HospitalInspections.org

Based on interview and record review, the Governing Body failed to provide effective oversight when:

1. Compounded (mixed) medications prepared in the hospital's Pharmacy Department were not consistent with the immediate-use (for urgent situations) requirements of The United States Pharmacopeia (USP - standard of practice for sterile (germ-free) compounding) <797>. USP <797> indicates immediate-use compounded sterile preparations (CSPs) must be prepared under conditions described for Low-Risk Level (category of contamination risk) CSPs. Medium-Risk Level CSPs (category of contamination risk) must not be prepared as immediate-use CSPs. The facility identified 39 medications were not prepared adhering to Low-Risk Level criteria when they were compounded on the Pharmacy counter outside of a compounding device certified with International Organization for Standardization (ISO - a standard-setting organization) Class 5 (measure of air cleanliness) environment. This occurred when the compounding process involved the simple transfer of more than three commercially manufactured packages of sterile nonhazardous products to 28 (Patient 38, Patient 39, Patient 40, Patient 41, Patient 42, Patient 43, Patient 44, Patient 45, Patient 46, Patient 47, Patient 48, Patient 49, Patient 50, Patient 51, Patient 52, Patient 53, Patient 54, Patient 55, Patient 56, Patient 57, Patient 58, Patient 59, Patient 60, Patient 61, Patient 62, Patient 63, Patient 64, and Patient 65) of 65 sampled patients. This failure had the potential to expose patients to increased risk of infections since compounding in an environment worse than ISO Class 5 conditions increases the likelihood of microbial (germ) contamination. (Please refer to A-0083)

2. The facility failed to ensure six of 65 sampled patients (Patients 26, 13, 16, 18, 1 and 4) received safe care when conserved (the patient has a legal guardian due to mental or physical disability and cannot care for self) or suicidal patients eloped (left facility without treatment) or conserved and signed out against medical advice (leaving the hospital-AMA). These failures had the potential to cause actual harm or death of the patients. (Refer to A-0144)

3. The facility failed to ensure a non-employee licensed nurse was educated on the hospital's elopement (patient leaving the hospital without a physician discharge order) policy when one of 65 sampled patients (Patient 27) eloped from the facility without staff knowledge and her whereabouts were unknown. This failure had placed Patient 27's life in jeopardy for serious injuries, accidents or death. (Refer to A-0398)

4. The facility failed to provide a safe and secure environment in the Urgent Care Department for two patients (Patients 1 and 4) under conservatorship (a legal guardian who makes decisions for the patient) eloped from the Urgent Care Department. This failure had the potential to cause serious harm or death. (Refer to A-1081)

The cumulative effects of these systemic problems had the potential to result in substandard healthcare which could subsequently lead to harm, disability, and death for all facility patients.

Based on interview and record review, the Governing Body failed to ensure compounded (mixed) medications prepared in the hospital's Pharmacy Department were consistent with the immediate-use (for urgent situations) requirements of The United States Pharmacopeia (USP - standard of practice for sterile (germ-free) compounding) <797>. USP <797> indicates immediate-use compounded sterile preparations (CSPs) must be prepared under conditions described for Low-Risk Level (category of contamination risk) CSPs. Medium-Risk Level CSPs (category of contamination risk) must not be prepared as immediate-use CSPs. The facility identified 39 medications were not prepared adhering to Low-Risk Level criteria when they were compounded on the Pharmacy counter outside of a compounding device certified with International Organization for Standardization (ISO - a standard-setting organization) Class 5 (measure of air cleanliness) environment. This occurred when the compounding process involved the simple transfer of more than three commercially manufactured packages of sterile nonhazardous products to 28 (Patient 38, Patient 39, Patient 40, Patient 41, Patient 42, Patient 43, Patient 44, Patient 45, Patient 46, Patient 47, Patient 48, Patient 49, Patient 50, Patient 51, Patient 52, Patient 53, Patient 54, Patient 55, Patient 56, Patient 57, Patient 58, Patient 59, Patient 60, Patient 61, Patient 62, Patient 63, Patient 64, and Patient 65) of 65 sampled patients. This failure had the potential to expose patients to increased risk of infections since compounding in an environment worse than ISO Class 5 conditions increases the likelihood of microbial (germ) contamination.

Findings:

On November 5, 2018, at 8:33 AM, during record review and concurrent interview, the compounding logs were reviewed with the Director of Pharmacy (DOP) and Pharmacy Manager for Patient 38, Patient 39, Patient 40, Patient 41, Patient 42, Patient 43, Patient 44, Patient 45, Patient 46, Patient 47, Patient 48, Patient 49, Patient 50, Patient 51, Patient 52, Patient 53, Patient 54, Patient 55, Patient 56, Patient 57, Patient 58, Patient 59, Patient 60, Patient 61, Patient 62, Patient 63, Patient 64, and Patient 65. The DOP acknowledged 291 medications were compounded in the hospital's Pharmacy Department on the Pharmacy counter outside of a compounding device certified with ISO Class 5 environment from October 12, 2018, to November 1, 2018. The DOP stated 39 medications out of 291 medications were prepared as Medium-Risk Level CSPs.

On November 5, 2018, at 3:39 PM, during an interview, a group meeting was conducted with Governing Board members. The Chief Executive Officer (CEO - the highest ranking individual in the organization responsible for making decisions) stated there was a misunderstanding on Low-Risk Level CSPs versus Medium-Risk Level CSPs.

A review of USP <797> indicated, "Preparations that are medium-risk level and high-risk level shall not be prepared as immediate-use CSPs. Immediate-use CSPs are exempt from the requirements described for Low-Risk Level CSPs only when all of the following criteria are met: The compounding process involves simple transfer of not more than three commercially manufactured packages of sterile nonhazardous products ...from the manufacturers' original containers and not more than two entries into any one container or package (e.g., bag, vial) of sterile infusion solution or administration container/device."

Continued review of USP <797> indicated, "Examples of Low-Risk Compounding ...simple aseptic measuring and transferring with not more than three packages of manufactured sterile products, including an infusion or diluent solution to compound drug admixtures and nutritional solutions."

The facility document titled "Compound IV's [abbreviation for intravenous - into the patient's vein] For Immediate Use Only" dated October 12, 2018, indicated "All Pharmacy Staff: Effective immediately, Pharmacy department at [the name of the city] will compound IV's preparations for Immediate Use only. The following definition will be adopted as immediate use. The immediate-use provision is intended only for those situations where there is a need for emergency or immediate patient administration of a Compounded Sterile Product (CSP). Such situations may include cardiopulmonary resuscitation [CPR - emergency technique when a patient's heart or breathing has stopped], emergency room treatment, preparation of diagnostic agents, or critical therapy where the preparation of the CSP under conditions described for Low-Risk Level CSPs subjects the patient to additional risk due delays in therapy."

The facility policy and procedure titled, "Pharmacy Compounding" dated March 2018, indicated " ...the handling of immediate-use CSPs must meet all of the following criteria ...Preparations that are medium-risk level and high-risk level CSPs shall not be prepared as immediate-use CSPs." The policy indicated, "References ...USP <797>."

The facility document titled, "Bylaws of [the name of the healthcare system]" dated January 1, 2014, indicated "Section 3. Role and Functions for the Local Governing Board ...Subject to the foregoing, the Local Governing Board's responsibilities shall include, but not be limited to: (g) Direct all reasonable and necessary steps be taken by the Medical Staff and the Hospital CEO [Chief Executive Officer] for meeting ...applicable accrediting body, and complying with the licensing requirements of the State of California, and federal and state requirements for certification and payment under the Medicare [federal agency that provides healthcare] and Medicaid [agency that provides health coverage for low income individuals] programs."

Based on interview and record review, the hospital failed to ensure the Condition of Participation for Patient Rights was met by failing to ensure the following:

1. That six of 65 sampled patients (Patients 26, 13, 16, 18, 1 and 4) received safe care when conserved (the patient has a legal guardian due to mental or physical disability and cannot care for self) or suicidal patients eloped (left facility without treatment) or conserved and signed out against medical advice (leaving the hospital-AMA). (Refer to A-0144)

2. The facility failed to ensure a non-employee licensed nurse was educated on the hospital's elopement (patient leaving the hospital without a physician discharge order) policy when one of 65 sampled patients (Patient 27) eloped from the facility without staff knowledge and her whereabouts were unknown. This failure had placed Patient 27's life in jeopardy for serious injuries/accidents or death. (Refer to A-0398)

The cumulative effect of this systemic problem had the potential to result in serious harm or death of the patients.

