HospitalInspections.org

The Condition of Participation is NOT met as evidenced by:

Based on observation, interview, and record review, the hospital's Governing Body (GB) failed to assume full legal responsibility for providing quality health care, in a safe environment as follows:

The hospital failed to implement patient rights in accordance with acceptable standards of practice, and hospital policy and procedures, and failed to provide care in a safe setting. These failures resulted in the hospital not meeting the Condition of Participation (COP) for Patient Rights (Cross Reference A-0115)

The hospital failed to ensure that a hospital wide quality assurance performance improvement program (QAPI - data driven program that focuses on systems of care, outcomes of care, and quality of life) had been developed, implemented, and maintained an ongoing, effective, hospital-wide, data-driven quality assessment, and performance improvement program. (Cross reference A-0263).

The hospital failed to ensure that safe nursing services had been provided, failed to follow policy and procedures, and meet the needs of each patient. These failures resulted in the hospital not meeting the Condition of Participation (COP) for Nursing Services (Cross Reference A-0385).

The cumulative effects of these systemic problems resulted in the hospital's inability to ensure the provision of quality patient care in a safe environment.

The Condition is NOT MET as evidenced by:

Based on observation, interview, and record review it was determined that the hospital failed to follow it's policies and procedures and the standard of care to protect and promote patient's rights when:

1. Patient 105 and 108 privacy notice forms were not completed correctly. Patient 106, 107, and 108 conditions of admission and treatment (COAT) forms were not read, not completed correctly and/or a copy was not given to the patient. (Cross Reference A - 0116)

2. Patient 500's father failed to be provided with a qualified interpreter. (Cross Reference A - 0129)

3. Patient 200 procedural, surgical, and blood transfusion consents were incomplete. Patient 300 multiple consents were incomplete. Patient 603 cancer medication consent was incomplete. Patient 202 surgical consent did not match the procedure and no blood transfusion consent was done prior to the procedure. Patient 500 interpreter services policy and procedure was not implemented. (Cross Reference A - 0131)

4. Patient 500 was not assessed or reassessed according to their care need, antibiotic administration was delayed and handoff of patient information between nurses failed to occur. Patient 500's care resulted in an adverse event (death). The facility failed to notify Patient 500's family the death was an adverse event. (Cross Reference A - 0142)

5. Patient 507 was not provided privacy during the triage interview and assessment. (Cross Reference A - 0143)

6. Patient 101 ventilator circuit, bacteria filter, and suction catheter were not labeled with a date to be changed to prevent infections. Patient 102 ventilator bacteria filter was not labeled with a date to be changed or changed for two dates to prevent infections. Interventional Radiology had clean supplies stored uncovered and within reach of potential patient splashing. Operating Room and Hospital 2/Rehab Department had clean supplies stored in dirty utility rooms. Hospital 2/Emergency Department patient exam room had sharps in an unlocked cart. Out-Patient Laboratory refrigerators storing supplies were not monitored for temperature. Out-Patient Imaging Center procedure room 1 had a medication box key accessible to anyone. (Cross Reference A - 0144)

7. Patient 408 did not have the least restrictive alternative interventions attempted or considered before being restrained. (Cross Reference A - 0164)

8. Patient 300 twice remained in restraints more than 24 hours without a new physician order. (Cross Reference A - 0169)

9. Two registered nurses (RNs) did not have restraint training and competency checks. (Cross Reference A - 0194)

The cumulative effects of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.

Based on observation, interview, and record review the facility failed to ensure the notice of rights requirements were met when:

1. Patient 105's privacy notice form was not completed correctly when patient received services in the outpatient physical/occupational rehabilitation.

2. Patient 106 was not provided with the opportunity to read the conditions of admission and treatment (COAT)content and was not given a copy of the COAT form when patient 106 received services in the outpatient/physical occupational rehabilitation.

3. Patient 107's COAT was not fully completed when patient 107 received services in the outpatient cardiovascular rehabilitation.

4. Patient 108 was not provided with the privacy notice and the COAT was not completed correctly when patient 108 received services in the outpatient laboratory.

These facility failures have the potential to violate patient's rights by not providing notices and/or completing the COAT form incorrectly.

Findings:

1. During a review of the facility's policy and procedure titled, "Notice of Privacy Practices", dated 10/1/20, the policy and procedure indicated in the, "Acknowledgement" part of policy, "If an individual or his/her personal representative does not sign the acknowledgement, designated staff will document his/her good faith effort to obtain the signature and the reason(s) it was not obtained ..."

During a concurrent tour of the outpatient physical/occupational rehabilitation and interview with the rehabilitation director (RehabD) on 9/4/24 at 10:45 a.m., Patient 105 was observed receiving therapy. The patient's COAT documents were requested. Upon review of the privacy notice form, the area where it asked the patient to sign acknowledging the content, the patient did not sign, patient wrote his initials instead of signing. The RehabD was asked if the patient's initials were a signature. The RehabD stated, "No, the patient should have signed here, and the receptionist should have verified this was a signature."

2. During a review of the COAT form on the, "Patient Certification" section, the section indicated, "By signing this form, you certify that: * You have read this form * You have received a copy of the form * You were given the opportunity to ask questions ..."

During an observation of Patient 106's conditions of admission and treatment process with the RehabD present and interview with the receptionist (REC) in the outpatient/physical occupational rehabilitation on 9/4/24 at 11:30 a.m., the REC was observed notifying the patient the title of the COAT form and instructed patient to sign, without allowing the opportunity for patient to read the form and ask questions as needed. After completion of the process, the patient was asked, by the REC, to go sit in the waiting area until ready for therapy, without providing a copy of the COAT form to patient 106. The REC was asked if she provided a copy of the COAT form to patient 106. REC stated, "No, I did not."

3. During a concurrent tour of the outpatient cardiovascular rehabilitation and interview with the supervisor on 9/4/24 at 10:50 a.m., Patient 107 was observed receiving therapy. The patient's COAT documents were requested. Upon review of the COAT form, the patient's initials were missing on #5 in the form. The cardiovascular rehab supervisor (CVRS) stated, "Yes, I see, initials are missing."

4. During a concurrent tour of the outpatient laboratory and interview with the phlebotomist (Pheb 1) on 9/4/24 at 9:25 a.m., Patient 108 was observed getting blood drawn by the phlebotomist. The patient's COAT documents were requested. Pheb 1 reported not providing a notice of privacy form for patient to sign, and furhter indicated this was the reason a notice of privacy form was not in Patient 108's record. Upon review of the COAT form, the area where it asked the patient to sign acknowledging the content, there was no patient signature. Patient 108 wrote his initials instead of signing. (Pheb 1) stated, "Yes, this is not a signature."

Based on interview and record review the facility failed to honor patient's rights when the facility failed to provide a qualified interpreter to effectively communicate to Patient 500's father, the patient's medical condition and possible reasons for expiring.

This failure had the potential for patient's father not receiving the correct information regarding his daughter's death.

Finding:

During a review of facility's "Patient's Rights and Responsibilities" pamphlet, the pamphlet indicated in part, "3. To communicate effectively with your care team. Receive free and in a timely manner aids and services if you have a disability or free language services if your primary language is not English ...qualified interpreters and information written in other languages."

During an interview with the Chief Nursing Officer (CNO) on 11/5/24 at 11:05 a.m., CNO was asked who was the interpreter that was interpreting for the family, the patient's medical condition and possible reasons Patient 500 expired on 5/20/24. CNO stated, "We try to speak to the significant other (they were not married) who I believe spoke Spanish, but he did not want to speak to us regarding the patient. He said to talk to the patient's father. The patient's father was contacted, and he came to the hospital, but he only spoke Mixteco (ancient language, unrelated to Spanish). The patient's father requested a Mixteco interpreter. Mixteco interpreter (MI) was the interpreter who was interpreting when the patient's father the patient 500's condition was explained and why it resulted in patient 500's death."

During a concurrent review of MI job description and interview with the CNO on 9/6/24 at 8:35 a.m., the MI job description indicated, the "MI was a basic level 1 interpreter with limited to no experience as an interpreter in the hospital setting, interpreting from Mixteco to English may require more practice". It also indicated, "Scope of work: will only participate in low-risk cases ... will not provide interpreter services to high-risk patients. Will provide low -risk basic level medical interpretation."

The CNO was asked if the facility had a list of Level 1, Level 2, Level 3, and Level 4 interpreters so staff can reference to the list when contacting interpreters according to their competency level. CNO stated, "No, we don't have a list of interpreters depending on their competency level. ...to ensure the interpreters with the correct competency are being called for the low- risk cases, high- risk cases and various situation according to competency level." When the CNO was asked if explaining to the patient's father the medical conditions and possible reasons that caused or contributed to the patient's death, is comprehensive and requires high level of medical terminology explanation? CNO stated, "I agree, a Level 3 interpreter should have been used to explain to the father the conditions and possible reasons his daughter death. MI was not a Level 3 interpreter..."

During a review of the facility policy and procedure titled, "Interpreter Services", dated 4/7/23, the policy and procedure indicated, "It is the policy of [facility name] to provide 24-hour interpreter coverage to the facilities patient population who are limited English proficient to promote quality patient care through accurate communication."

Based on interview and record review, the facility failed to follow their policy and procedures for informed consents and interpreter services when:

1. Procedural, Surgical, and Blood Transfusion consents were incomplete for one of 41 sampled patients (Patient 200).

2. The surgical consent did not match the actual procedure done for one of 41 sampled patients (Patient 202).

3. There was no documentation of a blood transfusion consent prior to doing the surgical procedure for one of 41 sampled patients (Patient 202).

4. There were multiple informed consents that were incomplete, per facility policy and procedure, prior to doing the procedure for one of 41 sampled patients (Patient 300).

5. The consent to receive cancer medication for treatment was incomplete for one of 41 sampled patients (Patient 603).

6. The interpreter services were not implemented per policy and procedures for one of 41 sampled patients (Patient 500).

These facility failures have the potential to place patients at risk by not providing them the right to make informed decisions about their surgical procedures and medical treatments.

Findings:

1. During a concurrent interview and record review on 9/5/24, at 4:14 p.m., with the perinatal director (PD), Patient 200's medical record was reviewed. The medical record indicated Patient 200 did not speak English and spoke the Mixteco language. The medical record indicated Patient 200 needed an interpreter to understand her medical care. The medical record indicated Patient 200 was consented for a Labor Epidural (procedure to administer pain medication into a woman's lower back during labor to relieve pain), for a Vaginal Delivery with Possible Episiotomy (an incision through the area between your vaginal opening and anus also called perineum), for a Possible Blood Transfusion, and for a Cesarean Section (the surgical delivery of a baby through a cut made in the woman's abdomen and uterus). During a review of these consents the signature page had a line for the interpreter to sign their name and was left blank. PD verbalized Patient 200 required an interpreter when signing the consents and acknowledged the interpreter signature was missing from the consent forms and should be there. PD further acknowledged the consent forms were incomplete.

During a review of the facility's policy and procedure titled, "Informed Consent" dated 6/3/24, the policy and procedure indicated in part, "Informed Consent: an exchange of information that helps the patient to understand significant or material facts about the recommended intervention ...significant information includes, at a minimum, the nature of the recommended intervention, its risks, complications, expected benefits or effects, and any alternatives, along with their risks and benefits ...if in the judgement of the physician, a language barrier interferes with the patient's ability to understand the nature of treatment plan, an interpreter or interpreter service should be requested and the use of an interpreter will be documented in the medical record ...if the use of an interpreter is required, documentation should include the name of the interpreter, his/her position or relationship to the patient, if appropriate ..."


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2.During a review of Patient 202's "Consent to Surgery or Special Procedure (CSSP)," dated 9/4/24, the "CSSP" indicated, Patient 202 was to be consented for, "Cardiac catheterization, possible percutaneous coronary intervention, use of intravenous, intra-arterial, intra-coronary contrast media, procedural sedation with possible general anesthesia."(Insertion of a catheter into the hears under sedation with dye injection to see how the heart is functioning and to look for blockages).

During an interview on 9/6/24 at 10:00 a.m. with the Director of the Cath lab (DCL), DCL stated, "Normally the consent would say left and right heart Cath if that was what the planned procedure was." DCL stated that she has talked with the physician in being more descriptive with his consent orders.

During a review of Patient 202's "Outpatient Treatment Procedures (OPTP)," dated 9/4/24, the "OPTP" indicated, Patient 202's procedure would be RHC/LHC [For right heart catheterization, your healthcare provider threads the catheter through a vein into the right side of your heart. For left heart catheterization, your provider threads the catheter through an artery (femoral, brachial, or axillary artery) to the left side of your heart].

During a review of Patient 202's "Nursing Communication (NC)," dated 9/4/24, the "NC" indicated, Anticipated left radial artery and right internal jugular vein access.

During a review of Patient 202's "Cardiology Office/Clinical Note (CN)," printed on 9/5/24, the "CN" indicated, Recommended right heart catheterization, left heart catheterization, and coronary angiography to assess hemodynamic/volume status and evaluate for coronary artery disease.

During a review of the facility's policy and procedure (P&P) titled, "Universal Protocol Procedure," dated 7/12/2024, the P&P indicated, "Department staff, physicians, and Licensed Independent Practitioners ("LIP") participating in a surgical or invasive procedure will actively participate in verification of the procedure to assure the correct patient, procedure, and site ..."

3. During a review of Patient 202's "Consent to Blood Transfusion (CBT)," dated 9/4/24, the "CBT" indicated the form is blank with no signatures.

During an interview on 9/6/24 at 9:40 a.m. with ANM 2, ANM 2 stated that the blood consent should be signed.

During a review of Patient 202's "Physician Orders (PO)," dated 9/4/24, the "PO" indicated, Patient 202 was to be consented for possible blood transfusion if emergently needed.

During a review of the facility's policy and procedure (P&P) titled, "Informed Consent," dated 6/3/2024, the P&P indicated, "Nursing staff will witness the patient's signature on the consent form."


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4. During an interview with Coronary Care Unit Director (CCUD) and Director of Neonatal Intensive Care Unit/Pediatrics (DNP) on 09/05/24 at 09:15 a.m. and concurrent review of patient 300's medical record, Patient 300's medical record had multiple informed consents that were missing documentation. The CCUD confirmed that the consents were incomplete, and that staff were not following the "Informed Consent" P&P.

During a review of facility policy and procedure (P&P) titled, "Informed Consent" dated 06/03/24, the P&P indicated in part, "PURPOSE: To define the circumstances under which consent for treatment and medical surgical procedures is to be obtained from adult patients or their surrogate decision-makers...3. Adult Patients without Decision-Making Capacity c) The treating physician is responsible for ensuring that the patient's surrogate decision-maker is informed of the risks, benefits and alternatives of the proposed treatment...4. Consent by Telephone or Fax ... c) The telephone discussion between the patient's legal representative and the physician should be witnessed by a hospital employee. The patient's surrogate decision-maker must be informed of the presence of the hospital employee on the phone. d) The exact time and the reason for obtaining the consent by telephone or fax will be fully documented on the consent form. e) The physician will document the disclosure on the consent form, noting the manner in which the consent was obtained, and the witness will sign to corroborate the consent of the patient's surrogate decision-maker...7. Nursing Documentation a) Nursing will witness the signature of the patient or patient's legal representative on the consent form. Additional documentation in the nurse's notes will be entered when there are questions or complex consent issues. b) The RN [registered nurse] or LVN [licensed vocational nurse] who witnessed the patient sign the consent form will sign and date the consent form. c) If the use of an interpreter is required, documentation should include the name of the interpreter, his/her position or relationship to the patient, if appropriate."


