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

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

Provide one of one sampled patient (Patient 2) information and direction in Spanish, the language Patient 2 understands, before the insertion of a Vascular Catheter (Vas Cath - a large vein access device) for Dialysis (a mechanical process to filter waste and water from the blood when the kidneys can no longer function) into Patient 2's right jugular vein (large neck vein).

Provide three of three non-English speaking sampled patients (Patient 31, Patient 32, Patient 33) the appropriate light blue-colored patient wristband indicating the patient's preferred language to communicate.

These failures resulted in a violation of Patient 2's right to be informed and had the potential to result in staff being unaware of the patients' (Patient 31, Patient 32, Patient 33) preferred language and the need for interpreter services. (Refer to A-0117)

2. Based on interview and record review, the facility failed to ensure three of 36 sampled patients (Patient 1, Patient 14, Patient 22), Informed Consents (the process in which a healthcare provider educates a patient about the risks, benefits, and alternatives of a given procedure or intervention) for "Central Line Insertion Procedure" were completed in accordance with the hospital policy and procedure.

This failure resulted in Patient 1, Patient 14, and Patient 22 not being given the opportunity to weigh the risks and benefits of the procedure prior to the procedure. (Refer to A-0131)

3. Based on observation, interview, and record review, the hospital failed to ensure one of one sampled patient (Patient 35) was provided physical privacy in the Emergency Department (ED) Triage area (area used to assess patients' severity of illness/injury within a short time and assigning priorities) when he verbalized his health issues to the Emergency Department Registered Nurse/Start Nurse (EDRN 5).

This failure had the potential for other patients, family member, hospital staff and visitors to overhear the health issues of Patient 35. (Refer to A-0143)

4. Based on observation, interview, and record review, the facility failed to ensure one oxygen e-tank was stored safely and securely.

This failure had the potential to result in injures to patient, staff, and visitors. (Refer to A-0144)

5. Based on interview and record review, the facility failed to ensure two of two sampled patients' (Patient 17 and Patient 19) restraints (measure keep someone under control or within limits) were monitored every two hours, according to the facility's policy and procedure.

This failure had the potential to compromise the safety and comfort of Patient 17 and Patient 19 while on restraints. (A-0167)

The cumulative effect of these systemic failures resulted in the hospital's inability to ensure the provision of quality health care, in compliance with the Condition of Participation for Patient Rights.

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

a. Provide one of one sampled patient (Patient 2) information and direction in Spanish, the language that Patient 2 understands, before the insertion of a Vascular Catheter (Vas Cath - a large vein access device) for Dialysis (a mechanical process to filter waste and water from the blood when the kidneys can no longer function) into Patient 2's right jugular vein (large neck vein). This failure resulted in a violation of Patient 2's right to be informed.

b. Provide three of three non-English speaking sampled patients (Patient 31, Patient 32, Patient 33) the appropriate light blue-colored patient wristband indicating the patient's preferred language to communicate. This failure had the potential to result in staff being unaware of the patients' preferred language and the need for interpreter services.

Findings:

a. During a review of Patient 2's "Face Sheet (FS - a document that contains a summary of a patient's personal and demographic information)," dated 4/29/24, the "FS" indicated, Patient 2 is a 58-year-old male, Hispanic/Latino, preferred Spanish language.

During an interview on 4/29/24 at 2:15 p.m. with Resident 2 (first year doctor in Residency Program [training for doctors to go into their specialization]) and Emergency Department Physician (MD 3), they both stated they did not speak Spanish.

During an observation on 4/29/24 at 2:16 p.m. with Resident 2 and MD 3 in Patient 2's room, Patient 2 was on a gurney with the head of the gurney in an upright position. Resident 2 stated she was going "to lay him down." Resident 2 did not speak to Patient 2 in Spanish to explain what she was going to do and laid the head of the gurney down. Resident 2 repositioned Patient 2's head and turned his neck toward the left side, cleansed the right side of the neck with chlorhexidine (antiseptic - substance that inhibits the growth of microorganism) and covered Patient 2 with a full body drape without speaking with Patient 2 in Spanish.

During a concurrent observation and interview on 4/29/24 at 2:50 p.m. with Resident 2 and MD 3 in Patient 2's room, Resident 2 secured the placement of the triple lumen catheter with sutures (a stitch used to sew up a cut in a person's body) without communicating in Spanish with Patient 2. Resident 2 ripped the plastic sheet from Patient 2's neck and removed the full body drape from the patient without informing Patient 2 the procedure was over. There was no staff interpreter in the room nor a language line in Spanish to inform Patient 2 of what to expect during the procedure or asked Patient 2 how he was during the procedure. Resident 2 and MD 3 confirmed they did not speak in Spanish while providing treatment to Patient 2.

During an interview on 4/30/24 at 10:25 a.m. with Emergency Department Registered Nurse (EDRN) 4, EDRN 4 stated when she had a Spanish-speaking patient, she would call an interpreter especially if she needed to ask more detailed questions to meet the patient's needs. EDRN 4 stated during a procedure sometimes there is a need to keep the interpreter in the room or use the language line which is available 24/7.

During a review of the hospital's policy and procedure (P&P) titled, "Interpreter Services," the P&P indicated, "It is the policy of the facility to provide, to the extent possible, the use of qualified interpreters or assistive devices whenever a language or communication barrier exists...A. The facility recognizes that individuals and Healthcare Providers must be able to communicate effectively.

b. During a concurrent observation and interview on 5/1/24 at 9:46 a.m. with Patient 31 and Director of Emergency Department (DED), in Patient 31's room, Patient 31 was in bed with his eyes closed. Patient 31 did not open his eyes when greeted and when Interpreter (IS) 1 explained the purpose of the visit. Patient 31's family member was at the bedside and stated Patient 31 speaks Spanish and he was not at his best today. Patient 31 appeared lethargic and responded yes to every question asked by IS 1. Patient 31's arm band was observed and DED stated Patient 31's wristband was white in color with the patient's name, birthdate, account number, and medical record number. DED stated there was no interpreter service contact information on the ID band. DED stated there was no light blue-colored patient wristband.

During a concurrent observation and interview on 5/1/24 at 9:55 a.m. with Patient 32 and DED, in Patient 32's room, Patient 32 was in bed, awake and responsive to questions. Patient 32's family member was at the bedside. With IS 1 interpreting in Spanish, Patient 32 stated he speaks Spanish. Family member stated she was there to assist to interpret for the nurses when they come to the room. Patient 32 stated he was admitted today, and no one informed him about the availability of interpreter services. Patient 32 stated he was not provided with a number to contact for interpreter services if he needed one. DED checked Patient 32's wristband and stated Patient 32 had a white-colored ID band with the patient's name, date of birth, account number, and medical record number. DED stated there was no interpreter service contact information on the ID band. DED stated there was no light blue-colored patient wristband.

During a concurrent observation and interview on 5/1/24 at 10 a.m. with Patient 33, DED, and IS 1 in Patient 33's room. Patient 33 was in her bed and spoke in Spanish. With IS 1 interpreting in Spanish, Patient 33 stated she was not feeling well. Patient 33 stated, "Nobody really speaks Spanish here. I had to yell for the nurses to come and help me. They did not give me a call light to use. I just yell for them." DED checked Patient 33's wristband and stated Patient 33 had a white-colored ID band with the patient's name, date of birth, account number, and medical record number. DED stated there was no interpreter service contact information on the ID band. DED stated there was no light blue-colored patient wristband.

During a review of the hospital's P&P, titled, "Interpreter Services," dated 2/27/23, the P&P indicated, "...H. A patient is not required or expected to use friends or family members as interpreters because the use of such individuals may result in breach of confidentiality and reluctance from the patient to reveal personal information critical to the services to be provided...III. Inform Patients of their Right to Have Interpreter Services: a. If the patient speaks a language other than English at home, the statement informing patients of their rights to interpreter services will also be provided to patients in written form in their primary language. IV. Patient Wristbands: a. The wristband is light blue with the message: Dial ext. 8989 for Interpreter...b. To ensure that the preferred communication preferences follow the patient from department/facility to department/facility, a light blue wristband will be placed on the patient's wrist (dominant arm) and secured to identify and visually communicate to all staff that the patient has requested interpreter services be provided during his/her stay. The procedure is applicable to all staff that initially register/admit the patient, as well as staff who provide patient care."