Based on observation, interview, and record review, the facility failed to ensure six of 65 sampled patients (Patients 26, 13, 16, 18, 1 and 4) received safe care when conserved (the patient has a legal guardian due to mental or physical disability and cannot care for self) or suicidal patients eloped (left facility without treatment) or conserved and signed out against medical advice (leaving the hospital-AMA). These failures had the potential to cause actual harm or death of the patients.

Findings:

An unannounced complaint validation survey was conducted on October 30, 2018 due to facility reported incidents of a conserved patient elopement from the urgent care department and a conserved patient in the medical-surgical department who was allowed to sign out AMA.

A list of patients who had eloped or signed out AMA was requested and reviewed. The list contained the following patients:

1. During a review of the record for Patient 26, the Facesheet (patient demographics) indicated admission on August 15, 2018 at 7:11 PM. Chief complaint included vomiting, headache, and stomach ache. The emergency contact information indicated a name as "LAPG Unit 6."

During a review of the record for Patient 26, the ED (Emergency Department) Triage dated August 15, 2018, at 3:00 PM, indicated past medical history which includes Schizoaffective disorder (a mental disorder in which a person experiences a combination of symptoms, such as hallucinations or delusions, depression or mania) and hypertension (elevated blood pressure).

During an interview with the Assistant Chief Nursing Officer (ACNO 1), on November 2, 2018, at 2:53 PM, she stated Patient 26 signed AMA (leaving the hospital Against Medical Advice) on August 16, 2018 at 12:59 PM. She stated the facesheet contact information indicated LAPG "which means Los Angeles Public Guardian." LAPG Unit 6 was not contacted prior to Patient 26 signing for AMA.

2. On August 22, 2018, at 12:30 AM, Patient 13 presented to the urgent care with the Chief (main) Complaint of Suicidal Ideation.

During a review of the clinical record for Patient 13, the Emergency Department Triage (assessment of patient) dated August 22, 2018, at 12:49 AM, indicated a Chief Complaint of Suicidal Ideation and the Suicide Risk Screen with Thoughts of Suicide/Self-Harm indicated "Yes."

During a review of the clinical record for Patient 13, the Emergency Department Medical Doctor notes dated August 22, 2018, at 2:07 AM, indicated, Chief Complaint Details of anger outbursts, Homicidal Ideation and Presenting Symptoms of Homicidal thoughts.

During a review of the clinical record for Patient 13, the Nursing Narrative Note dated August 22, 2018, at 4:05 AM, indicated, "0400 (4 AM) - Pt (patient) left facility without letting staff know ...Code green was called. Security searched facility's vicinity ...Patient was not found around the hospital's vicinity.

During an interview with Chief Nursing Officer (CNO) on November 1, 2018, at 10:50 AM, she stated, "...patients are considered an elopement risk if they are suicidal, have a conservator, or if they have tried to harm themselves."

The facility policy and procedure titled, "Suicidal Patient Care and Transfer" dated April 26, 2016, indicated, " ...A sitter shall be assigned to the patient until the patient is deemed non-suicidal by a psychiatrist, or transferred to the Behavioral Health Unit."

3. On August 6, 2018, at 9:59 PM, Patient 16 presented to the Urgent Care with the Chief (main) Complaint of Depression and Suicidal.

During a review of the clinical record for Patient 16, the patient face sheet (demographic information) dated August 6, 2018, at 9:59 PM, indicated, Depressed and Suicidal.

During a review of the clinical record for Patient 16, the Emergency Department Triage (assessment of patient) dated August 6, 2018, at 11:45 PM, the Chief Complaint indicated "SI (Suicidal Ideation)", Elopement Risk Assessment indicated "No," and Suicidal Thoughts, Plans, Intention, Lethality indicated "Run into traffic."

During a review of the clinical record for Patient 16, the Emergency Department Medical Doctor notes dated August 6, 2018, at 11:49 PM, indicated, Chief Complaint details of Suicidal Ideation-run into traffic, back pain, homeless and Intent of Suicidal.

During a review of the clinical record for Patient 16, the Discharge Note Nursing dated August 7, 2018, at 5:11 AM, indicated, "...Patient couldn't be found in the vicinity when transportation was ready to pick him up. Called code green..."

During an interview with Registered Nurse (RN 2), on November 5, 2018, at 11:40 AM, she stated that if she has a suicidal patient that is at risk for elopement she will try to make them a 1:1 (close supervision) or ask someone, such as a Certified Nurse Assistant (CNA), if they can help watch the patient more closely if the patient is trying to leave. RN 2 said sometimes she is unable to place the patient on 1:1 supervision because there is not enough staff.

During an interview with Chief Nursing Officer (CNO) on November 1, 2018, at 10:50 AM, she stated, ' ...patients are considered an elopement risk if they are suicidal, have a conservator, or if they have tried to harm themselves."

The facility policy and procedure titled, "Suicidal Patient Care and Transfer" dated April 26, 2016, indicated, " ...A sitter shall be assigned to the patient until the patient is deemed non-suicidal by a psychiatrist, or transferred to the Behavioral Health Unit."

4. On September 4, 2018, at 1:09 PM, Patient 18 presented to the Urgent Care with the Chief (main) Complaint of Suicidal Ideation.

During a review of the clinical record for Patient 18, the patient face sheet (demographic information) dated September 4, 2018, at 1:09 PM, indicated, Suicidal Ideation.

During a review of the clinical record for Patient 18, the Emergency Department Triage notes dated September 4, 2018, at 2:52 PM, the Chief Complaint indicated Suicidal Ideation, Elopement Risk indicated "No," and Suicide Risk Screen Thoughts of Suicide Self Harm indicated "Yes.'

During a review of the clinical record for Patient 18 on November 5, 2018, at 11:15 AM, there were no physician notes.

During a review of the clinical record for Patient 18, the Nursing Narrative Note dated September 4, 2018, at 3:31 PM, indicated, "...Patient ran out after the phlebotomist tried drawing blood ...Nursing supervisor aware ...staff will call the police to give report."

During an interview with Registered Nurse (RN 2), on November 5, 2018, at 11:40 AM, she stated that if she has a suicidal patient that is at risk for elopement she will try to make them a 1:1 (close supervision) or ask someone, such as a Certified Nurse Assistant (CNA), if they can help watch the patient more closely if the patient is trying to leave. RN 2 said sometimes she is unable to place the patient on 1:1 supervision because there is not enough staff.

During an interview with the Chief Nursing Officer (CNO) on November 1, 2018, at 10:50 AM, she stated, " ...patients are considered an elopement risk if they are suicidal, have a conservator, or if they have tried to harm themselves."

The facility policy and procedure titled, "Suicidal Patient Care and Transfer" dated April 26, 2016, indicated, "...A sitter shall be assigned to the patient until the patient is deemed non-suicidal by a psychiatrist, or transferred to the Behavioral Health Unit."

5. During an observation of the Urgent Care Clinic on October 31, 2018 at 2:26 PM, the main care area was observed with an unsecured electric push button activated sliding double door exit to the outside immediately adjacent to the main care area of the Urgent Care Clinic.

A concurrent interview was conducted in the Urgent Care main area on October 31, 2018 at 2:35 PM with Licensed Vocational Nurse (LVN 1). LVN 1 was asked how are patients under the care of a conservatorship identified and who is responsible for determining conserved patients? LVN 1 stated, "Admitting clerks are responsible for designating patients who are under conservatorship, they document that information on the face sheet (Patient demographic information) and in the conditions of admission packet. The conservator paperwork with the patient chart is delivered to the urgent care unit. The patients are placed with a pink bracelet by admitting clerks which indicates the patient is under a conservator."

LVN 1 was also asked where do you place patients who are under the care of the conservatorship in the Urgent Care Clinic? LVN 1 stated, "All of those patients are either on an ambulance stretcher in the overflow with the crew or in the main care area being watched by the staff." LVN 1 was asked, is it possible a patient under a conservatorship could elope without the staff observing the patient elopement? LVN 1 stated, "It is possible, but the staff are here watching patients including conserved patients, but sometimes patients leave (elope) on occasion and are not found, they leave out the back door."

During an interview via phone on November 5, 2018 at 2:10 PM with RN 3, the RN was asked, how are patients, under the care of a conservatorship identified, and who is responsible for determining conserved patients? RN 3 stated, "Admitting clerks are responsible for determining patients who are under conservatorship, they document that information on the face sheet and in the conditions of admission packet. The conservator documentation usually accompanies the patient chart when they come to the urgent care unit. The patients also receive a pink bracelet by admitting clerks which indicates the patient is under conservatorship."