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5. During a concurrent review of Patient 603's clinical record (CR) with the oncology nurse (OCN) at the outpatient infusion center (OIC3) on 9/5/24 at 11:09 a.m., the CR indicated the following:

-The physician order (PO), dated 4/11/24, and signed at 11:11 a.m., indicated that the provider (MD1) had ordered a regimen (Drug Name-cancer treatment) to be administered monthly for six months. Patient 603's diagnoses included, but were not limited to, malignant neoplasm (abnormal tissue growth) of unspecified site in the left female breast and of the lower lobe, left bronchus (delivers air to the left lung), or lung (supplies the body with air).

-The consent titled, "Consent for Infusion Therapy" indicated patient 603's daughter had consented to patient 603's infusion therapy on 4/11/24 at 11:15 a.m. The consent form where the provider signs was blank.

The OCN acknowledged the space for the provider's signature had been left blank and the consent to receive cancer medication was incomplete. No additional supporting documentation was provided.

During a review of the hospital's policy and procedure (P&P) titled, "Chemotherapy Administration" dated 12/13/23, the P&P indicated, "Written consent must be signed by the patient and the ordering Medical Oncologist and placed on the medical record prior to administration of chemotherapy ..."

During a review of the hospital's policy and procedure (P&P) titled, "Informed Consent" dated 6/3/24, the P&P indicated, "It is the treating physician's responsibility for obtaining informed consent. Physician documentation of the informed consent process will be either by the physician signature on the consent form attesting to the fact that the discussion took place or by a separate note in the medical record ..."


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6. During a review of the facility's policy and procedure (P&P) titled, "Limited English Proficiency (LEP): Language Access for Patents and Companions," dated 4/2/23, the P&P indicated, "Patients and companions who are Limited English Proficient (LEP) shall have information and services provided to them in their primary language while receiving healthcare services at all [facility name] facilities."

During a review of Patient 500's "Instrucciones De Despedida Postparto (discharge instructions)," dated 5/11/24, the discharge instructions indicated a Mixteco interpreter was requested.

During an interview on 9/4/24 at 4:15 p.m. with a registered nurse (RN22), RN22 recalls Patient 500 told RN22 she prefers to communicate in her primary language, "Mixteco."

During an interview on 9/5/24 at 3:45 p.m. with Mixteco Interpreter (MI), MI stated MI recalls interpreting for Patient 500. MI also stated MI was assisting to translate English to Mixteco.

During a review of Patient 500's "ED [Emergency Department] Triage (EDT)," dated 5/20/24 at 9:14 a.m., the EDT indicated, "Interpreter Services Offered: Yes ... Type of Interpreter Services: In person."

During an interview on 9/6/24 at 8:55 a.m. with a registered nurse (RN5), Patient 500's EDT was reviewed. RN5 stated RN5 spoke to Patient 500 in Spanish. RN5 further stated RN5 was not aware Patient 500's primary language was Mixteco.

During a review of Patient 500's, "Consentimiento para anestesia (Consent)," dated 5/20/24 at 1:40 p.m., the Consent indicated, "Inhouse interpreter [staff name]. "Consentimiento Para Cirugia O Procedimiento Especial (Consent)," dated 5/20/24 at 1:41 p.m., the Consent indicated, "Inhouse interpreter [staff name]."

During an interview on 9/5/24 at 11:10 a.m. with a registered nurse (RN9), Patient 500's consents were reviewed. RN 9 stated, "A certified Spanish interpreter," was used to interpret for Patient 500.

Based on interview and record review, the facility failed to ensure one of 41 sampled patients (Patient 500) received care in a safe setting when:

1. Patient 500 was not assessed and reassessed according to their level of acuity (how critical they were and the level of care they required), intravenous ((IV) into the vein) access was delayed resulting in delayed antibiotic administration, and a breakdown in the standardized approach to communication between nurses (handoff) occurred.

2. Patient 500's care at facility resulted in an adverse event (AE- an adverse event or series of adverse events that cause the death or serious disability of a patient, personnel, or visitor) requiring event to be reported to the California department of Public health (CDPH) and the family to be notified of the AE by the time the report to the CDPH is made. However, the facility failed to notify the family patient's death was reported as an AE.

The facility's failures resulted in Patient 500's increased risk of mortality and resulted in Patient 500's family not being aware the patient's death was an adverse event.

Findings:

During a review of Patient 500's, "ED [Emergency Department] Physician Notes (EDPN)," dated 5/20/24 at 1:15 p.m., the EDPN indicated, Patient 500 was a 30-year-old female who was 10 days postpartum (time since giving birth) with complaints of nausea, vomiting, abdominal discomfort and headache. Diagnosis (identified problems) included acute severe sepsis (life-threatening illness) from a gas-forming infection (bacteria) causing endometritis (inflammation of the uterus), acute kidney injury (kidneys suddenly cannot filter waste from the blood), acute tachycardia (fast heart rate), acute dehydration hemoconcentration (concentrated blood), acute nausea and vomiting, acute pelvic (area between the hips) pain. The plan for Patient 500 was to admit to Cardiac Telemetry (heart monitoring area). Patient 500's condition was guarded (very sick).

1. During an interview on 9/6/24 at 8:55 a.m., with a registered nurse (RN5), RN5 stated Patient 500 was identified as having a suspected infection in triage.

During an interview on 9/4/24 at 9:45 a.m. with RN6, RN6 stated no handoff report regarding Patient 500 was done between the triage nurse, the waiting room nurse and the ED primary patient nurse. RN6 further stated it was the general practice in the ED not to give handoff report.

During a concurrent interview and record review on 9/4/24 at 4:15 p.m. with RN 7, Patient 500's electronic medical record (eMR) was reviewed. RN7 stated RN7 had no idea Patient 500 was suspected of having an infection.

During a review of the facility's policy and procedure (P&P) titled, "Emergency Services Nursing Standards of Practice," dated 6/1/24, the P&P indicated, "All patients in the ED are reassessed as warranted by ESI acuity and presentation ... ESI ... Level 2 ... Vital signs pertinent to patient condition will be initially monitored a minimum of every 15 minutes."

During a review Patient 500's "Hemodynamics/Vitals ((HV) measurable values that reflect a patients overall state of health)," the HV indicated Patient 500's vital signs (VS) were recorded while in the ED 5/20/24 at 9:14 a.m., 12 p.m., and 1:25 p.m.

During an interview on 9/5/24 at 10:20 a.m. with assistant nurse manager (ANM), ANM stated, "There was a delay starting the second IV access."

During a review of Patient 500's "Orders" and "Medication Administration (MAR)" dated 5/20/24, the Orders and MAR indicated the following antibiotics were ordered, "STAT (to be given immediately)" and were delayed due to Patient 500 not having a second IV access:
-Vancomycin ordered at 12:25 p.m. and administered at 2 p.m.
-Ampicillin-sulbactam ordered at 12:42 p.m. and administered at 3:50 p.m.

During a concurrent interview and record review on 9/5/24 at 11:10 a.m. with RN9, Patient 500's "eMR" was reviewed. RN9 stated RN9 did not perform a sepsis specific assessment. RN9 also stated patients are not usually assigned to a nurse while they are on the Surgical Holding Unit because they don't usually stay for very long. RN9 further stated no report was needed when RN9 went home because RN9 and RN10 worked together the whole time.

During a concurrent interview and record review on 9/5/24 at 11:20 a.m. with RN10, the facility's Sepsis checklist (SLC) titled, "Severe Sepsis / Septic Shock Pathway," dated 9/22 was reviewed. RN10 stated RN10 did not recall seeing the SCL for Patient 500. RN10 further stated RN10 was not aware Patient 500 had a kidney issue or needed to have their urine measured.


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2.The facility's "Patient's Rights and Responsibilities" pamphlet indicated the patient/family has the right to, "5. Receive information about (patient's) health status, diagnosis, prognosis, course of treatment, prospects for recovery and outcomes of care (including unanticipated outcomes) ... 14. Receive care in a safe setting ..."

During a concurrent review of Patient 500's medical record and an interview with the chief nurse officer (CNO) on 9/5/24 at 10:25 a.m., CNO reported Patient 500 presented to the emergency department ED on 5/20/24 with complaints of abdominal pain after delivering a newborn on 5/10/24. Patient 500 was diagnosed with Sepsis (a life-threatening emergency that happens when the body response to an infection, damages vital organs and, often, causes death) requiring immediate treatment including a surgical procedure to remove the possible source of infection from the uterus, competency of the staff in the surgical holding unit (SHU) and the administration of antibiotics immediately for which there was a delay in the administration of the antibiotics. Patient 500 was transfered to the SHU where Patient 500 was held longer than expected. The physician performing the surgical procedure on Patient 500 was pulled away to treat another patient requiring emergency surgical procedures. The on-call or back up physician was not called in to perform the surgical procedure Patient 500 required. Patient 500 had a cardiac arrest while in the SHU resulting in Patient 500's death before the surgical procedure could be performed.

The facility reported Patient 500's death as an AE to CDPH on 5/24/24.

During a concurrent review of Patient 500's medical record and interview with the manager of patient safety (MPS) on 9/5/24 at 4:30 p.m., the MPS was asked to show the documentation indicating Patient 500's family was notified that Patient 500's death was reported as an AE to CDPH. The MPS wa not able to locate any documentation in the medical record to indicate the AE was disclosed to the Patient 500's family. The MPS stated, "No, the family was not notified of the adverse event, there is no documentation in the record indicating the physician or anyone else notified the family." The MPS and the CNO both verified the family was not made aware Patient 500's death was reported as an AE.

Based on observation, interview and record review, the facility failed to ensure one of two unsampled patients (Patient 507) was provided physical privacy in the Emergency Department (ED) during triage (interview and assessment of the patient by a nurse).

This failure had the potential to result in Patient 507's health concerns being observed and overheard by other patients and visitors in the ED Waiting room.

Findings:

During a concurrent observation on 9/3/24 at 3:49 p.m. with a registered nurse (RN23) in the ED Triage room, Patient 507 was observed to be triaged with the ED Triage room door left open to the ED waiting room.

During a concurrent observation and interview on 9/3/24 at 4:20 p.m. with the Interim Director of the ED (EDD) in the ED waiting room, a triage was in progress with the Triage room door open. EDD stated, "Yes," a trige was in progress with an unidentified patient. EDD also stated EDD was able to watch the patient having their blood pressure taken.

During a concurrent observation and interview on 9/4/24 at 9:10 a.m. with EDD and the Manager of the ED (EDM) in the ED waiting room, a triage was in progress with the Triage door open. EDD and EDM stated they were able to overhear the unidentified patient's triage with the Triage door open. EDD and EDM also stated it was a patient's rights and privacy issue.

During a review of the facility's policy and procedure (P&P) titled, "Patient Rights and Responsibilities," dated 2/24, the P&P indicated, "Patient Rights: See Patient's Rights and Responsibilities located in the Patient Handbook."

During a review of the facility's Patient Handbook (PH) titled, "Patient Right's and Responsibilities," dated 9/2017, the PH indicated, "Have personal privacy respected. Case discussion, consultation, examination and treatment are confidential and should be conducted discreetly."

Based on observation, interview and record review the facility failed to ensure that patients received care in a safe setting and in accordance with acceptable standards of practice when:

1. Clean supplies were stored uncovered in Interventional Radiology (IR) patient care area exposing to potential splashing.

2. Clean supplies that are used for patient care in the Operating Room (OR), were stored in the OR dirty utility room.(ORDU)

3. Clean supplies were stored in the Hospital 2/Rehab Department dirty utility room.

4. Hospital 2/Emergency Department (ED) supply cart, in exam room number 6, was found unlocked and contained sharp objects.

5. Patient 101's ventilator a) circuit, b) bacteria filter and c) suction catheter were not labeled with the date they needed to be changed to prevent infections.

6. Patient 102's ventilator bacteria filter was not labeled and changed for two dates (8/31/24 and 9/2/24) to prevent infections.

7. The Out-Patient Laboratory refrigerators containing, Glucola (a drink a type of sugar used to screen for diabetes and gestational diabetes), and containing specimens (samples), the temperature inside the refrigerators was not checked daily.

8. An anaphylaxis kit (containing emergency medications to treat severe or life-threatening reactions) contained an expired medication (aminophylline - used to treat shortness of breath) at an outpatient imaging center (OIC2).

9. The procedure room (PR 1) in an outpatient imaging center (OIC 1) had a medication box key that is accessible to anyone.

These failures placed patients at increased risk of infection and potential injury, and medications being less effective due to being expired and stored at inappropriate temperatures.

Findings:

1. During a concurrent observation and interview with the Imaging Manager (IM) on 09/03/24 at 3:10 p.m. in Interventional Radiology (IR), clean patient supplies were observed hanging on the wall approximately 5 feet from the head of the patient in packages without protective plastic barriers or in a clean storage cabinet. IM confirmed the supplies on the wall were considered clean, were in a patient procedure room, were unprotected, and were at risk of contamination from exposure.

2. During a concurrent observation and interview on 09/04/24 at 10:00 a.m. with the Patient Safety Coordinator Registered Nurse (PSC) in the ORDU clean supplies were observed which included bottles of 70% Rubbing Alcohol, Peroxide Betadine Solution, Peroxide, and Chlorhexidine Gluconate. PSC stated these solutions are poured into a sterile bowl and used on the patients in OR. PSC confirmed that these clean supplies should not be stored in the ORDU.

3. During a concurrent observation and interview on 09/04/24 at 11:42 a.m. with a Registered Nurse (RN) 25 in the Rehab dirty utility room at Hospital 2, clean supplies were observed including headphones and face shields. RN 25 confirmed that these clean supplies should not be stored in the dirty utility room.

4. During a concurrent observation and interview on 09/04/24 at 12:21 p.m. with the Assistant Manager Emergency Department (AMED) at Hospital 2 in the emergency department (ED), in ED exam room number 6, a supply cart that contained needles and was not locked was observed. AMED acknowledged that patients and families are left unaccompanied at times in exam rooms. The AMED confirmed the supply cart was not locked, had needles that were easily accessible, and that the supply cart should be locked after use.


35399

5. During a tour of the critical care unit (CCU) on 9/3/24 at 2:58 p.m., Patient 101's ventilator (machine that act as bellows to move air in and out of the lungs) was observed with the circuit (the tubing that connects the ventilator to a patient), bacteria filter (device with a high capacity to prevent the passage of microorganisms and are placed in the breathing circuit in order to protect the patient from possible respiratory infections carried by the respirator) and in-line closed suction catheter (a protected suction tube (catheter) inside a sterile plastic sleeve) not labeled with the dates when they were last changed or with the date the next change was due.

During an interview with the respiratory therapist supervisor (RTS) on 9/3/24 at 3:15 p.m., the RTS indicated the ventilator circuit needs to be changed weekly, the bacteria filter every 24 hours per manufacturers recommendations and the close suction catheter is change every 72 hours or as needed. The RTS explained inside the circuit and suction catheter package there is a label where the respiratory therapist (RT) writes down the date the circuit or suction catheter needs to be changed. The label is attached to the circuit or catheter. The RT writes down on top of the bacteria filter, the date, the filter needs to be changed. The RTS acknowledged the Patient 101's ventilator circuit, filter and suction catheter were not labeled and stated, "Yes, I agree there is education to be done."

