HospitalInspections.org

Based on record review and interview, the Governing Body failed to:

A. obtain or maintain credentialing records for 9 (#33, 34, 35, 36, 37, 41, 42, 43, and 44) of 9 Physicians and 1 (#45) Nurse Practitioner.

Cross-Refer to Tag: A0046

B. ensure a binding contract or agreement for telemedicine radiology services. Also, the facility failed to obtain or maintain credentialing records for 25 (#52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, and #76) of 25 radiologists.

Cross-Refer to Tag: A0052


C. appoint a chief executive officer who was responsible for managing the hospital.


Cross-Refer to Tag: A0057


D. provide safe care for patients that required intubation. The Governing Body allowed a paramedic/registered nurse (staff #86) that had no contract and was not an employee of the facility to intubate patients having difficulty breathing or may not be able to breathe on their own in 1 (#14) of 1 patient chart review.The facility failed to ensure the paramedic/registered nurse was following his scope of practice, had competencies, or had a supervising physician that was credentialed at the facility.

The deficient practices identified were determined to pose Immediate Jeopardy to patient health and safety and placed all patients at risk for the likelihood of harm, serious injury, and possibly subsequent death.

Cross-Refer to Tag: A0083

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

A.
to provide the second IMM (Important Message from Medicare) letter prior to discharge in 2 (Patient #25 and #26) of 2 patient records reviewed.

Cross Refer to Tag A0117


B. ensure that patients or their representatives were provided the risks and benefits of a PICC Line (Peripherally inserted central catheter) placement from the physician prior to having the informed consent signed in 2 (Patient #2 and Patient #7) of 2 medical records reviewed. The facility also failed to follow their own policy.

Cross Refer to Tag A0131


C.
1. ensure "Dummy" drip chambers were in a secure place in the facility and not available for staff to use in preparing a dialysis machine. The Bio-Medical technician failed to follow the policy on guidance for setting dialysis delivery system safety parameters.

It was determined that the deficient practices posed an Immediate Jeopardy to patient health and safety and placed all patients at risk for the likelihood of harm, serious injury, impairment, and/or subsequent death.

This deficient practice has the likelihood to be hazardous to patient safety and risks of the undetected infusion of air into a patient if the "dummy" drip chamber was not removed at the initiation of dialysis.

2. ensure that 11.5 grams of powdered potassium chloride additive packages and calcium chloride 5.7 grams of powdered packages were within date.

3. ensure the chlorine checks were conducted at initial start-up and every 4 hours on the portable reverse osmosis (RO) water treatment systems and that the facility policy was followed for chlorine checks.

4. follow the patient's dialysis prescription by using the ordered BFR (Blood Flow Rate) in 1 (#9) of 6 of the hemodialysis records reviewed. Patient #9's record showed 5 of 14 treatments where the BFR (Blood Flow Rate) did not follow the patient's dialysis prescription written by the nephrologist.

5. ensure dialysis staff were maintaining a clean and sanitary environment for the acute dialysis patient.

Cross Refer to Tag A0144

D.
1. ensure staff conducted comprehensive patient assessments to determine patient needs and interventions prior to the administration of chemical restraints/emergency behavioral medication, and continuous monitoring after administering a chemical restraint/emergency behavioral medication for side effects, respiratory or cardiac distress, and assessment of medication effectiveness and safety after administration in 1 (Patient #28) of 1 medical record reviewed.

2. ensure that psychotropic medications administered IM/IV for behavioral emergencies were identified as chemical restraints and not therapeutic treatments in 1 (Patient #28) of 1 medical record reviewed.

3. ensure chemical restraints were added to the restraint log and monitored through Quality

4. ensure the policy and procedure gave clear instructions to the RN Staff on the frequency of assessment and reassessment of a patient after a chemical restraint was administered.

5. follow their own policy and have verbal orders for chemical restraints authenticated by the ordering physician within 24 hours.

It was determined that the deficient practices posed an Immediate Jeopardy to patient health and safety and placed all patients at risk for the likelihood of harm, serious injury, impairment, and/or subsequent death.

Cross Refer to Tag A0160


E. ensure that chemical restraints were only ordered by a physician in 1 (Patient #28) of 1 medical record reviewed.

It was determined that the deficient practices posed an Immediate Jeopardy to patient health and safety and placed all patients at risk for the likelihood of harm, serious injury, impairment, and/or subsequent death.

Cross Refer to Tag A0168


F. ensure restraint orders were not written on a PRN (as needed) basis in 1 (Patient #28) of 1 medical record reviewed. The facility also failed to follow their own policy.

It was determined that the deficient practices posed an Immediate Jeopardy to patient health and safety and placed all patients at risk for the likelihood of harm, serious injury, impairment, and/or subsequent death.

Cross Refer to Tag A0169


G.
1. ensure a 1-hour Face to Face was completed by the provider or a trained RN (Registered Nurse) within one hour of the administration of a chemical restraint/EBM (emergency behavioral medication) in 1(Patient #28) of 1 medical record reviewed.

2. ensure RN's completed training for the 1-hour face to face evaluation before evaluating a patient after a chemical restraint.

3. ensure the hospital policy required a 1-hour face to face to be completed by a physician or a trained RN after a chemical restraint was administered.

The deficient practices identified under the following Conditions of Participation were determined to pose Immediate Jeopardy to patient health and safety and placed all patients at risk for the likelihood of harm, serious injury, and possibly subsequent death.

Cross Refer to Tag A0178

Based on document review and interview the governing body failed to ensure the hospital maintained an effective, ongoing, hospital-wide, data driven QAPI (quality assessment and performance improvement) program.

Findings include:

A review of the 1st quarter Quality meetings dated 4/12/2023 revealed there were 2 different campuses reporting. Staff #1 confirmed that one campus had been closed and they were only providing services on 1 campus effective May 26, 2023.

No documentation was provided for review on how the data was collected, and analyzed, or how it was monitored for sustainability.

Staff #4 confirmed on 7/19/2023 that there had been no quality meetings since April 2023.


An interview was conducted on 7/19/2023 after 10:30 AM with Staff #4. Staff #4 was asked how she was tracking the data that was reported to the quality department. Staff #4 stated, "I have only been in this position since May. The only data that I have is what the previous quality director had. I have not received any new data since I started. Dietary has reported their data regarding problems with patients' daily weight, but I have not done anything with the information they gave me". Staff #4 was asked how often the departments were required to report to her. She confirmed each department was required to report monthly. Staff #4 was asked if she was receiving any data from any of the contracted services the facility uses. Staff #4 stated, "I know we have contracts for lab, radiology, dietary, vascular access, and Dialysis but I have not gotten any data from them either."



A review of the policy titled, "QUALITY & PERFORMANCE IMPROVEMENT PLAN" with a review date of 3/2023 was as follows:

" ...Quality Management/Performance Improvement Committee:
The committee shall meet at least quarterly.

SCOPE OF PLAN:
The entire organization shall participate in the Quality Management/Performance Improvement efforts. This philosophy pervades all the interactions and transactions that we perform on an ongoing basis and establishes a culture that supports and rewards continuous performance improvement.

The scope of the plan covers every individual providing services in the Hospital, regardless of their capacity. Our plan integrates external customers who directly affect the process within our organization. It includes every process performed for any customer ..."


An interview was conducted with Staff #1 and Staff #4 on 7/19/2023 at 10:30 AM. Staff #4 was asked if she knew what departments had ongoing P.I. (Performance Improvement) Projects. Staff #4 stated, "I have a notebook with some PI Plans in them that the last director had but I have not really had time to get involved in that paperwork.

Staff #1 confirmed that Staff #4 was the Quality Director, Risk Manager Director, Employee Health/Education Dept, Infection Control Preventionist, and Emergency Preparedness Coordinator. Staff #1 and Staff #4 confirmed the hospital had not maintained an effective, ongoing, hospital-wide quality assessment and performance improvement program.

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


A. ensure the nursing staff developed and maintained a current care plan for 3 (# 1, # 3, and # 6) of 3 patients that reflected the patient's goals and needs in accordance with the facility's policy, "Interdisciplinary Treatment Planning" dated 04/12. The facility staff did not keep the patient's care plans current through the ongoing assessment of the patient's needs and response to nursing interventions.

Cross Refer to Tag: A0396

B.

(1.) ensure a physician gave orders to access and use the PICC (Peripherally Inserted Central Catheter) line before administering IV medications in 2 (Patient #2 and #7) of 2 medical records reviewed.

(2.) ensure there was documentation in the medical record that the placement of the PICC line was confirmed through chest x-ray or IC-ECG (an intracavity electrocardiogram) prior to administering IV medications in 1 (Patient #7) of 2 medical records reviewed.



Cross Refer to Tag: A0409

C.

(1.) ensure a physician order was written prior to transfusing PRBCs (Packed Red Blood Cells-blood) in 1 (Patient #15) of 2 patient medical records reviewed. The facility staff failed to follow their own policy for blood transfusions in 2 (patients #15 and #16) of 2 medical records reviewed.

(2.) document the time that TPN (Total Parenteral Nutrition) was started and completed, failed to document the date and time when the TPN bags were changed, and failed to document an assessment of the central vein access site in 2 (Patient #23 and #24) of 2 medical records reviewed.

Cross Refer to Tag: A0410

Based on review and interview the Governing Body (GB) failed to.

A. appoint physicians to the Utilization Review (UR) committee, approve a utilization plan, or provide information on the duties of the facility's Quality Improvement Organization (QIO).

Refer to Tag A654

B. provide a Utilization Review Plan, a process for reviewing admissions, duration of stays, professional services offered or outlier cases.

Refer to Tag A655

C. have a Utilization Review (UR) Committee, UR Plan, or practioners to assess and decide if a patient's admission or continued stay was medically necessary or not.

Refer to Tag A656

D. have a Utilization Review (UR) Plan, Committee, or appointed physicians to determine if patients are receiving professional services for availability and use of necessary services, timely services and availability of therapeutic services.

Refer to Tag A658

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

A. demonstrate that an individual who was qualified through education, training, experience, or certification in infection prevention and control was appointed by the governing body as the infection control professional.

Cross-Refer to Tag: A0748

B. employ methods for preventing and controlling the transmission of infections within the hospital and between the hospital and other institutions and settings.

Cross-Refer to Tag: A0749

C. provide and maintain a clean and sanitary environment to avoid sources and transmission of infection in 7 of 7 areas(Emergency Treatment Room, Medical and Rehabilitation Nursing Stations, Clean Linen Room, Clean Supply Room, Medication Room, Patient Room #112, and Dietary Department).


Cross-Refer to Tag: A0750

D. ensure the infection control professional maintained communication and collaboration with the hospital's QAPI (Quality Assurance and Performance Improvement) Program on infection prevention and control issues.

Cross-Refer to Tag: A0774

E. ensure active collaboration between the facility's Antibiotic Stewardship Committee and the facility's Infection Control Program. The facility was unable to provide documentation of the Infection Control Program's meeting minutes. Also, the facility was unable to provide documentation of the Antibiotic Stewardship Committee's meeting minutes.

Cross-Refer to Tag: A0777

F. establish an individual responsible for the development and implementation of a hospital-wide antibiotic stewardship program to monitor and improve the use of antibiotics. The facility failed to provide documents to support the establishment of an antibiotic stewardship committee within the facility.

Cross-Refer to Tag: A0778


It was determined that the deficient practices posed an Immediate Jeopardy to patient health and safety and placed all patients at risk for the likelihood of harm, serious injury, impairment, and/or subsequent death.

Based on record review and interview, the governing body failed to obtain or maintain credentialing records for 9 (#33, 34, 35, 36, 37, 41, 42, 43, and 44) of 9 Physicians, and 1( #45) Nurse Practitioner.

Findings include:

A request was made for credentialing files for 3 days of the survey. The facility was unable to provide complete credentialing files on Physicians #41, 42, 43, 44, and Nurse Practitioner #45

A review of Physician #41's credentialing file revealed an incomplete delineation agreement with approved privileges and a missing signature page by the facility and the Physician.

A review of Physician #42's credentialing file revealed it was missing a delineation agreement with approved privileges determined by the facility and Physician.

A review of Physician #43's credentialing file revealed it was missing a delineation agreement with approved privileges determined by the facility and Physician.

A review of Physician #44 credentialing file revealed an incomplete delineation agreement with approved privileges determined by the facility and the Physician. Further review showed an expired insurance policy and missing documentation of continuing education.

A review of Nurse Practitioner #45's credentialing file revealed a missing delineation agreement with approved privileges determined by the facility and the Nurse Practitioner. Further review showed an expired DEA licensure and insurance policy.

An interview was conducted with Staff #12 on 07/19/2023 at 10:15 AM who stated they had just started this position and were unable to provide the documents requested at this time. Also, Staff #12 stated, "I realized there are missing credentials, and have reached out to others for assistance. Will reach out again and try to obtain missing documentation."



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On the morning of 7/19/2023, in the multipurpose room, the credentialing files for medical staff #33, #34, #35, #36, and #37 were reviewed. The lack of completed credentialing files may be reviewed below:

Physician #33:

No request for or delineation privileges were found in the credentialing record. Physician #33 had been appointed to the active medical staff.

Physician #34:

Physician #34 documented a request for specific pulmonary privileges. The document was signed on the last page by the requesting physician, and members of the medical staff leadership. There was no date recorded of evaluation, acceptance, and approval of the requested privileges.

Physician #35:

This physician was an internal medical physician that had not submitted a request for privileges. There was no date recorded that the medical staff had requested or evaluated privileges prior to re-appointment to the active medical staff.

Physician #36:

This physician was a cardiologist that had made request for specific cardiology privileges. The document was signed on the last page by the requesting physician, and members of the medical staff leadership. There was no date recorded of evaluation, acceptance, and approval of the requested privileges.

Physician #37:

No request for or delineation privileges were found in the credentialing record. Physician #37 had been appointed to the active medical staff.

A review of the facility's Medical Staff Bylaws Policies and Procedures dated 04/18/2023 revealed the following:

"Article VI
Medical Staff Clinical Privileges
Exercise of Clinical Privileges Every Practitioner providing direct clinical services at the Hospital, by virtue of membership or otherwise, shall, in connection with such practice, and except as provided in Article VI, Sections 3 (Temporary Privileges), 4 {Emergency Privileges) and 5 (Disaster Privileges) below, be entitled to exercise only those Clinical Privileges specifically granted to him by the Governing Body. The Clinical Privileges must be within the scope of the license authorizing the Practitioner to practice in this State. Regardless of the Clinical Privileges granted, each Practitioner must obtain consultation when necessary for the safety of his patients or when required by these bylaws, the rules and regulations and other policies of the Medical Staff, any of its clinical programs, or the Hospital.
Delineation of Clinical Privileges

Vl.2. Application
Clinical Privileges may be granted only upon formal request on current forms provided by the Hospital with subsequent processing and approval. Every application for Staff appointment and reappointment must contain a request for the specific Clinical Privileges desired by the applicant.

Vl.2-2. Basis for Privilege Determination
Requests for Clinical Privileges shall be evaluated on the basis of the Practitioner's training, experience, and education; his demonstrated current competence and results of treatment; any required references; and other relevant information, including health status as it may affect the Practitioner's ability to exercise the Clinical Privileges if granted. In granting Clinical Privileges, consideration must be given to objective information received from sources outside the Hospital, to the need for an adequate ongoing experience {volume) to maintain proficiency, to the Hospital's ability to support such patient

Vl.2-3. Procedure
All requests for Clinical Privileges shall be processed pursuant to the procedures outlined in Article Ill for Medical Staff membership.

