HospitalInspections.org

Based on document reviews and interviews, the hospital failed to:
1. Inform a patient of his/her rights in advance of providing care for one (1) of ten (10) sampled patients (Patient #2) (see A-0117); and
2. Provide a written response that contained the final results of the grievance process for three (3) of five (5) patients who filed grievances (Patient 1G, 2G and 4G) (see A-0123); and
3. Document that each patient was asked if they had an advanced directive and/or did they want to execute one for one (1) of ten (10) patients reviewed (Patient #2) (A-0132); and
4. Ensure that patients received care in a safe setting and are free from abuse and neglect based on the hospital's failure to identify and thoroughly investigate a report of potential abuse for one (1) of ten (10) patients reviewed (Patient #1) (see A-0145); and
5. Ensure a patient received a face-to-face evaluation by the provider within one (1) hour of initiating a restraint for one (1) of five (5) patients that were restrained (Patient 2R) (see A-0178).

Based on document reviews and interviews, the hospital failed to inform a patient of his/her rights in advance of providing care for one (1) of ten (10) sampled patients (Patient #2).

Finding:

The hospital's "Consent for Treatment and Payment" policy, last revised 1/2020, states, in part, "Patients Rights - Notice: I have been made aware of the Patient Rights & Responsibilities Statement and I understand that as a patient, I have rights and I am entitled to file a complaint if I feel that those rights are violated".

On 11/10/2022 at 3:04 PM, Patient #2's medical record was reviewed with the Quality Manager. The hospital failed to provide evidence that Patient #2 received a copy of the Patient Rights information, nor any evidence of a signed acknowledgement.

On 11/1/2022 at approximately 4:00 PM, this finding was confirmed by the Quality Manager at the time of the review.

Based on document reviews and interviews, the hospital failed to provide a written response that contained the final results of the grievance process for three (3) of five (5) patients who were involved in grievances filed (Patient 1G, 2G and 4G).

Findings:

The hospital's "Patient Complaints And Grievances" policy, last revised 2/2020, states, in part, "The resolution of a patient grievance is provided in writing to the complainant. Release of Information policies and procedures are followed when responding to patient complaints. On occasion or at the complainant's request, response to a grievance may be accomplished via email (the email contains the exact wording contained in the formal grievance letter). Written response includes:The name of the contact person, Steps taken on behalf of the patient to investigate the grievance, The final results of the grievance process, and Date of completion".

1. On 5/27/2022, the hospital received a grievance involving Patient 2G.

The written response, dated 6/14/2022, did not contain the final results of the grievance process.

2. On 7/16/2022, the hospital received a grievance involving Patient 4G.

The written response, dated 8/8/2022, did not contain the final results of the grievance process.

3. On 10/2/2022, the hospital received a grievance involving Patient 1G.

The written response, dated 10/24/2022, did not contain the final results of the grievance process.

On 11/8/2022 at 3:27 PM, the above findings were confirmed by the System VP Risk Management/System Privacy Officer.

Based on document reviews and interviews, it was determined that the facility failed to document that each patient was asked if they had an advanced directive and/or did they want to execute one for one (1) of ten (10) patients reviewed (Patient #2).

Finding:

The hospital's "Advance Healthcare Directive and Surrogacy" policy, last revised in 9/2018, states in part, "Distribution of written information to patients concerning their right to make decisions about medical care: Patients are informed of their rights about Advance Directives in the patient rights statement...As part of the admission process for all patients, representatives of the healthcare system ask and document in each patient's record whether the patient has completed an Advance Directive".

On admission, the registration personnel are required to document when they ask the patient about their advance directive or offered information related to advance directive planning.

On 11/10/2022 at 3:04 PM, Patient #2's medical record was reviewed with the Quality Manager. The record failed to contain evidence that advance healthcare directive information was provided to or discussed by the patient and/or an authorized representative.

On 11/10/2022 at approximately 4:00 PM, this finding was confirmed by the Quality Manager at the time of the review.

