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Based on interview and record review, the facility failed to ensure the Condition of Participation for Patient Rights was met, as evidenced by:

1. The facility failed to ensure one of 30 sampled patients (Patient 3) had an informed consent (voluntary agreement to accept treatment and/or procedures after receiving education regarding the risks, benefits, and alternatives offered) for a procedure (a treatment or intervention used to diagnose, manage, or treat medical problems) in the medical record, in accordance with the facility's policy and procedures (P&P).

The deficient practice had the potential to result in the patient not being adequately informed about the risks and benefits involved with the procedure including the opportunity to ask questions. (Refer to A-0131)

2. The facility failed to inform one of 30 sampled patients (Patient 11) that there was vaginal (the external parts of the female genital structures) packing (any material that is intentionally placed in an orifice [an opening to a space through which something can pass]) in place, the location of the packing, and the plan for removal per P&P.

This deficient practice resulted in Patient 11 being unaware that the vaginal packing was supposed to be removed prior to discharge (when a patient is allowed to leave a hospital after treatment), causing Patient 11 significant pain and placing Patient 11 at risk for infection or septic shock. (Refer to A-0131)

3. The facility failed to ensure personal privacy was provided for one of 30 sampled patients (Patient 12) when Patient 12's room privacy curtains and/or door were not closed during Patient 12's treatment care.

This deficient practice resulted in Patient 12's personal privacy and dignity not being maintained during the treatment care and exposing Patient 12's vulnerable state to anyone coming into the respective facility, which could have negatively affected the patient's right to receive respectful care and maintain their psychosocial well-being. (Refer to A-0143)

4. The facility failed to ensure two of 30 sampled patients (Patient 2 and Patient 4) had a comprehensive assessment (an evaluation required to be done and documented for the episode requiring the use of non-violent restraints [the use of physical or chemical methods to restrict a patient's movement or behavior, often to prevent harm to themselves or others]) prior to the initiation of restraints or in the time after the initiation of a restraint. The facility failed to document if any less restrictive measures or alternatives to restraints were attempted prior to the initiation of restraints.

The deficient practice had the potential to result in inappropriate, unnecessary, and prolonged use of physical restraints. (Refer to A-0164)

The cumulative effect of these deficient practices resulted in the facility's inability to provide quality health care in a safe environment.

Based on interview and record review, the facility failed to ensure its patients had the right to make informed decisions regarding their care when:

1. The facility failed to ensure one of 30 sampled patients (Patient 3) had an informed consent (voluntary agreement to accept treatment and/or procedures after receiving education regarding the risks, benefits, and alternatives offered) for a procedure (a treatment or intervention used to diagnose, manage, or treat medical problems) in the medical record, in accordance with the facility's policy and procedures (P&P).

This deficient practice had the potential to result in the patient not being adequately informed about the risks and benefits involved with the procedure including the opportunity to ask questions.

2. The facility failed to inform one of 30 sampled patients (Patient 11) that there was vaginal (the external parts of the female genital structures) packing (any material that is intentionally placed in an orifice [an opening to a space through which something can pass]) in place, the location of the packing, and the plan for removal per P&P.

This deficient practice resulted in Patient 11 being unaware that the vaginal packing was supposed to be removed prior to discharge (when a patient is allowed to leave a hospital after treatment), causing Patient 11 significant pain and placing Patient 11 at risk for infection or septic shock

Findings:

1. During a review of Patient 3's "Face Sheet (front page of the chart that contains a summary of basic information about the patient)," undated, the face sheet indicated Patient 3 was admitted to the facility on 8/8/2025 at 4:37 p.m.

During a review of Patient 3's "History and Physical (H&P - a formal and completed assessment of the patient and the problem)," dated 8/7/2025, the H&P indicated Patient 3 was admitted for upset stomach, fatigue (extreme tiredness), weakness, diarrhea (frequent, loose, and watery bowel movements) 3 to 4 time a day, and follow-up for multiple myeloma (a cancer that forms in the white blood cells [cells that help protect against infections and diseases]. Patient 3 had a history of multiple myeloma not having achieved remission (signs and symptoms of a disease such as cancer have lessened or disappeared) and CAR T (a process that takes a patient's own cells and modifies the cells to target the cancer cells once the now modified cells are re-introduced into the patient's body) infusion July 2024.

During a review of Patient 3's "Informed Consent to Surgery or Special Procedure, Esophagogastroduodenoscopy (EGD - a medical procedure that allows a doctor to examine the upper gastrointestinal tract) with Possible Interventions, Possible Moderate Sedation (medication given to help a patient relax during a procedure), Possible Monitored Anesthesia (a complete state of no awareness, typically used during surgeries) Care (MAC)," dated 8/15/2025, the "Informed Consent to Surgery or Special Procedure" designated a signature line for 'Signature of Surrogate Decision Maker.' The 'Signature of Surrogate Decision Maker' line was blank. The "Informed Consent to Surgery ..." document indicated the name of Patient 3's cousin as the Durable Power of Attorney (DPOA - a legal document that allows a person to appoint another person to make financial, legal, or health-related decisions on their behalf). The "Informed Consent ..." document included the signature of the Consenting Provider (MD 1) and Witness (MD 2).

