad for translation services and nurses would witness the encounter. The RNCN was unsure if two consents were signed in English and in the patient's preferred language (Spanish). The RNCN stated, they have seen consent forms printed in other languages, including Spanish. The RNCN further stated, patients needed to understand what they were signing, and nurses needed to be re-educated regarding this facility policy.

During a concurrent interview and record review on 8/21/2024 at 10:37 a.m. with the Chief Patient Safety Officer/Attending Critical Care Medical Doctor (CPSO), Patient 16's Spanish-printed "Verification of Consent for Blood Transfusion," was requested for review. The CPSO reviewed Patient 16's EHR and stated they were unable to locate a documented Spanish-printed blood transfusion informed consent for Patient 16. Regarding the process of obtaining informed consent from a non-English speaking patient, the CPSO stated, they were expected to request an interpreter (ensure that patients and medical staff can communicate clearly and accurately, which is vital for patient safety), explain the procedure and treatment to the patient through the applicable interpreter, have the nurse witness the encounter, and the informed consent form would be printed in the patient's preferred language. The CPSO further stated, if the form was not in the patient's preferred language, then the culture department would be contacted for assistance.

During a review of the facility's policy and procedure (P&P) titled, "Informed Consent," revised October 2023, the P&P indicated, "Patients and/or their legal representatives must be able to understand what they are being asked to authorize, whether it is an agreement to general terms and conditions of hospitalization or to give Informed Consent for Surgical or other procedure. If a non-English version of the Verification Form for Consent to Surgery or Special Diagnostic or Therapeutic Procedure is used to obtain Informed Consent, the Treating Practitioner or Authorized Designee must ensure that the name of the treatment or procedure to be performed is written in English as well as the language that the patient/legal representative speaks.

During a review of the facility's policy and procedure (P&P) titled, "Patient and Family Rights and Responsibilities," revised in February 2024, the P&P indicated, "Patient rights should be promoted and protected by all hospital and medical staff. [ ...] For families who do not read or understand English or Spanish or who are deaf or hard of hearing an interpreter speaking the language they understand should be procured in compliance with Hospital policies and procedures."

2.b. During a review of Patient 15's "Face Sheet (a document containing a patient's medical and demographic information)," (undated), the "Face Sheet" indicated, Patient 15 was admitted to the facility on 7/9/2024 at 5:25 p.m., with a medical diagnosis of congenital diaphragmatic hernia (a hole in the diaphragm [muscle that separates chest from stomach] that allows stomach organs to move into the chest during fetal [unborn baby] development, which can crowd the heart and lungs). Patient 15's "Face Sheet" further indicated, Patient 15's parent's preferred language was Mandarin.

During a concurrent interview and record review on 8/20/2024 at 3:14 p.m. with the Registered Nurse Specialist (RNS), the Clinical Informatics/Kid Specialist (CKS), and the Clinical Senior Informatics (CSI), Patient 15's electronic health record (EHR - a digital version of paper chart), dated 7/9/2024 through 8/20/2024, was reviewed. The EHR indicated, Patient 15's family's preferred language was Mandarin. The CKS stated, admitting staff used a system to document a patient's language and initiate their admission document process. Patient 15's Condition of Admission (COA, a contract between the hospital and patient regarding treatment, payment for services rendered by the facility, etc.) documentation was signed on 7/11/2024 at 11:32 a.m. in English, with no interpreter (ensure that patients and medical staff can communicate clearly and accurately, which is vital for patient safety) use documented. The CKS further stated, no documentation was available to indicate an interpreter assisted Patient 15's family to complete their COA documentation for Patient 15.

During a concurrent interview and record review on 8/21/2024 at 9:06 a.m. with Supervisor Patient Access Revenue 1 (SPA 1) and the Supervisor Patient Access Revenue 2 (SPA 2), SPA 2 stated, when a patient's preferred language was different from English, a translator was provided, and documents were presented in the respective patient's language and copies were provided upon request. SPA 2 was requested to show the COA documentation that was provided in Mandarin for Patient 15, as well as the translator documentation for Patient 15's COA completion. Documentation of Patient 15 being provided with COA documentation written in Mandarin, or the use of any translator being provided for Patient 15 was not found. SPA 2 stated, it was important for translators to be used for patients to understand what they were signing, and it was part of their rights, and it was part of the standard procedure to at least enter a note explaining a deviation from this process.

During an interview on 8/23/2024 at 8:45 a.m. with SPA 1 and the Admitting Representative II (AR II), AR II stated, they were able to speak Spanish and English, but AR II did not speak Mandarin. AR II stated, once a patient stated their preferred language, a translator was called and used to translate for the respective patient. AR II stated, Patient 15 would have qualified for translation services, but she (AR II) did not provide translation for Patient 15. SPA 1 stated, the facility must do their part in providing translation assistance for the patients and documenting it.

During a review of the facility's policy and procedure (P&P) titled, "Patient and Family Rights and Responsibilities," revised in February 2024, the P&P indicated, "Patient rights should be promoted and protected by all hospital and medical staff. [ ...] For families who do not read or understand English or Spanish or who are deaf or hard of hearing an interpreter speaking the language they understand should be procured in compliance with Hospital policies and procedures."

During a review of the facility's policy and procedure (P&P) titled, "Communication Assistance," revised in June 2023, the P&P indicated, "In situations when a vital document is not available in a non-English language, the content and intent of such document will be explained to the Limited English Proficiency (LEP) patient and family member by the health care team member involved in the encounter, in the presence of an interpreter. The interpreted encounter will then be documented in the patient's medical record."

During a review of the facility's policy and procedure (P&P) titled, "Admission Process: Forms Requiring Signature in Admitting," effective May 2021, the P&P indicated, "It is the responsibility of the Admitting Department to obtain the required parent signature at pre-admission, admission or as soon as possible thereafter. The parent or guardian should be asked to sign the following documents. Condition of admission: Required under California law establishes the conditions under which a patient is admitted for in-patient services. The primary function is to document the patient's consent to hospital and routine services and also to document financial responsibility for payment of hospital charges for services rendered."