Based on document reviews and interviews, the hospital failed to:
1. Ensure that one (1) of ten (10) patients were free from abuse and/or neglect (Patient #1); and
2. Failed to thoroughly investigate a report of abuse for one (1) of ten (10) (Patient #1).

As a result of these deficient practices, an Immediate Jeopardy ("IJ") was identified which placed all patients at risk for serious injury and/or harm. Immediate jeopardy is defined as a situation in which a recipient of care has suffered or is likely to suffer serious injury, harm, impairment, or death as a result of a provider's noncompliance with one or more health and safety requirements. Immediate Jeopardy was identified at the Condition of Participation for Patient Rights.

On 11/16/2022 at 9:00 AM, an IJ was identified for failure to identify and thoroughly investigate an allegation of abuse.
- IJ template given to provider on 11/16/2022 at 2:00 PM
- The final removal plan was reviewed and approved by the State Agency on 11/18/2022 at 12:50 PM
- IJ abated as confirmed by on-site visit on 11/21/2022

On 11/21/2022, surveyors verified that the hospital's plan to remove the IJ was implemented and was effective. The surveyors determined the abatement of the IJ by interviewing fourteen (14) staff members from four (4) units. All staff members verified the training provided on 11/18/2022 through 11/21/2022 and their understanding of the new protocols.

Findings:

On 11/2/2022, the Division of Licensing and Certification ("DLC") received an anonymous complaint with the following information: [Patient #1] was admitted to the hospital on 9/14/2022 with possible sepsis. While at the hospital, [Patient #1] had an indwelling foley urinary catheter placed. On 10/2/2022, [Patient #1] was transferred to another medical facility. Upon arrival at the other medical facility, a nursing assessment revealed that an rubber band was wrapped three (3) times around the patient's genitalia, and suffered a significant pressure injury as well as "chunky white substances" were present on the patient's genitalia. On 10/2/2022, the hospital was notified by [Patient #1's] family of these findings and filed a grievance.

The Centers for Medicare and Medicaid ("CMS") defines abuse as "The willful infliction of injury, unreasonable confinement, intimidation, or punishment, with resulting physical harm, pain, or mental anguish. This includes staff neglect or indifference to infliction of injury or intimidation of one patient by another. Neglect, for the purpose of this requirement, is considered a form of abuse and is defined as the failure to provide goods and services necessary to avoid physical harm, mental anguish, or mental illness".

An investigation was initiated by the DLC into the reported incident.

The hospital's "Patient Access to Protective Services for Suspected Abuse, Neglect, Assault, Domestic Violence, and Human Trafficking" policy, last revised 12/2021 states in part, "All patients have the right to be free from verbal, mental, sexual and physical abuse, including injuries of unknown source, neglect and misappropriation of property".

The hospital's "Patient Access to Protective Services for Suspected Abuse, Neglect, Assault, Domestic Violence, and Human Trafficking" policy, last revised on 12/2021, defines abuse, in part, "Physical Abuse - The act of intentionally inflicting or allowing to be inflicted physical injury on a patient or resident by an act or failure to act...". The policy defines neglect, in part, states "Acts of Neglect - Acts of omission or commission which constitute a failure of an individual responsible for care giving to respond adequately to established needs for care, such as withholding medical or personal care, inattention to daily needs and lack of necessary supervision...".

The hospital's "Patient Complaints And Grievances" policy, last revised 02/2020 states in part, "Any complaint or grievance that alleges an imminent threat to health and safety is reported...Review of such matters is expedited to minimize risks to patients and staff".

The failure to identify and thoroughly investigate a grievance and report suspected abuse and injury of unknown source in accordance with hospital policy and acceptable standards of practice resulted in the following:

1. On 9/14/2022 at 12:39 AM, Patient #1 arrived at the hospital Emergency Department and was found to have a urinary tract infection as well as severe sepsis. Patient #1 was admitted to the Intensive Care Unit ("ICU") on 9/14/2022 at 2:38 PM.

Per hospital policy and procedure, a complete nursing assessment is required on the ICU within the first 24 hours of admission. On 9/14/2022 at 4:30 PM, Registered Nurse ("RN")#1 completed a nursing assessment. Per the medical record, perineal care and a gown change were documented as being performed with no abnormal findings.