Article Ill
Medical Staff Membership
111.1 Nature of Membership

111-1-1. Membership is a Privilege Membership on the Medical Staff of the hospital is a privilege that shall be granted only to legally and professionally qualified and currently competent Practitioners who continuously meet the qualifications. Standards and requirements set forth in the Medical Staff bylaws, rules and regulations and policies. Governing Body bylaws and Hospital policies, including, but not limited to temperament and health status for the performance of Clinical Privileges granted. Appointment to the subsequent membership on the Medical Staff shall confer on the Member only such Clinical Privileges and rights as have been granted by the Governing Body in accordance with these bylaws.

111. 7-2. Applicant's Burden and Responsibility
The applicant shall have the burden of producing adequate information for a proper evaluation of his competence, character, skill, ethics, health status, ability to work with others, and other qualifications. Each applicant must attest to and continuously demonstrate he is physically and emotionally capable of performing all aspects of patient care for which he seeks Clinical Privileges. The applicant shall provide accurate, up-to-date information on the application. The applicant agrees to immediately report to the Chief Executive Officer any change in his information which occurs after he has submitted his application. Neither the Governing Body nor any Medical Staff Committee shall have any obligation to review any application until the applicant complete it in all respects and submits all required information and supporting material, including any required fees. The applicant shall be responsible for resolving any doubts regarding his application and qualifications for membership and all Clinical Privileges requested. The MEC or its designee may request the applicant to appear for an interview with regard to his application or to submit more of other information in support of his application. Failure to comply with any of these provisions, including failure to appear for requested interviews, may result in the application being deemed incomplete, or in the denial of membership or Clinic al Privileges, or may be subject the Practitioner to disciplinary action. The information shall include but not be limited to, the following which may be legible, true, and complete photostatic copies:
a. Identifying information
b. Undergraduate education.
c. postgraduate education.
d. internship.
e. residency/fellowship.
f. all past and present hospital and other health care entity affiliations.
g. memberships in professional associations, societies, academies, colleges, and faculty/training appointments.
h. specialty board certification status.
i. state licensure(s) with expiration date (s}.
j. DEA registration with expiration date, and all applicable State registrations with expiration dates.
k. professional references: two (2) references from professional peers (which, when possible, practice in the same specialty) other than family or affiliated by marriage who must have personal knowledge of the applicant's recent professional performance, his ethical character, current competence, current health status and his ability to work cooperatively with others.
I. previous practice data, including information on qualifications for Privileges applied for.
m. continuing medical education for the past two years related to the Clinical Privileges requested.
n. bibliography of publications, speeches, and meetings attended, with dates.
o. professional liability insurance, including carrier, amount, and dates of coverage, and professional litigation and liability history (past and present);
p. a request for Staff membership category.
q. specific clinical Privileges desired.
r. a specific signed consent for immunity and release from liability for all individuals involved in and performing the credentialing function, and a signed and dated confidentiality statement.
s. a small photo."


A interview with Staff #12 on 7/19/2023 in mid afternoon who was assisting with credentialing was interviewed. Staff #12 stated, "I found those incomplete credentialing files just after I began working. I reported the findings to leadership that the physician files were incomplete. I just haven't been able to get the information to complete them yet".

Based on record review and interview, the governing body failed to ensure a binding contract or agreement for telemedicine radiology services. Also, the facility failed to obtain or maintain credentialing records for 25 (#52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, and #76) of 25 radiologists.

Findings include:

A review of the facility's Proxy Credentialing and Privileging Agreement revealed it was not signed or dated by the contracted telemedicine radiology service. The only signature on the agreement was the facility's Chief Excutive Officer.

A request was made for credentialing files during 2 days of the survey. The facility was unable to provide credentialing files on contracted radiologists #52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, and #76.

An interview was conducted with Staff #12 on 07/19/2023 at 10:15 AM. Staff #12 stated" I do not have files on the radiologists."

A review of the facility's Medical Staff Bylaws Policies and Procedures dated 04/18/2023 revealed the following:

"V.3. Independent Allied Professional Qualifications to be eligible for Practice Prerogatives, an Independent Allied Professional must, at a minimum, meet the following requirements in addition to any requirements recommended by the MEC or the Governing Body:

V.3-1.
Hold a current, unrestricted license, certificate, or other appropriate legal credential in a category of Independent Allied Professionals that is permitted by law, the MEC and the Governing Body has identified as eligible for Practice Prerogatives.

V.3-2.
Document his background, relevant training, education, experience, demonstrated current competence, judgment, character, and physical and mental health status, with sufficient adequacy to demonstrate that patient care services will be provided by the Independent Allied Professional at the professional level of quality and efficiency established by the MEC and the Governing Body.

V.3-3.
Document his strict adherence to the ethics of the Medical Staff and the Independent Allied Professional's respective profession; his ability and agreement to work cooperatively with others in the Hospital setting; and his willingness to commit to and regularly assist the Hospital in fulfilling its obligations related to patient care, within the areas of the Independent Allied Professional's professional competence and credentials.

V.3-4.
Maintain a professional liability insurance policy with a carrier approved by the Governing Body with policy limits of no less than $1,000,000 per claim and $3,000,000 aggregate per year, or such other amount as may be deemed appropriate by the Governing Body and provide the Hospital with a current certificate of insurance. The Governing Body may request any Independent Allied Professional to add the Hospital as an additional insured under such policy. In the event that the applicant is insured under a claims-made policy, he shall continue to purchase such coverage for minimum of two (2) years following the discharge of the last patient he treats at the Hospital. The insurance must cover all types of procedures the Independent Allied Professional performs at the Hospital. He also agrees to immediately notify the Chief Executive Officer of any insurance policy changes or cancellation and authorize his insurance carrier to provide immediate notice of any change to the Hospital."

An interview was conducted with Staff #49 on 07/19/23 at 1:30 PM who confirmed that "all radiologists listed on the Proxy Credentialing and Privileging Agreement read x-rays for the facility."

Based on a record review and interview, the governing body failed to appoint a chief executive officer who was responsible for managing the hospital.

Findings included:

A review of the Governing body meeting minutes revealed the meeting dates were for January and April of 2023. The January meeting discussed the information from the last quarter (October, November, and December) of the year 2022. The April meeting discussed information from the first quarter (January, February, and March) of 2023. There were no governing body meeting minutes for the second quarter of the 2023 year. The chief executive officer was hired and began the management of the hospital on May 8, 2023. There had been no approval by the Governing body for the new chief executive officer.

An interview with the Chief Executive Officer on 07/20/2023 at 1:00 PM confirmed that the second quarter Governing Body meeting had not taken place and that no approval of the position had been approved by the governing body.

Based on document review and interviews, the Governing Body (GB) failed to provide safe care for patients that required intubation. The Governing Body allowed a paramedic/registered nurse (staff #86) that had no contract and was not an employee of the facility to intubate patients having difficulty breathing or who may not be able to breathe on their own in 1 (#14) of 1 patient chart review.The facility failed to ensure the paramedic/registered nurse was following his scope of practice, had competencies, or had a supervising physician that was credentialed at the facility.

The deficient practices identified were determined to pose Immediate Jeopardy to patient health and safety and placed all patients at risk for the likelihood of harm, serious injury, and possibly subsequent death.

Finding include:

A review of patient # 14's chart revealed on 1/31/22 staff # 86 documented he had intubated patient # 14 at 11:15 AM. Endotracheal intubation is a medical procedure in which a tube is placed into the windpipe (trachea) through the mouth or nose.

Review of the progress note dated 1/31/22 at 11:15 AM Staff # 86 documented, "Stat intubation using glide scope. 7.5 ETT. Given 30mg Etomidate. RT at bedside. 1st attempt upper denture plate dislodged. 2nd attempt successful, ETT secured at 23cm at lip. ETCO2 detected has positive color change; equal breath sounds. Cuff inflated post intubation. RT providing ventilation w/PEEP, see critical response note for times and vital signs."

A review of patient #14's chart revealed there was no physician order to intubate this patient or etomidate (sedation medication) given. There was no physician progress note discussing the intubation or request for intubation found in the chart.

On 2/1/22 at 8:00 AM a progress notes by staff #34 (MD). The note stated, "Replace ETT leak." There was no documentation on who was to replace the ETT (endotracheal tube). There was no physician order found to replace the tube and there was documentation of why there was a 5-hour delay.

A review of staff #86's progress note on 2/1/22 at 1:10 PM revealed staff #86 reintubated the patient. The note stated, "cuff leaking. Using bougie 7.5 ETT exchange without incident. Cuff inflated. ETCO2 detector has positive color change. RT at bedside. Secured tube at 23cm at lip. See nurses note for vital signs and times."

An interview was conducted with Staff #8 (RT Director) and Staff #46 (RT) on 7/18/23 at 10:00 AM. Staff #46 was asked what physicians intubated patients and did most of the vent care. Staff #46 stated that the physicians did not come in to intubate. If a patient required intubation, they would have to call 911 or they could call staff #86 to come in and intubate. Staff #46 stated that she had not seen Staff #86 in several months but stated that he was an option. Staff #46 stated that Staff #86 was an RN but had also worked as a flight nurse and paramedic. Staff # 46 stated that during COVID, staff #86 came in and did "multiple intubations." Staff #8 confirmed that staff #86 was available to intubate if needed. Staff #8 confirmed when 911 was called the patient was transferred out to the hospital.

An interview was conducted with Staff # 1 on 7/19/23 in the afternoon. Staff #1 was asked questions concerning Staff #86's role in the facility, and the intubation of patients. Staff #1 stated that they were no longer using staff #86's services for intubation. Staff #1 explained that Staff #86 was a contracted provider that came into the facility to start Peripherally Inserted Central Catheter (PICC) lines when needed (A PICC is a long, flexible catheter/thin tube that's put into a vein in the upper arm). Staff #1 confirmed that staff #86 had inserted ETT tubes for intubation in the past but his services were no longer used. Staff #1 was not aware that his respiratory staff was still under the impression that staff #86 was available for intubation services. Staff #1 confirmed that he did not have a contract with Staff #86 to intubate. Staff #86 could only insert PICC lines. Staff #1 confirmed and provided the surveyor with a written contract.

A review of a contract named Southeast Texas Vascular Access was given to the surveyor via staff #1. Staff #1 stated that this was the contracted service for staff #86. Staff #1 stated that Staff #86 was the president of Southeast Texas Vascular Access.

The contract stated, "SERVICES PICC Line Placement Services. Upon the request of Facility, Contractor shall provide PICC line placement services to Facility in compliance with the Conditions of Participation and any standard, ruling, or regulation of the State DOH, JCAHO, DHHS, CMS or any other federal, State, or local governmental agency exercising authority with respect to such. The Services shall also include Contractor providing all necessary equipment to perform the vascular access insertion services. The facility shall provide all additional supplies needed for care and maintenance of the vascular access device in the facilities. Facility shall compensate Contractor the following for PICC and MIDLINE Placement Services and further vascular access clinical support, and education as outlined below:.."

There was no documentation that the service included intubation services. Staff #1 confirmed the original contract did not have any information concerning intubation services. Staff #1 stated he had called staff #86 and staff #86 had sent over a copy of an addendum to the contract. The addendum stated, "the pricing as of June 4th, 2020" A price of 250.00 dollars was listed and stated, "intubation or ET Tube exchange." At the bottom of the addendum a statement was found, " ...Intubation and tube exchange supplies will be provided by the facility ...." Staff #86 had signed the bottom with no date or time. There was no signature from the administration of the facility and there was nothing outlining the intubation services, process, credentials, or physician involvement of any intubation services. According to the Contract 8. 7 Amendment. "No amendment or variation of the terms of this Agreement shall be valid unless made in writing and signed by both Facility and Contractor."

Staff #1 confirmed that he did not have any credentials or certifications on file for staff #86 but had staff #86 send over his current certification for PICC line insertion. Staff #1 was not able to provide any information or credentials that allowed staff #86 to intubate in the facility.

Based on document review and interview the facility failed to provide the second IMM (Important Message from Medicare) letter prior to discharge in 2 (Patient #25 and #26) of 2 patient records reviewed.

Findings:

A review of Patient #25's medical record revealed the IMM letter was signed and dated on the admission date of 7/06/2023. A copy was not presented to the patient prior to the discharge date of 7/15/2023.

A review of Patient #26's medical record revealed the IMM letter was signed and dated on the admission date of 7/11/2023. A copy was not presented to the patient prior to the discharge date of 7/17/2023.

During an interview with Staff #9 on 7/18/2023 after 9:00 AM it was confirmed that Staff #9 was not presenting the IMM letters to any patients prior to discharge. Staff #9 stated he was not aware that a 2nd IMM letter was to be delivered to the patient prior to discharge but not more than two calendar days before.

Based on record review and interview the hospital failed to ensure that the patients physician provided the patients and/or their representatives the risks and benefits of a PICC Line (Peripherally inserted central catheter-a thin flexible tube inserted into a large vein for long term use with antibiotics, blood, chemotherapy, and/or total parental nutrition) placement and the risk and benefits of a blood transfusion prior to having the informed consent signed in 4 (Patient #2, Patient #7, Patient #15, and Patient #16) of 4 medical records reviewed. The facility also failed to follow their own policy.

Findings:
A review of medical records was conducted with RN Staff #28 on 7/20/2023 after 9:00 AM.

Patient #2
Patient #2 was a 79-year-old female admitted to the hospital on 7/13/2023 with a diagnosis of Pneumonia, Pressure Ulcer of the Sacral region, Urinary Tract infection, and Escherichia coli (E-coli). On 7/19/2023 at 12:39 PM MD Staff #35 gave a verbal order to RN Staff #87 for a PICC line placement for Vancomycin (an antibiotic) therapy.

An informed consent was signed by Patient #2 and witnessed by RN Staff #84 on 7/19/2023 at 12:45 PM.
A review of the PICC Insertion Note dated 7/19/2023 at 2:00 PM documented by contracted RN Staff #86 was as follows:
"Procedure: Ultrasound guided placement of a Peripherally Inserted Central Catheter. Witnessed informed consent was obtained after the risks, benefits, and alternatives of the procedure were explained to the patient and/or family."

Patient #7
Patient #7 was a 68-year-old male admitted to the hospital on 7/12/2023 with a diagnosis of Cellulitis of the left lower limb, Metabolic encephalopathy, and Rhabdomyolysis.
An informed consent was signed by Patient #7 and witnessed by staff on 7/12/2023 at 2:40 PM. The staff signature was illegible.
A review of the PICC Insertion Note documented by contracted RN Staff #85 and dated 7/12/2023 at 5:00 PM was as follows:
"Procedure: Ultrasound guided placement of a Peripherally Inserted Central Catheter. Witnessed informed consent was obtained after the risks, benefits, and alternatives of the procedure were explained to the patient and/or family."

Patient #15
A review of the document titled, Blood or Blood Products Consent Form" revealed Patient #15 signed the informed consent for a blood transfusion on 6/13/2023. The consent was witnessed by 2 staff members. The staff members signatures were illegible. Physician #88 signed the consent on 6/14/2023 at 5:25 AM. There was no documentation in the medical record that the physician discussed the risks and benefits of the blood transfusion prior to the patient signing the informed consent.