A review of Patient 1 Conditions of Admission dated, August 8, 2018 at 4:39 PM indicated, "Does the patient have a conservator? Answered, "Yes." A review of the patient face sheet (Patient demographic information) indicated the patient was self-responsible with Patient 1 listed as guarantor." A review of clinical documentation ED Emergency Department) triage note dated August 8, 2018 at 4:46 PM indicated, "For Psych Clearance", answered, "Yes."

During a review of the clinical record for Patient 1, the Emergency Department Triage (assessment of patient) dated August 8, 2018, at 4:53 PM, indicated presenting symptoms as, "Depression, refuses meds/care."

A review of clinical record for Patient 1, "Discharge Note Nursing", dated August 8, 2018 indicated, "disposition: left against medical advice, patient elope at 2105 (9:05 PM). "Comments: at 2105 patient noted nowhere to be found, code green activated at 2112 (9:12 PM - 7 minutes after) security and Urgent Care (UC) MD and RN supervisor made aware ...Security checked hospital video camera, noted the patient left the hospital at 1946 (7:46 PM), patient just walked out of the hospital without notifying staff or UC MD." Review of clinical record "Admissions, Discharge and Transfer (ADT) document dated, August 8, 2018 at 6:49 AM indicated, "Discharge location, elopement."

6. A review of Patient 4 Conditions of Admission dated, October 2, 2018 at 3:13 PM indicated, "Does the patient have a conservator? Answered, "No." A review of the patient face sheet dated October 4, 2018 at 3:02 PM (Patient demographic information) indicated Patient 4 had an ER (Emergency Room) contact person, relationship, "Conservator", with Patient 4 listed as "self-guarantor." Conditions of Admission documentation indicated, "Patient unable to sign due to condition, altered mental status."

During a review of the clinical record for Patient 4, the Emergency Department Triage (initial assessment of patient) dated October 4, 2018, at 3:49 PM, indicated presenting symptoms as, "Mood disorder, Depression." Review of Emergency Department Triage note, dated October 5, 2018 at 1:02 AM, "Disposition of Care: Planned disposition, eloped, Transfer of care: Receiving physician, Eloped."

A review of clinical record, "Discharge Note Nursing", dated October 4, 2018 at 8:31 PM, indicated, "disposition: psychiatric hospital Bellflower documented at 8:32 PM.

A review of clinical record, "Nursing Narrative Note", dated October 5, 2018 at 12:27 AM indicated, "Patient wants to go AMA [against medical advice] but refuses to sign paperwork. Patient got agitated and violent and started fighting with security guards. Patient was instructed the benefits of being hospitalized rather than leaving the hospital without being discharged. Instructed patient that the hospital is not liable if anything happen(s) outside hospital premises. Patient verbalized understanding. Nursing supervisor and UC doctor are aware."

An interview with VPCO and ACNO 1 on November 1, 2018 at 2:37 PM, ACNO 1 was asked to confirm what the final disposition of Patient 4 from the Urgent Care, ACNO 1 stated, "Patient 4 eloped from the facility and did not return."

A review of facility policy and procedure titled, "Standards for Care Objective" dated July, 2003, indicated, "N. Safety precautions and policies will be followed."

A review of facility policy and procedure titled, "Elopement" dated November, 2011 indicated, "III. A. Admission risk assessment. ii. Appropriate interventions and precautions will be established to protect the patient from leaving the premises unattended ...C. Behavioral Health Patients-interventions and Plan of Care, i. Involuntary behavioral health patients on legal hold or conservatorship may be physically restrained to prevent elopement. Security/hospital staff may intervene to bring the patient back to respective unit as long as the patient is still on hospital grounds."

Based on interview and record review, the facility failed to maintain the Quality Assessment and Performance Improvement program to ensure the following:

1. Compounded (mixed) medications prepared in the hospital's Pharmacy Department were consistent with the immediate-use (for urgent situations) requirements of The United States Pharmacopeia (USP - standard of practice for sterile (germ-free) compounding) <797>. USP <797> indicates immediate-use compounded sterile preparations (CSPs) must be prepared under conditions described for Low-Risk Level (category of contamination risk) CSPs. Medium-Risk Level CSPs (category of contamination risk) must not be prepared as immediate-use CSPs. The facility identified 39 medications were not prepared adhering to Low-Risk Level criteria when they were compounded on the Pharmacy counter outside of a compounding device certified with International Organization for Standardization (ISO - a standard-setting organization) Class 5 (measure of air cleanliness) environment. This occurred when the compounding process involved the simple transfer of more than three commercially manufactured packages of sterile nonhazardous products to 28 (Patient 38, Patient 39, Patient 40, Patient 41, Patient 42, Patient 43, Patient 44, Patient 45, Patient 46, Patient 47, Patient 48, Patient 49, Patient 50, Patient 51, Patient 52, Patient 53, Patient 54, Patient 55, Patient 56, Patient 57, Patient 58, Patient 59, Patient 60, Patient 61, Patient 62, Patient 63, Patient 64, and Patient 65) of 65 sampled patients. This failure had the potential to expose patients to increased risk of infections since compounding in an environment worse than ISO Class 5 conditions increases the likelihood of microbial (germ) contamination. (Please refer to A-0283)

2. Patient elopements and sign out Against Medical Advice conserved patient events were monitored and analyzed for improvement. This failure resulted in continued patient elopement and AMA events, which had the potential for serious harm or death of the patients. (Refer to A-0286)

The cumulative effects of these systemic problems had the potential to result in substandard healthcare which could subsequently lead to harm, disability, and death for all facility patients.

Based on interview and record review, the Quality Assessment and Performance Improvement program failed to track and monitor implemented strategies were sustained to ensure compounded (mixed) medications prepared in the hospital's Pharmacy Department were consistent with the immediate-use (for urgent situations) requirements of The United States Pharmacopeia (USP - standard of practice for sterile (germ-free) compounding) <797>. USP <797> indicates immediate-use compounded sterile preparations (CSPs) must be prepared under conditions described for Low-Risk Level (category of contamination risk) CSPs. Medium-Risk Level CSPs (category of contamination risk) must not be prepared as immediate-use CSPs. The facility identified 39 medications were not prepared adhering to Low-Risk Level criteria when they were compounded on the Pharmacy counter outside of a compounding device certified with International Organization for Standardization (ISO - a standard-setting organization) Class 5 (measure of air cleanliness) environment. This occurred when the compounding process involved the simple transfer of more than three commercially manufactured packages of sterile nonhazardous products to 28 (Patient 38, Patient 39, Patient 40, Patient 41, Patient 42, Patient 43, Patient 44, Patient 45, Patient 46, Patient 47, Patient 48, Patient 49, Patient 50, Patient 51, Patient 52, Patient 53, Patient 54, Patient 55, Patient 56, Patient 57, Patient 58, Patient 59, Patient 60, Patient 61, Patient 62, Patient 63, Patient 64, and Patient 65) of 65 sampled patients. This failure had the potential to expose patients to increased risk of infections since compounding in an environment worse than ISO Class 5 conditions increases the likelihood of microbial (germ) contamination.

Findings:

On November 5, 2018, at 8:33 AM, during record review and concurrent interview, the compounding logs were reviewed with the Director of Pharmacy (DOP) and Pharmacy Manager for Patient 38, Patient 39, Patient 40, Patient 41, Patient 42, Patient 43, Patient 44, Patient 45, Patient 46, Patient 47, Patient 48, Patient 49, Patient 50, Patient 51, Patient 52, Patient 53, Patient 54, Patient 55, Patient 56, Patient 57, Patient 58, Patient 59, Patient 60, Patient 61, Patient 62, Patient 63, Patient 64, and Patient 65. The DOP acknowledged 291 medications were compounded in the hospital's Pharmacy Department on the Pharmacy counter outside of a compounding device certified with ISO Class 5 environment from October 12, 2018, to November 1, 2018. The DOP stated 39 medications out of 291 medications were prepared as Medium-Risk Level CSPs.

On November 5, 2018, at 2:59 PM, during an interview, a group meeting was conducted with Vice President Quality, Quality Manager, Director of Pharmacy (DOP), and Pharmacy Manager (RXM). The RXM stated "we were not on the same page as you [surveyor] in terms of Medium-Risk Level definition." When asked if anyone was monitoring or performing audits between the dates of October 12, 2018 to November 1, 2018, to ensure Medium-Risk Level medications were not being compounded, the RXM stated not every compounding log was looked at.