2.c. During a review of Patient 13's electronic health record (EHR - a digital version of paper chart), dated 7/14/2024 through 8/20/2024, the EHR indicated, Patient 13 presented to the facility as a direct admit on 7/14/2024 at 1:22 a.m., with a diagnosis of acute respiratory failure (a condition that occurs when the lungs are unable to get enough oxygen into the blood).

During a concurrent interview and record review on 8/20/2024 at 4:05 p.m. with the Registered Nurse Specialist (RNS), the Clinical Informatics/Kid Specialist (CKS), and the Clinical Senior Informatics (CSI), Patient 13's EHR, dated 7/14/2024 through 8/20/2024, was reviewed for Condition of Admission (COA, the process in which a healthcare provider educates a patient about the risks, benefits and alternatives, of a given procedure or intervention) documentation. The COA documentation was not found for Patient 13. The RNS and CSI stated, every patient or patient's family/representative was supposed to have a COA completed and signed, and they were unable to determine the reason for the COA not being available in Patient 13's clinical record.

During a concurrent interview and record review on 8/21/2024 at 8:35 a.m. with Supervisor Patient Access Revenue 1 (SPA 1) and the Supervisor Patient Access Revenue 2 (SPA 2), SPA 2 stated, a COA was required for every single patient that was admitted to the facility. SPA 2 stated, if the COA was missing, it would only be due to the patient being a direct transfer, then the facility would have to follow-up and make attempts to get the patient's COA signed and documented. Patient 13's COA was requested, but SPA 2 and SPA 1 stated Patient 13 did not have a completed COA on file, and two different attempts were made on 7/14/2024 and 7/15/2024 to obtain a signed COA document for Patient 13, but no other follow-ups were provided to Patient 13's parents beyond 7/15/2024. SPA 1 and SPA 2 further stated, their process was to follow-up with the patient and their representatives daily to complete the outstanding COA, and allowing a month to pass without getting the COA signed was not acceptable and it was missed.

During a review of the facility's policy and procedure (P&P) titled, "Admission Process: Forms Requiring Signature in Admitting," effective May 2021, the P&P indicated, "It is the responsibility of the Admitting Department to obtain the required parent signature at pre-admission, admission or as soon as possible thereafter. The parent or guardian should be asked to sign the following documents. Condition of admission: Required under California law establishes the conditions under which a patient is admitted for in-patient services. The primary function is to document the patient's consent to hospital and routine services and also to document financial responsibility for payment of hospital charges for services rendered."

Based on observation, interview and record review, the facility failed to:

1. Ensure safety for patients at risk for fall (an unintentional event that results in the person coming to rest on the ground or another lower level), when using a highchair, for one of 30 sampled patients (Patient 23), per manufacturer's instructions regarding highchair use, , when Patient 23 was left unattended in a highchair (a seat raised a far distance from the ground). This deficient practice had the potential to result in Patient 23 falling off from the highchair and sustain injury such as fracture (broken bone).

2. Ensure two of five sampled emergency crash carts (carts that store emergency medical equipment and medications) were inspected and verified for readiness, according to the facility's protocol on emergency carts' maintenance and readiness. This deficient practice had the potential to delay emergency patient care during an unexpected event requiring emergency crash cart use, due to the emergency crash cart equipment not being inspected and verified for availability and proper function, which could result in patient harm and/or death.

Findings:

1. During a review of Patient 23's "History and Physical (H&P, a formal and complete assessment of the patient and the problem)," dated 8/1/2024, the H&P indicated, Patient 23 was tracheostomy (a surgically created hole through the front of the neck and into the windpipe [trachea]) dependent requiring oxygen.

During a review of Patient 23's "Face Sheet (face sheet, document provides patient's demographic data including name, date of birth, emergency contact, admitting diagnosis and health insurance)," dated 8/20/2024, the face sheet indicated, Patient 23 was admitted to the facility with diagnosis of increased tracheal (surgically created hole through the front of the neck and into the windpipe [trachea]) secretions (fluid produced from the throat).

During a concurrent observation and interview on 8/20/2024 at 12:21 p.m. with the Clinical Supervisor (CS 3) of Medical Unit, at the doorway of Patient 23's room, Patient 23 was observed sitting in a gray color highchair (a seat raised a far distance from the ground alone, with no one in the room for supervision. CS 3 stated nursing staff made rounds to check on Patient 23.

During an interview on 8/21/2024 at 11 a.m. with the Registered Nurse (RN) 6, RN 6 stated nursing staff should be with the patient (Patient 23) at all times when placing the patient (Patient 23) in a highchair. RN 6 stated someone should be in the room while patient (Patient 23) was in the highchair to supervise patient (Patient 23) for safety because patient (Patient 23) could fall off from the highchair.

During a concurrent interview and record review on 8/21/2024 at 11:10 a.m. with RN 6, Patient 23's "Fall Risk Assessment (assessment performed by nursing staff to assess patient's risk for falling)," dated 8/14/2024, was reviewed. The fall risk assessment indicated Patient 23's fall risk score of 14. RN 6 stated fall risk score at 12 or above would indicate Patient 23 at risk for fall. RN 6 stated putting Patient 23 in highchair would place patient 23 at risk for fall, therefore close observation was needed.

During a concurrent interview and record review on 8/21/2024 at 2:22 p.m. with the Quality Coordinator (QC 1), the facility's highchair manufacturer's instruction titled, "The Classic Highchair Usage Instructions," dated 4/2017, was reviewed. The "Classic Highchair Usage Instructions" indicated, "Warning: Never leave child unattended." QC 1 stated nursing staff should follow manufacturer's instruction when using the highchair.

