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The hospital failed to meet the regulatory requirements for the Condition of Participation: CFR 482.13 Patient's Rights as evidenced by the following:

1. Based on interview and record review, the hospital failed to ensure the "CONDITIONS OF REGISTRATION [COR- a legal agreement between the patient and the hospital consenting to treatment, assignment of insurance benefits accepting financial responsibility for their medical services]" policy and procedure (P&P) was followed for two of 32 sampled patients (Patient 3 and Patient 4).

This failure resulted in Patient 3 and Patient 4 not being informed of the care agreement for care services and financial obligations during their hospitalization.
(Refer to A-0117)

2. Based on interview and record review, the hospital failed to ensure the "Advanced Healthcare Directives, Surrogate Decision Maker" policy and procedure (P&P) was followed for four of 32 sampled patients (Patient 1, Patient 10, Patient 11, and Patient 12).

This failure resulted in violation of patient right to make medical care decisions and formulate an advance directive (a written statement of a person's wishes regarding medical treatment, often including a living will, made to ensure those wishes are carried out should the person be unable to communicate them to a doctor). (Refer to A-0132)

3. Based on observation, interview, and record review, the hospital failed to:

Provide personal privacy to one of 32 sampled patients (Patient 2) when Patient 2's legs and brief were exposed in an area that could be seen by other patients, staff, and visitors.

Ensure that Protected Health Information (PHI- also referred to as personal health information like name, date of birth, medical histories, test and laboratory results, mental health conditions, insurance information and other data that a healthcare professional collects to identify an individual) was protected and not accessible by unauthorized persons for five of 32 sampled patients. (Patient 7, Patient 8, Patient 9, Patient 13, and Patient 16).

These failures resulted in violation of the right to privacy and dignity for Patient 2 and a violation of confidentiality for Patient 7, Patient 8, Patient 9, Patient 13, and Patient 16. (Refer to A-0143)

4. Based on observation, interview, and record review, the hospital failed to ensure a safe environment for one of 32 sampled patients (Patient 1) when:

Patient 1, who was not registered as a patient for treatment, was given access to a secured locked location.

Patient 1 accessed laboratory specimen collection supplies and collected her blood with the use of her Port-a-Cath (an implanted device used for blood draws and medications that is placed in front of a patient's chest).

Patient 1 collected her own blood specimen without proper training.

These failures had the potential to cause harm, infection, and contribute to adverse patient outcomes. (Refer to A-0144)

5. Based on interview and record review, the hospital failed to follow it's "STANDARD POLICY: RESTRAINT MANAGEMENT (MECHANICAL, CHEMICAL, SECLUSION) policy and procedure (P&P) for three of five sampled patients (Patient 2, Patient 3, and Patient 4) when nursing restraint ongoing patient assessment, least restrictive measures, alternative planning, and implementation of nursing restraint checks every two hours for Patient 2, Patient 3, and Patient 4 were not completed.

This failure had the potential to result in Patient 2, Patient 3, and Patient 4 experiencing adverse health outcomes due to restraint use. (Refer to A-0175)

The cumulative effect of these systemic problems resulted in the hospital's failure to ensure patient rights were protected.

Based on interview and record review, the hospital failed to ensure the "CONDITIONS OF REGISTRATION [COR- a legal agreement between the patient and the hospital consenting to treatment, assignment of insurance benefits accepting financial responsibility for their medical services]" policy and procedure (P&P) was followed for two of 32 sampled patients (Patient 3 and Patient 4). This failure resulted in Patient 3 and Patient 4 not being informed of the agreement for care services and financial obligations during their hospitalization.

Findings:

During a concurrent interview and record review on 7/26/24 at 9:14 a.m. with Patient Access Manager (PAM) the hospital's P&P titled, "CONDITIONS OF REGISTRATION," dated 4/20/20 was reviewed. The P&P indicated, Patients written documented agreement for care services with a signature page for consent. PAM stated the expectation was for the Patient Access Staff (PAS) to follow the Hospital's P&P. PAM stated when patients were unable to sign, the PAS were expected to document the reason the patient was unable to sign, have their designated representative sign on their behalf, and reattempts to sign the COR.

During a concurrent interview and record review on 7/26/24 at 9:17 a.m. with PAM, Patient 3's COR was reviewed. The COR indicated, a verbal notation for Patient 3's consent signature. PAM stated the hospital's COR P&P was not followed.

During a concurrent interview and record review on 7/26/24 at 9:20 a.m. with PAM, Patient 4's COR was reviewed. The COR indicated, a verbal notation for Patient 4's consent signature. PAM stated, "no it [COR P&P] was not" followed for Patient 4's consent signature.

During a review of the Hospital's P&P titled, "CONDITIONS OF REGISTRATION," 4/20/20 indicated, "POLICY SUMMARY/INTENT: It is the policy of the Patient Access Department to have all patients or their legal representative sign the Conditions of Registration at the time of admission given that the every patient has the legal right to agree to refuse medical treatment. . . Conditions of Registration (COR) or formally known as Conditions of Admission (COA): The COR is a legal agreement between the patient and the hospital consenting to treatment, assignment of insurance benefits, and accepting financial responsibility for their medical services. . . AFFECTED DEPARTMENT/SERVICES: 1. Patient Access 2. Patient Financial Services (PFS) 3. Health Information Management (HIM) 4. Risk Management. POLICY: COMPLIANCE - KEY ELEMENTS. . . C. Patients who are unable to sign the COR 1. When a patient is unable to sign due to their medical condition and there is not a legal representative, the Patient Access Associate will document in the COR field in Cerner unsigned and account notes. 2. A follow up label will be placed on the back of the unsigned CORs and they will be placed in the follow up folder in the Patient Access Department. Patient Access staff will attempt once a day to provide the patient or their representative with the COR and obtain signatures and document on the label."

Based on interview and record review, the hospital failed to ensure the "Advanced Healthcare Directives, Surrogate Decision Maker" policy and procedure (P&P) was followed for four of 32 sampled patients (Patient 1, Patient 10, Patient 11, and Patient 12). This failure resulted in violation of patient rights to make medical care decisions and formulate an advance directive (a written statement of a person's wishes regarding medical treatment, often including a living will, made to ensure those wishes are carried out should the person be unable to communicate them to a doctor).

Findings:

During a concurrent interview and record review on 7/24/24 at 2:13 p.m. with Registered Nurse 9 (RN 9), Patient 12's "Conditions of Registration ED [Emergency Department] [COR- a legal agreement between the patient and the hospital consenting to treatment, assignment of insurance benefits accepting financial responsibility for their medical services]," dated 7/18/24 was reviewed. The COR indicated, section "19. Patient Self Determination Act" was blank with no choices marked by Patient 12. RN 9 stated Patient 12's COR section 19. Patient Self Determination Act was blank and should have been completed.

