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Tag No.: A0115
Based on review of records and staff interviews, the facility failed to:
A) ensure that 5 patients (Patient #67, #68, #69, #70, and #71) of 5 patients who presented to the emergency department after a sexual assault were not provided with notice of all the patient rights required by state law in the Texas Health and Safety Code, Chapter 323, Subchapter A. Emergency Services for Survivors of Sexual Assault and the Texas Code of Criminal Procedure, Chapter 56A Rights of Crime Victims, Subchapter G. Forensic Medical Examination of Sexual Assault Victim, Art. 56A.303. Forensic Medical Examination.
Failure to provide the patient with notice of their rights as described on the State mandated information form as soon as possible prior to beginning services could result in the patient not receiving all the services entitled to. If the patient were forced to seek examination elsewhere or were to leave prior to receiving all the services they were entitled to, such as prophylaxis medications (medications meant to prevent disease), access to an advocate from the local crisis center if available and local resources for follow-up care, the patient could develop life threatening conditions such as sexually transmitted infections, acquired immunodeficiency syndrome (AIDS), or post-traumatic stress disorder leading to suicidal ideation.
Refer to Tag A0117
B) ensure timely grievance resolution in 1 of 1 sampled patients reviewed for complaint and grievances (Patient #4).
Patient #4's family voiced a grievance regarding care issues and HIPPA violations on 01/26/2025 and the grievance was not resolved until 06/17/2025 (over 4.5 months later).
Refer to TAG A0122
C) ensure timely communication of grievance results to the complainant in 1 of 1 sampled patients reviewed for complaint and grievances (Patient #4).
Patient #4's family voiced a grievance regarding care issues and HIPPA violations on 01/26/2025 and the grievance was not resolved until 06/17/2025 (over 4.5 months later).
Patient #4's family member who voiced the grievance was never informed of the results of the investigation.
Refer to TAG A0123
D) ensure proper execution of informed consent in 7 (#7, #11, #21, #22, #23, #30, #31) of 7 patient medical records reviewed. Additionally, the hospital staff did not follow the "Disclosure and Consent for Medical and Surgical Procedures" policy.
The hospital staff failed to ensure:
A. proper execution of informed consent for Hemodialysis for Patient #7.
B. patient # 11 was deemed competent to provide consent for blood transfusions prior to the initiation of blood products.
C. the hospital's "Refusal to Permit Examination, Treatment, Transport, or Transfer Form" listed the treatments refused, the risks for refusing treatment for Patient #21 and Patient #23. That all portions of the hospital's "Refusal to Permit Examination, Treatment, Transport, or Transfer Form" was signed, dated, and timed for Patient #21, #22, and #23.
D. consent to admission and notification of patient rights were obtained upon admission for Patient #31.
Refer to TAG A0131
Tag No.: A0117
Based on review of patient records, policies and procedures, interview, and Texas state law, the facility failed to ensure that 5 patients (Patient #67, #68, #69, #70, and #71) of 5 patients who presented to the emergency department after a sexual assault were not provided with notice of all the patient rights required by state law in the Texas Health and Safety Code, Chapter 323, Subchapter A. Emergency Services for Survivors of Sexual Assault and the Texas Code of Criminal Procedure, Chapter 56A Rights of Crime Victims, Subchapter G. Forensic Medical Examination of Sexual Assault Victim, Art. 56A.303. Forensic Medical Examination.
Sec. 323.004. MINIMUM STANDARDS FOR EMERGENCY SERVICES, Subsection (b) requires:
(b) A health care facility providing care to a sexual assault survivor shall provide the survivor with:
(1) subject to Subsection (b-1), a forensic medical examination in accordance with Subchapter B, Chapter 420, Government Code, and Subchapter G, Chapter 56A, Code of Criminal Procedure;
...
(3) access to a sexual assault program advocate, if available, as provided by Subchapter H, Chapter 56A, Code of Criminal Procedure;
(4) the information form required by Section 323.005; (Sec. 323.005. INFORMATION FORM. (a) The commission shall develop a standard information form for sexual assault survivors ...)
...
(7) the name and telephone number of the nearest sexual assault crisis center; and
...
CODE OF CRIMINAL PROCEDURE
TITLE 1. CODE OF CRIMINAL PROCEDURE
CHAPTER 56A. RIGHTS OF CRIME VICTIMS
SUBCHAPTER G. FORENSIC MEDICAL EXAMINATION OF SEXUAL ASSAULT VICTIM
Art. 56A.303. FORENSIC MEDICAL EXAMINATION.
(c) A victim of a sexual assault may not be required to participate in the investigation or prosecution of an offense as a condition of receiving a forensic medical examination under this article.
Failure to provide the patient with notice of their rights as described on the State mandated information form as soon as possible prior to beginning services could result in the patient not receiving all the services entitled to. If the patient were forced to seek examination elsewhere or were to leave prior to receiving all the services they were entitled to, such as prophylaxis medications (medications meant to prevent disease), access to an advocate from the local crisis center if available and local resources for follow-up care, the patient could develop life threatening conditions such as sexually transmitted infections, acquired immunodeficiency syndrome (AIDS), or post-traumatic stress disorder leading to suicidal ideation.
Findings included the following:
On 12-1-25 at 10:50 AM, Staff #128 and Staff #129 (patient registration staff) were interviewed in the Emergency Department (ED) at the Patient Registration Desk. Neither Staff #128 nor Staff #129 were aware of any handout to be given to Survivors of Sexual Assault when they presented to the ED for registration. Both stated they would register the patient, leave the reason for the visit blank, have the patient wait in the ED waiting area, and notify the triage nurse.
On 12-1-25 at 10:57 AM, Staff #130 (triage nurse) was interviewed in the triage room of the ED. Staff #130 stated that she was not aware of any paperwork specific to Sexual Assault Survivors that she would provide to the patient.
On 12-1-25 at 11:03 AM, Staff #48 (ED charge nurse) was interviewed in the ED. Staff #48 stated that they would call the police to obtain a police report. When asked what they would do if the patient did not want to involve the police, Staff #48 stated that they would still call the police even if the patient did not want them to. Staff #48 stated that they had to show that they "progressed" the case and reported the crime. Staff #48 stated that he was not aware of any specific handouts for patients who were sexual assault survivors but that the primary nurse would give a packet from DSHS (Department of State Health Services). Staff #48 said that they don't call for a sexual assault patient advocate to come to the hospital, if available, to assist the sexual assault survivor through the process of obtaining treatment and examination. When asked who explains to the sexual assault survivor their rights under Texas law, Staff #48 answered, "Great question." When Staff #48 was asked when during the visit the patient was provided a copy of their rights as required in Texas law, Staff #48 responded, "Great question. I would have to get the answer." When asked if the sexual assault survivor receives a list of local resources, Staff #48 stated that he did not believe they had a ready-made list. Staff #48 stated that patients could not get a Sexual Assault Nurse Examiner (SANE) examination in the ED, and their staff did not perform sexual assault forensic evidence collection in lieu of a SANE examination. The patient would be referred to a local community-based sexual assault program that would provide the SANE examination. When asked what would happen if the patient didn't want to go to the community-based program and wanted to have the examination at the hospital in the ED, Staff # 48 again stated that the patient was not able to have any type of sexual assault examination in the ED, only a medical screening examination per EMTALA (emergency medical treatment and active labor act).
On 12-2-25, Policy Title: Patient Rights and Responsibilities (Texas Markets), Next Review Date: November 2025 was reviewed.
The following was on page 2 under the heading Policy, A.
"A. It is the policy of St. Luke's Health to respect, protect, and promote each patient's rights in accordance with regulatory and accreditation standards. This policy should not be construed as a complete notation of patient rights and responsibilities. There may be additional rights and responsibilities pertaining to identified patient populations that are not contained in this policy."
Further review of the policy showed it did not contain specific information on the rights of the Sexual Assault Survivor population.
The following was listed on page 3 under the heading Procedures: 1. Notice of Rights:
"1. Notice of Rights
The patient or the patient's representative (as allowed under State law) has a right to receive information about his/her rights.
a. St. Luke's Health will inform each patient (inpatient or outpatient) or when appropriate, the patient's representative, of his/her rights at the time of admission and in advance of providing or discontinuing care or treatment whenever possible."
On 12-2-25, Policy Title: Care of the Sexual Assault Survivor, Next Review Date: December 9, 2026, was reviewed as follows:
Page 2, Procedures; Item 1 b): "The patient will be provided a copy of the Texas Department of State Health Services Information Sheet for Sexual Assault Patients."
Page 2, Procedures; Item 1 d): "If a law enforcement agency has not been notified, the nurse will contact the appropriate agency. A law enforcement case number must be obtained and recorded in the triage entry, if the patient is an adult patient choosing to report the exam, prior to the beginning of the sexual assault exam. i) Adult patients are not required to report to law enforcement. If an adult patient wants to report, the exam must be authorized by law enforcement.
Page 2, Procedures; Item 2: "A private area will be provided, if available, to wait or speak with the appropriate medical, legal, or sexual assault crisis staff until the QMP (qualified medical provider) is able to treat the patient.