During a review of the facility's policy and procedure (P&P) titled, "Patient Falls Prevention," dated 6/2024, the P&P indicated, "To reduce the likelihood and severity of patient injury related to falls through the means of identifying those at risk, classifying the level of risk, and initiating falls prevention interventions... High Risk Standard Protocol (score 12 and above)... v. assess need for 1:1 supervision."

2.a. During a current observation and record review on 8/19/2024 at 2:44 p.m., in the Pediatric Intensive Care Unit (a specialized unit of the hospital where the very sickest pediatric [infants, children, and adolescents] patients are admitted), three emergency crash carts (carts that store emergency medical equipment and medications) were observed on the unit. Emergency Crash Cart # 52's log titled, "Emergency Cart/Defibrillator (a device that delivers an electric shock to the heart to restore a normal rhythm) - Daily Shift and Weekly Shock Test," dated 8/20241, did not have an initial of the individual inspecting the cart on 8/18/2024 during the PM (afternoon) shift.

During a concurrent interview and record review on 8/19/2024 at 3 p.m. with the Director of the Emergency Department (DED), the DED reviewed the emergency crash cart log titled, "Emergency Cart/Defibrillator - Daily Shift and Weekly Shock Test," dated 8/2024 for Emergency Crash Cart # 52. The DED verified there was no documentation that the emergency crash cart was inspected for emergency medical supplies, medications, and for functioning equipment on 8/18/2024 during the PM shift. The DED stated that nursing staff should write their initials on the log after the cart has been inspected to indicate that inspection was done. The DED stated that the cart should be checked every shift to ensure all emergency supplies are available and equipment are functioning, in the event of a medical emergency.

During a review of the facility's policy and procedure (P&P) titled, "Emergency Cart Maintenance," revised September 2023, the P&P indicated, "To ensure that appropriate emergency cart contents and equipment are available and functioning properly...
2.b. During a concurrent observation, interview, and record review on 8/20/2024 at 10:48 a.m. with the Manager of Clinical Perioperative Services (MCP) on the second floor Post Anesthesia Care Unit (PACU, a recovery room where patients are monitored after procedures that require anesthesia or sedation [medications that cause sleep]), two emergency crash carts (carts that store emergency medical equipment and medications) were observed, and the PACU's "Emergency Cart/Defibrillator (a device that delivers an electric shock to the heart to restore a normal rhythm) -Daily Shift and Weekly Code Readiness Test" log documents, dated July 2024, were reviewed. The "Emergency Cart/Defibrillator-Daily Shift and Weekly Code Readiness Test" log document included checking the following on the emergency crash cart: locks, medication expiration dates, oxygen tank availability, supplies and defibrillator plugged into power source, peds pads (pediatric electrode pads that help deliver a lifesaving shock) plugged/ready for use, battery life and heart monitor paper in-place.

During a continued concurrent observation, interview, and record review on 8/20/2024 at 10:48 a.m. with the MCP on the second floor PACU, one emergency crash cart for the month of July 2024 had a missed inspection and verification sign-off for 7/30/2024. The MCP stated, emergency crash carts were checked daily to verify everything was working properly, in case of emergency and for patient safety. The MCP further stated, the "Emergency Cart/Defibrillator-Daily Shift and Weekly Code Readiness Test" log should be completed and signed daily for all the emergency crash carts, and the facility will need to figure out which assigned Registered Nurse did not complete this daily inspection.

During a review of the facility's policy and procedure (P&P) titled, "Emergency Cart Maintenance," revised September 2023, the P&P indicated, "To ensure that appropriate emergency cart contents and equipment are available and functioning properly... Emergency carts will be locked. The integrity of the lock is checked every shift by a licensed provider in units that are open 24hrs and daily in other areas. This check is documented on the Emergency Crash/Cart/Defibrillator Check Sign-off sheet or Emergency Crash Cart/AED Check Sign-off sheet."

Based on observation, interview, and record review, the facility failed to ensure patient protected health information (PHI - private identifiable patient information) was safeguarded and secured against unauthorized use for two of 30 sampled patients (Patient 18 and Patient 20), when Patient 18's and Patient 20's individual identification sticker labels containing their PHI were left affixed onto a workstation on wheels (WOW - a mobile computer workstation used for clinical record documentation), accessible and visible to anyone accessing the unit hallway, including visitors and staff members.

This deficient practice had the potential for unauthorized individuals to access and misuse these patients' PHI and compromise the confidentiality that was expected for these patients as they received care in the facility.

Findings:

During a review of Patient 18's "Face Sheet (a document containing a patient's medical and demographic information)," (undated), the "Face Sheet" indicated, Patient 18 was admitted to the facility on 8/20/2024 at 9:23 a.m., with a medical diagnosis of congenital nevus of back (a mole/birthmark).

During a review of Patient 20's "Face Sheet," (undated), the "Face Sheet" indicated, Patient 20 was admitted to the facility on 8/20/2024 at 8:42 a.m., with a medical diagnosis of sleep apnea (disorder that causes breathing to stop or get shallow during sleep).

During an observation on 8/20/2024 at 12:03 p.m. on the seventh-level Ambulatory Surgery Unit (where patients undergoing surgery have the ability to leave the hospital on the same day of the surgery without being admitted), a Workstation on Wheels (WOW, a mobile computer workstation used for clinical record documentation) was stationed in the hallway with two patient identification sticker labels, identifying Patient 18 and Patient 20, affixed to the WOW, along the table-top surface underneath the computer monitor, visible within plain sight. The sticker labels for Patient 18 and Patient 20 contained the following PHI for each patient: patient name, date of birth, medical record number (MRN), and admission date.

During a concurrent observation and interview on 8/20/2024 at 12:03 p.m. with the Associate Director of Perioperative Services (ADP) and the Vice President of Perioperative Services Executive (VPPSE) on the seventh-level Ambulatory Surgery Unit, the ADP stated, when discarding medication labels, shredders were provided, and nurses were expected to log-off their WOW when away from their WOW. The ADP observed the two identification sticker labels affixed to the WOW in the hallway, identifying Patient 18 and Patient 20, and stated nursing was expected to discard patient PHI (Protected Health Information, private identifiable patient information) in the shredder, including the identification sticker labels that were observed, and the identification sticker labels should not have been attached to the WOW as observed.

