HospitalInspections.org

Based on observation, document review, and interview, the Governing Board (Board of Trustees) failed to:

1.
ensure a properly executed informed consent was completed in 9 (Patient #5, #6, #12, #13, #14, #15, #16, #65, and #66) of 9 patient medical records reviewed in 3 (Emergency Room, Anesthesia, and Labor and Delivery) of 3 departments. Also, the hospital failed to follow its policies titled, "Consent and Disclosure for Medical and Surgical Procedures and Administration of Moderate Sedation by Non-Anesthesia Personnel With Appendix in the Emergency Department".

Refer to A 0131

2.
implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program when:

a. the facility failed to ensure the QAPI program measured, analyzed, and tracked quality indicators and used the data to monitor the effectiveness and safety of services and quality of care when there was no evidence these were being completed through the quality council.

Refer to Tag A0273

3.
a. the facility failed to ensure the Quality Program took actions aimed at performance improvement and, after implementing those actions, measured its success, and tracked performance to ensure that improvements were sustained when actions/resolutions and follow-ups were not documented.

Refer to Tag A0283

4.
a. the facility failed to ensure the hospital's governing body ensured the QAPI program involved all hospital departments and services when dietary staff were not involved in QAPI meetings, and each department, the clinical subcommittee, and hospital committee reports were not discussed and updated each meeting.

b.ensure the hospital's governing body ensured the QAPI program involved all hospital departments and services when dietary staff were not involved in QAPI meetings, and each department, the clinical subcommittee, and hospital committee reports were not discussed and updated each meeting.

Refer to A 0308

5.
ensure Staff #30 (Charge Nurse), on the 3rd Floor Medical-Surgical Unit, was competent in the use of the Life Pack emergency defibrillator on 2 of 2 emergency crash carts. Also, the hospital failed to identify and remove expired supplies from the emergency crash carts.

Refer to Tag A0386

6.
a. ensure adequate staffing was provided for all patient care units, was unable to provide a patient acuity tool to determine the staff needed to provide safe care, or an acuity grid/matrix to determine the number of minimal staff needed for 7 out of 7 ( Inpatient Rehabilitation, Emergency Department, Mother/ Baby 606, Psych PRU 1 and PRU 2, Medical/Surgical 605, and ICU) patient care units.

b. ensure the dialysis department had, at a minimum, 2 trained Registered Nurses readily available to provide direct patient care to patients receiving hemodialysis. Also, the hospital failed to have a staffing matrix and plan for the dialysis department.

Refer to Tag A0392

7.
ensure the physician was explaining to the patient the risk and benefits of blood while obtaining the blood consent. The facility failed to ensure that the blood administration policy and procedure gave accurate instructions on obtaining blood consent and ensure the consent had a signature line, date, and time for the physician to sign in 2 of 2 (pt #4 and 8) charts reviewed.

Refer to Tag A0410

8.
ensure patient medical record entries were legible, completed, dated, timed, and authenticated by staff on the Cardiopulmonary Resuscitation Report in 5 (#29, #32, #33, #43, #44) of 5 patients records reviewed. Also, the Quality Department failed to monitor these reports for opportunities for improvement as required in the hospital's policy, "Cardiopulmonary Resuscitation/Adult or Pediatric Code Blue and Neonatal Code Blue"

Refer to Tag A0450

9.
maintain a clean and sanitary environment in 7 (Medical/Surgical, Materials Management, Behavioral Health PRU #1 and PRU #2, Respiratory, Labor and Delivery/Womens Services, and Emergency Room,) of 7 Departments observed to avoid sources and transmission of infection when infection control tour findings throughout the survey were observed and infection control rounds were not being performed regularly.

Refer to A 0750

10.
develop and implement a hospital-wide infection surveillance, prevention, and control policies and procedures that adhered to nationally recognized guidelines when there was no active surgical site infection [SSI] surveillance.

Refer to A0772

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

A. a properly executed informed consent was completed in 9 (Patient #5, #6, #12, #13, #14, #15, #16, #65, and #66) of 9 patient medical records reviewed in 3 (Emergency Room, Anesthesia, and Labor and Delivery) of 3 departments. Also, the hospital failed to follow its policies titled, "Consent and Disclosure for Medical and Surgical Procedures and Administration of Moderate Sedation by Non-Anesthesia Personnel With Appendix in the Emergency Department".

Refer to Tag A0131

B. the Emergency Department had a working emergency call system in 2 (Exam Room # 8 and Exam Room # 7) of 14 patient exam rooms. The nursing staff failed to ensure 3 (Patient # 22, # 23, and # 24) of 3 patients had the emergency call light within reach to utilize in the event assistance was needed. Also, the hospital failed to ensure a staff member monitored and responded to the patient call lights in the Emergency Department.

C. 3 (# 67, # 68, and # 69) of 3 patients undergoing hemodialysis treatment with an unknown Hepatitis B status were treated in a location that prevented the transmission of Hepatitis B to other patients and staff members. Also, the hospital staff failed to follow the facility policy, "Hemodialysis Infection Prevention".

D. dialysate samples were sent to the laboratory for testing when dialysate manufacturers were changed.


Refer to Tag A0144

Based on document review and interview the hospital failed to ensure a properly executed informed consent was completed in 9 (Patient #5, #6, #12, #13, #14, #15, #16, #65, and #66) of 9 patient medical records reviewed in 3 (Emergency Room, Anesthesia, and Labor and Delivery) of 3 departments. Also, the hospital failed to follow its policies titled, "Consent and Disclosure for Medical and Surgical Procedures" and "Administration of Moderate Sedation by Non-Anesthesia Personnel With Appendix in the Emergency Department".

Findings:

Patient #5
Patient #5 was admitted to the Labor and Delivery Unit on 3/16/2024. A review of the document titled, "Disclosure and Consent Medical Care and Surgical Procedures" revealed Patient #5 and the Physician (signature illegible) signed, dated, and timed the informed consent on 2/22/2024 at 4:45 PM. The witness, LVN Staff #74 failed to date or time her signature on the informed consent.

A review of the Disclosure and Consent for Anesthesia was signed, dated, and timed by Patient #5 on 3/16/2024 at 1:55 PM. Patient #5 consented to General anesthesia and an Epidural. There was no witness signature on the consent. There was no signature by the anesthesia provider that explained the risks and benefits of anesthesia to the patient on the informed consent.

Patient #6
Patient #6 was admitted to the Labor and Delivery Unit on 3/07/2024. A review of the document titled, "Disclosure and Consent Medical Care and Surgical Procedures" was as follows:

" ...Cesarean section including assisted delivery with forceps and/or vacuum with bilateral salpingectomy ..."
Patient #6 and the Physician signed, dated, and timed the informed consent on 2/15/2024 at 12:00 PM. The witness, LVN Staff #73 signed, dated, and timed the informed consent on 2/15/2024 at 11:30 AM. This was 30 minutes before the patient and physician signed the consent.

A review of the Disclosure and Consent for Anesthesia was signed, dated, and timed by Patient #5 on 3/07/2024 at 11:45 AM. Patient #5 consented to General anesthesia, Regional Block Anesthesia, and Spinal Anesthesia. The witness's signature was not dated or timed. There was no signature by the anesthesia provider that explained the risks and benefits of anesthesia to the patient on the informed consent.

An interview was conducted with RN Staff #16 on 3/18/2024 at 10:45 AM. RN Staff #16 was asked if the procedure on the consent was correct. RN Staff #16 stated, "No, it is not. The part about the forceps and the vacuum should have been removed because you do not use them during a C-section. The consent was obtained in the physician's office and the error was not caught and corrected here."

Patient #12
Patient #12 was admitted to the hospital for surgery by Physician #75 on 1/08/2024. A review of the document titled, "Disclosure and Consent Medical Care and Surgical Procedures" revealed Patient #12 and the provider (signature illegible) signed, dated, and timed the informed consent on 1/05/2024 at 9:28 AM. The witness failed to date or time her signature.

A review of the Disclosure and Consent for Anesthesia had been signed, dated, and timed by Patient #12 on 1/04/2024 at 8:28 AM. Patient #12 consented to General anesthesia, Regional Block Anesthesia, and Deep Sedation Anesthesia. There was no signature by the anesthesia provider that explained the risks and benefits of anesthesia to the patient on the informed consent.



Patient #13
Patient #13 was admitted to the hospital for surgery on 1/17/2024. A review of the document titled, "Disclosure and Consent Medical Care and Surgical Procedures" was as follows:

" ...Cold knife conization of cervix, removal of IUD ...". IUD is an abbreviation of Intrauterine Device.
Patient #13 and the Physician signed, dated, and timed the informed consent on 1/17/2024 at 7:30 AM. The witness failed to date or time her signature.

A review of the Disclosure and Consent for Anesthesia had been signed, dated, and timed by Patient #13 on 1/17/2024 at 7:10 AM. Patient #13 consented to General anesthesia. The witness's signature, RN Staff #77 was not dated or timed. There was no signature by the anesthesia provider that explained the risks and benefits of anesthesia to the patient on the informed consent.

Patient #14
Patient #14 was admitted to the hospital for surgery on 2/15/2024. A review of the document titled, "Disclosure and Consent Medical Care and Surgical Procedures" revealed Patient #14 and the provider (signature illegible) signed, dated, and timed the informed consent on 2/9/2024 at 11:39 AM. The witness failed to date or time her signature.

A review of the Disclosure and Consent for Anesthesia had been signed, dated, and timed by Patient #14 on 2/15/2024 at 9:16 AM. Patient #14 consented to General anesthesia and Deep Sedation. The witness's signature was not dated or timed. There was no signature by the anesthesia provider that explained the risks and benefits of anesthesia to the patient on the informed consent.

Patient #15
Patient #15 was admitted to the hospital for surgery on 1/08/2024. A review of the document titled, "Disclosure and Consent Medical Care and Surgical Procedures" revealed the Physician signed, dated, and timed the informed consent on 12/27/2023 at 10:20 AM. Patient #15 signed, dated, and timed the informed consent on 1/02/2024 at 1:30 PM. The witness failed to date or time her signature.

A review of the Disclosure and Consent for Anesthesia had been signed, dated, and timed by Patient #15 on 1/08/2024 at 10:33 AM. Patient #15 consented to General anesthesia and Deep Sedation. The witness's signature was not dated or timed. There was no signature by the anesthesia provider that explained the risks and benefits of anesthesia to the patient on the informed consent.

Patient #16
Patient #16 was admitted to the hospital for a procedure on 3/06/2024. A review of the document titled, "Disclosure and Consent Medical Care and Surgical Procedures" revealed Patient #16 and the Physician signed, dated, and timed the informed consent on 2/21/2024 at 9:19 AM. The witness failed to date or time her signature.

A review of the Disclosure and Consent for Anesthesia had been signed, dated, and timed by Patient #16 on 3/06/2024 at 10:15 AM. Patient #16 consented to General anesthesia and Deep Sedation. The witness's signature was not dated or timed. There was no signature by the anesthesia provider that explained the risks and benefits of anesthesia to the patient on the informed consent.



An interview was conducted with Certified Registered Nurse Anesthetist (CRNA), Staff #38 and CRNA Staff #71 on 3/18/2024 at 10:05 AM. Staff #38 was asked if the anesthesia providers were required to sign the informed consent for anesthesia. Staff #38 replied, "This is the only place that I have worked that we do not sign the anesthesia consent. We have to sign them everywhere else." Staff #38 was asked if the risks and benefits of the selected anesthesia were explained to the patient. Staff #38 replied, "We talk to the patient about the risks and benefits before the procedure we just do not sign the consent". Staff #38 was asked if there was documentation in a patient's medical record that confirmed the risks and benefits of anesthesia had been explained by an anesthesia provider. Staff #38 stated, "No". Staff #71 confirmed the anesthesia consent should be signed by the anesthesia provider that explained the risks and benefits of anesthesia.


Patient #65
Patient #65 was a 46-year-old male admitted to the Emergency Department (ED) on 3/05/2024 with a dislocated Right Shoulder. He had a past medical history of Asthma, Chronic Depression, Gastroesophageal Reflux, High Blood Pressure, Paroxysmal tachycardia (abnormally fast heart rate), Seizure, and venous embolism (blood clot in the vein).

A review of the document titled, "Disclosure and Consent Medical Care and Surgical Procedures" was as follows:

" ... I voluntarily request my physician/health care provider Physician #78, (last name only) to treat my condition which is: Dislocation of R Shoulder.

I understand that the following care/procedure(s) are planned for me: Sedation & Reduction...

The Use of Blood consent was left blank and not addressed by the staff or the physician ..."

Patient #65 and the RN signed the informed consent but failed to document a date and time. Physician #78 signed, dated, and timed the consent on 3/05/2024 at 9:30 PM.

A review of the document titled, "Sedation for Procedure Consent" revealed Patient #65 and the witness signed, dated, and timed the consent on 3/05/2024 at 9:20 PM. Physician #78 failed to sign the informed consent for sedation. The informed consent for sedation failed to document if the procedural sedation was for moderate sedation or deep sedation.

A review of the medical record with RN Staff #69 was conducted on 3/19/2024 at 1:20 PM. Physician #78 ordered the medication etomidate (general anesthetic) 10 mg (milligrams) IVP (intravenous push) once at 9:16 PM. The medication was administered by RN Staff #79 at 9:35 PM.

RN Staff #69 confirmed Physician #78 failed to document and/or explain the risks and benefits of the procedural sedation or the type of procedural sedation to Patient #65. It was also confirmed Physician #78 used abbreviations on the informed consent and failed to identify the site of the reduction in the planned procedure.

Patient #66
Patient #66 was admitted to the ED on 3/08/2024 and 3/12/2024 with a dislocated right shoulder. He had a past medical history of Seizures.

Date of Service 3/08/2024
A review of the medical records was conducted with RN Staff #69 on 3/19/2024 at 1:45 PM.