Page 2, Procedures; Item 3a): "Contact the (local crisis center name redacted) on the 24-hour hotline at (phone number redacted)
Page 2, Procedures: Item 4: "If indicated by the history of sexual contact, the patient will be provided with appropriate prophylaxis medication for exposure to sexually transmitted infections. Any appropriate medical referrals and instructions for follow-up care will be included on the patient's discharge instructions. a) Referrals should be made to the appropriate crisis intervention services even if the need is not apparent at the time.
Page 3, Procedures; Item 5: "At the referring facility (local community-based program), the SANE nurse will complete any further assessments, exams, provision of kit, collection and chain of custody. A) the forensic file will be maintained by (name of community-based program redacted).
Page 4 was the beginning of the English version of the Texas Health and Human Services required information handout that was incorrectly previously identified in this policy on Page 2, Procedures; Item 1 b) as "The patient will be provided a copy of the Texas Department of State Health Services Information Sheet for Sexual Assault Patients." The handout was 8 pages and ended on policy page 11. This version of the handout was dated 3-18-2022 and was outdated without the most current information. The most recent handout was last updated on 12-20-2023.
Page 12 was the beginning of the Spanish version of the Texas Health and Human Services required information handout. This version of the handout was dated 3-18-2022 and was outdated without the most current information. The most recent handout was last updated on 12-20-2023.
Patient records were reviewed on 12-2-25 as follows:
Patient #67
Patient #67 was a 3-year-old child brought in on 6-18-25 by her mother and grandmother for a possible sexual assault. The sexual assault was thought to have occurred at the end of March.
Per the physician's note under History of Present Illness, "Apparently the patient told her mother about a week ago that someone may have put a wooden block into her vagina. The details are very vague regarding this. Patient has seen her pediatrician for recurrent urinary tract infection and was placed on 2 different antibiotics. She apparently is still complaining of pain to the vaginal area and pain when she urinates. She has had no fever or chills."
Per the physician's note under Medical Decision Making, "CPS (child protective services) report was conducted. Patient has great follow-up in caring mother and grandmother. Urinalysis reviewed which showed many budding yeast. No sign of bacterial infection at this time. Suspect candidiasis due to recent antibiotic therapy. Differential diagnoses considered are: UTI (urinary tract infection, candidiasis, sexual assault;"
There was no evidence in the medical record review that the mother or grandmother was provided the State mandated information form. On page 2 of the State mandated information form under Your Rights as a Survivor, the form stated "For parents, or guardians of a minor child, your child has the right to receive the forensic medical examination at any time, regardless of when the assault occurred."
There was no evidence in the medical record review that the mother or grandmother was explained this right or that a referral to the local child advocacy center was made for a forensic interview and examination to rule out a sexual assault as listed in the physician's notes as a considered differential diagnosis (a possible diagnosis that could be causing the symptoms presented by the patient).
There was no evidence in the medical record that a sexual assault advocate had been requested if available to assist the family. Page 1 of the State mandated information form advised patient of their right to have a trained sexual assault advocate in the exam room with them. "If an advocate is available, they will come and have a confidential conversation with you. An advocate can answer any questions about the process and inform you of your options every step of the way."
There was no evidence in the medical record review that the mother or grandmother was provided the name and telephone number of the nearest sexual assault crisis center.
Patient #68
Patient #68 was a 43-year-old who presented to the ED on 11-4-24 via Emergency Medical Services (EMS), stating she was sexually assaulted 2 days prior. Patient reported she was homeless.
There was no evidence in the medical record review that the patient was provided the State mandated information form.
There was no evidence in the medical record that a sexual assault advocate had been requested if available to assist the patient. Page 1 of the State mandated information form advised patient of their right to have a trained sexual assault advocate in the exam room with them. "If an advocate is available, they will come and have a confidential conversation with you. An advocate can answer any questions about the process and inform you of your options every step of the way."
The physician examination notes showed, "Progress comments: Spoke with Detective (name redacted) with ACSO (Angelin County Sherrif's Office) and they are going to arrange for her to Shelter tonight and have SANE exam in am. Spoke with on call nurse with (name of community-based program redacted) and she requested UA (urine analysis) and UDS (urine drug screening)"
There was no evidence in the medical record review that the patient was advised of her right to have an examination in the ED and not have to wait until the next day to have an examination performed by a SANE. On page 2 of the State mandated information form under Your Rights as a Survivor, the form stated, "Texas law requires health care facilities that are not SAFE-ready to give survivors of sexual assault this informational handout and notify of your right to choose to have an exam conducted at this facility or to be transferred to another facility. It is your decision about whether you want to be transferred to another facility."
There was no evidence that the patient's right to receive prophylactic medications for sexually transmitted infections (STIs), human immunodeficiency virus (HIV), or unwanted pregnancy was discussed with the patient, offered, or ruled out for personal or medical reasons.
Patient #69
Patient #69 was a 15-year-old who presented to the ED on 1-2-25. "Patient arrives to ER private vehicle with a friend to report a sexual assault, does not remember the exact day it happened, thinks it might have been Tuesday evening at a house she was staying at. Pt reports the incident happened while she was sleeping, the male living at the house got into her bed, started touching her lower body while the patient told the male to stop."
There was no evidence in the medical record review that the patient was provided the State mandated information form.
There was no evidence in the medical record that a sexual assault advocate had been requested if available to assist the patient. Page 1 of the State mandated information form advised patient of their right to have a trained sexual assault advocate in the exam room with them. "If an advocate is available, they will come and have a confidential conversation with you. An advocate can answer any questions about the process and inform you of your options every step of the way."
The physician examination notes showed, "Progress comments: Patient reports alleged sexual assault 2 days ago. Patient medically cleared there is no evidence of other trauma or any other issue requiring workup in the ER. Patient is medically cleared to go to (name of community-based program redacted) for SANE exam."
There was no evidence in the medical record review that the patient was advised of her right to have an examination in the ED and not have to wait until the next day to have an examination performed by a SANE. On page 2 of the State mandated information form under Your Rights as a Survivor, the form stated, "Texas law requires health care facilities that are not SAFE-ready to give survivors of sexual assault this informational handout and notify of your right to choose to have an exam conducted at this facility or to be transferred to another facility. It is your decision about whether you want to be transferred to another facility."
There was no evidence that the patient's right to receive prophylactic medications for sexually transmitted infections (STIs), human immunodeficiency virus (HIV), or unwanted pregnancy was discussed with the patient, offered, or ruled out for personal or medical reasons.
Patient #70
Patient #70 was a 39-year-old who presented to the ED on 3-22-25 with complaint of "patient states she was sexually assaulted 16 days ago, she has not filed a police report at this time and is here today because (sic) he (sic) husband found out about the assault. She reports lower abdominal pain, pressure and frequency with urination. Information given to her about how to obtain resources through (name of community-based program redacted) and her rights."
There was no evidence in the medical record review that the patient was provided the State mandated information form.
There was no evidence in the medical record that a sexual assault advocate had been requested if available to assist the patient. Page 1 of the State mandated information form advised patient of their right to have a trained sexual assault advocate in the exam room with them. "If an advocate is available, they will come and have a confidential conversation with you. An advocate can answer any questions about the process and inform you of your options every step of the way."
Patient #71
Patient #71 was a 35-year-old who presented to the ED on 5-2-25 with complaint of, "Pt accompanied by friend, reports she was sexually assualted on last Friday, states that her assaulter inserted either himself, and object or both into her rectum, states she has been experiencing rectal bleeding since then, also reports that last wednesday her assualter physically attacked her injuring her left wrist, pt also brings up complaints of generalized rash and states a sore on her left shin is leaking "lymphatic fluid", reports SA occured in Nacogdoches county, Charge RN made aware and reports will contact that county to get a police report and case number." (sic)
"05/02/2025 17:26 Category Note: Patient reports physical assault on 4/23, went to (name of hospital redacted) for wrist/arm pain. Patient reports then a sexual assault on 4/25, did not go to hospital, states that she went to a homeless/domestic violence shelter where she has found a friend who has accompanied her to ER and has recommended having a ultrasound of her rectum. Patient reports sexual assault at (location redacted). I attempted to contact garrison pd, no answer. I then contacted Nacogdoches SO at 1726, spoke with (name redacted) #2461, states he will have garrison PD contact us. I then spoke with officer (name redacted) at 1734, states he will call me back shortly but he believes he is going to come out to speak with patient."
"05/02/2025 17:57 Category Note: Spoke with patient, patient states that she doesnt want to release name of the person who assaulted her. She states that she has a legal advocate that she is going thru and is filing this sexual assault on monday with S/O, S/O states that this is a garrison PD area. I explained that to patient and also officer (name redacted) who states he is in route to eval patient. Patient states that she will not speak to a male officer."
"05/02/2025 18:15 Category Note: Spoke with (name redacted) who is the forensic nursing coordinator at (name of community-based program redacted). She states that she has autism and that this assault is out of the time frame for a exam. That patient is strictly here for rectal pain. Patient does have a legal guardian that is helping her thru the family crisis center and (community-based program name redacted) to help her."