During a concurrent interview and record review on 7/25/24 at 10:03 a.m. with Emergency Department Manager 2 (EDM) 2, Patient 11's "COR" dated 7/20/24 was reviewed. The COR indicated, section "Number 19. Patient Self Determination Act" was blank with no choices marked by Patient 11. EDM 2 stated Patient 11's COR section 19. Patient Self Determination Act was blank and should have been completed.

During a concurrent interview and record review on 7/25/24 at 11:36 a.m. with Regulatory Accreditation Registered Nurse (RARN), Patient 10's "COR" dated 7/3/24 was reviewed. The COR indicated, section "Number 19. Patient Self Determination Act" was blank with no choices marked by the patient. RARN stated Patient 10's COR Number 19. Patient Self Determination Act was blank and should have been completed. RARN stated the COR informs patients of their right to formulate an advance directive.

During a concurrent interview and record review on 7/25/24 at 5:33 p.m. with EDM 2, Patient 1's "COR," dated 6/21/24 was reviewed. The COR indicated, section "Number 19. Patient Self Determination Act" was blank with no choices marked by the patient. EDM 2 stated Patient 1's COR Number 19. Patient Self Determination was blank and should have been completed.

During a review of the hospital's P&P titled, "Advanced Healthcare Directives, Surrogate Decision Maker," dated 6/17/2020, the P&P indicated, "The intent of this policy is to support a patient's right to formulate advance directives and to guide [Hospital] staff and LIP's [licensed independent practitioners] who provide care in complying with these directives. This includes the rights of a patient to make medical care decisions, the right to request or refuse treatment, the right to formulate an advance directive and the right to designate a surrogate decision maker. A. ADVANCE DIRECTIVES 1. [Hospital] shall provide to each adult individual, at the time of his or her admission as an inpatient, written information describing: a. An individual's right under California statutes and court decisions to accept or refuse medical or surgical treatment, to formulate advance directives; and b. The hospital's policies regarding these rights to make health care decisions and to formulate advance directives, and regarding the way such decisions and directives will be implemented to the hospital. 2. The hospital shall document in the individual's medical record whether or not the individual has an advance directive."

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

1. Provide personal privacy to one of 32 sampled patients (Patient 2) when Patient 2's legs and brief were exposed in an area that could be seen by other patients, staff, and visitors.

This failure resulted in a violation of the right to privacy and dignity for Patient 2.

2. Ensure that Protected Health Information (PHI- also referred to as personal health information like name, date of birth, medical histories, test and laboratory results, mental health conditions, insurance information and other data that a healthcare professional collects to identify an individual) was protected and not accessible by unauthorized persons for five of 32 sampled patients. (Patient 7, Patient 8, Patient 9, Patient 13, and Patient 16).

This failure resulted in a violation of confidentiality for Patient 7, Patient 8, Patient 9, Patient 13, and Patient 16.

Findings:

1. During a concurrent observation and interview on 7/22/24 at 11:18 a.m. with Registered Nurse (RN) 12 in the intensive care unit (ICU-patient care area for critical patients), Patient 2 was lying in her hospital bed sideways without a blanket or privacy curtain pulled. Patient 2's legs and brief were exposed. RN 12 stated Patient 2 should have been covered with a blanket and had the privacy curtain pulled for more patient privacy.

During a review of the Hospital's P&P titled, "RIGHTS AND RESPONSIBILITIES OF PATIENTS," dated 3/28/24, the P&P indicated, "POLICY: COMPLIANCE-KEY ELEMENTS . . . B. Patient Rights-The following patient rights . . . 1. Considerate and respectful care, and to be made comfortable. Patient has the right to respect for patient's cultural, psychosocial, spiritual, and personal values, beliefs, and preferences . . . 11. Have personal privacy respected . . . Privacy curtains will be used . . ."

2a. During a concurrent observation and interview on 7/22/24 at 9:57 a.m. with Emergency Department Manager (EDM) 1, in the ED, Patient 7, Patient 8, Patient 9, and Patient 13's laboratory specimen labels (attached to specimen container with patient identification like Patient name, Date of birth or Medical record number) were found inside an unlocked lab cart. EDM 1 stated, "the labels should have been shredded, that is the process." EDM 1 stated healthcare staff are expected to follow protected privacy practices, that did not include leaving the labels in an unsecured lab cart. EDM 1 stated, "they should have been discarded properly, not placed in there [lab cart]."

2b. During a concurrent observation and interview on 7/22/24 at 11:52 a.m. with RN Lead (RNL) and RN Manager (RNM), in the GI Lab (area where gastrointestinal procedures are done), documents containing Patient 16's PHI was found in the basket of an ultrasound machine that was sitting in the hallway where staff, visitors, and patients walked through. RNL and RNM stated the documents contained confidential information from Patient 16's chart dated 2023 and should have been shredded per Policy and Procedure (P&P).

During a review of the Hospital's P&P titled, "Confidentiality of Protected Health Information (PHI)," dated 9/7/22, the P&P indicated, "The purpose of this policy is to provide procedures to ensure the confidentiality and integrity of patient information. . . [Hospital] is committed to protecting the privacy and security of protected health information (PHI) and our commitment. . . is an extension of our mission, vision, and values. Definitions: P. Protected Health Information (PHI): Individually identifiable information that is: 1) transmitted by electronic media, 2) maintained in electronic media, or 3) transmitted or maintained in any other form or medium. Policy: Compliance- Key Elements: A. Leaders of [Hospital] have the responsibility of creating and promoting a climate for maintaining the confidentiality of patient information a "culture of confidentiality," [Hospital] must demonstrate commitment and leadership across the organization to the principles embodies in the HIPAA Privacy rule. It is the policy of [Hospital] to maintain confidentiality for individuals at all times and under all circumstances. This commitment must be supported by working to see: 1. That access to the medical record is restricted based on the minimum amount of PHI necessary to accomplish the intended purpose of any use, disclosure or request. . . B. Protection of PHI: 1. [Hospital] and its subsidiaries may not disclose, share, or otherwise use any individually identifiable health information except for the purposes of treatment, payment, and health care operations unless expressly authorized by the patient or permitted or otherwise required by law. 2. All information contained in patient medical and billing record is confidential regardless of format. These confidentiality protections extend not only to the patient's medical record, but also to information from the record. This includes, but is not limited to, abstracts of charts, medical record numbers, diagnoses, case histories, and descriptions of medical procedures that include or refer to the patient's name, social security number or other identifying information. In addition, information orally communicated about a patient must be maintained as confidential PHI. C. 1. All [Hospital] workforce members are responsible for maintaining the security and confidentiality of PHI. This responsibility includes both the physical record and all information contained in, or derived from, the medical record, including information disclosed or transmitted orally. c. Safeguards to Protect PHI: i. In addition to protecting the privacy of a patient's health information by complying with regulations regarding use and disclosure of PHI, workforce members are responsible to protect PHI with reasonable physical, technical, and administrative safeguards. It is the responsibility of all workforce members to secure PHI that they have access to complete assigned responsibilities. ii. Reasonable safeguards are to be used at all times to ensure that confidential information is not disclosed to individuals who are not authorized to receive the information and to minimize incidental disclosures of PHI. I. Physical Safeguards A. Each workforce member is responsible to protect the physical security of the PHI they are using, accessing or maintaining in their work area, including but not limited to, 1. Ensuring that PHI is not readily visible to visitors or to the public; 2. Maintaining charts in designated secure areas and not leaving charts unattended in areas that the public has access to; 3. Locking areas that contain medical and billing records at the end of the day or when there are no staff in the area."