Based on interview and record review, the facility failed to ensure three of 36 sampled patients (Patient 1, Patient 14, Patient 22), Informed Consents (the process in which a healthcare provider educates a patient about the risks, benefits, and alternatives of a given procedure or intervention) for "Central Line Insertion Procedure" were completed in accordance with the hospital policy and procedure. This failure resulted in Patient 1, Patient 14, and Patient 22 not being given the opportunity to weigh the risks and benefits of the procedure prior to the procedure.

Findings:

1. During a concurrent interview and record review on 5/1/24 at 1:44 p.m. with Quality Manager (QM), Patient 14's "Critical Care/Intervention Procedure Note (CC/IP)," dated 4/11/24 was reviewed. The CC/IP indicated, on 4/9/24, a Central Line Insertion Procedure (the insertion of a tube through the neck and into a large vein that connects to the heart) was performed on Patient 14. QM stated the medical records were reviewed and there was no informed consent found for Patient 14 prior to the procedure.


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2. During a concurrent interview and record review on 5/1/24 at 2:38 p.m. with Clinical Informaticist (CI) 2, Patient 1's "History and Physical (H&P)," dated 3/14/24, was reviewed. The H&P indicated, Patient 1 had a central line inserted into the right jugular (large blood vessel in the neck connected to the heart) vein. CI 2 was unable to find a signed informed consent.

During an interview on 5/2/14 at 8:30 a.m. with Risk Management Manager (RMM), RMM stated and validated Patient 1 did not have a signed informed consent for the central line insertion prior to the insertion.


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3. During a concurrent interview and record review on 4/30/24 at 4:06 p.m. with Clinical Risk Management Specialist (CRMS) and CI 2, Patient 22's "Final Report (FR)," dated 2/1/24, was reviewed. The FR indicated, "Procedure: Central Line Placement & Ultrasound Guidance. . . Informed consent: Obtained from the surrogate decision maker." The documentation regarding informed consent was not found for the Central Line Placement & Ultrasound Guidance. CI 2 was not able to provide documented evidence of a signed patient consent form for Patient 22.

During a review of the hospital's policy and procedure (P&P) titled, "Informed Consent for Surgical, Diagnostic, or Therapeutic Procedure," dated 11/23/21, the P&P indicated, "Policy:...3. It is the provider's responsibility to obtain informed consent and to document this consent in the patient's hospital medical record before the provider is permitted to perform any procedure that requires consent. 4. The hospital's role in the consent process is to verify the patient's informed consent was obtained by the provider before the provider is permitted to perform the procedure."

During a review of the facility's policy and procedure titled, "Informed Consent for Surgical, Diagnostics, or Therapeutic Procedure," dated 11/23/21, the P&P indicated, "Procedure: 1. The provider performing the procedure is responsible to conduct the informed consent discussion with the patient...2. The provider is responsible to document that this discussion occurred by signing the "Informed Consent for Surgical, Diagnostics, or Therapeutic Procedure,"...4. On behalf of the hospital, it is licensed staff who conducts the verification process, as a witness to the patient's signature, and as a patient advocate."

Based on observation, interview, and record review, the hospital failed to ensure one of one sampled patient (Patient 35) was provided physical privacy in the Emergency Department (ED) Triage area (area used to assess patients' severity of illness/injury within a short time and assigning priorities) when he verbalized his health issues to the Emergency Department Registered Nurse/Start Nurse (EDRN 5). This failure had the potential for other patients, family member, hospital staff and visitors to overhear the health issues of Patient 35.

Findings:

During a concurrent observation and interview on 4/30/24 at 8:40 a.m. with Patient 35 and EDRN 5, in the ED Triage check-in area, Patient 35 approached the ED glass-covered window where EDRN 5 was sitting. Patient 35 spoke to EDRN 5 in Spanish. EDRN 5 handed Patient 35 an ED complaint form but did not speak to Patient 35. EDRN 5 stated she did not speak Spanish and did not understand what Patient 35 said. EDRN 5 was trying to get someone on the phone who could interpret for Patient 35. EDRN 5 handed the phone to Patient 35 as Patient 35 discussed his presenting problem. It was noted there were several ED employees, including registration clerks, patients, and visitors in the triage area. At 8:48 a.m., Interpreter Service (IS) 1 arrived and personally spoke with Patient 35. Patient 35 talked about his health issues, audible to approximately five to six patients in line, and by patients/family members/visitors waiting and seated in the lobby/waiting area.

During a concurrent observation and interview on 4/30/24 at 9:01 a.m. inside the triage area and by the counter where ED physician (MD 4) stays and examines the patients, two patients and two family members were seated, separated by a cloth folding screen, but not enclosed where everyone passing through the hallway could hear and see MD 4 interviewing and examining the patient.

During an interview on 4/30/24 at 9:02 a.m. with Patient 36, Patient 36 and his family member stated they could hear everything the patient and the doctor were saying.

During an observation and interview on 4/30/24 at 9:14 a.m. with Director of Facilities and Planning (DFP), using the facility's measuring tape, DFP measured the distance from where Patient 35 was standing by the glass window to the next person in line, and stated the distance was three feet. DFP measured the distance from Patient 35 standing by the glass window to the patient/family seated on the right side of the wall. DFP stated the distance was six feet. DFP measured the distance from one patient to another separated by the folding screen in the medical screening area, DFP stated the distance was eight feet.

During an interview on 4/30/24 at 9:45 a.m. with MD 4, MD 4 stated the triage area is not an "ideal set up."

During a review of the document Office for Civil Rights (OCR) HIPAA Privacy titled, "Incidental Uses and Disclosure," dated 12/3/02, the document indicated, "Many health care providers and professionals have long made a practice to ensure reasonable safeguards for individuals' health information - for instance: By speaking quietly when discussing a patient's condition with family members in a waiting room or other public area..."

During a review of the article of the US Department of Health and Human Services titled, "Does the HIPAA Privacy Rule require hospitals and doctor's offices to be retrofitted, to provide private rooms, and soundproof walls to avoid any possibility that a conversation is overheard?," dated 12/28/22, the article indicated, "Covered entities must implement reasonable safeguards to limit incidental and avoid prohibited, uses and disclosures. Covered entities must review their own practices and what steps are reasonable to safeguard their patient information. In determining what is reasonable, covered entities should assess potential risks to patient privacy, as well as consider such issues as the potential effects on patient care..."

Based on observation, interview, and record review, the facility failed to ensure one oxygen e-tank was stored safely and securely. This failure had the potential to result in injures to patient, staff, and visitors.

Findings:

During a concurrent observation and interview on 4/29/24 at 10 a.m. in the Emergency Department (ED) ED nurses' station with Clinical Risk Management Specialist (CRMS) and Emergency Department Assistant Manager (EDAM) 1, an oxygen e-tank was stored freestanding outside of an oxygen storage rack. EDAM 1 acknowledge the finding and stated, "They (oxygen e-tank) are supposed to be stored in the rack, that e-tank is not stored in the rack. Staff are trained on proper storage of e-tanks."

During a review of the hospital's policy and procedure (P&P) titled, "Compressed Gas and Oxygen Use," dated 4/01/2010, indicated, "PROCEDURE: 1. Cylinder must be secured by two restraints in order to reduce the chance of falling . . .OXYGEN USE; Oxygen and other gases are potentially dangerous. Special safety precautions shall be followed at all times while using or storing oxygen."

Based on interview and record review, the facility failed to ensure two of two sampled patients' (Patient 17 and Patient 19) restraints (measure keep someone under control or within limits) were monitored every two hours, according to the facility's policy and procedure. This failure had the potential to compromise the safety and comfort of Patient 17 and Patient 19 while on restraints.