During a review of the facility's policy and procedure (P&P) titled, "Equipment Change", dated 8/16/24, the P&P indicated, "To decrease the possibility of potentially contaminated equipment remaining in use for prolonged periods of time and serving as a source of patient contamination. 5) Mechanical Ventilation: a) All the following equipment will be changed on the ventilator every seven days with heated wire circuit or as needed within HME circuit: i) disposable circuit (tubing) ...b) Bacteria filters on volume ventilators will be changed per manufacturer's recommendations. c) In-line suction device will be changed per manufacturers recommendations (24-72 hours)."

The [manufacturer's name] manufacturer's recommendations for use indicated, "Warnings: when used on the expiratory limb, replace Filter at least every 24 hours or earlier if increased resistance is noted."

6. A record reviewed for Patient 102 was conducted on 9/3/24 at 4:30 p.m., with the RTS navigating the record. The record indicated Patient 102 was intubated (process where a healthcare provider inserts a tube through patient's mouth or nose, then down into their trachea (airway/windpipe). The tube is connected to a machine that delivers oxygen) and was placed on the ventilator (breathing machine) on 8/30/24 at 4:00 p.m. Patient 101 was extubated (removal of the breathing tube) on 9/3/24 around noontime.

In the, "Respiratory Ventilator Settings", under the, "Patient Assessment" section, in the, "Equipment Change" area, is where the equipment such as circuit, filter, suction catheter ... is documented. This area was blank for 8/31/24 and 9/2/24 indicating the bacteria filter was not changed every 24 hours as indicated by the manufacturer's recommendations. The RTS confirmed there was no documentation or evidence indicating the bacteria filter was changed and those two dates for Patient 101. RTS stated, "I agree, there is no documentation the bacteria filter was changed. If it was not documented that means it was not done."

The [manufacturer's name] manufacturer's recommendations for use indicated, "Warnings: when used on the expiratory limb, replace Filter at least every 24 hours or earlier if increased resistance is noted."

7. During a concurrent tour of the Outpatient Laboratory and interview with a phlebotomist (Phleb 1) on 9/4/24 at 9:20 a.m., a refrigerator containing Glucola was observed with a thermometer inside the refrigerator. The Phleb 1 was asked to provide the daily refrigerator temperature logs. Phleb 1 opened a binder where thermometer temperature forms were located. Phleb 1 was able to locate one form titled, "Thermometer Temperature Record Glucola". This form was for the year 2023 and it cover the months of January to June. The refrigerator temperature was not recorded in for two dates in January, four dates in February, one date in March, five dates in April, and one date in June.

Another form was provided for which it was concluded by the Phleb 1, this was the remainder of year 2023 because the form did not have the year written on it. The refrigerator temperature was not recorded on seven dates in July, . two dates in August, four dates in September, three dates in October, eignt dates in November, and two dates in December.

The forms titled, "Thermometer Temperature Record Glucola Refrigerator", for the year 2024 from January to September, the forms indicated the refrigerator temperature was not recorded one date in March, one date in June, and one date in August.

The forms titled, "Thermometer Temperature Record Specimen Processing", for the year 2023 from January to December, the forms indicated the refrigerator temperature was not recorded for two dates in January,one date in February, one date in March, six dates in April, three dates in June, five dates in July, three dates in August, six dates in September, five dates in October, eight dates in November, and four dates in December.

The forms titled, "Thermometer Temperature Record Specimen Processing", for the year 2024 from January to September the forms indicated the refrigerator temperature was not recorded on one date in March and one date in June.

During an interview with the patient safety manager (MPS) on 9/4/24 at 9:35 a.m., the MPS confirmed the missing temerature recordings and agreed the refrigerators temperatures we're not recorded daily and should have been.

During a review of the facility's policy and procedure (P&P) titled, "Refrigerators and Freezers", the P&P indicated, "To assure that refrigerators and freezers are clean, contents properly store, and the temperature monitored. B. Temperature: 2. The temperature of any refrigerator/freezer that contains drugs, patient food, blood, or specimens should be checked, and logged daily utilizing the approved temperature log to ensure proper temperature control."


37886

8. During an observation of the outpatient imaging center (OIC2) and concurrent interview on 9/4/24 at 9:53 AM, with the senior director of imaging (SDI), the quality patient safety manager (QPSM), the CCU director (CCUD) and the CT radio technician (CTRT1), an anaphylaxis kit (AK-containing emergency medications to treat severe or life-threatening reactions) was observed on top of a cart in the hallway. The AK is inside the red container with lock number 17656147, and the label sticker reads: Date of first exp drug: 11/2/24; Drug name: 23 gauge butterfly needle; Lock # 17656147; Check completed on: 12/13/23; Checked by: [Initials]. Inside the AK was a medication, Aminophylline (used to treat shortness of breath) 500 mg (milligrams)/20 ml (milliliters) with an expiration date of 9/1/24. The CTRT1 acknowledged the medication had expired on 9/1/24 and should have been disposed of rather than kept at the center. The CTRT1 explained that it is the pharmacy department's responsibility to keep the AK up to date.

The CTRT1 was asked to inspect the contents of the AK in the surveyor's presence. During an inspection of the contents in the AK, an expired medication was discovered. One aminophylline (used to treat shortness of breath) 500 milligrams (mg)/20 milliliters (ml) expired on 9/1/24.

During a concurrent interview, the CTRT1 acknowledged that the medication had expired on 9/1/24 and should be disposed of rather than kept at the center. The CTRT1 explained that it is the pharmacy department's responsibility to keep the AK up to date.

During a review of the hospital's policy and procedure (P&P) titled, "Emergency Medications," dated 1/31/2020, the P&P indicated, "The pharmacy is responsible for the integrity and security of emergency medications. Pharmacy will inspect the emergency medication supplies monthly..."

9. During an observation of the outpatient imaging center (OIC1) and concurrent interview on 9/4/24 at 12 PM, with the senior director of imaging (SDI), QPSM, CCUD, imaging supervisor (IS1) and Mammo lead tech (MLT1), a lockable medication box was found on top of the counter in the procedure room. The MLT1 obtained the key from an unlocked cabinet which allowed unlimited access to the medications. The medication box contained twenty individually packaged tablets of Valium (used to treat anxiety) each 10 milligrams (mg) and two vials of Flumazenil (an antidote) each 0.5 mg/5 milliliter (ml). The IS1 confirmed they do not lock the procedure room. The IS1 acknowledged the medication box was not locked and the key was accessible to anyone.


39814

Based on observation, interview, and record review, the facility failed to ensure the least restrictive alternative interventions were attempted or considered prior to placing a Patient 408 in restraint (devices that limit a patients movement).

This failure had the potential for Patient 408 to be placed in an unnecessary restraint.

Findings:

During a concurrent interview and record review on 9/4/24 at 11:15 a.m. with the facility's (patient safety program manager (PSPM), Patient 408's electronic medical record (EMR) was reviewed. The EMR showed that Patient 408 was admitted to the facility on 7/31/24 with history of stroke (when the brain's blood supply is blocked and damages brain tissue) resulting in chronic right-sided hemiparesis (inability to move on one side of the body). PSPM indicated that Patient 408's left had was restrained to prevent the removal of medical devices.

During a review of Patient 408's physician orders dated 9/3/24, at 5:21 p.m., the physician orders indicated, "Restraints Non-Violent/Non-Destructive, Type of Restraint: Mittens Location: Hand, Left 'patient is continuously pulling at PEG (percutaneous endoscopic gastrostomy - feeding tube in the stomach) tube with left hand."

During an interview on 9/4/24 at 11:25 a.m. with PSPM, PSPM was questioned about the initial placement of Patient 408's restraints. PSPM was not able to provide any information or documentation regarding the date and time when Patient 408's restrains were applied.

During a concurrent interview and record review on 9/4/24 at 11:30 a.m. with a registered nurse (RN) 13, Patient 408's restraint documentation flow sheet (FS) dated 9/3/24 at 7:00 p.m. was reviewed. The FS indicated "restraint removed, care given, & reapplied." The facility was not able to provide any documentation to indicate any less restrictive alternative interventions were attempted or considered prior to placing Patient 408 in restraints. RN 13 stated, "It's not in here."

During an observation on 9/9/24, at 11:55 a.m., in the medical/surgical (M/S) area, Patient 408 was lying in bed dressed in a hospital gown. Patient 408's right arm was flaccid (inability to move, a type of paralysis). Pt. 408's left hand was covered with a light green soft mitten restraint.

During a review of the facility's policy and procedure (P&P) titled, "Restraints, Use of", dated 5/8/24, the P&P indicated, "When restraint is necessary, such activity will be undertaken in a manner that protects the patient's health and safety and preserves his or her dignity, rights, and well-being. The use of restraints is a last resort, after alternative interventions have either been considered or attempted. Restraint use may occur only after less restrictive interventions are ineffective." The P&P further indicated, "Documentation: For each episode of restraint, the patient's medical record should contain at least the following documentation: Alternatives or other less restrictive interventions attempted or considered."

Based on interview and record review facility failed to ensure staff followed policy and procedure for one of 41 sampled patients (Patient 300) when, Patient 300 remained in restraints for more than 24-hours without a new physician order on 2 occasions.

This failure had the potential for creating an increased risk of unnecessary restraints for Patient 300.

Findings:

During a concurrent interview with Critical Care Unit Director (CCUD) on 09/05/24 at 09:20 a.m. and review of Patient 300's medical record, the medical record indicated, Patient 300 had an order placed for soft limb wrist restraints, on 08/24/24 at 1700 (5:00 p.m.). The next order was not placed untill 08/25/24 at 1900 (7:00 p.m.). CCUD confirmed the restraints had not been discontinued during this time and that the order on 08/25/24 was placed 2 hours late per the facility's policy. On 08/26/24 at 1400 (2:00 p.m.) another order was placed for soft limb wrist restraints. The next order was not placed untill 08/27/24 at 1900 (7:00 p.m.). CCUD confirmed the restraints had not been discontinued during this time and that the order placed on 08/27/24 was placed 5 hours late per the facility's policy and procedure.

During a review of facility's policy and procedure (P&P) titled, "Use of Restraints", dated 03/2024, the P&P indicated in part, "POLICY: When restraint is necessary, such activity will be undertaken in a manner that protects the patient's health and safety and preserves his or her dignity, rights, and well-being. The use of restraints is a last resort, after alternative interventions have either been considered or attempted." "2. General Requirements for Ordering of Restraints: c. Restraint orders may not be written as standing orders or on an as needed basis (PRN) ... 3. Additional Requirement for the Ordering of (non-Violent Restraints): b. The initial order for non-violent restraints must be episode specific, time limited and shall not exceed 24 hours ... d) The ordering physician or licensed practitioner must perform a face-to-face assessment within 24 hours of restraint application ..."

Based on interview and record review the facility failed to conduct restraints training and competency checks for one of two sampled registered nurses (RN 24).

The facility's failure placed patients at risk for harm when using restraints.

Finding:

During review of the facility's policy and procedure (P&P) titled, "Restraints, Use of", data 5/8 24, the P&P indicated, "10. Training and Competency of Staff: a. Restraint education and training must be provided both as part of the initial orientation of all new and contracted staff and as part of ongoing in-service training for all staff who have direct patient care responsibilities and others who may be involved in the application of restraints ...C. Registered nurses (RNs) will receive education and training specific to assessment, emergency application of restraint and ongoing re-evaluation."

During a concurrent review of Patient 104's restraints in the medical record and an interview with the patient safety program manager (PSPM) on 9/4/24 at 4:40 p.m., there was a concern regarding how often the restraint reassessment is conducted by RNs. RN 24's restraint competency check was requested.

During a concurrent review of RN 24s, "2023 Annual Fall Skills Update" (AFSU), and an interview with the CNO on 9/5/24 at 5:45 p.m., RN 24's AFSU was dated 8/17/23 (past due). A document titled "Restraints Annual Demo" (competency check form) was attached to the AFSU summary. However, the restraints competency check form was blank. The CNO was asked the rationale for RN 24's competency form being blank. The CNO confirmed having blank competency check forms does not demonstrate the staff is competent with the content described in the competency check form. CNO stated "Yes, I agree we have to reevaluate our training and education process."

During review of the facility's P & P titled, "Staff Competency", dated 5/2024, the P&P indicated "1. b) Competency Testing. i) Is defined as the validation process used to verify that the staff member can demonstrate the appropriate knowledge, skills, and behaviors to achieve and maintain performance expectations... Competency testing may take several forms included written testing, skill demonstration, and observation of performance, completion of education and training programs... 2. d) Continuous education and competency testing will be conducted and based on topics appropriate to the staff's role ..."

The Condition of Participation is NOT met as evidenced by:

Based on staff interview and document review, the hospital's Governing Body (GB) failed to ensure the hospital had developed, implemented, and maintained an effective, ongoing, hospital-wide, data-driven quality assessment, and performance improvement program, when:

1.Hospital failed to conduct a quality assurance performance improvement (QAPI) program by conducting performance improvement projects (PIPs) as part of its quality assessment and performance improvement program and failed to document the quality improvement projects, that are being conducted, the reasons for conducting these projects, and the measurable progress achieved on these projects utilizing the selected PDSA model approach. The facility's failure resulted in PIPs being conducted as presentations instead of PIPs. (Cross Reference A-0297)

2. Hospital failed to conduct a quality assurance performance improvement (QAPI) program by conducting quality performance improvement activities based on identifying opportunities for improving their services and reflecting the hospital's priorities focusing on high risk, high volume, or problem prone areas. The facility's failures place hospital services or departments at risk of not improving their patient care delivery process and provide high quality patient care. (Cross Reference A-0283)

3. Hospital failed to track adverse patient events thoroughly to ensure health and safety code 1279.1 requirement was met for Patient 500 when patient's death occurred within 42 days post-delivery of a newborn and failed to disclose the adverse event to the patient's family. The facility's failure resulted in family not being aware that patient's death was an adverse event. (Cross Reference A- 0286)

4. Hospital failed to have the hospital's governing body ensure that the program reflects the complexity of the hospital's organization and services; involves all hospital departments and services including the outpatient services. The facility's failure resulted in the outpatient cardiovascular rehabilitation, physical/occupational therapy rehabilitation and outpatient laboratory services not participating in the quality assurance performance improvement (QAPI) program by not performing performance improvement projects (PIPs) to identify a service problem, conduct a PIP, to monitor and improve the service provided to the patients. (Cross Reference A- 0308)

These failures placed patients at potential risk for substandard care, adverse events, and negative outcomes. The cumulative effect of these systemic problems resulted in the inability of the hospital to comply with the statutorily mandated Condition of Participation for Quality Assessment and Performance Improvement.

The facility failed to conduct a quality assurance performance improvement (QAPI) program when they did not conduct quality performance improvement activities based on identifying opportunities for improving their services and reflecting the hospital's priorities focusing on high risk, high volume, or problem prone areas.

These facility's failures placed hospital services and departments at risk of not improving their patient care delivery process and prevented the facility from providing high quality patient care.