47095

Based on observation, interview, and record review, the hospital failed to ensure a safe environment for one of 32 sampled patients (Patient 1) when:

1. Patient 1, who was not registered as a patient for treatment, was given access to a secured locked location.

2. Patient 1 accessed laboratory specimen collection supplies and collected her blood with the use of her Port-a-Cath (an implanted device used for blood draws and medications that is placed in front of a patient's chest).

3. Patient 1 collected her own blood specimen without proper training.

These failures had the potential to cause harm, infection, and contribute to adverse patient outcomes.

Findings:

1. During a concurrent observation and interview on 7/22/24 at 9:30 a.m. with Emergency Department Manager (EDM) 1 in the emergency room entrance and waiting area. EDM 1 stated, "It is possible for a patient to bypass the start nurse and registrar and have a seat in the lobby without staff knowledgement."

During an interview on 7/22/24 at 4:45 p.m. with Security Manager (SM), SM stated Patient 1 came into the Emergency Department (ED) front entrance on 6/21/24 and provided a text message to Security Guard [SG] 1, who was on duty that evening. SM stated Patient 1 was allowed access to a secure patient area without being registered for treatment and was not a patient visitor. SM stated Patient 1 should not have been allowed into a secure area. SM stated this was a breach of security and safety concern to other patients and staff.

During an interview on 7/22/24 at 4:55 p.m. with SG 1, SG 1 stated she was the security guard on duty 6/21/24 during night shift. SG 1 stated Patient 1 showed her a text message that stated "something to the sort that staff told her [Patient 1] that she could go ahead and come back to be seen for an infusion (a method of infusing fluids)." SG 1 stated, "She seemed legit so I led her back and badged her into the back." SG 1 stated she should have verified her identity and asked her more questions then directed her to the triage nurse. SG 1 stated this was a security and safety breach.

During a review of the hospital's policy and procedure (P&P) titled, "Badge and Building Access Policy," dated 1/31/24, the P&P indicated,". . .C. Enforcement: 1. Any employee encountering an unknown person without proper identification in a non-public area should offer assistance. If the employee has any doubt as to the person's response or demeanor, security should be notified.

During a review of the facility's policy and procedure (P&P) titled, "Patient Identification Policy," dated 1/25/23, the P&P indicated, "The intent of this policy is to ensure that patients in all area of the hospital are correctly identified prior to any service treatment or procedure, patient identification should reliably identify the individual as the person for whom the service, treatment or procedure is intended. A. 1. Principles of identification: 1. A system for positive identification of all hospital patients fulfills four (4) basic functions; a. Provides positive identification of patients from the time of admittance or acceptance for treatment. b. Provides a positive method of liking patients to their medical records and treatment. c. Minimizes the possibility that identifying date can be lost or transferred from one patient to another. D. Improves the accuracy of patient identification. . . 3. No procedure shall be conducted when the patient's identity cannot be verified because the imprinted band/label is illegible or missing. . .C. 1. Before any procedure is carried out, the identification of the patient will be verified by the responsible care provider using the two identifiers listed below to ensure that the right patient is involved. the room number will not be used as a patient identifier.

2. During an interview on 7/22/24 at 9:45 a.m. with EDM 1, EDM 1 stated when a patient comes in with a Port-a-Cath, staff are expected to obtain an order from the provider to access a Port-a-Cath for blood specimen collection.

During a concurrent observation and interview on 7/22/24 at 9:48 a.m. with EDM 1 in ED nursing station, a lab cart was located in between the nurses station and patient treatment rooms. The lab cart was unlocked and contained lab supplies including needles, laboratory blood specimen tubes, and vacutainers (a double ended needle blood collection device). EDM 1 stated the observed lab cart should be locked and not accessible to unauthorized individuals. EDM 1 stated the observed lab cart was always kept unlocked with a box of normal saline syringes that was "always" on the top of the lab cart.

During a concurrent observation and interview on 7/22/24 at 9:55 a.m. with EDM 1 in a procedure room in ED, there was an unlocked "procedure" cart next to the patients bed. The procedure cart had a metal arm that was labeled "lock/unlock." The metal arm was able to move from lock to unlock without a key or a code. The procedure cart had 4 drawers that contained 18 gauge (g-unit for measurement) needles, scalpels, razors used for hair shaving, skin staplers, suture removal kits, various size sutures (in boxes), laceration (deep cut) trays (providers use for laceration repair), normal saline, sterile water, and betadine (antiseptic used for skin disinfection) bottles. EDM 1 stated, "This presents a safety concern." EDM 1 stated a patient could open the cart if unattended and access any supplies that are inside. Also in the procedure room, there were unlocked cabinets and drawers that contained normal saline syringes and a bag of IVF's (Intravenous Fluids-electrolytes administered into a persons vein). EDM 1 stated the cabinets and drawers should be locked and the normal saline syringes and IVF's should not be inside of the procedure rooms unlocked cabinets and drawers.

During a concurrent observation and interview on 7/22/24 at 10:10 a.m. with Quality and Safety Registered Nurse (QSRN) in ED procedure room, unlocked cabinets and drawers had 18g (grams), IV insertion devices inside. QSRN stated, "This should not be stored like this, it is a safety risk concern."

During a concurrent observation and interview on 7/22/24 at 10:12 a.m. with EDM 1 at ED nursing station, a mobile computer on wheels was located next to a patient's room and contained a compartment connected to the back of the computer cart. There was one saline syringe and three 18g needles. EDM 1 stated, "These items should not be there and a patient could get a hold of them."

During a concurrent observation and interview on 7/22/24 at 10:15 a.m. with EDM 1 at ED nursing station, a second mobile computer on wheels next to "triage chair #4" that had a pediatric patient and a family member next to it, had seven normal saline syringes found in the compartment connected to the cart. EDM 1 stated these should not have been accessible to the patient and family member and is a safety concern.

During a concurrent observation and interview on 7/22/24 at 10:28 a.m. with EDM 1 at ED nursing station, a large cart in the hallway where foot traffic was noted was found unlocked. Cart contained scalpels, needles, arterial line kits (used to access arterial lines in patients by providers). EDM 1 stated this is a "Central Line Cart [cart where a catheter often place in a large vein in the neck]" and should not be unlocked. EDM 1 stated it contains supplies that could pose a safety concern to patient's and visitors.

During a concurrent observation and interview on 7/22/24 at 10:30 a.m. with EDM 1 at ED nursing station, an Ultrasound machine (imaging test that uses sound waves to make pictures of the organs) on wheels was observed in the hallway by the nurses station. Long needles used by provides to place a guided intravenous line was found in an attached compartment behind the ultrasound machine. EDM 1 stated these are considered sharps and should not be accessible to patients or visitors.