A review of the document titled, "Disclosure and Consent Medical Care and Surgical Procedures" was as follows:

" ... I voluntarily request my physician/health care provider Physician #78, (last name only) to treat my condition which is: (this information was left blank).
I understand that the following care/procedure(s) are planned for me: Right Shoulder Closed Reduction ..."

Patient #66 signed the informed consent on 3/08/2024 at 2:15 AM. The RN witnessed the informed consent but failed to document a date and time. Physician #78 signed, dated, and timed the consent on 3/08/2024 at 4:10 AM. This was 1 hour and 55 minutes after the patient signed the informed consent. There was no other documentation provided that Physician #78 discussed the risks and benefits of the procedure before Patient #66 signed the consent.

A review of the document titled, "Sedation for Procedure Consent" revealed Patient #66 and the witness signed, dated, and timed the consent on 3/08/2024 at 2:15 AM. Physician #78 failed to sign the informed consent for sedation. The informed consent for sedation failed to document if the procedural sedation was for moderate or deep sedation. RN Staff #69 confirmed there was no documentation in the medical record that Physician #78 explained the risks and benefits of the sedation to Patient #66 before getting a signed informed consent for sedation.

Physician #78 ordered etomidate (general anesthetic) 10 mg (milligrams) IVP (intravenous push) once at 1:57 AM. The medication was administered by Physician #78 at 4:16 AM.

In an interview on 3/19/2024 after 12:30 PM, RN Staff #69 confirmed there should be no blanks on the informed consent and the physician's name should include the first and last name.



Date of Service 3/12/2024

A review of the document titled, "Disclosure and Consent Medical Care and Surgical Procedures" was as follows:

" ... I voluntarily request my physician/health care provider Physician #78, (last name only) to treat my condition which is: Right Shoulder Dislocation.
I understand that the following care/procedure(s) are planned for me: Reduction of Right Shoulder ..."

Patient #66 and Physician #78 signed the informed consent on 3/12/2024 at 8:40 PM. The RN witnessed the informed consent but failed to document a date and time.

In an interview on 3/19/2024 after 12:30 PM, RN Staff #69 confirmed the physician's name on the informed consent should include the first and last name and stated, "It is apparent that the RN documented the date and time for the physician and the patient."

A review of the document titled, "Sedation for Procedure Consent" revealed Patient #66 and the RN witness (signature illegible) signed, dated, and timed the consent on 3/12/2024 at 8:39 PM. Physician #78 failed to sign the informed consent for sedation. The informed consent for sedation failed to document if the procedural sedation was for moderate sedation or deep sedation. RN Staff #69 confirmed there was no documentation in the medical record that Physician #78 explained the risks and benefits of the sedation to Patient #66 before getting a signed informed consent for sedation.

Physician #78 ordered etomidate (general anesthetic) 10 mg IVP once at 8:30 PM. The medication was administered by the RN at 8:58 PM.

Physician #78 ordered an additional dose of etomidate (general anesthetic) 10 mg IVP once at 9:02 PM. The medication was administered by the RN at 9:02 PM.


An interview was conducted with RN Staff #69 on 3/19/2024 at 2:15 PM. RN Staff #69 was asked if the RNs were trained in moderate and deep sedation. RN Staff #69 confirmed the RN Staff were only trained in moderate sedation. RN Staff #69 was asked if the physician was in the room with the nurse and the patient until the patient returned to baseline from the anesthesia. RN Staff #69 confirmed the physician was not always in the room after the procedure was complete, but they were always available.

An interview was conducted with Physician #82 on 3/19/2024 at 2:30 PM. Physician #82 was asked what medications were used for sedation in the ED. Physician #82 stated, "We use several different medications. I use Propofol (a general anesthetic) because it works faster and it's easier on some patients". Physician #82 was asked if deep sedation was allowed in the ED by a non-anesthesia provider. Physician #82 was asked if Etomidate and Propofol, both a general anesthetic drug, could go from moderate to deep sedation at any time during procedural sedation. Physician #82 stated, "I guess it could, but we don't use it as a deep sedation". He was then asked if the patients consented to moderate or deep sedation. He replied, "We talk to the patient about moderate and deep sedation but we always have respiratory therapy in the room when we do procedures in case they are needed. The patients give consent and are required to sign a sedation consent before we start the procedure". Physician #82 was asked if the physicians signed the informed consent after explaining the risks and benefits to the patient. He replied, "No the nurses get the consent after we talk to the patient".

RN Staff #69 confirmed Physician #78 failed to document that the risks and benefits of sedation were explained to the patient in the medical record and did not sign the informed consent for sedation.



A review of the Amidate (etomidate) packet insert was as follows:

" ...Etomidate Description
It is intended for the induction of general anesthesia by intravenous injection ...

Warnings:
WARNINGS INTRAVENOUS AMIDATE SHOULD BE ADMINISTERED ONLY BY PERSONS TRAINED IN THE ADMINISTRATION OF GENERAL ANESTHETICS AND IN THE MANAGEMENT OF COMPLICATIONS ENCOUNTERED DURING THE CONDUCT OF GENERAL ANESTHESIA ..."


A review of the policy titled, "Consent and Disclosure for Medical and Surgical Procedures' with an approved date of 11/2021 was as follows:

" ...POLICY:
It is the policy of (Name of Hospital) that the patient and/or family, as appropriate, has the right to be informed about and participate in decisions regarding his/her care. Prior to the performance of certain medical, diagnostic, and any surgical procedure, the medical staff (physician, oral surgeon, or podiatrist) must first inform the patient about their condition and the recommended surgical, medical, or diagnostic procedure to be used so that they may make the decision whether or not to undergo the procedure after knowing the benefits, risks, and hazards. This explanation includes the patient's current condition, proposed procedure, and benefits; risks and undesired effects of the procedure; potential problems related to recuperation; the [probability of improvement; the possible results/prognosis of non-treatment, and significant alternative treatments ...

PROCEDURE:
It is the policy of PRMC that the process of obtaining consents complies with the following:
A. Procedures requiring written consent

1. Prior to any surgical, medical or invasive diagnostic procedure performed, a Disclosure and Consent form must be completed. This also includes procedures done using epidural, spinal, and general anesthesia ...

F. Requirements Regarding Completion and Validity of a Consent Form...
...
5. Consent forms may not contain unfilled blanks except for the alternate signer's signature and corresponding witness blank. Deletion of unfilled blanks should be done by drawing a line.
6. Consent forms must contain the date and time of signing,
...
8. Consent forms may NOT contain abbreviations, erasures, or eradication ...

Obtaining a written consent
...
2. Write the name of the physician, oral surgeon, or podiatrist performing the procedure on the form if not already present. If the physician is not a MD, write in the appropriate title (i.e. DO, DDS, PD, etc). Confirm the presence of the provider's signature with date and time ...

Responsibility
1. It is the responsibility of the Medical Staff (physician/oral surgeon/podiatrist) to inform the patient (or person authorized to sign for the patient) and document in the patient's medical record of the following: The patient's condition(s) and proposed procedure, benefits, risks, and undesired effects of the procedure; potential problems related to recuperation, the probability of improvement, the possible results/prognosis or nontreatment, significant alternative treatments and type of anesthesia to be given. Staff is also required to inform the patient of ethical issues, identify and professional status of caregivers, and conflicts of interest, other health care, business or educational relationships.

2. It is the responsibility of the physician, oral surgeon, or podiatrist to:
a. designate the condition that makes the procedure necessary;
b. designate the name of the procedure and the site-specific information.
3. It is the responsibility of the physician ordering or performing special treatments, tests, or procedures to inform the patient as applicable above.
...
5. It is the responsibility of the nurse or imaging technologist to review any consent completed in the physician's office to insure the form is properly filled out. It is the responsibility of the licensed nurse or imaging technologist to ascertain that a properly completed consent form has been obtained prior to the administration of pre-operative medication ..."

A review of the facility policy titled, "Administration of Moderate Sedation by Non-Anesthesia Personnel With Appendix in the Emergency Department" PolicyStat ID 13263990, with an approved date of 5/2023 was as follows:

" ...II. PURPOSE:
To establish safe, standardized guidelines for the administration of Moderate Sedation to all patients undergoing invasive and/or non-invasive diagnostic and therapeutic procedures.
...
IV. DEFINITIONS:
...
"Operator" shall refer to the physician who performs a diagnostic or therapeutic procedure during which Moderate Sedation is administered.
...
V. PROCEDURE:
...
7. PRE-PROCEDURE DOCUMENTATION...
* Informed Consent- Prior to the commencement of any procedure utilizing Moderate Sedation, informed consent for Conscious Sedation and for the procedure, shall be properly obtained from the Patient or the patient's legally authorized representative and shall be documented in the patient's medical record, in accordance with federal and state law. The operator must discuss the risks, benefits, and alternatives of the procedures and the planned sedation with the patient and answer any questions. A printed informed consent form may be used.."

During an interview on 3/19/2024 after 2:00 PM with RN Staff #69 and Staff #14 it was confirmed the Medical Staff and Nursing Services failed to follow the hospital policies for Informed Consent and Moderate Sedation.

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

A. the Emergency Department had a working emergency call system in 2 (Exam Room # 8 and Exam Room # 7) of 14 patient exam rooms. The nursing staff failed to ensure 3 (Patient # 22, # 23, and # 24) of 3 patients had the emergency call light within reach to utilize in the event assistance was needed. Also, the hospital failed to ensure a staff member monitored and responded to the patient call lights in the Emergency Department.

B. 3 (# 67, # 68, and # 69) of 3 patients undergoing hemodialysis treatment with an unknown Hepatitis B status were treated in a location that prevented the transmission of Hepatitis B to other patients and staff members. Also, the hospital staff failed to follow the facility policy, "Hemodialysis Infection Prevention".

C. dialysate samples were sent to the laboratory for testing when dialysate manufacturers were changed.



Findings:

A. This deficient practice had the likelihood to cause harm to a patient by not having a process in place to identify a patient in need of assistance which could result in patient harm and a delay in care.

During a tour of the hospital's Emergency Department with Staff # 69 (Emergency Department Director) on 03/20/2024 at 10:00 AM, the surveyor entered Exam Room # 8. The exam room was designated as clean and ready for patient admission. The surveyor hit the patient emergency call button inside the room. The surveyor waited 4 minutes before asking Staff # 69 why there was no response from the nursing staff. Staff # 69 went to the nurses' station to check on the inadequate response time. Staff # 69 reported there was no staff member at the nurses' station to answer the call light.

The surveyor then entered Exam Room # 7 at 10:40 AM where Patient # 22 was admitted. The surveyor observed the patient's emergency call light was not plugged into the wall and was not within the patient's reach. The surveyor tested the emergency call cord and observed no alarm and no response from the nursing staff.

The surveyor entered Exam Room # 5 at 10:45 AM where Patient # 23 was admitted. The surveyor observed the patient's emergency call light was not within the patient's reach and inaccessible to the patient in the event of an emergency.

The surveyor entered Exam Room # 4 at 10:50 AM where Patient # 24 was admitted. The surveyor observed the patient's emergency call light was not within the patient's reach and inaccessible to the patient in the event of an emergency.

The surveyor observed the nurses' station of the Emergency Department at 11:00 AM. There were no staff members at the nurses' station present to monitor and respond to the emergency call lights.

In an interview with Staff # 69 on 03/20/2024 at 11:20 AM, Staff # 69 acknowledged the nursing staff did not ensure patients had access to working call lights and that staff were available to answer the call lights from patients. Staff # 69 stated, "We do not have a job position for someone to sit at the nurses' station and answer call lights".



B. This deficient practice had the likelihood to result in the transmission of Hepatitis B between patients and staff members due to the treatment location and staffing assignments which were determined before the patient's hepatitis B status was known.

A review of treatment records for Patients # 67, # 68, and # 69 revealed the facility staff were not treating unknown Hepatitis B status patients as if they were potentially positive when determining treatment location and staffing assignments.


A review of treatment records for Patient # 67 revealed the following,

Patient # 67 required hemodialysis treatment on 02/03/2024 in the Intensive Care Unit. Staff # 8 was the Registered Nurse caring for the patient during hemodialysis treatment. Treatment was initiated at 3:23 PM and ended at 6:03 PM. During treatment, the patient's hepatitis B status was unknown. The patient's hepatitis B surface antigen was reported to the hospital by Labcorp as negative on 02/05/2024 at 8:09 AM.


A review of treatment records for Patient # 68 revealed the following,

Patient # 68 required hemodialysis treatment on 02/03/2024 in the Intensive Care Unit. Staff # 8 was the Registered Nurse caring for the patient during hemodialysis treatment. Treatment was initiated at 11:26 AM and ended at 12:27 PM. The patient's hepatitis B status was unknown during the entire hospital admission.


A review of Staff # 8's personnel file revealed Staff # 8 had positive hepatitis B immunity on 03/16/2017. Staff # 8 had no titers drawn since 03/16/2017. Staff # 8's hepatitis B immunity was unknown at the time Staff # 8 provided nursing care and treatment to Patient # 67 and Patient # 68.

Staff # 8 had unknown hepatitis B immunity while caring for Patients # 67 and # 68, who had unknown hepatitis B status at the time of treatment.


A review of treatment records for Patient # 69 revealed the following,

Patient # 69 required hemodialysis treatment on 02/03/2024 in the 3rd-floor Dialysis Suite. Staff # 9 was the Registered Nurse caring for the patient during hemodialysis treatment. Treatment was initiated at 12:03 PM and ended at 4:36 PM. The patient's hepatitis B status was unknown during the hemodialysis treatment on 2/3/2024.


A review of Staff # 9's personnel file revealed Staff # 9 signed a Hepatitis B Vaccination Declination Form on 02/11/2002. There was no evidence that Staff # 9 had positive immunity to Hepatitis B.

Staff # 9 had unknown hepatitis B immunity while caring for Patient # 69, who had unknown hepatitis B status.