Findings:

a. During a concurrent interview and record review on 5/1/24 at 4:11 p.m. with Quality Manager (QM), Patient 17's "Flowsheet for Restraints (FR)," dated 4/10/24 through 4/15/24 was reviewed. Patient 17's FR indicated the restraint monitoring was not conducted every two hours. The following FR documentation:

4/10/24 5 p.m. "Restraint Episode Activity: Initiate episode...Restraint Observation Behavior: Calm. Restraint Monitoring Attestation: No adverse Response..."
4/11/24 5 a.m. "Restraint Monitoring Attestation: No adverse Response..."
4/11/24 6:30 p.m. "Restraint Episode Activity: Continue episode...Restraint Observation Behavior: Restless/Agitated. Restraint Monitoring Attestation: No adverse Response..."
4/12/24 4 a.m. "Restraint Episode Activity: Continue episode...Restraint Observation Behavior: Calm. Restraint Monitoring Attestation: No adverse Response..."
4/12/24 6 a.m. "Restraint Episode Activity: Continue episode...Restraint Observation Behavior: Calm. Restraint Monitoring Attestation: [no documentation]."
4/12/24 5 p.m. "Restraint Monitoring Attestation: No adverse Response..."
4/12/24 5:13 p.m. "Restraint Observation Behavior: Calm...Restraint Monitoring Attestation: [no documentation]."
4/13/24 6 a.m. "Restraint Episode Activity: Continue episode...Restraint Observation Behavior: Calm. Restraint Monitoring Attestation: [no documentation]."
4/13/24 3:04 p.m. "Restraint Observation Behavior: Calm...Restraint Monitoring Attestation: [no documentation]."
4/13/24 5 p.m. "Restraint Monitoring Attestation: No adverse Response..."
4/14/24 7 a.m. "Restraint Episode Activity: Continue episode...Restraint Observation Behavior: Calm. Restraint Monitoring Attestation: [no documentation]."
4/14/24 4 p.m. "Restraint Monitoring Attestation: No adverse Response..."
4/15/24 3 a.m. "Restraint Observation Behavior: Calm...Restraint Monitoring Attestation: [no documentation]."
4/15/24 6:30 a.m. "Restraint Episode Activity: Continue episode...Restraint Observation Behavior: Calm. Restraint Monitoring Attestation: No adverse Response..."
4/15/24 1:15 p.m. "Restraint Episode Activity: Discontinue episode...Restraint Monitoring Attestation: No adverse Response..."

QM stated these were the dates and times restraints were documented and monitored; there were no documentation the restraints were monitored every two hours.

b. During a concurrent interview and record review on 5/1/24 at 4:42 p.m. with QM, Patient 19's FR, dated 4/25/24 through 5/1/24 were reviewed. Patient 19's FR indicated monitoring was not conducted every two hours. The following FR documentation:

4/25/24 p.m. "Restraint Episode Activity: Initiate episode...Restraint Observation Behavior: disoriented/confused. Restraint Monitoring Attestation: [no documentation]."
4/25/24 6 p.m. "Restraint Episode Activity: Continue episode...Restraint Observation Behavior: disoriented/confused. Restraint Monitoring Attestation: [no documentation]."
4/25/24 7:41 p.m. "Restraint Observation Behavior: Calm... Restraint Monitoring Attestation: [no documentation]."
4/26/24 4:55 a.m. "Restraint Episode Activity: Continue episode...Restraint Observation Behavior: [no documentation]. Restraint Monitoring Attestation: No adverse Response..."
4/27/24 6:11 am "Restraint Observation Behavior: Calm... Restraint Monitoring Attestation: [no documentation]."
4/27/24 7 a.m. "Restraint Episode Activity: Continue episode...Restraint Observation Behavior: Calm. Restraint Monitoring Attestation: [no documentation]."
4/27/24 7 p.m. "Restraint Episode Activity: Continue episode...Restraint Observation Behavior: Calm. Restraint Monitoring Attestation: [no documentation]."
4/28/24 5 a.m. "Restraint Monitoring Attestation: No adverse Response..."
4/28/24 5:32 a.m. "Restraint Observation Behavior: Calm...Restraint Monitoring Attestation: [no documentation]."
4/28/24 7 a.m. "Restraint Episode Activity: Continue episode...Restraint Observation Behavior: Calm. Restraint Monitoring Attestation: [no documentation]."
4/28/24 5 p.m. "Restraint Monitoring Attestation: No adverse Response..."
4/28/24 5:33 p.m. "Restraint Observation Behavior: Calm."
4/28/24 7 p.m. "Restraint Episode Activity: Continue episode...Restraint Observation Behavior: Calm. Restraint Monitoring Attestation: [no documentation]."
4/29/24 4:05 a.m. "Restraint Episode Activity: Continue episode...Restraint Observation Behavior: Calm. Restraint Monitoring Attestation: [no documentation]."
4/29/24 5 a.m. "Restraint Monitoring Attestation: No adverse Response..."
4/29/29 7 a.m. "Restraint Episode Activity: Continue episode...Restraint Observation Behavior: disoriented/confused. Restraint Monitoring Attestation: [no documentation]."
4/29/24 5 p.m. "Restraint Monitoring Attestation: No adverse Response..."
4/30/24 7 a.m. "Restraint Episode Activity: Continue episode...Restraint Observation Behavior: disoriented/confused. Restraint Monitoring Attestation: No adverse Response..."
4/30/24 6 p.m. "Restraint Episode Activity: Continue episode...Restraint Observation Behavior: disoriented/confused. Restraint Monitoring Attestation: No adverse Response..."
4/30/24 6:29 p.m. "Restraint Observation Behavior: Calm."

QM stated restraints were not monitored every two hours.

During a review of the facility's policy and procedure (P&P) titled, "Restraints/Seclusion of Patients," dated 11/1/19, the P&P indicated, ". . . 6. Protective Restraints shall be subject to ongoing monitoring and assessment as specified in the patient's plan of care. Monitoring and assessments shall occur at least every 2 [two] hours and be documented in the patient care record every shift."

Based on interview and record review, the hospital failed to develop and update individualized, person-centered care plans for two of two sampled patients (Patient 12 and Patient 15). This failure had the potential for unmet care needs.

Findings:

During a concurrent interview and record review on 4/30/24 at 4:39 p.m. with Quality Manager (QM), Patient 12's "History and Physical (H&P)," dated 3/30/24 was reviewed. The H&P indicated, "[Patient 12] developed chest pain/difficulty breathing...send patient [12] to the ED [Emergency Department]...ongoing Medical diagnosis Chest pain...SOB (shortness of breath)" QM stated there were no care plans for respiratory, impaired gas exchange, and pain management.

During a concurrent interview and record review on 4/30/24 at 4:56 p.m. with Clinical Informaticist (CI) 1, Patient 12's "Medical Records (MR)," were reviewed. CI 1 stated she did not see discontinued or current care plans for respiratory, impaired gas exchange, and pain management in the medical record.

During a review of Resident 12's "Flowsheet for Pain (FP)," dated 4/1/24, the FP indicated, Resident 12 had a CPOT (Critical Care Pain Observation Tool - used for patients who cannot express a numerical pain scale) score of 7 (Scores: Mild =2-3, Moderate = 4-6, Severe = 7-8).

During a review of Resident 12's "Orders" dated 4/1/24, the orders indicated, Resident 12 had an order for use of ventilator (a device used medically to assist with breathing).

During an interview on 5/2/24 at 9:50 a.m. with Registered Nurse (RN) 8, RN 8 stated care plans are done every shift and on admission. RN 8 stated as soon as she gets the patient she writes the care plan. RN 8 stated if a patient complains of pain she will write a care plan for pain.

During a concurrent interview and record review on 5/1/24 at 3:57 p.m. with QM, Resident 14's H&P, dated 3/22/24 was reviewed. The H&P indicated, "History of Present Illness:...Patient [14] presented to emergency department for chief complaint of right upper quadrant pain and nausea for the last week." QM stated Patient 14 does not have a plan of care for the right upper quadrant pain.