There was no evidence in the medical record review that the patient was provided the State mandated information form.
There was no evidence in the medical record that a sexual assault advocate had been requested if available to assist the patient. Page 1 of the State mandated information form advised patient of their right to have a trained sexual assault advocate in the exam room with them. "If an advocate is available, they will come and have a confidential conversation with you. An advocate can answer any questions about the process and inform you of your options every step of the way."
The record reflected that Law Enforcement was notified but no evidence that the patient was asked if she wanted to involve Law Enforcement prior to contacting them. On page 2 of the State mandated information form under Your Rights as a Survivor, the form stated, "If you are 18 or older, you may choose whether or not to report the assault to law enforcement."
Tag No.: A0122
Based on interview and record review, the facility failed to ensure grievances were resolved timely in 1 of 5 patients reviewed for complaint and grievances (Patient #4).
Patient #4's family voiced a grievance regarding care issues and HIPPA violations on 01/26/2025 and the grievance was not resolved until 06/17/2025 (over 4.5 months later).
This deficient practice had the likelihood to affect all patients who filed a grievance.
Findings include:
Review of the ED (emergency department) record of Patient #4 revealed he was a 37 year old male who presented to the ED (emergency department) on 01/23/2025. Patient #4 came in with complaints of blood from his left nephrostomy tube for 1.5 days. According to the notes Patient #4 said he was told to come to the ED for emergent dialysis.
Documentation in nurses notes dated 01/26/2025 revealed the house supervisor was informed of Patient #4's mom was requesting to speak to him regarding the patient's care and wanting to transfer her son.
Review of the facility's complaint and grievance log revealed Patient#4's mom made a grievance on 01/26/2025. The following was documented:
Patient #4's mom"came up to the nursing station requesting to speak to the on call MD, house supervisor and patient advocate. "Wanting to initiate transfer to outside facility. (Patient #4's mom) was visibly upset and was asked to lower her voice due to other patients on unit other staff present ... ... ....She state that her son is dying in room, suffering and fluid is building up and toxins are accumulating. Explained that is one doctor in house at this time, but ...RN would notify (the doctor) of her wishes to initiate transfer. I would reach out to ...the house sup and I would obtain information about patient advocate. These steps would be taken and asked her to go back to patient's room and we would inform her of information as it became available. Once she was back in room she stated that when she requested those things to (Staff #139) he became "upset" and that's why she came up to the nurses station. She also states that she could hear (Staff #139) giving everyone her son's medical information and when she came outside to tell him that not everyone needed to know her son's medical information (Staff #139) "got in her face and shook his finger at her" (Staff #139) present at bedside an states he was speaking to (the doctor). She also states that (Staff #86) was called yesterday and she was promised he would round and never did." According to documentation on the form the complaint was escalated to a grievance and sent to legal.
Review of another grievance form revealed the grievance was received on 05/23/2025 (almost 4 months later). The mother was upset and alleged medical negligence, nurses failed to render care, manage his pain, failed to insert a Foley catheter and the urologist failed to render care. There was documentation on the form that legal has agreed that we can go ahead with the process of investigating the mother's allegations. According to the form the grievance was resolved, and the first letter was sent to Patient #4 on 05/29/2025 and the final response on 06/17/2025.
During an interview on 12/03/2025 at 10:23 a.m., Staff #136 said the original complaint came in on 01/28/2025 and it was from the mom. Staff #140 told her to escalate to legal. Staff #136 said she tried to call Patient #4 but never got in touch with him. She reopened the complaint as soon as legal let her know something. Staff #136 said she sent the letter to Patient #4 instead of the mom.
During an interview on 12/04/2025 at 9:28 a.m., Staff #140 revealed the complaints was originally made in January 2025. The family was threatening to get a lawyer, and they wanted their legal opinion. Staff #140 said their legal department dropped the ball and did not get back to them for about 3-4 months.
Review of a facility's policy named "Grievance and Complaint Management" dated June 2024 revealed the following:
B. IDENTIFYING A GRIEVANCE
...2. Grievances may be made by patients, visitor or their representatives. If someone other than a patient or visitor complains about a patient or visitor's experience at the organization, attempts shall be made to contact the patient or visitor to confirm that the individual making the complaint is their representative.(Note: References to patients and visitors throughout this Procedure are intended to include their representatives.)
A. If the individual making the complaint is a patient's representative, then the patient's explicit permission is needed to discuss Personal Health Information (PHI) in accordance with applicable privacy laws ...
...D. PROCEDURES APPLICABLE TO ALL GRIEVANCES: ....
...2. The organization must attempt to resolve all grievances as soon as possible ...
...E. COMPLAINTS RELATED TO PATIENT CARE AND SERVICES (Patient Care Grievance(s)"):1.
Grievance Process and Decision
a. The Point of Contact shall provide a response to a Grievance in writing within seven (7) calendar days of the complaint.
i. If the investigation will not be completed, or if the Grievance will not be resolved, within (7) calendar days, the organization shall inform the patient or visitor that the organization needs additional time to resolve the Grievance and indicate the timeframe in which the response will be provided.
b. Reasonable efforts shall be made to resolve all Grievances within thirty(30) calendar days and in accordance with regulatory requirements. If the matter cannot be resolved within thirty (30) calendar days, then a written status report shall be provided to the patient or visitor within that time frame. This status report shall include the estimated timeframe for completing the investigation and issuing a written report.
c. A written report regarding the outcome of the investigation as to each Grievance must be provided to the patient or visitor ..."
Tag No.: A0123
Based on interview and record review, the facility failed to ensure communicate results of a grievance timely to the complainant 1 of 5 sampled patients reviewed for complaint and grievances (Patient #4).
Patient #4's family voiced a grievance regarding care issues and HIPPA violations on 01/26/2025 and the grievance was not resolved until 06/17/2025 (over 4.5 months later).
Patient #4's family member who voiced the grievance was never informed of the results of the investigation.
This deficient practice had the likelihood to affect all patients who filed a grievance.
Findings include:
Review of the ED (emergency department) record of Patient #4 revealed he was a 37 year old male who presented to the ED (emergency department) on 01/23/2025. Patient #4 came in with complaints of blood from his left nephrostomy tube for 1.5 days. According to the notes Patient #4 said he was told to come to the ED for emergent dialysis.
Documentation in nurses notes dated 01/26/2025 revealed the house supervisor was informed of Patient #4's mom was requesting to speak to him regarding the patient's care and wanting to transfer her son.
Review of the facility's complaint and grievance log revealed Patient#4's mom made a grievance on 01/26/2025. The following was documented:
Patient #4's mom"came up to the nursing station requesting to speak to the on call MD, house supervisor and patient advocate. "Wanting to initiate transfer to outside facility. (Patient #4's mom) was visibly upset and was asked to lower her voice due to other patients on unit other staff present ... ... ....She state that her son is dying in room, suffering and fluid is building up and toxins are accumulating. Explained that is one doctor in house at this time, but ...RN would notify (the doctor) of her wishes to initiate transfer. I would reach out to ...the house sup and I would obtain information about patient advocate. These steps would be taken and asked her to go back to patient's room and we would inform her of information as it became available. Once she was back in room she stated that when she requested those things to (Staff #139) he became "upset" and that's why she came up to the nurses station. She also states that she could hear (Staff #139) giving everyone her son's medical information and when she came outside to tell him that not everyone needed to know her son's medical information (Staff #139) "got in her face and shook his finger at her" (Staff #139) present at bedside an states he was speaking to (the doctor). She also states that (Staff #86) was called yesterday and she was promised he would round and never did." According to documentation on the form the complaint was escalated to a grievance and sent to legal.
Review of another grievance form revealed the grievance was received on 05/23/2025 (almost 4 months later). The mother was upset and alleged medical negligence, nurses failed to render care, manage his pain, failed to insert a Foley catheter and the urologist failed to render care. There was documentation on the form that legal has agreed that we can go ahead with the process of investigating the mother's allegations. According to the form the grievance was resolved, and the first letter was sent to Patient #4 on 05/29/2025 and the final response on 06/17/2025.
During an interview on 12/03/2025 at 10:23 a.m., Staff #136 said the original complaint came in on 01/28/2025 and it was from the mom. Staff #140 told her to escalate to legal. Staff #136 said she tried to call Patient #4 but never got in touch with him. She reopened the complaint as soon as legal let her know something. Staff #136 said she sent the letter to Patient #4 instead of the mom.
During an interview on 12/04/2025 at 9:28 a.m., Staff #140 revealed the complaints was originally made in January 2025. The family was threatening to get a lawyer, and they wanted their legal opinion. Staff #140 said their legal department dropped the ball and did not get back to them for about 3-4 months.
Review of a facility's policy named "Grievance and Complaint Management" dated June 2024 revealed the following:
B.IDENTIFYING A GRIEVANCE
...2. Grievances may be made by patients, visitor or their representatives. If someone other than a patient or visitor complains about a patient or visitor's experience at the organization, attempts shall be made to contact the patient or visitor to confirm that the individual making the complaint is their representative.(Note: References to patients and visitors throughout this Procedure are intended to include their representatives.)