During a record review of Patient 3's "iMedConsent Solution EGD with Possible Interventions, Possible Moderate Sedation, Possible Anesthesia," undated, the iMedConsent form indicated three spaces for Mobile Sign (electronic) signatures. Line one was for Consenting Provider, with mobile sign date entered as 8/15/2025 at 9:46:44 a.m., no name of signee entered. The third line was for Witness, mobile sign Date entered as 8/15/2025 at 09:48:51 a.m., no name of signee entered. The second line was for Surrogate, Mobile Sign Date indicated 'Incomplete.'

There was no documentation in Patient 3's medical record to indicate that the physician obtained informed consent from the patient or the legal representative for the procedure, nor was there documentation to justify the existence of an emergency that required an emergency procedure.

During a concurrent interview and record review on 8/21/2025 at 10:30 a.m. with Registered Nurse (RN) 1, RN 2, and RN 3, Patient 3's "Informed Consent to Surgery or Special Procedure," dated 8/15/2025, was reviewed. The Informed Consent designated a signature line for "Signature of Surrogate Decision Maker (a designated person, typically a family member or trusted friend, who has the legal authority to make health care decisions for an individual who has lost the capacity to make those decisions for themselves)"; however, the signature line was blank. RN 1 stated there was no signature of Patient 3 or Patient 3's DPOA on the Informed Consent's designated signature line. RN 2 stated the review of the medical record did not indicate if (1) the informed consent for procedure was obtained in another manner not obvious to RN 2 and (2) if informed consent was obtained, whether it was obtained by telephone or in person.

During a concurrent interview and record review on 8/21/2025 at 10:45 a.m. with Registered Nurse (RN) 4, Patient 3's "Informed Consent" was reviewed. RN 4 stated the signature line where the DPOA would sign was blank and documentation regarding possible telephone consent was not found. RN 4 stated the Informed Consent form should have a designation, such as a check box, for telephone consent and this was an opportunity to improve the Informed Consent form.

During a record review of the facility's policy and procedure (P&P) titled, "Consents: Obtaining and Verifying," revised 9/19/2024, the P&P indicated:
- Policy. 4. The following clinical interventions require the Informed Consent process and documentation as herein described ... (a) Surgery and Other Invasive (a procedure involving the introduction of instruments or other objects into the body) Procedures as defined below, (b) Therapeutic (a process to cure or improve diseases and other conditions) or diagnostic (a process that identifies a disease illness) procedures for which anesthesia services are planned, except for non-invasive (not requiring the introduction of instruments into the body) diagnostic procedures including CTs (a diagnostic tool) or MRIs (a diagnostic tool using magnets).
- Point of Emphasis. 1. General Consent Information. (a) Every competent adult has the fundamental right of self-determination over his or her body and property. Consent to surgery or special diagnostic or therapeutic procedures must be freely given and must not be obtained through the exercise of duress or coercion. Individuals who are unable to exercise this right, such as minors and adults lacking capacity to consent, have the right to be represented by another person who will protect their interests and preserve their basic rights ... (c) A provider has both a legal and ethical duty to obtain the patient's consent, or the consent of the patient's legal representatives, to medical treatment. Therefore, the provider, not the hospital, has the responsibility to obtain consent. The role of the hospital in this process shall be limited to verifying the patient's informed consent has been obtained by the provider before the provider is permitted to perform the medical procedure. The verification is documented on the "Authorization and Informed Consent to Surgery or Special Diagnostic or Therapeutic Procedures" form (hospital consent form).
- Point of Emphasis. 2. Informed Consent. (a) It is the provider's responsibility to obtain the patient's informed consent, or the consent of the patient's legal representative for a procedure or medical treatment. The elements of the informed consent must be explained in terms the patient can understand. Informed consent includes the following elements:
i. The name of the procedure,
ii. The facility where the surgical procedure or intervention is taking place,
iii. The risks, complications, and expected benefits or effects of the procedure including the possible risks of not receiving care, treatment, or surgery,
iv. Any alternatives to the treatment and their risks and benefits,
v. Potential problems during recuperation,
vi. Any potentially conflicting interest the provider may have (such as research or financial interest),
vii. A discussion regarding the attending provider's presence and participation in the key/critical portions of the procedure that he/she may not be present to the entire procedure, if applicable.

2. During a review of Patient 11's "History and Physical (H&P, a formal and complete assessment of the patient and the problem)," dated 7/3/2024, the H&P indicated Patient 11 was admitted to the facility for Urethral Diverticulectomy (UD-is a surgical procedure to remove a urethral diverticulum [a sac or pocket that forms along the urethra [the duct by which urine is conveyed out of the body from the bladder]).