On November 5, 2018, at 4:10 PM, during an interview, the DOP and RXM acknowledged the hospital could not provide documentation to demonstrate the monitoring of the compounded medications on the Pharmacy counter outside of a compounding device certified with ISO Class 5 environment between the dates of October 12, 2018, to November 1, 2018.

A review of USP <797> indicated, "Preparations that are medium-risk level and high-risk level shall not be prepared as immediate-use CSPs. Immediate-use CSPs are exempt from the requirements described for Low-Risk Level CSPs only when all of the following criteria are met: The compounding process involves simple transfer of not more than three commercially manufactured packages of sterile nonhazardous products ...from the manufacturers' original containers and not more than two entries into any one container or package (e.g., bag, vial) of sterile infusion solution or administration container/device." Continued review of USP <797> indicated, "Examples of Low-Risk Compounding ...simple aseptic measuring and transferring with not more than three packages of manufactured sterile products, including an infusion or diluent solution to compound drug admixtures and nutritional solutions."

The facility document titled "Compound IV's [abbreviation for intravenous - into the patient's vein] For Immediate Use Only" dated October 12, 2018, indicated "All Pharmacy Staff: Effective immediately, Pharmacy department at [the name of the city] will compound IV's preparations for Immediate Use only. The following definition will be adopted as immediate use. The immediate-use provision is intended only for those situations where there is a need for emergency or immediate patient administration of a Compounded Sterile Product (CSP). Such situations may include cardiopulmonary resuscitation [CPR - emergency technique when a patient's heart or breathing has stopped], emergency room treatment, preparation of diagnostic agents, or critical therapy where the preparation of the CSP under conditions described for Low-Risk Level CSPs subjects the patient to additional risk due delays in therapy."

The facility policy and procedure titled, "Pharmacy Compounding" dated March 2018, indicated " ...the handling of immediate-use CSPs must meet all of the following criteria ...Preparations that are medium-risk level and high-risk level CSPs shall not be prepared as immediate-use CSPs." The policy indicated, "References ...USP <797>."

The facility policy and procedure titled, "Performance Improvement Plan" dated September 2017, indicated "Reviews, analyzes and acts upon ...Center for Medicare [federal agency that provides healthcare] /Medicaid Services [agency that provides health coverage for low income individuals], California Department of Public Health Services [state agency to evaluate compliance with regulations] and other local regulatory agency mandated required measures."

Based on interview and record review, the hospital failed to ensure patient elopements and sign out Against Medical Advice (AMA) conserved patient events were monitored and analyzed for improvement. This failure resulted in continued patient elopement and AMA events, which had the potential for serious harm or death of the patients.

Findings:

An unannounced complaint validation survey was initiated on October 30, 2018 due to hospital reported incidents involving two conserved patient who eloped from the hospital's urgent care department in August 2018. During the investigation other conserved patients and suicidal patients were identified as having eloped from the hospital since August.

1. During a review of the clinical record for Patient 26 , the Facesheet (patient demographics) indicated admission on August 15, 2018 at 7:11 PM. Chief complaint included vomiting, headache, and stomach ache. The emergency contact information indicated a name as "LAPG Unit 6."

During an interview with the Assistant Chief Nursing Officer (ACNO 1), on November 2, 2018, at 2:53 PM, she stated Patient 26 signed AMA on August 16, 2018 at 12:59 PM. She stated the facesheet contact information indicated LAPG "which means Los Angeles Public Guardian."

A review of the Nursing Narrative Note dated August 16, 2018 at 1:59 PM, indicated " ...12:45 pt (patient) came to nurse station, upset, stating he was leaving AMA. Nurse supervisor made aware patient wanted to leave AMA. Pt signed papers and he did not want to wait for supervisor."

2. A review of Patient 1 Conditions of Admission dated, August 8, 2018 at 4:39 PM indicated, "Does the patient have a conservator? Answered, "Yes." A review of the patient face sheet (Patient demographic information) indicated the patient was self-responsible with patient 1 listed as guarantor." A review of clinical documentation ED triage note dated August 8, 2018 at 4:46 PM indicated, "For Psych Clearance", answered, "Yes."

During a review of the clinical record for Patient 1, the Emergency Department Triage (assessment of patient) dated August 8, 2018, at 4:53 PM, indicated presenting symptoms as, "Depression, refuses meds/care."

A review of clinical record for Patient 1, "Discharge Note Nursing", dated August 8, 2018 indicated, "disposition: left against medical advice, patient elope at 2105 (9:05 PM). "Comments: at 2105 patient noted nowhere to be found, code green activated at 2112 (9:12 PM) security and Urgent Care (UC) MD and RN supervisor made aware ...Security checked hospital video camera, noted the patient left the hospital at 1946 (7:46 PM), patient just walked out of the hospital without notifying staff or UC MD." Review of clinical record "Admissions, Discharge and Transfer (ADT) document dated, August 8, 2018 at 6:49 AM indicated, "Discharge location, elopement."

3. On August 22, 2018, at 12:30 AM, Patient 13 presented to the Urgent Care with the Chief (main) Complaint of Suicidal Ideation.

During a review of the clinical record for Patient 13, the Emergency Department Triage (assessment of patient) dated August 22, 2018, at 12:49 AM, indicated a Chief Complaint of Suicidal Ideation and the Suicide Risk Screen with Thoughts of Suicide/Self-Harm answered Yes.

During a review of the clinical record for Patient 13, the Nursing Narrative Note dated August 22, 2018, at 4:05 AM, indicated, 0400 - Pt left facility without letting staff know ...Code green was called. Security searched facility's vicinity ...Patient was not found around the hospital's vicinity.

4. On August 6, 2018, at 9:59 PM, Patient 16 presented to the Urgent Care with the Chief (main) Complaint of Depression and Suicidal.

During a review of the clinical record for Patient 16, the patient face sheet (demographic information) dated August 6, 2018, at 9:59 PM, indicated, Depressed and Suicidal.

During a review of the clinical record for Patient 16, the Emergency Department Triage (assessment of patient) dated August 6, 2018, at 11:45 PM, indicated a Chief Complaint of Suicidal Ideation, Elopement Risk Assessment of No, and Suicidal thoughts, plans, Intention, Lethality of Run into traffic.

During a review of the clinical record for Patient 16, the Emergency Department Medical Doctor notes dated August 6, 2018, at 11:49 PM, indicated, Chief Complaint Details of Suicidal Ideation-run into traffic, back pain, homeless and Intent of Suicidal.

During a review of the clinical record for Patient 16, the Discharge Note Nursing dated August 7, 2018, at 5:11 AM, indicated, "...Patient couldn't be found in the vicinity when transportation was ready to pick him up. Called code green..."

5. On September 4, 2018, at 1:09 PM, Patient 18 presented to the Urgent Care with the Chief (main) Complaint of Suicidal Ideation.

During a review of the clinical record for Patient 18, the patient face sheet (demographic information) dated September 4, 2018, at 1:09 PM, indicated, Suicidal Ideation.

During a review of the clinical record for Patient 18, the Emergency Department Triage notes dated September 4, 2018, at 2:52 PM, indicated, Chief Complaint Suicidal Ideation, Elopement Risk of No and Suicide Risk Screen Thoughts of Suicide Self Harm of Yes.

During a review of the clinical record for Patient 18 on November 5, 2018, at 11:15 AM, there were no physician notes.

During a review of the clinical record for Patient 18, the Nursing Narrative Note dated September 4, 2018, at 3:31 PM, indicated, "...Patient ran out after the phlebotomist tried drawing blood ...Nursing supervisor aware ...staff will call the police to give report."

6. A review of Patient 4 Conditions of Admission dated, October 2, 2018 at 3:13 PM indicated, "Does the patient have a conservator? Answered, "No." A review of the patient face sheet dated October 4,2018 at 3:02 PM (Patient demographic information) indicated Patient 4 had an ER (Emergency Room) contact person, relationship, "Conservator", with Patient 4 listed as "self-guarantor." Conditions of Admission documentation indicated, "Patient unable to sign due to condition, altered mental status."

During a review of the clinical record for Patient 4, the Emergency Department Triage (initial assessment of patient) dated October 4, 2018, at 3:49 PM, indicated presenting symptoms as, "Mood disorder, Depression." Review of Emergency Department Triage note, dated October 5, 2018 at 1:02 AM, "Disposition of Care: Planned disposition, eloped, Transfer of care: Receiving physician, Eloped."

In an interview with the Vice President of Quality on November 5, 2018 at 2:32 PM, she stated that they identify elopement issues via incident reports (reports made to inform leadership of a issue) and that elopements had not been reported to quality prior to the survey.