Patient #16
A review of the document titled, "Blood or Blood Products Consent Forms" revealed Patient #16 signed a consent for a blood transfusion on 6/09/2023 at 8:45 PM. Staff #89 witnessed the consent. Physician #47 electronically signed the consent on 6/14/2023 at 5:25 AM.

Further review revealed Patient #16 signed an informed consent for a blood transfusion on 6/14/2023 at 11:49 AM. The nursing staff witnessed the consent. Physician #47 signed the informed consent on 6/20/2023 at 4:06 PM.

There was no documentation in the medical record that the Physician #47 explained the risks and benefits prior to Patient #16 signing the informed consents on 6/09/2023 and 6/14/2023. .


A review of the facility policy titled "Informed Consent" with a reviewed date of 3/2023 was as follows"

"PURPOSE
To support patient right to determine care
To define the obligations and documenting informed consent by physicians and healthcare professionals.

POLICY
*Adult patients have the right to make decisions regarding their treatment and to be provided sufficient information in order to make informed decisions regarding their healthcare. Incompetent adult's rights regarding informed consent will be exercised through their legal representative. The physician performing a medical or surgical procedure on a patient is generally responsible for obtaining the patients informed consent prior to the treatment or procedure.
...
KEY POINTS TO PROCEDURE
...
5. For any scheduled medical/surgical procedure or for any procedure that has potential for harm, patient or patient's legal representative will be provided with appropriate information regarding the procedure. (It is the responsibility of the medical staff to provide education; it is the responsibility of the healthcare professional to assure that the patient understands what was told to her/him).
...
PROCEDURE
A. Element of Informed Consent
Informed consent is a process in which the physician provides adequate information for the patient or patient's legal representative to make an informed decision on the proposed treatment, including medications or procedure. Specifically, the physician must disclose in a reasonable manner all significant information that the physician believes is relevant and material to making an informed decision by the patient in deciding whether or not to undergo the procedure or treatment. This information should include all of the following:
1. The nature of the patient's condition;
2 The proposed treatment, possible treatment alternatives, including no treatment;
3. The benefits of the proposed procedure, as well as frequently occurring and significant risks of the proposed treatment and alternative's;
4. The consequences of no treatment;
5. The patient or patient's legal representative should be given the opportunity to ask questions and received additional information requested.
The patient should also be advised that it is not possible to predict or guarantee results.

B. Documentation
...
2. The physician must document in the medical record, or record, on an approved hospital form when available, consent for all therapeutic and diagnostic procedures where disclosure of significant medical information, including significant and frequently occurring risks involved, would assist a patient in making an informed decision whether to undergo the proposed treatment or procedure. Such procedures include surgical and other invasive procedures, treatments with significant risks, and transfusion of blood and/or blood products.
...

F. Role of Licensed Nursing Staff in the Informed Consent Process

1. The treating physician has the duty to disclose all information relevant to the patient's decision and obtain the patient's informed consent. Regarding informed consent, it is the responsibility of the licensed nurse involved in the patient's care to witness, when requested, the signature of the physician, and the patient or responsible individual giving consent. The licensed nurse should also verify with the patient and/or by specific documentation of informed consent in the medical record that consent has been obtained by the physician prior to the procedure or treatment.
2. In the event the licensed nurse determines that informed consent has not been obtained or documented, the licensed nurse will contact the physician who will complete the consent process, speak with the patient, and/or provide specific documentation of the informed process which has previously taken place ..."


An interview was conducted with RN Staff #28 on 7/20/2023 after 9:00 AM. RN Staff #28 was asked if the nurse has the consent signed before the physician explains the risks and benefits of the PICC line to the patient. RN Staff #28 stated, "Yes, I guess we do".

RN Staff #28 confirmed there was no documentation by the physician explaining the risks and benefits of the PICC line prior to the nurse having the informed consent signed in 2(Patient #2 and #7) of 2 patient medical records reviewed.

An interview was conducted with RN Staff #83 and RN Staff #22 on 7/17/2023 at 2:30 PM. RN Staff #83 was asked if the nurse was getting the signature of the patient on the informed consent for the PICC line before the physician informed the patient of the risks and benefits of the procedure. RN Staff #83 and RN Staff #22 confirmed the nurses were just getting the consents signed so that when the contracted service shows up to place the PICC line, they do not have to wait. RN Staff #22 was asked who was responsible for explaining the risks and benefits of the procedure to the patient. RN Staff #22 stated, "I guess that would be the doctor or the nurse that is actually putting the line in."

Staff #28 confirmed that the nursing staff had the patients sign the informed consents signed prior to any risks and benefits being explained by the physician.

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

A. ensure "Dummy" drip chambers were in a secure place in the facility and not available for staff to use in preparing a dialysis machine. The Bio-Medical technician failed to follow the policy on guidance for setting dialysis delivery system safety parameters.

It was determined that the deficient practices posed an Immediate Jeopardy to patient health and safety and placed all patients at risk for the likelihood of harm, serious injury, impairment, and/or subsequent death.


This deficient practice had the likelihood to be hazardous to patient safety and risked an undetected infusion of air into a patient if the "dummy" drip chamber was not removed at the initiation of dialysis.


B. ensure that 11.5 grams of powdered potassium chloride additive packages and calcium chloride 5.7 grams of powdered packages were within date.


C. ensure the chlorine checks were conducted at initial start-up and every 4 hours on the portable reverse osmosis (RO) water treatment systems and that the facility policy was followed for chlorine checks.

D. follow the patient's dialysis prescription by using the ordered BFR (Blood Flow Rate) in 1 (#9) of 6 of the hemodialysis records reviewed. Patient #9's record showed 5 of 14 treatments where the BFR (Blood Flow Rate) did not follow the patient's dialysis prescription written by the nephrologist.


E. ensure dialysis staff were maintaining a clean and sanitary environment for the acute dialysis patient.


Findings included:


A. During a tour of the dialysis room on 07/17/2023 at 1:30 PM observed a "Dummy" drip chamber in the dialysis machine.

A review of the policy titled, "HEMODIALYSIS DELIVERY SYSTEM SAFETY CONDITIONS REQUIRED DURING TREATMENT" dated 10/2020 revealed the following:


PURPOSE: To provide guidance for setting dialysis delivery system safety parameters.

POLICY:

"1. The Air (Foam) Detector will be tested and armed in accordance with the manufacturer's recommendations. The detector will remain armed at all times during treatment. The only exception is when the alarm is being reset. When resetting the alarm, the blood pump will be turned off and the venous blood line clamped prior to opening the alarm latch.

2. To help detect any changes in the blood flow path, the Venous Pressure Alarm must be properly set. If dialysis delivery system allows user selection of alarm parameters, parameters should be set to the lowest selectable limit. If the lower venous pressure limit is individually user selectable, set lower limit as close to the actual current venous pressure reading as possible (asymmetrical option).

3. For treatments with arterial pressure monitoring, the Arterial Pressure Alarm must be properly set. For dialysis delivery systems with independently user selectable or automatically set alarm pressure limits, the limits should be set as tight as possible. Pre-pump arterial pressures should not exceed -260 mmHg. Pressures in excess of -260 mmHg indicate inadequate inflow from the vascular access.

4. If applicable to dialysis delivery system manufacturer guidance. The use of Venous Drip Chamber Test Devices ("dummy chambers") is acceptable only for machine maintenance purposes and only for use outside the patient treatment areas.

a. Only a trained Biomed teammate will utilize Venous Drip Chamber Test Devices ("Dummy Chambers") for calibration and verification purposes only.

b. Venous Drip Chamber Test Devices will only be utilized for testing and calibration purposes of dialysis equipment in an area designated for equipment maintenance and repair.

c. Venous Drip Chamber Test Devices will be accessible to Biomed teammates only. They will be stored in a secured locked area or carried in the Biomed Teammate's Toolbox."


An interview was conducted with Bio-Medical Technician #14 on 07/17/2023 at 2:30 PM. Surveyor asked why there was a "Dummy" drip chamber in the machine. Bio-Medical Technician #14 stated, "I forgot and left the "Dummy" chamber in the machine when I was repairing the machine. I know that the "Dummy" chamber should not be available to the dialysis staff."


B. During a tour of the dialysis room with Dialysis Staff Nurse #16 were packages and boxes of 11.5 grams of powdered potassium chloride additive packages and calcium chloride 5.7 grams of powdered packages that had expired observed in the locked cabinets.

* 2 boxes (100 count to a box) of 11.5 grams of powdered potassium chloride were observed to have expired on 12/07/2022

* 2 boxes (100 count to a box) of calcium chloride 5.7 grams of powdered packages were observed to have expired on 06/23/2023

An interview with Staff #16 on 07/19/2023 at 11:30 AM confirmed that there were 2 boxes of expired 11.5 grams of powdered potassium chloride and 2 boxes of calcium chloride 5.7 grams of powdered packages.


C. A review of the log titled, "Treatment Safety Record" for the month of May and June 2023 revealed the following:

Upon reviewing the June 2023 log for portable reverse osmosis machine #1379546, it was noted that the times for completing chlorine checks were missing. The absence of the first chlorine check time made it impossible to determine if the checks were completed on time. The following first-time chlorine checks were not recorded: 06/09/2023 X 2, 06/12/2023, and 06/19/2023.

Upon reviewing the June 2023 log for portable reverse osmosis machine #1379540, it was noted that the times for completing chlorine checks were missing. The absence of the first chlorine check time made it impossible to determine if the checks were completed on time. The following first-time chlorine checks were not recorded: 06/12/2023 X 3, 06/14/2023 X 2, 06/16/2023, 06/17/2023, and 06/23/2023.

A review of the policy titled, "TOTAL CHLORINE MONITORING OF PORTABLE
REVERSE OSMOSIS (RO) WATER TREATMENT SYSTEMS" dated 9/2016 revealed the following:

"PURPOSE: To establish total chlorine testing is regularly performed and that patients are
dialyzed only with water having chlorine/chloramine levels within the limits specified by the Association for the Advancement of Medical Instrumentation (AAMI).

NOTE: The terms mg/L and parts per million (ppm) are interchangeable, that is 1 mg/L
equals 1 ppm.

POLICY:
1. DaVita hospitals/facilities measure Total Chlorine to verify that levels are less than or
equal to 0.1 ppm (< 0.1 ppm) as specified by AAMI.
2. Total Chlorine testing is performed prior to treatment and every four (4) hours after the
initial test while dialysis-quality water is being utilized. A final Total Chlorine test is
recommended to be performed at the end of the treatment day to verify that the portable
carbon tank/filters have not exhausted.
3. All samples are to be drawn after the portable RO has been operating for at least 15 minutes at the location in which the treatment is being performed."


An interview with Staff #16 on 07/19/2023 at 11:30 AM confirmed that chlorine checks were not being checked every 4 hours per the contract provider's acute dialysis parameters due to the first-time checks missing from the log.


D. A review of the Patient #9's record revealed that Staff # 32 did not follow the patient's dialysis prescription by using the ordered BFR (Blood Flow Rate). There were 4 of 14 treatments where the BFR (Blood Flow Rate) was run at 350 and did not follow the patient's dialysis prescription as written by the nephrologist. The dialysis prescription for the BFR was to be running at 400.

A review of the Patient #9 record revealed on 05/26/23, 06/03/23, 06/09/23, and 06/12/23 the BFR was run at 350.

An interview with Staff #22 (House supervisor) on 09/19/2023 at 2:00 PM confirmed the BFR was run at 350 and not 400 per the physician's dialysis prescription. Staff #22 reviewed the medical records with the surveyor and found no physician orders for changing the BFR (blood flow rate).


E. During a tour of the dialysis unit on 07/18/2023 at 1:45 PM observed the following infection control issues:


Acute dialysis room:

1. In the supply area where patient dialysis supplies were stocked observed dust particles on the shelves where jugs of dialysate were stored.

2. There was a large black trash bag in a rolling trash can full of cardboard boxes, trash, and used filters

3. Observed a linen container full of dirty dried towels.

3. The metal wire rack holding clean and sterile dialysis supplies was rusted.

There had not been a dialysis patient in the facility since 06/22/2023.

The dialysis staff had failed to follow the facility policy "Infection Control in the Hospital Dialysis Setting".


A review of the facility's policy titled, "Infection Control in the Hospital Dialysis Setting" revision date October 2021 revealed the following:

"PURPOSE: To promote a safe, clean environment for all patients and teammates of the dialysis unit and to reduce the risk of spreading infections or bloodborne pathogens in a hospital dialysis setting.


25. Clean areas should be clearly designated for the preparation, handling, and storage of unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled.

26. Cleaning and/or disinfection of equipment and work surfaces, including sinks will be performed as soon as possible following exposure to blood or other potentially infectious materials. Use an appropriate disinfectant such as a 1:100 bleach solution for environmental surfaces or a hospital-approved disinfectant."


An interview with Staff #16 on 07/19/2023 at 2:00 PM confirmed the infection control issues found in the acute dialysis unit and storage area. There was trash and linen that needed to be removed from the dialysis area and the metal wire rack was rusted.

Based on document review and interview the hospital failed to:

1. ensure staff conducted comprehensive patient assessments to determine patient needs and interventions prior to the administration of chemical restraints/emergency behavioral medication, and continuous monitoring after administering a chemical restraint/emergency behavioral medication for side effects, respiratory or cardiac distress, and assessment of medication effectiveness and safety after administration in 1 (Patient #28) of 1 medical record reviewed.

2. ensure that psychotropic medications administered IM/IV(intramuscular/intravenous) for behavioral emergencies were identified as chemical restraints and not therapeutic treatments in 1 (Patient #28) of 1 medical record reviewed.

3. ensure chemical restraints were added to the restraint log and monitored through quality

4. ensure the policy and procedure gave clear instructions to the RN (Registered Nurse) Staff on the frequency of assessment and reassessment of a patient after a chemical restraint was administered.

5. follow their own policy and have verbal orders for chemical restraints authenticated by the ordering physician within 24 hours.

The deficient practices identified under the following Conditions of Participation were determined to pose Immediate Jeopardy to patient health and safety and placed all patients at risk for the likelihood of harm, serious injury, and possibly subsequent death.

Findings:

Patient #28
A review of the medical record for Patient #28 was conducted on 7/18/2023 with Staff #9 and revealed the following:

Review of the History and Physical documented by Staff #47 revealed Patient #28 was a 65-year-old male admitted to the facility on 6/21/2023 with a diagnosis of Pneumonitis due to inhalation of food and vomit, Acute respiratory failure with hypoxia, Hemiplegia (paralysis) affecting left side, Nontraumatic intracranial hemorrhage, Bradycardia (slow heart rate), Hypertension (high blood pressure), Type 2 Diabetes on long term use of insulin.

Review of the nurses note dated 7/07/2023 at 23:05 (11:05 PM) documented by RN Staff #51 was as follows:
" ...Talked to NP Staff #78 (Nurse Practitioner) for Staff #34 (MD) ...patient was combative earlier and was taking off the BPAP and was swing (sic) at me, asked him if he wants to give him something to settle him down, he ordered Geodon (Antipsychotic medication) 10 mg IM X 1 dose ..."

Review of the pharmacy order dated 7/07/2023 at 23:13 (11:13 pm) revealed a verbal order was given by MD Staff #34 to RN Staff #51 that read, "Geodon (antipsychotic medication) Inject 10mg (0.5 ml) intramuscularly one time NOW PRN Fall Risk, Indication: agitation."