On 9/20/2022 at 11:20 AM, Patient #1 had a foley "urinary catheter" inserted by RN #7.

On 10/2/2022 at 12:50 PM Patient #1 was transferred to another medical facility. A nursing assessment was completed on 10/2/2022 at 1:17 PM, at the receiving medical facility, by RN #2 who identified an elastic rubber band wrapped two (2) to three (3) times around the patient's genitalia. A significant pressure injury, as well as "chunky white substances" were noted as findings during the nursing assessment, only twenty seven (27) minutes after leaving St. Mary's Regional Medical Center.

On 10/2/2022 at 7:27 PM, Patient #1's family reported the findings to hospital leadership and filed a grievance.

On 10/11/2022, per the System Vice President ("VP") Risk Management/System Privacy Officer and the Director of Quality, they began an investigation regarding the grievance related to Patient #1.

On 10/24/2022, the System VP Risk Management/System Privacy Officer sent a closure letter, related to the grievance, to Patient #1 stating that the investigation of the grievance was complete as of 10/21/2022.

On 11/15/2022 at 3:39 PM, the hospital provided the survey team evidence of their investigation. The System VP Risk Management/System Privacy Officer was asked if this was the entirety of the investigation. She stated, "This contains all of the documented evidence of the investigation". The investigation included the following:
- Five (5) interviews of nursing staff; and
- A brief timeline of Patient #1's hospitalization, taken from the medical record.

The hospital failed to provide any evidence that Patient #1's medical record was reviewed by clinical leadership during the investigation.

As of 11/21/2022, the hospital has failed to provide any additional documentation as evidence of a thorough and credible investigation. Surveyors have received no evidence through interviews and document reviews to demonstrate that a thorough and credible investigation was conducted to determine how and why a patient who was an inpatient for approximately nineteen (19) days, immediately upon transfer by healthcare professionals at a different medical facility, were able to identify an extensive pressure ulcer tissue injury from a rubber band that was wrapped three times around Patient #1's genitalia.

Based on document reviews and interviews, the hospital failed to ensure the patient received a face-to-face evaluation by the provider within one (1) hour of initiating a restraint for one (1) of five (5) patients that were restrained (Patient 2R).

Finding:

The hospital's "Violent Restraint Policy (Self-Destructive)", last revised on 9/2022, states in part, "When restraint is used for the management of violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others, the patient must be seen face to face within 1 hour after initiation of the intervention...".

On 11/9/2022 at 9:39 AM, Patient 2R's medical record was reviewed with the Quality Manager. This review revealed the following:

- On 9/30/2022 from 1:19 PM to 6:30 PM, Patient 2R was in four (4) point restraints; and
- There was no documented evidence of a face-to-face evaluation by a provider within one (1) hour of the restraint initiation.

On 11/9/2022, the Quality Manager confirmed that the medical record failed to contain the documentation of a face to face within the required timeframe.

Based on document reviews and interviews, the hospital failed to conduct a review of a serious adverse event to analyze its causes and implement preventive actions for one (1) of ten (10) patients reviewed (Patient #1). In addition, the hospital failed to follow its own policy related to root cause analysis completion for this event.

See A-0286 for details.

The cumulative effect of this deficient practice resulted in noncompliance with this Condition of Participation.

Based on document reviews and interviews, the hospital failed to conduct a thorough review of a serious adverse event to analyze its causes and to implement preventive actions for one (1) of ten (10) patients reviewed (Patient #1). In addition, the hospital failed to follow its own policy related to root cause analysis completion for this event.

Findings:

The hospital's "Root Cause Analysis Process - Adverse Events" policy, last revised 6/2020 states in part, Root Cause Analysis ("RCA") is part of an overall response to Adverse Events and prevention of future harm to patients. It requires the following procedures:
- In Depth investigation is completed within 7 - 10 days of identification of the adverse event;
- Confirmation and Consensus Meeting - Complete within 7 to 21 Days of discovery of the adverse event; and
- Solutions Meeting - Complete within 7 to 30 days of the event.