During a review of Patient 11's "NCI Main OR Record (MOR)", dated 7/3/2024, the "MOR" indicated on 7/3/2024, Patient 11 had a urethral diverticulectomy surgical procedure. The "MOR" further indicated on 7/3/2024 at 12:28 p.m. Patient 11 was applied one vaginal packing, and the wound packing armband was placed to the left arm.

During an interview on 8/19/2025 at 1:44 p.m. with RN 11, RN 11 stated that on 7/5/2024 at 10:41 a.m. she called Patient 11 for a post op call (a follow-up telephone call made to a patient after they have been discharged from the hospital to address any concerns or potential complications) and Patient 11 verbalized that there was "gauze halfway hanging out of the perineum (the area between the anus and the vulva in females) and it felt like there is more gauze inside her vagina." RN 11 stated Patient 11 asked when the gauze will be taken out and if she needed to take it out by herself.

In the same interview, RN 11 stated that on 7/5/2024 at 10:41 a.m. she reviewed Patient 11's clinical record. RN 11 stated the clinical records indicated that there was no documentation regarding patient education on vaginal packing for the date of 7/3/2024. RN 11 stated nurses were expected to educate and document they had informed the patient or patient representative that there is packing in place, the location of the packing and the plan for removal. RN 11 stated it was important to have an order for packing removal to keep Patient 11 informed on the plan for the vaginal packing removal.

During a concurrent interview and record review on 8/19/2025 at 2:41 p.m. with RN 10, Patient 11's medical record was reviewed. RN 10 stated nurses were expected to educate and document they had informed the patient or patient representative that there was packing in place, the location of the packing and the plan for removal. RN 10 verified that there was no documentation from Registered Nurse 12 (RN 12), who was assigned to Patient 11, indicating education was provided regarding the vaginal packing for the date of 7/3/2024.

During a review of the facility's policy and procedure (P&P) titled, "Monitoring and Removal of Wound Packing and Armband", policy #NA 10-206, dated 7/23/2021, the P&P indicated:
"The purpose of this policy is to ensure a sequence of safe communication strategies and best practices are followed by multiple care providers in multiple sites, to protect the patient against unintended retained packing within an orifice ...Packing armband: Serves as a reminder to staff at each transition of care that there is packing place ...the process defined in this policy details the procedure for transferring critical information from primary agents (the physician who inserts the packing and the circulating nurse who is present during the insertion of packing) to secondary agents (the patient care nurses in Post Anesthesia Care Unit (PACU) and other units who are responsible for removing the packing if applicable), and the patient, who is told once awake, and at each subsequent hand-off that they have packing in place that needs to be removed. Procedure 1. Intra-operative/Intra-procedural circulating nurse will: a. Verbally verify, with the physician placing the packing, the location, type, and number of packing placed and plan for removal of packing ... 2. The receiving nurse will ...c. Inform patient and/or patient surrogate that there is packing in place, the location of the packing and the plan for removal. d. Document who was notified in EMR (electronic medical record) ..."

During a review of the facility's document titled, "Nursing Bulletin Wound Packing Armbands", dated 8/27/21, provided by the facility indicated "Roles and Responsibilities: OR Circulator: Verifies packing with surgeon and documents in the PeriOp Doc, Places purple wrist band on the patient, Relays information in report to the receiving nurse. Receiving nurse: document hand-off and packing confirmation in i-View, confirm placement of wristband with reporting nurse, Patient education on packing. Removing nurse: Verify order to remove, call provider for clarification if needed (i.e.-incomplete, packing not visible, or missing armband), remove packing as ordered, confirm items removed, then document in i-View, Remove wrist band from patient"

Based on observation, interview, and record review, the facility failed to ensure personal privacy was provided for one of 30 sampled patients (Patient 12) when Patient 12's room privacy curtains and/or door were not closed during Patient 12's treatment care.

This deficient practice resulted in Patient 12's personal privacy and dignity not being maintained during the treatment care and exposing Patient 12's vulnerable state to anyone coming into the respective facility, which could have negatively affected the patient's right to receive respectful care and maintain their psychosocial well-being.

Findings:

During a review of Patient 12's "Face Sheet (front page of the chart that contains a summary of basic information about the patient)," undated, the Face Sheet indicated Patient 12 was admitted to the facility on 8/14/2025, with admit reason of "follow up" (monitoring a patient's health or condition after an initial visit or treatment).

During an observation on 8/18/2025 at 3:24 p.m. outside Patient 12's room with the Chief Nurse Executive (CNE), Patient 12's door was observed wide open with Registered Nurse (RN) 13 at the bedside, administering Jejunostomy tube (JT - a flexible tube surgically placed into the small intestine, used for the administration of food and medication) feedings (provide nutrition) and treatment care. Patient 12's JT treatment care could be seen by anyone passing by the Patient 12's room resulting in compromising his dignity and privacy.