Finding:

During the review of the facility document titled, "Quality Improvement Plan" for year 2024, the document indicated in part, "V111. Selection of Improvement Priorities: A. Prioritization: The hospital and medical staff select processes and outcomes that affect the quality of care and services provided to its patients. The following criteria are employed when determining the allocation of resources to address opportunities to improve performance. 1. Risk to patients. 2. The number of patients involved. 3. Problem prone areas. 4. Newness of the service or process involved. 5. Patient satisfaction. 6. Organizations mission, vision, and strategic plan. 7. Changing regulatory requirements. 8. Assessment of community needs. B. Characteristics: Data collection focuses on those processes or outcomes that contain the following characteristics: 1. High risk; 2. High volume; 3. Problem prone. Considering these elements, the team members will evaluate the priorities for the team ... The quality department, with collaboration and approval from medical executive committee, quality improvement council, and community board will establish priorities for performance improvement efforts for the organization as a whole based on the above guidelines."

During a concurrent interview and review of the hospital's Service Line Quality Metrics (Activities) for year 2024 with the quality patient safety manager (QPSM) and CNO on 9/5/24 at 9:17 a.m., the QPSM explained the hospital's metrics are being analyzed, measured and tracked. The metrics are used and corporate assigns them to be conducted. When asked to share the metrics/activities being conducted at this hospital focusing on high-risk high-volume or problem prone areas within the services provided and/or departments at this hospital, the QPSM explained they had the readmissions metric, under the high-volume category, to share which was a corporate metric that was assigned for hospital to track. The QPSM and CNO were asked for more high-volume category metrics/activities focusing on concerns within their hospital services. They had no other metrics/activities they were currently tracking. The QPSM and CNO confirmed the hospital does not have metrics/activities to share focusing on high-risk or problem prone areas.

Based on interview and record review the facility failed to track adverse patient events to ensure health and safety code 1279.1 requirement was met for Patient 500 when Patient 500's death occurred within 42 days post-delivery of a newborn and the facility failed to disclose the adverse event to patient 500's family. (Adverse Event (AE) an adverse event or series of adverse events that cause the death or serious disability of a patient, personnel, or visitor requiring event to be reported to the California department of Public health (CDPH)).

The facility's failure resulted in Patient 500's family not being aware patient 500's death was Adverse Event .

Finding:

During the review of the facility policy and procedure (P&P) titled, "Sentinel events/adverse events" dated 6/18/24, the P&P indicated, "7) It shall be the policy of [facility name] to report an adverse event, as defined within health and safety code 1279.1 (below) to the California Department of public health services (CDPH) no later than (5) five days after the event has been detected .... Adverse event includes any of the following: o) maternal death or serious disability associated with labor or delivery in a low -risk pregnancy, including events that occur within 42 days post-delivery and excluding deaths from pulmonary or amniotic fluid embolism, acute fatty liver of pregnancy or cardiomyopathy. 3) Disclosure of Adverse Event to Patient or Patient Representative, a) The patient, or the party responsible for the patient, will be notified by the patient's physician, administrator, or administrative designee of the nature of the adverse event by the time the report to the California department of public health services (CDPHS) is made. Such disclosure shall be reflected in the patient's record."

During a concurrent review of Patient 500's medical record and an interview with the chief nurse officer (CNO) on 9/5/24 at 10:25 a.m., CNO reported Patient 500 presented to the emergency department ED on 5/20/24 with complaints of abdominal pain after delivering a newborn on 5/10/24. Patient 500 was diagnosed with Sepsis (a life-threatening emergency that happens when the body response to an infection, damages vital organs and, often, causes death) requiring immediate treatment including a surgical procedure to remove the possible source of infection from the uterus, competency of the staff in the surgical holding unit (SHU), and the administration of antibiotics immediately. There was a delay in the administration of the antibiotics. Patient 500 was transfered to the SHU where Patient 500 was held longer than expected.The physician performing the surgical procedure on Patient 500 was pulled away to treat another patient requiring emergency surgical procedures. The on-call or back up physician was not called in to perform the surgical procedure Patient 500 required. Patient 500 had a cardiac arrest while in the SHU resulting in Patient 500's death before the surgical procedure could be performed.

The facility reported Patient 500's death as an AE to CDPH on 5/24/24.

During a concurrent review of Patient 500's medical record and interview with the manager of patient safety (MPS) on 9/5/24 at 4:30 p.m., the MPS was asked to show the documentation patient 500's family was notified that patient 500's death was reported as an AE to CDPH. MPS was not able to locate any documentation in Patient 500's medical record to indicate the AE was disclosed to Patient 500's family. The MPS stated, "No, the family was not notified of the adverse event, there is no documentation in the record indicating the physician or anyone else notified the family." The MPS and the CNO both verified Patient 500's family was not made aware that Patient 500's death was reported as an AE.

The facility failed to conduct a quality assurance performance improvement (QAPI) program when they did not conduct performance improvement projects (PIPs) as part of their quality assessment and performance improvement program, and they failed to document the quality improvement projects, that are being conducted, the reasons for conducting these projects, and the measurable progress achieved on these projects utilizing the selected PDSA model approach.

The facility's failure resulted in PIPs being conducted as presentations instead of PIPs.

Finding:

The facility's document titled, "Quality Improvement Plan" for year 2024, indicated in part, "V11. Approach and Purpose... "In an effort to continually improve organizational performance and maintain high quality of patient care, [facility name] evaluates the development of new processes as well as the redesign or improvement of existing processes. A systematic approach is utilized to: A. Identify the new process or potential improvement B. Assess/test the strategy for change C. Analyze data from the test (to determine if that change produced the desired result) D. Implement the improvement strategy system wide when applicable. The following approaches are used as applicable, in ensuring performance improvement: A. PDSA MODEL (PLAN, DO, STUDY, ACT). The purpose of the performance improvement function is to continuously improve existing processes and outcomes and then sustain the improved performance. Using the PSA Model, existing processes are incrementally improved or redesigned. In addition, the processes are designed and monitored for effectiveness in the same manner ..."

During a concurrent review of the hospital's, "Service Line Quality Metrics for year 2024" with the quality patient safety manager (QPSM) and CNO on 9/5/24 at 9:17 a.m., the QPSM explained the hospital's metrics were being analyzed, measured and tracked.The metrics are used andthen corporate assigns them to be conducted. The metrics included were heart failure, sepsis, readmissions, hospital acquired infections, surgical complications, pressure injuries, and serious safety events. Upon review of the readmission metric documents, the documentation format equates to a topic presentation. The QPSM and CNO were asked to show how the PDSA model approach was integrated into this metric documentation process. The QPSM and CNO were not able to explain the PDSA model approach based on the provided readmission metric documents.

The CNO provided a schedule reporting calendar for the year 2024 which included several hospital services indicating the month that particular service was going to present their service operations report or PIPs information. It was unclear as to what would be presented. The CNO was asked to provide a list of the PIPs each service is currently conducting, which they have presented or are going to present, the reasons for conducting the PIPs, and the measurable progress achieved on these PIPs utilizing the selected PDSA model approach, based on the calendar schedule. The CNO stated, "No, we don't have a list of the current PIPs being conducted."

Based on interview and record review the facility failed to have the hospital's governing body ensure that the quality assurance performance improvement (QAPI) program reflected the complexity of the hospital's organization and services; involved all hospital departments and services included the outpatient services.

The facility's failure resulted in the outpatient cardiovascular rehabilitation, physical/occupational therapy rehabilitation and outpatient laboratory services not participating in the QAPI program when they did not do any performance improvement projects (PIPs) to identify a service problem, conduct a PIP, to monitor and improve the services being provided to the patients.

Findings:

During a concurrent tour of the outpatient physical/occupational therapy rehabilitation service and interview with the rehabilitation director (RehabD) 9/4/24 at 10:50 a.m., the RehabD was asked which PIPs were being conducted in his department/service to improve the service provided to the patients. The RehabD was unaware of what a PIP was and what the proces was for conductiong a PIP. After an explanation to the RehabD about what a PIP was and the process to conduct a PIP, the RehabD stated, "Ohh, No, I am not doing anything like that."

During a concurrent tour of the outpatient cardiovascular rehabilitation service and interview with the cardiovascular rehabilitation supervisor (CVRS) on 9/4/24 at 11:05 a.m., the CVRS was asked which PIPs were being conducted in the department/service to improve the service provided to the patients. The CVRS sis not know what a PIP was or how to conduct one. After providing an explanation as to what a PIP was and the process in conducting a PIP, the CVRS stated "I understand now but we are not doing anything like that in the department."

During a concurrent review of the hospital's, "Service Line Quality Metrics for year 2024" with the quality patient safety manager (QPSM) and CNO on 9/5/24 at 9:17 a.m., the CNO was asked to provide the PIPs being conducted in the outpatient services departments. The CNO was unable to provide PIP documentation for the following outpatient service areas visited suring the survey on 9/4/24; the outpatient laboratory, the physical/occupational therapy rehabilitation, and the cardiovascular rehabilitation services.

The Condition of Participation is NOT met as evidenced by:

Based on observation, interview, and record review, the hospital failed to ensure nursing care and services were provided in a safe manner and failed to ensure hospital policies and procedures (P&P) and standards of practice were followed when:

1. Patient 500 was not adequately monitored, assessed, and reassessed as required by facility policy and procedure. (Cross Reference A-395)

2. Care plans (a document that outlines the care a patient will receive based on their needs and goals of care) were not developed for eight out of 41 sampled patients (Patient 200, Patient 202, Patient 204, Patient 302, Patient 305, Patient 401, Patient 402 and Patient 501). (Cross Reference A-396)

3. Staff did not have the necessary training for procedural sedation (a level of sedation where a person is asleep but can wake up when spoken to or touch) before performing the procedure for Patient 202) (Cross Reference A-397)

4. Adult crash cart (a wheeled cart containing medical equipment and medications for use during life-saving emergencies) in the telemetry unit was not checked to ensure there were no expired supplies and made it ready for use during an emergency. (Cross Reference A-398)

5. Intravenous (IV - within a vein) sites and IV tubing were not labeled with the start date and time as per policy and procedure for three of 41 sampled patients (Patient 201, Patient 403 and Patient 407). (Cross Reference A-398)

6. Glucometers (blood glucose meter) were not cleaned and disinfected per policy and procedure. (Cross Reference A-398)

7. IV sites were not documented in the medical record for one out of 41 sampled patients (Patient 201). (Cross Reference A-398)

8. Expired ChloraPrep (sterile antiseptic solution) was stored in the operating room (OR) on the labor and delivery unit. (Cross Reference A-398)

9. Sterile towels, in plastic peel pouches, were stored in the blanket warming cabinet in the OR hallway, on the labor and delivery unit. (Cross Reference A-398)

10. Staff infused normal saline without using an IV infusion pump during conscious sedation (sedation in which a person is asleep but wakes when spoken to or touched). (Cross Reference A-398)

11. Staff did not wear a dosimeter (detects and measures radiation exposure) badge while administering medication in a cardiac catheterization procedure (inserting a long thin flexible tube into a blood vessel and threading it into the heart [using x-ray images to guide the tube] to treat heart conditions). (Cross Reference A-398)

12. Endoscope (tube-like instrument used to look inside the body) was not reprocessed according to policy and procedure, which requires reprocessing every 14 days. (Cross Reference A-398)

13. Staff did not check the neonatal intensive care unit (NICU) crash cart to safeguard against expired supplies and ensure it was ready for use during an emergency. (Cross Reference A-398)

14. Pain assessments were not performed per policy and procedure for six out of 41 sampled patients (Patient 200, Patient 202, Patient 203, Patient 204, Patient 302 and Patient 304). (Cross Reference A-398)

15. Critical laboratory results were not reported to the physician. (Cross Reference A-398)

16. The stop time of a medication infusion was not documented for Patient 603. (Cross Reference A-398)

17. Staff did not document providing discharge instructions to Patient 603. (Cross Reference A-398)

18. Expired containers of disinfectant were stored in the emergency department (ED) clean storage room. (Cross Reference A-398)

19. The Emergency Department (ED) crash cart defibrillator (device that sends an electric pulse or shock to the heart to restore normal heartbeat) functioning was not checked daily as per policy and procedure. (Cross Reference A-398)

20. The ED crash cart was not checked to safeguard there were no expired supplies and was ready for use by staff during an emergency. (Cross Reference A-398)

21. Staff brought personal food items into patient's room. (Cross Reference A-398)

22. Staff did not perform hand-off (real-time sharing of important patient information between nurses) for a septic (the body's extreme reaction to infection) patient (Patient 500). (Cross Reference A-398)

23. Levophed (vasoconstrictor used to treat life-threatening low blood pressure (hypotension) that can occur with certain medical conditions) medication drip was not titrated (giving in a certain concentration slowly over time) per the physician's order for Patient 101. (Cross Reference A-405)

24. Ketamine (an anesthetic to put patient to sleep and to help prevent pain and discomfort) medication drip was not titrated per physician's order for Patient 101. (Cross Reference A-405)

25. Pepcid (provides relief for heartburn) and Bicitra (used to make the urine less acidic) medications were not administered per physician's order for Patient 200. (Cross Reference A-405)

26. Critical care nurse staff did not sign off physician's medication orders for Fentanyl (potent synthetic opioid drug for use as an analgesic (pain relief) and anesthetic) and Versed (drug used to treat anxiety and tension and to relax muscles) for Patient 202. Cross Reference A-405)

27. Post-Op (after an operation) nurse staff did not administer normal saline (a crystalloid fluid) per physician orders, while patient was in Post-Op Unit for Patient 202. (Cross Reference A-405)

28. Nurse staff in the surgical holding unit (SHU) did not administer antibiotics STAT (without delay, immediately) to a septic patient (Patient 500) as per policy and procedure. (Cross Reference A-405)

29. Verbal orders were entered into the electronic health record (EHR) without being authenticated by the provider for two of 41 sampled patients (Patient 300 and 301). (Cross Reference A-409)

The cumulative effects of the hospital's systemic failure to adhere to policies and procedures, standards of nursing practice, protocols and physician orders, resulted in the hospital's inability to ensure the delivery of safe and effective nursing care services.

Based on interview and record review, the facility failed to ensure one of 41 sampled patients (Patient 500), was assessed and reassessed according to facility policy and procedure when:

1. The Emergency Severity Index ((ESI) triage acuity) assigned to Patient 500 failed to reflect their actual level of acuity.
2. Monitoring of Patient 500's vital signs (VS) failed to occur as frequently as required in the emergency department (ED) for their level of acuity.
3. Sepsis (serious life-threatening infection) guidelines were not followed when:
a. Urine output (UOP) was not measured,
b. VS were not documented before, during or after intravenous fluid (IVF) bolus (given all at once),
c. Second intravenous access (IV) was delayed,
d. Sepsis specific reassessment was not completed.
4. Antibiotic administration was delayed.
5. Hand-off (real-time sharing of important patient information) communication between nurses for transferring care of Patient 500 failed to occur per policy and procedure.

These facility failures resulted in delayed intervention for the treatment of Patient 500's life-threatening illness.

Findings:

During a review of Patient 500's, "ED Physician Notes (EDPN)," dated 5/20/24 at 1:15 p.m., the EDPN indicated, Patient 500 was a 30-year-old female who was 10 days postpartum (time since giving birth) with complaints of nausea, vomiting, abdominal discomfort and headache. Diagnosis (identified problems) included acute severe sepsis (life-threatening illness) from a gas-forming infection (bacteria) causing endometritis (inflammation of the uterus), acute kidney injury (kidneys suddenly cannot filter waste from the blood), acute tachycardia (fast heart rate), acute dehydration hemoconcentration (concentrated blood), acute nausea and vomiting, acute pelvic (area between the hips) pain. The plan for Patient 500 was to admit to Cardiac Telemetry (heart monitoring area). Patient 500's condition was guarded (very sick).