During a concurrent observation and interview on 7/22/24 at 11:05 a.m. with Registered Nurse (RN) 15 in the Intensive Care Unit (ICU- a patient care area for critical patients). Observed multidrawer carts in three different rooms unlocked. The 4th drawer of all the carts contained needles, normal saline syringes, laboratory specimen tubes, various size needles used to start IV's. RN 15 stated these should be locked and not accessible to patients or visitors and could potentially cause safety concerns.

During an interview on 7/22/24 at 11:25 a.m. with Nurse Manager Intensive Care Unit (NMICU), NMICU stated all of the carts in ICU 1 and ICU 2 are "end of life" and don't lock. NMICU stated the RN's do keep sharps and normal saline flushes in them so they can be easily accessible to them and stated these carts should be locked. NMICU stated none of the carts lock and stated she has brought this safety concern to her nurse leadership team. NMICU stated there are 20 "end of life" carts in her department that do not lock. NMICU stated patients and visitors could access these carts when left unattended.

During an interview on 7/22/24 at 4:15 a.m. with Emergency Department Director (EDD). EDD stated nurses should not initial specimens that they did not draw directly from a patient. EDD stated this is not a standards of practice. EDD stated patients and visitors should not be able to access any sharps, syringes, or normal saline syringes in the ED. EDD stated this poses a safety concern with patients and visitors.

During a concurrent interview and record review on 7/23/24 at 10:30 a.m. with LVN 2, Patient 1's "Nursing Note (NN)," dated 6/19/24 was reviewed. The NN indicated, "[Patient 1] accessed supply cart without approval to do her own labs from PICC line [sic]." LVN 2 stated on 6/19/24 she noticed Patient 1 lying on a stretcher with a syringe full of blood hooked up to her port-a-cath with blood in it. LVN 2 stated Patient 1 should not have been able to access supplies in the ED and should not have been obtain her own blood specimens. LVN 2 stated this is not normal practice and is a safety and infection concern.

During an interview on 7/23/24 at 11:15 a.m. with Emergency Department Nurse Practitioner (EDNP), EDNP stated "I heard staff was upset with Patient 1 because she was caught drawing her own blood." EDNP stated, "I saw her [Patient 1]grabbing the supplies from the white lab cart and was pulling syringes then drawing her blood from her Port-a-Cath." EDNP stated, "It is absolutely not acceptable for a patient to draw her own blood." EDNP stated, "I told the patient that if she wasn't going to follow the rules, that she wasn't going to take care of her. I don't think patients should have access to the supplies, I have never witnessed this in 19 years."

During an interview on 7/23/24 at 1:15 p.m. with Emergency Department Medical Director (EDMD). EDMD stated it is unacceptable to find sharps, normal saline flushes, and laboratory specimen tubes unsecured and accessible to patients and/or visitors. EDMD stated it is not standard practice or safe for a patient to access their own Port-a-Cath to collect blood specimens and should be left for the RN's that are trained to do that procedure.

During an interview on 7/23/24 at 3:11 p.m. with Emergency Department Physician's Assistant (EDPA), EDPA stated on 6/19/24, she witnessed Patient 1 flushing her Port-a-Cath with a normal saline flush syringe. EDPA stated it is not safe for Patient 1 to access her own Port-a-Cath and should not have drawn her own blood. EDPA stated this is a safety concern and also concern for infection preventions. EDPA stated this is not normal practice and patients and visitors should not have access to supplies including syringes, normal saline flushes, or laboratory specimen tubes.

During a review of the hospital's policy and procedure (P&P) titled, "Stop the Line," dated 5/14/21, the P&P indicated, "All hospital employees, medical staff, students, and volunteers have the responsibility and authority to immediately intervene to protect patients' rights and safety of a patient, to prevent a patient safety event and subsequent patient harm or patient safety violations. It is the expectation that any person providing patient car will immediately stop and respond to the request to stop for clarification to reassess the patient's safety. This is a proactive practice to SPEAK UP in advocating for patient safety and is applicable for all patients receiving Hospital services. Compliance-Key Elements A. Any person who observes or becomes aware of an imminently harmful situation in patient care, or witnesses a disruptive behavior has the authority and responsibility to speak up and request the process be stopped; to clarify the patient safety situation. This person needs to say in a firm, clear and respectful manner: "STOP, I am Concerned," If that request does not produce safety, the person should continue with the CUS statement, "I am Uncomfortable" and finally, if the situation persists, "This is a Safety Issue." B. Utilizing 3Ws, state: What is the safety observation, What is the concern, and What needs to occur to maintain safety. C. "Stop the line" request needs to be clear and timely to restore patient safety and minimize intrusion into the care process.

During a review of the hospital's policy and procedure (P&P) titled, "Scope of Service-Emergency Dept," dated 3/2/24, the P&P indicated, ". . .E. The goal of the Emergency Department will be to ensure that all patients treated will receive high quality care in the most expedient and professional manner possible. . .G. All individuals who provide emergency services are licensed or registered and have the appropriate training and competence. Staff include: . .5. Licensed Vocational Nurses. M. Department Objectives: . . 2. To deliver safe, effective, and appropriate care in a cost effective manner. . .7. To provide necessary expertise, technology, instrumentation and equipment for the management of patients. 8. To provide nursing care based on the nursing process.

3. During an interview on 7/22/24 at 2:48 p.m. with Infection Prevention Registered Nurse (IPRN) and Director of Infection Prevention (DIP), IPRN stated, "It is against our policy to have patients access their own implanted devices." DIP stated, "Only staff that have competency can draw from central lines." DIP stated patients should not have access to normal saline syringes and laboratory specimen tubes. DIP stated Patient 1 should not have been able to obtain her own blood specimens. DIP stated, "This is a high priority and an infection control risk."

During an interview on 7/24/24 at 4:46 p.m. with LVN 1, LVN 1 stated Patient 1 collected her own laboratory blood specimens in two syringes and handed him (LVN 1) the blood filled syringes. LVN 1 stated he accepted Patient 1's self collected blood filled syringes and transferred the blood into laboratory specimen tubes. LVN 1 stated he labeled Patient 1's blood specimen with his initials and sent Patient 1's blood specimens to the laboratory for processing. LVN 1 stated this is not a normal practice and that he should not have accepted blood he did not collect. LVN 1 stated Patient 1 should not have access to ED supplies, including syringes, laboratory tubes, or normal saline syringes.

During an interview on 7/24/24 at 10:11 a.m. with RN 30 and EDM 1, RN 30 stated he saw Patient 1 standing at the nursing station with a syringe full of blood hanging from a lumen of her Port-a-Cath. RN 30 stated patient should not have access to supplies, including laboratory specimen tubes, sharps, needles, and normal saline syringes and is a patient safety concern including a "infection control risk."