During a concurrent observation and interview on 8/18/2025 at 3:26 p.m. with the Nurse Manager (NM), NM was observed closing the privacy curtains for Patient 12. NM stated RN 13 was administrating JT feedings to Patient 12 and privacy curtains would be used to respect patient privacy.

During an interview on 8/18/2025 at 3:26 p.m. with the CNE, the CNE stated the RN 13 did not provide privacy to Patient 12 during the JT treatment care. The CNE stated patients should have dignity and privacy during any type of patient care.

During a review of the facility's policy and procedure (P&P) titled, "Admission of Patient," policy #CP 1-109, dated 8/27/2024, the P&P indicated, "Privacy curtains will be used to respect patient privacy during all exams, treatments and procedures."

During a review of the facility's document titled, "Patient Rights", dated 6/2024, provided by the facility, the "Patient Rights" document indicated, "You have the right to: ...11. Have personal privacy respected. Case discussion, consultation, examination, ant treatment are confidential and should be conducted discreetly ...Privacy curtains will be used ..."

Based on interview and record review, the facility failed to ensure two of 30 sampled patients (Patient 2 and Patient 4) had a comprehensive assessment (an evaluation required to be done and documented for the episode requiring the use of non-violent restraints [the use of physical or chemical methods to restrict a patient's movement or behavior, often to prevent harm to themselves or others]) prior to the initiation of restraints or in the time after the initiation of a restraint. The facility failed to document if any less restrictive measures or alternatives to restraints were attempted prior to the initiation of restraints.

The deficient practice had the potential to result in inappropriate, unnecessary, and prolonged use of physical restraints.

Findings:

1. During a review of Patient 2's "Face Sheet (front page of the chart that contains a summary of basic information about the patient)," undated, the face sheet indicated Patient 2 was admitted to the facility on 8/17/2025 at 8:12 p.m.

During a review of Patient 2's "History and Physical (H&P - a formal and complete assessment of the patient and the problem upon admission to the hospital)," dated 8/17/2025, the H&P indicated Patient 2 was transferred from an outside hospital for worsening shortness of breath (difficulty breathing) and metastatic (cancer that has spread from its original location to other parts of the body) melanoma (a serious type of skin cancer) of lungs and brain.

During a review of Patient 2's "Bedside Procedures" document, dated 8/18/2025 at 11:27 a.m., the "Procedures" indicated Patient 2 underwent a bedside endotracheal intubation (a procedure to place a tube into the windpipe [trachea] to maintain an open airway for breathing). The "Bedside Procedures" document indicated the reason for intubation as: "Establish, protect, and maintain a patent airway (an open and unobstructed passageway for air between the mouth or nose and the lungs), Facilitate oxygenation (the process of delivering oxygen to the body to maintain life) and ventilation (the process of moving air in and out of the lungs), Reduce the risk of aspiration (the accidental breathing in of foreign substances, such as food, liquid, or saliva, into the lungs), Facilitate clearance (help make the process of removing easier) of secretions (substances produced and released by the body)."

During a review of Patient 2's provider order (a formal, authorized instruction from a licensed healthcare provider such as a doctor, nurse practitioner, or physician assistant for a patient's medical treatment, care, or services, including medications, lab tests, or diagnostic imaging) titled, "Order Information for: Restraint - Non-Violent," dated 8/18/2025 at 1:16 p.m. by Nurse Practitioner (NP) 1, the order indicated:
- Reason for Restraint: Interfering with medical devices
- Cognitive Impaired: Yes
- Restraint Type: Soft Wrist Left, Soft Wrist Right.
- Frequency: One Time Unscheduled
- Restraint Discontinuation Criteria: Refrains from self-injurious activity
- Stop Date/Time: 8/25/2025 1:15 p.m.
- Constant Indicator: No.
- Comment: Consider pre-existing contraindications (a specific situation where a treatment, procedure, or medication should not be used because it could be harmful to the individual) prior to use of restraint.

During a review of Patient 2's provider order titled, "Order Information for: Restraint Evaluate Need to Continue," entered and electronically signed on 8/18/2025 at 1:16 p.m. by NP 1, the order indicated, "Special Instructions: Per hospital Policy."

During a concurrent interview and record review on 8/19/2025 at 11:00 a.m. with Registered Nurse (RN) 1 and RN 2 regarding Patient 2's order for restraints, RN 1 stated soft restraints were used so patients did not pull out their tracheostomy (a surgical procedure that creates an opening in the windpipe to provide a direct airway for breathing, bypassing the mouth and nose) or endotracheal tube, especially when the patient was waking up from anesthesia (the use of medicines to make a patient temporarily lose feelings or awareness, allowing them to undergo surgery or other medical procedures without pain or discomfort). After an online record review, RN 1 stated there was no comprehensive assessment on record indicating Patient 2 would benefit from soft restraints (medical devices made of cushioned materials, like foam or quilted fabric, used to restrict a patient's movement).

