HospitalInspections.org

Based on policy reviews and interview the facility failed to ensure that policies had been approved by the governing board of the specifically named hospital and that those policies and procedures were clearly for the specific hospital in 2 of 2(Complaint and Grievance Process and Medical Records: Verbal and Telephone Orders) policies reviewed.

A review of the policy and procedure, "Complaint and Grievance Process" revealed it was revised on 1/23/24. The policy stated that the "scope" was for all the LTAC hospitals by an organization that no longer owns the facility.
An interview with staff # 3 on 1/27/25 stated that the facility was bought by another corporation a year ago and not all policies have been changed or approved. Staff #3 stated the facility department head was to bring the revised policy to the committee for approval, take it through medical staff, and then send it for approval by the Governing Board.

A review of the policy and procedure, "Medical Records: Verbal and Telephone Orders" revealed it was reviewed on 3/2023. The policy stated that the scope was "Organization-Wide." The facility was not listed, and the organization no longer owns the facility.

A review of the policy and procedure "Policies and Procedures Guidelines"
The two policy and/or procedure types that may be developed and approved for Sciara Hospital Harlingen, LP, and Brownsville Campus are defined as follows:

1 Organization-Wide Policies and/or Procedures - Policies and/or procedures developed by a department or by administration with applicability to more than two departments shall be approved by the Administration Staff and formatted and indexed in accordance with the following. There are four organization-wide policy and procedure manuals located in appropriate departments.

Administration Leadership
Human Resources (including Employee Health and Education)
Environment of Care (including Safety, Security, Hazardous Materials, Infection
Control, Emergency Preparedness, Life Safety, Medical Equipment, Utility Systems)
Nursing Services (as applicable)

Departmental Policies - Each department director will develop and approve internal policies governing his/her operation provided these policies have no influence or control over another department's functioning. The Executive Staff member over the department will have final authority of policy and procedure manual alterations.
Departmental policies and procedures will be developed in the standardized format and indexed according to the uniform system developed and utilized by Sciara Hospital Harlingen, LP and Brownsville Campus.

2. Policies pertinent to patient care will be submitted to the medical staff body for approval or revision/approval."

The policy failed to ensure that all policies were to be approved by the governing board. Staff #3 was unable to provide any governing body meeting minutes where the policies were approved.

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Based on document review and interview the facility failed to;

1. ensure a properly executed informed consent was completed before the administration of blood and blood products in 2 (Patient #7 and Patient #9) of 2 medical records reviewed. Also, the facility failed to follow the policy titled, "Consent for Medical and Surgical Procedures".

Refer to TAG A0131


2.
A. ensure that chemical restraints administered were identified as chemical restraint/ emergency behavioral medications (EBM) in 2 of 2(pt #10 and 13) charts reviewed.

B. ensure psychotropic medications ordered IV or IM were not written as PRN orders for behavioral emergencies in 2 of 2 (pt #10 and 13) charts reviewed.

C. ensure a process was in place for monitoring after administering a chemical restraint/emergency behavioral medication for side effects, respiratory or cardiac distress, and assessment of medication effectiveness, safety after administration, and for how long in 2 of 2 (pt #10 and 13) charts reviewed.

D. follow their own policy and procedures to ensure the restraint packet was filled out appropriately and completely, a face-to-face was conducted by a trained individual, and patient/ staff debriefing was completed and appropriate in 2 of 2 (pt #10 and 13) charts reviewed.

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

Refer to TAG A0160

3. Based on document review and interview the facility failed to:

1. ensure 3 (Physician #10, Physician #11, and Nurse Practitioner #9) of 3 provider orders included the rate or duration for the transfusion of blood/blood products in 2 (Patient #7 and #9) of 2 patient medical records reviewed.

2. ensure 3 (Physician #10, Physician #11, and Nurse Practitioner #9) of 3 providers gave orders to increase the rate of transfusion from the initial rate of the blood/blood product transfusion in 2 (Patient #7 and #9) of 2 patient medical records reviewed.

3. ensure the nursing staff followed the facility policy titled, "Blood and Blood Components-Administration" and documented the vital signs (blood pressure, pulse, respirations, temperature, and oxygen level) during and after a blood/blood product transfusion in 2 (Patient #7 and #9) of 2 medical records reviewed.

4. ensure the nursing staff had a properly executed informed consent before initiating a blood/blood product transfusion in 2 (Patient #7 and #9) of 2 patient medical records reviewed.