On 10/2/2022 at 7:27 PM, the hospital's nursing supervisor sent an email to the Vice President ("VP") of Patient Services/Chief Nursing Officer ("CNO"), the Interim Nurse Director of the Intensive Care Unit ("ICU") and the Cardiac Care Unit ("CCU"), and other nursing supervisors. This email outlined a call the nurse received from a family member of Patient #1 stating, "They [the receiving medical facility] found a rubber band wrapped around the [genitalia]. They told her that [Patient #1] has sustained permanent damage to [Patient #1's genitalia] and that it might be irreparable".

On 11/4/2022 at 12:25 PM, an interview was conducted with the Director of Quality related to the adverse event involving Patient #1. She stated the following:
- an investigation consisting of document reviews and interviews was completed; and
- an RCA was going to be done by 12/9/2022, but no preparation has begun at this time other than the investigation.

On 11/4/2022 at 12:41 PM, an interview was conducted with the System VP Risk Management/System Privacy Officer related to the adverse event involving Patient #1. She stated the following:
- I became aware of the issue on 11/5/2022;
- I followed up with the CMO and the Director of Quality same day;
- There was a grievance by the family and we did send an acknowledgement letter to the patient and then we did a closing letter;
- We have completed the investigation; and
- Haven't done an RCA.

On 11/4/2022 at 1:05 PM, an interview was conducted with the CMO related to the adverse event involving Patient #1. He stated the following:
- I saw an email from an evening supervisor;
- I reached out to the CMO at the receiving facility and he confirmed the information and described a yeast infection, some degree of skin damage, and that it might require surgical intervention due to the injury;
- I reached out to the risk and quality team, did a chart review and didn't see anything;
- There is no doubt with the description from the other CMO, it had to have been a significant amount of time that it [the rubber band] was on...there is a possibility [Patient #1] came with it and I am unclear why it wasn't detected;
- Patient #1 was provided hygiene care prior to leaving for the other medical facility and I don't recall anyone describing concerns related to the hygiene care; and
- It is perplexing and frankly, disappointing and I am at a loss for explanation...The nursing staff were looking at Patient #1 often, but it was not discovered.

On 11/4/2022 at 1:33 PM, an interview was conducted with the VP of Patient Services/CNO related to the adverse event involving Patient #1. She stated the following:
- I learned about it [the adverse event] from an email with my evening supervisor;
- We started Monday having conversations with quality and risk to start talking with nurses;
- Staff denied ever seeing the rubber band...and were sure that [hygiene care] was done; and
- I have not looked at the medical record.

On 11/4/2022 at 1:59 PM, a follow-up interview was conducted with the System VP Risk Management/System Privacy Officer. She stated the following:
- Yes, this was an adverse event;
- There are different time frames in the RCA policy for adverse events; and
- We have not had an RCA and there is nothing scheduled at this time.

On 11/7/2022 at 9:00 AM, an interview was conducted with the hospital's President related to the RCA for this adverse event. He stated the following:
- I asked to have the RCA done immediately;
- It started but they didn't complete it per policy;
- We have a huddle every day where we talk about RCA's and I talked about it a week later, and I told the team we need to continue working on the RCA; and
- No, I didn't hear about it again.

On 11/15/2022 at 9:41 AM, an interview was conducted with the Interim ICU and CCU Director, where Patient #1 was during the hospitalization. She was asked if she reviewed Patient #1's record after she knew about the adverse event. She stated, "I think I did review parts of it when it came to my attention".

On 11/18/2022 at 9:59 AM, a final interview was conducted with the System VP Risk Management/System Privacy Officer. She stated the following:
- No, we did not follow our policy.

Our investigation concluded, as of 11/3/2022, the hospital failed to conduct a credible and thorough investigation of Patient #1's care to determine the root cause and to develop any potential improvement plans. In addition, the hospital failed to conduct a root cause analysis, per their policy, within thirty (30) days.