Based on interview and record review, the hospital failed to ensure the Condition of Participation Nursing Services was met by failing to ensure the following:

1. Identify a conserved (a person who is protected by a public guardian and is mentally and/or physically unable to take care of themselves) patient (Patient 26), and did not allow him to sign and leave the facility Against Medical Advice (AMA). Patient 26's whereabouts were unknown. (Refer to A-0395)

2. Their policy and procedure was followed when they did not provide a sitter for suicidal patients (Patient 13, 14, 15, 16, 17 and 18). (Refer to A-0395)

3. A non-employee licensed nurse was educated on the hospital's elopement (patient leaving the hospital without a physician discharge order) policy when one of 65 sampled patients (Patient 27) was able to leave the facility without staff knowledge and her whereabouts were unknown. This failure had the potential for other patients to elope from the facility which can result in serious injuries/accidents or death of a patient. (Refer to A-0398)

The Cumulative effect of these systemic problems resulted in the hospital not meeting the Condition of Participation for Nursing Services and had the potential to result in serious harm or death of a patient..

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

1. Identify a conserved (a person who is protected by a public guardian and is mentally and/or physically unable to take care of themselves) patient (Patient 26), and did not allow him to sign and leave the facility Against Medical Advice (AMA). Patient 26's whereabouts were unknown. This failure had the potential for other conserved patients to leave AMA which can result in serious injuries/accidents or death of a patient.

2. Their policy and procedure was followed when they did not provide a sitter for suicidal patients (Patient 13, 14, 15, 16, 17 and 18). This failure had the potential to cause serious harm or death.

Findings:

1. During a review of the clinical record for Patient 26, the Facesheet (patient demographics) indicated admission on August 15, 2018 at 7:11 PM. Chief complaint included vomiting, headache, and stomach ache. The emergency contact information indicated a name as "LAPG Unit 6."

During an interview with the Assistant Chief Nursing Officer (ACNO 1), on November 2, 2018, at 2:53 PM, she stated Patient 26 signed AMA on August 16, 2018 at 12:59 PM. She stated the facesheet contact information indicated LAPG "which means Los Angeles Public Guardian."

During a review of the clinical record for Patient 26, the ED (Emergency Department) Triage dated August 15, 2018, at 3:00 PM, indicated past medical history which includes Schizoaffective disorder (a mental disorder in which a person experiences a combination of symptoms, such as hallucinations or delusions, depression or mania) and hypertension (elevated blood pressure).

A review of the Nursing Narrative Note dated August 16, 2018, at 1:59 PM indicated " ...12:45 pt (patient) came to nurse station, upset, stating he was leaving AMA. Nurse supervisor made aware patient wanted to leave AMA. Pt signed papers and he did not want to wait for supervisor."

During an interview with Registered Nurse (RN 1), on November 5, 2018, at 1:48 PM, she stated, "I was not aware that patient is conserved." When asked if that information was given during change of shift, she stated, "No." RN 1 further stated patients who are conserved will normally wear a pink bracelet and will have a pink sticker on their chart to alert the staff. During the incident, "He does not have a pink bracelet and a pink sticker on his chart." The incident was reported to the doctor and the police, but they were unable to locate the patient.

The undated policy and procedure titled "Against Medical Advice," was created after the incident and in the process of approval. The policy indicated " ...IV ...D. Adults under Conservatorship in general do not have the right to leave the facility Against Medical Advice ..."




39646

2a. On August 22, 2018, at 12:30 AM, Patient 13 presented to the Urgent Care with the Chief (main) Complaint of Suicidal Ideation.

During a review of the clinical record for Patient 13, the patient face sheet (demographic information) dated August 22, 2018, at 12:30 AM, indicated, Suicidal Ideation, Danger to self, Medical clearance to Psychiatric, as the Admitting Reason/Chief Complaint.

During a review of the clinical record for Patient 13, the Emergency Department Triage (assessment of patient) dated August 22, 2018, at 12:49 AM, indicated a Chief Complaint of Suicidal Ideation, and the Suicide Risk Screen with Thoughts of Suicide/Self-Harm answered Yes.

During a review of the clinical record for Patient 13, the Emergency Department Medical Doctor notes dated August 22, 2018, at 2:07 AM, indicated, Chief Complaint Details of anger outbursts, Homicidal Ideation and Presenting Symptoms of Homicidal thoughts.

During a review of the clinical record for Patient 13, the Nursing Narrative Note dated August 22, 2018, at 4:05 AM, indicated, "0400 (4 AM) - Pt (patient) left facility without letting staff know ...Code green was called. Security searched facility's vicinity ...Patient was not found around the hospital's vicinity.

During an interview with Registered Nurse (RN 2), on November 5, 2018, at 11:40 AM, she stated that if she has a suicidal patient that is at risk for elopement she will try to make them a 1:1 (close supervision) or ask someone, such as a Certified Nurse Assistant (CNA), if they can help watch the patient more closely if the patient is trying to leave. RN 2 said sometimes she is unable to place the patient on 1:1 supervision because there is not enough staff.

During an interview with Chief Nursing Officer (CNO) on November 1, 2018, at 10:50 AM, she stated, "...patients are considered an elopement risk if they are suicidal, have a conservator, or if they have tried to harm themselves."

The facility policy and procedure titled, "Suicidal Patient Care and Transfer" dated April 26, 2016, indicated, " ...A sitter shall be assigned to the patient until the patient is deemed non-suicidal by a psychiatrist, or transferred to the Behavioral Health Unit."

b. On August 7, 2018, at 3:38 PM, Patient 14 presented to the Urgent Care with the Chief (main) complaint of Medical Clearance because of suicidal thoughts.

During a review of the clinical record for Patient 14, the patient face sheet (demographic information) dated August 7, 2018, at 3:38 PM, indicated, Medical Clearance, as the Admit Reason/Chief Complaint.

During a review of the clinical record for Patient 14, the Emergency Department Medical Doctor notes dated August 7, 2018, at 6:00 PM, indicated, Chief Complaint Details are depressed and suicidal ideation, Presenting Symptoms are suicidal thoughts and Intent is Suicidal.

During a review of the clinical record for Patient 14, the Nursing Narrative Note dated August 8, 2018, at 1:20 AM, indicated, Patient went outside the hospital premises and wants to leave the hospital ...Informed (name of Case Manager). Left voice messages to (name of Niece).

During an interview with Registered Nurse (RN 2), on November 5, 2018, at 11:40 AM, she stated that if she has a suicidal patient that is at risk for elopement she will try to make them a 1:1 (close supervision) or ask someone, such as a Certified Nurse Assistant (CNA), if they can help watch the patient more closely if the patient is trying to leave. RN 2 said sometimes she is unable to place the patient on 1:1 supervision because there is not enough staff.

During an interview with Chief Nursing Officer (CNO) on November 1, 2018, at 10:50 AM, she stated, ' ...patients are considered an elopement risk if they are suicidal, have a conservator, or if they have tried to harm themselves."

The facility policy and procedure titled, "Suicidal Patient Care and Transfer" dated April 26, 2016, indicated, " ...A sitter shall be assigned to the patient until the patient is deemed non-suicidal by a psychiatrist, or transferred to the Behavioral Health Unit."

c. On September 4, 2018, at 5:57 PM, Patient 15 presented to the Urgent Care with the Chief (main) Complaint of Medical Clearance because of Suicidal thoughts.

During a review of the clinical record for Patient 15, the patient face sheet (demographic information) dated September 4, 2018, at 6:54 AM, indicated, Medical Clearance as the Admitting Reason/Chief Complaint.

During a review of the clinical record for Patient 15, the Emergency Department Medical Doctor notes dated September 5, 2018, at 6:54 AM, indicated, Chief Complaint of Suicidal Ideation with a plan to overdose on medications and a Tentative Diagnosis of Suicidal Ideation.

During a review of the clinical record for Patient 15, on November 5, 2018, at 11:00 AM, there were no nursing or physician discharge notes in the medical record.

During an interview with Registered Nurse (RN 2), on November 5, 2018, at 11:40 AM, she stated that if she has a suicidal patient that is at risk for elopement she will try to make them a 1:1 (close supervision) or ask someone, such as a Certified Nurse Assistant (CNA), if they can help watch the patient more closely if the patient is trying to leave. RN 2 said sometimes she is unable to place the patient on 1:1 supervision because there is not enough staff.