A review of the hospital's policy, "Hemodialysis Infection Prevention" with a revision date of 06/2023 revealed the following,

"PURPOSE:

To limit the spread of infections among staff and patients.

STATEMENT OF POLICY:

PERSONNEL:

All employees will comply with the hospital's Employee Health Program .... Employees are to be knowledgeable of infection control practices and Universal/Standard Precautions. HBV Precautions should be followed for known or unknown HB-positive patients.
Dialysis staff must be Hepatitis B immune if dialyzing a Hep B patient. Hepatitis titers will be drawn yearly to check for immunity ...

MANAGEMENT OF HEPATITIS B-POSITIVE PATIENTS:

Patients will be tested per CDC recommendations for Hepatitis B. Their hepatitis B status will be communicated appropriately when orders are received. Dialysis nurse has access to the most recent labs via computer. Close communication between Acute and Chronic hemodialysis units is deemed necessary to enhance infection control efforts. Hepatitis B patients are to be dialyzed without any other patients, on a separate machine and have separate equipment ..."


In an interview with Staff # 10 on 03/20/2024 at 9:30 AM, Staff # 10 acknowledged there is no process in place to identify a patient's hepatitis B status before treatment initiation to ensure there is no risk of exposure and transmission to other patients and staff members.



C. During a tour of the hospital's 3rd-floor dialysis suite on 03/18/2024 at 10:16 AM, the surveyor observed 2 different manufacturers of bicarbonate dialysate stored in the dialysis suite supply room. The surveyor observed 3 jugs of Centrisol 45X liquid bicarbonate dialysate solution and 3 jugs of Sterilyte 45X liquid bicarbonate dialysate solution stored together on the same shelf.

During an interview on 3/18/2024 at 10:16 AM, the surveyor asked Staff # 10 if both manufacturers of bicarbonate solution were being used on the same hemodialysis machine. Staff # 10 reported both were being used and the staff were not aware samples were to be sent to the laboratory for testing when changing between the 2 manufacturers on the same dialysis machine.

Based on review of facility documents and staff interview, the facility failed to implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program when:

A. the facility failed to ensure the QAPI program measured, analyzed, and tracked quality indicators and used the data to monitor the effectiveness and safety of services and quality of care when there was no evidence these were being completed through the quality council (Cross refer A0273).

B. the facility failed to ensure the Quality Program took actions aimed at performance improvement and, after implementing those actions, measured its success, and tracked performance to ensure that improvements were sustained when actions/resolutions and follow-ups were not documented (Cross refer A0283).

C. the facility failed to ensure the hospital's governing body ensured the QAPI program involved all hospital departments and services when dietary staff were not involved in QAPI meetings, and each department, the clinical subcommittee, and hospital committee reports were not discussed and updated each meeting (Cross refer A0308).

Based on review of facility documents and staff interview, the facility failed to ensure the QAPI program measured, analyzed, and tracked quality indicators and used the data to monitor the effectiveness and safety of services and quality of care when there was no evidence these were being completed through the quality council.

Findings:

Review of facility-based Quality and Patient Safety Council meeting minutes for 3/21/23 through 2/20/24 revealed some data was being collected, such as readmission rates, sepsis, and fibrinolytic therapy, however, there was no indication what the goals were, if there were actions/resolutions/assignments related to the priorities, nor if there was any follow-up. The quality program was not monitoring the effectiveness and safety of services.

In an interview on the afternoon of 3/19/24 with Staff #14, Director of Quality/Regulatory, stated, "Yes, this is happening, but it's not documented."

Facility-based "Quality/Patient Safety Plan" last revised 02/2024 stated in part, "Quality Management (QM) Department:
*The Quality Management Department serves as a resource to the Quality and Patient Safety Council, chartered teams, the medical staff, and all departments. The Quality Management Department will be responsible for gathering reports from throughout the organization and analyzing them for patterns and trends that require performance improvement activities, including patient safety initiatives. These reports include patient satisfaction, variance reports, database reports, committee reports, etc. The Quality and Patient Safety Council reports identified patterns and trends, which may require a performance improvement initiative to the involved departments ...

Committee Structure:
-The committee structure supports Performance Improvement at [Facility name]. Activities of these committees are documented in minutes or memos, which, when appropriate, document conclusions (data analysis), recommendations (improvement strategies), action (implementation of improvement activities or committee assignments), and follow-up (effectiveness of actions)."

Based on review of facility documents and staff interview, the facility failed to ensure the Quality Program took actions aimed at performance improvement and, after implementing those actions, measured its success, and tracked performance to ensure that improvements were sustained when actions/resolutions and follow-ups were not documented.

Findings:

Review of facility-based Quality and Patient Safety Council meeting minutes for 3/21/23 through 2/20/24 revealed meetings were held monthly for the past year but the columns titled "Action/Resolution/Assignment" and "Follow-up" were not consistently documented. For example, the data driven priorities #1 - 3 (Falls, Primary C-Section Rates, and Patient Satisfaction, respectively) were discussed for each quarter at every meeting; however, there was no indication what the goals were, if there were actions/resolutions/assignments related to the priorities, nor if there was any follow-up.

The agenda item "Departmental PI [performance improvement]" documented the following:
*11/14/23: "asked that each department choose their PI initiatives for 2024 and sent to her by November 30th."
*1/30/24: "No Update at this time."
*2/20/24: "No Update at this time."

A list of the Quality Improvement Report calendars was requested but were never provided.

In an interview on the morning of 3/19/24 with Staff #14, Director of Quality/Regulatory, she reported they had a non-medical person taking meeting minute notes and did not document everything that happened in the meetings. She verified the columns were not complete and this process needed to be improved as actions aimed at performance improvement, implementing actions, and tracking performance to ensure improvements were sustained were not evidenced in the Quality Meeting Minutes for the past year.


Facility-based "Quality/Patient Safety Plan" last revised 02/2024 stated in part, "Quality Management (QM) Department:
Sustained Improvement: In order to sustain improvements that are initiated in the design of new processes or modification of existing processes, Palestine Regional Medical Center uses all necessary resources and staff to identify, plan and test changes. Education of staff in the changes is a key aspect of this process. Performance measures are established prior to implementing changes in order to determine whether improvements are sustained."

Based on review of facility documents and staff interview, the facility failed to ensure the hospital's governing body ensured the QAPI program involved all hospital departments and services when dietary staff were not involved in QAPI meetings, and each department, the clinical subcommittee, and hospital committee reports were not discussed and updated each meeting.

Findings:

Review of the "Quality and Patient Safety Council" meeting minutes for the past year revealed many departments and services, such as surgery, dietary, respiratory therapy, and behavioral health, were not involved in the QAPI meetings. Several managers and directors throughout the survey discussed quality data was being collected and sent to quality but have not presented their data or discussed their performance improvement.

Review of facility-based Quality and Patient Safety Council meeting minutes for 3/21/23 through 2/20/24 revealed meetings were held monthly for the past year but no representative from dietary was identified as being present or absent.

In an interview on the morning of 3/19/24 with Staff #25, Dietician, she reported the department does track quality measures including patient satisfaction and quarterly audits but does not attend any facility quality meetings and does not have performance improvement projects with the facility quality council.

In an interview on the morning of 3/19/24, with Staff #24, Dietary Manager, he reported his department does track quality measures including patient satisfaction and temperature monitoring but does not attend any facility quality meetings. Staff #24 reported he does report to the quality director but does not have performance improvement projects with the facility quality council.

In an interview on the morning of 3/19/24, with Staff #14, Director of Quality/Regulatory, she reported dietary quality was wrapped up in patient satisfaction but was unaware they were not involved in the meetings.

Review of the "Quality and Patient Safety Council" meeting minutes dated 6/20/23, stated in part, "*Agenda Item: Clinical Subcommittee Reports;
*Key Discussion:
-Falls Committee - Met in June
-Patient Experience - Meets next week.
-Health Equity Committee - Scheduled to meet in June.
-Workplace Violence Prevention Committee - Met in May.
-Culture of Safety Committee - CoSe Survey results are back;
*Action/Resolution/Assignment: Need more participation from staff members who are on these committees.
If a staff member who was previously on these committees has left [facility name] - please review list and assign another staff member.
*Follow-up" was left blank.
For the each of meetings that followed on 7/18/23, 8/15/23, 9/19/23, 10/17/23, 11/14/23, 1/30/24, the Agenda Item of Clinical Subcommittee Reports stated, "Action/Resolution/Assignment: Need more participation from staff members who are on these committees;" and the Follow-up column was left blank.
For the meeting dated 2/20/24, both the Action/Resolution/Assignment and Follow-up Columns were not completed.

In an interview on the afternoon of 3/19/24, Staff #14 reported 2/20/24 meeting minutes were not yet complete as they become complete after approval at the next meeting, therefore, none of the Action/Resolution/Assignment or Follow-up Columns were completed. Staff #14 reported some committees do not have volunteers to head them and reported that some departments do not report their numbers or performance improvement regularly. Staff #14 reported she was aware some departments and committees reported "No Updates" for several months, such as EOC [Environment of Care]/Emergency Preparedness, Health Equity Committee, P&T [Pharmacy and Therapeutics]/Antibiotic Stewardship, Staffing Effectiveness, Dialysis and some were not addressed such as surgery, respiratory, and behavioral health and stated, "Some have not gotten me data and some have but we've been so bust and haven't had time to check it." Staff #14 reported several things were discussed in the meetings but verified all the requirements of Quality were not addressed or documented.

Based on observation, record review, and staff interviews, the hospital failed to.

1.
ensure Staff #30 (Charge Nurse), on the 3rd Floor Medical-Surgical Unit, was competent in the use of the Life Pack emergency defibrillator on 2 of 2 emergency crash carts. Also, the hospital failed to identify and remove expired supplies from the emergency crash carts.

Refer to Tag A0386

2.
A. ensure adequate staffing was provided for all patient care units, was unable to provide a patient acuity tool to determine the staff needed to provide safe care, or an acuity grid/matrix to determine the number of minimal staff needed for 7 out of 7 ( Inpatient Rehabilitation, Emergency Department, Mother/ Baby 606, Psych PRU 1 and PRU 2, Medical/Surgical 605, and ICU) patient care units.

B. ensure the dialysis department had, at a minimum, 2 trained Registered Nurses readily available to provide direct patient care to patients receiving hemodialysis. Also, the hospital failed to have a staffing matrix and plan for the dialysis department.

Refer to Tag A0392

3.
ensure the physician was explaining to the patient the risk and benefits of blood while obtaining the blood consent. The facility failed to ensure that the blood administration policy and procedure gave accurate instructions on obtaining blood consent and ensure the consent had a signature line, date, and time for the physician to sign in 2 of 2 (pt #4 and 8) charts reviewed.

Refer to Tag A0410

4.
ensure patient medical record entries were legible, completed, dated, timed, and authenticated by staff on the Cardiopulmonary Resuscitation Report in 5 (#29, #32, #33, #43, #44) of 5 patients records reviewed. Also, the Quality Department failed to monitor these reports for opportunities for improvement as required in the hospital's policy, "Cardiopulmonary Resuscitation/Adult or Pediatric Code Blue and Neonatal Code Blue"

Refer to Tag A0450

Based on observation, record review, and staff interviews, the hospital failed to ensure Staff #30 (Charge Nurse), on the 3rd Floor Medical-Surgical Unit, was competent in the use of the Life Pack emergency defibrillator on 2 of 2 emergency crash carts. Also, the hospital failed to identify and remove expired supplies from the emergency crash carts.

Findings inclued:

During a tour of the 3rd floor Medical-Surgical Unit on March 19, 2024, at 11:34 AM, the surveyor observed 2 emergency crash carts with Life Pack emergency defibrillators.

A review of the Daily Crash Cart Logs revealed the unit charge nurses were required to check the emergency crash carts daily, which included a test run of the Life Pack emergency defibrillator to ensure working order.

During an interview with Staff #30 (Charge Registered Nurse) on March 19, 2024, at 11:34 AM, Staff #30 stated, "Charge Nurses check the crash carts daily. Once completed it is recorded in the crash cart log".

The surveyor requested Staff #30 demonstrate a test run of the Life Pack defibrillator. Staff #30 was unable to successfully demonstrate the test on 2 of 2 emergency defibrillators. During the first attempt, Staff #30 stated, "I'm unsure how to test the Life Pack, I need to run over to ICU and ask." Two minutes passed, and Staff #30 returned to the unit and attempted the test again but was still unable to perform the test.

When asked whose initials were on the log showing that testing and crash cart maintenance had been done that day, RN Staff #30 stated, "Those are my initials. I check the tag on the crash carts to make sure it is secure every time I work."

In an interview on March 19, 2024 at 11:37 AM with Staff #10 (Medical Surgical Director), Staff # 10 stated, "I need to make sure all of the charge nurses are all educated and comfortable with using and testing the Life Packs."
During the inspection of the supplies in both crash carts, it was discovered that there were expired sterile supplies. These included a Multi-Lumen CVC Kit with Blue Flex Tip Catheter, expired 4/2023 in 1 of 2 crash carts, and a 16F Foley Catheter Kit, expired 5/2023 in 2 of 2 crash carts.

A review of the policy "Crash Cart Maintenance", Dated: 10/2022 revealed:

"Procedure

1.Maintenance of emergency drugs/supplies (crash cart) is the responsibility of the Unit Manager.
2.Crash carts must be checked for completeness and acceptable dating and condition at least daily by unit personnel ...The cart must be opened, and contents checked at least monthly if the cart has not been used.
...5. It is the responsibility of the Unit manager to ensure that Unit personnel are knowledgeable of and skilled in the use of emergency drugs/supplies and equipment.
...7. It is the responsibility of the Chief Nursing Officer to ensure that all supervisory staff are knowledgeable of and skilled in the use of emergency drugs/supplies and equipment.
8. Defibrillators must be checked daily ..."

An interview with Staff #81, RN, Unit Director, on March 19, 2024, at 11:47 AM, on the 3rd floor, Medical-Surgical Unit, confirmed that 2 of 2 crash carts have not been maintained per policy.