During a review of Resident 14's FP dated 3/23/24, the FP indicated, Resident 14 had a pain scale of "5 = Moderate pain".

During a review of the hospital's policy and procedure (P&P) titled, "Interdisciplinary Pt Assessment, Reassessment & Care Planning for the Acute Setting," dated 9/23/21, the P&P indicated, "V. Care decisions will be based upon data and information gathered in assessments and reassessments. This data will be utilized in prioritizing patient care needs and selecting appropriate interventions...VI. Prioritizing patient care needs will be as follows: A. Emergent/Urgent B. Actual C. Potential D. Education."

Based on interview and record review, the hospital failed to ensure the physician and the supervising attending physician for nine of 36 sampled patients (Patient 1, Patient 2, Patient 3, Patient 4, Patient 5, Patient 6, Patient 7, Patient 8, and Patient 9) who performed the procedure and signed the informed consent (the process in which a healthcare provider educates a patient about the risks, benefits, and alternatives of a given procedure or intervention) forms could be identified. This failure resulted in illegible medical records.

Findings:

During a concurrent interview and record review on 5/1/24 at 2:38 p.m. with Clinical Informaticist (CI) 2, Patient 1's Informed Consent, dated 3/15/24, was reviewed. The informed consent indicated "Bilateral Radial and Femoral Arterial Line Placement, (procedure to obtain more accurate measurement of blood pressures for critically ill patients receiving vasoactive drugs [powerful drugs that work quickly to narrow one's blood vessels and raise one's blood pressure])." The Informed Consent Form had signatures, but the signatures of the physician who performed the procedure and the signature of the supervising attending physician could not be identified. CI 2 stated the physician signatures on the Informed Consent Form could not be identified.

During a concurrent interview and record review on 5/1/24 at 2:45 p.m. with CI 2, Patient 2's Informed Consent, dated 4/29/24, was reviewed. The informed consent indicated, "Dialysis Catheter in right internal jugular vein, or left internal jugular vein, or right femoral vein, or left femoral vein (insertion of a large bore tube into a large blood vessel for hemodialysis [process of removing waste and fluid for someone whose kidneys can no longer function normally]). The Informed Consent Form had signatures, but the signature of the physician who performed the procedure and the signature of the supervising attending physician could not be identified on the form. CI 2 stated the physician signatures could not be identified on the form.

During a concurrent interview and record review on 5/2/24 at 9 a.m. with CI 2, Patient 3's Informed Consent, dated 2/27/24, was reviewed. The informed consent indicated, "Image guided Percutaneous Left-sided Thoracentesis with possible Chest Tube Placement with Procedural Sedation (a procedure to remove fluid or air from around the lungs with possible insertion of a tube to remove fluid from the space between the lungs and the wall of the chest, and using a medication that would induce depression of consciousness during a procedure). The Informed Consent Form had the signature of the name of the physician who performed the procedure, but the signature was not identifiable. CI 2 stated the physician signature could not be identified on the form.

During a concurrent interview and record review on 5/2/24 at 9:10 a.m. with CI 2, Patient 4's Informed Consent, dated 3/12/24, was reviewed. The informed consent indicated, "Arteriogram (an imaging test that uses x-rays and a special dye to see inside the arteries) with possible Embolization (blockage of the blood vessel ) under Procedural Sedation (giving a medication to the patient to depress consciousness during the procedure). The Informed Consent Form did have a signature of the physician who performed the procedure, but the signature was not identifiable. CI 2 stated the physician signature could not be identified on the form.

During a concurrent interview and record review on 5/2/24 at 9:15 a.m. with CI 2, Patient 5's Informed Consent, dated 3/12/24, was reviewed. The informed consent indicated, "upper endoscopy (involves insertion of a long, flexible tube called an endoscope down one's throat and into the esophagus [organ that food travels through to reach the stomach for further digestion]) with all the necessary intervention." The Informed Consent Form had a signature of the physician who performed the procedure, but the signature was not identifiable. CI 2 stated the physician signature could not be identified on the form.

During a concurrent interview and record review on 5/2/24 at 9:25 a.m. with CI 2, Patient 6's Informed Consent, dated 3/12/24, was reviewed. The informed consent indicated, "Bilateral Internal Jugular and Femoral Central Venous Catheter Placement (insertion of a large bore tube into a large blood vessel)." The Informed Consent Form had a signature of the physician who performed the procedure and a signature of the supervising attending physician, but the signatures were not identifiable. CI 2 stated the physician signatures could not be identified on the form.

During a concurrent interview and record review on 5/2/24 at 9:30 a.m. with CI 2, Patient 7's Informed Consent, dated 3/17/24, was reviewed. The informed consent indicated, "Left or right internal jugular central venous catheter insertion, Left or right radial arterial line placement, and Bronchoscopy (a procedure that lets doctors look into one's lungs and air passages). The Informed Consent Form did have the signature of the physician who performed the procedure and the signature of the supervising attending physician, but the signatures were not identifiable. CI 2 stated the physician signatures could not be identified on the form.

During a concurrent interview and record review on 5/2/24 at 9:35 a.m. with CI 2, Patient 8's Informed Consent, dated 3/17/24, was reviewed. The informed consent indicated, "Arterial line of left or right radial artery." The Informed Consent Form did have the signature of the physician who performed the procedure and a signature of the supervising attending physician but the signatures were not identfiable. CI 2 stated the physician signatures could not be identified on the form.

During a concurrent interview and record review on 5/2/24 at 9:45 a.m. with CI 2, Patient 9's Informed Consent, dated 3/19/24, was reviewed. The informed consent indicated, "Central venous access, Arterial access." The Informed Consent Form had the signature of the physician who performed the procedure and the signature of the supervising attending physician but the signatures were not identifiable. CI 2 stated the physician signatures could not be identified on the form.

During a review of the hospital's "Medical Staff Rules and Regulations (MSRR)," dated 9/27/23, the MSRR indicated, "2.2 Responsibilities of Attending Physicians:...b. At all times during a patient's hospitalization, the identity of the attending physician will be clearly documented in the medical record...Medical Records 3.1 General Requirements:...c. Authentication: Authentication means to establish authorship by signature or identifiable initials and may include computer entry using unique electronic signatures for electronic entries...Written signatures must include the responsible practitioner's identification numbers."

The hospital failed to meet the regulatory compliance for §482.42 Condition of Participation: Infection Prevention and Control and Antibiotic Stewardship Programs as evidenced by the following:

1. Based on observation, interview, and record review, the hospital failed to have an effective infection prevention and control program to provide a sanitary environment and minimize the sources of infections for 346 admitted patients, and all emergency room patients as evidenced by:

One of one sampled medical staff (Resident 2) did not use aseptic technique (methods used to prevent or reduce bacteria that cause disease on skin, tissue or surfaces) during the insertion of a Vascular Catheter (Vas Cath, large vein access device) for one of one sampled patient (Patient 2).

Two of two sampled medical staff (MD 3 and Resident 2) contaminated the sterile (germ free) field during one sampled patient's (Patient 2) Vas Cath insertion.

One of one sampled medical staff (MD 3) did not use sterile water to clean the Vas Cath access site for one sampled patient (Patient 2).

One of one sampled clean linen cart was uncovered, and additional items were stored on top of the clean linen cart.

One of one sampled sink in Zone 6 had patient care items in the splash zone (area around sink which can be contaminated from water splash from drains and faucets).

One of one sampled Registered Nurse (RN) 9 did not disinfect the medication vial's (small bottle) septum (seal) prior to injecting the needle and drawing medication for one of one sampled patient (Patient 30).

Medical supplies were stored on the floor.

One of one sampled patient treatment chair was not cleaned between patients.

Outside food was stored on the Central Line Cart.

One of one sampled sharp (used needles, syringes, vials) container was maintained in a safe and sanitary manner and was properly disposed of.

These failures had the potential to transmit infections to patients, staff and visitors. (Refer to A-0749)

2. Based on interview and record review, the hospital failed to ensure the Infection Preventionist provided Infection Prevention and Control Training to the Medical Staff.