A. If the individual making the complaint is a patient's representative, then the patient's explicit permission is needed to discuss Personal Health Information (PHI) in accordance with applicable privacy laws ...
...D. PROCEDURES APPLICABLE TO ALL GRIEVANCES: ....
...2. The organization must attempt to resolve all grievances as soon as possible ...
...E. COMPLAINTS RELATED TO PATIENT CARE AND SERVICES (Patient Care Grievance(s)"):1.
Grievance Process and Decision
a. The Point of Contact shall provide a response to a Grievance in writing within seven (7) calendar days of the complaint.
i.If the investigation will not be completed, or if the Grievance will not be resolved, within (7) calendar days, the organization shall inform the patient or visitor that the organization needs additional time to resolve the Grievance and indicate the timeframe in which the response will be provided.
b.Reasonable efforts shall be made to resolve all Grievances within thirty(30) calendar days and in accordance with regulatory requirements. If the matter cannot be resolved within thirty (30) calendar days, then a written status report shall be provided to the patient or visitor within that time frame. This status report shall include the estimated timeframe for completing the investigation and issuing a written report.
c.A written report regarding the outcome of the investigation as to each Grievance must be provided to the patient or visitor ..."
Tag No.: A0131
Based on record review and staff interviews, the hospital staff failed to ensure proper execution of informed consent in 7 (#7, #11, #21, #22, #23, #30, #31) of 7 patient medical records reviewed. Additionally, the hospital staff did not follow the "Disclosure and Consent for Medical and Surgical Procedures" policy.
The hospital staff failed to ensure:
A. proper execution of informed consent for Hemodialysis for Patient #7.
B. patient # 11 was deemed competent to provide consent for blood transfusions prior to the initiation of blood products.
C. the hospital's 'Refusal to Permit Examination, Treatment, Transport, or Transfer Form" listed the treatments refused, the risks for refusing treatment for Patient #21 and Patient #23.That all portions of the hospital's 'Refusal to Permit Examination, Treatment, Transport, or Transfer Form" was signed, dated, and timed for Patient #21, #22, and #23.
D. consent to admission and notification of patient rights were obtained upon admission on Patient #31.
Findings include:
A.
A review of medical records was conducted with Staff #29 on 12/01/2025 at 3:30 PM.
Patient # 7
A 57-year-old with CKD, diabetes, hypertension, CHF, and CAD presented to the outside ER with complaints of volume overload and fluid retention for the last several weeks. Patient states that she has been compliant with medications, but has progressively gotten more swollen. The Patient denies any worsening dyspnea. Patient states that she is on a 2 L nasal cannula at night. Denies any chest pain, fever chills currently. Patient #7 was receiving hemodialysis on 12/01/2025 with complaints of weakness.
A review of the consent for Hemodialysis on 12/01/2025 indicated that the patient's signature was not signed with the patient's actual signature. The surveyor confirmed that the signature differed from her usual signature by reviewing other hospital consents that the patient had signed. Additionally, the informed consent had the wrong date (1/14/2025) signed by staff # 34. There was no indication of who signed the patient's name to the consent, and if it was a verbal consent, there were no witnesses. If the signature was signed by a family member, there was no indication of which family it was.
An interview was conducted with Staff #30 (ICU Director) on 12/01/2025 at 4:00 PM and confirmed that hospital Staff #34 did not follow the procedure for obtaining informed consent for Hemodialysis for Patient #7. There were no witnesses to the signature on the consent or to who had signed the consent.
An interview was conducted with Staff #29 on 12/01/2025 at 4:30 PM and confirmed that the hospital staff were not obtaining proper consent before performing treatment and care on patients at the hospital. Staff #29 confirmed that the hospital staff were not following the hospital's Informed Consent policy in obtaining two signatures if a patient could not sign.
48653
B.
A review of Patient # 11's medical record was conducted with Staff # 20 on 12/01/2025.
Patient # 11 was admitted to the hospital on 11/26/2025 with a diagnosis of AMS (Altered Mental Status).
A review of Staff # 124's (ER Physician) provider note dated 11/26/2025 revealed,
"A 86 year old male with a history of diabetes mellitus and deep vein thrombosis presents to the ED via EMS with complaints of altered mental status. EMS reports that the patient's neighbor found him confused this morning. The patient reports that he has been having diarrhea for the last 2 days ....Physical Examination: Neuro: Appears confused ...."
A review of nursing assessment completed on 11/26/2025 at 2:30 PM revealed,
"Neurological: Weakness, and confused ..."
The patient had severe anemia (low blood levels) and required a blood transfusion.
A review of the "Disclosure and Consent for Medical Care and Surgical Procedures, Blood Transfusion" revealed that the patient signed the consent form on 11/26/2025 at 5:53 PM after ER Physician Staff # 124 and nursing staff documented that the patient was confused.
The ER Physician Staff # 124 obtained consent from a patient with a known altered mental status and confusion.
An interview was conducted with Staff # 20 on 12/01/2025 at 2:00 PM, which confirmed the patient was documented as being confused and having an altered mental status, which would render the patient incompetent to provide consent.
48749
C.
Patient #21
Patient #21, a 56-year-old male, arrived at the Hospital's Emergency Department (ED) on 11/13/2025 at 6:20 PM for complaints of numbness and weakness. The ED Triage nurse activated a Code Stroke at 6:20 PM. The ED Physician evaluated patient #21 at 6:24 PM. The ED Physician documented admission for an MRI and further workup. Patient #21 refused admission and requested discharge. Patient #21 signed the hospital's "Refusal to Permit Examination, Treatment, Transport, or Transfer Form. Further review of the hospital's 'Refusal to Permit Examination, Treatment, Transport, or Transfer Form" revealed that the section for the declination of services provided and the risks of refusing services was blank. Also, the ED staff did not date and time the form.
Patient #22
Patient #22, a 13-year-old female, arrived at the Hospital's Emergency Department (ED) on 11/19/2025 at 7:46 PM for complaints of headache, chest pain, dizziness, and middle back pain. At 23:02, the ED nurse documented that the patient's mother did not want an intravenous line or medication. The patient's mother signed the hospital's against medical advice form. A review of the hospital's 'Refusal to Permit Examination, Treatment, Transport, or Transfer Form" revealed that it was not dated, timed, or signed by the ED Physician.
Patient #23
Patient #23, a 56-year-old male, arrived at the Hospital's Emergency Department (ED) on 11/05/2025 at 1:20 PM with a complaint of a hole in the bottom of the right foot. The patient was evaluated by the ED Physician at 2:40 PM and was diagnosed with sepsis and diabetic foot wound. The ED Physician recommended admission and transfer to a higher level of care. The patient refused transfer and admission. A review of the hospital's 'Refusal to Permit Examination, Treatment, Transport, or Transfer Form" revealed that the risks for refusing treatment were not listed, and there was no witness signature.
An interview conducted on 12/02/2025 at 10:20 AM with Staff #22 confirmed that the hospital's 'Refusal to Permit Examination, Treatment, Transport, or Transfer Forms" were not completed in their entirety.
51905
D.
A review of Patient #31's medical record was conducted with Staff #58 on 12/03/2025.
Patient #31 was admitted to the hospital on 11/27/2025 at 8:24 P.M. with a diagnosis of sepsis.
A review of Staff #151's (ER Physician) provider notes on 11/27/2025 at 11:28 P.M. revealed,
Patient #31 presented to the ER (emergency room) via ambulance from a nursing home, with a critical blood glucose level of 30. Patient #31's Glasgow Coma Scale (a scale used to determine a patient's level of consciousness) was 15, indicating that the patient was conscious and alert, and oriented times three, knowing person, place, and time.
A review of the "General Consent on Admission" and "Patient Rights" revealed that Patient #31 was "medically unable to sign". There was no hospital representative signature or witness signature to verify that Patient #31 was unable to sign.
Patient #31 was admitted to the hospital without consent to admission or notification of patient rights.
An interview was conducted with Staff #58 on 12/03/2025 at 1:45 P.M., which confirmed Patient #31 was documented as being alert and oriented and competent to provide consent.
A review of the hospital's policy titled "Disclosure and Consent for Medical and Surgical Procedures" with a date of September 2024 revealed the following:
"Policy:
DEFINITIONS
Analgesia -Medication to provide relief of pain through the blocking of pain receptors in the peripheral and/or central nervous system.
Anesthesia -Medication to produce a blunting or loss of:
* pain perception (Analgesia);
* voluntary and involuntary movements;
* autonomic function; and/or
* memory and/or consciousness, depending on where along the central neuraxial (brain and spinal cord) the medication is delivered.
Decision-Making Capacity -The ability to understand and appreciate the nature and consequences of a decision regarding medical treatment and the ability to reach and communicate an informed decision in the matter.
Disclosure -In the context of informed consent, means communicating the risk, benefits and alternatives to medical treatment. The act of making something known.