During an Interview on 7/25/24 at 8:30 a.m. with Emergency Department Provider (EDP) EDP stated, "This is completely unacceptable, this is a danger for [Patient 1]. [Patient 1] should not be allowed to provide herself care with supplies and drawing her own blood. The house supervisor should have been called. This is not standard of care and should have been escalated to security/law enforcement of theft, stealing supplies. [Patient 1] was a danger to herself and is not a trained professional to access a line. The ball was dropped. Breached the standard of care." EDP stated all carts with supplies should have been secured. EDP stated "ER should be a safe haven."

During a review of the facility's policy and procedure (P&P) titled, "CLABSI Prevention-Central Venous Catheter management," dated 8/15/23, the P&P indicated, "Compliance-Key Elements B. Education, Training and Qualifications; 1. Patient/Family Education: Prior to catheter insertion and as needed, educate patients and their families about central line associated bloodstream infection prevention. Include topics such as rationale for device, expected dwell time and care/maintenance of device. 2. Healthcare Personnel Education and Training: 1. insertion, care and maintenance of CVC will be performed by healthcare personnel who are educated and trained about indications for intravascular catheter use, insertion, maintenance, and appropriate infection prevention measures to prevent intravascular catheter-related infections."

During a review of "Infection Prevention and Control Program Plan (IPCP)," dated 2024, the "IPCP" indicated, "Purpose: The IPC [Infection Program Control] program assists patient care by reducing the risk of infection in patients, visitor, associates and others through education, surveillance, prevention, control, and continuous review and evaluation of infection prevention practices. Policy: It is the policy of [Hospital] to provide safe and effective care for all our patients. The infection prevention and control program will implement and maintain active hospital-wide activities for the prevention, control and investigation of infections and communicable diseases.

During a review of the hospital's policy and procedure (P&P) titled, "Rights and Responsibilities of Patients," dated 3/38/24, the P&P indicated, ". . .B. Patient Rights- The following patient rights information is provided as supplemental descriptive information to the patient or their representative. It may not contain all of the patient rights on the lists provided to the patient. . .13. Receive care in a safe setting, free from mental physical, sexual or verbal abuse and neglect, exploitation or harassment, the patient has the right to access protective and advocacy services including notifying government agencies of neglect or abuse.

Based on interview and record review, the hospital failed to follow it's "POLICY: RESTRAINT MANAGEMENT (MECHANICAL, CHEMICAL, SECLUSION) policy and procedure (P&P) for three of five sampled patients (Patient 2, Patient 3, and Patient 4) when nursing restraint ongoing patient assessment, least restrictive measures, alternative planning, and implementation of nursing restraint checks every two hours for Patient 2, Patient 3, and Patient 4 were not completed. This failure had the potential to result in Patient 2, Patient 3, and Patient 4 experiencing adverse health outcomes due to restraint use.

Findings:

During a concurrent interview and record review on 7/24/24 at 10:44 a.m. with Quality Safety Registered Nurse (QSRN), Patient 3's "Restraint Flowsheet (RF)" dated 7/9/24 at 10 p.m. and on 7/10/24 at 12 a.m. was reviewed and incomplete. QSRN stated the restraint checks were expected to be completed every two hours per hospitals P&P.

During an interview on 7/24/24 at 10:48 a.m. with QSRN, QSRN stated the expectation for patients that are restrained are assessed "every two hours" and the restraint order is renewed by a doctor every three days. QSRN stated the hospital's patient care staff were to "follow policy" for restraint use and management.

During a concurrent interview and record review on 7/24/24 at 2:41 p.m. with QSRN, Patient 2's, "RF" dated 7/18/24 was reviewed. The RF indicated, no restraint assessment was done at 6 p.m. QSRN stated the expectation was for Patient 2 to have ongoing restraint assessments every two hours.

During a concurrent interview and record review on 7/25/24 at 12:09 p.m. with Registered Nurse (RN) 17, Patient 4's, "RF" dated 6/30/24 was reviewed. The RF indicated, restraint assessment, monitoring, and least restrictive interventions were not done from "7 a.m. to 7 p.m." RN 17 stated, "There are gaps and the expectation was for nurses to follow the hospital restraint P&P, which included a restraint for use patient assessment every two hours."

During an interview on 7/26/24 at 1:16 p.m. with Director Critical Care (DCC), DCC stated the hospital process was to perform ongoing assessments for the restrained patient(s) for their needs with a safety goal to discontinue restraints. DCC stated restraint use is a patient safety priority. DCC stated the restraint use process involved nursing communicating with the physician for restraint use and involved "every 2 hours" assessments, least restrictive interventions, hydration, elimination, redirecting and orienting, planning, and work towards discontinuing the restraint use. DCC stated the importance of following the hospital process was to "make sure not causing [patient] harm."

During a review of the hospital's P&P titled, "Restraint Management (Mechanical, Chemical, Seclusion)" dated 01/20/2021, the P&P indicated, "POLICY SUMMARY/INTENT: A. To outline an organizational approach to restraints that protects the patient health and safety and preserves their dignity, rights and well-being. This includes a description of patient's health and safety and preserves their dignity, rights and well-being. This includes a description of patients' basic rights, organizational intent to. . . manage restraint initiation, monitoring, discontinuation, documentation, staff education and reporting. . . B. This organization recognizes that restraint use has the potential to produce serious consequences, such as physical and psychological harm, loss of dignity, violation of patient's rights and even death. It is our intent to provide an environment that minimizes circumstances that give rise to use of restraint (s). . . and maximizes safety when restraint or seclusion is used. . . E. Licensed Independent Practitioner (LIP): An individual permitted by law and by the organization to provide care, treatment, and services without direction or supervision. A licensed independent practitioner operates within the scope of his or her license. . . A. Applies to all licensed hospital departments, including, but not limited to medical/surgical, critical care. . . and all patients. . . c. Application of handcuffs, manacles, or shackles is performed by non-employed or contracted and/or law enforcement personnel only and will be documented by nursing staff in the medical record accordingly. . . c. RN may authorize /initiate mechanical or seclusion restraints (excluding chemical) in emergency situations without an order but must obtain an order from the LIP during the emergency application of the restraint or seclusion, or immediately (within a few minutes) after the restraint has been applied. D. LIP or clinical psychologist is consulted , as soon as possible, if they did not order the restraint(s) or seclusion. . . 5. Ongoing Monitoring/Documentation a. Documentation of restraint and/or seclusion episodes (s) to include, but not limited to: assessments/re-assessments, interventions, care plan/plan of care modifications, response to interventions, criteria met for discontinuation. i. Ongoing assessments/interventions are documented according to the frequency. . . E. RESTRAINT CONSIDERATION- NON-VIOLENT/NON-SELF-DESTRUCTIVE 1. These types of restraint orders are used to protect the physical safety of non-violent or non-self-destructive patients. 2. Orders will be renewed every 3 days if continued restraints are needed. 3. Assessment and monitoring will be conducted at minimum, every 2 hours. . . iv. Documents in the log the patient's name, date of birth, date of death, name of LIP responsible for the care of the patient, medical record number, and primary diagnosis."