This failure has the potential to result in the Medical Staff unaware of current infection prevention and control practices. (Refer to A-0775)

The cumulative effect of these systemic failures resulted in the hospital's inability to adhere to infection control practices for the provision of a safe and sanitary environment for all patients, staff, and visitors in compliance with the Condition of Participation for Infection Prevention and Control and Antibiotic Stewardship Programs.

Based on observation, interview, and record review, the hospital failed to have an effective infection prevention and control program to provide a sanitary environment and minimize the sources of infections for 346 admitted patients, and all emergency room patients as evidenced by:

1. One of one sampled medical staff (Resident 2) did not use aseptic technique (methods used to prevent or reduce bacteria that cause disease on skin, tissue or surfaces) during the insertion of a Vascular Catheter (Vas Cath, large vein access device) for one of one sampled patient (Patient 2).

2. Two of two sampled medical staff (MD 3 and Resident 2) contaminated the sterile (germ free) field during one sampled patient's (Patient 2) Vas Cath insertion.

3. One of one sampled medical staff (MD 3) did not use sterile water to clean the Vas Cath access site for one sampled patient (Patient 2).

4. One of one sampled clean linen cart was uncovered, and additional items were stored on top of the clean linen cart.

5. One of one sampled sink in Zone 6 had patient care items in the splash zone (area around sink which can be contaminated from water splash from drains and faucets).

6. One of one sampled Registered Nurse (RN) 9 did not disinfect the medication vial's (small bottle) septum (seal) prior to injecting the needle and drawing medication for one of one sampled patient (Patient 30).

7. Medical supplies were stored on the floor.

8. One of one sampled patient treatment chair was not cleaned between patients.

9. Outside food was stored on the Central Line Cart.

10. One of one sampled sharp (used needles, syringes, vials) container was maintained in a safe and sanitary manner and was properly disposed of.

These failures had the potential to transmit infections to patients, staff and visitors.

Findings:

1. During an observation on 4/29/24 at 2:16 p.m. in Patient 2's room, with Resident 2 and MD 3, during the preparation of Patient 2 for the insertion of the Vas Cath on the right jugular (large neck vein) vein, Resident 2 cleaned the right side of Patient 2's neck using a chlorhexidine (antiseptic-substance inhibits the growth of microorganism) swab in a circular motion moving from inside and extending outwards of the access site but returned back to the access site using the same contaminated swab.

During an interview on 4/30/24 at 3:23 p.m. with Resident 2, Resident 2 stated she used chlorhexidine swabs and cleaned Patient 2's access site from center outwards but did not realize she went back to the access site after.

During an interview on 4/30/24 at 3:01 p.m. with MD 3, MD 3 stated she was an attending physician in the Emergency Department and provided direct supervision to Resident 2 during the insertion of the Vas Cath for Patient 2. MD 3 acknowledged the breaches in aseptic technique when Resident 2 used the chlorhexidine swab starting inward and then outward and then went back inward.

During a review of the manufacturer's instructions for use (MIFU), dated 2009, the MIFU indicated "maximal treatment area for one applicator is approximately 2.5 in. [inches] x [by] 2.5 in ...Place the foam flat side down on the treatment area. Completely wet treatment area with antiseptic dry surgical sites (e.g., abdomen or arm): use gentle repeated back-and-forth strokes for 30 seconds. Allow the area to air dry for approximately 30 seconds ...Discard the applicator after a single use ..."

2. During an observation on 4/29/24 at 2:16 p.m. in Patient 2's room, during the insertion of Patient 2's Vas Cath, MD 3 and Resident 2 contaminated the sterile field when:

2a. MD 3 did not wear a mask, while standing over the sterile field,
2b. MD 3's sterile gown exposed her back and the waist ties were not secured to prevent accidental touch onto the sterile field.
2c. MD 3, while wearing a sterile gown, reached under Patient 2's sterile drape, to check Patient 2's arm band during the time-out (assures the correct procedure is performed on the correct patient) process.
2d. MD 3 positioned herself behind Resident 2's back, close enough for the front of MD 3's sterile gown, to touch Resident 2's gown.
2e. MD 3 assisted Resident 2 in inserting the dilator (an instrument used to expand the puncture hole), into Patient 2's access site, without changing her gown.
2f. During an observation on 4/29/24 at 2:56 p.m. in Patient 2's room, during the insertion of Patient 2's Vas Cath, Resident 2 stepped out of Patient 2's room, still wearing a contaminated gown and a bloody glove on her left hand, to wait for the portable chest x-ray to be completed.

During an interview on 4/30/24 at 3:23 p.m. with Resident 2, Resident 2 stated she did not realize she stepped out of the room while wearing her contaminated gown and gloves.

During a review of the hospital's policy and procedure (P&P) titled, "Basic Aseptic Technique," 3/17/14, the P&P indicated, "1. Scrubbed persons will wear sterile gowns and gloves...III. All items used in the sterile field should be sterile. IV. All items introduced into a sterile field will be dispensed by methods that maintain sterility of the item and integrity of the sterile field."

During a review of the Centers for Disease Control and Prevention (CDC, national health organization) guideline titled "Guidelines for the Prevention of Intravascular Catheter-Related Infections, 2011, updated 2017, the guideline indicated "4. * Maximal Sterile Barrier Precautions 1. Use maximal sterile barrier precautions, including the use of a cap, mask, sterile gown, sterile gloves, and a sterile full body drape, for the insertion of CVCs, [central vein catheters ..."
During a review of the article in the Association of periOperative Nurses (AORN, national nurse association provides evidence-based recommendations) Journal, titled, "Recommended Practices for Maintaining a Sterile Field," dated 7/7/06, the Article indicated, "The front of a sterile gown is considered sterile from the chest to the level of the sterile field. The sterile area of the gown front extends to the level of the sterile field. The back of the gown is not considered sterile, because it cannot be observed by the sterile team member."

During a review of the "AORN Guidelines for periOperative Practice," dated 2019, the Guidelines indicated: Perioperative personnel should select and wear surgical gowns that wrap around the wearer's body and completely cover the wearer's back...The part of the surgical gown that should be considered contaminated or unsterile include the neckline, shoulders, and axillary region, the gown back, and the sleeves cuffs after the scrubbed team member's hands pass through and beyond the cuff...Personnel should move within or around a sterile field in a manner that prevents contamination of the sterile field."

3. After Patient 2's Vas Cath procedure, MD 3 wet a piece of gauze with tap water from the room's sink. MD 3 cleansed Patient 2's neck using tap water from the room's sink.

During a review of the CDC guideline titled "Guidelines for the Prevention of Intravascular Catheter-Related Infections, 2011, updated 2017, the guideline indicated, "2. Maintain aseptic technique for the insertion and care of intravascular catheters."

During a review of the CDC guideline titled "Healthcare-Associated Infections (HAIs), dated 9/11/2019, the guideline indicated "Tap water meets stringent safety standards in the United States, but it is not sterile. Certain numbers and types of bacteria and other microbes may be present when water leaves the tap ...in healthcare settings, the ways we use water are more varied and patients might be more vulnerable to infection. Certain conditions within healthcare plumbing systems can even encourage microbial growth. This can lead to dangerously high levels of potential pathogens. Moreover, the risk does not stop at the tap-every use of water in patient care settings must be scrutinized and evaluated for its risk to harbor and transmit healthcare-associated pathogens . . ."


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4. During a concurrent observation and interview on 4/29/24 at 10:20 a.m. with Emergency Department Assistant Manager (EDAM) 1, in Zone 5 hallway, a clean linen cart had its cover pulled to the top. On top of the uncovered linen cart were two waffle mattresses, one pillow, and one bag of paper blankets. EDAM 1 stated the linen cart should be closed and there should not be anything on top of the cart. EDAM 1 stated, two waffle mattresses, one pillow, one bag of paper blankets were observed on top of the clean linen cart.

5. During a concurrent observation and interview on 4/29/24 at 10:40 a.m. with EDAM 1 in Zone 6 sink area, a folded gown with a syringe and gauze were in the sink's splash zone (on the side of the sink). EDAM 1 stated patient care supplies should not have been placed on the side of the sink.