Informed Consent - The permission given by a patient to perform a medical treatment or surgical procedure after the patient has been advised of and fully understands the risks, benefits and alternatives or hazards that could influence a reasonable person in deciding whether or not to consent. In order for the patient to make an informed decision about whether to consent, the patient needs information from the Responsible Practitioner about the treatment or procedure, including the associated risks, benefits and alternatives. Informed Consent deals with the information provided by the Responsible Practitioner to the patient, in a language or means of communication he/she understands, and how it is provided when obtaining the patient's permission to perform the treatment or procedure.
List A Procedures - Medical treatments and surgical procedures that the Texas Medical Disclosure Panel has determined require a full Disclosure of specific risks and hazards when obtaining Informed Consent.
List B Procedures - Medical treatments and surgical procedures that the Texas Medical Disclosure Panel has determined do not require any Disclosure of specific risks or hazards associated with the treatment or procedure.
Minor - A person under 18 years of age who is not and has not been married or who has not had the disabilities of minority removed for general purposes.
Responsible Practitioner - The attending practitioner or the practitioner performing the treatment or procedure.
Surrogate Decision Maker - An adult (18 years of age or older) who may consent to medical treatment or surgical procedures on behalf of a patient lacking capacity, provided such Surrogate Decision Maker:
1. Has Decision-Making Capacity;
2. Is available after a reasonably diligent inquiry; and
3. Is willing to consent to medical treatment or surgical procedures on behalf of the patient. In the case of a Minor, the Surrogate Decision Maker is a parent, managing or possessory conservator or guardian. Texas Medical Disclosure Panel (TMDP) - A panel appointed by the Texas Commissioner of Health to determine which risks and hazards related to medical care and surgical procedures must be disclosed by health care providers or physicians to their patients or persons authorized to consent for their patients, and to establish the general form and substance of such Disclosure.
A. It is the policy of St. Luke's Health (St. Luke's) Texas Division to comply with applicable regulatory and accreditation requirements pertaining to Disclosure and Informed Consent for medical treatment or care and surgical procedures, including specific procedures outlined by:
* Code of Federal Regulation ( 42 CFR Part 482), CMS Conditions of Participation, Appendix A
* DNV NIAHO Interpretive Guidelines and Surveyor Guidance
* Texas Administrative Code (TAC) Hospital Licensing Rules, Title 25 Part 1 Chapter 133
* Texas Medical Disclosure Panel (TMDP), Chapter 601, Informed Consent, Title 25 Part 7 Chapter 601
B. It is the policy of St. Luke's Health (St. Luke's) Texas Division entities that physicians, employees and individuals associated with a St. Luke's organization are required to abide by the Ethical and Religious Directives for Catholic Health Care Services ("Directives").
a. Per Directive #26: The free and informed consent of the person or the person's surrogate is required for medical treatments and procedures, except in an emergency situation when consent cannot be obtained and there is no indication that the patient would refuse consent to the treatment.
Per Directive #27: Free and informed consent requires that the person or the person's surrogate receive all reasonable information about the essential nature of the proposed treatment and its benefits; its risks, side effects, consequences, and cost; and any reasonable and morally legitimate alternatives, including no treatment at all.
C. The patient or his/her Surrogate Decision Maker, as allowed under Texas law, has the right to make informed decisions regarding his/her care, including consent to or refusal of medical treatments and surgical procedures, including transfusion of blood and blood components. Exceptions to individuals authorized to consent for a patient are addressed in Procedure.
D. The attending practitioner, the practitioner providing the medical treatment or performing the surgical procedure, including transfusion of blood and blood components, the practitioner's associate, or a practitioner under the Responsible Practitioner's supervision is responsible for discussing the process of and obtaining Informed Consent from the patient or his/her Surrogate Decision Maker.
PROCEDURES:
1. Requirements for Disclosure and Consent
Informed Consent is one type of informed decision that a patient or his/her Surrogate Decision Maker may need to make with respect to a medical treatment or surgical procedure related to his/her plan of care.
a. In order for the patient or his/her Surrogate Decision Maker to make an informed decision, it is necessary to provide adequate information in a manner that he/she can understand about:
the planned medical treatment or surgical procedure in a manner that he/she can understand and the potential for examinations or invasive procedures by students, residents, advanced practice providers (such as nurse practitioners and physician assistants), and fellows for educational and training purposes, including but not limited to, breast, pelvic, prostate, and rectal examinations, as well as others specified under state law which are not a medically necessary part of the planned procedure while anesthetized or unconscious.
2. Discussion for Informed Consent
a. Medical Treatments or Surgical Procedures
The attending practitioner, the practitioner performing the treatment or procedure, the practitioner's associate, or a practitioner under the Responsible Practitioner's supervision conducts the Informed Consent discussion with the patient or his/her Surrogate Decision Maker.
b. Anesthesia and/or Analgesia
An Anesthesia provider and/or the Operating practitioner administering the Anesthesia and/or Analgesia conducts the Informed Consent discussion with the patient or his/her Surrogate Decision Maker. Non-physician health care providers, such as a Certified Registered Nurse Anesthetist (CRNA) or an Anesthesiologist Assistant (AA), are also qualified to conduct the Informed Consent process for Anesthesia and/or Analgesia if they are credentialed and privileged to administer Anesthesia.
c. The Informed Consent responsibility may not be delegated to members of the nursing staff or other members of the hospital's workforce.
d. Verify that the consent form is completed and patient or his/her Surrogate Decision Maker signed the Informed Consent form prior to commencing the medical treatment or surgical procedure.
e. Sign, with date and time, the statement on the consent form that the medical treatment or surgical procedure including the risks, benefits and alternative were explained to the patient or his/her Surrogate Decision Maker prior to commencing the medical treatment or surgical procedure.
a. Include the following components in the discussion with the patient or his/her Surrogate Decision Maker:
1. A description of the proposed medical treatment or surgical procedure including the Anesthesia to be used.
11. Indications for the proposed medical treatment or surgical procedure, including:
1. Disclosure of the risks, benefits, and alternatives of the medical treatment or surgical procedure.
2. List A Procedures, the Disclosure of risks must comply with the requirements of the TMDP and The Texas Medicaid Program (sterilization).
3. List B Procedures or other procedures not on List A or List B, Disclosure of specific risks is at the discretion of the attending practitioner or practitioner performing the medical treatment or surgical procedure.
iii. Material risks and benefits for the patient related to the surgery and Anesthesia, if applicable, including the likelihood of each.
b. Telephone Consent
Oral consent over the telephone may be obtained when the patient lacks capacity to give Informed Consent, and the patient's Surrogate Decision Maker is not physically present at the healthcare facility where the treatment or procedure will be performed and cannot reasonably be expected to attend such facility prior to the start of the treatment or procedure.
i. The Responsible Practitioner obtains verbal consent in accordance with the procedures described for obtaining written consent.
ii. The Responsible Practitioner [see Procedure Section 2. above] is required to obtain oral consent by talking with the patient's Surrogate Decision Maker in the presence of a witness who is listening to both parties as Informed Consent is obtained.
iii. Record the name of the Surrogate Decision Maker giving Informed Consent and that individual's relationship to the patient on the consent form.
iv. Record the name of the Responsible Practitioner obtaining consent and the witness on the consent form with a notation that Informed Consent was obtained by telephone.
6. Informed Consent - Adult Patient
a. Decision-Making Capacity
Adult patients (18 years or older) must sign authorizations for treatment on their own behalf unless they lack Decision-Making Capacity to give Informed Consent.
b. Lack of Decision-Making Capacity
A patient lacks Decision-Making Capacity if he/she is less than 18 years old or when his/her mental status is altered and he/she cannot comprehend information regarding the proposed treatment or procedure as a result of his/her underlying medical condition (as determined by the Responsible Practitioner).
1. If the patient lacks Decision-Making Capacity, the Responsible Practitioner, or the Responsible Practitioner's designee, will make an entry into the Progress Notes documenting the following:
1. Patient's mental status;
2. Physical condition;
3. Patient's inability to make informed decisions; and
4. The proposed medical treatment or procedure.
ii. The Responsible Practitioner, or the Responsible Practitioner's designee, shall make a reasonably diligent effort to contact or cause to be contacted the persons eligible to serve as surrogate decision-makers. Efforts to contact those persons shall be recorded in detail in the patient's medical record.
iii. Obtain Informed Consent from the patient's Surrogate Decision Maker if the patient lacks Decision-Making Capacity (in the following order of priority):
1. A court-appointed guardian with guardianship over the person;
2. The patient's agent under a Medical Power of Attorney, or proxy under a Directive to Physicians and Family or Surrogates; refer to St. Luke's policy and procedure regarding advance directives; or
3. The following individuals, in order of priority:
a. Patient's spouse;
b. Patient's reasonably available adult children;
c. Patient's parents;
d. Patient's nearest living relative; or
e. The attending physician, with the concurrence of a second physician not involved in the treatment of the patient..."