Based on document reviews, observations, and interviews, the hospital failed to ensure nursing services and interventions were provided, as evidenced by a significant injury noted immediately upon transfer to another medical facility when healthcare professionals at that medical facility discovered a rubber band wrapped three (3) times around a patient's genitalia, resulting in a significant pressure injury for one (1) of ten (10) patients reviewed (Patient #1).

See A-0395 for details.

The cumulative effect of this deficient practice resulted in noncompliance with this Condition of Participation.

Based on the document reviews, observations, and interviews, the hospital failed to ensure appropriate nursing services and interventions were provided which resulted in an injury that was not detected by staff prior to transfer to another medical facility for one (1) of ten (10) patients reviewed (Patient #1).

Findings:

The hospital's "Nursing Documentation" policy last reviewed 2/2022 states in part, "It is the policy of Covenant Health to ensure nursing documentation for each patient is clear, accurate, and accessible. Complete documentation is an essential element of safe, quality, evidence-based nursing practice:
- Nursing staff shall complete an assessment of a patient's condition within twenty-four hours of admission to an inpatient setting
- Nursing staff will reassess the patient at regular time defined intervals and if the patient's condition changes
- If one or more of the criteria are not within the defined limit or a difference exists from the current Registered Nurse ("RN") initial or previous assessment, an "X" is placed in the system field and the abnormality is documented in the appropriate row
- Minimum required frequency for Cardiac Care Unit and Intensive Care Unit is the following: completed within 24 hours of admission, at shift change and upon transfer to another unit and drains/tubes/airways assessed on admission, each shift and change in condition".

The hospital's "Management of Urinary Catheters and CAUTI Prevention" policy last reviewed 10/2022 states in part, "Care and Maintenance of Urinary Catheters:
- The nurse cleanses the catheter and the urinary meatus in a male and/or female patient, retract the foreskin, if present away from the urethral orifice, clean the urinary meatus and the first few inches of the urinary catheter; and
- Catheter care is to be performed at least three (3) times daily and after every bowel movement and as needed with soap and water and/or other hospital-approved cleanser".

Patient #1 was an 87-year-old who presented to the Emergency Department on 9/14/2022 with a fever, complaining of generalized weakness, who had fallen at home. Patient #1 stated he/she had multiple falls that day and had dysuria [painful or difficult urination] for the past two (2) days. Patient #1 denied any other associated symptoms. Patient #1 was treated for a urinary tract infection.

1. Nursing Assessments - Based on the Plan for the Provision of Patient Care policy, for CCU and ICU, a full nursing assessment with documentation is required upon admission, each shift and when transferred to another unit.

A review of Patient #1's medical record documentation of full nursing assessments revealed the following:
- From 9/14/2022 to 10/2/2022, it was documented that Patient #1 received the appropriate number of assessments and reassessment as required; and
- From 9/20/2022 to 10/2/2022, the medical record lacked documentation that the genitalia was part of the full nursing assessment for the twenty-five (25) completed assessments.

2. Foley Catheter Care - Based on the Management of Urinary Catheters and CAUTI Prevention policy, catheter care with documentation is required to be performed at least three (3) times daily and after every bowel movement and as needed with soap and water and/or other hospital-approved cleanser.

A review of Patient #1's medical record documentation of catheter care revealed the following:
- From 9/14/2022 to 10/2/2022, it was documented that Patient #1 received the appropriate number of times catheter care required, with no documentation of abnormal findings.

3. Hygiene - On 11/9/2022 at 2:09 PM, the Interim Manager of ICU and CCU stated in an interview that every patient receives a full bath once per day, at a minimum.

A review of Patient #1's medical record documentation of hygiene revealed the following:
- From 9/14/2022 to 10/2/2022, it was documented that Patient #1 received only two (2) full baths, on 9/16/2022 and 9/27/2022; and
- There was no documentation of Patient #1 receiving hygiene care on 9/18/2022, 9/20/2022, 9/23/2022 and 9/24/2022.

On 10/2/2022 at 12:50 PM, Patient #1 left St. Mary's Regional Medical Center, due to services not available, via ambulance for another medical facility. During an interview with RN #3, foley urinary catheter and hygiene care were completed immediately prior to transfer with no drainage or abnormalities noted.