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

A. ensure adequate staffing was provided for all patient care units, was unable to provide a patient acuity tool to determine the staff needed to provide safe care, or an acuity grid/matrix to determine the number of minimal staff needed for 7 out of 7 ( Inpatient Rehabilitation, Emergency Department, Mother/ Baby 606, Psych PRU 1 and PRU 2, Medical/Surgical 605, and ICU) patient care units.

B. ensure the dialysis department had, at a minimum, 2 trained Registered Nurses readily available to provide direct patient care to patients receiving hemodialysis. Also, the hospital failed to have a staffing matrix and plan for the dialysis department.


Findings:

A. The surveyor reviewed the staffing sheets and staffing grids/matrix on 3/18/24 - 3/20/24 for the following units Inpatient Rehabilitation, Emergency Department, Mother/ Baby 606, Psych PRU 1 and PRU 2, Medical/Surgical 605, and ICU. Staffing grids are planning tools that assign the minimum number of staff needed to care for the number of patients on the unit per the hospital's Nurse Staffing Effectiveness Committee. An acuity tool is a tool used to determine when the staff needs to be increased based on the clinical patient characteristics, admissions, discharges, and the care involved to provide safe patient care. The facility was found out of compliance for nurse staffing on October 19th of 2023.

A review of the facility nursing grid revealed that the Registered Nurse (RN) and Licensed Vocational Nurse (LVN) were listed as the same discipline and counted as the same on the grid. However, an RN and LVN cannot be counted as the same. An LVN must have supervision by an RN and cannot be scheduled as an RN. The grid did not clarify if an RN was to be scheduled or an LVN. The surveyor was unable to determine if the schedule was covered appropriately without a way to identify if an RN or LVN was to be scheduled.

According to the Texas State Board of Nursing, " The LVN scope of practice is a directed scope of practice and requires appropriate supervision of a registered nurse, advanced practice registered nurse, physician assistant, physician, dentist, or podiatrist."

A review of the Staffing Effectiveness Committee Meeting Minutes dated 3/7/2024 revealed under new business: "Discussed and reviewed the updated unit matrix to include increasing the staff number if the unit is closed. Rehab and WU will have two staff on each shift. Also discussed changes to the staffing matrix that clearly demonstrate RN from LVN column." There was no mention of a staffing acuity plan.

An interview was conducted with staff # 60 RN on 3/19/24 concerning staffing for the ICU. Staff #60 confirmed that an acuity tool was not being used to determine staffing. There was no acuity tool used. The tool should assist in determining when nurse staffing should increase or decrease. Staff #60 stated that she or the house supervisor determines when staffing needs to be increased or decreased. Staff #60 confirmed there was no written process, and the determination was person dependent. Staff #60 was asked about staffing for breaks and lunches when the staffing grid was currently at the lowest minimal level. Staff # 60 stated that when a nurse goes to lunch there would be someone to cover for them. Staff #60 was asked how that would be documented. Staff #60 stated that there was no documentation of who covered for the RN. There was no further evidence that any other staff member would be available to assist in case of an emergency. There was no process for when the nurse would be allowed breaks, or who would relieve the nurse.

An interview with Staff # 15 was conducted on 3/20/24. Staff #15 stated that she had been working on a plan since the facility received citations from October of 2023. Staff # 15 stated that she was working on an acuity tool to help determine staffing needs, but the plan had not been approved by the governing body or implemented. Staff #15 stated she planned on putting it through to the governing board in a few months. Currently, there was no evidence of a clear and safe staffing grid/matrix or an acuity tool to assist with safe staffing levels.

A review of the Nurse Staffing Plan stated under purpose, "The goal of this policy is to create a healthy environment for nurses and appropriate care for patients by establishing a Nurse Staffing Effectiveness Committee whereby nurses and hospital management shall participate in a joint process regarding decisions about nurse staffing ... The plan will set minimum staffing levels for patient care units, will include a contingency plan when patient care needs unexpectedly exceed direct patient care staff resources, and will include a method for adjusting the staffing plan for each patient care unit to provide staffing flexibility to meet patient needs."


48653



B. This deficient practice had the likelihood of resulting in a delay in hemodialysis patient care and/or an incomplete dialysis treatment. Dialysis patients who do not complete or miss treatment are at an increased risk of electrolyte imbalances which can cause heart arrhythmias, cardiac arrest, and death.

During a tour of the 3rd-floor dialysis suite on 03/18/2024 at 1:15 PM with Staff # 10 (Dialysis Director), the surveyor observed Staff # 11 (Dialysis RN) initiating dialysis treatment on Patient # 3.

The surveyor observed Staff # 11 did not have additional support from a trained and qualified Registered Nurse to assist in the event Staff # 11 needed to leave the patient for a lunch break or personal emergency. There were no other staff in the hospital who had completed dialysis competency at the time of the observation.

In an interview with Staff # 10 on 3/18/2024 at 3:00 PM, the surveyor asked if there was an additional qualified staff member available to monitor and provide direct patient care to Patient # 3. Staff # 10 stated, "I am here, and my office is right across the hall from the dialysis suite, but I have not completed the Tablo training and dialysis competencies. I only did the introduction courses."



A review of daily staffing assignments for the dialysis department was conducted with Staff # 10.


Saturday, February 17th, 2024

Staff # 11 (Dialysis Registered Nurse) was on call and clocked in from 8:00 AM to 3:30 PM in the hemodialysis department. Staff # 11 provided dialysis treatment to patients in the dialysis suite.
Staff # 9 (Intensive Care Unit Charge Nurse) was deemed competent to provide direct patient care to hemodialysis patients treated on the Tablo machine.

Staff # 9 was clocked in and working as the Charge Nurse in the Intensive Care Unit from 6:49 AM to 11:00 AM. Staff # 9 clocked out for a lunch break from 11:00 AM to 11: 30 AM. Staff # 9 clocked out for the day at 7:08 PM. Staff # 9 was unable to leave the Intensive Care Unit (ICU) due to the role of Charge Nurse.

In the event Staff # 11 needed to leave for a break or personal emergency, there were no additional Registered Nurses who had been deemed competent and available to provide direct patient care to dialysis patients in the hospital.



Saturday, March 2nd, 2024

Staff # 11 (Dialysis Registered Nurse) was on call and clocked in from 7:30 AM to 10:39 PM in the hemodialysis department. Staff # 11 provided dialysis treatment to patients in the dialysis suite. Staff # 11 did not clock out for a break during the entire 14-hour shift.

Staff # 8 (Intensive Care Unit Nurse) was deemed competent to provide direct patient care to hemodialysis patients treated on the Tablo machine.

Staff # 8 was clocked in from 1:03 PM to 8:00 PM in the dialysis department.

Staff # 11 was working alone and did not have additional support in the dialysis department for approximately 7 hours.



The surveyor requested a staffing matrix and staffing plan for the dialysis department from Staff # 10 on 3/19/2024 at 9:00 AM. The hospital was unable to provide the surveyor with a staffing matrix and staffing plan for the dialysis department.


In an interview with Staff # 10 on 3/19/2024 at 10:00 AM, Staff # 10 acknowledged the dialysis department requires additional trained and qualified Registered Nurses available to provide direct patient care to hemodialysis patients.

Based on review and interview the facility failed to ensure the physician was explaining to the patient the risk and benefits of blood while obtaining the blood consent. The facility failed to ensure that the blood administration policy and procedure gave accurate instructions on obtaining blood consent and ensure the consent had a signature line, date, and time for the physician to sign in 2 of 2 (pt #4 and 8) charts reviewed.

A review of patient #4's chart revealed a blood consent dated and signed by the patient and an RN on 3/16/24 at 15:19 (3:19 PM). There was no physician signature nor a place on the consent form to sign. There was no found documentation that the physician had explained to the patient or representative the risks or benefits of blood administration. The patient had received multiple units of blood.

A review of patient #8's chart revealed a blood consent obtained by the RN on 2/20/24 at 17:57 (5:57 PM). There was no physician signature or progress note found that the physician had explained the risks and benefits. The patient received multiple units of blood.

A review of the policy and procedure "Blood Transfusions" revealed the facility gave instructions for the staff to obtain blood consent.

"PROCEDURE: ...
3. Unless the transfusion is an emergency, obtain a disclosure and consent from the patient or the patient's representative if patient unable to sign consent before initiating transfusion therapy and ensure that the consent form is in the patient's medical record. Operative consents may be used as long as all items concerning blood are initialed ..."
According to https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1312305/#sec1_4title, "The duty to obtain a patient's consent for treatment rests on the patient's treating physician (6). Hospitals, nurses, surgical assistants, and referring physicians do not owe this duty to their patients (7). The treating physician's duty to obtain a patient's informed consent cannot be delegated (8) ...
When patients are admitted to a hospital, they usually sign a general "consent to treat," which covers many diagnostic and therapeutic interventions. Interventions with the potential for significant morbidity or mortality require the specific informed consent of the patient, however. Most hospitals develop policies, specifying which interventions require documented informed consent (eg, central line placement, most surgical procedures, and most endoscopy procedures). This list includes transfusion of blood components and transplantation of tissues and organs. Blood components, tissue, and organs are biologically complex and vulnerable to contamination with infectious agents and thus may carry significant risk."

An interview was conducted with staff # 16 RN on 3/18/24 at 2:00 PM. Staff # 16 confirmed that the blood consents were not obtained by the physician and confirmed there was no place for the physician to sign the consent. An interview was conducted with staff # 60 RN on 3/19/24 at 11:00 AM and confirmed the blood consent had no place for the physician to sign. Staff #60 stated the physician should be giving the patient the risks and benefits but was unable to find any documentation during chart reviews.

Based on record review, and staff interview the hospital's nursing staff failed to ensure patient medical record entries were legible, completed, dated, timed, and authenticated by staff on the Cardiopulmonary Resuscitation Report in 5 (#29, #32, #33, #43, #44) of 5 patients records reviewed. Also, the Quality Department failed to monitor these reports for opportunities for improvement as required in the hospital's policy, "Cardiopulmonary Resuscitation/Adult or Pediatric Code Blue and Neonatal Code Blue"

On 3/21/2024, at 11:17 AM in the Conference Room, a review of the Cardiopulmonary Resuscitation Records for patients #29, #32, #33, #43, and #44 revealed multiple, significant errors.

Findings include:

Patient #29

Patient #29 required emergency resuscitative measures on 2/10/2024 at 7:46 PM. A review of the document titled, "Cardiopulmonary Resuscitation Record" lacked information regarding the responders to the emergency. While the recorder, Intensive Care Unit (ICU) nurse, and physician are identified, it was unclear who was responsible for tasks such as managing the airway, administering chest compressions, Intravenous (IV) medications, or operating the defibrillator.

The document failed to specify when the first assisted ventilation took place and did not provide a reason for ending the resuscitation.

The ICU nurse's signature was illegible.

According to the American Heart Association (AHA), it is suggested to have a "6-Person High-Performance Team," which includes a Compressor, CPR Monitor/Defibrillator Coach, Airway, Team Leader, IV Medication administrator, and Recorder.

Patient #32

Patient #32 required emergency resuscitative measures on 2/28/2024 at 9:08 AM. A review of the document titled, "Cardiopulmonary Resuscitation Record" lacked information regarding the responders to the emergency. While the recorder, ICU nurse, and physician are identified, it was unclear who was responsible for tasks such as managing the airway, administering chest compressions, IV medications, or operating the defibrillator.

The document failed to specify when the first assisted ventilation took place, what time, size, and by whom the ETT (the endotracheal tube that assists with the delivery of oxygen when in respiratory failure) was placed, or how the placement was confirmed.

The report did not provide a time the resuscitation event ended with the patient's outcome or the reason for ending the resuscitation.

There was no documentation of when chest compressions were started, or if there were any interventions with the AED (an Automated External Defibrillator is a medical device designed to deliver an electric shock to restore the heart rhythm to normal).

The ICU nurse and Recorder failed to date and sign the record and both signatures were illegible.

Patient #33

Patient #33 required emergency resuscitative measures on 12/31/2023 at 3:56 PM. A review of the document titled, "Cardiopulmonary Resuscitation Record" lacked information regarding the responders to the emergency. While the recorder, ICU nurse, and physician are identified, it was unclear who was responsible for tasks such as managing the airway, administering chest compressions, IV medications, or operating the defibrillator.

The document failed to specify when the first assisted ventilation took place.

The report did not provide a time the resuscitation event ended with the patient's outcome or the reason for ending the resuscitation.

Patient #43

Patient #43 required emergency resuscitative measures on 1/15/2024 at 6:00 PM. A review of the "Cardiopulmonary Resuscitation Record" document lacked essential information about the timing of the first assisted ventilation. An ETT was placed 8 minutes after the patient was apneic (not breathing).

The report did not provide a reason for ending the resuscitation.

The ICU nurse's signature was illegible.

Patient #44

Patient #44 required emergency resuscitative measures on 1/14/2024 at 11:55 AM. A review of the document titled "Cardiopulmonary Resuscitation Record" lacked information regarding the responders to the emergency. While the recorder, ICU nurse, and physician are identified, it was unclear who was responsible for tasks such as managing the airway, administering chest compressions, IV medications, or operating the defibrillator.

The document failed to specify when the first assisted ventilation took place.

The report did not provide a time the resuscitation event ended with the patient's outcome or the reason for ending the resuscitation.

There was no documentation of when chest compressions were started, or if there were any interventions with the AED.

The ICU nurse failed to sign, date, and time the record.

A record review of the hospital's policy titled, "Cardiopulmonary Resuscitation/Adult or Pediatric Code Blue and Neonatal Code Blue" Dated: 12/2023, revealed:

"Purpose

...establish a standard for restoring cardiopulmonary function utilizing guidelines from American Heart Association (AHA) ...