Tag No.: A0392
Based on observation, interview and record review, the facility failed to ensure adequate staffing on 2 of 2 units reviewed for staffing (Progressive care unit/PCU, Intensive Care unit/ICU): The facility failed to:
A.Ensure adequate numbers of licensed nurses and patient care techs on PCU.
B. Ensure patient acuity was utilized and appropriately used to staff on ICU and PCU.
This deficient practice had the likelihood to cause harm on all patients housed on both units.
Findings include:
Observations
Progressive Care Unit on 12/3/2025 at 11:47 A.M.:
The floor nurse currently has 3 patients, and 1 is an ICU patient.
The charge nurse was assigned 2 patients.
During the survey, multiple phone calls rang while on the unit. No nurse was available to answer them. Staff #58, from Quality, who was assisting the surveyors, was answering the calls. This was observed from 11:47 A.M. to 1:12 P.M.
During confidential interviews the following was stated about staffing:
The ICU patient had been on the PCU floor since "12/02/2025 at 12:04 P.M.The ICU patient currently on the PCU floor was stable and on a Lasix drip."
"The nurse-to-patient ratio is still 1 to 4 with ICU patients, though 1 to 3 is ideal. Technicians are 1 to 15. It was stated that" the unit has had 2 to 3 sheaths on the unit before, with only 2 to 3 nurses available. When discontinuing a sheath, the patient has to be monitored every 15 minutes and pressure has to be held on the site for an hour. This ties up a nurse and isn't safe for patient care. Nurses are responsible for their own EKGs, lab work, vital signs, and transport. Nurses have difficulty obtaining timely lab work due to the workload and no techs until the census reaches 12-18. There is typically not a unit secretary available."
"The charge nurse is assigned to patients and is typically unable to assist other nurses. Though we currently have 2 patients, 1 patient became agitated and was running out of the room into other patient rooms. A "code gray" was called for physical assistance. The patient was subsequently medicated and ordered a sitter."
"Nurses are responsible for their own patient transport. If only 2 nurses are on the unit, the nurse cannot go, and the plan is for the house supervisor to take the patient."
"Day shift staffing is an issue. Nurses are assigned to 4 patients each. Sometimes there are 2 to 3 sheaths on the floor with only 2 to 3 nurses, and it takes 2 nurses to discontinue the sheath."
"Staffing on the ICU floor is 1 nurse to 2 patients. However, it isn't unusual to have 1 nurse to 3 patients. I had 3 patients as recently as the week before."
10135
During confidential interviews the following was stated about staffing:
"We have new levels of care. We have observation and cath lab patients. We have the same acuity tool as before. There has been conversation about using the tool in ICU instead of here. It doesn't really fit us now. The patient census is 1:4. We get a tech when there are 12 patients and a unit secretary at 18. The unit secretaries and tech are trained to draw blood, but that does not help when we are under those numbers."
"Patient census is down. Only thing we have trouble with is not having a tech. If we have 6 patients, the nurse takes 4 and the charge nurse takes 2. We could run into issues if the nurses are in patients room. There is no one to answer the phone or call lights. We could use a tech to answer call lights and phones promptly and assist with total patient care and turning."
"Have to have up to 12 patients to get an aide. On the day shift we have baths, foley cath care, turning and repositioning and incontinent care."
"Problem with staffing is the acuity of patients. When the patients are admitted they are classified as observation, but the doctor changes them to inpatient which increases the care they need."
"Sometimes the PCU patients come to ICU and the nurses have to take 3 patients"
"The patient census has increased (on ICU) we do not use an acuity tool to determine staffing."
Review of assignment sheets, staffing sheets and the staffing matrix on 12/03/2025 after 3:11 p.m. for the timeframe of 11/19/2025 to 12/01/2025 the following was revealed:
Every shift during this timeframe the charge nurse took patients except for 11/21st night shift.
On 11/22,24,25 (night shift only),26,27,28,29,30/2025 there were two nurses on duty and both nurses had patients.
On 11/25/2025 the census increased to 11 patients during the day shift. The staffing matrix called for 4 nurses and there was only 3 nurses.
On 11/30/2025 the census increased to 9 patients during the day shift. The staffing matrix called for 3 nurses and there was only 2 nurses.
There was no patent care techs mentioned except for when there was a patient needing a sitter.
Staff #63 and 137 confirmed the numbers.
During an interview on 12/03/2025 after 3:11 p..m. Staff #63 stated they took care of patients who had heart catherization during the pre and post operative timeframe. When reviewing the staffing sheets Staff #63 said she could not tell the surveyor which patients were catherization patients from looking at her assignment sheets. The information was not being kept up with.
Protocols were provided for care on catherization patients and the following was revealed:
"TR Band Patent Hemostasis Protocol"
TR Band (Radial compression device)
"Monitor access site and extremity distal to puncture wound every 15 minutes until TR Band is removed ...
...Limit movement in the affected arm for 6 hours post procedure ...
..Bed rest until 2 hours after device placement ....
...90 minutes after TR Band is applied, deflate 2 cc of air from the curr. If no bleeding occurs from the site, deflate 2 cc of air from the TR Band every 10 minutes until all air has been removed ..."
"Skills: Femoral Arterial and Venous Sheath Removal.."
"Maintain manual pressure for 15 to 30 minutes ..."
Review of the facility's policy named "Nurse Staffing Plan-Nursing Services (TX Markets)" dated March 2025 revealed the following:
"...The Nurse Staffing Plan Characteristics:..
...h. Is consistent with current standards established by the Texas Board of Nursing for RNs and LVNs, applicable private accreditation organizations, governmental entities, national nursing professional associations, and other health professional organizations, as appropriate; ...
...l. Sets minimum staffing levels for patient care units as determined by the nursing assessment and in accordance with evidenced-based safe nursing standards as based upon multiple nurse and patient considerations;
m. Includes a method for adjusting the nurse staffing grid for each patient care unit to provide staffing flexibility to meet patient needs; ...
...Nurse staffing are to be used by the hospital as a component in setting the nurse staffing budget and as a guide in assigning nurses hospital- wide ..."
Tag No.: A0395
Based on interview and record review, the facility failed to ensure nurses evaluated care on 2 of 3 sampled patients who were reviewed for Foley catheter care (Patient #'s 30 and 39). The facility failed to ensure:
A. Nurses obtained physician orders for continued use of Foley catheters and for placement of purewick catheters on Patient #39.
B. Nurses obtained physician orders for continued use of a Foley catheter on Patient #30.
This deficient practice had the likelihood to cause harm patients with Foley catheters.
Findings include:
Patient #39
Review of the clinical record of Patient #39 revealed he was a 92-year-old male who transferred from a sister facility on 11/17/2025. According to an admission assessment report Patient #39 arrived on the unit at 2:10 a.m. and had a diagnosis of a urinary tract infection. Staff documented that Patient #39 was a direct admit and had a Foley catheter that was inserted on 11/16/2025.
At 4:30 a.m. there was documentation in nurses notes of Patient #39 being confused and trying to pull his Foley catheter out.
At 10:50 p.m., there was documentation that Patient #39 had an indwelling catheter.
On 11/18/2025 at 11:30 a.m. the Foley catheter was clamped for bladder training.
On 11/19/2025 at 7:00 p.m., 11/20/2025 at 10:46 a.m. and 11/22/2025 at 12:29 p.m. there was documentation that
Patient #39 had a pure wick Foley (external catheter).
There was no documentation of nursing, changing out the Foley catheter that Patient #39 came into the facility with.
Review of the clinical record revealed no physician's order for an indwelling catheter or a purewick catheter.
During an interview after 10:14 a.m., Staff #4 confirmed there was no physician orders for Patient #39 to have the Foley catheters.
51905
Patient #30
Review of the clinical record of Patient #30 revealed she was an 81-year-old female who presented from home via EMS (emergency medical services) on 11/30/2025 at 10:40 A.M. Patient #30 had a diagnosis of altered mental status and seizures. Patient #30 was intubated and sedated in the ER. At 2:21 P.M., an order was placed to admit Patient #30 to the intensive care unit.
There was no documentation in the ER (emergency room) nurses' notes of Patient #30 having a Foley Catheter inserted. No order for a Foley Catheter was placed at that time.
On 12/01/2025 at 12:54 A.M., a nurse's assessment documented Patient #30's indwelling Foley catheter.
Documentation of Patient #30's Foley catheter continues throughout Patient #30's admission.
Review of the clinical record revealed no physician's order for an indwelling catheter during Patient #30's admission to the intensive care unit.
During an interview on 12/02/2025 at 4:31 P.M., Staff #75 confirmed that there was no Foley catheter order documented in Patient #30's clinical record. Staff #75 indicated that during interdisciplinary rounds on patients, Foley catheters are discussed as to when they need to be removed. Additionally, Staff #75 stated that the Foley catheter order prompts the Foley discontinuation.