During an interview with Chief Nursing Officer (CNO) on November 1, 2018, at 10:50 AM, she stated, ' ...patients are considered an elopement risk if they are suicidal, have a conservator, or if they have tried to harm themselves."
The facility policy and procedure titled, "Suicidal Patient Care and Transfer" dated April 26, 2016, indicated, " ...A sitter shall be assigned to the patient until the patient is deemed non-suicidal by a psychiatrist, or transferred to the Behavioral Health Unit."

d. On August 6, 2018, at 9:59 PM, Patient 16 presented to the Urgent Care with the Chief (main) Complaint of Depression and Suicidal.

During a review of the clinical record for Patient 16, the patient face sheet (demographic information) dated August 6, 2018, at 9:59 PM, indicated, Depressed and Suicidal.

During a review of the clinical record for Patient 16, the Emergency Department Triage (assessment of patient) dated August 6, 2018, at 11:45 PM, the Chief Complaint indicated "Suicidal Ideation (SI)", Elopement Risk Assessment indicated "No," and Suicidal Thoughts, Plans, Intention, Lethality indicated "Run into traffic."

During a review of the clinical record for Patient 16, the Emergency Department Medical Doctor notes dated August 6, 2018, at 11:49 PM, indicated, Chief Complaint Details of Suicidal Ideation-run into traffic, back pain, homeless and Intent of Suicidal.

During a review of the clinical record for Patient 16, the Discharge Note Nursing dated August 7, 2018, at 5:11 AM, indicated, ...Patient couldn't be found in the vicinity when transportation was ready to pick him up. Called code green ...

During an interview with Registered Nurse (RN 2), on November 5, 2018, at 11:40 AM, she stated that if she has a suicidal patient that is at risk for elopement she will try to make them a 1:1 (close supervision) or ask someone, such as a Certified Nurse Assistant (CNA), if they can help watch the patient more closely if the patient is trying to leave. RN 2 said sometimes she is unable to place the patient on 1:1 supervision because there is not enough staff.

During an interview the with Chief Nursing Officer (CNO) on November 1, 2018, at 10:50 AM, she stated, " ...patients are considered an elopement risk if they are suicidal, have a conservator, or if they have tried to harm themselves."

The facility policy and procedure titled, "Suicidal Patient Care and Transfer" dated April 26, 2016, indicated, " ...A sitter shall be assigned to the patient until the patient is deemed non-suicidal by a psychiatrist, or transferred to the Behavioral Health Unit."

e. On September 7, 2018, at 6:08 PM, Patient 17 presented to the Urgent Care with the Chief (main) Complaint of Medical Clearance because of Suicidal Ideation.

During a review of the clinical record for Patient 17, the patient face sheet (demographic information) dated September 7, 2018, at 6:08 PM, indicated, Medical Clearance.

During a review of the clinical record for Patient 17, the Emergency Department Medical Doctor notes dated September 7, 2018, at 9:49 PM, indicated, Chief Complaint Details of Depression with Suicidal Ideation, Presenting Symptoms of Depression, and Tentative Diagnosis of Depression with Suicidal Ideation Drug Overdose.

During a review of the clinical record for Patient 17, the Nursing Narrative Note dated September 8, 2018, at 4:44 AM, indicated, ...Patient came in voluntarily for medical clearance. ...just waiting for hospital transport ...when driver arrived patient refuses to go to ...says he is no longer suicidal.

During an interview with Registered Nurse (RN 2), on November 5, 2018, at 11:40 AM, she stated that if she has a suicidal patient that is at risk for elopement she will try to make them a 1:1 (close supervision) or ask someone, such as a Certified Nurse Assistant (CNA), if they can help watch the patient more closely if the patient is trying to leave. RN 2 said sometimes she is unable to place the patient on 1:1 supervision because there is not enough staff.

During an interview with the Chief Nursing Officer (CNO) on November 1, 2018, at 10:50 AM, she stated, " ...patients are considered an elopement risk if they are suicidal, have a conservator, or if they have tried to harm themselves."

The facility policy and procedure titled, "Suicidal Patient Care and Transfer" dated April 26, 2016, indicated, " ...A sitter shall be assigned to the patient until the patient is deemed non-suicidal by a psychiatrist, or transferred to the Behavioral Health Unit."

f. On September 4, 2018, at 1:09 PM, Patient 18 presented to the Urgent Care with the Chief (main) Complaint of Suicidal Ideation.

During a review of the clinical record for Patient 18, the patient face sheet (demographic information) dated September 4, 2018, at 1:09 PM, indicated, Suicidal Ideation.

During a review of the clinical record for Patient 18, the Emergency Department Triage notes dated September 4, 2018, at 2:52 PM, indicated, Chief Complaint Suicidal Ideation, Elopement Risk of No and Suicide Risk Screen Thoughts of Suicide Self Harm of Yes.

During a review of the clinical record for Patient 18 on November 5, 2018, at 11:15 AM, there were no physician notes.

During a review of the clinical record for Patient 18, the Nursing Narrative Note dated September 4, 2018, at 3:31 PM, indicated, ...Patient ran out after the phlebotomist tried drawing blood ...Nursing supervisor aware ...staff will call the police to give report.

During an interview with Registered Nurse (RN 2), on November 5, 2018, at 11:40 AM, she stated that if she has a suicidal patient that is at risk for elopement she will try to make them a 1:1 (close supervision) or ask someone, such as a Certified Nurse Assistant (CNA), if they can help watch the patient more closely if the patient is trying to leave. RN 2 said sometimes she is unable to place the patient on 1:1 supervision because there is not enough staff.

During an interview with the Chief Nursing Officer (CNO) on November 1, 2018, at 10:50 AM, she stated, " ...patients are considered an elopement risk if they are suicidal, have a conservator, or if they have tried to harm themselves."

The facility policy and procedure titled, "Suicidal Patient Care and Transfer" dated April 26, 2016, indicated, " ...A sitter shall be assigned to the patient until the patient is deemed non-suicidal by a psychiatrist, or transferred to the Behavioral Health Unit."

Based on interview and record review, the facility failed to ensure a non-employee licensed nurse was educated on the hospital's elopement (patient leaving the hospital without a physician discharge order) policy when one of 65 sampled patients (Patient 27) eloped from the facility without staff knowledge and her whereabouts were unknown. This failure had placed Patient 27's life in jeopardy for serious injuries, accidents or death.

Findings:

During an interview with Charge Registered Nurse (CRN 1), on October 31, 2018, at 11:00 AM, when asked about the incidence of elopement on Medical-Surgical Unit, CRN 1 stated, "We have one patient who eloped a few days ago." CRN 1 checked on the list of the patients and provided Patient 27's information. Patient 27 eloped on October 30, 2018. CRN 1 stated a registry (non-employee) licensed nurse (RRN 1) was taking care of the patient at the time of incident.

During a review of the record for Patient 27, the Facesheet (patient demographics), indicated Patient 27 was admitted on October 26, 2018 due to respiratory failure, acute status asthmaticus (severe acute asthma).

During a review of the employee file record for RRN 1, the Registry Orientation Checklist dated July 18, 2018 indicated that Code Green and elopement protocol was not included on Safety Management education for RRN 1.

During an interview with CRN 1 on November 1, 2018, at 10:05 AM, she stated she cannot find a documentation on Patient 27's record that code green was called. There was no documentation that attempts were made to locate and contact the patient nor the family. CRN 1 further stated part of their intervention to monitor a patient is to do patient rounds every hour, and document it on the log.

The facility policy and procedure titled "Elopement" dated March 2016, indicated " ...D. Staff Response to Unanticipated Absence of Patient: i. Overhead page a "Code (used in hospitals to alert staff to various emergencies) Green" and location where assistance is needed ....G. Documentation in the Medical Record: ...ii. The time and details of when the patient was last seen, staff actions, status of how, when and where the patient was found, if applicable ...v. Record notification of all persons contacted regarding elopement."

A review of the record for Patient 27, the Purposeful Rounding Log indicated staff rounds conducted on October 29, 2018 from 10:00 PM to 6:00 AM the next day. There was no documentation of rounds after 6:00 AM, the day of elopement.

During an interview with RRN 1, on November 1, 2018, at 11:15 AM, she stated she last saw Patient 27 around 12:00 PM on October 30, 2018. She stated the patient told her that she wants to go home due to patient yelling in another room. When RRN 1 was asked if she was educated with the code green and elopement policy, RRN 1 stated, "No I was not oriented about code green and elopement policy."

During an interview with the Director of Risk Management (DRM), on November 1, 2018, at 11:38 AM, he stated he was not aware that Patient 27 had eloped. There was no incident report submitted. Risk management was not able to follow up the location of the patient.