Review of the EMAR (Electronic Medication Administration Record) revealed Geodon 10mg was administered IM by LVN Staff #79 on 7/08/2023 at 6:05 AM. This was 5 hours and 8 minutes after the NOW order was given by MD Staff #34.

Review of the nurses note dated 7/08/2023 at 6:05 AM by LVN (Licensed Vocational Nurse) Staff #79 was as follows;
" ...Pt is very agitated and removing non-rebreather. Attempted to reapply non-rebreather. Pt became very combative swinging on nurse and removing mask. Notified charge nurse. Geodon 10mg IM administered x1dose per order given by Charge nurse (RN Staff #51) ..."

A late entry was made by RN Staff #51 that read, "Before shift change, approximately 6:10 am of (sic) 7/08/2023 patient already waking up is pulling his oxygen off resulting in desaturation. I administered Geodon 10mg as order from NP Staff #78 for MD Staff #34 earlier. Administered medication intramuscularly in his right lateral thigh. BP: 129/77, HR:69, RR:34, Temp:97.4F, Sat: 99%. Report given to incoming charge nurse that I administered the said medication to the patient."

A telephone interview was conducted with RN Staff #51 on 7/19/2023 at 8:50 AM. RN Staff #51 was asked who gave the verbal order for the 10 mg of IM Geodon. RN Staff #51 confirmed NP Staff #78 gave the verbal order. RN Staff #51 was asked why the verbal order was entered into the computer system under MD Staff #34's name. RN Staff #51 replied, "I called the group that was on call for the hospital and MD Staff #34 was the physician on call for the group. NP Staff #78 takes call for them at night." RN Staff #51 was asked if he took the verbal order from the NP or the MD. RN Staff #51 confirmed the verbal order for the IM Geodon was given by NP Staff #78. RN Staff #51 stated that LVN Staff #79 gave Patient #28 Lorazepam at 10:50 PM and he calmed down and did not need the Geodon at that time. The next morning around 6:00 AM the patient was combative and agitated with the nurse and I told her to give him the Geodon. RN Staff #51 was asked if he called the physician to get a new order for the emergency medication. Staff #51 stated, "No because I already had an order for the Geodon from last night that we never gave to the patient."


A review of the document titled "Restraint Flowsheet" dated 7/08/2023 at 6:05 am and signed by RN Staff #51 at 6:59 AM was as follows:

" ...Restraint plan discussed with: NP Staff #78 for MD Staff #34.
Medical Indications (requires q2h assessment): Combativeness, pulling at tubes, lines, drains
Type of Restraint: Chemical; Name of Drug: Geodon
Attempted Alternatives to Restraint: Frequent reality orientation/reorientation to surroundings, comfort measures (pain medications, repositioning, and anxiety reduction), frequent observation/companionship, medical evaluation to rule out underlying cause of behavior, concealing IV's/tubes with cling, clothing, etc.
Chemical Restraint Documentation: Patients response 1 hour after administration of medication: Patient awaken and was starting to pull on his oxygen resulting to rapid oxygen desaturation.
Chemical Restraint Vital Signs: Blood Pressure: 129/77, Heart Rate: 69, Respiratory Rate: 34
Oxygen Saturation: 99 Type: Oxygen 15 L/Min non-rebreather.
Nursing Interventions: Q 2-hour monitoring
Time: 6:30 AM (All information left blank)
Comments: Patient calmed down after a while and was able to telerate (sic) the non-rebreather without taking it off.
Restraints to be discontinued ..."

Review of the document titled, "Patient Rounding" by LVN Staff #79 on 7/08/2023 was as follows:

"6:05 AM Agitated/combative, PRN given
6:35 AM Pt relaxed, VS taken, Pt stable
6:45 AM BIPAP applied per respiratory."

During an interview on 7/18/2023 with Staff #9, it was confirmed the post 1-hour Chemical Restraint Documentation on the Restraint Flowsheet revealed the same set of vital signs that were taken at the initiation of the restraint. No other vital signs or continuous assessment was presented for review. Staff #9 also confirmed there was no documented RN assessment after the chemical restraint was administered until 7/08/2023 at 4:59 PM. This was greater than 10 hours after the chemical restraint was administered. Staff #9 confirmed there was only space on the restraint flowsheet for one set of vital signs. Staff #9 confirmed there was no Medical Restraint Order Form in Patient #28's medical record.

Staff #9 was asked to confirm who administered the restraint medication. Staff #9 stated, "Well, the LVN documented she did on the daily note on 7/08/2023 at 6:05 AM and on the EMAR but the RN also documented on the daily note at 6:10 AM that he administered the medication, so I am not really sure."

Staff #9 stated, "The verbal order given for the IM Geodon was not signed by the physician for greater than 24 hours after it was given to the RN. Staff #9 stated that was against the hospital policy because any restraint order given by telephone or verbal order has to be signed within 24 hours." Staff #9 confirmed MD Staff #34 gave the verbal order for 10 mg of IM Geodon on 7/07/2023 at 11:13 PM and he did not authenticate the order until 7/10/2023 at 10:11 AM.

An interview was conducted with RN Staff #22 on 7/18/2023 at 3:45 PM. RN Staff #22 was asked when she would reassess a patient after a chemical restraint was administered. RN Staff #22 stated she would go back in 2 hours to reassess the patient. She was then asked how often and for how long should she monitor the patient. RN Staff #22 replied, "If they were ok, I would only go that one time to complete an assessment after the restraint medication was administered."

On 7/18/2023 after 3:00 PM RN Staff #1 confirmed the Restraint policy failed to instruct the RN on how frequently the patient should be assessed after a chemical restraint was administered.

An interview was conducted with Staff #4 on 7/19/2023 after 10:00 AM. Staff #4 was asked if she was monitoring Restraints through the Quality Program. Staff #4 stated, "Nursing has not reported any restraints to me."

Staff #4 was asked if she was aware that a chemical restraint was administered on 7/08/2023. Staff #4 replied, "No I was not but if nursing does not give me the information how would I know. I guess I will have to find a way for me to that information on a regular basis. I know that they do not use physical or chemical restraints very often, but I still need to be aware of them when they do use them."

A review of the Restraint Log for April-July 2023 did not reveal any restraints were used in the facility. Staff #4 confirmed that Patient #28 was not placed on the restraint log on 7/08/2023.


A review of the hospital policy titled, "RESTRAINTS-COMPREHENSIVE PLAN" with a reviewed date of 3/2023 was as follows:
" ...RULES FOR USE OF RESTRAINTS MEDICAL SURGICAL:
...
3. Order of Restraints:
a. Must have a start time and must be time-limited.
b. One calendar day for adult patients.
c. Must be written or verbal by an independent licensed practitioner.
d. Verbal orders must be authenticated within 24 hours.
e. PRN orders will not be accepted.
...
RESTRAINT/SECLUSION FOR BEHAVIOR MANAGEMENT: (hospital name) does not use restraints for behavioral management.
...
Performance Improvement:

Recognizing that restraints are high risk and problem prone, the hospital will monitor restraint use. The monitoring will include use of restraints through ordering, justification, and meeting patient needs. The Charge Nurse/RN will also monitor each use of restraint to further enhance patient safety. The hospital will understand the root cause of restraint use and Performance Improvement activities will be geared toward appropriate use of restraints.
...
CHEMICAL RESTRAINT PROCEDURE:
1. Least restrictive measures shall be implemented first. If the least restrictive techniques fail to remedy the situation, consideration may be given for a chemical restraint per physician's order.

2. A Registered Nurse (RN) shall observe the individual for a minimum of 60 minutes following administration of the medication and shall document the individual's response including vital signs on the Medical Restraint Order Form under section 8. The RN shall immediately notify the primary care physician or on call physician of any adverse effects.

3. The primary care physician shall conduct a face-to-face examination of the individual within 24 hours of the administration of the medication.

4. Physicians orders expire after each dose and must be rewritten for each subsequent dose. Chemical Restraint may not be ordered on a PRN basis.

5. The RN shall:
a. Write the physician's order. Example: Give (drug name), (route, dose, and amount) x 1 for agitation/combativeness.
b. Geodon, Haldol, Ativan, and Thorazine single dose injections ordered as a restrictive measure will be considered as a chemical restraint ..."

During an interview with Staff #1 on 7/19/2023 after 3:00 PM, Staff #1 confirmed the Restraint Policy was not followed and did not give clear direction to the nursing staff on assessment and reassessment of a patient after receiving a chemical restraint to manage a patient's behavior. Staff #1 also confirmed that restraints were not reported or monitored through Quality.

Based on document review and interview the hospital failed to ensure that chemical restraints were only ordered by a physician in 1 (Patient #28) of 1 medical record reviewed.

The deficient practices identified under the following Conditions of Participation were determined to pose Immediate Jeopardy to patient health and safety and placed all patients at risk for the likelihood of harm, serious injury, and possibly subsequent death.

Findings:

Patient #28
A review of the medical record for Patient #28 was conducted on 7/18/2023 with Staff #9 and revealed the following:

Review of the History and Physical documented by Staff #47 revealed Patient #28 was a 65-year-old male admitted to the facility on 6/21/2023 with a diagnosis of Pneumonitis due to inhalation of food and vomit, Acute respiratory failure with hypoxia, Hemiplegia (paralysis) affecting left side, Nontraumatic intracranial hemorrhage, Bradycardia (slow heart rate), Hypertension (high blood pressure), Type 2 Diabetes on long term use of insulin.

A review of the nurses note dated 7/07/2023 at 23:05 (11:05 PM) documented by RN Staff #51 was as follows:

" ...Talked to NP (Nurse Practitioner) Staff #78 for MD Staff #34 ...patient was combative earlier and was taking off the BPAP and was swing (sic) at me, asked him if he wants to give him something to settle him down, he ordered Geodon (Antipsychotic medication) 10 mg IM X 1 dose ..."

Review of the pharmacy order dated 7/07/2023 at 23:13 (11:13 pm) revealed a verbal order was given by MD Staff #34 to RN Staff #51 that read, "Geodon Inject 10mg (0.5 ml) intramuscularly one time NOW PRN Fall Risk, Indication: agitation."

Review of the EMAR (Electronic Medication Administration Record) revealed Geodon 10mg was administered IM by LVN Staff #79 on 7/08/2023 at 6:05 AM. This was 5 hours and 8 minutes after the NOW order was given by MD Staff #34.

A late entry was made by RN Staff #51 on 7/08/2023 that read, "Before shift change, approximately 6:10 am of (sic) 7/08/2023 patient already waking up is pulling his oxygen off resulting in desaturation. I administered Geodon 10mg as ordered from NP Staff #78 for MD Staff #34 earlier. Administered medication intramuscularly in his right lateral thigh. BP: 129/77, HR:69, RR:34, Temp:97.4F, Sat: 99%. Report given to incoming charge nurse that I administered the said medication to the patient."

A telephone interview was conducted with RN Staff #51 on 7/19/2023 at 8:50 AM. RN Staff #51 was asked who gave the verbal order for the 10 mg of IM Geodon. RN Staff #51 confirmed NP Staff #78 gave the verbal order. RN Staff #51 was asked why the verbal order was entered into the computer system under MD Staff #34's name. RN Staff #51 replied, "I called the group that was on call for the hospital and MD Staff #34 was the physician on call for that group. NP Staff #78 takes call for them at night." RN Staff #51 was asked if he took the verbal order from the NP or the MD. RN Staff #51 confirmed the verbal order for the IM Geodon was given by NP Staff #78 and entered into the electronic ordering system as a verbal order from MD Staff #34. RN Staff #51 was asked if he instructed the NP to call the on-call physician so that the physician could call and give a direct verbal order for the chemical restraint. RN Staff #51 replied, "No."

A review of the Texas Administrative Code Title 25 Chapter 415, Subchapter F, Rule 415.260 (a)(2)(b) was as follows:
"(a) Initiation.
(1) Only staff authorized by the facility's policies and procedures and who have met the training requirements of §415.257 of this title (relating to Staff Member Training) and demonstrated competency in the facility's restraint and seclusion training program, may initiate personal restraint in a behavioral emergency.

(2) Only a physician, registered nurse, or physician assistant in accordance with a physician's delegated authority, may initiate mechanical restraint or seclusion.

(b) Physician's order. Only a physician member of the facility's medical staff may order restraint or seclusion."

RN Staff #51 confirmed that he was not aware that a NP could not order a restraint.

Based on document review and interview the facility failed to ensure restraint orders were not written on a PRN (as needed) basis in 1 (Patient #28) of 1 medical record reviewed. The facility also failed to follow their own policy.

The deficient practices identified under the following Conditions of Participation were determined to pose Immediate Jeopardy to patient health and safety and placed all patients at risk for the likelihood of harm, serious injury, and possibly subsequent death.

Findings:

A Review of the pharmacy order dated 7/07/2023 at 23:13 (11:13 pm) for Patient #28 revealed a verbal order was given by MD Staff #34 to RN Staff #51 that read, "Geodon Inject 10mg (0.5 ml) intramuscularly one time NOW PRN, Fall Risk, Indication: agitation."

An interview was conducted with Staff #9 on 7/18/2023 after 9:00 AM. Staff #9 was asked if the order was written as a 1 x dose for now or a PRN (as needed) order. Staff #9 confirmed the order was written as a NOW order and PRN order.

During a telephone interview with RN Staff #51 on 7/19/2023 at 8:50 AM, RN Staff #51 confirmed the order for the chemical restraint was written as a NOW order and a PRN order. RN Staff #51 stated, "The medication was no longer needed when I got the order and since there was a PRN order, I gave it at a later time."

A review of the hospital policy titled, "RESTRAINTS-COMPREHENSIVE PLAN" with a reviewed date of 3/2023 was as follows:

"RULES FOR USE OF RESTRAINTS MEDICAL SURGICAL:
...
3. Order of Restraints:
a. Must have a start time and must be time-limited.
b. One calendar day for adult patients.
c. Must be written or verbal by an independent licensed practitioner.
d. Verbal orders must be authenticated within 24 hours.
e. PRN orders will not be accepted ..."

RN Staff #51 and Staff #9 confirmed the chemical restraint was written as a PRN order.

Based on record review and interview the facility failed to:

A. ensure a 1-hour Face to Face was completed by the physician or a trained RN (Registered Nurse) within one hour of the administration of a chemical restraint/EBM (emergency behavioral medication) in 1(Patient #28) of 1 medical record reviewed.

B. ensure RN's completed training for the 1-hour face to face evaluation before evaluating a patient after a chemical restraint.

C. ensure the hospital policy required a 1-hour face to face to be completed by a physician or a trained RN after a chemical restraint was administered.

The deficient practices identified under the following Conditions of Participation were determined to pose Immediate Jeopardy to patient health and safety and placed all patients at risk for the likelihood of harm, serious injury, and possibly subsequent death.


Findings:

Patient #28

A review of the medical record for Patient #28 was conducted on 7/18/2023 with Staff #9 and revealed the following:

Patient #28 was a 65-year-old male admitted to the facility on 6/21/2023 with a diagnosis of Pneumonitis due to inhalation of food and vomit, Acute respiratory failure with hypoxia, Hemiplegia (paralysis) affecting left side, Nontraumatic intracranial hemorrhage, Bradycardia (slow heart rate), Hypertension (high blood pressure), Type 2 Diabetes on long term use of insulin.