RN 1 and RN 2 independently stated there was no documented evidence of 'less restrictive measures and alternatives to restraints' attempted prior to the soft restraints being used, per the facility's restraint policy. RN 1 stated she understood it was against patient's rights to not be in restraints without a valid reason and stated the restraint protocol was not followed. RN 1 stated she was not aware of the policy requiring a comprehensive assessment and less restrictive measures or alternatives to restraints to be attempted before restraints should be initiated.

During a concurrent interview and record review with RN 1 on 8/19/2025 at 11:00 a.m., Patient 2's "Interprofessional Plan of Care" was reviewed. RN 1 stated there was no reference to restraints in the plan of care. RN 1 stated a care plan identifies areas of specific concerns for each patient, and Patient 2 would benefit from the plan of care specific to him.

During a review of the facility's policy and procedure (P&P) titled, "Restraint," revised 09/21/2023, the P&P indicated:
- "Definitions. 2. "Restraint" is any manual method, physical or mechanical device, material, or equipment that immobilizes or reduces the activity of a patient to move his or her arms, legs, body, or head freely.
- "Definitions. 4. "Non-Violent Behavior" is behavior that interferes with the medical/surgical healing treatment (e.g. pulling and/removing tubes, dressing, and/or therapeutic devices, trying to climb out of bed, engaging in activities that can injure self).
- Policy. 1. Patients shall be restrained only when clinically justified to prevent the patient from causing injury to themselves or other or to enhance medical healing ..."
- Policy. 6. A comprehensive assessment of the patient will determine that the risks associated with the use of the restraints are outweighed by the risk of not using it. Less restrictive measures and alternatives to restraint will be attempted (or considered and rejected as ineffective in relationship to the given circumstance).
- Policy. 3. b. Restraint used for the management of Non-Violent Behavior shall be subject to monitoring and assessment as specified in the patient's plan of care.

2. During a review of Patient 4 "Face Sheet (front page of the chart that contains a summary of basic information about the patient)," undated, the Face Sheet indicated Patient 4 was admitted to the facility on 7/31/2025 at 7:02 p.m.

During a review of Patient 4's "History and Physical (H&P)," dated 7/31/2025, the H&P indicated Patient 4 was transferred to the facility from an outside hospital for hypoxia (a condition where there is an inadequate supply of oxygen to the body's tissues) and fever (elevated body temperature above the normal range). Patient 4 had a history of AML (acute myeloid leukemia - a rare cancer that affects the bone marrow [part of the bone responsible for producing red blood cells, white blood cells, and platelets] and blood), MDS (myelodysplastic syndrome - a group of blood disorders characterized by abnormal blood cell production in the bone marrow), a previous bone marrow transplant [a procedure to replace diseased or damaged bone marrow with healthy blood cells], and thrombocytopenia (a low platelet [cells in the blood essential for forming blood clots to stop bleeding after an injury] count).

During a review of Patient 4's "Endotracheal Intubation (a procedure where a flexible tube is inserted through the mouth or nose into the windpipe to keep the airway open so the patient can breathe) Note" dated 8/5/2025 at 2:42 p.m., the Note indicated Patient 4 underwent an endotracheal intubation with Medical Doctor (MD) 4 supervising. The "Endotracheal Intubation Note" indicated the reason for intubation to be: "Establish, protect, and maintain a patent airway (an open and unobstructed passageway for air between the mouth or nose and the lungs), Facilitate oxygenation (the process of delivering oxygen to the body to maintain life) and ventilation (the process of moving air in and out of the lungs), Reduce the risk of aspiration (the accidental breathing in of foreign substances, such as food, liquid, or saliva, into the lungs), Facilitate clearance (help make the process of removing easier) of secretions (substances produced and released by the body)."

During a review of Patient 4's provider order (a formal, authorized instruction from a licensed healthcare provider such as a doctor, nurse practitioner, or physician assistant for a patient's medical treatment, care, or services, including medications, lab tests, or diagnostic imaging) titled, "Order Information for: Restraint - Non-Violent," date entered and electronically signed on 8/5/2025 at 11:45 p.m. by Nurse Practitioner (NP) 2, the order indicated:
- Reason for Restraint: Interfering with medical devices
- Cognitive Impaired: Yes
- Restraint Type: Soft Wrist Left, Soft Wrist Right.
- Frequency: One Time Unscheduled
- Restraint Discontinuation Criteria: Refrains from self-injurious activity
- Stop Date/Time: 8/12/25 23:45 PDT
- Constant Indicator: No.
- Comment: Consider pre-existing contraindications prior to use of restraint.