...Documentation

A.Resuscitation "Code Blue" calls will have a code documentation form completed and placed/scanned in the patient's medical record.
1. An adult or pediatric "Code Blue" will be documented using the Adult Code Blue form ...

Quality Monitoring and Evaluation

A. Code Blue events should be reviewed for compliance with ACLS standards, code duration, patient outcomes, and identified issues. The Quality Department will review Code Blue Events for opportunities for improvement in the resuscitation process and data will be shared during the Quality Patient Safety Council.
B. Identified individual performance issues or identified learning needs are referred to the appropriate director, education department, or Nursing Chart Review committee as appropriate."

During an interview with RN, Staff #13 on 3/21/2024 at 11:17 AM in the Board Room, it was confirmed that the Cardiopulmonary Resuscitation Record was consistently not, legible, completed, dated, timed, or authenticated by staff, and the Quality department was not regularly monitoring for opportunities for improvement as per hospital policy.

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

A. Ensure secure storage of Radioactive Contrast (Intravenous Contrast) in 1 of 5 units observed Post Anesthesia Care Unit (PACU).

B. Ensure the IV Contrast was stored at temperature ranges recommended by the manufacturer in 1 of 5 units observed (Post Anesthesia Care Unit).

C. Ensure storage and security of controlled drugs in accordance with Federal and the State rules and regulations in 2 of 5 units, (Post Anesthesia Care Unit) and the dialysis suite located on the 3rd floor of the hospital.

Findings:

A. During a tour of the post-anesthesia care unit (PACU) on 03/18/2024 at 11:20 AM with Staff #36 the following safety issues:

Observations:
1. It was observed that there were 6 cases of IV Contrast bottles stored in an area behind a curtain, PACU Bay#2, on the metal cart. This area had no door and is only separated from the main treatment are by two walls and a pull curtain.
2. The IV Contrast located in the PACU was not locked or under constant monitoring by an authorized staff member 24 hours
Documentation Review:
1. Policy- Storage Of Drugs (General) #9137543, Effective 03/2021, Last revision Dated 06/2012, Expiration 03/2024.
a. "Procedure: Drugs shall be stored under the proper conditions of sanitation, temperature. Light, moisture, ventilation, segregation, and security".
2. Policy- Medication Management #7914452, Effective 06/2020, Last revision Dated 08/2014, Expiration 06/2023.
a. "Storage Of Medication":
1. Medications are secure so that unauthorized personnel cannot obtain access to them.
2. All medication storage areas are periodically inspected by the pharmacy. Each nursing unit is inspected monthly by pharmacy and floor stock inspected sheet is filled out for each area.

Interviews:
1. An interview with the Director of Surgery #36 on 03/18/2024 at 11:30 AM acknowledged the evening housekeeper for the surgical department has access to the IV Contrast located in the PACU area.


B. During a tour of the post-anesthesia care unit (PACU) on 03/18/2024 at 11:20 AM with Staff #36 the following safety issues:

Observations:
1. It was observed that there were 6 cases of IV Contrast bottles stored in an area behind a curtain, PACU Bay#2, on the metal cart. This area had no door and is only separated from the main treatment are by two walls and a pull curtain.
2. PACU has no monitoring for the environment for temperature and or humidity that is monitored.

Documentation Review:
1. Policy- Storage Of Drugs (General) #9137543, Effective 03/2021, Last revision Dated 06/2012, Expiration 03/2024.
a. "Procedure: Drugs shall be stored under the proper conditions of sanitation, temperature. Light, moisture, ventilation, segregation, and security".
2. Policy- Medication Management #7914452, Effective 06/2020, Last revision Dated 08/2014, Expiration 06/2023.
a. "Storage Of Medication":
1. Medications are secure so that unauthorized personnel cannot obtain access to them.
2. All medication storage areas are periodically inspected by the pharmacy. Each nursing unit is inspected monthly by pharmacy and floor stock inspected sheet is filled out for each area.

Interview:
1. An interview with the Director of Surgery #36 on 03/18/2024 at 11:30 AM acknowledged there is no current way to monitor humidity control in PACU although there is a thermostat located in the area it also is not documented or checked on a regular basis of temperature control.

C. During a tour of the post-anesthesia care unit (PACU) on 03/18/2024 at 11:20 AM with Staff #36 the following safety issues:

Observations:
1. The medication refrigerator located in the PACU was not locked or under constant monitoring by an authorized staff member.
2. The following medication was in the medication refrigerator included:
a. Rocephin
b. Humulin Regular 4 bottles
c. Famotidine 20 mg/per ml 13 vials
d. Promethazine suppository
e. Hemabate 250 mcg
f. Methagine 0.2 mg/ml

Documentation Review:
1. Policy- Storage Of Drugs (General) #9137543, Effective 03/2021, Last revision Dated 06/2012, Expiration 03/2024.
a. "Procedure: Drugs shall be stored under the proper conditions of sanitation, temperature. Light, moisture, ventilation, segregation, and security".
2. Policy- Medication Management #7914452, Effective 06/2020, Last revision Dated 08/2014, Expiration 06/2023.
a. "Storage Of Medication":
1. Medications are secure so that unauthorized personnel cannot obtain access to them.
2. All medication storage areas are periodically inspected by the pharmacy. Each nursing unit is inspected monthly by pharmacy and floor stock inspected sheet is filled out for each area.

Interview:
1. An interview with the Director of Surgery #36 on 03/18/2024 at 11:30 AM acknowledged the medications in the refrigerator were not secured. Staff #36 stated, "We never locked the refrigerator; I don't even know where the key is located."
2. An interview with the Director of Surgery #36 on 03/18/2024 at 11:30 AM acknowledged the evening housekeeper for the surgical department has access to the medication located in the PACU area.
During a tour of the Dialysis Suite on the third floor of the hospital on 03/18/2024 at 1:34 PM the following issues:

Observations:
1. The medication cabinet located in front of dialysis machine # 4 was not locked or under constant monitoring by an authorized staff member. The following was located in the medication cabinet: Included:
a. 3 boxes of heparin (each containing 25 (1ml) vials of heparin)
b. 3 boxes of xylocaine (each containing 25 (1ml) vials of Xylocaine)
c. 10 (1000ml) bags of Normal Saline IV fluid

Document Review:
1. Policy- Storage Of Drugs (General) #9137543, Effective 03/2021, Last revision Dated 06/2012, Expiration 03/2024.
a. "Procedure: Drugs shall be stored under the proper conditions of sanitation, temperature. Light, moisture, ventilation, segregation, and security".
2. Policy- Medication Management #7914452, Effective 06/2020, Last revision Dated 08/2014, Expiration 06/2023.
a. "Storage Of Medication":
1. Medications are secure so that unauthorized personnel cannot obtain access to them.
2. All medication storage areas are periodically inspected by the pharmacy. Each nursing unit is inspected monthly by pharmacy and floor stock inspected sheet is filled out for each area.

Interview:
1. During an interview with Staff #10 on 3/18/24 at 2:30 PM, Staff #10 acknowledged the cabinet with medications in it was unlocked and accessible to unauthorized personnel.

Based on review of records, observation, and staff interviews, the facility failed to have an active hospital-wide program for the surveillance, prevention, and control of HAIs and other infectious diseases when:

A. the facility failed to ensure policies and procedures were implemented and enforced (Cross Refer A0749).

B. the facility failed to maintain a clean and sanitary environment and infection control rounds in 7 (Medical/Surgical, Materials Management, Behavioral Health PRU #1 and PRU #2, Respiratory, Labor and Delivery/Womens Services, and Emergency Room,) of 7 Departments observed. (Cross Refer A0750).

C. the facility failed to ensure policies and procedures adhered to nationally recognized guidelines when there was no active surgical site infection surveillance (Cross Refer A0772).

Based on review of records and staff interview, the facility failed to ensure the hospital infection prevention and control policies and procedures were implemented and enforced when:
A. The dialysis staff failed to perform hand hygiene and ensure proper use of PPE (personal protective equipment). Also, the dialysis staff failed to follow the hospital policy, "Hemodialysis Infection Prevention".
B. The linen and laundry service was not maintained to prevent and control transmission of infections; and
C. The dietary service did not maintain temperatures, humidity, or concentration of sanitizer.

These deficient practices had the likelihood to result in the transmission of infectious agents between patients and hospital staff.

Findings:

A. During a tour of the hospital's 3rd-floor dialysis suite on 03/18/2024 at 1:30 PM, the surveyor observed Staff #11 wearing a pair of gloves to touch the Tablo (hemodialysis machine). Staff # 11 wore the same pair of gloves when touching Patient # 9's CVC (central venous catheter).

During a tour of the hospital's 3rd-floor dialysis suite on 03/18/2024 at 1:34 PM, the surveyor observed Staff # 11 wearing an isolation gown while caring for Patient # 9. Staff # 11 did not remove the isolation gown before going to the nurse's station to chart. Staff # 11 had food and drinks at the nurse's station where she was charting.


A review of the hospital's policy titled, "Hemodialysis Infection Prevention" with a revision date of 06/2023 revealed,

"PURPOSE: To limit the spread of infections among the staff members and patients.

STATEMENT OF POLICY:

PERSONNEL:

All employees will comply with the hospital's Employee Health Program ...
Employees are to be knowledgeable of infection control practices and Universal/Standard Precautions. HBV Precautions should be followed for known or unknown HB-positive patients.
Dialysis staff must be Hepatitis B immune if dialyzing a Hep B patient. Hepatitis titers will be drawn yearly to check for immunity.

TRAFFIC CONTROL:

No visitors are allowed while the patient is receiving dialysis due to the high risk of exposure to blood or bloodborne pathogens.
Appropriate Use of Personal Protective Equipment (PPE):
Staff members are to wear fluid-resistant gowns, face shields/eyewear, and masks when performing procedures in which contact with blood or blood splatter may occur. Gloves should be worn when touching bloodlines, dialyzer, or dialysis delivery system during or after dialysis.

Appropriate PPE will be always worn when performing the dialysis treatment, whether in the dialysis suite or an individual patient room.
When caring for two patients in the dialysis suite, all PPE will be kept separate, hands must be washed or sanitized, and new PPE donned before moving from one patient machine to the next.
PPE worn during the treatment will be disposed of post-treatment in the regulated waste container.

PPE should be worn when it is likely that contact with blood may occur, such as but not limited to:
*The initiation and completion of dialysis treatment.
*When touching patients during activities with potential exposure to bloodborne pathogens and other potentially infectious material.
*Any time that the dialysis system is required to be open. (re-circulating, re-cannulating, or interruption of treatment for any reason).
*When performing venipunctures or other vascular access procedures ..."


During an interview with Staff # 10 on 03/18/2024 at 1:45 PM, Staff # 10 acknowledged dialysis staff were not changing PPE at the appropriate intervals.


B. The following was observed on the morning of 3/20/24 with Staff #44, Area VP EVS [Environmental Services], Staff #54, EVS Director, and Staff 55, Core Measures/Abstractor:
*The washer room:
-discolored metal, wood, and tiles throughout, indicating these areas were not cleaned appropriately
-dust build-up on hoses and equipment behind the three washers, indicating these areas were not cleaned
-bubbling paint on the wall

*The dryer room:
-four (4) bins with debris noted along the bottom where clean clothes used to remove clothes from the dryer and into the clean linen folding room.
-standing fan with a build-up of white substance on the blades. Staff #44 reported this fan was not used and will be removed.
-discolored metal and chipped ceiling tiles, making it impossible to clean
-a clear thick plastic barrier with six (6) flaps between the dryer room and clean linen folding room with brown and black spots and a hazy build-up throughout. Staff #54 reported they were unsure how often these were cleaned but would get replaced.
-Staff #59 had appropriate PPE [Personal Protective Equipment] while de-bagging and sorting soiled linen. Staff #59 removed PPE and walked through the washer room and began removing clean linens from the dryer without washing hands up to elbows. Staff #44 asked if Staff #59 washed their hands prior to removing clean linens, Staff #59 went into the clean linen room and used alcohol-based hand rub.

*The clean linen folding room:
-Four (4) blue metal tables had clean linens folded and had discoloration along the lips, making it impossible to clean
-The wheels on the four (4) tables had visible dirt; the table closest to the dryer room had a thick build-up of dust

*The hallway:
-A linen cart for the East campus covered with a mesh substance with visible discoloration. Staff #44 and 54 reported these mesh coverings were used to protect the linens and verified the mesh and holes would not protect clean linens from the air during transport.

*The loading dock:
-Contaminated linen bins were noted with build-up on the insides and outside, indicating they were not effectively cleaned
-All contaminated linens were in bags and the bins had no covers


During the tour, Staff #44 reported trucks would deliver dirty linen from the East campus and the same truck would transport the clean linen back. Staff #44 reported the trucks should be cleaned each time between dropping off dirty linens and loading the clean linens but was not sure if this was being completed.

The above findings were verified during the tour with Staff 44, 54, and 55.

EVS contract-based policy and procedure titled "EVS Linen Operations" with a last review date of 12/2023 stated in part, "Infection Prevention Requirements:
*We're required to cover the clean linen carts with a compatible protective cover To [sic] minimize any possible airborne contamination of the clean linen.
*Carts should remain covered at all times when they're being transported and stored on units.
...Keep Carts Clean & Check their Condition Daily
*Disinfect linen delivery carts daily.
*Before using a cart, check to make sure it's in good condition. There should be no tears in the cart cover, no damaged wheels, etc. Notify your manager if the cart or cover is not in good condition.
Delegate Team Member Responsibilities Appropriately:
To help ensure that linen stays clean, the team member responsible for the collection of contaminated linen should not be the same team member who handles clean linen.
...Covering Soiled Linen Carts:
*Secure the soiled linen collection cart with a protective cover to minimize any possibility of cross-contamination.
*This cart should remain covered at all times and should only be opened when you're placing contaminated linen inside.
...Cleaning Soiled Linen Carts: Every Day!
*Every day, soiled linen collection carts must be completely cleaned with an approved disinfectant ...