Review of the nurses note dated 7/07/2023 at 23:05 (11:05 PM) documented by RN Staff #51 was as follows:
"Talked to NP (Nurse Practitioner) Staff #78 for Staff #34 (MD) ...patient was combative earlier and was taking off the BPAP (sic) and was swing (sic) at me, asked him if he wants to give him something to settle him down, he ordered Geodon (Antipsychotic medication) 10 mg IM X 1 dose."

Review of the pharmacy order dated 7/07/2023 at 23:13 (11:13 pm) revealed a verbal order was given by MD Staff #34 to RN Staff #51 that read, "Geodon Inject 10mg (0.5 ml) intramuscularly one time NOW PRN, Fall Risk, Indication: agitation." The medication was administered by LVN Staff #79 on 7/08/2023 at 6:05 AM. This was 5 hours and 8 minutes after the NOW order was given by MD Staff #34.

A review of the document titled "Restraint Flowsheet" dated 7/08/2023 at 6:05 am and signed by RN Staff #51 at 6:59 AM was as follows:

" ...Restraint plan discussed with: NP Staff #78 for MD Staff #34.
Medical Indications (requires q2h assessment): Combativeness, pulling at tubes, lines, drains
Type of Restraint: Chemical; Name of Drug: Geodon
Attempted Alternatives to Restraint: Frequent reality orientation/reorientation to surroundings, comfort measures (pain medications, repositioning, and anxiety reduction), frequent observation/companionship, medical evaluation to rule out underlying cause of behavior, concealing IV's/tubes with cling, clothing, etc.
Chemical Restraint Documentation: Patient awaken and was starting to pull on his oxygen resulting to rapid oxygen desaturation.
Chemical Restraint Vital Signs: Blood Pressure: 129/77, Heart Rate: 69, Respiratory Rate: 34 Oxygen Saturation: 99 Type: Oxygen 15 L/Minute non-rebreather.
Nursing Interventions: Q 2-hour monitoring
Time: 6:30 AM (All information left blank)
Comments: Patient calmed down after a while and was able to telerate (sic) the non-rebreather without taking it off. Restraints to be discontinued ..."

A review of the employee file for RN Staff #51 confirmed there was no documented training that qualified him to complete a 1-hour face to face evaluation.


A review of the hospital policy titled, "RESTRAINTS-COMPREHENSIVE PLAN" with a revised date of 3/2023 was as follows:

" ... CHEMICAL RESTRAINT PROCEDURE:
1. Least restrictive measures shall be implemented first. If the least restrictive techniques fail to remedy the situation, consideration may be given for a chemical restraint per physician's order.
2. A Registered Nurse (RN) shall observe the individual for a minimum of 60 minutes following administration of the medication and shall document the individual's response including vital signs on the Medical Restraint Order Form under section 8. The RN shall immediately notify the primary care physician or on call physician of any adverse effects.
3. The primary care physician shall conduct a face-to-face examination of the individual within 24 hours of the administration of the medication ..."

During an interview with Staff #1 on 7/19/2023 after 10:00 AM it was confirmed that the policy does not cover a 1-hour face to face, who can evaluate a patient, and what training is required to complete a 1-hour face to face evaluation. Staff #1 confirmed that the policy only requires the primary care physician to conduct a "face-to-face" exam within 24 hours. Staff #1 also confirmed that no RN had training to complete a 1-hour face to face evaluation after a chemical restraint had been administered to a patient.

Staff #9 confirmed there was no 1-hour face to face evaluation completed by a physician or a trained RN. Staff #9 also confirmed that the vital signs documented on the restraint flowsheet for the 1-hour post evaluation by RN Staff #51 was the same set of vital signs documented by the nurse at the time of administration.

Based on record review and interview, the hospital failed to ensure the nursing staff developed and maintained a current care plan for 3 (# 1, # 3, and # 6) of 3 patients that reflected the patient's goals and needs in accordance with the facility's policy, "Interdisciplinary Treatment Planning" dated 04/12. The facility staff did not keep the patient's care plans current through the ongoing assessment of the patient's needs and response to nursing interventions.

A review of the facility's policy, "Interdisciplinary Treatment Planning" revealed, "Planning of care shall begin upon admission post assessment of the patient and shall continue throughout the patient's hospitalization as the patient's needs or changes in current planned care are identified. Plan of cares are reviewed or revised a minimum of bi-weekly before and/or during team conferences and as a change in patient condition warrants."

A review of 3 (# 1, # 3, and # 6) of 3 patient medical records revealed the facility was not in compliance with the facility's policy, "Interdisciplinary Treatment Planning." The facility staff did not maintain a current care plan on Patient #1, #3, and #6.

A review of the EMR (electronic medical records) of Patient # 1 revealed the patient's plan of care was not updated bi-weekly as required in the facility's policy, "Interdisciplinary Treatment Planning."

A review of the EMR of Patient # 3 revealed the patient's plan of care was not updated bi-weekly as required in the facility's policy, "Interdisciplinary Treatment Planning."

A review of the EMR of Patient # 6 revealed the patient was admitted on 07/07/2023. The care plan was initiated on 07/07/2023. The care plan had not been updated since admission as of 07/20/2023." The facility staff failed to update the care plan for the patient in accordance with the facility's policy, "Interdisciplinary Team Planning."

An interview with Staff # 9 on 07/20/2023 at 11:00 AM confirmed the facility staff was not documenting and updating care plans in accordance with the facility's policy.

Based on record review and interview Nursing Services failed to ensure a physician gave orders to access and use the PICC (Peripherally Inserted Central Catheter) line before administering IV medications in 2 (Patient #2 and #7) of 2 medical records reviewed, and failed to ensure there was documentation in the medical record that the placement of the PICC line was confirmed through chest x-ray or IC-ECG (an intracavity electrocardiogram) prior to administering IV medications in 1 (Patient #7) of 2 medical records reviewed.


Findings include:


A review of medical records was conducted with RN Staff #28 on the morning of 7/20/2023.

Patient #2

Patient #2 was a 79-year-old female admitted to the facility on 7/13/2023 with a diagnosis of Pneumonia, Stage 3 pressure ulcer to the sacral region, Urinary tract infection, and Escherichia coli (E-coli infection).

A verbal order was given to the nurse on 7/19/2023 at 12:39 PM that read, "PICC line for vancomycin therapy". Vancomycin is a medication that is used to treat a bacterial infection but also has serious side effects like hearing loss and damage to the kidneys.

A review of the document titled, "PICC Insertion Note" completed by the contracted services RN Staff #86 was signed and dated on 7/19/2023 at 2:00 PM. RN Staff #86 documented 1% Lidocaine was administered to numb the skin prior to placement of the PICC Line. There was no documentation of how much was used. Further review read, "3CG Technology and Sherlock System utilized for confirmation of PICC tip in SVC. Max P-wave height obtained on internal ECG. No x-ray needed. PICC ready for use".

RN Staff #28 confirmed that RN Staff #86 confirmed proper placement of the PICC line tip and documented that it was ready for use.

RN Staff #86 was not an employee of the hospital. He was a contracted service and can only confirm through training and certification that the PICC line was in the proper place and ready for use upon a physician's order.

An interview was conducted with RN Staff #28 on 7/20/2023. RN Staff #28 was asked once the PICC line was placed how was the staff informed that it was ready for use. RN Staff #28 replied, "The nurse that comes and puts them in tells us. He uses his equipment to confirm placement and puts it on a thumb drive. Then he gives it to the unit clerk to print it and scan it into the patient's medical record. We have a PICC/Mid-line order set that the doctor is supposed to sign and then we scan it into the record. That's what we call our PICC protocol. We enter some of that information into the computer."

RN Staff #28 confirmed the PICC/Mid-line order set should be completed and signed by the ordering physician prior to the PICC/Mid-line placement. RN Staff #28 was asked to show this surveyor where the order set was in the electronic record for patient #2. RN Staff #28 confirmed there was no PICC/Mid-line order set signed by a physician in patient #2's medical record. RN Staff #28 was asked how the nurses cared for the PICC lines without any physician orders, like flushing the line, dressing changes, and what complications to look for. The nurse stated, "All of that is on the order set but there is not one in this patient's chart, but Patient #2's line did not need to be flushed because she had saline infusing".

RN Staff #28 confirmed Patient #2's PICC line was currently being used for antibiotic therapy and that the medical record did not contain any physicians orders for the use or care of the PICC Line.


Patient #7
Patient #7 was a 68-year-old male admitted to the hospital on 7/12/2023 with a diagnosis of Cellulitis of the left lower limb, Metabolic encephalopathy, and Rhabdomyolysis.

A verbal order was given to the nurse on 7/12/2023 at 2:13 PM that read, "PICC line placement one time now."
Further review of the medical record did not reveal that a PICC/Mid-line order set had been completed and signed by the ordering physician.

A review of the document titled, "PICC Insertion Note" completed by Contracted Services RN Staff #85 was signed and dated on 7/12/2023 at 5:00 PM. RN Staff #85 documented 1% Lidocaine was administered to numb the skin prior to placement of the PICC Line. There was no documentation of how much was used.

RN Staff #28 confirmed there was no documentation by RN Staff #85 confirming that proper placement of the tip of the PICC line was confirmed.

RN Staff #85 was not an employee of the hospital. He was a contracted service and can only confirm through training and certification that the PICC line was in the proper place and ready for use upon a physician's order.


The Unit Clerk stated, "The nurses with the contracted service were having trouble with their machine at some point, and he was not able to give that information to us," but she was not sure if this was one of the patients during that time. RN Staff #28 and the unit clerk tried to view the thumb drive that Staff #85 saved his confirmation reports to and were unable to find this patient on the thumb drive.

RN Staff #28 was asked if a chest x-ray was ordered to confirm proper placement. This surveyor was informed there was no order placed by the physician and no chest x-ray was completed to verify proper placement of the PICC line's tip.

A review of the EMAR (electronic medication administration record) confirmed Patient #7 was administered Saline continuously through the PICC line until 7/16/2023. He also had 11 doses of 750 mg (milligrams) of Vancomycin (antibiotic) between 7/14/2023-7/20/2023 and 11 doses of 2.25 gms (grams) of Zosyn (antibiotic) between 7/14/2023-7/20/2023.

RN Staff #28 confirmed Patient #7 was receiving IV (intravenous) fluids and antibiotic therapy through the PICC line before the proper tip position was confirmed.

A review of the document titled, "PICC/Mid-Line Order Set" revealed that 16 of the 17 predetermined physician orders were automatically checked. The order for the chest x-ray for the PICC tip confirmation was not predetermined or ordered automatically. RN Staff #28 confirmed the chest x-ray order was only needed if the contracted service placing the PICC line was unable to confirm placement with their equipment. The order set covered use, care of the PICC line, dressing changes, when to notify the vascular access specialist or provider for complications, removal of catheters, contraindications for blood pressure checks and blood draws on the affected extremity, intradermal or subcutaneous medication orders for use prior to the placement of the PICC line to relieve any discomfort, and medications not to give through the PICC line.

During an interview on 7/20/2023 with RN Staff #28 it was confirmed there was no PICC/Mid-Line order set on the chart or in the electronic medical record for Patients #2 or #7. Therefore, there was no physician orders given to RN Staff #85 or #86 for the use of 1% Lidocaine prior to insertion of the PICC lines. Furthermore, there was no orders given to the facility staff for the PICC Line use, care of the PICC line, chest x-ray for placement when required, sterile dressing changes, blood sampling, saline flushes, when to contact the provider or the vascular access specialist, medications not to be used through the PICC line, or removal of catheter.

RN Staff #28 confirmed there was no physician orders or PICC Line protocol on 2 (Patients #2 or #7) of 2 medical records reviewed.

Based on document review and interview the facility failed to:

A. ensure a physician order was written prior to transfusing PRBCs (Packed Red Blood Cells-blood) in 1 (Patient #15) of 2 patient medical records reviewed. The facility staff failed to follow their own policy for blood transfusions in 2 (patients #15 and #16) of 2 medical records reviewed.

B. document the time that TPN (Total Parenteral Nutrition) was started and completed, document the date and time when the TPN bags were changed, and document an assessment of the central vein access site in 2 (Patient #23 and #24) of 2 medical records reviewed.

This deficient practice had the likelihood to cause harm to all patients receiving blood products and/or TPN (Total Parenteral Nutrition) at the facility.

Findings:

A.

Patient #15

A review of Patient #15's medical record revealed there was no physician order for the transfusion of 2 units of PRBCs on 6/24/2023.

A review of the document titled, "BLOOD & BLOOD PRODUCT TRANSFUSION PROTOCOL" revealed the physician did not document the type of blood component to be transfused.

The Physician's Signature line was as follows:
"Physician Signature: TORB (Telephone order read back, illegible physician name and staff name that received the order) dated on 6/13/2023 at 0345 (3:45 AM)." Physician #88 electronically signed the document on 6/14/2023 at 5:25 AM.

Staff #4 confirmed there was no verbal or written order by the physician to transfuse blood or blood components on the document titled, "Blood & Blood Product Transfusion Protocol.".


Patient #15 was transfused 2 units of packed red blood cells on 6/24/2023 without a physician's order.



A review of the document titled; "Blood/Blood Components Transfusion Record" revealed the following:

Unit #1 dated 6/24/2023

A review of the Blood/Blood Components Transfusion record revealed
The nursing staff failed to document the Typenex number (blood bank identification number). The start time for the transfusion was documented at 0340 (3:40 AM). The completion time was documented at 0834 (8:34 AM). This was 54 minutes longer than the hospital policy allowed for blood transfusions.

Staff #90, #91, and #92 failed to document the time of the verification process prior to starting the blood transfusion as required by the hospital policy.

Vital signs: Blood Pressure, Temperature, Pulse Rate, and Respirations were taken at the following times: 3:40 AM, 3:55 AM, 4:10 AM, 4:40 AM, 5:10 AM, 6:10 AM, and 9:34 AM.

According to the facility policy, the nurses failed to document the vital signs at 5:40 AM, 6:40 AM 7:40 AM, and at the completion time of the transfusion at 8:34 AM.


Unit #2 dated 6/24/2023

A review of the Blood/Blood Components Transfusion record revealed the start time for the transfusion was documented at 10:40 AM. The completion time was documented at 1500 (3:00 PM). This was 20 minutes longer than the hospital policy allowed for blood transfusions.

Staff #27 and #92 failed to document the time of the verification process prior to starting the blood transfusion as required by the hospital policy.

Vital signs: Blood Pressure, Temperature, Pulse Rate, and Respirations were taken at the following times: 10:40 AM, 10:55 AM, 11:10 AM, 11:40 AM, 12:10 PM, 1:10 PM, and 4:00 PM.

According to the facility policy, the nurses failed to document the vital signs at 12:40 PM, 1:40 PM, 2:40 PM, and at the completion time of 3:00 PM.


Staff #4 confirmed there was no written or verbal physician order to transfuse blood or blood products to Patient #15.



Patient #16

A review of patient #16's medical record revealed Physician #41 gave a verbal order (Order #36) to RN Staff #28 on 6/16/2023 at 9:51 AM that read, "Type/Cross and transfuse 2 units of PRBCs when blood available."

Physician #41 failed to include the indication or rate of infusion as required by the hospital policy.


Staff #4 confirmed there was no verbal or written physician order to follow the hospital protocol for blood transfusions.