During a review of the CDC guideline titled "Healthcare-Associated Infections (HAIs), dated 9/11/2019, the guideline indicated "Recent evidence indicates sinks and other drains, such as toilets or hoppers, in healthcare facilities can become contaminated with multidrug-resistant organisms (MDROs). These pathogens [organism that causes disease] can stick to the pipes to form biofilms [colony of germs and microbes], which allow the organisms to persist in drains for long periods of time and are often difficult to impossible to fully remove. Because different types of bacteria may contaminate the same drain, drains can serve as sites where antibiotic resistant are transferred between bacterial species. Patients may be exposed to organisms in drains when water splashes from the drain."

6. During an observation on 4/30/24 at 9:22 a.m. in the Interventional Radiology Procedure Room (IRPR), RN 9 uncapped a new medication vial for and inserted the needle without disinfecting the rubber septum with alcohol.

During an observation on 4/30/24 at 10:45 a.m. in IRPR, RN 9 uncapped a new medication vial and inserted the needle without disinfecting the rubber septum with alcohol.

During an interview on 4/30/24 at 11:03 a.m. with RN 9, RN 9 stated he should have cleaned the rubber top (septum) with alcohol pads before drawing the medication.

During a review of the Centers for Disease Control and Prevention (CDC) guideline titled, "FAQs regarding Safe Practices for Medical Injections: Medication Preparation Questions" dated 6/20/19, the guideline indicated, "the rubber septum should be disinfected with alcohol prior to piercing it."


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7. During an observation on 4/29/24 at 10:10 a.m. in the ED patient triage area, in a small alcove, a green plastic bag with multiple white items inside, a square white plastic bucket, and a paper bag on top of the square white plastic bucket were on the floor.

During a concurrent observation and interview on 4/29/24 at 10:11 a.m. with Clinical Risk Management Specialist (CRMS) and EDAM 1 in the ED triage area, EDAM 1 removed the green plastic bag from the floor to discover a second green plastic bag underneath the first green plastic bag. CRMS stated, "Looks like blood pressure cuffs, approximately 40." EDAM 1 stated, "It's just overstock." EDAM 1 stated the white plastic bucket contained used pulse Oximeters (used to measure the level of oxygen in the blood) and the paper bag contained multiple specimen bags with a specimen cup inside each bag.

During a concurrent observation and interview on 4/29/24 at 10:15 p.m. with RN 12, in the ED triage area. RN 12 noted two green plastic bags, the white bucket and the paper bag. RN 12 stated, nothing should be stored on the floor.

The facility policy and procedure regarding storing items on the floor was requested; none were provided.

8. During a concurrent observation and interview on 4/29/24 at 10:11 a.m. with EDAM 1, in the Fast Track area, an eggplant-colored treatment chair, was in the reclined position for patient observation. Under the treatment chair was a used elastic wrap and a used emesis (nausea) bag. EDAM 1 stated there was used elastic wrap and a used emesis bag under the treatment chair.

During a review of a facility document titled, "Recommendation III", [undated] the facility document indicated, "A clean environment should be reestablished after the patient is transferred from the area."

9. During a concurrent observation and interview on 4/29/24 at 2:18 p.m. outside Patient 2's room, was a six-drawer "Central Line Cart." On the top of the Central Line cart, a plastic bag labeled "Biohazard [contaminated items]" contained several round orange fruits (cumquats). The Central Line cart was currently in use in an active procedure for Patient 2. Director of Emergency Department (DED) stated there were approximately 15 - 20 cumquats stored inside the biohazard bag. DED stated, "Outside food is not allowed."

During a concurrent observation and interview on 4/29/24 at 3:06 p.m. with MD 3, MD 3 stated, "Someone put them down for me on the cart, another provider handed them to me. He [other provider] placed them (the cumquats) on the cart."

The facility policy and procedure regarding food on Central Line Carts was requested; none was provided.

10. During a concurrent observation and interview on 4/29/24 at 3:06 p.m. in the ED hallway with CRMS, a Sharps storage container (storage for used needles, syringes, and other used medical devices) mounted on the wall at the nurses' station was overflowing with used IV (intravenous into vein) tubing, used needles, and used dressings sticking out of the top of the full Sharps storage container. Two patients were seen seated across the hall from the Sharps storage container. CRMS stated the sharps container was overflowing in a patient care area.

During an interview on 4/29/24, at 3:43 p.m. with Environmental Services (EVS) 1, EVS 1 stated she should have changed the Sharps container; the Sharps container was full, and patients could remove items from the Sharp storage container.

During a review of the facility's policy and procedure (P&P) titled, "Biohazard Waste/Sharps Waste," dated 11/8/2023, indicated, "Procedure: . . .B. Sharps Waste 1. Sharps waste, i.e.., fistula needles, hypodermic needles and syringes are contained for disposal in a puncture resistant rigid plastic red container. 2. The container comes equipped with a lid that can close and permanently lock when it is three quarters full and discarded . . .B Sharps Waste 1. The sharps containers are used until they are three quarters full."

Based on interview and record review, the hospital failed to ensure the Infection Preventionist provided Infection Prevention and Control Training to the Medical Staff. This failure has the potential to result in the Medical Staff unaware of current infection prevention and control practices.

Findings:

During an interview on 4/30/24 at 4:15 p.m. with Director of Medical Staff Services (DSS), DMSS stated the Medical Staff did not have training on infection prevention and control.

During an interview on 5/1/24 at 1:47 p.m. with Medical Director 1, Medical Director 1 stated the Medical Staff did not receive formal hospital training on infection control. Medical Director 1 stated the Medical Staff had no infection control training.

During a concurrent interview and record review on 5/2/24 at 10:20 a.m. with Infection Preventionist (IP) and Infection Prevention Manager (IPM), IPM stated Infection Control education materials were provided to the Medical Staff Office. The Medical Staff infection control education materials included Hospital Acquired Infections (infection a patient gets while in the hospital), hand hygiene, masking, COVID-19 (serious lung infection), measles (highly contagious disease), and others. IP was unable to provide evidence of infection control training for the Medical Staff. IP stated she had not provided a formal education/training on infection control for the Medical Staff.

During a review of the hospital's policy and procedure (P&P) titled, "Infection Prevention Department Plan," the P&P indicated, "Policies: Develop communication systems with independent practitioners, staff, students, volunteers...visitors, patients, families and the community about infection prevention and control issues, including their responsibilities in preventing the spread of infection within the hospital...9. Provide education to employees, staff, patients, and visitors on current disease trends, infection prevention and control practices and other patient safety topics as appropriate...11. Coordinate and integrate infection prevention and control activities with medical staff to encourage collaborative and consistent infection control practice with other health care disciplines."

The hospital failed to meet the regulatory compliance for §482.55 Condition of Participation: Emergency Services as evidenced by:

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

1. Ensure one of one resident (Resident 1) in the first year of Emergency Medicine Residency Program (post-graduate training for physicians going for their specialty), under direct supervision, followed the procedure for central line (a flexible tube inserted into a large blood vessel that goes directly to the heart) insertion.

This failure resulted in the guidewire to be retained in the right jugular vein (large neck vein) for one of one sampled patient (Patient 1). (Refer to A-1112)

2. Based on observation, interview, and record review, the hospital failed to provide Registered Nurses to function as Triage (process to prioritize the order in which patients will be treated based on the types of disease and severity) Nurses in the Emergency Department (ED) for patients seen on 4/29/24.

This failure had the potential to result in these patients to not receive proper triage assessment and appropriate Emergency Severity Index (ESI - sorts patients into five groups from 1 [emergent] to 5 [least urgent] based on predicted acuity and resource needs) designation. (Refer to A-1112).

3. Ensure ED Registered Nurse (EDRN) 5 provided immediate triage assessment for one of one sampled patient (Patient 34) who presented to the ED with mid-sternum chest pain.

This failure resulted in a delay of physician examination. (Refer to A-1112).