Review of a facility's policy named "Indwelling Urinary Catheter and Care Policy" dated 05/11/2023 revealed the following:
"B. Present on Admission (POA)
1. Assess indication and possibility of use of alternatives
2. Indications for replacing a Foley Catheter that is POA include:
a. suspicion of infection
bono-aseptic insertion is reported
schoolyard catheter malfunction
d. broken seal
e. device cannot be properly maintained
3. If Foley is still indicated, get order for continuation through physician order ..."
Tag No.: A0467
Based on record review and staff interviews, the hospital's emergency room staff failed to ensure vital signs were obtained and documented according to each patient's Emergency Severity Index (ESI) level on two patients (#16 and #54) of the two medical records reviewed. Additionally, the hospital staff did not follow the policies, "Assessment/Reassessment and Core Nursing Standards of Practice - Med Surg, Telemetry, Ortho, Acute Rehab."
This inadequate practice could lead to delays in care and treatment because the emergency room staff did not obtain and document the patient's vital signs promptly.
All healthcare staff involved in the patient's treatment and care could not monitor and provide the appropriate medical care because they did not have the most up-to-date information, including the patient's vital signs.
A review of patient medical records was conducted with Staff #24 on 12/03/2025 at 11:00 AM.
Patient # 16
Patient # 16 was admitted to the Emergency Department on 11/18/2025 at 2:45 AM with complaints of Shortness of breath and black toe. The patient was rated as ESI level 3. Patient #16 was admitted with influenza, Pneumonia, Steph, and had a black toe with Staph.
The patient had the last set of vital signs documented in the Emergency Department visit at 6:31 AM. The following vital signs were documented:
"6:31 AM: Heart Rate: 98 H, Respirations: 7" L, Blood Pressure: 142/46, Pulse Oxygen Saturation: 93 % on Room Air."
Patient #16 was admitted as an inpatient at 5:30 AM but remained in the emergency room. According to policy, vital signs are taken every 4 hours. There were no documented 4-hour vital signs taken or with a change in condition, and there was a noted change in the condition.
The patient was discharged from the Emergency Department and transferred to dialysis on 11/18/2025 at 10:27 AM. Patient #16's next set of vital signs was 4 hours later in the dialysis unit: B/P 125/74, Heart rate 95. The patient's blood pressure continued to decrease during treatment with a low BP of 63/40, and then respiratory arrest occurred.
Patient #16 had a respiratory arrest in dialysis at 2:23 PM. Patient expired in the Intensive Care Unit on 11/20/2025 at 6:00 PM.
Patient # 54
Patient # 54 was admitted to the Emergency Department on 11/21/2025 at 11:07 AM with complaints of a burning sensation all over her body. The patient was rated as ESI level 3.
The patient had 1 set of vital signs documented during the entire Emergency Department visit.
The following vital signs were documented:
"11:07 AM: Heart Rate: 65, Respirations: 18, Blood Pressure: 112/50, Pulse Oxygen Saturation: 98 % on Room Air."
The patient was discharged from the Emergency Department to go home on 11/21/2025 at 1:23 PM. There were no other Vital signs taken.
A review of the hospital policy, "Level 3 Urgent: Assignment to be within 10 minutes of bedding and Vital signs, depending on patient stability or the physician's order. After interventions or a change in condition."
A review of the hospital policy "Nursing interventions minimum frequency and documentation" revealed the following:
* Upon admission(within 30 min.)
* Approximately Q8 h.
* telemetry patients: Q4h. while awake, minimum of Q6h.
* within 1 hour prior to discharge."
An interview with Staff # 24 (Quality Department) on 12/3/2025 at 11:00 AM confirmed that the Emergency Department staff were not obtaining and documenting the patient's vital signs according to the hospital's policies and /or a change in condition.
Tag No.: A0491
Based on observation and interview, the facility failed to ensure narcotics were destroyed in accordance to acceptable professional principles and in a safe manner on 1 of 1 medication room on K5 Medical-Surgical unit.
This deficient practice had the likelihood to affect all patients on narcotics.
Findings include:
During an observation on 12/01/2025 after 11:12 a.m. the following was found:
Medication room K5 Medical surgical unit
The Stericycle hazardous waste container was stored inside a metal bin in the medication room. The top of the bin was soiled with a black buildup and remnants of white pills. When the top was opened pieces of medications were still sitting on top of the bin. They were not pushed down into the solution to properly dissolve.
Staff #'s 58 and 59 confirmed the observation.
Review of a facility's policy named "Controlled Substance Management " dated March 2024 revealed the following:
...A controlled substance is not considered wasted until the waste is documented and the controlled substance has been destroyed ...."
Staff #'s 58 and 59 confirmed the observation.
Tag No.: A0750
Based on observation, record review, and staff interviews, the hospital failed to maintain a clean and sanitary environment to avoid sources of infection in 9 (Clinical Laboratory, Kitchen, Emergency Department, Inpatient Rehabilitation Unit, Intensive Care Unit/ICU, Progressive care unit/PCU, K5 Medical/Surgical unit, Labor and Delivery unit, and the outside biohazard storage room) of 9 areas of the hospital when the hospital failed to:
A. ensure the clinical laboratory was free of dust, dirt, rust, and other unknown debris, and that all laboratory supplies were within the manufacturer's expiration date.
B. maintain one commercial ice machine in the kitchen in a clean and sanitary condition, creating a potential risk for contamination of ice used in patient food service. The hospital failed to follow the "Environmental Infection Prevention" policy.
C. ensure the emergency department was free of dust, debris and other unknown substances, creating a potential risk of contamination.
D. ensure their infection control policy was followed for patients in contact isolation.
E. ensure hazardous and nonhazardous waste stored in medication rooms were free from rust and not soiled with dried spills. The facility failed to ensure supply storage bins in the medication room and emergency supply cart supplies were stored in a manner to prevent contamination. They failed to ensure expired medications were discarded (K5 medical surgical unit).
The facility failed to ensure the emergency supply cart supplies were bagged to prevent contamination (PCU unit).
The facility failed to ensure sterile supplies, medication and medication labels were stored in a manner to prevent contamination. Expired storage supplies were discarded, expired anesthesia filters were changed in Operating room 1 and 2 on the labor and delivery unit.
A.
Findings include:
During a tour of the hospital's clinical laboratory with Staff # 8 on 12/01/2025 at 10:41 AM, the surveyor observed the following infection control issues:
*Expired Iris System Cleanser (425 milliliters) with an expiration date of 10-31-2025. The bottle was labeled as open on 10-28-25.
*Expired Reagent A Buffer Solution Lot 238288 with an expiration date of 10/01/2025. The bottle was labeled as open on 09/23/2025.
*Expired 2440-058MC:BHB Method Comparison Set Lot # 213645 with an expiration date of 07/31/2024.
*There were two large wooden islands in the center of the clinical laboratory. The islands had areas where the wood was chipped, leaving pieces of raw wood exposed. The raw wood could not be adequately cleaned and disinfected. The hinges on the cabinet doors and drawers were covered in rust. There were areas where the rust was flaking off onto the floor.
*There were old newspapers, dust, dirt, and other unknown debris located in the cabinets under the sink. The cabinet and associated piping had areas of corrosion and water damage inside the cabinets.
*The freezer labeled "Chemistry Control Freezer # 8" had a thick buildup of ice on the walls and shelves of the freezer. The freezer could not be adequately cleaned and disinfected due to the large amount of ice buildup.
*The freezer labeled "Calibrator Freezer #11" had a thick buildup of ice on the walls and shelves of the freezer. The freezer could not be adequately cleaned and disinfected due to the large amount of ice buildup.
An interview was conducted with Staff # 8 on 12/01/2025 at 11:30 AM in the Clinical Laboratory. Staff # 8 confirmed the infection control issues in the Clinical Laboratory and stated, "We will get work orders placed".
43853
B.
Findings include:
On December 1, 2025, at 11:11 a.m., during a kitchen tour, the commercial ice machine adjacent to the Chemical Storage Room was inspected in the presence of Staff #16 and #17. The interior upper edge of the ice machine and bin was examined from below, revealing visible brown and black build-up along the seam where the upper panel meets the side panels. The substance appeared as dark, irregular patches and streaks concentrated in the caulked areas, indicating accumulated residue that resembled mold or biofilm.
On December 1, 2025, at 1:25 p.m., during an interview in the Nutrition Director's office, Staff #17 indicated that Facilities Management was responsible for the cleaning and maintenance of the ice machine. Staff # 17 also stated that the infection control preventionist made frequent observation rounding of the kitchen and dietary areas; issues identfied were then corrected by staff.
On December 1, 2025, at 1:40 p.m., an interview with Staff #13 in the conference room revealed that hospital staff were responsible for routine cleaning of the exterior of the ice machine, while the vendor conducts annual preventive maintenance (PM). A review of the facility's Annual Ice Machine Preventive Maintenance binder showed that the last documented vendor maintenance occurred on June 6, 2025. Staff #13 confirmed that during the vendor PM, the ice machine and bin would be emptied, cleaned, and sanitized, and presented an invoice documenting that the machine had been descaled, sanitized, and that filters were replaced on June 6, 2025. The Ice Machine Preventive Maintenance- Semi Annual log reflected maintenance occurring on June 6, 2025. Staff #13 was asked if there was a policy regarding the cleaning of the ice machine and bin located in the kitchen, no policy was presented. Staff #20 provided a copy of the Environmental Infection Prevention policy, effective August 30, 2022. The policy stated:
"6) Ice machines: Should be maintained to help to prevent water-borne illnesses. EVS (Environmental Services) should wipe down the machine cabinet and clean the tray routinely. Facilities Management is responsible for management of the cleaning of filters and components as well as Preventive Maintenance including monitoring for rust."