1. During a review of the California Emergency Nurses Association (ENA) website," https://californiaena.org/wp-content/uploads/2023/05/ESI-Handbook-5th-Edition-3-2023.pdf," accessed 9/12/24, the ENA's ESI Handbook indicated, "High-risk vital signs: Reassess to determine whether the patient warrants a higher acuity level if a patient has one or more vital signs outside the normal parameters for the patient ... All patients who have a pain rating of 7/10 or greater should be considered for meeting ESI level-2 criteria ... Pregnancy or postpartum status are important data elements that can influence understanding of patient risk ... Critical determinants of acuity include ... abdominal, head, or chest pain."

During a review of Patient 500's "ED Triage (EDT)," dated 5/20/24 at 9:14 a.m., the EDT indicated, "Chief Complaint ... vomiting ... Headache [critical detail] ... Tracking Acuity ... 4 - Non-urgent ... Heart Rate ... 137 [high-risk] ... Pain Intensity ... 10 [high-risk] ... Pregnancy Status: Pt has delivered in the past 6 weeks [important data element] ... Suspected Infection: Yes [critical detail]."

During a review of the facility's P&P titled, "Triage Classification," 3/13/2024, the P&P indicated, "Patients will be assessed and assigned a triage category according to the 5 Level Emergency Severity Index ... Level 2 EMERGENT ... Conditions that could deteriorate rapidly if treatment is delayed ... Patients have a high risk situation and potential for rapid decline ...Patients are taken to any available treatment area ... Level 3 URGENT ... Conditions that are stable ... Level 4 SEMI URGENT ... Conditions that are less sever and the patient can safely wait for treatment."

During an interview on 9/6/24 at 8:55 a.m. with a registered nurse (RN5), Patient 500's EDT was reviewed. RN5 stated Patient 500 was assigned an ESI level 4. RN5 further stated RN5 would change the ESI level to 3 if they could redo it.

During an interview on 9/4/24 at 9:45 a.m. with a registered nurse (RN6), Patient 500's EDT was reviewed. RN6 stated based on Patient 500's pain and heart rate RN6 would have assigned ESI level 2.

2. During a review of the facility's P&P titled, "Assessment and Reassessment," dated 2/14/24, the P&P indicated, ESI Level 2 ... Vital signs pertinent to patient condition will be monitored a minimum of every 15 minutes ... ESI Level 3 ... Any abnormal vital sign will be rechecked within 1 hour."

During a review of Patient 500's "Hemodynamics/Vitals ((HV) measurable values that reflect a patients overall state of health)," the HV indicated Patient 500's blood pressure (BP) reference range 91-139/51-89, heart rate (HR) reference range 51-119, respiratory rate (RR) reference range 13-20, temperature (T) reference range 36.4-37.5 and pain intensity (pain) was recorded 5/20/24:
- at 9:14 a.m., BP 113/80, HR 137 (abnormal), RR 20, T 36.1 (abnormal), pain 10 (abnormal)
-at 12 p.m., BP 118/90 (abnormal), HR 112, RR 20, T not recorded, and pain not recorded
-at 1:25 p.m., BP 117/81, HR 128 (abnormal), RR 20, T 36.1 (abnormal), and pain not recorded

During a concurrent interview and record review on 9/4/24 at 9:45 a.m., with RN6, Patient 500's EDT, dated 5/20/24 at 9:14 a.m. was reviewed. RN6 stated based on Patient 500's HR and pain RN6 would have rechecked Patient 500's VS every 30-60 minutes.

3a. During a review of the facility's Sepsis checklist (SCL), titled, "Severe Sepsis / Septic Shock Pathway," dated 9/22, the SCL indicated, "Nursing Focused Exam for Sepsis Shock Patients ...document the following in Adult System Assessment section ... I&Os [intake and output]: Notify the provider [physician] if urine output is less than 0.5 ml/kg/hr."

During a concurrent interview and record review on 9/5/24 at 11:10 a.m. with RN9, Patient 500's electronic medical record (eMR) was reviewed. RN9 stated Patient 500 got up to the bathroom. RN9 further stated Patient 500's urine was not measured.

During a concurrent interview and record review on 9/5/24 at 11:20 a.m. with RN10, Patient 500's eMR was reviewed. RN10 stated RN10 assisted Patient 500 to the bedside commode (portable toilet). RN10 further stated Patient 500's urine was not measured.

During a concurrent interview and record review on 9/5/24 at 11:40 a.m. with RN8, Patient 500's eMR was reviewed. RN8 stated RN8 collected a urine sample. RN8 further stated Patient 500's urine was not measured.

During an interview on 9/5/24 at 10:20 a.m. with Assistant Nurse Manager (ANM), ANM stated ANM expects the nurses to follow the SCL and measure urine output.

3b. According to Fundamentals of Nursing, Tenth Edition (Potter et al.; Elsevier: 2021, p. 468), "When to Measure Vital Signs ... Before, during, and after the administration of medication or therapies that affect cardiovascular, respiratory, or temperature-control functions."

During a review of Patient 500's "Orders," printed 9/4/24 at 5:04 p.m., the Orders indicated Patient 500 had Sodium Chloride 0.9% (NS), IVF, 1,000 ml (milliliter), bolus (the whole amount), STAT (to be given immediately), and infused over one hour ordered three times while in the ED on:
- 5/20/24 at 10:42 a.m.,
- 5/20/24 at 10:42 a.m., and
- 5/20/24 at 12:04 p.m.

During a review of Patient 500's "Medication Administration (MAR)," printed 9/4/24 at 5:04 p.m., the MA indicated Patient 500 was administered NS 0.9%, 1,000 ml, bolus, three times while in the ED on:
- 5/20/24 at 10:59 a.m.,
- 5/20/24 at 10:59 a.m., and
- 5/20/24 at 12:36 p.m.

During a review of the facility's "SCL," dated 9/22, the SCL indicated, "Monitor BP q [every] 15 minutes x 1 hour [hr] after ... IVF bolus."

During a review of Patient 500's "HV," the HV indicated Patient 500's BP was recorded after the IVF bolus on 5/20/24 at 12 p.m., 1:25 p.m. and 2:14 p.m.

During an interview on 9/4/24 at 4:30 p.m. with RN7, RN7 stated RN7 was the primary nurse for Patient 500 in the ED. RN7 also stated two liters of IVF were hung by RN7 on 5/20/24 at 10:59 a.m. RN7 further stated RN7 had no idea Patient 500 had sepsis or why Patient 500 was getting the IVF.

During an interview on 9/5/24 at 4:55 p.m. with the Interim ED Director (EDD), EDD stated EDD's expectation is for the nurses to initiate and follow the SCL if there is a concern for sepsis.

3c. During a review of the facility's P&P titled, "Severe Sepsis / Septic Shock Clinical Guidelines," dated 1/23, the P&P indicated, "Below treatment parameters will be followed according to the latest version of the CMS SEP-1 Measure [a quality metric that assess how hospitals treat patients with sepsis] where applicable ... start with 2 large bore peripheral IV's."

During a concurrent interview and record review on 9/4/24 at 4:30 p.m. with RN7, Patient 500's "Vascular Access Devices (VAD)," dated 5/20/24 at 10:59 a.m. was reviewed. The VAD indicated, "Peripheral [away from the center of the body] Antecubital [front of the elbow] Right 20 gauge [IV size] Insert new site. LN3 stated LN3 was the assigned nurse for Patient 500. LN3 further stated this was the first IV site and LN3 did not start a second IV.

During a concurrent interview and record review on 9/5/24 at 11:40 a.m. with RN8, Patient 500's eMR was reviewed. RN8 stated RN8 did not start a second IV.

During an interview on 9/5/24 at 4:55 p.m. with EDD, EDD stated the expectation is for septic patients to have two IV sites.

3d. During a review of the facility's "SCL," dated 9/22, the SCL indicated, "Nursing Focused Exam for Sepsis Shock Patients ...document the following in Adult System Assessment section ... Vital Signs ... Cardiopulmonary Exam ... Peripheral Pulses ... Skin Exam ... Capillary Refill ... I&Os."

During a concurrent interview and record review on 9/5/24 at 11:10 a.m. with RN9, Patient 500's electronic medical record (eMR) was reviewed. RN9 stated RN9 did not listen to Patient 500's lung sounds [part of cardiopulmonary exam] or check the capillary refill [a quick way to assess blood flow changes for signs of shock].

During a concurrent interview and record review on 9/5/24 at 11:20 a.m. with RN10, Patient 500's eMR was reviewed. RN10 stated RN10 was not aware of the Nursing Focused Exam for Sepsis Patients or where to record the assessment in the eHR. LN6 further stated the SCL was not used.

During an interview on 9/5/24 at 10:20 a.m. with ANM, ANM stated the nurses are expected to use the paper (SCL) and to follow the nursing focused exam on page two of the SCL. ANM further stated if the SHU receives a septic patient without a paper SCL, then the expectation is they will start one.

4. During a review of the facility's P&P titled, "Medication Management," dated 2/14/24, the P&P indicated, "Medications NOT eligible for scheduled dosing times include ... STAT [give immediately] ... Medications must be administered in accordance with the ... time designated by the physician's orders ... Administer medications according to the "7 rights of Medication Administration" ... Right time."

During a review of Patient 500's "Orders," dated 5/20/24, the Orders indicated:
-at 12:03 p.m. cefepime (an antibiotic medication) was ordered. Order details indicated, "2,000 mg [dose], IV [route] ... Indication [reason]: Sepsis ... priority: STAT [time], Infuse over: 30 min, Start: 5/20/24 12:03."
-at 12:25 p.m. vancomycin (an antibiotic medication) was ordered. Order details indicated, "1,250 mg, IV ... Indication Bacteremia [bacteria in the blood], Infuse over: 1.5 hr, Start: 5/20/24 12:30."
-at 12:42 p.m. ampicillin-sulbactam (an antibiotic medication) was ordered. Order details indicated, "3 gm, IV ... Indication: Pelvic Infection ... priority: STAT, infuse over: 30min, Start: 5/20/24 12:42."

During a review of Patient 500's "Medication Administration (MAR)," dated 5/20/24, the MAR indicated:
-at 12:41 p.m. cefepime was administered. Action details indicated, "Order ... 12:03 ... Perform ... 12:42."
-at 2 p.m. vancomycin was administered. Action details indicated, "Order ... 12:25 ... Perform ... 14:00."
-at 3:50 p.m. ampicillin-sulbactam was administered. Action details indicated, "Order ... 12:42 ... Perform ... 1551."

During an interview on 9/5/24/24 at 10:20 a.m. with ANM, ANM stated there was a delay starting the second IV access. ANM also stated ANM expected the nurses to use the second IV access and not delay administration of the antibiotics.

During an interview on 9/5/24 at 4:55 p.m. with EDD, EDD stated the expectation is for septic patients to have two IV sites.

5. During a review of the facility's P&P titled, "Communication among Caregivers: Improving the Effectiveness," dated 5/8/24, the P&P indicated, "The purpose of the handoff is to ensure the continuity and safety of patient care ... This policy applies to situations where care is "Handed off" from one provider or another or one department to another, for both temporary and permanent transfers ... The primary objective of a hand-off is to provide accurate information about a patient's care, treatment, and services, current condition, and any recent or anticipated changes ... The opportunity for exchange/discussion of the patient must be provided."

During an interview on 9/4/24 at 9:45 a.m. with RN6, RN6 stated handoff did not happen when Patient 500 was transferred between the triage nurse and the "Pit Boss" nurse or between the "Pit Boss" nurse and primary ED nurse. RN6 further stated handoff was not the general practice in the ED.

During an interview on 9/4/24 at 4:30 p.m. with RN7, RN7 stated the ED tech (non-licensed medical staff) transfers the patient from the ED waiting room into the ED treatment room. The licensed nurse for the ED treatment room area is not given a handoff report from the triage nurse or the "Pit Boss" nurse.

During an interview on 9/4/24 at 4:30 p.m., with RN7, RN7 stated RN7 went to lunch at 1203 for 30 minutes. RN7 also stated (RN8 name) was the lunch relief nurse. RN7 further added RN7 mistakenly thought Patient 500 was no longer in the ED because RN7 did not get a handoff about Patient 500 on return from lunch.

During an interview on 9/5/24 at 11:10 a.m. with RN9, RN9 stated, "Handoff was not given," when (RN10 name) took over care for Patient 500 in the Surgical Holding Unit (SHU).

During an interview on 9/5/24 at 10:20 a.m. with the Assistant Nurse Manager (ANM), ANM stated it was, "Absolutely," the expectation for a handoff report to occur between licensed nurses whether it's for a lunch break or for end of shift. ANM further stated, "Handoffs always occur."

Based on interview and record review, the facility failed to ensure staff initiated and documented person-centered (identifies the person's goals, medical needs, discharge needs, and home needs), individualized care plans (outlines the care to be provided and is a communication tool for caregivers) based on nursing assessments for 8 of 41 sampled patients (Patient 501, 202, 200, 204, 302, 305, 401, and 402) when:

1. Patient 501 did not have a care plan for skin integrity.
2. Patient 202 did not have a care plan for being at risk of bleeding.
3. Patients 200 and Patient 204 did not have a care plan for their language barrier.
4. Patients 302 and 305 did not have care plans for pain.
5. Patient 401 did not have a care plan for Dilaudid needs.
6. Patient 402 did not have a care plan for blood transfusion needs.

These failures placed patients at risk for poor patient outcomes due to the absence of nursing care plans (nursing actions to identify patient problems, implement interventions, set goals, and evaluate the effectiveness of interventions to promote multidisciplinary continuity of care, patient safety and quality care) based on individual needs according to policy and procedure.

Findings:

1. During a concurrent interview and record review on 9/6/24, at 9:45 a.m., with the Critical Care Unit Director (CCUD), Patient 501's medical record was reviewed. The medical record indicated Patient 501 was admitted directly from the emergency room to the critical care unit on September 3, 2024. Patient 501's nursing admission skin assessment identified Patient 501 to be a high risk for skin breakdown with a Braden Score of 11 (an evidenced-based tool that predicts the risk for developing a hospital or facility-acquired pressure ulcer or injury. Scores range from less than or equal to 9 to as high as 23. The lower the number, the higher the risk is for developing an acquired ulcer or injury). Further review of the medical record had no documentation of a care plan for Impaired Skin Integrity when Patient 501 was identified as high risk for skin breakdown. The CCUD acknowledged there was no care plan developed and/or implemented for Patient 501 when identified by initial nursing assessment to be a high risk for skin breakdown.

During a review of the facility's policy and procedure (P&P) titled "Interdisciplinary Plan of Care" dated 5/08/24, the P&P indicated in part, "2. Nursing a. The Registered nurse is required to create a care plan, in collaboration with the patient/family which ensures the direct and indirect nursing care services provide for the patient's goals, safety, comfort, hygiene, protection, and for disease prevention and restorative measures. All aspects of Patient Care, such as teaching, interventions, referrals, follow-up, collaboration, community referrals, changes in plan, etc. should be linked with the POC. b. Nursing care planning starts upon admission. It includes planning the patient's care while in the hospital as well as planning for discharge to meet post-hospital needs. A nursing care plan is based on assessing the patient's nursing care needs (not solely those needs related to the admitting diagnosis). The assessment considers the patient's treatment goals and, as appropriate, physiological and psychosocial factors and patient discharge planning. The plan develops appropriate nursing interventions in response to the identified nursing care needs ..."