Facility-based policy titled "Portable Fan Use" policy #14190908 stated in part, "Fans should not be used in medication rooms, clean supply or soiled utility rooms which are located in small confined spaces ...
Care and Maintenance
Regular inspection is required for product integrity and safety prior to placement ...
Cleaning and Disinfection
...Develop a preventative maintenance schedule and assign responsibility that includes:
-Visual inspection after use
-Weekly cleaning and disinfection of all components
-Additional cleaning and disinfection when visibly soiled."

B. Review of Dietary temperature monitoring book revealed the following:
*Sandwich #1 Refrigerator dated January 2024, indicated temperature checks to be monitored two times a day with "Refridgerator [sic] temperature should be maintained at or below 41°F.
-Sandwich #1 Refrigerator dated February 2024, indicated temperature checks to be monitored three times a day with the range as 34-40 °F [degrees Fahrenheit]. 23 of 87 checks were documented out of range with no corrective action noted; the morning of 2/20/24 was documented "not working;" and no temperature was recorded for the evening of 2/29/24.

*Food Warmer #2 for January 2024 stated, "Warmer temperature should be maintained at or above 141°F."
-Food Warmer #2 for February 2024 stated "Take the temperature of at least 1 pan of food inside box at each time period; record below.
...Standard = 140°F or above
Corrective Action if food is less than 140°F:
~Reheat to 165°F if food had been less than 140°F for less than 2 hours.
~Discard if food has been less than 140°F for more than 2 hours.
~Inform Manager/Supervisor immediately whenever corrective action is needed"
-Food Warmer #2 for February 2024 had two times for each meal to check the food warmer at breakfast 6:30 AM and 8:30 am, lunch at 11:00 am and 1:00 pm, and dinner at 4:00 pm and 6:00 pm. The first breakfast column at 6:30 am had times written for the 1st-29th. The second breakfast column had initials for the 1st-29th except of the 24th and 25th which was documented as "Off." The lunch 11:00 am and 1:00 pm had 5 of 36 documented out of range without corrective actions noted. The dinner column marked 4:00 pm was documented as times for 1st -23rd ; the column marked 6:00 pm were documented as initials for 1st - 27th; the column marked "sup/mgr initials" was documented as "off" for 3 of 29 days.

*Hot Holding Box log #1 for February 2024 had two times for each meal to check the food warmer at breakfast 6:30 AM and 8:30 am, lunch at 11:00 am and 1:00 pm, and dinner at 4:00 pm and 6:00 pm. The breakfast column at 6:30 am had times written for the 1st-29th. The breakfast column for 8:30 am had initials for the 1st-29th. The lunch 11:00 am and 1:00 pm had 5 of 36 documented out of range without corrective actions noted. The dinner column marked 4:00 pm was documented as times for 1st -27th.

*"Reach thru cooking" for February 2024 stated, "Maintain cold potentially hazardous food at 40F/5C or below;" 2 of 44 were out of range with no corrective action noted.

*"Patient Reach In" for February 2024 indicated temperature checks to be monitored three times a day with the range as 34-40 °F. 6 of 87 checks were out of range with no corrective actions noted or not documented.

*Women's refrigerator temperature record indicated temperature range as 34-40 °F. 6 of 29 checks were out of range with no corrective actions noted.

*East Dish Machine Temp Log for January 2024 stated in part, "List comments or problems under "Actions Taken". Notify manager whenever standards are not met.
If wash temp <160°F or rinse temperature <180°F:
-Test surface temp with waterproof thermometer (std=160F) and notify manager ..." However, above the Breakfast, Lunch, and Dinner columns, the was temp stated "150° or > and the rinse temp stated "180°F or >." 26 of 84 temperatures were out of range without any actions taken documented.

*The 3-compartment sink temperature record for February 2024 stated in part, "Standard: Check the instructions on the test strips package - some types specify that the test solution must be at 65°F to 75°F when tested. When in use, the solution must be at a minimum of 75°F. The 1st sink temperature must be at a minimum of 110°F. The 3rd sink temperature and ppm is dependent on the sanitizer solution used. Enter the correct 3rd sink temperature and ppm [parts per million] on the form above for the solution being used." The columns for "Sanitizer Test Temp" and "PPM" were not completed. The breakfast column "Wash Temp" was documented as initials from 2/7/24 through 2/29/24 (23 of 29 days). Lunch sanitizer test temp ranged from 200-400 and ppm ranged from 100-180. Dinner sanitizer test temp ranged from 200-400 and ppm ranged from 60-400. It was unable to be determined if the temperatures and wash temps were appropriate for 87 of 87 checks as the form was not completed as indicated and lunch and dinner were not completed for lunch and dinner of 2/27/24 and 2/29/24.

*"Concentration log: Sanitizer solution from dispenser" dated February 2024 listed times instead of PPM from 2/19/24 through 2/29/24, 11 of 29 days.

*Dry Storage Temperature West Log for January 2024 stated in part, "Dry Storage temperature should be maintained between 50°F to 75°F ... Call engineering whenever temperature rises above 75°F." 2 of 62 temperature checks were out of range without corrective actions documented. Relative humidity was not monitored for January 2024.
*Dry Storage Temperature & Humidity West Log for February 2024 stated in part, "Dry Storage temperature should be maintained between 50°F to 70°F [5°F below the range from January 2024] with a relative humidity of 60%. List comments or problems under 'Corrective Action'. Notify manager whenever standards are not met ..." 40 of 58 temperature and 14 of 58 relative humidity checks were out of range without corrective actions documented.
*Dry Storage Temperature East Log for January 2024 stated in part, "Dry Storage temperature should be maintained between 50°F to 75°F ... Call engineering whenever temperature rises above 75°F." 59 of 62 temperature checks were out of range without corrective actions documented.

*Victory wash solution concentration log for January 2024 indicated the concentration should be between 40-80 ppm; 26 of 31 checks were out of range without corrective actions documented.

*Victory wash solution concentration log for February 2024 indicated the concentration should be between 40-80 ppm; 29 of 29 checks were out of range without corrective actions documented.

During an interview on the morning of 3/19/24, Staff #24, Food Services Director, verified the logs changed from month to month and did not always indicate which range temperatures, concentrations, and humidity should be. Staff #24 reported they did not sign-off on the logs indicating they checked them and did not consistently check the logs.


Facility-based policy 603147 titled "Kitchen Sanitation" stated in part, "1. Temperature Checks:
A. Refrigerators and Freezers
...2. Temperature checks are made and recorded on record sheets by Supervisory personnel.
...3. Equipment
A. Steam table
1. Food temperature is checked with thermometer before serving, and temperatures are recorded.
a. Hot food should be held at temperatures of 135 degrees F or above.
...4. Preparation for Dishwashing
...Insure [sic] temperature gauges are at proper temperatures before washing dishes. **140 degrees F (Wash), 160 degrees F (Pre-Rinse), and 180 degrees F (Final Rinse).
5. Dish Washing
A. Automatic Dishwasher
3. The wash period is at least 40 seconds with the temperature being at least 160 degrees F.
4. The sanitizing rinse period is at least 20 seconds with the temperature 180 degrees F or higher.
...B. Wash Dishes: ... Monitor temperature dials on machine to insure [sic] proper temperature.
...7. Storage Refrigerators
...C. All refrigerators have thermometers which are monitored two times a day.
1. Fruits, vegetables, dairy products: 33-40 degrees
...Storage of Frozen Fruits, Vegetables, and Bakery Goods, etc.
...Storekeeper will place items in freezer at 10 to 0 degrees F ...
G. Storage of Dairy Products, eggs cheeses, salad dressing, jelly, etc.
...Storekeeper will place items in appropriate walk-in refrigerator to 40-45 degrees F ..."

Facility-based policy number 11354505 titled "Refrigerator" stated in part, "Temperature should be monitored and recorded daily.
-Normal patient nourishment refrigerator temperature is between 36F and 40F and patient nourishment freezer temperatures maintained between 14F and -4F ..."

Based on observation, review of records, and staff interview, the facility failed to maintain a clean and sanitary environment in 7 (Medical/Surgical, Materials Management, Behavioral Health PRU #1 and PRU #2, Respiratory, Labor and Delivery/Womens Services, and Emergency Room,) of 7 Departments observed to avoid sources and transmission of infection when infection control tour findings throughout the survey were observed and infection control rounds were not being performed regularly.

Findings:

During a tour of the 3rd floor medical-surgical unit on the morning of 3/19/24, Staff #30 verified following expired supplies were found in the crash carts:
*Central Venous Catheter kit expired 4/2023
*(3) 16 French Foley Catheter kits expired 5/2023

During a tour of Materials Management on the afternoon of 3/19/24, with Staff #58, Director of Supply Chain and Staff #14, Director Quality/Regulatory, shipping boxes were noted throughout mixed with clean open and sterile supplies. There was no separation of sterile, clean, and dirty.
The nationally accepted standards set forth by the Association for the Advancement of Medical Instrumentation (AAMI) state, "External shipping containers have been exposed to unknown and potentially high microbial contamination. Also, shipping cartons, especially those made of corrugated material; serve as generators of and reservoirs for dust." (AAMI 5T46-Section 5.2 Receiving Items).

During a tour of the Behavioral Health [BH] area on the morning of 3/20/24, the following was observed and verified by Staff #53, Director of BH Services and Staff #52, BH Quality:
PRU 1:
*Clean linen room with an open chip along counter and trim, making it impossible to clean
*Crack on the floor of the seclusion room
*Nutrition room ice maker with build-up noted on filter vents
*Janitor room closet with items stored on the ground and a dark build-up noted on the ceiling vent

PRU 2:
*Noisy Activity/Dining/Kitchen Room:
-laminate on bookshelf peeling
-dirt in overhead light
-gap along the crack of the door leading to the courtyard allowing light to enter and possible for pests and other contaminates to enter
*Seclusion room with spiderwebs in windowsill
*Patient Room 462 with chip on the wall

During a tour of the Respiratory Department on the afternoon of 3/20/24 the following was observed and verified with Staff #47, Respiratory Manager:
*Crack in the main station countertop
*Crack in the wall above the door of sleep lab #2

Review of the facility-provided "Infection Control/EOC [Environment of Care] Rounding" logs for October 2023 through March 2024 revealed these were not performed consistently nor for each department:
*Radiology rounds in 11/2023 was not completed as only "General Cleanliness, Sprinkler Head Escutcheon plates, and No stained or broken ceiling tiles" were addressed; none of the items under "Infection Control" were addressed.
*There were no rounds for Surgery, Sterile Supply, Dietary, Respiratory, Inpatient Rehab, Behavioral Health, Materials Management, Linen and Laundry

In an interview on the afternoon of 3/20/24, Staff #14 verified the above findings.

Infection Control and Prevention Nurse job description stated in part, "Conduct regular rounds in hospital departments for discussing, monitoring, and following practices of infection control with hospital staff and volunteers.
...Monitoring the execution of preventative measures and providing guidance to staff."

Facility-based policy number 12771192 titled "Sp6036 Storage of Sterile Supplies" last approved 03/2023 stated in part, "Sterile supplies shall be separated from clean supplies.
*A clean nonsterile storage area is designated for this purpose.
...Do not store any item in the sterile or clean area in their original cartons. Articles are to be removed from the shipping boxes and placed on small transfer cart which can be wheeled into the area ...
All personnel in Central Service, Materials Management and other areas with sterile supplies are responsible for proper storage of these supplies."





29191

Emergency Room

During a tour of the emergency room with Staff #14 on 03/20/2024 at 11:15 AM the following infection control issues were observed:

* Trauma room #1 had an overhead light fixture missing. Observed a straight pole hanging down with open wiring over the patient's bed.

* In exam room #3 expired supplies were found in the drawers.

Chloraprep pads expired 07/2022
Hologic swabs expired 04/30/2023

* During the tour of the emergency room observed housekeeping staff clean exam #3. Housekeeping cleaned under the foam mattress, but the underneath was left wet there was no dry time allowing the disinfectant to activate.

* The emergency call cord in the bathroom that is in the back of the emergency area fell out of the alarm panel when the surveyor touched the cord. There were dead bugs in the overhead light fixture of this bathroom and observed rust spots on the A/C vent.

* Observed an intravenous pole in the back closet of the emergency room that was rusted. Rusted metal can not be disinfected.

* Observed several entrances to the patient exam rooms that had chipped and missing paint from the door frames.

An interview with Staff #14 on 03/20/2024 at 11:15 AM acknowledged the infection control and safety issues observed on the emergency room tour.


40989

Labor and Delivery/Women Services Unit

A tour of the Labor and Delivery Unit/Women Services Unit was conducted on 3/18/2024 at 10:00 AM with RN Staff #16. The following was observed:

Findings:

Labor Room 2 (LDR 2)
In LDR 2 the cabinets under the handwashing sink were unlocked. Inside the cabinet, under the faucet, a dried brown liquid was noted that resembled a water stain. A wooden rocking chair in the room had exposed, unsealed wood on both arms and the base of the chair. The drop-down door on the wooden cabinet that stored the fetal monitor was scratched and chipped exposing the bare wood. The porous surface was not able to be cleaned and sanitized to mitigate the spread of infectious diseases. This room was identified as clean a ready to receive a new patient.