The policy section on ice machines appeared to address maintenance of the ice and water dispensers (hydration stations) located in the nourishment rooms found on patient units. However, it did not appear to include the commercial ice machine and bin located in the kitchen.
On December 2, 2025, Staff #13 provided a copy of the Hoshizaki Instruction Manual for the Modular Flaker (ice machine) and noted the following under A. Maintenance Schedule:
Frequency "Monthly", Area "Underside of Icemaker and Top Kits; Bin Door and Snout", Task "Wipe down with a clean cloth and warm water".
Frequency of "Every 6 Months", Area included "Icemaker and Dispenser Unit/Ice Storage Bin", Task "Clean and sanitize per the cleaning and sanitizing instructions provided in this manual."
On December 1, 2025, at 11:15 a.m. Staff #16 and #17 confirmed the findings related to the commercial ice machine adjacent to the Chemical Storage Room.
32143
Findings;
A tour was conducted of the Inpatient Rehabilitation unit on 12-2-2025 at 9:13 AM with staff #78 marketing director of rehab services, and staff #24 RN.
Patient room 176 was confirmed as a terminally cleaned room and was waiting for a patient.
The bedside table base was covered in food crumbs, spilled dried fluids, dust, and hair.
The seat cushions were removed from the two chairs. Under the seat cushions were food crumbs, dust, and hair.
On the base of the bed, there was a dried, spilled liquid, off white in color. The mattress was removed, and the metal bed was rusted in multiple places underneath. There was rust, dirt, hair, and unidentifiable debris in the head and foot of the bed.
The bathtub was heavily stained with minerals, and there was no cover for the overflow drain. The waterspout was heavily covered in mineral deposits, preventing the tub and faucets from being cleaned properly. Staff # 78 stated the patient did not use this bathtub and was taken across the hall to a shared shower room. The bathroom was larger and had a walk-in shower and a bathtub. A sign in the room stated the shower was clean. The tub was heavily stained with minerals, causing a black ring in the tub. The non-slip decals that were on the bottom of the tub were missing pieces and worn, allowing bacteria to grow.
ICU Equipment Room 3079
A tour was conducted with staff #24 RN, staff #38 Nurse Manager, 4th floor on 12-02-2025 at 3:40 PM. The storage room had clean and sterile supplies in the room, on shelves against the wall. The nurse manager confirmed these were clean and sterile patient supplies in the room. In the middle of the room were multiple pieces of equipment, 12 ventilators, and 2 wound care carts. The equipment had clear plastic bags over it. The nurse manager was asked why the equipment that went back and forth to patient rooms was in the clean supply room. Staff #38 stated the vents were wiped down thoroughly before being covered and placed in the supply room. The surveyor pulled one of the vents out of the pile and uncovered the vent, exposing the soiled equipment. The vent was soiled on the bottom with a brown, dried liquid and dust. Staff #38 wiped off the dried liquid with a Sani wipe. Staff #38 confirmed the vent was not thoroughly cleaned. The clean and sterile supplies were exposed to soiled equipment and could cross-contaminate the supplies.
ICU Equipment Storage 3056
A tour was conducted with staff #24 RN, staff #30 nurse manager, and staff #20 ortho coordinator on 12-02-2025 at 3:43 PM. The storage room had clean and sterile supplies in the room, on shelves against the wall. The nurse manager confirmed these were clean and sterile patient supplies in the room. In the middle of the room were multiple pieces of equipment, such as a portable EKG, and 4 large rolling carts with wheels against the clean and sterile patient supplies. The equipment was covered with a clear plastic bag to show that the equipment was clean. The bases of the carts were soiled with dried liquids, dirt, and hair. Staff #30 confirmed the carts were not cleaned appropriately. The clean and sterile supplies were exposed to soiled equipment and could cross-contaminate the supplies.
48749
C.
Observation rounds were conducted on 12/01/2025 after 10:00 AM of the Emergency Department(ED) and the Outside Biohazard Storage. The following was observed.
Emergency Department(ED)
*There was an accumulation of dirt and debris on the floor of the helipad foyer.
*There was trash overflowing from the trash can onto the floor of the helipad foyer.
*There was an accumulation of dead insects inside the light covers of the elevator that accesses the helipad. Foyer.
*There was an accumulation of dust and dirt on the floor of Trauma Room #3.
*An uncovered ultrasound machine was sitting in the main hallway by the nurse's station. There was an accumulation of dust on the base and shelf. There was an unknown dried, clear substance on the wands and in the wand holders. The Surveyor was unable to determine if the ultrasound machine was clean and ready for patient use.
*There was an accumulation of dust and white particles in the plastic bins storing sterile supplies in the ED medication room.
*There was an accumulation of dust and debris on the bottom of the Pyxis and inside the plastic bins in the Pyxis of the ED Medication room.
*There was an unknown yellow substance stuck on the top shelf of the freezer, and there was an accumulation of food debris on the bottom of the freezer used to store patient nutrition.
Outside Biohazard Storage
*There were holes in the walls, broken drywall, and exposed insulation in the biohazard storage room.
An interview was conducted with Staff #22 on 12/01/2025 at 3:20 PM. Staff #22 confirmed the Surveyor's infection control findings in the Emergency Department.
An interview was conducted with Staff #15 on 12/01/2025 at 11:00 AM. Staff #15 confirmed the Surveyor's infection control findings in the biohazard storage room.
51905
D.
On 12/01/2025 at 4:25 P.M., during a tour of the intensive care unit, Patient #30's room had a contact precaution isolation sign on the door.
On 12/02/2025 at 4:31 P.M., during a tour of the intensive care unit, Patient #30's room did not have a contact precaution isolation sign on the door. A review of Patient #30's chart revealed an order to discontinue isolation.
On 12/02/2025 at 4:31 P.M., an interview with Staff #75, RN, Staff #75 indicated that Patient #30 no longer met the requirements for isolation as their wound culture came back as negative gram rods.
Review of "Standard and Transmission-Based Precautions" policy, under "Multi-drug resistant organisms (MDROs)," gram-negative bacilli meet the requirement of contact precautions to prevent transmission of MDROs.
On 12/03/2025 an interview with Staff #95, Infection Prevention nurse, stated the units do not isolate for ESBL, VRE, or MRSA (multi-drug resistant organisms (MDROs)). Staff #95 indicated that gram-negative bacilli is not isolated. Staff #95 was shown the "Standard and Transmission-Based Precautions" policy that lists the MDROs and gram-negative bacilli under contact isolation. Staff #95 agreed Patient #30 should be in isolation.
On 12/03/2025 an interview with Staff #4, Quality Manager, revealed that the units do not isolate for ESBL, VRE, or MRSA. Staff #4 was shown the "Standard and Transmission-Based Precautions" policy. Staff #4 stated the hospital "needs to review the policy on isolation."
10135
E.
During observations on 12/01/2025 after 11:12 a.m. the following was found:
K5 Medical Surgical unit
Medication room
The Stericycle hazardous waste container was stored inside a metal bin in the medication room. The bin was rusted and missing paint in areas. The top of the bin was soiled with a black buildup and remnants of white pills.
A nonhazardous waste bin was stored underneath a supply shelf. The outside of the bin was soiled with a dried white substance.
Supply bins which had sterile needles, intravenous tubing and lubricating jelly stored in them were soiled with white particles.
Emergency crash cart
Triple lumen central venous catheter kit expired 12/31/2024 was found on the emergency crash cart.
Ambu bag with mask attached was stored in the respiratory box unbagged.
Progressive care unit (PCU)
After 12:44 p.m., an Ambu bag with mask attached was stored in the respiratory box unbagged on the emergency crash cart.
Labor and delivery (L&D) unit
Operating room #1
After 3:24 p.m., the anesthesia cart bins had a buildup of spills and black debris in the supply drawers.
Two pressure infusion extension sets expired on 08/01/2025.
A pulse oximeter sensor expired on 05/25/2025.
A syringe with a needle attached was in the drawer along with batteries and cords.
An unopened multidose vial of the paralytic agent succinylcholine which was tagged 11/25/2025 was still in the drawer.
A non-sterile, single patient use pressure infuser was hanging up in the room. There was no indication as if it was clean or dirty.
The filter on the anesthesia cart expired on 08/2021 (over 4 years ago).
Operating room #2
A forehead oxygen saturation sensor was stored in the anesthesia cart which expired on 03/31/2025.
The labels used to attach to vials of medication when opening them were housed on a metal container which was covered in brown rust.
Staff 58 and 59 confirmed the observation.