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2. During a review of Patient 202's, "Discharge Order" (DO), dated 9/4/24, the DO indicated, Patient 202 strict bed rest/patient to lay flat for 2 hours post procedure. Ambulate 4 hours post procedure. Assuming no bleeding or other complications, okay to discharge.

During a review of Patient 202's "Plan of Care" (POC), (no date), the POC indicated, Patient 202 had POC for at risk for infection, fall risk, anxiety, and pain.

During an interview on 9/6/24 at 9:36 a.m. with Assistant Nurse Manager Cath Lab (ANM 2), ANM 2 stated that a routine care plan for post Cath lab patient would include a care plan for at risk for bleeding.

During a review of the facility's policy and procedure (P&P) titled, "Interdisciplinary Plan of Care," dated 5/8/24, the P&P indicated, "Each discipline providing care prioritizes and incorporates the patient problems/needs into the interdisciplinary Plan of Care in the EHR."


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3. During a concurrent interview and record review on 9/5/24, at 4:00 p.m., with the perinatal director (PD), Patient 200's medical record was reviewed. The medical record indicated Patient 200 did not speak English and spoke the Mixteco language. The medical record indicated Patient 200 needed an interpreter to understand her medical care. Further review of the medical record revealed there was no documentation of a care plan for language barrier when Patient 200 did not speak English. PD acknowledged there was no care plan developed and/or implemented for Patient 200 when having a language barrier.

During a concurrent interview and record review on 9/6/24, at 9:36 a.m., with the perinatal director (PD), Patient 204's medical record was reviewed. The medical record indicated Patient 204 did not speak English and spoke the Spanish language. The medical record indicated Patient 204 needed an interpreter to understand her medical care. Further review of the medical record had no documentation of a care plan for language barrier when Patient 204 did not speak English. PD acknowledged there was no care plan developed and/or implemented for Patient 204 when having a language barrier.

During a review of the facility's policy and procedure (P&P) titled, "Interdisciplinary Plan of Care" dated 5/08/24, the P&P indicated in part. "2. Nursing b. Nursing care planning starts upon admission. It includes planning the patient's care while in the hospital as well as planning for discharge to meet post-hospital needs. A nursing care plan is based on assessing the patient's nursing care needs (not solely those needs related to the admitting diagnosis). The assessment considers the patient's treatment goals and, as appropriate, physiological and psychosocial factors and patient discharge planning. The plan develops appropriate nursing interventions in response to the identified nursing care needs ..."

During a review of the facility's, "Patient Rights and Responsibilities" written pamphlet, the pamphlet indicated in part, "3. To communicate effectively with your care team. Receive free and in a timely manner, aids and services if you have a disability or free language services if your primary language is not English. Qualified sign language interpreters, written information in other formats (large print, audio, accessible electronic formats), qualified interpreters, and information written in other languages ..."


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4. During a concurrent interview with Critical Care Unit Director (CCUD) on 09/05/24 at 10:26 a.m. and review of Patient 302 medical record, Patient 302's care plans were reviewed. There was no care plan for pain. CCUD confirmed that Patient 302 was being treated for pain and should have had a care plan for pain.

During a concurrent interview with CCUD on 09/05/24 at 10: 26 a.m. and review of Patient 305 medical record Patient 305's care plan indicated there was no care plan for pain. CCUD confirmed that Patient 305 was being treated for pain and should have had a care plan for pain.

During a concurrent interview with CCUD and a review of facility policy and procedure (P&P) titled, "Pain Management (Acute and Chronic) Assessment, Reassessment and Management", dated 05/08/24, the P&P indicated in part, "PATIENT CARE PROVIDER RESPONSIBILITIES: 1. Registered nurses are responsible for the initial pain history and should review home medications, routine pain screening, assessment/reassessment, and ongoing evaluation of the individualized pain management plan of care as determined by patient status/need ..." CCUD acknowledged that patients with pain are expected to have an up-to-date care plan in their medical record.


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5. During a concurrent interview and record review on 9/3/24 at 2:54 p.m. with registered nurse (RN15), Patient 401's electronic medical record (EMR) was reviewed. The EMR indicated, Patient 401 was admitted to the facility on 8/22/24 with severe lower extremity (lower leg) cellulitis (a serious bacterial skin infection) and required pain medication. The department was not able to locate a care plan in the EMR for Patient 401's need for pain medication. RN 15 confirmed a plan of care to direct the patient's needs was not developed. RN 15 stated, "there should be a care plan."

6. During a concurrent interview and record review on 9/3/24 at 3:22 p.m. with RN15, Patient 402's electronic medical record (EMR) was reviewed. The EMR indicated, Patient 402 was admitted to the facility on 9/1/24 with diagnoses gastrointestinal (digestive tract) bleeding and required a blood transfusion. The department was not able to locate a care plan in the EMR for Patient 402's blood transfusion needs. RN 15 confirmed a plan of care to direct the patient's needs for blood transfusion was not developed. RN 15 stated, "there should be a care plan."

During a review of the facility's policy and procedure (P&P) titled, "Interdisciplinary Plan of Care" effective 5/8/24, the P&P indicated, "The care team will develop/create an interdisciplinary individualized plan of care (POC) that reflects the patient's goals and the nursing care to be provided to meet the patients' needs. The POC will integrate the problems, expected outcomes, and interventions for the patient." The P&P further indicated, "The registered nurse is required to create a care plan, in collaboration with the patient/family which ensures that direct and indirect nursing care services provide for the patients goals, safety, comfort, hygiene, protection and for disease prevention and restorative measures."

Based on interview and record review, the facility failed to ensure registered nurse (RN 18), had the required training for procedural sedation (technique of administering sedatives or dissociative agents with or without analgesics to induce a state that allows the patient to tolerate unpleasant procedures while maintaining cardiorespiratory function) completed prior to performing procedural sedation.

This failure had the potential to cause harm to all patients receiving procedural sedation in the Cath Lab.

Findings:

During an interview on 9/6/24 at 9:57 a.m. with Director of Cath Lab (DCL), DCL stated we have all compliance training done prior to new staff doing procedures in the Cath lab, procedural sedation training should be completed prior to administrating procedural sedation.

During a review of RN 18's, "Compliance Training (CT)," dated 9/4/24, the CT indicated, RN 18 completed his procedural sedation training after the Cath lab procedure for Patient 202, while providing procedural sedation for that procedure.

During a review of the facility's policy and procedure (P&P) titled, "Staff Competency," dated 5/2024, the P&P indicated, "New staff will be required to complete the general and department specific orientation checklists which outline the knowledge, skills and behaviors selected for competency testing during the orientation period."

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

1. Staff checked the telemetry unit adult crash cart (a wheeled cart containing medical equipment and medications for use during life-saving emergencies) to ensure there were no expired supplies and made it ready for use during an emergency.

2. Staff labeled intravenous (IV - within a vein) sites with the start date and time as per policy and procedure for two of 41 sampled patients. (Patient 403 and Patient 407).

3. Staff labeled IV tubing with the start date and time for Patient 407 as per policy and procedure.

4. Staff cleaned and disinfected the cardiovascular unit's glucometer (blood glucose meter) per policy and procedure.

5 (a) Two IV sites were labeled with the date and initials for one out of 41 sampled patients (Patient 201).

5 (b) Two IV sites were documented in the medical record for one out of 41 sampled patients (Patient 201).

6. Expired ChloraPrep (sterile antiseptic solution) was not stored in the operating room on the labor and delivery unit.

7. Sterile towels, in plastic peel pouches, were not stored in the blanket warming cabinet in the OR hallway, on labor and delivery unit.

8. Staff performed pain assessments before and after a labor epidural (procedure to administer pain medication into a woman's lower back during labor to relieve pain) placement for Patient 200.

9. Staff performed pain reassessments after pain medication intervention for Patient 203 and Patient 204 on the perinatal unit.

10. Staff infused normal saline via IV infusion pump during conscious sedation (sedation in which a person is asleep but wakes when spoken to or touched) instead of allowing it to flow freely.

11. Staff wore a dosimeter (detects and measures radiation exposure) badge while administering medication in a Cardiac Catheterization Procedure (inserting a long thin flexible tube into a blood vessel and threading it into the heart [using x-ray images to guide the tube] to treat heart conditions).

12. Endoscope (tube-like instrument used to look inside the body) was reprocessed according to policy and procedure, which requires reprocessing every 14 days.

13. Staff performed pain assessments before and after pain medication intervention for Patient 202 in the Cardiac Catheterization procedure room.

14. Staff checked the crash cart in the neonatal intensive care unit (NICU) to safeguard against expired supplies and ensure it was ready for use during an emergency.

15. Staff cleaned and disinfected the glucometer (blood glucose meter) as per policy and procedure.

16. Staff performed pain assessments as per policy and procedure for Patient 302 and 304.

17. Staff reported critical laboratory results to the physician.

18. Staff documented the stop time of a medication infusion for Patient 603.

19. Staff documented providing discharge instructions to Patient 603.

20. Staff removed expired containers of disinfectant from the emergency department (ED) clean storage room.

21. The ED crash cart defibrillator (device that sends an electric pulse or shock to the heart to restore normal heartbeat) functioning was checked daily as per policy and procedure.

22. The ED crash cart was checked to safeguard there were no expired supplies and was ready for use by staff during an emergency.

23. Staff did not bring personal food items into patient's room.

24. Staff performed hand-off (real-time sharing of important patient information between nurses) for a septic (life-threating infection) patient per policy and procedure.

These failures placed patients at risk of not receiving the appropriate nursing care and services, and had the potential to result in injury, harm, and even death, and jeopardized the quality of patient care.

Findings:

1. During an interview on 9/3/2024, at 1:56 p.m., with the director of medical/surgical and telemetry (DMST), an initial tour of the telemetry (a floor in a hospital where patients received continuous heart monitoring) unit was conducted. DMST stated, emergency crash carts (a wheeled container that carries medicine and equipment for use in life-saving emergencies) should be checked by nursing staff every shift to ensure equipment is operational and supplies and medications are available in case of an emergency.

During a concurrent interview and record review on 9/3/24 at 1:59 p.m. with DMST, the facility document titled "Adult Daily Crash Cart Checklist" was reviewed. The checklist indicated, "Month/Year: September 2024 - Unit: Telemetry - Crash Cart Name, Number, or Location: #2" On 9/2/24 and 9/3/24 the crash cart checklist was not completed to ensure the emergency crash cart was ready for use. DMST confirmed the crash cart checklist for crash cart #2 had not been completed since 9/1/24.

During a review of the facility's policy and procedure (P&P) titled, "Crash Cart Policy" Effective October 2019, the P&P indicated, "Purpose: To provide a guideline for maintaining crash cart integrity for emergency use at all times." The P&P further indicated, "For departments operating 7 days a week, the crash cart locks, and equipment are checked daily."

2. During an observation on 9/4/24 at 9:28 a.m. in the telemetry unit (a floor in a hospital where patients received continuous heart monitoring), Patient 403 was seen sitting upright in a chair wearing a hospital gown. Patient 403 was observed to have a Heparin-Lock (Hep-lock)(intravenous (a catheter put into a vein to administer medications or fluid into the bloodstream)) placed into the left antecubital (inner surface of elbow area) which was covered with an undated transparent dressing.

During a concurrent observation and interview on 9/4/24 at 9:28 a.m. with a registered nurse (RN16), RN 16 acknowledged Patient 403's Hep-Lock had a transparent dressing and was not dated. RN 16 stated, "It should have a date on it."

During a concurrent observation and interview on 9/4/24 at 9:37 a.m. with RN 14 in the telemetry unit, Patient 407 was lying in bed wearing a hospital gown. Patient 407 was observed to have a Hep-Lock placed in the left forearm which was covered with a transparent dressing that was not dated. RN 14 stated, "It supposed to be dated."

During a review of the facility's policy and procedure (P&P) titled, "Peripheral Intravenous Catheter (PIVC) Insertion, Maintenance, Removal (Adult) effective 3/7/2/3, the P&P indicated, "The policy of [facility] is to provide care which is evidence-based for the insertion, maintenance and removal of peripheral intravenous catheters (PIVCs)...Site care and dressings change: Dressings will be labeled with time, date and clinical staff's initials to identify when the dressing was placed."

3. During a concurrent observation and interview on 9/4/24 at 9:38 a.m. with DMST in the telemetry unit, Patient 407 was seen lying in bed. Next to the patient, an IV pump was set up, but IV administration tubing was found to be unlabeled and undated. DMST confirmed the IV tubing was unlabeled and undated. DMST stated, "IV tubing should be labeled and dated."

During a review of the facility's policy and procedure (P&P) titled, "Peripheral Intravenous Catheter (PIVC) Insertion, Maintenance, Removal (Adult) effective 3/7/23, the P&P indicated, "The policy of [facility] is to provide care which is evidence-based for the insertion, maintenance and removal of peripheral intravenous catheters (PIVCs)...Intravenous Therapy: Administration sets will be labeled with time, date and clinical staff's initials. The date and time used may be the date of set change or the date that the tubing should be changed next, depending on facility policy. The label should clearly indicate which date/time reference is used."


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4. The policy and procedure (P&P) titled, "Whole Blood Glucose Testing Using the ACCU-CHECK Inform 11 Meter", dated 7/12/24, indicated, "k. Wipe the meter clean with a Super Sani Cloth. l. Disinfect the meter with a new Super Sani-Cloth by wiping all surfaces three times horizontally and three times vertically".

During a tour of the outpatient cardiovascular rehabilitation department on 9/4/24 at 10:30 a.m., RN 4 was observed cleaning the glucometer after a patient use. RN 4 was observed using a purple tub sani-cloth wipe to wipe the glucometer up and down (vertical), on the front, the back, and the sides of the glucometer. However, RN 4 did not wipe the glucometer left -to right (horizontal) at all. After this, RN 4 placed the glucometer on the docking station, ready to be used for another patient.

RN 4 was asked to demonstrate the cleaning process of the glucometer a second time. RN 4 again was observed using a purple tub sani- cloth wipe to wipe the glucometer vertically numerous times however RN 4 did not wipe the glucometer horizontally at all. RN 4 indicated the glucometer was cleaned and ready to be used for another patient.

After reviewing the glucometer policy with RN 4 and cardiovascular rehab supervisor (CVRS), RN 4 and CVRS confirmed RN 4 had not followed the glucometer cleaning and disinfecting process as per their policy and procedure.


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5. (a) During a concurrent observation and interview on 9/3/24 at 3:50 p.m. with RN 17, on the postpartum unit, Patient 201 was observed to have an IV (intravenous-in the vein to deliver fluids and medication) site on the right hand and a second IV site on the middle of the left arm (antecubital). Both IV sites were not labeled with a start date, time, and initials. RN 17 acknowledged both of the IV sites were not labeled and they should have been.

During a review of the facility's policy and procedure (P&P) titled, "Peripheral Intravenous Catheter (PIVC): Insertion, Maintenance, Removal" dated 3/7/23, the P&P indicated in part, "I. Site Care and dressings change: c. Dressings will be labeled with time, date, and clinical staff's initials to identify when the dressing was placed ..."

5. (b) During a concurrent interview and record review on 9/3/24, at 3:52 p.m. with RN 17, on the postpartum unit, Patient 201's medical record was reviewed. Patient 201's medical record indicated the patient was admitted today (9/3/24) through the emergency department (ED) and then brought up to the postpartum unit. Further review of the medical record had no documentation of any IV's being started on Patient 201. When asked if the IV sites were supposed to be documented in Patient 201's medical record, RN 17 acknowledged they should be documented and verbalized they must have been started in the ED. RN 17 further verbalized Patient 201 already had the IVs placed before she arrived to the postpartum unit.