A review of the document titled, "BLOOD & BLOOD PRODUCT TRANSFUSION PROTOCOL" revealed the physician did not document the type of blood component to be transfused.

The Physician's Signature line was as follows: The signature was illegible and dated on 6/16/2023. The physician failed to document the time of the signature.


Unit #1 dated 6/16/2023

A review of the Blood/Blood Components Transfusion record revealed the start time was 1515 (3:15 PM). The completion time was 1828 (6:28 PM).

RN Staff #93 and LVN Staff #94 failed to document the time of the verification process prior to starting the transfusion as required by the hospital policy.

Vital signs were taken at the following times: 3:15 PM, 3:30 PM, 3:45 PM, 4:15 PM, 4:45 PM, 5:45 PM, and 7:28 PM.

According to the facility policy, the nursing staff failed to document the vital signs at 5:15 PM, 6:15 PM, and on completion at 6:28 PM.



Unit #2 dated 6/16/2023

A review of the Blood/Blood Components Transfusion record revealed the start time was 2120 (9:20 PM). The completion time was 0025 (12:25 AM on 6/17/2023).

RN Staff #95 and RN Staff #82 failed to document the time of the verification process prior to starting the transfusion as required by the hospital policy.

Vital signs were taken at the following times: 9:20 PM, 9:35 PM, 9:50 PM, 10:20 PM, 10:50 PM, 11:50 PM, and 1:25 AM on 6/17/2023.

According to the facility policy, the nursing staff failed to document the vital signs at the completion of the blood transfusion at 12:25 AM on 6/17/2023.


Further review of the medical record revealed Physician #47 gave a verbal order (Order #41) to RN Staff #87 on 6/21/2023 at 11:56 AM that read, "Transfuse 2 units PRBC per hospital protocol when available."

There was no, "BLOOD & BLOOD PRODUCT TRANSFUSION PROTOCOL" signed by Physician #47 in the medical record for the blood transfusions dated on 6/21/2023.


Unit #1 dated 6/21/2023

A review of the document titled; "Blood/Blood Components Transfusion Record" revealed the start time was 7:15 PM. The completion time was documented at 10:20 PM.

RN Staff #95 and RN Staff #96 failed to document the time of the verification process prior to starting the transfusion as required by the hospital policy.

Vital signs were documented according to facility policy.



Unit #2 dated 6/22/2023

A review of the document titled; "Blood/Blood Components Transfusion Record" revealed the start time of the transfusion was 12:10 AM. The completion time was documented at 3:00 AM.

RN Staff #95 and LVN Staff #97 failed to document the time of the verification process prior to starting the transfusion as required by the hospital policy.

Vital signs were taken at the following times: 12:25 AM, 12:40 AM, 1:10 AM, 1:40 AM, 2:40 AM, and 4:00 AM.

The nursing staff failed to document vital signs at the completion of the blood transfusion.



A review of the facility policy titled, "BLOOD ADMINISTRATION" with a reviewed date of 3/23 was as follows:

"SCOPE:
...Administration of blood products must follow strict guidelines to ensure patient safety. Patient identification, blood product identification, and concurrent infusion fluids must be strictly verified to avoid transfusion errors.

Materials Needed:
The following items are required for blood product transfusion:

*Physician order
*Patient informed consent
...
PROCEDURE:
To infuse blood products, perform the following steps:
1. Verify written physician's order, noting the indication, rate of infusion, and any premedication orders.
...
8. Document identification verifications. Record the identity of both licensed nurses completing the verifications including date and time verification was performed.
...
17. Obtain and document vital signs at 15, 30, 60, and every 60 minutes thereafter until completion of the transfusion. Additionally, evaluate the patient for signs of transfusion reaction.
...
Notes:
Blood products infusion rates should not exceed 4 hours."


An interview with Staff #4 was conducted on 07/19/2023 at 11:00 AM. Staff #4 was asked if the BLOOD & BLOOD PRODUCT TRANSFUSION PROTOCOL" was the same as a physician order. Staff #4 confirmed the protocol did not include an order to transfuse blood or blood components. Also, Staff #4 confirmed that the Blood/Blood component transfusion record did not match the facility policy. There was no space to complete the appropriate number of vital signs and no place for the staff to document the time of the verification process.




47892


B.

Findings include:

Medical record review for patients #23 and #24 was completed with Staff #2 and Staff #9 on 7/19/2023 at 2:40 PM.

During the medical record review Staff #2 and Staff #9 were unable to determine if the nurse completed an assessment on Patient #23 or Patient #24 prior to changing the bag of TPN.

Review of Policy and Procedure on Total Parenteral Nutrition (TPN) Stated, "Inspect condition of the central vein access site for the presence of inflammation, edema, and tenderness". The nurse failed to document patient assessment after a new medication was started. A review of the policy stated "F. Do not interrupt TPN infusion (e.g., showers, transport to procedure, blood transfusion, IV Antibiotics) and be sure that rate does not exceed ordered rate)." The policy failed to say what to do in the event of an emergency if TPN infusion had to be stopped.

During an interview with Staff #9 and #7 (pharmacist) on 7/19/2023 at 2:40 PM Staff #9 stated, "The chart doesn't show when the TPN bags are changed, all the chart shows is that the TPN is infusing. I am unable to find the nursing assessment prior to the changing of the TPN." Staff #2 and Staff #9 also confirmed there was no date or time documented when the TPN bag was changed. Staff #7 stated "all TPN bags are prepared two hours before administration. All TPN bags must start at the same time each day."

During an interview with Staff #2 on 7/19/23 at 2:45 PM Staff #2 stated, "I can't believe it's not in there, but the chart doesn't show when the bags are changed or if an assessment was done."

Staff #2 and Staff #9 confirmed there was no nursing assessment completed prior to changing the TPN bags and no date or time was documented when the TPN bag was changed.

Based on record review and interview, the facility failed to obtain or maintain credentialing records for 1 (#49) of 1 Radiology Technician.

Findings included:

A request was made for credentialing files during 2 days of the survey. The facility was unable to provide credentialing file on the contracted Radiology Technician #49.

An interview was conducted with Staff #12 on 07/19/2023 at 10:15 AM. Staff #12 stated" I do not have files on the radioloy staff."

An interview was conducted with Staff #49 and Staff #50 on 07/19/23 at 1:30 PM. Staff# 49 stated, "The Radiology Technicians will come to the facility to perform x-rays." Staff #50 stated, "The Radiology Technicians will rotate and cover each other. A Radiology Technician was assigned to the facility every day."

Based on review and interview the Governing Body (GB) failed to appoint physicians to the Utilization Review (UR) committee, approve a utilization plan, or provide information on the duties of the facility's Quality Improvement Organization (QIO).

A review of the Governing Body (GB) bylaws approved on 4/18/23 revealed that the GB "shall review and report on the following topics ... Utilization Review ..."(d.) Utilization Review. "The Governing Body shall require the implementation of a utilization review plan designed to monitor both the under-utilization and over-utilization and efficient use of Hospital resources regardless of patient disease, payor classification, patient age, sex, race, color, religion or national origin. Specifically, the utilization review plan, along with the quality assessment and improvement plan should work to ensure one level of care that is of a high and consistent quality to all patients. As with the quality assessment and improvement plan, results of the utilization review activities, as required by the utilization review plan, shall be assessed by the Governing Body at its quarterly meetings and corrective actions shall be reduced to writing and delivered to the Administrator. The utilization review plan shall be evaluated and/or revised at least annually."
A review of the GB meeting minutes for January 2023 stated, "Utilization Review - January 18, 2023 The Board was informed that acute care transfers are down to 5%, After discussion and motion duly made and which is in the Hospital's target rate. Additionally, ____ (quality director no longer employed)informed seconded, the same was unanimously the Board of the importance of the Hospital ensuring that patients approved are offered Freedom of Choice."

A review of the Medical Executive Committee meeting minutes from April 18, 2023, stated, "Utilization Review ..."CEO: Our LOAs in Beaumont saw a small increase this past quarter. When we looked at these numbers, we noticed missed opportunity to educate on Rapid Responses. The remaining of our Quality Data is within normal parameters. There were no numbers or information on "LOAs" (Length of Admissions), and there was no QAPI data provided or attached to the meeting minutes.

An interview was conducted with Staff # 4 on 7/18/23. Staff #4 confirmed that there had been no current UR meetings and was unable to provide any meeting minutes, a UR plan, or names of the members of the committee. Staff #4 was unable to describe or name the facility's QIO or contracted service.

An interview was conducted with Staff #1 on 7/19/23. Staff #1 stated that there had not been a committee for several months and the UR physician was no longer at the facility. Staff #1 stated that Staff # 41 was going to be the UR director but there was no appointment in the credential file and there was no mention of the appointment in the last GB meeting minutes.

Based on review and interviews the Governing Board (GB) failed to provide a Utilization Review Plan, a process for reviewing admissions, duration of stays, professional services offered or outlier cases.

A review of the Governing Body (GB) bylaws approved on 4/18/23 revealed that the GB "shall review and report on the following topics ... Utilization Review ..."(d.) Utilization Review. "The Governing Body shall require the implementation of a utilization review plan designed to monitor both the under-utilization and over-utilization and efficient use of Hospital resources regardless of patient disease, payor classification, patient age, sex, race, color, religion or national origin. Specifically, the utilization review plan, along with the quality assessment and improvement plan should work to ensure one level of care that is of a high and consistent quality to all patients. As with the quality assessment and improvement plan, results of the utilization review activities, as required by the utilization review plan, shall be assessed by the Governing Body at its quarterly meetings and corrective actions shall be reduced to writing and delivered to the Administrator. The utilization review plan shall be evaluated and/or revised at least annually."

An interview was conducted with Staff # 4 on 7/18/23. Staff #4 confirmed that there had been no current UR meetings and was unable to provide any meeting minutes, a UR plan, or names of the members of the committee. Staff #4 was unable to describe or name the facility's QIO or contracted service.

An interview was conducted with Staff #1 and #9 on 7/19/23. Staff #1 stated that there had not been a committee for several months and the UR physician was no longer at the facility. Staff #1 stated that Staff # 41 was going to be the UR director but there was no appointment in the credential file and there was no mention of the appointment in the last GB meeting minutes. Staff #9 stated that he does look at the patients charts and documents the information that he had to send to insurance companies. Staff #9 was unable to provide a list of outliers. Staff #9 stated that the facility was not conducting UR meetings for review of patient stays.

Based on review and interview the Governing Board (GB) failed to have a Utilization Review (UR) Committee, UR Plan, or practioners to assess and decide if a patient's admission or continued stay was medically necessary or not.

A review of the Governing Body (GB) bylaws approved on 4/18/23 revealed that the GB "shall review and report on the following topics ... Utilization Review ..."(d.) Utilization Review. "The Governing Body shall require the implementation of a utilization review plan designed to monitor both the under-utilization and over-utilization and efficient use of Hospital resources regardless of patient disease, payor classification, patient age, sex, race, color, religion or national origin. Specifically, the utilization review plan, along with the quality assessment and improvement plan should work to ensure one level of care that is of a high and consistent quality to all patients. As with the quality assessment and improvement plan, results of the utilization review activities, as required by the utilization review plan, shall be assessed by the Governing Body at its quarterly meetings and corrective actions shall be reduced to writing and delivered to the Administrator. The utilization review plan shall be evaluated and/or revised at least annually."

An interview was conducted with Staff # 4 on 7/18/23. Staff #4 confirmed that there had been no current UR meetings and was unable to provide any meeting minutes, a UR plan, or names of the members of the committee. Staff #4 was unable to describe or name the facility's QIO or contracted service.

An interview was conducted with Staff #1 on 7/19/23. Staff #1 stated that there had not been a committee for several months and the UR physician was no longer at the facility. Staff #1 stated that Staff # 41 was going to be the UR director but there was no appointment in the credential file and there was no mention of the appointment in the last GB meeting minutes.

Based on review and interview the Governing Body (GB) failed to have a Utilization Review (UR) Plan, Committee, or appointed physicians to determine if patients are receiving professional services for availability and use of necessary services, timely services and availability of therapeutic services.

A review of the Governing Body (GB) bylaws approved on 4/18/23 revealed that the GB "shall review and report on the following topics ... Utilization Review ..."(d.) Utilization Review. "The Governing Body shall require the implementation of a utilization review plan designed to monitor both the under-utilization and over-utilization and efficient use of Hospital resources regardless of patient disease, payor classification, patient age, sex, race, color, religion or national origin. Specifically, the utilization review plan, along with the quality assessment and improvement plan should work to ensure one level of care that is of a high and consistent quality to all patients. As with the quality assessment and improvement plan, results of the utilization review activities, as required by the utilization review plan, shall be assessed by the Governing Body at its quarterly meetings and corrective actions shall be reduced to writing and delivered to the Administrator. The utilization review plan shall be evaluated and/or revised at least annually."

An interview was conducted with Staff #1 on 7/19/23. Staff #1 stated that there had not been a committee for several months and the UR physician was no longer at the facility. Staff #1 stated that Staff # 41 was going to be the UR director but there was no appointment in the credential file and there was no mention of the appointment in the last GB meeting minutes.

Based on record review and interview, the facility failed to provide evidence of fire drills one per shift per quarter (at least 12 in a year) for the facility from August 2022 through July 21, 2023, for 12 months.

This deficient practice had the likelihood to cause harm to all patients and staff in the hospital.

Findings included:

On the morning of 7/18/2023, while touring the physical plant, Staff #3 was asked who conducted the quarterly fire drills. Staff #3 stated, " I don't really know. I've just been in this position about a month." Staff #3 further stated, "I haven't done any".

On the afternoon of 7/18/2023, Staff #4 was identified by leadership as responsible for emergency preparedness. Staff #4 was asked, "Who conducted the quarterly fire drills. Staff #4 replied staff #3, I think".

A request was made for evidence of fire drills one per quarter per shift. No fire drills were available for review.

Interview with staff #1, confirmed by statement, "To my knowledge, no fire drills have been conducted since May of 2022. The facility had been recently consolidated and fire drills for the previous quarters were not found for review.

"NFPA (National Fire Protection Association) code 101 (g) Fire drills. The hospital shall conduct at least 12 fire drills each year, one fire drill per shift per quarter, which shall include communications of alarms, simulation of the evacuation of patients and other occupants, and use of fire-fighting equipment".

The facility failed to provide evidence that fire drills had been conducted in compliance with NFPA requirements for 12 months.

Based on observation, record review and interview, the facility failed to ensure emergency equipment and supplies including a cardiac defibrillator, was functioning for staff in an emergency situation.

Findings include:

Observation of the facility's Phillips Heartstart MR Cardiac #1 monitor/defibrillator (used in cardiac events to assist with emergencies in life and death, when the heart is not beating or not beating efficiently to maintain life), located in the facility's treatment room revealed an incorrect timestamp on the sample test strip printed.

Observation of the facility's Phillips Heartstart MR Cardiac monitor/defibrillator #2 (used in cardiac events to assist with emergencies in life and death, when the heart is not beating or not beating efficiently to maintain life), located at the nurse's station revealed an incorrect timestamp on the sample test strip printed and was unable to be corrected at the time of inspection.

A review of the equipment emergency check list for the Phillips Heartstart MR Cardiac monitor/defibrillator in the treatment room revealed dates listed as "not defibrillating." Documentation was not provided to indicate the machine was taken out of service.