During a review of the facility's policy and procedure (P&P) titled, "Safeguarding Protected Health Information," revised June 2023, the P&P indicated, "[Abbreviated Name of Facility] Team Members are responsible for safeguarding the privacy, confidentiality, and security of PHI. The safeguards that shall be implemented by [Abbreviated Name of Facility] Team Members when handling paper and other tangible PHI includes but are not limited to: Placing unused or discard PHI in confidential shred bin."

Based on observation, interview and record review, the facility failed to ensure nursing staff initiated and developed a restraint (any method, physical or chemical, or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move or access any part of his/her body) care plan (provides a framework for evaluating and providing patient care needs related to the nursing process) upon restraints initiation, in accordance with the facility's policy and procedure regarding restraints, for three of 30 sampled patients (Patient 21, 23 and 28) when the restraint care plan was initiated:

1. on 7/27/2024, two (2) days after Patient 21 was placed on mitten (a soft, padded gloves that covers a patient's hands and fingers to prevent them from grabbing or dislodging tubes, catheters, or other medical equipment) restraints)
2. on 8/14/2024, 14 days after Patient 23 was placed in an enclosed bed (tent-like enclosure entirely covering a hospital bed. Someone on the outside of the bed must unzip one of the tent flaps before an individual can exit the bed)
3. on 8/18/2024, four (4) days after Patient 28 was placed in an enclosed bed

This deficient practice had the potential to result in unnecessary restraints use for Patients 21, 23 and 28 as there was no care plan developed for nursing staff to monitor progress and evaluate restraints use. This deficient practice also had the potential to result in complications of restraints use such as skin integrity issues (a break in the skin), etc.

Findings:

1. During a review of Patient 21's "Face Sheet (face sheet, document provides patient's demographic data including name, date of birth, emergency contact, admitting diagnosis and health insurance)," dated 8/20/2024, the face sheet indicated, Patient 21 was admitted to the facility with diagnoses of sepsis (a body's overwhelming and life-threatening response to infection) and hyperkalemia (high potassium level in blood).

During a review of Patient 21's "History and Physical (H&P, a formal and complete assessment of the patient and the problem)," dated 7/27/2024, the H&P indicated Patient 21 had gastrostomy (surgical opening from stomach to allow access for food fluids and medications) and ileostomy (a surgical procedure in which a part of the small bowel is brought through the abdominal wall via a surgical-created opening called a stoma to evacuate stool from body).

During an observation on 8/20/2024 at 12:38 p.m. with the Nurse Manager (NM 5) of Medical Unit (an inpatient unit that provides medical and nursing care to patients with a variety of conditions) at Patient 21's room, Patient 21 had mitten (a soft, padded gloves that covers a patient's hands and fingers to prevent them from grabbing or dislodging tubes, catheters, or other medical equipment) restraint on his (Patient 21) left hand. NM 5 stated Patient 21 needed the mitten restraints to prevent him (Patient 21) from pulling lines and tubes.

During a review of Patient 21's "physician restraints non-violent order (physician order for restraint use)," dated 7/27/2024, the restraint order indicated, Patient 21 was placed on two-point soft mitten restraints due to pulling at tubes or lines.

During a concurrent interview and record review on 8/20/2024 at 3:24 a.m. with the Registered Nurse (RN) 5, Patient 21's "care plan (provides a framework for evaluating and providing patient care needs related to the nursing process)," dated from 7/27/2024 to 7/29/2024, was reviewed. The care plan indicated restraints care plan was initiated on 7/29/2024. RN stated the care plan for restraints was initiated two (2) days after the initiation of mitten restraints (7/27/2024). RN 5 stated care plan should be initiated upon restraints application. RN 5 stated care plan was needed to monitor Patient 21 for continual need for restraints and evaluate the earliest time for restraints removal.

During a review of the facility's policy and procedure (P&P) titled, "Restraint Policy," dated 1/2024, the P&P indicated, "Plan of care. Upon initiation of restraints, plan of care should be initiated. Plan of care should be reviewed and modified to reflect current interventions during the shift in which the changes occurred."

2. During a review of Patient 23's "History and Physical (H&P, a formal and complete assessment of the patient and the problem)," dated 8/1/2024, the H&P indicated, Patient 23 was tracheostomy (a surgically created hole through the front of the neck and into the windpipe [trachea]) dependent requiring oxygen.

During a review of Patient 23's "Face Sheet (face sheet, document provides patient's demographic data including name, date of birth, emergency contact, admitting diagnosis and health insurance)," dated 8/20/2024, the face sheet indicated, Patient 23 was admitted to the facility with diagnosis of increased tracheal (surgically created hole through the front of the neck and into the windpipe [trachea]) secretions (Fluids produced from the throat) .

During a review of Patient 23's "physician restraints (any method, physical or chemical, or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move or access any part of his/her body) non-violent order (physician order for restraint use)," dated 8/1/2024, the restraint order indicated, "Enclosed bed (tent-like enclosure entirely covering a hospital bed. Someone on the outside of the bed must unzip one of the tent flaps before an individual can exit the bed) due to cognitively (pertains to thinking, learning, remembering, or problem-solving ability) unable to follow direction."

During a concurrent interview and record review on 8/21/2024 at 10:50 a.m. with the Registered Nurse (RN) 6, Patient 23's "care plan," dated from 8/1/2024 to 8/14/2024 was reviewed. The care plan indicated restraints care plan was initiated on 8/14/2024. RN 6 stated the restraints care plan was initiated two (2) weeks after the initial restraints were ordered and applied (8/1/2024). RN 6 stated care plan should be developed when restraint was first applied for Patient 23. RN 6 stated care plan was needed to provide nursing interventions to guide staff what to do on a daily basis to monitor and evaluate outcome while Patient 23 was on restraints.