4. Ensure two of two EDRNs (EDRN 6 and EDRN 7) were familiar with the "Resident Directory" to determine whether the ED Residents possess the skills, knowledge, and training to perform certain procedures in the ED.

This failure had the potential to result in adverse consequences if resident physicians perform procedures they were not competent and trained in. (Refer to A-1112).

5. Ensure EDRN 1 received adequate training when assigned to assist and monitor during insertion of a Vas Catheter (large vein access device) for one of one sampled patient (Patient 2).

This failure resulted in EDRN 1 not recognizing the need to notify the physician when changes occurred during a procedure. (Refer to A-1112).

The cumulative effects of these systemic failures had the potential to negatively impact health and safety of all patients seeking emergency care at the facility, in compliance with the Condition of Participation for Emergency Services.

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

1. Ensure one of one resident (Resident 1) in the first year of Emergency Medicine Residency Program (post-graduate training for physicians going for their specialty), under direct supervision, followed the procedure for central line (a flexible tube inserted into a large blood vessel that goes directly to the heart) insertion.

This failure resulted in the guidewire to be retained in the right jugular vein (large blood vessel) for one of one sampled patient (Patient 1).

2. Provide Registered Nurses to function as Triage (process to prioritize the order in which patients will be treated based on the types of disease and severity) nurses in the Emergency Department (ED) for patients seen on 4/29/24.

This failure had the potential to result in patients not receiving proper triage assessment and appropriate Emergency Severity Index (ESI- sorts patients into five groups from 1 [emergent] to 5 [least urgent] based on predicted acuity and resource needs) designation

3. Ensure the ED Registered Nurse (EDRN) 5 provided immediate triage assessment for one of one sampled patient (Patient 34) who arrived to the ED with mid-sternum chest pain.

This failure resulted in a delay of physician examination.

4. Ensure two of two EDRNs (EDRN 6 and EDRN 7) were familiar with "Resident Directory" to determine whether the ED Residents possess the skills, knowledge, and training to perform certain procedures in the ED.

This failure had the potential for adverse consequences if resident physicians were allowed to perform procedures they were not competent and trained in.

5. Ensure EDRN 1 received adequate training when assigned to assist and monitor during insertion of a Vas Catheter (large vein access device) for one of one sampled patient (Patient 2).

This failure resulted in EDRN 1 not recognizing the need to notify the physician when changes occurred during a procedure.

Findings:

1. During an interview on 5/1/24 at 8:39 a.m. with Resident 1, Resident 1 stated Patient 1 was hemodynamically unstable (low blood pressure that leads to insufficient blood flow to the body), and already hit the threshold for Levophed (medication to raise blood pressure). Patient 1 could not continue the medication using the peripheral line (intravenous fluid administered through the hands/arms) as it would cause damage to the peripheral veins. Resident 1 stated the need to establish a central line was necessary to continue medications to increase blood pressure support. Resident 1 stated he performed the insertion of central line on Patient 1's right jugular vein under direct supervision from the ED Physician (MD 2). Resident 1 stated, "It was towards the end of the procedure when I was threading the catheter over the guidewire and advancing the catheter when I realized the guidewire did not stick out of the 'brown port' (used for infusion)." Resident 1 stated the guidewire must stick out of the port before the catheter is inserted. Resident 1 stated, "I was rushing through the procedure. It was a high stress environment. I did not withdraw the guidewire." Resident 1 stated, "I realized I did not have the guidewire. I tried to remove the catheter hoping the guidewire would come out with the catheter, but when I pulled only the catheter came out. I knew something was wrong. The guidewire remained inside the patient."

During an interview on 5/1/24 at 9:33 a.m. with MD 2, MD 2 stated Resident 1 inadvertently advanced the triple lumen catheter (multi-lumen flexible tube which allows for several different infusion with only one access site) with the guidewire. MD 2 stated he provided direct supervision, standing about two to three feet away, behind Resident 1's right shoulder.

During a review of Patient 1's "Interventional Radiology Foreign Body Retrieval Report," dated 3/15/24 at 6:18 a.m., the retrieval report indicated, "Initial images demonstrate the guidewire within the region of the right internal jugular vein and extending to loop in the region of the right atrium."

During a concurrent interview and record review on 5/2/24 at 8:13 a.m. with MD 2 and Risk Management Manager (RMM), Resident 1's Central Line Checklist, dated 4/2024, was reviewed. The central line checklist indicated, "Advance the catheter over the wire. Ensure the guidewire exits the distal lumen enough to be grasped. Advance the catheter into the vessel, again, NEVER LETTING GO OF THE WIRE..." MD 2 stated Resident 1 did not "walk-back" the guidewire, meaning Resident 1 needed to draw back the guidewire before advancing the catheter, but Resident 1 did not "walk-back" the catheter in time.

During a review of the article of "the National Institute of Health Library of Medicine" titled, "Central Line Placement," dated 12/21/22, the article indicated,
"1. While holding the guidewire in place, remove the introducer needle hub.
2. Advance the Central Venous Line (CVL) over the guidewire. Ensure the distal lumen of the central line is uncapped to facilitate the passage of the guidewire.
3. Once the CVL is in place, remove the guidewire. Next, flush and aspirate all ports with sterile saline."

2. During a concurrent observation and interview on 4/29/24 at 9:39 a.m. with Director of Emergency Department (DED) and RMM, in the ED waiting room, inside a closed glass window was EDRN 3 and a registration clerk. A patient approached the glass window and EDRN 3 handed the patient a form to fill out. DED stated the registered nurse at the window was the "Start Nurse," whose role was to obtain patient's chief complaint. DED stated once the chief complaint was received, EDRN 3 would hand the form to the registration clerk for a quick registration. DED stated the patient would be sent back to the waiting room until the ED Technician calls the patient for vital signs. Once vital signs were entered into the computer, EDRN 3 would complete the triage note and would assign the patient his/her ESI designation. DED stated, "We do not have a triage nurse."

During an interview on 4/29/24 at 3:50 p.m. with EDRN 3, EDRN 3 stated Start Nurse or Triage Nurse were used fairly frequently and interchangeably to identify us (registered nurses) in the triage area. EDRN 3 stated, "There are no other nurses here to assess the patients. If we have enough staffing, then we would have a triage nurse." EDRN 3 stated her role at triage was to visually observe the patients who come to the window. EDRN 3 stated she just looked at airway, breathing, and circulation. EDRN stated once the vital signs of the patients were inputted in the computer, EDRN 3 would assign the patients' ESI levels based upon the quick assessment from the window when patients first present themselves in the department. EDRN 3 stated, "Most often than not, we do not have a triage nurse."

During an interview on 4/29/24 at 4:18 p.m. with DED, DED stated Administration realized the need for a triage nurse in August 2023. DED stated there was a work group consisted of the Medical Director, Director of Emergency Department, Chief Nursing Officer, Director of Quality, Director of Risk Management, and Emergency Physicians, that investigated the ED throughput and assigning a triage nurse at Triage. DED stated the project was scheduled to go live in November 2023, but the ED did not have enough registered nurses to take on the duties and responsibilities of a triage nurse. DED stated it's been since August that the ED had no triage nurse.

During an interview on 4/30/24 at 10:25 a.m. with EDRN 4, EDRN 4 stated as the start nurse you are the triage nurse; however, just looking at the patient coming in is not triage. EDRN 4 stated there is a better way to do it. EDRN 4 stated, "As the triage nurse I must lay my hands on the patients and do a full assessment of the patient." EDRN 4 stated visual observation of the patient was not adequate. EDRN 4 stated unless the ED has an extra nurse then the nurses could take the patient to a triage room and conduct full assessment of the patient and assign an accurate ESI level.