Refer to TAG A0410

Based on document review and interview the facility failed to

1. ensure a properly executed informed consent was completed before the administration of blood and blood products in 2 (Patient #7 and Patient #9) of 2 medical records reviewed. Also, the facility failed to follow the policy titled, "Consent for Medical and Surgical Procedures".

Refer to TAG A0131


2.
A. ensure that chemical restraints administered were identified as chemical restraint/ emergency behavioral medications (EBM) in 2 of 2(pt #10 and 13) charts reviewed.

B. ensure psychotropic medications ordered IV or IM were not written as PRN orders for behavioral emergencies in 2 of 2 (pt #10 and 13) charts reviewed.

C. ensure a process was in place for monitoring after administering a chemical restraint/emergency behavioral medication for side effects, respiratory or cardiac distress, and assessment of medication effectiveness, safety after administration, and for how long in 2 of 2 (pt #10 and 13) charts reviewed.

D. follow their own policy and procedures to ensure the restraint packet was filled out appropriately and completely, a face-to-face was conducted by a trained individual, and patient/ staff debriefing was completed and appropriate in 2 of 2 (pt #10 and 13) charts reviewed.

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

Refer to TAG A0160

Based on document review and interview the facility failed to:

1. ensure 3 (Physician #10, Physician #11, and Nurse Practitioner #9) of 3 provider orders included the rate or duration for the transfusion of blood/blood products in 2 (Patient #7 and #9) of 2 patient medical records reviewed.

2. ensure 3 (Physician #10, Physician #11, and Nurse Practitioner #9) of 3 providers gave orders to increase the rate of transfusion from the initial rate of the blood/blood product transfusion in 2 (Patient #7 and #9) of 2 patient medical records reviewed.

3. ensure the nursing staff followed the facility policy titled, "Blood and Blood Components-Administration" and documented the vital signs (blood pressure, pulse, respirations, temperature, and oxygen level) during and after a blood/blood product transfusion in 2 (Patient #7 and #9) of 2 medical records reviewed.

4. ensure the nursing staff had a properly executed informed consent before initiating a blood/blood product transfusion in 2 (Patient #7 and #9) of 2 patient medical records reviewed.

Refer to TAG A0410

Based on document review and interview the facility failed to ensure a properly executed informed consent was completed before the administration of blood and blood products in 2 (Patient #7 and Patient #9) of 2 medical records reviewed. Also, the facility failed to follow the policy titled, "Consent for Medical and Surgical Procedures".

Findings:

Patient #7
A review of the medical record for Patient #7 was conducted on 1/28/2025 after 9:00 AM with Chief Clinical Officer (CCO)/Chief Operating Officer (COO) Staff #3 and Director of Quality Manager (DQM) Staff #6. The review revealed Patient #7 was a 92-year-old female admitted to the facility on 11/01/2024. Further review revealed Patient #7 received a transfusion of Packed Red Blood Cells (PRBC) on 11/19/2024 at 2350 (11:50 PM).

Further review of the medical record revealed a document titled; "Informed Consent for Transfusion" dated 11/16/2024. The document was as follows:

" ...1. Proposed Treatment(s)/Physician(s)
For:____________(Patient #7)
Transfusion(s) proposed: 1 unit of PRBC ...".

The signature page revealed a telephone consent was obtained from the patient's daughter and witnessed by two employees of the hospital on 11/16/2024 at 2240 (10:40 PM).

" ... PHYSICIAN CERTIFICATION: I hereby certify that I have discussed the treatment(s) described above with the patient (or patient's legal representative). The discussion was held prior to treatment and included the risks/benefits, consequences/ alternatives and other pertinent information about the proposed treatment(s).
__I hereby certify that the patient has received a copy of the California Department of Health Care Services information pamphlet, A Patient's Guide to Blood Transfusion. (CA only)

(Printed Name/Signature of Physician) Time: ____:____ AM/PM Date:____/____/______..."

The final page of the 4-page consent was as follows:

"Policy or Resource: INFORMED CONSENT/ PROCEDURE REQUIRING INFORMED CONSENT. Completion Instructions: CONSENT FOR TRANSFUSION

Use this consent form for every patient requiring transfusion.

It is the treating physician's responsibility to obtain informed consent. Hospital personnel should not be involved in providing the information necessary to secure the patient's informed consent.
Personnel can answer general questions the patient has regarding the treatment. The hospital's role in the consent process should be limited to verifying that the physician obtained informed consent. This form serves the dual purposes of assuring that the physician obtained informed consent from the patient prior to the proposed treatment and indicating that the patient is aware of the right to give informed consent or refusal to the treatment recommended by the physician.

Instructions for use: The entire form should be read to the patient.