During a review of the facility's policy and procedure (P&P) titled, "Restraint Policy," dated 1/2024, the P&P indicated, "Plan of care. Upon initiation of restraints, plan of care should be initiated. Plan of care should be reviewed and modified to reflect current interventions during the shift in which the changes occurred."

3. During a review of Patient 28's "History and Physical (H&P, a formal and complete assessment of the patient and the problem)," dated 8/14/2024, the H&P indicated, Patient 28 was admitted to the facility with diagnoses including but not limited to global developmental delay (a delay in multiple developmental areas such as speech, motor [movement of the body], etc.), gastrojejunostomy tube (GJ-tube, a tube that is surgically inserted into the stomach and intestine to allow access for food, fluids and medications) feeding intolerance (difficulty to digest enteral feedings [a method of providing nutrition directly into the gastrointestinal tract]) and increased seizure (sudden surge of electrical activity in the brain when a person experiences abnormal behavior, symptoms, and sensations, sometimes including loss of consciousness) activities.

During an observation on 8/20/2024 at 11:24 a.m. in Patient 28's room, there was an enclosed bed (tent-like enclosure entirely covering a hospital bed. Someone on the outside of the bed must unzip one of the tent flaps before an individual can exit the bed) placed.

During a review of Patient 28's "physician restraints (any method, physical or chemical, or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move or access any part of his/her body) non-violent order (physician order for restraint use)," dated 8/14/2024, the restraint order indicated, "Enclosed bed due to cognitively (pertains to thinking, learning, remembering, or problem-solving ability) unable to follow direction."

During a concurrent interview and record review on 8/21/2024 at 3:25 p.m. with the Registered Nurse (RN) 6, Patient 28's "care plan," dated from 8/14/2024 to 8/18/2024, was reviewed. The care plan indicated restraints care plan was initiated on 8/18/20024. RN 6 stated the restraints care plan was initiated four (4) days after restraints application (8/14/2024). RN 6 stated restraints care plan should be initiated when restraints are started. RN 6 stated care plan was needed to monitor and evaluate Patient 28's progress and need for restraints.

During a review of the facility's policy and procedure (P&P) titled, "Restraint Policy," dated 1/2024, the P&P indicated, "Plan of care. Upon initiation of restraints, plan of care should be initiated. Plan of care should be reviewed and modified to reflect current interventions during the shift in which the changes occurred."

Based on observation, interview and record review, the facility failed to ensure there was a restraints (any method, physical or chemical, or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move or access any part of his/her body) renewal order from the qualified licensed practitioner (QLP, any individual permitted by state law and organization policy to order restraints and seclusion for patients), in accordance with the facility's policy and procedures regarding restraints for two of 30 sampled patients (Patients 21 and 23), who were both placed in restraints when:

1. Patient 21 had mitten (a soft, padded gloves that covers a patient's hands and fingers to prevent them from grabbing or dislodging tubes, catheters, or other medical equipment) restraints
2. Patient 23 was placed in an enclosed bed (tent-like enclosure entirely covering a hospital bed. Someone on the outside of the bed must unzip one of the tent flaps before an individual can exit the bed)

This deficient practice had the potential to result in unnecessary restraints use as Patients 21 and Patient 23 were not being evaluated by the providers for the need of continued use of restraints. This deficient practice also had the potential to result in complications regarding restraints use such as skin breakdown (damage to the skin), etc.

Findings:

1. During a review of Patient 21's "Face Sheet (face sheet, document provides patient's demographic data including name, date of birth, emergency contact, admitting diagnosis and health insurance)," dated 8/20/2024, the face sheet indicated, Patient 21 was admitted to the facility with diagnoses of sepsis (a body's overwhelming and life-threatening response to infection) and hyperkalemia (high potassium level in blood).

During a review of Patient 21's "History and Physical (H&P, a formal and complete assessment of the patient and the problem)," dated 7/27/2024, the H&P indicated Patient 21 had gastrostomy (surgical opening from stomach to allow access for food fluids and medications) and ileostomy (a surgical procedure in which a part of the small bowel is brought through the abdominal wall via a surgical-created opening called a stoma to evacuate stool from body).

During an observation on 8/20/2024 at 12:38 p.m. with the Nurse Manager of the medical unit (an inpatient unit that provides medical and nursing care to patients with a variety of conditions) (NM 5), at Patient 21's room, Patient 21 had mitten (a soft, padded gloves that covers a patient's hands and fingers to prevent them from grabbing or dislodging tubes, catheters, or other medical equipment) restraint on his (Patient 21) left hand. NM 5 stated Patient 21 needed the mitten restraints to prevent him (Patient 21) from pulling lines and tubes.

During a concurrent interview and record review of 8/20/2024 at 3:30 p.m. with the Quality Coordinator (QC 1), Patient 21's "physician restraints (any method, physical or chemical, or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move or access any part of his/her body) non-violent order (physician order for restraint use)," dated from 7/27/2024 to 8/3/2024, was reviewed. The physician restraints non-violent order indicated, "two-point soft mittens due to cognitively (pertains to thinking, learning, remembering, or problem-solving ability) unable to follow directions and pulling at tubes or lines, with missing restraint renewal order on 8/1/2024. QC 1 stated physician restraints renewal order was needed every calendar day per facility's policy and procedure. QC 1 stated nursing staff should not apply restraints without a physician order.

During a review of the facility's policy and procedure (P&P) titled, "Restraint Policy," dated 1/2024, the P&P indicated, "An order written by a qualified licensed practitioner (QLP, any individual permitted by state law and organization policy to order restraints and seclusion for patients) is required for use of restraints. The order must include the following components: type of restraints, clinical rationale, date of order, start and end time ... order renewal ... non-violent: once every calendar day."

2. During a review of Patient 23's "History and Physical (H&P, a formal and complete assessment of the patient and the problem)," dated 8/1/2024, the H&P indicated, Patient 23 was tracheostomy (a surgically created hole through the front of the neck and into the windpipe [trachea]) dependent requiring oxygen.