During a review of Patient 4's provider order titled, "Order Information for: Restraint - Non-Violent," date entered and electronically signed on 8/12/2025 at 5:42 by NP 2, the order indicated:
- Reason for Restraint: Interfering with medical devices.
- Cognitive Impaired: Yes.
- Restraint Type: Soft Wrist Right.
- Frequency: One Time Unscheduled
- Restraint Discontinuation Criteria: Refrains from self-injurious (self-harming) activity
- Stop Date/Time: 8/19/25 5:41 PDT
- Constant Indicator: No.
- Comment: Consider pre-existing contraindications prior to use of restraint.

During a review of Patient 4's provider order titled, "Order Information for: Restraint - Non-Violent," date entered and electronically signed on 8/14/2025 at 12:34 by NP 2, the order indicated:
- Reason for Restraint: Interfering with medical devices
- Cognitive Impaired: Yes
- Restraint Type: Soft Wrist Left, Soft Wrist Right.
- Frequency: One Time Unscheduled
- Restraint Discontinuation Criteria: Refrains from self-injurious activity
- Stop Date/Time: 8/21/25 7:59 PDT
- Constant Indicator: No.
- Comment: Consider pre-existing contraindications prior to use of restraint.

During a review of Patient 4's "Interprofessional Plan of Care (a detailed document summarizing a person's health conditions, goals, and the specific treatments or services needed to achieve those goals)," dated 8/5/2025 and "Interprofessional Plan of Care," dated 8/14/2025, a plan of care regarding restraints was not on record.

During a concurrent interview and record review on 8/20/2025 at 11:20 a.m. with RN 1 and RN 2, Patient 4's provider order for restraints was reviewed. RN 2 stated she was now aware of the Restraint P&P. An electronic medical record chart review for Patient 4 found no evidence of a comprehensive assessment and less restrictive measures were tried before restraints were initiated.

During a concurrent interview and record review on 8/21/2025 at 11:20 a.m. with RN 1 and RN 2, Patient 4's Interprofessional Plan of Care was reviewed. RN 2 stated any reference to restraints in the current and past care plans could not be found.

During a review of the facility's policy and procedure (P&P) titled, "Endotracheal and Nasotracheal (a tube inserted through the nose, down the throat and into the windpipe, allowing for a clear airway) Tube Care and Airway Management," revised 10/17/2024, the P&P indicated no reference to restraints to be used post-endotracheal tube placement.

During a review of the facility's P&P titled, "Restraint," revised 9/21/2023, the P&P indicated:
- "Definitions. 2. "Restraint" is any manual method, physical or mechanical device, material, or equipment that immobilizes or reduces the activity of a patient to move his or her arms, legs, body, or head freely.
- "Definitions. 4. "Non-Violent Behavior" is behavior that interferes with the medical/surgical healing treatment (e.g. pulling and/removing tubes, dressing, and/or therapeutic devices, trying to climb out of bed, engaging in activities that can injure self).
- Policy. 1. Patients shall be restrained only when clinically justified to prevent the patient from causing injury to themselves or other or to enhance medical healing ..."
- Policy. 6. A comprehensive assessment of the patient will determine that the risks associated with the use of the restraints are outweighed by the risk of not using it. Less restrictive measures and alternatives to restraint will be attempted (or considered and rejected as ineffective in relationship to the given circumstance).
- Policy. 3. b. Restraint used for the management of Non-Violent Behavior shall be subject to monitoring and assessment as specified in the patient's plan of care."

Based on interview and record review, the facility failed to ensure their staff adhered to the policy and procedure (P&P) for "Monitoring and Removal of Wound Packing (any material that is intentionally placed in an orifice [an opening to a space through which something can pass]) and packing armband (a lilac-colored wrist armband that serves as a reminder to staff at each transition of care that there is a packing in place)" when:

1. The facility's staff failed to ensure a plan was in place for the removal of vaginal (the external parts of the female genital structures) packing for one of 30 sampled patients (Patient 11).

This deficient practice resulted in the discharge of Patient 11 with vaginal packing left inserted into the vagina, causing Patient 11 significant pain and placing Patient 11 at risk for infection or septic shock.

2. The facility's staff failed to verify with the physician the plan for removal of vaginal packing for one of 30 sampled patients (Patient 11).

This deficient practice resulted in lack of a physician's order for removal of vaginal packing, causing Patient 11 to be discharged with vaginal packing left inserted and the facility's "packing armband (an armband that serves as a reminder to staff at each transition of care that there is a packing in place)" left on Patient 11's arm.

Findings:

1. During a review of Patient 11's "History and Physical (H&P, a formal and complete assessment of the patient and the problem)," dated 7/3/2024, the H&P indicated Patient 11 was admitted to the facility for Urethral Diverticulectomy (UD - a surgical procedure to remove a urethral diverticulum [a sac or pocket that forms along the urethra [the duct by which urine is conveyed out of the body from the bladder]).

During a review of Patient 11's "NCI (refers to the National Cancer Institute's designation of the facility) Main OR (Operating Room) Record (MOR)", dated 7/3/2024, the "MOR" indicated on 7/3/2024, Patient 11 had a urethral diverticulectomy surgical procedure. The "MOR" further indicated on 7/3/2024 at 12:28 p.m. Patient 11 was applied one vaginal packing (material that is intentionally placed in an orifice) and the wound packing armband was placed to the left arm.