A review of the equipment emergency check list for March of 2023 revealed the following:

03/02/23- staff documented no defibrillation 7A-7P
03/02/23- staff documented no defibrillation 7P-7A
03/05/23- staff documented no defibrillation 7A-7P
03/06/23- staff documented no defibrillation 7A-7P
03/06/23- staff documented no defibrillation 7P-7A
03/07/23- staff documented no defibrillation 7A-7P
03/07/23- staff documented no defibrillation 7P-7A
03/08/23- staff documented no defibrillation 7A-7P
03/08/23- staff documented no defibrillation 7P-7A
03/09/23- staff documented no defibrillation 7P-7A
03/16/23- staff documented no defibrillation 7A-7P
03/21/23- staff documented no defibrillation 7A-7P
03/26/23- staff documented no defibrillation 7A-7P
03/27/23- staff documented no defibrillation 7A-7P
03/28/23- staff documented no defibrillation 7A-7P
03/28/23- staff documented no defibrillation 7P-7A
03/29/23- staff documented no defibrillation 7A-7P
03/29/23- staff documented no defibrillation 7P-7A
03/30/23- staff documented no defibrillation 7A-7P
03/30/23- staff documented no defibrillation 7P-7A

A review of the equipment emergency check list for April of 2023 revealed the following:

04/01/23- staff documented no defibrillation 7A-7P
04/03/23- staff documented no defibrillation 7A-7P
04/03/23- staff documented no defibrillation 7P-7A
04/04/23- staff documented no defibrillation 7A-7P
04/04/23- staff documented no defibrillation 7P-7A
04/05/23- staff documented no defibrillation 7A-7P
04/05/23- staff documented no defibrillation 7P-7A
04/06/23- staff documented no defibrillation 7A-7P
04/08/23- staff documented no defibrillation 7A-7P
04/09/23- staff documented no defibrillation 7A-7P
04/10/23- staff documented no defibrillation 7A-7P
04/11/23- staff documented no defibrillation 7A-7P
04/11/23- staff documented no defibrillation 7P-7A
04/12/23- staff documented no defibrillation 7A-7P
04/12/23- staff documented no defibrillation 7P-7A
04/13/23- staff documented no defibrillation 7P-7A
04/17/23- staff documented no defibrillation 7A-7P
04/17/23- staff documented no defibrillation 7P-7A
04/18/23- staff documented no defibrillation 7A-7P
04/18/23- staff documented no defibrillation 7P-7A
04/19/23- staff documented no defibrillation 7A-7P
04/20/23- staff documented no defibrillation 7A-7P
04/22/23- staff documented no defibrillation 7A-7P
04/23/23- staff documented no defibrillation 7A-7P
04/24/23- staff documented no defibrillation 7A-7P
04/25/23- staff documented no defibrillation 7A-7P
04/26/23- staff documented no defibrillation 7A-7P
04/26/23- staff documented no defibrillation 7P-7A
04/27/23- staff documented no defibrillation 7A-7P
04/27/23- staff documented no defibrillation 7P-7A
04/28/23- staff documented no defibrillation 7A-7P
04/28/23- staff documented no defibrillation 7P-7A
04/30/23- staff documented no defibrillation 7A-7P
04/31/23- staff documented no defibrillation 7A-7P

A review of the equipment emergency check list for May of 2023 revealed the following:

05/01/23- staff documented no defibrillation 7A-7P
05/01/23- staff documented no defibrillation 7P-7A
05/02/23- staff documented no defibrillation 7A-7P
05/02/23- staff documented no defibrillation 7P-7A
05/03/23- staff documented no defibrillation 7A-7P
05/03/23- staff documented no defibrillation 7P-7A
05/04/23- staff documented no defibrillation 7A-7P
05/04/23- staff documented no defibrillation 7P-7A
05/05/23- staff documented no defibrillation 7A-7P
05/06/23- staff documented no defibrillation 7A-7P
05/07/23- staff documented no defibrillation 7A-7P
05/08/23- staff documented no defibrillation 7A-7P
05/09/23- staff documented no defibrillation 7A-7P
05/10/23- staff documented no defibrillation 7A-7P
05/10/23- staff documented no defibrillation 7P-7A
05/11/23- staff documented no defibrillation 7A-7P
05/11/23- staff documented no defibrillation 7P-7A
05/15/23- staff documented no defibrillation 7A-7P
05/15/23- staff documented no defibrillation 7P-7A
05/16/23- staff documented no defibrillation 7A-7P
05/16/23- staff documented no defibrillation 7P-7A
05/17/23- staff documented no defibrillation 7P-7A
05/20/23- staff documented no defibrillation 7A-7P
05/20/23- staff documented no defibrillation 7P-7A
05/21/23- staff documented no defibrillation 7A-7P
05/21/23- staff documented no defibrillation 7P-7A
05/22/23- staff documented no defibrillation 7A-7P
05/22/23- staff documented no defibrillation 7P-7A
05/23/23- staff documented no defibrillation 7A-7P
05/23/23- staff documented no defibrillation 7P-7A
05/24/23- staff documented no defibrillation 7A-7P
05/24/23- staff documented no defibrillation 7P-7A
05/25/23- staff documented no defibrillation 7A-7P
05/25/23- staff documented no defibrillation 7P-7A
05/26/23- staff documented no defibrillation 7A-7P

A review of the facility's policy and procedures titled, "MID JEFFERSON POLICY TITLE:
MEDICAL EQUIPMENT MANAGEMENT" dated 03/2023 revealed the following:

"MEDICAL EQUIPMENT MANAGEMENT
Maintaining, Inspecting, and Testing Frequencies:

The Safety Officer and Biomedical Contractor identifies frequencies for inspecting, testing, and maintaining medical equipment on the inventory. The frequency of planned maintenance is determined based on criteria including manufacturer recommendations, risk levels, and current hospital experience. The frequency of maintenance is determined at the time of initial evaluation of the medical equipment based on the following:
Interval testing
Run-time based inspections
Corrective maintenance
Metered maintenance based on hours of use, or other time of use processes (this strategy uses on-board clocks or event recorders to trigger specific tests, inspections, or service)
Other strategies, based on the use of the equipment may include inspection immediately prior to each use, for equipment used infrequently, borrowed, or rented from vendors or others.

A work order is used to manage the work for each planned maintenance event. Work orders are issued for maintenance performed by in-house staff and by contractors. The Safety Officer, through contract Bio-med, manages the work order generation and completion process. Work done by outside contractors is tracked to ensure the work is completed in accordance with the terms of a contract."

An interview was conducted with Staff #83 on 07/17/2023 at 4:00 PM. Staff #83 was unable to demonstrate how to test or print the test strip for the facility's Phillips Heartstart MR Cardiac monitor/defibrillator #2 located at the nurse's station. Staff #83 relayed "I don't know how to run the test."

An interview was conducted with Staff # 2 on 07/18/2023 at 2:30 PM. The surveyor asked about staff checking the crash carts and the process of the defibrillator check off sheets. Staff # 2 stated " all staff have been educated on the emergency equipment. Will look into the defibrillator check off sheets."

An interview was conducted with Staff # 22 on 07/17/2023 at 2:30 PM. The surveyor asked how often the crash carts and defibrillators were being checked by the nursing staff? Staff # 22 stated "I check it on my shifts. The nurses should be checking it." The surveyor asked about the no defibrillation documented on the check list and missing test strips. Staff # 22 stated " the machine was not working. I think we were waiting on a part."

Based on record review, and interview, the facility failed to demonstrate that an individual who was qualified through education, training, experience, or certification in infection prevention and control was appointed by the governing body as the infection control professional.

During a review of Staff # 4 personnel records, it was revealed that Staff # 4 did not meet the requirements of the infection control professional as stated in the facility's policy, "Infection Control Plan." Staff # 4 had the following credentials, "Licensed Vocational Nurse"

A review of the Texas Board of Nursing Scope of Practice revealed, "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." (Board of Nursing (2023, January 1). Texas Board of Nursing. Retrieved August 8, 2023, from https://www.bon.texas.gov/practice_scope_of_practice_lvn.asp.html)

A review of the facility's policy titled, "Infection Control Plan" dated 02/20, revealed the infection control professional will demonstrate, "training in surveillance, prevention, and control."

During an interview on 07/18/2023 at 9:00 AM Staff # 4 stated, "I am working on getting my APIC training, but I have not completed it yet. I have 5 more modules to complete. I don't know how to report my data to NHSN (National Healthcare Safety Network) yet." Staff # 4 was asked, "Have you received any training or oversight from a Registered Nurse who had training in infection prevention and control?" Staff # 4 stated, "No, I have not received any help or training from a Registered Nurse who has training in infection prevention or control. I started in this role in May of 2023."

A review of the Governing body meeting minutes revealed the meeting dates were for January and April of 2023. The January meeting discussed the information from the last quarter (October, November, and December) of the year 2022. The April meeting discussed information from the first quarter (January, February, and March) of 2023. There were no governing body meeting minutes for the second quarter of the 2023 year. The infection control professional was hired and began working at the hospital in May 2023. There had been no approval by the Governing body for the new infection control professional.


An interview with Staff # 1 on 07/19/2023 at 4:00 PM confirmed the infection control professional had not completed the required training, been appointed by the facility's governing body, or had required oversight.

Based on observation, record review, and interview, the facility's infection prevention and control program failed to employ methods for preventing and controlling the transmission of infections within the hospital and between the hospital and other institutions and settings.

This deficient practice has the likelihood to cause harm to patients and staff members within the facility.

Findings Include:

During a tour of the facility on 07/17/2023 at 1:30 PM, 2 out of 2 (# 22, # 81) staff members were observed not performing hand hygiene upon entering patient rooms.

During a tour of the facility on 07/17/2023 at 1:50 PM, 1 out of 1 (# 3) staff members were observed not performing hand hygiene upon exiting the soiled utility room.

During a tour of the facility on 07/17/2023 at 1:30 PM, Staff # 81 was observed entering patient room 111 without performing hand hygiene or dawning PPE (personal protective equipment). The patient in room 111 (Patient #7) was observed to be on contact precautions.

During a tour of the facility on 07/17/2023 at 1:45 PM, Staff #11 was observed cleaning a patient Hoyer lift. Staff # 11 was observed cleaning the top of the lift but did not clean the bottom of the lift.

In an interview with Staff # 11 on 07/17/2023 at 1:45 PM, Staff # 11 was asked, "Do you know how long the equipment is supposed to stay wet before it is considered clean?" Staff # 11 replied, "No, I do not know how many minutes the lift needs to stay wet before it is considered clean. I am cleaning it with a bleach wipe and cover it with plastic covering once it has dried. We place a green sticker that says clean on it once we have cleaned the equipment."

During an interview with Staff # 82 on 07/18/2023 at 09:45 AM, Staff #82 was asked, "Can you tell me the reason your patient in room 111 is in isolation with contact precautions?" Staff # 82 stated, "He has a wound infection with pseudomonas. He is receiving long-term antibiotic therapy for the wound infection and has a PICC (peripherally inserted central catheter) line." Staff # 82 was asked, "When was the patient's PICC line dressing changed? How frequently are PICC line dressings supposed to be changed?" Staff # 82 replied, "We change PICC line dressings every 72 hours. I am not sure when the patient's dressing was changed last. We can go look at it together."

During a tour of the facility with Staff # 82 on 07/18/2023 at 09:50 AM the following was observed:

-Staff # 82 entered the patient room labeled as 111 without performing hand hygiene.

-Staff # 82 entered the patient room labeled as 111 without dawning PPE (personal protective equipment)
The patient in room 111 was in isolation on contact precautions.

-Observed Patient # 7 PICC (peripherally inserted central line) dressing to be peeling up at the corners, exposing a portion of the central line open to the air.

In an interview with Staff # 82 on 07/18/2023 at 9:50 AM, Staff # 82 stated, "His dressing (Patient # 7) was peeling up like this yesterday, but I didn't change it because I knew that I was coming back today and would change it since it is due for a dressing change today."

A review of the facility's policy titled, "Central Line & Temporary Hemodialysis Catheter Care and Maintenance" dated 11/20, revealed the following, "Routine dressing changes are to be done every 7 days and PRN (as needed). Mid-Jefferson Extended Care Hospital central line dressing changes are performed every Saturday, odd-numbered patient rooms on the day shift; and even-numbered patient rooms on the night shift. Change dressing immediately if it becomes loose, damp, soiled or any signs or symptoms of site infection occur." The staff failed to follow the facility policy, "Central Line and Temporary Hemodialysis Catheter Care and Maintenance."

A review of Patient # 7 EMR (electronic medical record) revealed Patient # 7 was admitted to the facility on 7/12/2023 and there was no documentation of PICC (peripherally inserted central catheter) dressing changes occurring while the patient had been admitted to the facility.

During a tour of the facility on 07/20/2023 at 1:00 PM, Staff # 48 and Staff # 77 were observed cleaning patient room 111 after the patient had been discharged from the hospital. The patient who had been discharged from room 111 was in isolation on contact precautions. The staff members observed were not wearing PPE (personal protective equipment) during the cleaning of the room.

During an interview on 07/20/2023 at 1:00 PM, Staff # 48 was asked, "Is your process for cleaning a room that has isolation precautions any different than cleaning a room that does not have any isolation precautions?" Staff # 48 stated, "No, we clean the rooms the same way. We start by wiping everything down with the bleach solution. I always work my way from the back of the room to the front toward the door." Staff # 48 was asked, "Do you wear any personal protective equipment when you clean a room that is under isolation precautions?" Staff #48 stated, "No, because the patient is no longer in the room and the patient was on contact precautions, I do not worry about getting any type of bug while cleaning the room but if the patient was on airborne precautions, I would wear an n-95 mask while cleaning the room."

A review of facility's policy titled, "Standard and Universal Precautions" dated 02/20, revealed the following, "Personnel who may have occupational exposure are required to use PPE when they have reasonable anticipation of exposure." Facility Staff # 48 and # 77 failed to comply with the policy, "Standard and Universal Precautions."

An interview with Staff # 1 on 07/20/2023 at 11:00 AM confirmed the facility's infection prevention and control program failed to employ methods for preventing and controlling the transmission of infections within the hospital and between the hospital and other institutions and settings. Staff # 1 was made aware of the surveyor's observaions of facility staff failing to perform hand hygiene, dawn PPE, and follow the facility's policies for central line care and documentation.

Based on observation, record review, and interview, the facility's infection prevention and control program failed to provide and maintain a clean and sanitary environment to avoid sources and transmission of infection in 7 of 7 areas(Emergency Treatment Room, Medical and Rehabilitation Nursing Stations, Clean Linen Room, Clean Supply Room, Medication Room, Patient Room #112, and Dietary Department).

These findings had the likelihood to cause harm by increasing the risk of infection to all patients and staff at the facility.

A.

During a tour of the facility on 07/17/2023 at 1:30 PM the following infection control issues were observed and photographs were taken:

Medical and Rehabilitation Nursing Stations:

* Outside patient room #111 it was noted the hand sanitizer was expired. The expiration date was 6/2023. Patient # 7 was on contact isolation precautions. (Contact Isolation Precautions require medical staff and visitors to wear gowns and gloves when entering the patient's room to prevent the spread of an infectious disease).

* 2 of 2 ventilators stored in the hallway next to patient room #116 were covered with plastic and labeled as "clean". Dust and debris build-up was on the bottom portion of the ventilators.