During a review of Patient 23's "Face Sheet (face sheet, document provides patient's demographic data including name, date of birth, emergency contact, admitting diagnosis and health insurance)," dated 8/20/2024, the face sheet indicated, Patient 23 was admitted to the facility with diagnosis of increased tracheal (surgically created hole through the front of the neck and into the windpipe [trachea]) secretions (fluids produced in the throat).

During a concurrent interview and record review of 8/21/2024 at 10:40 a.m. with the Quality Coordinator (QC 1), Patient 23's "physician restraints (any method, physical or chemical, or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move or access any part of his/her body) non-violent order (physician order for restraint use)," dated from 8/1/2024 to 8/20/2024, was reviewed. The physician restraints non-violent order indicated, "enclosed bed due to cognitively (pertains to thinking, learning, remembering, or problem-solving ability) unable to follow directions" with missing restraint renewal orders on 8/8/2024, 8/9/2024, 8/10/2024, 8/13/2024, 8/17/2024 and 8/18/2024 (days in which Patient 23 remained in an enclosed bed without physician restraints renewal order). QC 1 stated there were six (6) days without physician renewal orders and physician restraints renewal order was required every calendar day per facility's policy.

During a concurrent interview and record review on 8/21/2024 at 10:45 a.m. with the Registered Nurse (RN) 6, Patient 23's "restraints flowsheet (nursing document for restraint assessment and monitoring)," dated from 8/1/2024 to 8/20/2024 was reviewed. The restraints flowsheet indicated enclosed bed was used for Patient 23 on 8/8/2024, 8/9/2024, 8/10/2024, 8/13/2024, 8/17/2024 and 8/18/2024. RN 6 stated physician order was required for use of enclosed bed on the above days.

During a review of the facility's policy and procedure (P&P) titled, "Restraint Policy," dated 1/2024, the P&P indicated, "An order written by a qualified licensed practitioner (QLP, any individual permitted by state law and organization policy to order restraints and seclusion for patients) is required for use of restraints. The order must include the following components: type of restraints, clinical rationale, date of order, start and end time ... order renewal ... non-violent: once every calendar day."

Based on observation, interview and record review, the facility failed to ensure staff performed ongoing assessment, monitoring and documentation of restraints (any method, physical or chemical, or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move or access any part of his/her body) use, every two (2) hours for 14 hours, for one of 30 sampled patients (Patient 28), in accordance with the facility's policy and procedure regarding restraints, when Patient 28 was placed in an enclosed bed (tent-like enclosure entirely covering a hospital bed. Someone on the outside of the bed must unzip one of the tent flaps before an individual can exit the bed).

This deficient practice had the potential to result in Patient 28's needs not being met and not being monitored while in the enclosed bed.

Findings:

During a review of Patient 28's "History and Physical (H&P, a formal and complete assessment of the patient and the problem)," dated 8/14/2024, the H&P indicated, Patient 28 was admitted to the facility with diagnoses including but not limited to global developmental delay (a delay in multiple developmental areas such as speech, motor [movement of the body], etc.), gastrojejunostomy tube (GJ-tube, a tube that is surgically inserted into the stomach and intestine to allow access for food, fluids and medications) feeding intolerance (difficulty to digest enteral feedings [a method of providing nutrition directly into the gastrointestinal tract]) and increased seizure (sudden surge of electrical activity in the brain when a person experiences abnormal behavior, symptoms, and sensations, sometimes including loss of consciousness) activities.

During an observation on 8/20/2024 at 11:24 a.m. in Patient 28's room, there was an enclosed bed (tent-like enclosure entirely covering a hospital bed. Someone on the outside of the bed must unzip one of the tent flaps before an individual can exit the bed) placed.

During a review of Patient 28's "physician restraints (any method, physical or chemical, or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move or access any part of his/her body) non-violent order," dated 8/14/2024, the restraint order indicated, "Enclosed bed due to cognitively (pertains to thinking, learning, remembering, or problem-solving ability) unable to follow direction."

During a concurrent interview and record review on 8/21/2024 at 3:14 p.m. with the quality coordinator (QC1), Patient 28's "restraints flowsheet (nursing document for restraint assessment and monitoring)," dated 8/17/2024, was reviewed. The restraints flowsheet indicated there was no documentation of assessment and monitoring every 2 hours from 8/17/2024 at 5 a.m. to 8/17/2024 at 7 p.m. (14 hours). QC 1 stated nursing staff was required to document restraints assessment every two (2) hours while Patient 28 was in the enclosed bed.

During an interview on 8/21/2024 at 3:20 p.m. with the Registered Nurse (RN) 6, RN 6 stated nursing assessment was required every two (2) hours while patients are on restraints to assess patients for skin and circulation, and check patient for needs for hydration and toileting to make sure patient's needs are met. RN 6 stated nursing staff needs to monitor patients every two (2) hours to ensure patient's safety while on restraints.

During a review of the facility's policy and procedure (P&P) titled, "Restraints Policy," dated 1/2024, the P&P indicated, "nursing assessment documentation for non-violent restraints: the following must be monitored every two (2) hours by RN: circulation and extremity description, mental status, rational for continued restraint, criteria for release met, type of restraint and location, hydration/nutrition needs, toileting needs, skin assessment, range of motion, restraint safety. All assessment and monitoring must be documented in patient's electronic medical record (EMR, digital version of paper chart)."

Based on interview and record review, the facility failed to ensure nursing staff demonstrated satisfactory restraints (any method, physical or chemical, or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move or access any part of his/her body) application competency (ability to perform skilled learned) during onboarding in accordance with the facility's policy and procedure regarding restraints training, when one of one sampled Registered Nurse competency record (RN 8), did not have a restraints competency record.

This deficient practice had the potential to result in RN 8 not being monitored and evaluated for restraints application skills, monitoring and assessment of patients while on restraints, which may put patients at risk for harm due to improper restraints use.