During an interview with the Director of Medical-Surgical Unit (DMS), on November 1, 2018, at 11:45 AM, DMS stated he was not aware about Patient 27's elopement. He stated, "I just found it out this morning."

On November 1, 2018, at 4:42 PM, an Immediate Jeopardy (a situation with the potential to harm the patient's health and safety) was called in the presence of the facility Chief Executive Officer (CEO), Vice Chief of Staff (VCOS), Vice President of Hospital Operations (VPHO), Assistant Chief Nursing Officer (ACNO) and the Vice President of Quality (VPQ). The facility Administrators were verbally notified that registry nurses were not oriented to the hospital's elopement policy and procedure which resulted in the patient to leave the hospital without the hospital staff and management's knowledge. It was also discussed that Nursing staff were not ensuring patients who were conserved and/or suicidal did not elope or sign out Against Medical Advice. These deficiencies had the potential to jeopardize the health and safety of patients.

On November 2, 2018, at 3:38 PM, the Immediate Jeopardy was abated (lifted) in the presence of the CEO, the VPQ, VPHO, ACNO, and the Director of Risk Management (DRM). The facility Corrective Action Plan was approved through interview and record review, as evidenced by the Nursing and Registry staff being able to state the process for preventing elopements from the hospital Urgent Care and inpatient areas. The training sign-in sheets were reviewed and all staff that were currently working had been in-serviced.

The Corrective Action Plan included the following components:

1. When independently mobile conserved patients present to the Urgent Care, the patients will be maintained under continuous observation. Patients identified to be at risk for elopement, or with suicidal/homicidal ideation, will also be maintained under continuous observation.

2. Hospital staff will be in-serviced on this process beginning immediately and will continue until 100% compliance has been achieved.

3. Persons assigned as monitors will maintain a log of the time patients spend in observation.

4. A notation referencing monitoring will be documented in the charts of all conserved patients.

5. A review of all conserved patients will be performed monthly to ensure that a monitoring process was implemented. These results will be reported up to the Quality Council, MEC (Medical Executive Committee), and Governing Body monthly for a period not to exceed 6 months, or until optimal compliance is achieved and sustained.

6. The hospital's policy titled Observation for Patient Risk has been revised to include conserved patients, with an identified elopement risk, as an example of situations requiring continuous observations. This policy has received emergency approval by the Chief of Staff for immediate roll-out and staff education.

7. Hospital staff, to include registry personnel, will be in-serviced on the hospital's Elopement Policy. Registry personnel will not be assigned a shift until they have received the referenced in-service. Code Green (called when a patient is missing) drills, to include Security Staff, will be conducted weekly for a period of 90 days at all locations, at various shifts and times. These results will be reported up to the Quality Council, MEC, and Governing Body monthly, for a period not to exceed 3 months, or until optimal compliance is achieved and sustained. The Chief Nursing Officer, or qualified designee shall be responsible for implementation and sustainment of the corrective action plan.

Based on interview and record review, the facility failed to ensure the safe preparation of compounded (mixed) medications prepared in the hospital's Pharmacy Department were not consistent with the immediate-use (for urgent situations) requirements of The United States Pharmacopeia (USP - standard of practice for sterile (germ-free) compounding) <797>. USP <797> indicates immediate-use compounded sterile preparations (CSPs) must be prepared under conditions described for Low-Risk Level (category of contamination risk) CSPs. Medium-Risk Level CSPs (category of contamination risk) must not be prepared as immediate-use CSPs. The facility identified 39 medications were not prepared adhering to Low-Risk Level criteria when they were compounded on the Pharmacy counter outside of a compounding device certified with International Organization for Standardization (ISO - a standard-setting organization) Class 5 (measure of air cleanliness) environment. This occurred when the compounding process involved the simple transfer of more than three commercially manufactured packages of sterile nonhazardous products to 28 (Patient 38, Patient 39, Patient 40, Patient 41, Patient 42, Patient 43, Patient 44, Patient 45, Patient 46, Patient 47, Patient 48, Patient 49, Patient 50, Patient 51, Patient 52, Patient 53, Patient 54, Patient 55, Patient 56, Patient 57, Patient 58, Patient 59, Patient 60, Patient 61, Patient 62, Patient 63, Patient 64, and Patient 65) of 65 sampled patients. This failure had the potential to expose patients to increased risk of infections since compounding in an environment worse than ISO Class 5 conditions increases the likelihood of microbial (germ) contamination. (Please refer to A-0501)

The cumulative effects of these systemic problems had the potential to result in substandard healthcare which could subsequently lead to harm, disability, and death for all facility patients.

Based on interview and record review, the facility failed to ensure the safe preparation of compounded (mixed) medications prepared in the hospital's Pharmacy Department were consistent with the immediate-use (for urgent situations) requirements of The United States Pharmacopeia (USP - standard of practice for sterile (germ-free) compounding) <797>. USP <797> indicates immediate-use compounded sterile preparations (CSPs) must be prepared under conditions described for Low-Risk Level (category of contamination risk) CSPs. Medium-Risk Level CSPs (category of contamination risk) must not be prepared as immediate-use CSPs. The facility identified 39 medications were not prepared adhering to Low-Risk Level criteria when they were compounded on the Pharmacy counter outside of a compounding device certified with International Organization for Standardization (ISO - a standard-setting organization) Class 5 (measure of air cleanliness) environment. This occurred when the compounding process involved the simple transfer of more than three commercially manufactured packages of sterile nonhazardous products to 28 (Patient 38, Patient 39, Patient 40, Patient 41, Patient 42, Patient 43, Patient 44, Patient 45, Patient 46, Patient 47, Patient 48, Patient 49, Patient 50, Patient 51, Patient 52, Patient 53, Patient 54, Patient 55, Patient 56, Patient 57, Patient 58, Patient 59, Patient 60, Patient 61, Patient 62, Patient 63, Patient 64, and Patient 65) of 65 sampled patients. This failure had the potential to expose patients to increased risk of infections since compounding in an environment worse than ISO Class 5 conditions increases the likelihood of microbial (germ) contamination.

Findings:

On November 5, 2018, at 8:33 AM, during record review, the compounding logs were reviewed with the Director of Pharmacy (DOP) and Pharmacy Manager for Patient 38, Patient 39, Patient 40, Patient 41, Patient 42, Patient 43, Patient 44, Patient 45, Patient 46, Patient 47, Patient 48, Patient 49, Patient 50, Patient 51, Patient 52, Patient 53, Patient 54, Patient 55, Patient 56, Patient 57, Patient 58, Patient 59, Patient 60, Patient 61, Patient 62, Patient 63, Patient 64, and Patient 65. The DOP acknowledged 291 medications were compounded in the hospital's Pharmacy Department on the Pharmacy counter outside of a compounding device certified with ISO Class 5 environment from October 12, 2018, to November 1, 2018.

During a concurrent interview with the DOP, the DOP stated 39 medications out of 291 medications were prepared as Medium-Risk Level CSPs.

A review of USP <797> indicated, "Preparations that are medium-risk level and high-risk level shall not be prepared as immediate-use CSPs. Immediate-use CSPs are exempt from the requirements described for Low-Risk Level CSPs only when all of the following criteria are met: The compounding process involves simple transfer of not more than three commercially manufactured packages of sterile nonhazardous products ...from the manufacturers' original containers and not more than two entries into any one container or package (e.g., bag, vial) of sterile infusion solution or administration container/device." Continued review of USP <797> indicated, "Examples of Low-Risk Compounding ...simple aseptic measuring and transferring with not more than three packages of manufactured sterile products, including an infusion or diluent solution to compound drug admixtures and nutritional solutions."

The facility document titled "Compound IV's [abbreviation for intravenous - into the patient's vein] For Immediate Use Only" dated October 12, 2018, indicated "All Pharmacy Staff: Effective immediately, Pharmacy department at [the name of the city] will compound IV's preparations for Immediate Use only. The following definition will be adopted as immediate use. The immediate-use provision is intended only for those situations where there is a need for emergency or immediate patient administration of a Compounded Sterile Product (CSP). Such situations may include cardiopulmonary resuscitation [CPR - emergency technique when a patient's heart or breathing has stopped], emergency room treatment, preparation of diagnostic agents, or critical therapy where the preparation of the CSP under conditions described for Low-Risk Level CSPs subjects the patient to additional risk due delays in therapy."