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The hospital failed to meet the regulatory requirements for the Condition of Participation: CFR 482.23 Professional Standards as evidenced by the following:

1. Based on observation, interview, and record review, the hospital failed to ensure Registered Nursing (RN) care met the professional standards when:

Critical laboratory results were not reported to a physician for three of 32 sampled patients (Patient 2, Patient 14, and Patient 15).

Wound assessment and prevention were not completed for 3 of 3 sampled patients (Patient 4, Patient 5 and Patient 6).

These failures resulted in providers not being updated on patient care changes and outcomes for Patient 2, Patient 4, Patient 5, Patient 6, Patient 14, and Patient 15.(Refer to A-0395)

2. Based on interview and record review, the hospital failed to ensure a nursing care plan was developed, implemented, and revised to meet professional standards for three of three sampled patients (Patient 4, Patient 5 and Patient 6).

This failure resulted in Patient 4, Patient 5, and Patient 6's needs not met and had the potential to contribute to an adverse health outcome. (Refer to A-0396)

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure nursing services were provided in a safe manner and patient care needs were being met.

Based on observation, interview, and record review, the hospital failed to ensure Registered Nursing (RN) care met the professional standards when:

1. Critical laboratory results were not reported to a physician for three of 32 sampled patients (Patient 2, Patient 14, and Patient 15).

2. Wound assessment and prevention were not completed for 3 of 3 sampled patients (Patient 4, Patient 5 and Patient 6).

These failures resulted in providers not being updated on patient care changes and outcomes for Patient 2, Patient 4, Patient 5, Patient 6, Patient 14, and Patient 15.

Findings:

1. During a concurrent interview and record review on 7/24/24 at 11 a.m. with RN 21, Patient 15's "Laboratory-MRSA [Methicillin Resistant Staphylococcus Aureus-type of bacteria] results (LR)," dated 7/19/24 was reviewed. The LR indicated, MRSA result was positive. RN 21 stated the process is the lab will notify their department head in charge the day the result comes back and the provider and parent/guardian of patient will be notified. RN 21 stated that the test result was received after Patient 15 was discharged home and was unable to provide documentation that the parent/guardian and provider was notified of the result.

During a concurrent interview and record review on 7/24/24 at 4:41 p.m. with Quality Safety Registered Nurse (QSRN), Patient 2's, "Troponin" (a protein involved in the muscle contraction of the heart) result dated 7/17/24 was reviewed. The Troponin result on 7/17/24 at 11:46 a.m. indicated a critical high value of 4621.2. (between 0- 0.04 ng/ml (nanogram per milliliter-unit of measurement). QSRN stated the facility process was "typically within one-hour critical labs" are reported to the physician. QSRN was unable to provide documentation that Patient 2's critical Troponin was reported within the hospitals P&P of one hour.

During a concurrent interview and record review on 7/25/24 at 3:53 p.m. with Emergency Department Manager (EDM) 2, Patient 14's "Laboratory-Troponin results (TRW)," dated 6/24/24 was reviewed. The TRW indicated, Troponin result was 141.9 ng/ml and the result was called to Registered Nurse (RN) 20. EDM 2 stated that when the results reach a critical level, the laboratory staff will notify the RN in charge of the patient's care then it is the responsibility of the RN to notify the provider of the patient with the result and document under "Provider Notification." EDM 2 stated there is no documentation that RN 20 notified the provider of Patient 14's critical Troponin level.

During a review of the hospital's policy and procedure (P&P) titled, "Critical Tests and Critical Results Reporting," dated 3/27/20, the P&P indicated, "Policy Summary/Intent: [Hospital entity] adopts the following systemwide policy to standardize the process when critical results of tests fall significantly outside the normal range and may indicate a life-threatening situation. The objective of this policy is to provide guidelines for management and reporting of critical tests and critical results of test to provide patients with prompt treatment. Applies to all licensed entities [inpatient/outpatient] including but not limited to medical/surgical, critical care, forensic units, emergency department or psychiatric units and all patients, regardless of age who have critical reports or results that need to be reported. . . C. Receiving Results/Reports 1. Registered Nurse for inpatients. . . a. Communicates to ordering provider/designee with 60 minutes and documents the following: . . . i. Provider notified ii. Date/time collected iii. Two patient identifiers confirmed with provider/designee iv. Critical result reported v. Read-back completed vi. Actions taken. . . D. Reporting Time frames: 1. Critical Results of Test measurement Parameters-The maximum length of time between the availability of critical result(s) and reporting of such critical result(s) to the ordering provider/designee should not exceed 60 minutes."

2. During a review of Patient 4's "Wound Care Order (WCO)," dated 7/24/24 at 4:19 p.m. The WCO indicated, ". . . 3. Sacrum/Buttocks- clean with warm bath wipes and pat dry, apply Calazime [Skin barrier protective] Cream BID [twice a day] and with any incontinence episode. (NO MEPILEX). 4. Spine-Bony Areas- Cover with Mepilex Change Q3D [every three days]."

During a concurrent interview and record review on 7/25/24 at 3:20 p.m. with RN 17, Patient 6's, "Medical Record (MR)," was reviewed. The MR indicated, Patient 6 was admitted on 7/1/24 and discharged on 7/22/24. RN 17 stated Patient 6 was admitted to the intensive care unit on 7/15/24 for Pneumonia (infection of the lungs) and was intubated (insertion of a breathing tube). RN 17 stated there were wound photos of Patient 6's right and left buttocks and coccyx photographed wound was "maroon red" and not blanchable (manual pressure applied goes away after pressure is removed). RN 17 stated Patient 6's right and left buttock coccyx area pressure injury wound's first photo was taken on 7/15/24. RN 17 stated there was no documentation of the right and left buttock coccyx area pressure injury wound. RN 17 stated Patient 6 was admitted with "no skin issue." RN 17 stated, "He [Patient 6] didn't have it [right and left coccyx wound]" on admission. RN 17 stated there was no documentation to provide that Patient 6 was admitted with a wound to the right and left buttocks and coccyx.

During a concurrent observation and interview on 7/25/24 at 7:50 p.m., with Director Critical Care (DCC), in Patient 4's room, Patient 4's buttock and backside had a Mepilex (a soft silicone dressing for pressure offloading of bony body parts) located on his lower spine area above the buttock area. DCC stated the observed upper right and left buttock area below the spine was a "maroon" color. DCC stated, "that's [Mepilex dressing] not supposed to be like that." DCC was observed removing Patient 4's lower spine Mepilex dressing and reapplied the same Mepilex dressing to cover Patient 4's upper right and left buttock area below Patient 4's spine. DCC stated the location that needed to be covered was the "right and left buttock and coccyx [bone at the lower part of the spine]" area.