* The floor in the nurse's stations had dust and dirt build-up.

* The eyewash station located at the central nurse's station had a white and orange substance splattered in the sink.

* There were stains and debris particles in 2 of the drawers of the nurses' station.

* Observed a dead bug and dust in a purple caddy where the facility stored lab tubes and supplies used to draw blood.

* There were 2 non-sterile woven gauze packets open and being used for patient blood sugar checks. The gauze packages were labeled as "single-use only."

* Two glucometers (a machine used to check blood sugars) in the docking stations. One of the glucometers in the docking station had a hair on it. Also, observed brown and red liquid stains on 1 glucometer. The glucometer serial number was labeled as, "UU14544098." The glucometer was docked at the docking station. Two glucometer strips were open and in use with no label to indicate when the strips had been opened. The lot number on 1 glucometer strip was labeled as, "670107." And the other glucometer was labeled "670108."

An interview with Staff #80 stated, "That glucometer machine is clean because if it is docked at the station."

Medication Room

*Visible dirt and debris build-up was observed behind the door and on the medication crusher (a device used to crush a patient's medication). A sharps container was filled past the "fill" line and stored on the floor. Inside a drawer was a dirty spoon wrapped in a napkin with brown stains.

Clean Supply Room

*Dust and debris particles on the shelves of 2 of 3 patient supply carts in the supply room.

Clean Linen Room

* In the clean linen room, the hand soap next to the sink was expired with an expiration date of "04/2023"

* The linen on the clean linen cart was wrapped in a plastic covering. The plastic covering seal on the patient gowns had been broken and the patient gowns were not covered to prevent contamination from the traffic of staff working in the clean linen room.

* There was a black bag with a staff member's personal items stored on the counter in the clean linen storage room. During an interview on 07/17/2023 at 1:35 PM, Staff # 3 stated, "I am not sure which staff member that bag belongs to, but I will have it removed from this room."

Patient Room #112

Patient room #112 was labeled as clean and ready to receive a new patient. Upon entering the room, the following infection control issues were observed:

* Brown and red liquid on the tile of the bathroom floor.

* Washcloth lying on the floor of the patient shower. The washcloth was positioned under one of the legs of a shower chair to balance the chair.

* Thick layer of dust buildup on the bathroom ceiling vent.

* Dead bugs and dust particles were observed on the windowsill in the patient's room.

* There was a tan liquid observed on the legs and bottom of the patient's bedside table and the legs of the patient's chair.

* Debris and dust particles were located on the floor behind the door entering the room.

* There were missing pieces of wood from the wall molding at the base of the wall under the television.

During an interview with Staff # 1 and # 3 on 07/18/2023 at 11:00 AM the infection control observations were discussed, and pictures were made available. Staff # 1 and Staff # 3 acknowledged the facility had infection control issues.


48749


During an observation tour of the facility with Staff #22 on 07/17/2023 at 1:30 PM, the following infection control issues and expired supplies were identified:

Treatment Room:

* Trash and soda cans were observed in red biohazard trash container. Only biohazardous waste should be placed inside red bags for disposal such as contaminated dressings, gauze, tubing, or blood products.

* An open box of surgical masks in the top cabinet, with an expiration date of 07/31/2022.

* A Blood and Body Fluid Spill Kit in a drawer with a written replacement date of 05/25/2020 on the label.

* A package of opened antibacterial wipes in a drawer located next to the sink with an expiration date of 07/19/2022.

* The treatment room gurney was covered with a clear plastic bag and tagged with a "clean" sticker. The railings of the gurney were noted to have dust build-up.

* There was visible dust and a dead bug under the sink in the treatment room.

Defibrillator Cart #1 (an emergency cart with emergency supplies and drugs) in the treatment room.

* The top of defibrillator cart #1 was covered in dust.

* The following expired supplies were discovered on defibrillator cart #1:

15- 10ml saline flushes expired 06/2022
7 lubricating jellies expired 04/2022
1 Foley catheter kit expired 05/2022
1 Foley catheter expired 09/2022
10- 18 gauge 1.5inch needles expired 03/2023
1 package of sterile gloves expired 06/2023
1 package of ECG electrodes expired 12/2021
2 IV (intravenous) start kits expired 11/2022

* An oxygen delivery regulator and a wall suction regulator, not tagged as clean, are stored in the bottom drawer of the defibrillator cart.

* In the treatment room on the storage shelves, observed empty supply packages that had been opened by the staff.

* Opened an unknown bag that had used tubing, a can of disinfectant spray, and an open package with a ventilator filter.

* The glidescope (this is- a portable video laryngoscope used as an aide to help place a breathing tube in a patient) was covered with a clear, plastic bag, tagged "clean" and was noted to have dust build up on the base. Also, there were 4 lubricating jelly packets with an expiration date of 06/2023 hanging in a bag from the stand.

* A buildup of dust and debris on the floor.

Defibrillator Cart #2 at the central Nurse's Station

* Visible dust on top of the defibrillator cart #2. Also, the following supplies were discovered to be expired:

17- 10ml saline flushes expired 09/2022
8 lubricating jelly expired 04/2022
2 central line kits expired 11/2022
3 sterile glove packages expired 10/2022
2 packages of defibrillator pads expired 04/2022
3 packages of ECG electrodes expired 06/2022
2 packages of ECG electrodes expired 07/2022

Defibrillator Cart #3 in the main hallway between 2 nursing stations

There was visible dust on the top of defibrillator cart #3.

The following expired supplies were found:

1 Foley catheter kit expired 03/2023
1 Foley catheter kit expired 04/2023
5 packages of ECG electrodes expired 12/2021

* An oxygen delivery regulator and a wall suction regulator, not tagged as clean, stored in the bottom drawer of the defibrillator cart.


An interview was conducted with Staff #22 on 07/17/2023 at 2:30 PM. The surveyor asked how often the crash carts and defibrillators were being checked by the nursing staff. Staff # 22 stated, "I check it on my shifts. The nurses on the other shifts should be checking it." While touring the treatment room with Staff #22 and pulling expired supplies, Staff #3 walked in and stated, "It is my responsibility to make the supplies are good. I just have not had a chance to check them."



28659


C.

On 7/18/2023 the delivery of lunch food service trays was observed. Staff #81 was observed removing a patient's noon meal tray from the heated delivery cart. Staff #81 was followed to the patient's room by the surveyor. Staff #81 entered the room with the tray and positioned the tray on the overbed table for the patient and removed the cover on the plate. Staff #81 then removed the plastic covering over the dessert container, removed the paper off of the drinking straw, and with the palm of her hand grabbed the drink glass from the top, placed the straw in the glass, and placed it in front of the patient.

Staff #81 exited the patient's room and used the gel dispenser outside of the patient's room and stated, "See I remembered to use the gel on the way out. The surveyor stated. "Yes, but you failed to wash your hands or use gel prior to removing the tray from the cart and forgot to gel your hands prior to removing the tray cover and touching the utensils and drink".


A review of the cdc.gov (Center for Disease Control) Environmental Health Services, "Improving food worker hand washing practices is critical to preventing outbreaks of diseases like norovirus, Campylobacter, Salmonella, and
E-coli".

Based on record review and interview, the facility failed to ensure the infection control professional maintained communication and collaboration with the hospital's QAPI (Quality Assurance and Performance Improvement) Program on infection prevention and control issues.

A review of Staff # 4 personnel record revealed Staff # 4 was working as the facility's Infection Control Program Coordinator, Director of Quality, Director of Employee Health, Director of Education, and Director of Risk Management. Staff # 4 was not able to provide facility documents supporting the collaboration between the Infection Control Program and the facility's QAPI program. It was determined that the Infection Control Program Coordinator (Staff # 4) could not also function as the Director of Quality, as this would not allow for effective and unbiased reporting through chain of command channels.

During an interview with Staff # 1 on 07/18/2023 at 11:00 AM, it was confirmed that Staff # 4 was employed as the Infection Control Program Coordinator and as the Director of Quality at the facility. These assignments would not demonstrate effective and unbiased reporting.

Based on record review and interview, the facility failed to ensure the Organ Procurement Organization (OPO) was notified for 2 (#18 and#22) of 5 patient death records reviewed.

Findings include:

Patient # 18

A review of the form titled; "Funeral Home Release" has an area where the OPO (Organ Procurement Organization) was to be notified. The form was left blank and there was no way to know if the OPO had been notified. The patient's death was on 05/14/2023 at 12:31 PM. There was documentation that the patient's body was released to the funeral home on 05/14/2023 at 2:06 PM.

Patient # 22

A review of the form titled; "Funeral Home Release" has an area where the OPO (Organ Procurement Organization) was to be notified. The form was left blank and there was no way to know if the OPO had been notified. There was a comment written by the hospice nurse that said, "There is no need". The patient's death was on 05/16/2023 at 9:25 PM. There was documentation that the patient's body was released to the funeral home on 05/16/2023 time was left blank.

A review of the facility's policy titled, "Post Mortem Care Organ Procurement" revised date of 3/2023 revealed the following:

Purpose:
"To ensure that the families of all potential donors are offered the opportunity to donate organs and/or tissues and are allowed to accept or to decline that option.
To provide a service that makes possible the transplantation of organs and tissues from designated donors to recipients in order to improve quality of life and to save lives
To comply with federal and state laws to provide guidelines for the safe and ethical donation of organs and tissues.

Policy:
Pursuant to OBRA and the Southwest Transplant Alliance, the patient must be given the option to donate or decline to donate organs and/or tissues for transplant and/or research and the family members of deceased patients must be given the option of organ and tissue donation, with discretion and sensitivity to the circumstances, beliefs, and desires of the families of potential donors.
This facility has an agreement with Southwest Transplant Alliance for procurement of organs and tissue and services related to the recovery, testing, processing, storage, and distribution of eye (corneas and sclera) to coordinate approach and consent from families of potential donors.
Family members of every deceased patient determined to be medically suitable for organ or tissue donation will routinely be afforded the opportunity to consent to donation by the procuring agencies.
All deaths are required to be reported to the Southwest Transplant Alliance."

An interview with Staff #9 on 07/20/2023 at 9:30 AM confirmed that the death records had no notification to OPO (Organ Procurement Organization) on patients #18 and #22 and the comment written by the hospice nurse was not correct.

Based on document review and interview, the hospital failed to ensure a physician was appointed by the Governing Body as the Medical Director of Respiratory Services.

Findings include:

A review of the credential file for Staff #34 did not reveal any documentation that physician was appointed as the Medical Director of Respiratory Services by the Governing Body.

A review of the Governing Board and Medical Executive meeting minutes dated 7/18/2023 did not reveal Staff #34 had been appointed as the Respiratory Services Medical Director.

An interview was conducted on 7/18/2023 at 4:30 PM with Staff #1. Staff #1 was asked who the Medical Director for Respiratory Services was. Staff #1 stated, "Staff #34 is over Pulmonary." Staff #1 was informed there was no documentation that Staff #34 was appointed by the Governing Body as the Medical Director of Respiratory Services. Staff #1 stated, "Ok".

Staff #1 confirmed that there was no documentation by the Governing Body that Staff #34 was appointed as the Medical Director of Respiratory Services.

Based on observation, document review, and interview, the Biomedical engineering department and the Safety officer failed to ensure that complete preventative maintenance was performed on the 2 of 2 EKG (electrocardiogram) machines ready for use on patients.

A tour of the facility was conducted on 7/18/23 at 10:25 AM with staff #46. At the end of the hallway, an EKG machine was found. (An electrocardiogram (ECG or EKG) records the electrical signal from the heart to check for different heart conditions) Staff #46 was asked to turn on the EKG machine. The machine revealed that the time and date were not set appropriately. The date was revealed as 1/8/2010 and the time was 7:16 PM. Staff #46 confirmed that the date and time were incorrect. The second EKG machine was found in the Biomed room it was dated 7/19/23 (a day ahead) at 9:19 AM and staff #46 stated that it could be used at any time. There was no evidence of when maintenance had been performed.

Review of patient chart # 7 revealed he was admitted on 7/11/23 but his EKG was dated 1/2/2010 at 12:05PM.
Patient # 27 was admitted on 7/12/23 and the initial EKG was dated 1/3/2010 at 11:43 AM. Patient #28 was admitted on 7/17/23 and the EKG was dated 1/8/2010 at 12:25 PM.

Based on observation, record review and interview, the facility failed to conduct a tabletop disaster drill or emergency drill training for their disaster plan preparedness for all employees.

Findings include:

The facility was requested to provide this surveyor with their emergency preparedness plan, and any disaster drills or table top drills that have been completed. The facility was unable to provide documentation of a tabletop or disaster drill training.

An interview was conducted with Staff #1 on the morning of 07/18/2023. Surveyor asked has there been any tabletop or disaster training, Staff #1 stated, " There has not been a drill at this facility since I started this position."

An interview was conducted with Staff #2 on 07/18/2023 at 2:30 PM. Surveyor asked has there been any tabletop or disaster training, Staff #2 stated "We have not had a disaster drill while at this facility."

Based on record review and interview, the facility failed to ensure active collaboration between the facility's Antibiotic Stewardship Committee and the facility's Infection Control Program. The facility was unable to provide documentation of the Infection Control Program's meeting minutes. Also, the facility was unable to provide documentation of the Antibiotic Stewardship Committee's meeting minutes.

During a review of facility's policy titled, "Infection Control Plan" dated 02/20, the following was revealed, "Members of the Infection Control Committee will include Administration, Medical Staff, Pharmacy, Nursing, Infection Control Practitioner, Quality Improvement, Consulting representatives as needed." The facility failed to comply with the policy, "Infection Control Plan."

During an interview with Staff # 4 on 07/18/2023 at 11:00 AM, Staff # 4 stated, "I have been in this role since May of 2023, and we have not had an infection control committee meeting since I started." Staff # 4 was questioned, "Is there any involvement with the pharmacist in infection control activities within the facility?" Staff # 4 stated, "Not since I have started but we plan to have a meeting for this quarter soon. We had to reschedule it due to staff member's vacations."

A review of the facility's policy titled, "Antimicrobial Stewardship Program (ASP)" dated 03/23, revealed, "Infection Prevention RN commitment: Communication and collaboration with the antibiotic stewardship program." The facility failed to comply with the policy, "Antimicrobial Stewardship Program."

An interview with Staff # 4 on 07/18/2023 at 11:00 AM confirmed the facility was unable to provide documentation supporting collaboration between the Antibiotic Stewardship Committee and the Infection Control Committee.

Based on record review and interview, the facility failed to establish an individual responsible for the development and implementation of a hospital-wide antibiotic stewardship program to monitor and improve the use of antibiotics. The facility failed to provide documents to support the establishment of an antibiotic stewardship committee within the facility.

This deficient practice has to likelihood to result in the improper use of antibiotics within the facility.

During an interview with Staff # 7 on 07/18/2023 at 11:20 AM, Staff # 7 stated, "We do have an antibiotic stewardship committee. We meet once per quarter with the infectious disease doctor and other leaders within the facility. The committee discusses the usage and cost of antibiotics, and we look for ways to reduce the usage of antibiotics."

The facility was unable to provide documentation of the Antibiotic Stewardship Committee's meeting minutes when asked.

An interview with Staff # 1 on 07/20/2023 at 11:00 AM confirmed the facility was unable to provide documentation of the facility's Antibiotic Stewardship Committee.