During a review of the facility's policy and procedure (P&P) titled, "Peripheral Intravenous Catheter (PIVC): Insertion, Maintenance, Removal" dated 3/7/23, the P&P indicated in part, "G. Insertion: a. Follow procedures outlined in Elsevier Clinical Skills- which indicated: 49. Document the procedure in the patient's record ..."

6. During a concurrent observation and interview on 9/4/24, at 11:40 a.m., with the perinatal director (PD), during a tour of the operating room (OR 9), in the labor and delivery unit, an anesthesia cart was observed. In the bottom drawer there were several supplies and one applicator of Chloraprep was observed to have an expiration date of 12/2023. PD acknowledged the Chloraprep had expired and should not be in the drawer of the anesthesia cart.

During a review of the facility's, "Tracking Outdates and Cart Cleaning Process Form", dated 4/2024, the form indicated in part, "Each unit will be responsible to check their unit for outdated supplies and clean their procedure, crash, and isolation carts ...all supply expiration dates will be reviewed and those that will expire within the following month will be removed, this allows the prevention of outdated supplies ..."

7. During a concurrent observation and interview on 9/4/24, at 12:00 p.m., with the PD, during a tour of the OR hallway in the labor and delivery unit, a blanket warming cabinet was observed. Inside the warming cabinet there were several baby blankets, and sterile towels in plastic peel pouches, being warmed on a shelf. When asked if the sterile towels inside the peel pouches could be stored in the blanket warming cabinet, PD verbalized was not sure and would have to refer to the manufacture's instructions for use (MIFU's). Further observation of the warming cabinet showed the temperature inside the cabinet, where the sterile towels were being stored, was reading 122 degree F.

During a concurrent interview and review of the MIFU's for the sterile towels on 9/5/24, at 12:10 p.m., with PD, PD verbalized the MIFU's indicated the sterile towels in the plastic peel pouches should be stored in temperatures between 59 deg -89 deg F. PD acknowledged the blanket warming cabinet temperature range was too high and the sterile towels in plastic peel pouches, should not be stored in the blanket warming cabinet.

8. During a concurrent interview and record review on 9/5/24, at 4:22 p.m. with the PD, Patient 200's medical record was reviewed. Patient 200's medical record indicated the patient was admitted to the labor and delivery unit at 11:46 a.m., on 9/3/24, was having uterine contractions, and rated her pain, a 3/10. The medical record indicated Patient 200 requested a labor epidural at 1:15 p.m. The labor epidural was placed at 1:30 p.m. The medical record had no pain assessment documented when Patient 200 requested a labor epidural, and there was no pain assessment documented after Patient 200 received and the epidural. The next pain assessment that was documented in the medical record was at 4:00 p.m., and was documented at 0/10. PD acknowledged there was no pain assessment documented before or after the epidural placement and there should have been. PD verbalized there should be pain assessments performed before and after a pain intervention.

During a review of the facility's policy and procedure (P&P) titled, "Pain Management Assessment, Reassement and Management" dated 5/8/24, the P&P indicated in part, "Pain assessments will be performed with every report of pain, interventions/procedures/activities that typically result in pain and as determined by individual patient status /need ...Pain reassessment will be performed following the implementation of pain management interventions to determine effectiveness based on intervention type, onset, and action ..."

During a review of the facility's policy and procedure (P&P) titled, "Neuraxial Analgesia Intrapartum (Epidural or ITN)" dated 8/16/24, the P&P indicated in part, "21) Assessment: f) Pain is to be evaluated and documented minimally every hour. Call Anesthesia if pain not improved ...22) Required Documentation: c) Epidural x) vital signs, LOC (level of consciousness), pain, and dermatome/sensory levels ..."

9. During a concurrent interview and record review on 9/6/24, at 9:07 a.m. with the PD, Patient 203's medical record was reviewed. Patient 203's medical record indicated Patient 203 was having pain, a 3/10, at 6:49 p.m., on 9/5/24, and was given Toradol 15 mg (medication to relieve pain) IV (Intravenous-in the vein). Further review of the medical record had no documentation of a pain reassessment after the administration of Toradol. PD acknowledged there was no pain reassessment documented after the administration of Toradol and there should have been.

During a concurrent interview and record review on 9/6/24, at 9:23 a.m. with the PD, Patient 204's medical record was reviewed. Patient 204's medical record indicated Patient 204 was having pain, a 6/10, at 6:06 p.m., on 9/5/24, and was given Toradol 15 mg IV. Further review of the medical record revealed there was no documentation of a pain reassessment after the administration of Toradol. PD acknowledged there was no pain reassessment documented after the administration of Toradol and there should have been.

During a review of the facility's policy and procedure (P&P) titled, "Pain Management Assessment, Reassement and Management" dated 5/8/24, the P&P indicated in part, "Pain assessments will be performed with every report of pain, interventions/procedures/activities that typically result in pain and as determined by individual patient status /need ...Pain reassessment will be performed following the implementation of pain management interventions to determine effectiveness based on intervention type, onset, and action ...suggested pain reassessment intervals include: a. intravenous: within 15 minutes after administration ...b. PO (by mouth): within 60 minutes after administration ...c. Subcutaneous: within 30 minutes after administration ..."


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10. During an observation on 9/4/24 at 10:30 a.m. in Cath lab (CL) 2, there was normal saline hung to gravity and not running through the Intravenous pump while providing procedural sedation (A drug-induced depression of consciousness during which patients respond purposefully to verbal commands).

During an interviewwith ANM 2 on 9/4/24 at 10:35 a.m., ANM 2 indicated it was standard process to have IV fluids being administered through and IV pump in the Cath lab.

During a review of the facility's policy and procedure (P&P) titled, "Core Nursing Standards of Practice," dated 12/21, the P&P indicated, "Fluids and IV medications should be delivered via an IV pump utilizing the smart pump drug (or fluid) library."

11. During an observation on 9/4/24 at 10:30 a.m. in Cath lab (CL) 2, the procedural sedation nurse RN18 was observed not wearing a dosimeter badge during the procedure.

During an interview on 9/4/24 at 10:25 a.m. with ANM 2, ANM2 stated, "I do not see him wearing the dosimeter badge, and normal practice would be to wear it during the procedure".

During a review of the facility's policy and procedure (P&P) titled, "Radiation Safety," dated 9/8/2023, the P&P indicated, "Each employee will wear his film badge during work hours."

12. During an observation on 9/5/24 at 9:30 a.m., in Gastroenterology lab (GI) clean scope closet, there was a scope that had a tag on it reading to reprocess on 8/29/24. The reprocessing was 7 days past due.

During an interview on 9/5/24 at 9:35 a.m. with RN 19, RN 19 stated, "Scopes are to be reprocessed every 14 days."

During a review of the facility's policy and procedure (P&P) titled, "Management of Flexible Endoscopes," dated 11/8/2023, the P&P indicated, "The interval of storage after which endoscopes will be reprocessed if not used is 14 days."

13. During an interview on 9/6/2024 at 9:40 a.m. with ANM 2, ANM 2 stated, "I do not see a pain assessment when Tylenol was given pre or post med given."

During a review of Patient 202's "Medication Administration Record (MAR)," dated September 4, 2024, the "MAR" indicated there was no pain assessment conducted prior to, or after pain medication administration.

During a review of the facility's policy and procedure (P&P) titled, "Pain Management (Acute and Chronic) Assessment, Reassessment and management," dated 5/8/2024, the P&P indicated, "Pain management clinical practice expectations include admission pain history/assessment, assessment/reassessment, patient/family education, and individualized pain management plan using appropriate scale."


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14. During a concurrent observation of Neonatal Intensive Care Unit (NICU) and Interview with Director of NICU/ Pediatrics (DNP) on 09/03/24 at 3:07 p.m there was a NICU crash cart in hall outside of the NICU titled, "NICU/Hallway L&D" which was not checked on 09/02/24. DNP confirmed that the NICU/Hallway crash cart was not checked per facility policy.

During an interview with a Registered Nurse (RN) 1 on 09/03/24 at 3:07 p.m. RN1 confirmed the NICU/Hallway crash cart should have been checked and was not done on 09/02/24.

During a review of the facility policy and procedure (P&P) titled, "Crash Cart Policy" dated 06/22/18, the P&P indicated in part, "PROCEDURE: C. For departments operating 7 days a week, the crash cart locks, and equipment are checked daily". " IV. CRASH CART RESPONSIBILITIES: ... B. 1. Each day the crash cart will be inspected by the shift lead or designee for the following items: ...".

15. During a concurrent observation and interview on 09/03/24, at 3:23 p.m. with the DNP and RN 1, RN 1 verbalized that when cleaning the glucometer in the NICU, RN 1 would wipe with a clean purple top wipe and let the glucometer dry for 2 minutes. RN1 indicated the purple top wipes stay wet for 2 minutes, and then RN1 would dry the glucometer with a cloth.

During an interview on 09/04/24 at 8:50 a.m. in the NICU with DNP. DNP confirmed that RN 1 was not able to verbalize the correct cleaning and disinfecting procedure for the glucometer per the facility's P&P for glucometer cleaning and disinfection.

During a review of P&P titled, "Whole Blood Glucose Testing Using the ACCU-CHECK Inform II Meter", dated 07/12/24, the P&P indicated in part, "MAINTENANCE: 1) The meter should be cleaned and disinfected between each patient ... a) Clean to remove visible soil ad organic material ... k) Wipe the meter clean with a Super-Sani-Cloth. l) Disinfect the meter with a new Super Sani-Cloth by wiping all surfaces three times horizontally and three times vertically. m) Allow the surface of the meter to remain damp with the super Sani-Cloth solution for 2 minutes ..."

16. During a concurrent interview with Critical Care Unit Director (CCUD) on 09/05/24 at 10:26 a.m. and review of patient 302's medical record there was no documentation found for pain assessments on 09/04/24 between 06:00 a.m. and 1900 (7:00 p.m.). CCUD confirmed Patient 302 was a Telemetry (a unit a floor in a hospital where patients undergo continuous heart monitoring) patient per the medical record. CCUD confirmed there was no documentation by nursing staff of pain assessments during this time and that pain assessments should have been completed.

During a concurrent interview with CCUD on 09/05/24 at 10:26 a.m. and review of Patient 304's medical record, the medical record revealed there was no documentation of pain assessments between 09/03/23 at 2300 (11:00 p.m.) and 09/04/24 at 06:00 a.m. CCUD confirmed that Patient 304 was a Telemetry patient per the medical record. The CCUD verified there was no documentation by nursing staff of pain assessments during this time and that pain assessments should have been completed. CCUDnfurther indicated pain assessments should be completed routinely per unit specific standards of practice and that for telemetry patients, vital signs are completed every 4 hours while awake and a minimum of every 6 hours if asleep per policy.

During a review of the facility policy and procedure (P&P) titled, "Pain Management (Acute and Chronic) Assessment, Reassessment and Management" dated 05/08/24, the P&P indicated in part, "POLICY: 5. Pain screening will be performed with routine vital signs [VS] (i.e. not with frequent VS's as in vasoactive drip titration [medication being adjusted frequently]) based on unit specific standards of practice ..."

During a review of facility P&P titled, "Core Nursing Standards of Practice" dated 12/21, the P&P indicated in part, "STANDARD 1: NURSING PROCESS 1. Assessment c) ii. Telemetry patient vital signs should be monitored every 4 hours while awake, with a minimum frequency of every 6 hours to allow for uninterrupted sleep ..."

17. During a concurrent interview with DNP on 09/05/24 at 5:17 p.m. and review of Patient 301's medical record a critical high lab value result dated 08/07/24 at 06:31 a.m. for sodium was called and read back by a Registered nurse. There was no documentation this critical lab result was reported to the physician. DNP confirmed that there was no documentation the physician was notified of critical lab result on 08/07/24.

During a review of the P&P titled, "Core Nursing Standards of Practice" dated 12/21, the P&P indicated in part, "STANDARD 1: NURSING PROCESS 1. Assessment: e) Laboratory values and test results should be reviewed upon admission, every shift, and PRN for new results. i. Critical results and values should be reported to the LIP [Licensed Independent Practitioner] within 60 minutes of the registered nurse receiving results ..."


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18. During a review of patient 603's clinical record (CR) and concurrent interview with the oncology nurse (OCN) on 9/5/24 at 11:09 a.m., the CR indicated that patient 603 received the medication (Zometa-used to treat cancer that spread to the bone) 3 milligrams (mg) in 100 milliliters (ml) of normal saline via intravenous (IV-within a vein) on 9/3/24 at 15:38 PM, but the time the medication infusion completed was not documented. The OCN acknowledged that the STOP time was not entered in the electronic medication administration record (EMAR) and should have been.

During an interview with the oncology nurse (OCN2) on 9/5/24 at 11:11 a.m., patient 603's CR was discussed. The OCN2 admitted she was the infusion nurse for Patient 603 on 9/3/24 and she verbalized she forgot to mark the STOP time for the medication infused for Patient 603 on 9/3/24.

During a review of the hospital's policy and procedure (P&P) titled, "Chemotherapy Administration" dated 12/13/23, the P&P indicated, "Administration start and completion times will be documented by the primary RN in the events tab in Cerner. All documentation regarding administration, orders and MAR will be completed by the chemotherapy certified nurse in OncoEMR ..."

19. During a concurrent review of Patient 603's clinical record (CR) and interview with the OCN on 9/5/24 at 11:18 a.m., the CR revealed that Patient 603 received an intravenous infusion (Zometa-used to treat cancer that spread to the bone) on 9/3/24. There was no documented discharge summary that included a recapitulation of the patient's treatment on 9/3/24, a summary of the patient's status at discharge and what to expect in terms of potential adverse effects. The OCN acknowledged the nursing documentation for what happened on 9/3/24 during the visit was left blank.


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20. During an observation and concurrent interview on 9/4/24, at 11:50 a.m., with the Emergency Department Director (EDD) and Emergency Department Manager (EDM) during a tour of the Emergency Department Clean storage room, 12 bottles of One-Step Disinfectant by Protex were observed to have an expiration date of 9/25/2023. EDD and EDM both acknowledged the One-Step Disinfectant by Protex had expired and should not be in the Clean storage room.

During a review of the facility's, "Tracking Outdates and Cart Cleaning Process Form" dated 4/2024, the form indicated in part, "Each unit will be responsible to check their unit for outdated supplies and clean their procedure, crash, and isolation carts ...all supply expiration dates will be reviewed and those that will expire within the following month will be removed, this allows the prevention of outdated supplies ..."

21. During an observation and concurrent interview on 9/4/2024, at 12:10 p.m., with the Emergency Department Director (EDD) and Emergency Department Manager (EDM) an initial tour of the emergency room department was conducted. One emergency crash cart (a wheeled container that carries medicine and equipment for use in life-saving emergencies) was observed and found to contain a portable defibrillator (device that sends an electric pulse or shock to the heart to restore normal heartbeat) with printed test strips dated 9/1/24 and 9/4/24. The EDD, EDM, and the Emergency Room Assistant Manager (RN6) acknowledged the defibrillator was not checked by nursing staff on 9/2/24 and 9/3/24, and that the defibrillator should be checked by nursing staff every shift to ensure life-saving emergency equipment is operational in the event of an emergency.