During a concurrent interview and record review on 8/19/2025 at 10:45 a.m. with AAQ, Patient 11's "NCI Post Anesthesia Care Unit (PACU) Record (PACUR)", dated 7/3/2024, was reviewed. The "PACUR" indicated Patient 11 was discharged home on 7/3/2024 at 2:25 p.m. The AAQ stated Patient 11 was discharged home with vaginal packing intended to be removed at the time of discharge.

During a concurrent interview and record review on 8/19/2025 at 1:44 p.m. with Registered Nurse 11 (RN 11), Patient 11's clinical record was reviewed. RN 11 stated Patient 11 did not have a physician order for removal of vaginal packing in their clinical record. RN 11 stated the assigned nurse for Patient 11 should have called the physician for an order to remove the vaginal packing on 7/3/2024. RN 11 stated it was important to have an order for packing removal to keep patients informed.

In the same interview, RN 11 stated that on 7/5/2024 at 10:41 a.m. she called Patient 11 for a post-op call (a follow-up telephone call made to a patient after they have been discharged from the hospital to address any concerns or potential complications) and Patient 11 verbalized that there was "gauze halfway hanging out of the perineum (the area between the anus and the vulva in females) and it felt like there is more gauze inside her vagina." RN 11 stated Patient 11 asked when the gauze will be taken out and if she needed to take it out by herself. RN 11 stated Patient 11 complained of 7-8 out of 10 pain (pain score of 7-10 is severe pain) since coming home from the procedure. RN 11 stated Patient 11 was taking Tylenol (a medication used to treat pain), but the pain was unrelieved.

In the same interview, RN 11 stated that on 7/5/2024 at 10:41 a.m. she reviewed Patient 11's clinical record, RN 11 noted documentation of a vaginal packing placed in Patient 11 on 7/3/2025. Patient 11's clinical record indicated that there was no order or notes seen of when to remove the vaginal packing. RN 11 stated she placed Patient 11 on hold and RN 11 escalated the situation to Registered Nurse 10 (RN 10).

During an interview on 8/19/2025 at 2:12 p.m. with RN 10, RN 10 stated that on 7/5/2024 at 10:46 a.m. she spoke to Patient 11 and Patient 11 stated she had a lilac-colored wrist armband which alerted RN 10 that Patient 11 still had a packing in place. RN 10 reviewed Patient 11's clinical record which indicated Patient 11 had vaginal packing and no documentation of the vaginal packing being removed was found in the medical records. RN 10 then called the Medical Doctor 5 (MD 5), and MD 5 stated he needed Patient 11 to come to the office on 7/5/2024 for removal of the vaginal packing.

During a concurrent interview and record review on 8/19/2025 at 2:41 p.m. with RN 10, Patient 11's clinical record was reviewed. RN 10 verified that there was no documentation from Registered Nurse 12 (RN 12) the assigned nurse of Patient 11's indicating MD 5 was called to obtain an order for vaginal packing removal on 7/3/2024. RN 10 stated RN 12 should have clarified the plan for vaginal packing removal with MD 5 before discharging Patient 11 and this was not found in Patient 11's clinical record.

During a review of the Patient 11's "Urology Clinic Notes (UCN)," dated 7/5/2024, the "UCN" indicated MD 5 documented, "I was able to remove the vaginal packing today without an issue. I apologized to (Patient 11) as she was not supposed to go home with that in place ...She did ask about pain medications, and I told her that my suspicion is that she will feel much better with the vaginal packing out ..."

During a review of the facility's policy and procedure (P&P) titled, "Monitoring and Removal of Wound Packing and Armband", policy #NA 10-206, dated 7/23/21, the P&P indicated:
"the purpose of this policy is to ensure a sequence of safe communication strategies and best practices are followed by multiple care providers in multiple sites, to protect the patient against unintended retained packing within an orifice ...Packing armband: Serves as a reminder to staff at each transition of care that there is packing place ...the process defined in this policy details the procedure for transferring critical information from primary agents (the physician who inserts the packing and the circulating nurse who is present during the insertion of packing) to secondary agents (the patient care nurses in Post Anesthesia Care Unit (PACU) and other units who are responsible for removing the packing if applicable), and the patient, who is told once awake, and at each subsequent hand-off that they have packing in place that needs to be removed. Procedure 1.Intra-operative/Intra-procedural circulating nurse will: a. Verbally verify, with the physician placing the packing, the location, type, and number of packing placed and plan for removal of packing ... 2. The receiving nurse will ...c. Inform patient and/or patient surrogate that there is packing in place, the location of the packing and the plan for removal. d. Document who was notified in EMR (electronic medical record) ... 3. The nurse removing (if applicable) the packing will: a. Verify there is a written physician order regarding the removal of packing b. Call the physician to clarify the written order if any of the steps in the orifice packing process were omitted ... g. Remove the packing armband from the patient."