During a concurrent interview on 5/1/24 at 10:52 a.m. with Chief Nursing Officer (CNO), the CNO stated the intent is for a safe and effective care when patients come to the ED. CNO stated there was a work group and one of the goals was to have a triage nurse at triage. CNO stated it went live on 11/15/23. There were parts of the plan that did not move forward because of staffing challenges. CNO stated without a triage nurse, it would impact how the nurses score and determine the number of resources needed for an accurate ESI designation. CNO stated some patients were over triaged, which meant some patients were assigned an ESI of two or an ESI of three because the nurses could not properly identify accurate an ESI level. CNO stated she was not aware there was no triage nurse assigned at ED Triage.

During a review of the document titled, "Kaizen Action Plan: Safe, Efficient and Effective Care of the ED Patients," dated 8/18/23, the document indicated," QI Strategy: 1. Design workflow from patient entry to assessment which results in the safe care of ED patients. Safe care defined as vital signs obtained, assessments completed, action on change of condition executed. Action Step: The system shall reallocate resources to assign complete care team for all ED patients."

During a review of the ED Staffing Assignment, dated 3/2/24 to 3/10/24 and 4/22/24 to 4/29/24, there were no triage nurses assigned in the ED for the above dates, during both day and night shifts.

During a review of the "Emergency Nurses Association (ENA) Position Statement," dated 5/2017, the Position Statement indicated, "Triage is the process of collecting pertinent information about patients who are seeking emergency care and initiating a decision-making procedure that uses a valid and reliable triage acuity designation system. Rapid and accurate triage decisions are important for successful emergency department (ED) operations and optimal patient outcomes. This process includes collecting pertinent patient information, performing a focused assessment, assigning an acuity level, and prioritizing the needs of the patient seeking emergency care, all in a time-sensitive manner. Accuracy in problem identification is a crucial component of clinical decision making, especially in the triage encounter, and requires the nurse to establish boundaries of physiological and psychological stability as well as predict the potential trajectory of the patient's condition ..."

3. During an interview on 5/1/24 at 10:19 a.m. with EDRN 5, EDRN 5 stated she was assigned as the triage nurse for today. EDRN 5 stated there was one patient (Patient 34) who she had to call, but because there was no room available in the triage area, EDRN 5 stated she had not seen the patient.

During a concurrent interview and record review on 5/1/24 at 10:22 a.m. with EDRN 5, Patient 34's "ED Intake Form," dated 5/1/24, was reviewed. The intake form indicated Patient 34 was registered at 9:24 a.m. with complaints of "intermittent mid-sternum chest pain, tingling sensation on both hands since Monday, and worse today." EDRN 5 stated Patient 34 had an electrocardiogram (electrical tracing of the heart) completed at 9:31 a.m. EDRN 5 stated she had not seen [Patient 34] because there was no room available in the triage area. EDRN 5 stated she had not assigned an ESI for Patient 34. EDRN 5 stated as the triage nurse her role was to assess the patient and assign the acuity (a measurement of the level of care a patient needs based on the severity of either an illness or mental condition). EDRN 5 stated [Patient 34] had not been seen for almost an hour and patients with chest pain should be taken in right away.

During an interview on 5/1/24 at 10:24 a.m. with DED, DED stated [EDRN 5] could have taken the patient to another room in the ED.

During a review of Patient 34's Emergency Documentation, dated 5/1/24, the emergency documentation indicated, Patient 34 was evaluated by the emergency physician at 10:27 a.m. The ED Start Nurse (EDRN 11) documented "ED Triage Part 1" to indicate Patient 34's chief complaint, allergies, and fall risk screening. The ED MSE (medical screening examination-to determine if an emergency medical condition exists) was performed and completed at 10:42 a.m. There was no documentation that EDRN 5 completed a triage assessment for Patient 34.

During a review of the facility's policy and procedure (P&P) titled, "Standards of Care: Nursing," dated 12/19/23, the P&P indicated, "RN Assessment: The RN is responsible for completing and documenting an assessment based on patient's chief complaint. Assessment contributes to determination of patient acuity or classification and assist in determining staffing needs..."

4. During an interview on 4/30/24 at 2:47 p.m. with Chief of Medical Education (MD) 6, MD 6 stated the Resident Directory was rolled out to the nurses and physicians regarding the level of resident physicians' supervision and expectation. MD 6 stated it was important to revise the Resident Directory and update it monthly.

During a concurrent interview and record review on 4/30/24 at 3:50 p.m. with EDRN 6 and Risk Management Manager (RMM), Resident Directory was reviewed electronically. EDRN 6 was unable to locate the Resident Directory and EDRN 6 was not familiar on how the nurses verify whether the resident physician could perform certain procedure in the ED. EDRN 6 stated, "I do not know." RMM verified the findings.

During a concurrent interview and record review on 4/30/24 at 3:53 p.m. with EDRN 7 and RMM, Resident Directory was reviewed in the computer. EDRN 7 stated resident physicians are with the attending physician during the procedure. EDRN 7 stated she would go to the attending physician to ask if the resident physician could perform the procedure. EDRN 7 stated she was not aware about the Resident Directory in the computer.

5. During an observation on 4/29/24 at 2:24 p.m. in Patient 2's room, EDRN 1 entered the room with his Work-On-Wheels (WOW) computer and fixed the electrodes (electrical conductor) and lead placement (view of electrical activity of the heart) to ensure proper heart monitoring of Patient 2's heart rhythm.

During an observation on 4/29/24 at 2:31 p.m. in Patient 2's room, ED Physician (MD) 3 called for "Time Out," (a surgical pause conducted before the procedure to ensure right patient, right site, right consent signed for patient safety). EDRN 1 stood by his computer and did not go to the bedside to check for the patient's identification and EDRN 1 did not review Patient 2's record for accuracy of the Informed Consent and whether Informed Consent was obtained and signed.

During an observation on 4/29/24 at 2:35 p.m. in Patient 2's room, MD 3 was not wearing a mask during a sterile procedure. EDRN 1 did not recognize the need for MD 3 to be completely garbed with a cap, mask, gown, gloves, and face shield to maintain a maximum barrier for the sterile procedure.

During an observation on 4/29/24 at 2:46 p.m. in Patient 2's room, Patient 2's heart monitor displayed a heart rate of 30, bradycardia (slow heart rate), but EDRN 1 did not inform MD 3.

During an interview on 4/29/24 at 3:09 p.m. with EDRN 1, EDRN 1 stated he entered Patient 2's room and while he was in the room, he made sure the timeout process was done before the procedure and he observed, [MD 3]'s gown waist ties were not completely tied, and [MD 3] was not wearing a mask during the early part of the procedure. EDRN 1 stated, "I am supposed to document when the line was placed and monitor Patient 2's vital signs, but I did not. I was not sure what I was supposed to document for Vas Cath insertion. I was always (sic) used to monitor during a procedure under conscious sedation (an induced state of sedation characterized by a minimally depressed consciousness), but not familiar with procedures performed not under conscious sedation." EDRN 1 stated he identified Patient 2's heart rhythm was bradycardia, but he was waiting to see how long it would last. EDRN 1 stated, "I did not notify the doctor. I was supposed to let the doctor know of Patient 2's vital signs during the procedure, but I did not do that." EDRN 1 stated he also did not document anything during the procedure.

During a review of Patient 2's Vital Signs, dated 4/29/24 at 2:02 p.m., the vital signs indicated, "Respiratory Rate: 22." The vital signs record did not have documentation of Patient 2's heart rate, blood pressure, or oxygen saturation (measures the percentage of oxygen in the blood)."

During a review of the facility's policy and procedure (P&P) titled, "Standards of Care-Adult" dated 8/16/19, the P&P indicated, "The RN is responsible for assessment and surveillance: initial and ongoing assessment for changes in patient's condition and/or concerning vital signs. The RN is responsible for documenting changes in patient's condition and/or vital signs including ED Provider notified."

During a review of the facility's P&P titled, "Surgical/Procedure Site Verification (Universal Protocol)," dated 1/10/20, the P &P indicated, "V. Documentation: The completed components of the Universal Protocol (provides guidance for health care professionals key steps: conducting a pre-procedure verification process, marking the procedure site, and performing a time-out), and Time-Out are clearly documented by the Registered Nurse in the electronic medical record.: correct patient identity, correct die and site, an accurate procedure consent form..."