During a review of the facility's policy and procedure (P&P) titled, "Crash Cart Policy" Effective October 2019, the P&P indicated, "I. Purpose: To provide a guideline for maintaining crash cart integrity for emergency use at all times." The P&P further indicated ... "II. Procedure C. For departments operating 7 days a week, the crash cart locks, and equipment are checked daily ... "IV. Crash Cart Responsibilities: B. Department Responsibilities 1. Each day, the crash cart will be inspected by the shift lead or designee for the following items: b) Defibrillator Pacer Check passed c) Pacer module checked d) Medication and Central Supply expiration dates are present and all items are within the expiration dates ..."

22. During an observation and interview on 9/4/24 at 12:20 p.m. with the EDD and EDM one adult crash cart was observed to contain life-saving supplies with no expiration dates in drawer four (a Miller #4 a straight blade designed to obtain a view of the vocal cords by directly lifting the epiglottis during an emergent airway management procedure) and drawer five (one Salem-sump a dual-lumen tube which allows for suctioning of gastric contents as well as medication/nutrition delivery). The EDD and EDM acknowledged the crash cart should be checked by nursing staff every shift to ensure non-expired life-saving emergency supplies are available in the event of an emergency.

During a review of the facility's policy and procedure (P&P) titled, "Crash Cart Policy" Effective October 2019, the P&P indicated, "I. Purpose: To provide a guideline for maintaining crash cart integrity for emergency use at all times." The P&P further indicated, "II. Procedure C. For departments operating 7 days a week, the crash cart locks, and equipment are checked daily ... "IV. Crash Cart Responsibilities: B. Department Responsibilities 1. Each day, the crash cart will be inspected by the shift lead or designee for the following items: b) Defibrillator Pacer Check passed c) Pacer module checked d) Medication and Central Supply expiration dates are present and all items are within the expiration dates ..."


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23. During a concurrent observation and interview on 9/4/24 at 11:20 a.m. with RN26 outside patient room ED12, RN26 was observed pushing a workstation on wheels (WOW) into a patient room. A drink-stained paper coffee cup was on top of the WOW. RN26 stated the coffee cup belonged to RN26. RN26 further stated, "Probably shouldn't bring it into the patient room."

During an interview on 9/4/24 at 11:35 a.m. with EDD, EDD stated the nurse should not bring their coffee cup into the patient room with them. EDD added there is a concern for infection control.

During a review of the facility's policy and procedure (P&P) titled, "Isolation Precautions (Includes Standard Precautions)," dated 1/2008, indicated, "Standard Precautions ... This is the primary strategy for successful prevention of transmission of communicable disease. Standard Precautions are designed to reduce the risk of transmission of microorganisms from both recognized and unrecognized sources of potential infection in hospitals ... ALL patients are treated with Standard Precautions."

24. During an interview on 9/4/24 at 9:45 a.m. with RN6, RN6 stated handoff did not happen when Patient 500 was transferred between the triage nurse and the "Pit Boss" nurse or between the "Pit Boss" nurse and primary ED nurse. RN6 further stated handoff was not the general practice in the ED.

During an interview on 9/4/24 at 4:30 p.m. with RN7, RN7 stated the ED tech (non-licensed medical staff) transfers the patient from the ED waiting room into the ED treatment room. The licensed nurse for the ED treatment room area is not given a handoff report from the triage nurse or the "Pit Boss" nurse.

During an interview on 9/4/24 at 4:30 p.m., with RN7, RN7 stated RN7 went to lunch at 1203 for 30 minutes. RN7 also stated (RN8 name) was the lunch relief nurse. RN7 further added RN7 mistakenly thought Patient 500 was no longer in the ED because RN7 did not get a handoff about Patient 500 on return from lunch.

During an interview on 9/5/24 at 11:10 a.m. with RN9, RN9 stated, "Handoff was not given," when (RN10 name) took over care for Patient 500 in the Surgical Holding Unit (SHU).

During an interview on 9/5/24 at 10:20 a.m. with the Assistant Nurse Manager (ANM), ANM stated it is, "Absolutely," the expectation for a handoff report to occur between licensed nurses whether it's for a lunch break or for end of shift. ANM further stated, "Handoffs always occur."

During a review of the facility's P&P titled, "Communication among Caregivers: Improving the Effectiveness," dated 5/8/24, the P&P indicated, "The purpose of the handoff is to ensure the continuity and safety of patient care ... This policy applies to situations where care is "H

Based on observation, interview and record review, the facility failed to:
1. Ensure a registered nurse (RN) in the critical care unit (CCU) administered and titrated the Levephod (vasoconstrictor used to treat life-threatening low blood pressure (hypotension) that can occur with certain medical conditions) medication drip per the physician's order for Patient 101.
2. Ensure an RN in the CCU administered and titrated the ketamine (an anesthetic to put patient to sleep and to help prevent pain and discomfort) medication drip per physician's order for patient 101.
3. Ensure the Labor and Delivery RN administered Pepcid (provides relief for heartburn) and Bicitra (used to make the urine less acidic) medications per physician's order for Patient 200.
4. Ensure the catheterization laboratory RN administered Fentanyl (potent synthetic opioid drug for use as an analgesic (pain relief) and anesthetic) and Versed (drug used to treat anxiety and tension and to relax muscles) medications to Patient 202 and failed to signed off the medication physician's orders.
5. Ensure the Post-operative RN administered normal saline (a crystalloid fluid ) to Patient 202, as ordered by physician, while the patient was in the post opperative area.
6. Ensure the Emergency Department (ED) RN administered Patient 500's, a patient with sepsis (a life threatening infection), antibiotics STAT (immediately), as per policy and procedure.

These facility's failures placed patients at risk for suffering, harm, unneccesary side effects, and possibly death.

Findings:

1.During a tour of the critical care unit (CCU) on 9/3/24 at 3:19 p.m., Patient 101 was observed inside room 254 with a Levophed medication drip infusing.

During a concurrent review of the patient's electronic medication administration record (e-MAR) and interview with the CCU director (CCUD) on 9/6/24 at 9:00 a.m., the e-MAR indicated the following:
a) On 9/2/24 at 5:35 a.m., the blood pressure (B/P) was 80/51, the Levophed drip was started at 4 mcg/minute, instead of 6 mcg/min. The physician's order indicated, "Start dose based on systolic blood pressure (SBP): SBP 80-89: 6 mcg/min."
b) On 9/2/24 at 10:45 a.m., B/P 103/58, MAP 75, the Levophed drip was infusing at 2 mcg/min. Then the medication drip was titrated up to 6 mcg/min, instead of 4mcg/min at 2:00 p.m., B/P 115/56, MAP 81. The physician's order indicated "Titrate by 2mcg/min as often as every minute to achieve: mean arterial pressure MAP > 65."
c) On 9/2/24 at 2:04 p.m., the B/P was 82/36, MAP 42, the Levophed drip was titrated up by 4 mcg/min, instead of 20 mcg/min. The physician's order indicated, "If MAP < 50, then increase to 20 mcg/min and then resume titration."
d) On 9/2/24 at 6:15 p.m., B/P was 78/45, MAP 57, the Levophed drip was started at 2 mcg/min instead of 10 mcg/min. The physician's order indicated, "Start dose based on systolic blood pressure (SBP): SBP 70-79: 10 mcg/min."
e) On 9/2/24 at 7:42 p.m., B/P was 90/53, MAP 65, the Levophed drip was started at 2 mcg/min, instead of 4 mcg/min. The physician's order indicated, "Start dose based on systolic blood pressure (SBP): SBP > 90: 4 mcg/min."
f) On 9/2/24 at 11:30 p.m., B/P was 70/45, MAP 54. At 11:45 p.m., the B/P remined 70/45, MAP 54, the Levophed drip was not titrated up every minute to achieve MAP > than 65. The physician's order indicated, "Titrate by 2 mcg/min as often as every minute to achieve MAP > than 65."

The CCUD acknowledged and confirmed the CCU RN did not performed the Levophed medication drip titration according to physician's order.

2. During a tour of the critical care unit (CCU) on 9/3/24 at 3:19 p.m., Patient 101 was observed inside room 254 with a Ketamine medication drip infusing.

During a concurrent review of the patient's e-MAR, Ketamine order and interview with the CCU director (CCUD) on 9/6/24 at 9:30 a.m., the e-MAR indicated the following:
a) The Ketamine medication drip was started on 9/2/24 at 4:54 a.m. At 9:03 a.m., the drip was stopped. At 1:00 p.m., the drip was restarted at 2 mcg/kg/min, instead of 1 mcg/kg/min.
b) On 9/3/24 at midnight the Ketamine drip was stopped. The drip was re started at 2:16 a.m., at 6 mcg/kg/min, instead of 1 mcg/kg/min.
c) On 9/5/24 at 7:00 a.m., the Ketamine drip was infusing at 3 mcg/kg/min, then it was titrated up to 5 mcg/kg/min at 12 noon, instead of 4 mcg/kg/min.

During a concurrent review of the RASS scores, the scores were out of target for which the medication titration was indicated.

The physician Ketamine medication drip order read, "Titrate by 1 mcg/kg/min every 15 minutes, for target RASS goal of 0 to (-1) Awake too drowsy".

The CCUD acknowledged and confirmed the physician's orders were not implemented when titrating the Ketamine medication drip.


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3. During a concurrent interview and record review on 9/5/24, at 4:01 p.m. with the perinatal director (PD), Patient 200's medical record was reviewed. Patient 200's medical record indicated Patient 200 was admitted to the labor and delivery unit at 11:46 a.m. on 9/3/24. The physician's orders indicated to give Pepcid (Famotidine) 20 mg IV (Intravenous- in the vein) and Bicitra 30 ml PO (by mouth) and was ordered at 3:03 p.m. The medication administration record had no documentation of Pepcid and Bicitra being administered. PD acknowledged the medications were not documented and did not know if the medications had been administered per the Physician's orders. PD further acknowledged if the medications were not documented as having been administered then it was not done.

During a review of the facility's policy and procedure (P&P) titled, "Medication Management" dated 2/14/24, the P&P indicated in part, "Medications must be administered in accordance with the amount, route, and time designated by the physician's orders. Document administration of medications using the time and initials of the nurse ..."


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4. During a review of Patient 202's "Cath Lab Medication Record (CLMR)," dated 9/4/24, the "CLMR" indicated, RN 18 (sedation nurse) gave all sedation medications and RN 20 (circulating nurse) signed off the report. RN 18 did not sign off on the verbal orders given.

During an interview on 9/6/24 at 9:36 a.m. with ANM 2, ANM 2 stated normal process in the Cath lab would be for the sedation nurse to sign the orders not the circulating nurse.

During an interview on 9/6/24 at 10:00 a.m. with DCL, DCL stated the sedation nurse would normally sign the verbal medication orders that they administered.

During a review of the facility's policy and procedure (P&P) titled, "Medication Management," dated 2/14/24, the P&P indicated, "The person who prepares the medication is responsible for administrating and documenting the medication."

5. During a review of Patient 202's "Medication Administration Record Summary (MARS), dated 5/4/24, the "MARS" indicated, Patient 202 had no documented time of when the medication was administered.

During an interview on 9/6/24 at 10:15 a.m. with RN 21, RN 21 stated she does not see a start and stop time for the Sodium Chloride 0.9% 1,000 ml ordered by the physiscian and given on 9/4/24 for Patient 202.

During a review of Patient 202's, "Physician Orders (PO)," dated 9/4/24, the "PO" indicated, "Patient 202 to receive Sodium Chloride 0.9% 1,000 ml over four hours, requested start date and time 9/4/24 12:57 PDT, stop date and time 9/4/24 16:56 PDT".

During a review of the facility's policy and procedure (P&P) titled, "Medication Management," dated 2/14/24, the P&P indicated, "Medications must be administered in accordance with the amount, route, and time designated by the physician's orders."


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6. During a review of the facility's P&P titled, "Medication Management," dated 2/14/24, the P&P indicated, "Medications NOT eligible for scheduled dosing times include ... STAT [give immediately] ... Medications must be administered in accordance with the ... time designated by the physician's orders ... Administer medications according to the "7 rights of Medication Administration" ... Right time."

During a review of Patient 500's "Orders," dated 5/20/24, the Orders indicated:
-at 12:03 p.m. cefepime (an antibiotic medication) was ordered. Order details indicated, "2,000 mg [dose], IV [route] ... Indication [reason]: Sepsis ... priority: STAT [time], Infuse over: 30 min, Start: 5/20/24 12:03."
-at 12:25 p.m. vancomycin (an antibiotic medication) was ordered. Order details indicated, "1,250 mg, IV ... Indication Bacteremia [bacteria in the blood], Infuse over: 1.5 hr, Start: 5/20/24 12:30."
-at 12:42 p.m. ampicillin-sulbactam (an antibiotic medication) was ordered. Order details indicated, "3 gm, IV ... Indication: Pelvic Infection ... priority: STAT, infuse over: 30min, Start: 5/20/24 12:42."

During a review of Patient 500's "Medication Administration (MAR)," dated 5/20/24, the MAR indicated:
-at 12:41 p.m. cefepime was administered. Action details indicated, "Order ... 12:03 ... Perform ... 12:42."
-at 2 p.m. vancomycin was administered. Action details indicated, "Order ... 12:25 ... Perform ... 14:00."
-at 3:50 p.m. ampicillin-sulbactam was administered. Action details indicated, "Order ... 12:42 ... Perform ... 1551."

During an interview on 9/5/24/24 at 10:20 a.m. with ANM, ANM stated there was a delay starting the second IV access. ANM also stated the expectation was for the nurses to use the second IV access and not delay administration of the antibiotics.

During an interview on 9/5/24 at 4:55 p.m. with EDD, EDD stated the expectation is for septic patients to have two IV sites.

Based on interview and record review facility failed to ensure staff followed their policy and procedures (P&P) for Management of Orders in the Electronic Health Record (EHR) when verbal orders were entered into the EHR and not authenticated by the provider per the P&P for two of 41 sampled patients (Patient 300 and Patient 301).

This failure had the potential for patients not receiving up to date care.

Findings:

During an interview with Director of Neonatal Intensive Care Unit/Pediatrics (DNP) on 09/05/24 at 09:15 a.m. and concurrent review of Patient 301's medical record there was a medication order for Caffeine entered by the pharmacist on 08/16/24 at 12:23 p.m. which required a cosignature from a provider. The order was signed by the provider on 08/20/24 at 11:11 a.m. The DNP confirmed the order was signed late, after 48 hours.

During an interview with Coronary Care Unit Director (CCUD) on 09/05/24 at 09:20 a.m. and concurrent review of Patient 300's medical record there was a verbal order obtained and entered by Registered Nurse on 08/13/24 at 22:26 (10:26 p.m.). The order was signed by the provider on 08/18/24 at 02:10 a.m. The CCUD acknowledged that the order was signed late, after 48 hours.

During a review of the facility Policy and Procedure (P&P) titled, "Management of Orders in the Electronic Health Record (EHR)" dated 10/11/23, the P&P indicated in part, "Procedure: 1. Order Entry a) Orders will be entered directly into the EHR by the Provider using computerized order entry (COE) ..." "3. Order Authentication a) All orders must be authenticated by the responsible Provider within the time period specified by the facility rules and regulations, not to exceed 48 hours ..." "Authentication: A process whereby an electronic signature is used to signify knowledge, approval, acceptance or obligation by the individual who provided or ordered the service(s) specified in the EHR".