During a concurrent interview and record review on 7/26/24 at 10:26 a.m. with RN 13. Patient 4's "Turn q (every) 2 hours Flowsheet (T2F)," dated 6/27/24 to 7/24/24", Patient 5's "T2F," dated 7/10/24 to 7/24/24, and Patient's 6's "T2F," dated 7/3/24 to 7/22/24 were reviewed, these T2Fs indicated, there was missing documentation that these patients were turned every two hours. RN 13 stated pressure off-loading measures included repositioning patients every two hours and the expectation was for the intervention to be completed and documented in the patients' medical record.

During a concurrent interview and record review on 7/26/24 at 10:30 a.m. with RN 13, the hospital's, "Pressure Injury List (PIL)," dated 7/22/24 was reviewed. The PIL indicated, Patient 6 was not on the list provided by the hospital. RN 13 stated the patients listed on the "PIL" had pressure injury wounds. RN 13 stated Patient 6 was not on the list and should have been. RN 13 stated Patient 6 was admitted on 7/1/24, with a Braden score (scaled skin assessment score ) of 19-23 which indicated no risk for impaired skin. RN 13 stated on 7/16/24 Patient 6's Braden score was 11 which increased to high risk.

During a concurrent interview and record review on 7/26/24 at 10:35 a.m. with RN 13, Patient 6's, "MR" (Braden Scale) was reviewed. The MR indicated, Patient 6's Braden scale completed on 7/1/24 was 19-23. RN 13 stated on admission a "head to toe" physical assessment was expected to be completed which includes the skin. RN 13 stated she was unable to find documentation for a documented wound on admission. RN 13 stated the only documentation of Patient 6's right and left buttock coccyx pressure injury wound was on 7/15/24 and there was no prior documentation of the wound. RN 13 reviewed the photos taken on 7/15/24 of Patient 6's right and left buttocks and coccyx area and stated, "classify as DTI [Deep Tissue Pressure Injury]." RN 13 stated Patient 6's right and left buttock coccyx area was "purple, maroon" and should have been escalated to wound consult and the doctor for treatment. RN 13 stated there is no documentation to provide that Patient 6 had the DTI on admission and was "unacceptable."

During an interview on 7/26/24 at 11:12 a.m. with RN 13, RN 13 stated the expectation was to ensure that there was not a "rapid progression of the wound." RN 13 stated nursing interventions included assessing the patient for pressure injury and wounds, escalate concerns to the wound nurse and doctor, perform wound care as ordered, reevaluate the wound, report any changes, and document nursing care provided.

During a concurrent interview and record review on 7/26/24 at 12:05 p.m. with RN 13 the hospital's P&P titled, "MODEL POLICY: PRESSURE INJURY OR SKIN/WOUND CONDITIONS - ASSESSMENT, PREVENTION AND MANAGEMENT," dated 5/4/22 was reviewed. The P&P indicated, " To assess and document patient skin risk, develop a plan of care for prevention and /or management of skin condition, wound or pressure injury. . . 4. Deep Tissue Pressure Injury- DTPI: Persistent non-blanchable deep red, maroon or purple discoloration. In/tact or nonintact skin with localized area of persistent non-blanchable deep red, maroon, purple discoloration. . . This injury results from intense and/or prolonged pressure and shear forces at the bone-muscle interface." RN 13 stated DTPI's are concerning and nursing care included "pressure off loading [repositioning every 2 hours] and use of Mepilex to cover the boney areas." RN 13 stated this was a common wound management intervention that "every nurse" assigned to a patient is responsible for.

During an interview on 7/26/24 at 1:16 p.m. with Critical Care Director (CCD), CCD stated nursing interventions includes "off load the area" for the prevention of wounds. CCD stated the expectation was for all staff providing patient care services to document their care provided.

During an interview on 7/26/24 at 2:15 p.m. with DCC, DCC stated wound care prevention and management was a priority and the nursing process, included assessment, care planning, performing wound care as ordered and updating the patient care plan as needed based on the patients needs. DCC stated this process was expected to be followed by all nursing staff.

Based on interview and record review, the hospital failed to ensure a nursing care plan was developed, implemented, and revised to meet professional standards for three of three sampled patients (Patient 4, Patient 5 and Patient 6). This failure resulted in Patient 4, Patient 5, and Patient 6's needs not met, and had the potential to contribute to an adverse health outcome.

Findings:

1. During a concurrent interview and record review on 7/25/24 at 9:30 a.m., with Registered Nurse (RN) 17, Patient 5's, "Care Plan Section (CPS)" was reviewed. The "CPS" indicated, Patient 5 had a pressure injury wound care plan formulated and implemented on 7/23/24. RN 17 stated Patient 5 was admitted on 7/9/24 with a stage 3 (a full thickness skin loss- muscle, bone are not exposed) pressure injury to the left buttock. RN 17 stated the expectation for nurses was to formulate and implement a care plan "on [the]same day" pressure injury wound was noted. RN 17 stated the professional standard was not met and a care plan for Patient 5's pressure injury wound (Stage 3) should have been "done before the 23 rd."

2. During a concurrent interview and record review on 7/25/24 at 12:22 p.m. with RN 17, Patient 4's "CPS" was reviewed. The CPS indicated, a careplan for deep tissue pressure injury (DTPI- persistent non-blanchable deep red, maroon or purple discoloration, Skin intact or not intact resulting from intense or prolonged pressure or shear forces at the bone-muscle interface) to Patient 4's right and left buttocks coccyx (lower back upper buttock bone) area pressure injury was initiated on 7/25/24. RN 17 stated Patient 4 was admitted with a pressure injury wound on 6/27/24 and should have had a pressure injury wound care plan formulated and implemented prior to 7/25/24.

3. During a concurrent interview and record review on 7/25/24 at 4:21 p.m. with RN 17, Patient 6's "CPS," was reviewed. The CPS indicated, Patient 6 was admitted on 7/1/24 and did not have a care plan for his pressure injury wound to provide. RN 17 stated Patient 6 had a pressure injury wound located to his right and left buttocks coccyx area that was photographed on 7/15/24. RN 17 stated the expectation was for Patient 6 to have a pressure injury wound care plan formulated and implemented. RN 17 stated Patient 6 did not have a care plan documented for his right and left buttock coccyx are pressure injury wound. RN 17 stated, "not documented not done."

During an interview on 7/26/24 at 1:55 p.m. with Director of Critical Care (DCC). DCC stated care plans "drive the [nursing] care" and the expectation was for nursing staff to follow the hospital's P&P while providing patient care.

During a review of the hospital's P&P titled, "FACILITY POLICY:INTER-DISCIPLINARY CARE PLANNING," dated 12/3/19. The P&P indicated, "The written plan of care is based on the needs identified by the patient's assessment, results of diagnostic testing, patient's goals and time frames, settings, and services required to meet goals. C. The plan of care, goals for care, treatment, and services is dynamic and is revised as the needs of the patient changes. D. Based on the goals established in the patient's plan of care, staff evaluates the patient's progress to determine the progress towards the goal achievement and the effectiveness of the care plan. This evaluation takes place at least once every 24 hours. . . E. Within twenty-four hours of admission all patients shall have a plan of care initiated."