Findings:

During a concurrent interview and record review on 8/22/2024 at 2:32 p.m. with the Nurse Manager (NM 3) of the Medical Unit (an inpatient unit that provides medical and nursing care to patients with a variety of conditions), the Registered Nurse (RN) 8's personnel file record, undated, was reviewed. The personnel file record indicated restraints use patient care service online training was completed on 8/13/2024. NM 3 stated the restraints use patient care service was an online class which served as refresher course for restraints training. NM 3 stated there should be a hands-on restraints competency (demonstration in the use of restraints) completed to validate that RN 8 could demonstrate proper restraints use. NM 3 stated it was important for nursing staff to know how to apply restraints properly to ensure patient and staff safety. NM 3 stated she (NM 3) did not have RN 8's restraints competency record.

During an interview on 8/23/2024 at 9:56 a.m. with Quality Coordinator (QC 2), QC 2 stated RN 8 was hired on 9/4/2012 and the facility could not provide record that RN 8 had completed restraints competency.

During a review of the facility's policy and procedure (P&P) titled, "Restraint Policy," dated 1/2024, the P&P indicated, "Provide guidelines for safe and effective management of patients who required the use of violent or non-violent restraints, while preserving the dignity, safety, and rights of each individual ... training: direct patient care staff must have a working knowledge of the hospital policy regarding the use of restraints. Staff must be trained and able to demonstrate competency in the application of restraints, monitoring, assessment, and providing care for a patient in restraints before performing any of these above actions, as part of the orientation period ... training must be documented in the staff personnel records or via electronic learning module that the training and documentation of competency were successful completed."

Based on interview and record review, the facility failed to ensure a care plan (provides a framework for evaluating and providing patient care) was developed and implemented per policy and procedure for two of 30 sampled patients (Patient 10, and 4), to include the current care and interventions when:

1. Patient 10, who was admitted for hypoxemia (condition that occurs when there is not enough oxygen in the blood, which can lead to a lack of oxygen to tissues and organs) with continuous positive airway pressure (CPAP, a machine that uses mild air pressure to keep the airways open while a person sleeps) respiratory support, did not have a care plan implemented within 24 hours of admission, to address respiratory issues. This deficient practice had the potential for Patient 10's respiratory needs and risks to remain unidentified and unaddressed which may result in Patient 10's respiratory status to decline, leading to respiratory distress (a serious lung condition that causes low blood oxygen).

2. Patient 4, who was admitted for pulmonary hypertension crisis (a life-threatening emergency that occurs when there is a sudden, rapid increase in lung pressure, and can lead to temporary decrease in lung blood flow and airway obstruction) and respiratory failure (inadequate gas exchange in the respiratory system), did not have a care plan relating to Patient 4's respiratory problems, initiated in a timely manner within 24 hours of admission. This deficient practice had the potential for Patient 4's respiratory needs and risks to remain unidentified and unaddressed which may result in a decline of Patient 4's respiratory status.

Findings:

1. During a concurrent interview and record review on 8/21/2024 at 2:09 p.m. with the Manager of Patient Safety Team (MPS), the MPS verified the following information in Patient 10's medical record: Patient 10's Face Sheet indicated Patient 10 was admitted to the facility on 8/6/2024 at 4:29 a.m. Patient 10's "History and Physical (H&P, a formal and complete assessment of the patient and the problem), dated 8/6/2024, indicated Patient 10 was admitted to the facility with a diagnosis of hypoxemia (condition that occurs when there is not enough oxygen in the blood, which can lead to a lack of oxygen to tissues and organs). Patient 10's Care Plan (provides a framework for evaluating and providing patient care) for respiratory (related to the airway and lungs) care was not initiated on admission. Patient 10's Care Plan for respiratory care was delayed when initiated on 8/9/2024 (four days after admission date).

During an interview on 8/21/2024 at 2:09 p.m. with the Manager of Patient Safety Team (MPS), the MPS stated the following: Patient 10's respiratory Care Plan should have been initiated on admission by a member of the interdisciplinary team (IDT, a group of health care professionals with various areas of expertise who work together toward the goals of their patients). Patient 10's care plan should have been specific to Patient 10's admitting diagnosis (relating to respiratory issues) and should have reflected the current status of the patient. Care plans should be updated per policy. The Care Plan is a communication tool for the IDT to track goal progression. The Care Plan has patient specific interventions that supports the plan of care. The Care Plan allows the IDT to update interventions if the interventions are not effective.

During a review of Patient 10's History and Physical (H&P, a formal and complete assessment of the patient and the problem), dated 8/6/2024 at 6:20 a.m., the H&P indicated the following: Patient 10 had a past medical history of respiratory distress (a serious lung condition that causes low blood oxygen) at birth requiring continuous positive airway pressure (CPAP, a machine that uses mild air pressure to keep the airways open while a person sleeps). Patient 10 was admitted to the facility with diagnoses of hypoxemia and Trisomy 18 (a genetic disorder that can cause growth delays that are life threatening).

During a review of Patient 10's provider's orders (a provider's instructions for medical care and treatment), dated 8/6/2024 at 7:43am, the "Orders" indicated an order for a CPAP device.

During a review of Patient 10's nursing flowsheet, dated 8/6/2024 at 4:53 a.m., the flowsheet indicated the following: "Type of Oxygen Administration: With CPAP."

During a review of the facility's policy and procedure (P&P) titled, "Interdisciplinary Care Planning - General," dated 4/30/2024, the P&P indicated the following: ...The Registered Nurse (RN) is responsible for overseeing and supervising the patient's Interprofessional Plan of Care (IPOC), as well as initiating, updating, and discontinuing all plans of care ...IPOC will be initiated by the RN within 24 hours of admission.