The facility policy and procedure titled, "Pharmacy Compounding" dated March 2018, indicated " ...the handling of immediate-use CSPs must meet all of the following criteria ...Preparations that are medium-risk level and high-risk level CSPs shall not be prepared as immediate-use CSPs." The policy indicated, "References ...USP <797>."

On November 1, 2018, at 4:37 PM, an Immediate Jeopardy (a situation with the potential to harm the health and safety) was called in the presence of the facility Chief Executive Officer (CEO), Director of Pharmacy (DOP), Pharmacy Manager (RXM). The facility Administrators were verbally notified of the failure of Pharmacy staff not complying with the immediate-use compounding requirements of The United States Pharmacopeia <797>. The hospital's Pharmacy staff was found to be still engaging in preparing Medium-Risk Level CSPs on the counter in the Pharmacy Department. Multiple Pharmacy Department staff interviewed did not demonstrate knowledge of immediate-use (for urgent situations) requirements of The United States Pharmacopeia (USP - standard of practice for sterile compounding) <797>. The facility failed to follow their policy and procedure on immediate-use CSPs and jeopardized the health and safety of 28 patients who were prepared Medium-Risk Level CSPs.

On November 2, 2018, at 5:02 PM, the Immediate Jeopardy situation was abated (lifted) in the presence of the DOP, the RXM, Chief Operating Officer (COO), and the Vice President Quality (VPQ). The facility Corrective Action Plan was approved through observation, interview and record review, as evidenced by the Pharmacy Department's staff knowledge of immediate-use (for urgent situations) requirements of The United States Pharmacopeia (USP - standard of practice for sterile compounding) <797>.

The Corrective Action Plan included the following components:
1. Education and training for all Pharmacy Department staff on the definition of immediate-use sterile compounding.
2. Use of premix (already prepared) medications when commercially available.
3. Contacting prescriber to modify medication order in order to meet immediate-use requirements of USP <797>.
4. Contract with sister (affiliated) hospital to prepare CSPs when the facility is unable to prepare CSPs in accordance with immediate-use requirements of USP <797>.
5. Low-Risk Level CSP Monitoring Log effective November 2, 2018

Based on interview and record review, the hospital failed to ensure the Condition of Participation Outpatient Services was met by failing to ensure the following:

1. Identify a conserved (a person who is protected by a public guardian and is mentally and/or physically unable to take care of themselves) patient (Patient 26), and did not allow him to sign and leave the facility Against Medical Advice (AMA). Patient 26's whereabouts were unknown. This failure had the potential for other conserved patients to leave AMA which can result in serious injuries/accidents or death of a patient. (Refer to A-0395)

2. Their policy and procedure was followed when they did not provide a sitter for suicidal patients (Patient 13, 14, 15, 16, 17 and 18). This failure had the potential to cause serious harm or death. (Refer to A-0395)

3. The provision of a safe and secure environment in the Urgent Care Department for two patients (Patients 1 and 4) under conservatorship (a legal guardian who makes decisions for the patient) who eloped from the Urgent Care Department. (Refer to 1081)

The cumulative effect of this systemic problem had the potential to cause serious harm or death.

Based on observations, interviews, and record reviews, the facility failed to provide a safe and secure environment in the Urgent Care Department for two patients under conservatorship (a legal guardian who makes decisions for the patient) Patients 1 and 4. This failure had the potential to cause serious harm or death.

Findings:

During an observation of the Urgent Care Clinic on October 31, 2018 at 2:26 PM, the main care area was observed with an unsecured electric push button activated sliding double door exit to the outside immediately adjacent to the main care area of the Urgent Care Clinic.

A concurrent interview was conducted in the Urgent Care main area on October 31, 2018 at 2:35 PM with Licensed Vocational Nurse (LVN 1). LVN 1 was asked how are patients under the care of a conservatorship identified and who is responsible for determining conserved patients? LVN 1 stated, "Admitting clerks are responsible for designating patients who are under conservatorship, they document that information on the face sheet (Patient demographic information) and in the conditions of admission packet. The conservator paperwork with the patient chart is delivered to the urgent care unit. The patients are placed with a pink bracelet by admitting clerks which indicates the patient is under a conservator." LVN 1 was asked where do you place patients who are under the care of the conservatorship in the Urgent Care Clinic? LVN 1 stated, "All of those patients are either on an ambulance stretcher in the overflow with the crew or in the main care area being watched by the staff." LVN 1 was asked, is it possible a patient under a conservatorship could elope without the staff observing the patient elopement? LVN 1 stated, "It is possible, but the staff are here watching patients including conserved patients, but sometimes patients leave (elope) on occasion and are not found, they leave out the back door."

During an interview via phone on November 5, 2018 at 2:10 PM with RN 3, RN was asked how are patients, under the care of a conservatorship identified, and who is responsible for determining conserved patients? RN 3 stated, "Admitting clerks are responsible for determining patients who are under conservatorship, they document that information on the face sheet and in the conditions of admission packet. The conservator documentation usually accompanies the patient chart when they come to the urgent care unit. The patients also receive a pink bracelet by admitting clerks which indicates the patient is under conservatorship."

1. A review of Patient 1 Conditions of Admission dated, August 8, 2018 at 4:39 PM indicated, "Does the patient have a conservator? Answered, "Yes." A review of the patient face sheet (Patient demographic information) indicated the patient was self-responsible with Patient 1 listed as guarantor." A review of clinical documentation ED triage note dated August 8, 2018 at 4:46 PM indicated, "For Psych Clearance", answered, "Yes."

During a review of the clinical record for Patient 1, the Emergency Department Triage (assessment of patient) dated August 8, 2018, at 4:53 PM, indicated presenting symptoms as, "Depression, refuses meds/care."

A review of clinical record for Patient 1, "Discharge Note Nursing", dated August 8, 2018 indicated, "disposition: left against medical advice, patient elope at 2105 (9:05 PM). "Comments: at 2105 patient noted nowhere to be found, code green activated at 2112 (9:12 PM) security and Urgent Care (UC) MD and RN supervisor made aware ...Security checked hospital video camera, noted the patient left the hospital at 1946 (7:46 PM), patient just walked out of the hospital without notifying staff or UC MD." Review of clinical record "Admissions, Discharge and Transfer (ADT) document dated, August 8, 2018 at 6:49 AM indicated, "Discharge location, elopement."

2. A review of Patient 4 Conditions of Admission dated, October 2, 2018 at 3:13 PM indicated, "Does the patient have a conservator? Answered, "No." A review of the patient face sheet dated October 4, 2018 at 3:02 PM (Patient demographic information) indicated Patient 4 had an ER (Emergency Room) contact person, relationship, "Conservator", with Patient 4 listed as "self-guarantor." Conditions of Admission documentation indicated, "Patient unable to sign due to condition, altered mental status."

During a review of the clinical record for Patient 4, the Emergency Department Triage (initial assessment of patient) dated October 4, 2018, at 3:49 PM, indicated presenting symptoms as, "Mood disorder, Depression." Review of Emergency Department Triage note, dated October 5, 2018 at 1:02 AM, "Disposition of Care: Planned disposition, eloped, Transfer of care: Receiving physician, Eloped."

A review of the clinical record, "Discharge Note Nursing", dated October 4, 2018 at 8:31 PM, indicated, "disposition: psychiatric hospital Bellflower documented at 8:32 PM.

A review of clinical record, "Nursing Narrative Note", dated October 5, 2018 at 12:27 AM indicated, "Patient wants to go AMA [against medical advice] but refuses to sign paperwork. Patient got agitated and violent and started fighting with security guards. Patient was instructed the benefits of being hospitalized rather than leaving the hospital without being discharged. Instructed patient that the hospital is not liable if anything happen(s) outside hospital premises. Patient verbalized understanding. Nursing supervisor and UC doctor are aware."

An interview with VPCO and ACNO 1 on November 1, 2018 at 2:37 PM, ACNO 1 was asked to confirm what the final disposition of Patient 4 from the Urgent Care. ACNO 1 stated, "Patient 4 eloped from the facility and did not return."

A review of facility policy and procedure titled, "Standards for Care Objective" dated July, 2003, indicated, "N. Safety precautions and policies will be followed."

A review of facility policy and procedure titled, "Elopement" dated November, 2011 indicated, "III. A. Admission risk assessment. ii. Appropriate interventions and precautions will be established to protect the patient from leaving the premises unattended ...C. Behavioral Health Patients-interventions and Plan of Care, i. Involuntary behavioral health patients on legal hold or conservatorship may be physically restrained to prevent elopement. Security/hospital staff may intervene to bring the patient back to respective unit as long as the patient is still on hospital grounds."