During a review of the facility's document titled, "Nursing Bulletin Wound Packing Armbands", dated 8/27/21, provided by the facility indicated "Roles and Responsibilities: OR Circulator: Verifies packing with surgeon and documents in the PeriOp Doc, Places purple wrist band on the patient, Relays information in report to the receiving nurse. Receiving nurse: document hand-off and packing confirmation in i-View, confirm placement of wristband with reporting nurse, Patient education on packing. Removing nurse: Verify order to remove, call provider for clarification if needed (i.e.-incomplete, packing not visible, or missing armband), remove packing as ordered, confirm items removed, then document in i-View, Remove wrist band from patient"

2. During a review of Patient 11's "NCI Main OR Record (MOR)", dated 7/3/2024, the "MOR" indicated on 7/3/2024, Patient 11 had a urethral diverticulectomy surgical procedure. The "MOR" further indicated on 7/3/2024 at 12:28 p.m. Patient 11 was applied one vaginal packing, and the wound packing armband was placed to the left arm.

During a concurrent interview and record review on 8/19/2025 at 10:45 a.m. with AAQ, Patient 11's "NCI Post Anesthesia Care Unit (PACU) Record (PACUR)", dated 7/3/2024 was reviewed. The "PACUR" indicated Patient 11 was discharged home on 7/3/2024 at 2:25 p.m. The AAQ stated Patient 11 was discharged home with vaginal packing intended to be removed at the time of discharge.

During a concurrent interview on 8/19/2025 at 2:12 p.m. with RN 10, RN 10 stated that on 7/5/2024 at 10:46 a.m. she spoke to Patient 11 and Patient 11 stated she had a lilac-colored wrist armband which alerted RN 10 that Patient 11 had a wound packing in place. RN 10 reviewed Patient 11's clinical record which indicated Patient 11 had vaginal packing and no documentation of the vaginal packing being removed was found in the clinical records. RN 10 then called the Medical Doctor 5 (MD 5), and MD 5 stated he needed Patient 11 to come to the office on 7/5/2024 for removal of the vaginal packing.

During an interview on 8/19/2025 at 2:28 p.m. with the Operating Room Supervisor (ORS), the ORS stated the Operating Room (OR) nurses are responsible for applying the lilac-colored armband (wound packing armband) to the patient's wrist as soon as the medical doctor decides to apply packing. ORS stated the OR nurses will then verify with the physician placing the packing, the location, type, and number of packings placed and plan for removal of packing. ORS stated the lilac-colored armband should have alerted the nurse to call the physician to clarify the plan for removal of the vaginal packing and this was not done for Patient 11.

During a concurrent interview and record review on 8/19/2025 at 2:41 p.m. with RN 10, RN 10 verified that there was no documentation from Registered Nurse 12 (RN 12) the Patient 11's assigned nurse indicating MD 5 was called to obtain an order for vaginal packing removal. RN 10 stated RN 12 should have clarified the plan for vaginal packing removal with MD 5 before discharging Patient 11 and this was not found in Patient 11's clinical record.

During a review of the facility's policy and procedure (P&P) titled, "Monitoring and Removal of Wound Packing and Armband", policy #NA 10-206, dated 7/23/21, the P&P indicated:
"Packing armband: Serves as a reminder to staff at each transition of care that there is packing place ...the process defined in this policy details the procedure for transferring critical information from primary agents (the physician who inserts the packing and the circulating nurse who is present during the insertion of packing) to secondary agents (the patient care nurses in Post Anesthesia Care Unit (PACU) and other units who are responsible for removing the packing if applicable), and the patient, who is told once awake, and at each subsequent hand-off that they have packing in place that needs to be removed. Procedure 1.Intra-operative/Intra-procedural circulating nurse will: a. Verbally verify, with the physician placing the packing, the location, type, and number of packing placed and plan for removal of packing ... 3. The nurse removing (if applicable) the packing will: a. Verify there is a written physician order regarding the removal of packing b. Call the physician to clarify the written order if any of the steps in the orifice packing process were omitted ... g. Remove the packing armband from the patient."

During a review of the facility's document titled, "Nursing Bulletin Wound Packing Armbands", dated 8/27/2021, provided by the facility, the document indicated, "Roles and Responsibilities: OR Circulator: Verifies packing with surgeon and documents in the PeriOp Doc, Places purple wrist band on the patient, Relays information in report to the receiving nurse. Receiving nurse: document hand-off and packing confirmation in i-View, confirm placement of wristband with reporting nurse, Patient education on packing. Removing nurse: Verify order to remove, call provider for clarification if needed (i.e.-incomplete, packing not visible, or missing armband), remove packing as ordered, confirm items removed, then document in i-View, Remove wrist band from patient"