On 10/2/2022 at 12:55 PM Patient #1 arrived at another medical facility and was admitted to the ICU immediately. The medical record revealed the following occurred after admission:
- At 1:17 PM, RN #2 discovered a rubber band wrapped around Patient #1's genitalia while conducting her assessment;
- The Doctor of Osteopathic Medicine ("DO") was then called to examine the patient, per RN #2's request, and visualized a rubber band wrapped around Patient #1's genitalia; and
- The DO noted evidence of a significant amount of yeast; and
- The DO then removed the rubber band and found a significant pressure injury where it had previously been; and
- The DO observed a hole on the genitalia where the foley catheter could be visualized.

On 11/4/2022 at 1:05 PM, the CMO was interviewed in regard to the fact that the rubber band on Patient #1 had been undetected while the patient was at St. Mary's Regional Medical Center. He stated the following:
- I am unclear why it wasn't detected; and
- No staff member saw evidence of the rubber band; and
- It is perplexing and frankly, disappointing, and I am at a loss for explanation, as they were looking at [Patient #1] often but it wasn't discovered.

On 11/4/2022 at 1:33 PM, the CNO was interviewed in regard to the fact that the rubber band on Patient #1 had been undetected while the patient was at St. Mary's Regional Medical Center. She stated the following:
- We started Monday [10/3/2022] having conversations with Quality and Risk and started talking to nurses; and
- We determined that hygiene care was done; and
- Staff denied ever seeing the rubber band.

On 11/4/2022 at 2:17 PM, RN #2 at the receiving facility was interviewed via telephone related to her discovery of a rubber band wrapped around Patient #1's genitalia. She stated the following:
- I went to clean Patient #1 up and immediately stopped when I found the rubber band; and
- It appeared that Patient #1 had not had proper foley and hygiene care in a long time as it was very yeasty; and
- The rubber band was at the [beginning of the genitalia], you could clearly see it; and
- It was raw around the [beginning of the genitalia]; and
- I think it must have been at least a few days since Patient #1 received proper hygiene and foley care; and
- The underside of the genitalia had a hole, a deep tissue injury and I think the rubber band created the hole because it was so tight...I think it was there for some time.

On 11/4/2022 at 2:56 PM, the DO at the receiving facility was interviewed via telephone related to the rubber band wrapped around Patient #1's genitalia. She stated the following:
- I admitted Patient #1 due to having a gastrointestinal bleed and no gastrointestinal coverage at St. Mary's Regional Medical Center; and
- Upon arrival, I wanted to change the foley so I asked my nurse to change it; and
- My nurse then called me in quickly and I visualized a rubber band wrapped around the genitalia; and
- I was able to remove the rubber band; and
- I have no idea how long it had been there but definitely a significant period of time; and
- When I took it off, there was a significant amount of white chunky substance and a significant pressure injury.

On 11/7/2022 at 11:44 AM, RN #3 was interviewed in relation to Patient #1's foley catheter care. She stated the following:
- Catheter care is a complete cleaning and inspecting of [the genitalia]; and
- I wipe [the entire genitalia] and fully inspect for no ulcers or tears; and
- Patient #1 had a very large gastrointestinal bleed so a lot of foley and hygiene care was performed; and
- Patient #1 was cleaned three times (3) by me and one (1) with another nurse right before the transfer to the other medical facility;
- I didn't notice anything; and
- The Quality Director said there was a rubber band found wrapped around the genitals but I cleaned Patient #1 three (3) times that day, and I am 100% positive that there was nothing wrapped around the genitals.

On 11/15/2022 at 9:41 AM, the Interim Manager of ICU and CCU was asked why patients in her units would not receive a full bath every day. She stated the following:
- In an ICU, it gets really busy, patients are coming and going and those patients need a lot of care;
- On a shift, you may not have time to provide patients with a full bed bath; and
- You would then inform the colleagues on the next shift. I could imagine that happening, but not for days upon days.