During a review of the facility's policy and procedure (P&P) titled, "Interdisciplinary Care Planning," dated 4/30/2024, the P&P indicated the following: " ...Procedure: Inpatient: A. Interprofessional Plan of Care (IPOC, provides a framework for evaluating and providing patient care) requirements: ...1) ... a) Additional IPOCs should be initiated as the plan of care develops and patient needs change ... 3) The plans of care should be updated to reflect current orders and care. a) The Registered Nurse (RN) should discontinue and/ or add goals and interventions to reflect the current plan ..."

2. During a concurrent interview and record review on 8/21/2024 at 10:49 a.m. with the Manager of Patient Safety (MPS), the MPS reviewed Patient 4's medical record and stated the following: Patient 4 was admitted to the facility on 4/20/2024 at 2:37 a.m., for pulmonary hypertension crisis (a life-threatening emergency that occurs when there is a sudden, rapid increase in lung pressure, and can lead to temporary decrease in lung blood flow and airway obstruction). Patient 4's biggest problem was related to the respiratory system. The MPH reviewed Patient 4's care plan titled "Respiratory Care IPOC (Interprofessional Plan of Care, provides a framework for evaluating and providing patient care)," and verified that the care plan was not initiated within 24 hours of admission. The care plan was initiated on 4/22/2024 at 5:05 p.m. (Admission date was 4/20/2024 at 2:37 a.m.). The MPS stated the care plan should be initiated within 24 hours to ensure Patient 4 received the necessary interventions to help Patient 4 reach her (Patient 4) patient care goals.

During a review of Patient 4's History and Physical (H&P, a formal and complete assessment of the patient and the problem)," dated 4/20/2024 at 6:24 a.m., the H&P indicated Patient 4's chief complaint was pulmonary hypertension crisis and transferred to the facility for respiratory failure (inadequate gas exchange in the respiratory system).

During a review of Patient 4's care plan titled, "Respiratory Care IPOC," the care plan indicated it (the care plan) was initiated on 4/22/2024 at 5:04 p.m. (two days from admission date). Goals included ...Respiratory status will improve and will tolerate increased activity. Interventions included ...Assess respiratory rate, depth, and effort. Assess breath sounds. Monitory pulse oximetry ...Perform airway suctioning ...

During a review of the facility's policy and procedure (P&P) titled, "Interdisciplinary Care Planning - General," dated 4/30/2024, the P&P indicated the following: ...The Registered Nurse (RN) is responsible for overseeing and supervising the patient's Interprofessional Plan of Care (IPOC), as well as initiating, updating, and discontinuing all plans of care ...IPOC will be initiated by the RN within 24 hours of admission.

Based on observation, interview and record review, the facility failed to ensure one of 30 sampled patient's (Patient 9) enteral (a method of feeding that uses the gastrointestinal [GI, relating to the stomach and intestines] tract to deliver nutrition and calories) feeding bag was labeled, in accordance with facility policy and procedure regarding labeling of enteral feeding bags.

This deficient practice had the potential for the enteral feeding bag to be expired, leading to bacterial growth within the feeding bag which may result in Patient 9 developing gastrointestinal problems such as diarrhea (loose stools).

Findings:

During a concurrent observation and interview on 8/19/2024 at 3:41 p.m. with Nurse Manager 1 (NM 1) and Registered Nurse 10 (RN 10), in Patient 9's room, Patient 9 was observed in a crib with an enteral (a method of feeding that uses the gastrointestinal [GI, relating to the stomach and intestines] tract to deliver nutrition and calories) feeding bag and tubing was attached to his (Patient 9's) gastrostomy tube (g-tube, a device that administers nutrients, fluids and medications to the gastrointestinal [GI]) site.

During an interview on 8/19/2024 at 3:41 p.m. with Registered Nurse (RN 10), RN 10 verified formula was running continuously at 58 milliliter (ml, a unit of measurement) per hour from the enteral feeding bag to the g-tube, and that the enteral feeding bag was unlabeled. RN 10 stated the following: There should be a label on Patient 9's enteral bag. The label should have included the patient's name, time the bag was hung, type of formula, and expiration time. It is important to label the enteral feeding bag to ensure the correct formula is given to the correct patient. Also, it is important to label the enteral feeding bag with the time so you know when it will expire, so the patient does not get expired milk, which can grow bacteria.

During a review of Patient 9's History and Physical (H&P, a formal and complete assessment of the patient and the problem), dated 9/28/2023 at 5:03 p.m., the H&P indicated the following: Patient 9 was admitted to the facility with a diagnosis of congenital diaphragmatic defect (CDD, an opening in the diaphragm [muscle that separates the chest from abdomen] which allows the bowel, stomach, and liver to move upward into the chest cavity).

During a review of Patient 9's provider's orders, dated 8/14/2024 at 10:01 a.m., the "Orders," indicated the following: "Gentlease NeuroPro, Enfamil 22 (a type of infant formula), prepared, 58 mL (a unit of measurement) [per hour] continuous tube feeding."

During a review of Patient 9's nursing flowsheet (a standardized tool that helps healthcare providers record patient information in a grid-like format), dated 8/19/2024 at 8:00 a.m., the nursing flowsheet indicated Patient 9 had a g-tube to the left upper quadrant of abdomen.

During a review of the facility's policy and procedure (P&P) titled, "Administration of Feeding Via an Enteral Access Device," dated 5/15/2024, the P&P indicated the following: " ...Definition: ...G. Continuous Feeding: Feedings delivered to either the stomach or intestine via syringe or enteral feeding pump (a device that delivers nutrient fluids into a patient's stomach or intestines through enteral tubing) and sets at a constant rate of a period of hours, up to 24-hours per day ... D. Feeding Administration: 1. ... If the patient is a neonate or potentially immunocompromised, hang time is 4-hours ... 4. Change feeding sets every 24-hours, except in the case of the neonate... a. Neonates and potentially immunocompromised patients will have the feeding set changed consistent with the hang times ... c. Feeding bag must be labeled with patient's name, medical record number (MRN), name of formula/feeding, rate, time formula/feeding was hung and time new feeding set was hung ..."