Based on interview and record review the hospital failed to ensure physician's verbal orders were authenticated within 48 hours for two of 32 patients sampled (Patient 3 and Patient 5). This failure had the potential for Patient 3 and Patient 5 receiving medication error and potential for adverse health outcomes.

Findings:

During a concurrent interview and record review on 7/24/24 at 1:52 p.m. with QSRN, Patient 3's "MOS" dated 7/11/24 was reviewed. The MOS indicated, on 7/11/24 at 1:01 a.m. a VTO for a continuous IV infusion for Levophed (a critical life sustaining medication that improves blood pressure ) was received. QSRN stated the Levophed infusion was started on 7/11/24 at 1:02 a.m. QSRN stated the physician still hasn't authenticated the VTO at this time (13 days later). QSRN stated Patient 3's Levophed continuous IV medication infusion VTO should have been authenticated within 48 hours and had not been completed.

During a concurrent interview and record review on 7/24/24 at 3:11 p.m. with Quality Safety Registered Nurse (QSRN), Patient 3's "Medication Order Section (MOS)" dated 7/11/24, was reviewed. The MOS indicated, on 7/11/24 at 4:23 a.m. a verbal telephone order (VTO) for a continuous intravenous (IV) infusion for
Dopamine (a critical life sustaining medication that improves blood pressure and heart function) was received. QSRN stated Patient 3's Dopamine IV infusion was started on 7/11/24 at 4:31 a.m. The MOS indicated, the physician authenticated the verbal order on 7/17/24 at 11:22 a.m. (six days later). QSRN stated the hospital policy and procedure (P&P) and professional standard for VTO's was not met when the order was authenticated more than 48 hours.

During a concurrent interview on 7/24/24 at 3:14 p.m. with QSRN, the hospital's P&P, titled "Verbal /telephone orders,"dated 10/03/2018 was reviewed. The P&P indicated, "A. California: within 48 hours. . . 2. Verbal /Telephone orders must be authenticated by either the ordering provider or covering provider responsible for care of the patient and who in accordance with hospital policy; law and regulation; and medical staff bylaws, rules, and regulations, is authorized to write orders." QSRN stated Patient 3's continuous critical care medications VTO should have been co-signed and was a patient safety, quality care concern." QSRN stated, "Absolutely expect [P&P] to be followed."

During a concurrent interview and record review on 7/24/24 at 3:52 p.m. with QSRN, Patient 5's "MOS" dated 7/17/24 was reviewed. The MOS indicated, on 7/17/24 at 12:32 p.m. a VTO for a continuous IV infusion for Levophed was received. QSRN stated the continuous IV infusion of Levophed was initiated on 7/17/24 at 1 p.m. QSRN stated the physician authenticated the Levophed VTO on 7/22/24 at 12:10 p.m. which was five days later.

During a concurrent interview and record review on 7/24/24 at 4 p.m. with QSRN, Patient 5's "MOS" dated 7/17/24 was reviewed. The MOS indicated, on 7/17/24 at 12:51 p.m. a VTO for Fentanyl (A medication used to treat pain and/or sedate for comfort) was received. QSRN stated the continuous IV infusion for Fentanyl was initiated on 7/17/24 at 1 p.m. QSRN stated the doctor authenticated the Fentanyl VTO on 7/22/24 at 12:10 p.m. (five days later). QSRN stated, "This was past the hospital's P&P within 48 hour authentication requirement."

During a review of the hospital's P&P titled, "Verbal /telephone orders" dated 10/03/18. The P&P indicated, "[Hospital] adopts the following systemwide [Hospital] policy to outline the process for giving, receiving and authenticating verbal/telephone orders to reduce or prevent medical errors. . . Authentication: An order is considered authenticated when the ordering provider or covering provider has signed, dated and timed the order. . . Covering Provider: A provider that assumes responsibility for his/her colleague's patient while the attending provider is absent. . . Licensed or Certified Professional: A person holding a license, registration. . . according to state laws and functioning within their professional scope of practice. . . AFFECTED DEPARTMENTS/SERVICES: All clinical settings where patient care is provided. . . E. Authenticating Inpatient/Outpatient Verbal Orders: 1. Verbal/Telephone orders will route to the provider's message center for electronic signature. . . Orders must be dated, timed and signed within the established state law authentication timeframe. A. California: within 48 hours. . . 2. Verbal /Telephone orders must be authenticated by either the ordering provider or covering provider responsible for care of the patient and who in accordance with hospital policy; law and regulation; and medical staff bylaws, rules, and regulations, is authorized to write orders."

Based on observation, interview, and record review, the hospital failed to ensure medications were stored in a secured and locked area to prevent unauthorized use. This failure had the potential to result in unauthorized individuals tampering or taking medications.

Findings:

During a concurrent observation and interview on 7/22/24 at 10 a.m. with Emergency Department Manager (EDM) 1, in the emergency department (ED) procedure room, a cabinet drawer was unlocked and inside had four normal saline syringe flushes, 1 Liter normal saline bag, and a full bottle of Tetracaine eyedrops (medication used to numb the eye before surgery, tests, or procedures). EDM 1 stated patients should not have access to normal saline syringe flushes, normal saline bags, and Tetracaine medication. EDM 1 stated this is not a safe practice and these should be locked and secured.

During a concurrent observation and interview on 7/22/24 at 10:07 a.m. with QSRN, in ED procedure room, an unlocked cabinet had a container labeled "Dental Box". Inside the "Dental Box" was Lolicaine (topical numbing medication for the mouth), Benzocaine 20% (topical numbing medication for the mouth). QSRN stated, "These medications should be locked up."

During an interview on 7/22/24 at 10:10 a.m. with Quality Safety Registered Nurse (QSRN), QSRN stated normal saline flushes, normal saline bags, and Tetracaine medication should not be left in an unsecured, unlocked cabinet drawer. QSRN stated, "This [unlocked storage] is a safety concern."

During an interview on 7/22/24 at 11:36 a.m. with Pharmacy Director (PD), PD stated, "Medications and fluids controlled by the Drug Enforcement Agency [DEA] [e.g. saline flush syringes and bags of saline solution] should be locked and not accessible to patients and/or visitors and could cause a safety concern if used." PD stated Tetracaine, Lollicaine, and Benzocaine medication are controlled by pharmacy and should be locked in an area not accessible to patients.

During a review of the hospital's policy and procedure (P&P) titled, "Medication Access and Authorized Persons," dated 4/3/19, the P&P indicated, "Definitions: 3. Secure = To be in locked containers (carts, drawers, etc.) in a locked room, or under constant surveillance. Medications are considered secure if non-authorized individuals cannot access them. Policy: Compliance- Key Elements A. 7. Keys to cupboards, cabinets, rooms, etc. where medications are stored will be controlled at all times. Access will be limited to authorized hospital personnel only. Keys must be transferred to appropriate personnel at shift change, or must be secured so that only authorized peronnel may have access to them."






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