Operating Room (OR) for cesarean sections.
This room was clean and ready for a new surgical patient. EKG leads hanging over the IV pole had uncovered EKG pads attached and ready for patient use. The trash can next to the anesthesia machine contained trash such as dirty gloves and a dirty napkin. On a table next to the anesthesia machine were two laryngoscope handles that were not identified as clean, dirty, or disposable. Two laryngoscope blades were in an unsealed plastic bag. The surveyor was unable to determine if the laryngoscope blades were clean or dirty. Laryngoscope blades attach to a laryngoscope handle to assist in placing a breathing tube in a patient. One 20 ml (milliliter) syringe with a blunt tip needle and one 5 ml syringe with a blunt tip needle attached were left on the table under a blue towel. An endotracheal tube (a tube placed in a patient's airway to assist or breathe for a patient) was opened and a stylet (a flexible device placed inside an endotracheal tube to aid in directing the tube in the proper place of a patient's airway) was noted inside the tube. The CO2 line (a line connected to the patient's breathing circuit during anesthesia that gives instant information about the patient's ventilation and how well the patient is eliminating carbon dioxide while under anesthesia) was connected to the patient mask on one end and the opposite end was on the floor. On top of the anesthesia cart was a metal rack that held labels with drug names to be applied to a syringe once the medication was drawn up in it. Inside the metal rack was dirt, dust, and debris that was stuck to the bottom of the inside. A tube of Lubricant eye ointment was noted on the cart and the seal had been broken. There was no date of when the ointment was opened or when it expired. Hanging on the wall was a Stericycle disposal for pills, tablets, IV fluids, and patches. The top of the disposal was open for use. A lid was noted on the bracket that holds the canister in place. The opening where you dispose of the medications was covered with a brown and black colored stain/dried liquid. The metal rack holding the container was noted with white powder, dirt, and dust.

Sterile Supply Closet
The sterile supply closet stored clean and sterile supplies. The room was not monitored for temperature or humidity. There was no thermostat control in the room. A metal locker was noted with chipped paint exposing the metal surface beneath the paint. A camouflage jacket was observed being stored on top of the metal locker.

On 3/18/2024 after 10:00 AM RN Staff #16 confirmed the locker in the sterile supply room once belonged to the anesthesia department but had been placed in the room because it was no longer in use.

Dirty Utility Room
Inside the dirty utility room was storage for dirty linen, mop buckets, and trash. The mop bucket handle was reinforced with tape that was unraveled and exposed the rust inside the metal mop bucket handle. The inside and outside of the mop bucket was covered with dirt, dust, and water stains. Clean mops were placed in the bucket and then taken into patient rooms and the Operating Room to clean and sanitize the floors. The concrete floors in the dirty utility room were noted to have dried white and blue paint, dirt, dust, and debris.

Patient Medication Room
The wooden door leading into the patient medication room was chipped and missing wood exposing the porous surface beneath. The porous surface was unable to be cleaned and sanitized to prevent the spread of infectious diseases. On top of the patient medication cart was a pill crusher used to split and crush a patient's medication. The pill crusher had visible dust, dirt, debris, and reddish/brown colored dried liquid noted on the top and inside. On the bottom of the medication cart, directly above the wheel, a red dried liquid was observed.

Patient Nutrition Room
Inside the patient nutrition room was a refrigerator used to store patient nutrition. On the bottom of the refrigerator, a dried, brown-colored liquid was observed. The floor under the refrigerator was observed to have a black and brown colored sticky substance that aligned with the width of the refrigerator. In a lower cabinet, cleaning supplies were being stored. Inside this cabinet, a dried, yellow-colored liquid was on the shelf.

Exam Room
Inside a room designated as "EXAM ROOM" was a red examination chair that was electronic and could be laid flat to examine patients in the labor and delivery department. On the edge of the mattress, a brown-colored sticky residue was observed. An overhead light used for examinations was observed with dirt and dust.

Women's Services Unit
The room used to store clean and sterile supplies did not have a way to monitor temperature and humidity. Inside the storage room was a restroom that was used by the staff. There was no separation of clean and dirty in the supply room due to the restroom being utilized by staff.

RN Staff #16 confirmed there was no thermostat control in the sterile storage area.


A review of the AORN (Association of periOperative Registered Nurses) Perioperative Standards and Recommended Practices,
"Temperature should be maintained between 68 degrees F to 75 degrees Fahrenheit (20 degrees to 23 C) within the operating room suite ... Relative humidity should be maintained between 20% and 60% within the perioperative suite, including operating rooms, recovery area, cardiac catheterization rooms, endoscopy rooms, instrument processing areas, and sterilizing areas and should be maintained below 60% in sterile storage areas ...
Humidity should be monitored and recorded daily using a log format or documentation provided by the HVAC (heating, ventilation, and air conditioning) system.
Temperature should be monitored and recorded daily using a log format or documentation provided by the HVAC (heating, ventilation, and air conditioning) system."

A review of the ANSI/AAMI standards was as follows:

" ...ANSI/AAMI S179:2017 - Comprehensive guide to steam sterilization and sterility assurance in health care facilities
11 Storage and transportation

' 11.1 Sterile storage

11.1. Storage facilities

Sterile items should be stored under environmentally controlled conditions in a manner that reduces the
potential for contamination.

Sterile storage areas should be kept clean and dry..."


An interview was conducted with RN Staff #16 on 3/18/2024 after 10:00 AM. RN Staff #16 was asked how the sterile supplies were monitored to ensure the supplies stayed within the required temperature and humidity ranges to ensure the sterility of the package. RN Staff #16 confirmed the rooms used to store sterile and clean supplies were not monitored daily. Also, she confirmed the restroom in the sterile supply storage was used by staff daily.


32143

A tour was conducted in the Emergency Room on (ER) 3/19/24 at 2:50 pm with staff # 69 RN. The following items were found.

Findings:

The sink in the medication room did not have a splash guard. The eye wash station was attached to the sink.
Medications were stored next to the sink. There was spray and splash of sink water on the tops of normal saline bottles.

In the medication room soiled and full medication waste containers were found sitting next to clean and sterile patient medical supplies. The medication bio-hazard container was also pushed up against a cabinet door. The door was heavily soiled with dried liquids, dirt, dust, and hair. The paint was chipped and missing. The hinge on the door allowed the cabinet door to stay cracked. Inside the door were blood tubes and needles ready for patient use.

In the medication room, a trash can was found sitting on a box next to the clean and sterile patient supplies. Clean tourniquets were found spilling over into the trash can and ready for patient use.

The nurse's desk in the ER was found to have large chunks of missing laminate exposing bare wood surfaces that cannot be cleaned properly.

The ER refrigerator and freezer in the nourishment room were covered with ice and were not able to be cleaned properly.

4- ER stretchers were found to have tape on the beds and handles. The beds are unable to be cleaned properly due to the tape and tape residue.

Based on review of records and staff interviews, the facility failed to develop and implement a hospital-wide infection surveillance, prevention, and control policies and procedures that adhered to nationally recognized guidelines when there was no active surgical site infection [SSI] surveillance.

Findings:

In an interview on the morning of 3/19/24 with Staff #14, Director of Quality/Regulatory and Staff #55, Core Measures/Abstractor, they reported they were managing the Infection Control [IC] & Prevention program since the IC nurse position was vacant, and all information was provided they had access to. Staff #55 reported they monitor SSIs by reviewing lab reports for infections as they come through. Staff #55 verified there was no documentation of SSI monitoring and each patient who had surgery was not reviewed, only if an infection report came through.

In an interview on the afternoon of 3/19/24, Staff #36, Director of Surgery, reported they do not complete SSI monitoring and were notified through facility quality/infection control if an infection from a surgical patient came across. Staff #36 reported surgeons did not necessarily report if a patient came to see them on an outpatient basis for issues nor did they contact patients to see if they had an infection or issues after surgery.

There was no documented evidence provided of nosocomial or surgical site infection surveillance conducted after 30 days or implant infection surveillance conducted after 90 days.

Centers for Disease Control and Prevention [CDC] procedure-associated module titled "Surgical Site Infection (SSI) Event," dated January 2024 found at: https://www.cdc.gov/nhsn/pdfs/pscmanual/9pscssicurrent.pdf stated in part, "SSI monitoring requires active, patient-based, prospective surveillance. Concurrent and postdischarge surveillance methods should be used to detect SSIs following inpatient and outpatient operative procedures.
For example, these methods include:
o Review of medical records or surgery clinic patient records
o ...Visit the ICU and wards - talk to primary care staff
o Surgeon surveys by mail or telephone
o Patient surveys by mail or telephone (though patients may have a difficult time assessing their infections).
Any combination of these methods (or other methods identified by the facility) with the capacity to identify all SSIs is acceptable for use ..."

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


A. to provide documentation that the filters were changed on the Endoscope reprocessing washers per the IFU (instructions for use) of the water filtration system and identify that the chemical strips for checking the high-level disinfectant were within use date.


B. ensure the temperature and humidity in the Post Anesthesia Care Unit were within acceptable standards for patient supplies to inhibit microbial growth, reduce the risk of infection, promote patient comfort, and assure the physical safety of all patients.

C. ensure that clean and sterile tourniquets are left in the original package for surgical staff to determine if the tourniquets were clean or used.


D. ensure a sanitary environment for the provision of surgical services and patient care areas for 3 (surgery, pre-holding area before surgery, and Post post-anesthesia care Unit) of 3 areas.

E. check for expired supplies in the Crash Cart, pre-holding supply cart, and the designated isolation room in the Post Anesthesia Care Unit (PACU)

F. place a "Certificate Registration for Lasers" from the Department of State Health Services with a current employee who works for the surgical department.

G. the hospital's employee health nurse #70 failed to ensure that 1 (# 35) of 5 staff members working in a high-risk area (surgery) were vaccinated and/or had positive immunity against the Hepatitis B virus.


Findings Include:

A.

Water filters 1 micron, .45 micron, and 0.2 micron are to be changed every 6 months. Air filters for Station A and Station B are to be changed every 3 months. Carbon filter on the back of the "Medivators DSD reprocessor" every 6 months per the manufacturer guidelines.

A review of the "DSD, SSD, Filter Change Log" for March 2022 through March 2024 for Medivators reprocessor serial # 624624-041 and 624624-038 revealed the following:


Serial # 624624-041

The 6-month change for Water filters 1 micron, .45 micron, and 0.2 micron were due in September of 2023. Also, the filters for Station A and Station B and the Carbon filter on were all dated 9/28/2015 (sic..).

The Air filters for "Station A and Station B" were to be changed every 3 months, but were only being changed every 6 months.

Missed dates for changing the Air filters for Station A and Station B were the following:
6/2023
9/2015 was documented as 9-28-15 (sic ...)
12/2023


Serial # 624624-038

The 6-month change for Water filters 1-micron, .45-micron, 0.2-micron, and Carbon filter were due in September of 2023. There was no documentation found that the filters were changed.

The Air filters for "Station A and Station B" were to be changed every 3 months but were only being changed every 6 months.

Missed dates for changing the Air filters for Station A and Station B were the following:
6/2023
9/2023
12/2023

During the tour of the Endoscopy lab on 03/19/2024 at 2:17 PM observed the Medivators Rapicide chemistry strips expired on 05/04/2023. A surgical staff member had labeled the top of the Rapcide Chem-strip bottle opened on 03/18/2024 and expired on 06/15/2024. The bottle of Rapcide Chem-strip is good for 90 days once the bottle is opened per the manufacturer's guidelines. The issue was the staff was using a bottle of Rapcide Chem-strip that expired on 05/04/2023.

A review of the hospital policy titled, "Cleaning of Endoscopic Instruments"

"Test the liquid chemical disinfectant(Rapicide) using the designated test strips according to the manufacturer' guidelines. Immerse the test strip into the Rapicide reservoir for 3 seconds. Lay the strip flat for 75 seconds. Read the results. If the strip fails, do not use this station until the Rapicide is changed. Check the temperature of the Rapicide. It must be at a minimum of 35 degrees Celsius to provide high-level disinfection. The Medivator flushes the endoscopes with alcohol and air automatically at the end of each cycle."


An interview with the Director of Surgery #36 (RN) on 03/19/2024 at 2:30 PM acknowledged that there were missing dates on changing the water filters 1-micron, .45-micron, 0.2-micron, and Carbon filter every 6 months and the air filters were not changed every 3 months. Also, the staff working in the endoscopy department were using expired Rapcide Chem-strips to confirm the minimum recommended concentration of the disinfectant.

B.

Post-Anesthesia Care Unit (PACU)

Observed a large supply closet in the PACU area that stored clean and sterile patient supplies. When the surveyor opened the door, it was very warm in the room due to the computer wiring system being located in the supply closet. Also, observed numerous patient supplies were being stored in PACU Bay #2.

Aspire drainage system boxes X 3
Laparoscopic sealer X 4
Implant handle cartridge kit X 4
Radiofrequency single-use probes
Cotton rolls in a large cardboard box
Circular stapler X 3
Isovue-300 x 8

There were cardboard boxes stacked on sterile supplies. There were plastic bins and pieces of metal shelves being stored directly on the floor. The bay was cluttered with equipment, plastic bins, and cardboard boxes mixed with the sterile supplies on open carts. There was no organization to the arrangement of supplies, plastic bins, and equipment. The curtain used to enclose the supplies and equipment had a dark red stain unknown what the stain consisted of.


There was no documentation to show that the Post-Anesthesia Care Unit Temperature and humidity were monitored in this area.

An interview with Staff #36 on 2/18/2024 at 11:30 AM confirmed that no temperature and humidity was being checked in the Post-Anesthesia Care Unit.


Review of the AORN Perioperative Standards and Recommended Practices,

"Temperature should be maintained between 68 degrees Fahrenheit (F) to 75 degrees Fahrenheit (20 degrees to 23 C) within the operating room suite. Procedure rooms should be maintained between 70 degrees F to 75 degrees F. Temperature should be maintained at a maximum of 75 degrees F in sterile storage areas.
Relative humidity should be maintained between 20% and 60% within the perioperative suite, including operating rooms, recovery area, cardiac Catheterization rooms, endoscopy rooms, instrument processing areas, and sterilizing areas, and should be maintained below 60% in sterile storage areas.

C.

During a tour of the operating rooms on 2/18/2024 at 10:30 AM observed in operating Room #5 were sterile tourniquets out of the original package and lying in a basket of the tourniquet machine. There were 8 tourniquets all different sizes. There was no way to determine if the tourniquets were clean or had been used in a procedure. Observed in the sterile supply room were large gray plastic bins of open tourniquets of various sizes out of their original packages.

Tourniquets
18-inch X 8
30-inch X 6
34-inch X 5
42-inch X 11

All tourniquets stored out of the original packages.

An interview with Staff #58 on 02/18/2024 at 11:30 AM confirmed the tourniquets come in sterile individual packages.

An interview with staff #36 on 02/18/2024 at 11:45 AM confirmed the surgical staff have been removing the tourniquets from the original packages. There was no way to know if tourniquets were sterile or used.

D.

During a tour of the Surgery Department with Staff #36 on 2/18/2024 at 11:00 AM observed the following infection control issues.

* Observed an open package of Yankauer suction tip connected to the suction tubing on 3 of 3 operating rooms toured.

A review of the hospital policy titled, " Infection Control in the Operating Room" dated /approved 11/2021 revealed the following:

"ANESTHESIA EQUIPMENT

1. The anesthesia machine/cart may become contaminated during the course of providing
anesthesia services.
2. The exposed surfaces of the anesthesia machine/cart and the monitors are cleaned and wiped down each day and a clean towel placed on top. If the machine/cart become visibly contaminated, it should be cleaned immediately.
3. Single use equipment (ETT, face masks, breathing circuits, oral/nasopharyngeal airways) is disposed of.
4. Reusable equipment (laryngoscopes, LMAs, bougies) are cleaned and sterilized and returned to use.
5. An effective new bacterial/viral circuit filter is used for every patient.
6. Head straps and blood pressure cuffs are cleaned periodically and immediately if soiled."

* In operating room #6 observed the Boive unit ( electrosurgical unit ) had silk tape X 2 areas wrapped around the holding rod that held an instruction sign for GI Bleeds. Silk tape cannot be disinfected.

* In operating room #5 was a rusted intravenous pole with a worn enamel finish. Rusted metal cannot be disinfected.

* The gray plastic trash can outside operating room #5 had large gouges in the plastic making it difficult to disinfect.

* In the equipment storage area observed metal stirrups with blue plastic soft holders. One of the blue cushions on the stirrup was covered in white cloth silk tape which can not be disinfected after patient use.

* In the designated isolation room in the PACU area was a brown lounge chair with a cushion showing the vinyl. Cushion foam cannot be disinfected.

* There was a broken back green chair in the isolation room that could be a safety hazard for nursing staff that tried to use the chair.

* In the cabinet of the isolation room the following expired items were found:

1. Blunt tips X 15 expired 12/31/2021

2. 3 cc syringes X 5 expired 1/31/2024

3. 5 cc syringes X 5 expired 12/31/2022

4. 10 cc syringes X 5 expired 2/28/2022

5. A bottle of opened 1% lidocaine expired September 2023

* There was a pool of white dried substance under the ice machine located in the PACU unit. There was a wire lying in the white substance that was stuck in the dry substance.

* Observed personal items (2 paper gift bags) sitting on the bedside table in bay #10 of the PACU unit where patients were treated.

* In Bay #10 of the PACU unit was a staff-labeled refrigerator with food and drinks sitting up on a brown wooden table with a jar of peanuts. On the shelf was a red cup with an orange and blue bag. There was a bedside table with a scrub hat, a plastic bowl, and a paper bag. On the opposite side was another bedside table with a drinking cup, lotion, portable fan, and plastic cup of candy. On the shelf in bay #10 was a coffee cup, and another drinking cup. Surveyor observed 2 personal plaques in the cubicle designated as a PACU bay for treating patients.

An interview with Staff #37 on 03/18/2024 at 11:30 AM was asked by the surveyor why Bay #10 was set up with food and drinks. Staff #37 reported we didn't have time to go to the break room, so Bay #10 area was used for our break room.


A review of the AORN (Association of Perioperative Registered Nurses) 2019 Perioperative Standards and Recommended Practices, Guidelines for Sterilization, revealed the following:

" ...Recommendation IV.c. Supplies and equipment should be removed from external shipping containers and open-edged corrugated cardboard boxes before transfer to the sterile storage area or point of use.

External shipping containers and open-edged cardboard boxes may collect dust, debris, and insects during shipment and may carry contaminants into the surgical suite ..."


A review of ANSI/AAMI ST79:2017 revealed the following:
"11.1 Sterile Storage

Sterile items should be stored under environmentally controlled condition that reduces the potential for contamination ...

Supplies should be removed from external and web-edged shipping container before transport to any restricted area ..."

* Observed in the Bio-hazard closet were a Christmas tree, 6 "Olympus" cardboard endoscopic boxes for shipping scopes. Also, the black plastic cases that the endoscopes come to the hospital were being stored in the closet. The "Olympus" boxes and black cases are used to ship the endoscopes back to the company for repairs. All items were stored in the closet labeled with an orange sign "Bio-hazard waste".

E.

Pre-Holding Area Room

There was a blue cart in the room that stored patient supplies. The top of the cart was coated in dust, dirt, debris, and hair. The bins in the cart and in the room that stored sterile and non-sterile supplies were coated in dust, dirt, and debris.

Observed the following expired supplies in the blue cart.

1. Tegaderm expired 10/29/2022

2. Gloves 71/2 expired 4/28/2023
Gloves 71/2 expired 3/28/2023
Gloves 71/2 expired 5/28/2020
Gloves 81/2 expired 8/28/2022
Gloves 81/2 expired 4/28/2021

3. Nasopharyngeal airway expired 12/28/2022



F. Upon entering the Surgery department observed the "Certificate Registration for Lasers" from the Department of State Health Services with the name of an employee who no longer works at the hospital.


An interview with staff #36 on 02/18/2024 at 11:45 AM confirmed that the person name on the "Certificate Registration for Lasers" from the Department of State Health Services was no longer an employee of the hospital.


G.

This deficient practice had the likelihood to result in harm to staff members working in high-risk areas in the hospital due to failure to monitor hepatitis B immunity and vaccination status. The unknown immunity status of staff members could result in the transmission of the hepatitis B virus between patients and staff members.


Staff # 35

A review of Staff # 35's personnel file revealed Staff # 35 had a nonreactive HBV surface Antibody result on 06/29/2020. Staff # 35 received dose # 1 of the vaccine series on 07/13/2020 from the employee health nurse. Staff #35 did not receive dose # 2 or # 3 of the series. There was no evidence of a complete vaccine series or positive immunity for Staff # 35. Staff # 35 did not sign a Declination Form verifying refusal of vaccine and understanding of occupational risk and exposure to the hepatitis B virus.

A review of the hospital's policy titled, "Employee Health Program" with a revision date of 03/2023 revealed the following:

"POLICY:

1.0 Purpose: To establish the criteria for obtaining physical examination information and/or any other medical examination data deemed necessary to determine an individual's ability to perform the essential job functions of each position within the organization. As well as, set standards for reducing the
potential of introducing or acquiring infectious diseases in the hospital environment and to comply with established Infection Control, Federal, or State Guidelines.

Employment Requirements:
2.0 The following proof of testing or immunization will be required by Palestine Regional Medical Center and are stratified per high or low risk to establish potential exposure risk, especially to blood-borne pathogens. Each employee will have the opportunity to refuse vaccinations on the basis of allergies, conscience, religious, and/or per VIS for each vaccine describing potential contraindications and
precautions:

4.0 Employees will be rated as High risk, Medium risk, and Low risk to establish necessary vaccinations for their respective position. The following table designates positions in each group and what is established immunizations for that particular group.

High Risk: Respiratory Services, Laboratory, EMS, Nursing Clinical Personnel ( Includes all nurses, aides, techs, Psych techs, and social workers), and Radiology.
High Risk: Hep B vaccine required

Employee screen would include: medical history, Hepatitis B titer, Varicella titer, MMR titer, and TB skin test, only necessary titers will be drawn.

Note: High-Risk Employees are personnel who perform tasks that may involve exposure to blood or body fluids. Employees who decline the Hepatitis B vaccine, or those that are deemed NonResponders (refers to a person who does not develop protective surface antibodies after completing two full series of the hepatitis B vaccine and for whom an acute or chronic hepatitis b infection has been ruled out), will be counseled regarding proper protective equipment per OSHA standards (gloves, gowns masks, etc.) at screening and reiterated in employee orientation."


An interview with Staff #70 (Employee Health RN) on 03/19/2024 at 11:30 AM confirmed that Staff #35 had only been given the initial dose of the hepatitis B vaccine. The surveyor asked why Hepatitis B vaccines #2 and #3 were not given. Staff #70 stated, "I guess it just got overlooked."

Based on review of facility policies, random review of medical charts from March 2024, and confirmed in interview, the facility failed to follow its Adult Ventilator and BiPAP policy for three of three (Patient #58, 59, 60) respiratory records reviewed.

Findings included:

Review of the facility policy Adult Ventilator Protocol (AVP), 5/15 (PolicyStat ID 14298801, effective 10/2023), it stated:

"Guidelines for Using Ventilator Protocol
A. Physician's order for initiation of Adult Ventilator Protocol (AVP) ...
Ventilator Adjustments:
A. Initial assessment should be performed within 15 minutes from start of ventilation.
B. Identify patient. Assessment should include breath sounds, work of breathing, blood pressure, heart rate, ventilating pressures and volumes, Sp02, and respiratory rate.
C. ABG should drawn within 15 to 60 minutes from start of ventilation.
D. If ABG abnormalities are due to respiratory insufficiency ventilator should be adjusted.
1. If ph less than 7.30, may adjust rate first to a maximum of 20 breaths/minute if peak pressure and expiratory time will allow. If pH greater than 7.50 may adjust rate or tidal volume to achieve desired pH.
2. If unable to increase rate, may increase tidal volume up to a maximum of 10ml/Kg of ideal body weight if peak pressures will allow.
3. ABG should be repeated 30 minutes after changes.
4. Fi02 and PEEP should be adjusted to lowest level to maintain target P02 and Sp02.
Fi02 should be titrated first down to 40%, then PEEP should be weaned to lowest level to maintain adequate oxygenation.
5. If unable to maintain adequate oxygenation at Fi02 of.5 and PEEP of 10 cm H20 physician should be notified.
6. If any adjustments greater or less than those allowed by the protocol are necessary to maintain adequate ventilation the physician should be notified.
Special Considerations
A. Physician should be notified of
1. Increase in respiratory rate > 10 breaths/minute.
2. Decrease in Sp02 > 10 or of a value less than 85%.
3. Increase in peak airway pressures > 10cm H20.
4. Absence of breath sounds.
5. Frank bloody secretions."

Patient #58
Review of patient medical record (Patient #58) revealed she was admitted to the facility on 3/11/2024 for left distal femur displaced. She had surgery on the left femur on 3/14/2024 and she required intubation during the surgery. She was transferred to ICU after surgery.

Review of Patient #58's medical record revealed no physician orders to include the respiratory settings for her vent.

Further review of Patient #58's medical record on the RT (Respiratory Therapy) Ventilator Flowesheet revealed the respiratory therapist (Staff #68) increased the vent setting from 50% to 60% on 3/14/2024 at 7:58 PM and Peep settings were decreased to 7 from 10 on 3/14/2024 at 11:00 pm.

Review of Patient #58's record revealed no physician orders to increase the vent settings or decrease the Peep per facility policy.

In an interview on the morning of 3/21/24 with Staff #47, Respiratory Manager, regarding the vent order for patient #58, he could not find an order with parameters and stated, "There's not one for this patient. It was a very rare case. [Staff #68, Respiratory Therapist] unfortunately did not chart who she got the order from. Usually, it's from the CRNA." When discussing RT's decrease of PEEP from 10 to 7 at 11:00 pm, Staff #47 stated, "It should have been guided by a physician. Normally, the doctor would put in the orders."

Patient #59
Review of patient medical record (Patient #59) revealed he was intubated on 03/12/2024 at 06:25 AM due to "respiratory failure."

Review of Patient #59's record revealed no ABG's collected at 15 minutes to 60 minutes after intubation, per the facility policy. The next ABG was on 03/12/2024 at 8:35 AM, more than 120 minutes after intubation.

An interview with the Staff # 47 on 3/21/2024 at 11:00 AM in the nursing station confirmed the above findings.

Review of facility policy Non-invasive Ventilation (PolicyStat ID 13338363, effective 05/2023) it stated:
"BIPAP DEVICE PROCEDURE:
1. RECEIVE PHYSICIAN ORDER, IDENTIFY PATIENT.
2. UNCONSCIOUS PATIENTS OR PATIENTS WITH ALTERED MENTAL STATUS SHOULD BE PLACED IN ROOM WHERE VENT ALARMS ARE EASILY HEARD.
3. CALL LIGHT SHOULD BE IN REACH OF PATIENT
4. EXPLAIN THERAPY TO PATIENT AND FAMILY.
5. MEASURE PATIENT'S FACE WITH DEVICE PROVIDED WITH MASKS.
6. SET VENTILATOR TO PRESCRIBED SETTINGS."

Patient #60
Review of patient medical record (Patient #60) revealed she was placed on bipap on 03/19/2024. Review of the physician orders had no prescribed settings.

An interview with the respiratory therapist (Staff # 83) on 03/21/2024 at 12:30 PM in the Respiratory area confirmed that their usual process is that they would verify the settings with the provider and request the provider enter the settings discussed.


Glossary:
Bipap - bilevel positive airway pressure, type of ventilator device to help with breathing.
Peep - Positive end-expiratory pressure is used therapeutically during mechanical ventilation

Based on observation and interview, the hospital failed to post the required separate signage in English and Spanish in the Emergency restrooms (excluding the psych restroom) and the triage room for Human Trafficking.

Findings Include:

A tour of the Emergency Department on 03/21/2024 at 11:00 AM revealed no human trafficking signs observed in 1 of 2 bathrooms and the triage room which was located in the emergency department.

An interview with Staff #69 during the rounds of the emergency room on 03/21/2024 at 11:00 AM acknowledged that the human trafficking signage was missing from the triage room and one of the emergency room bathrooms.