...Section 1: All blanks must be filled in prior to the patient or legal representative signing the form.
*If multiple blood product types are ordered, they must each be listed on the consent form.
*If different blood products are ordered during the patient's hospitalization, a new informed consent is required.

Section 2:
*This form lists the risks of transfusion. The physician should document the informed consent
discussion in the progress notes, noting additional risks and benefits not addressed on the form.

Section 3:
o If the patient/legal representative consents to the proposed treatment(s), the form should be
signed. Complete the signature sections appropriately ...
*The physician should always sign the consent form prior to the transfusion ..."


Patient #9
A review of the medical record for Patient #9 was conducted on 1/28/2025 after 9:00 AM with Chief Clinical Officer (CCO)/Chief Operating Officer (COO) Staff #3 and Director of Quality Manager (DQM) Staff #6.

The review revealed Patient #9 was a 58-year-old female who was admitted to the hospital on 12/27/2024. Further review revealed Patient #9 received 1 unit of Packed Red Blood Cells (PRBC) on 12/29/2024 at 2:45 AM, one unit of platelets on 12/30/2024 at 2:03 PM, and one unit of platelets on 1/03/2025 at 4:32 PM.

A review of the document titled; "Informed Consent for Transfusion" was as follows;
"1. Proposed Treatment/Physician:
For: __________(Patient #9)
Transfusion(s) proposed: _______Anemia______
Transfusion(s) ordered by: Physician #11

On the bottom of page 1(1 of 2 pages) Patient #9 signed and the Registered Nurse (RN) signed the page. There was no date or time by the nurse or the patient. This was not the signature page for the informed consent. On page 2 of 2, the signature page for the patient or surrogate, the witness to the patient's signature, and the physician's signature. The page was blank. The physician failed to sign the informed consent.

An interview was conducted with Staff #6 on 1/28/2025 after 2:00 PM. DQM Staff #6 confirmed there was no way to determine when the consent was signed by Patient #9 and no proposed transfusion was documented.

The nursing staff and physician failed to obtain a signed informed consent for the transfusion of PRBC's and platelets before Patient #9 received the 3 of 3 blood/blood product transfusions.




A review of the facility policy titled, "Consent for Medical and Surgical Procedures", Policy # CL-4.0 with a revised date of 1/2023 was as follows:

PURPOSE:
To provide the patient with clearly defined written agreements for purpose performed medically or surgically and to morally, legally, and personally protect the rights of the patients and those rendering care to them.

POLICY:
Medical records must contain a properly executed and completed written informed consent form for all procedures and treatments as specified and approved by the Hospital's Medical Staff, or State or Federal laws or regulations.

Informed consent is the responsibility of the physician and must be obtained by them. A properly
executed informed consent form contains at least the following:
1. Name of patient, and when appropriate, patient's legal guardian;
2. Name of hospital;
3. Name of specific procedure(s);
4. Name of practitioner(s) performing the procedure(s) or important aspects of the procedures,
as well as the name(s) and specific significant surgical tasks that will be conducted by
practitioners other than the primary surgeon/practitioner. (Significant surgical tasks include:
harvesting grafts, dissecting tissue, removing tissue, implanting devices, altering tissues.);
5. Risks of the proposed procedure;
6. Alternative procedures, treatments or therapies;
7. Statement that procedure was explained to the patient or guardian and name/signature of
person who explained the procedure.
8. Implications for recovery, post procedure.
9. Signature of patient of legal guardian;
10. Date and time consent is obtained;
11. Signature of professional person witnessing the consent.

RESPONSIBILITIES:
The role of nursing in the informed consent process is to obtain the signature on the consent form and witness the signature, after ascertaining that the patient has been informed ...

GENERAL STAGEMENTS: (sic)
A ...
B. The Consent Form
1. The consent form must be signed prior to the start of the procedure and if the patient is signing
their own consent, prior to administration of any pre-operative medication or mind-altering drugs.
2. The consent form must include the name of the physician performing the procedure in the
appropriately designated space on the form.
3. The full terminology of the procedure(s) must be written in the designated space(s) on the
consent form without the use of abbreviations.
4. All blanks must be completed.
5. The patient must underline/circle and initial whether they do or do not consent to the use of blood or blood products.
6. The date, time of signing, patient/legal guardian's signature and witness' signature are required
and must be signed in ink. ..."

The policy titled, "Consent for Medical and Surgical Procedures" Policy # CL-4.0 with a reviewed date of 1/2023 had two attachments, 4.0A and 4.0B. 4.0A was a document titled Surgical & Therapeutic Procedure Consent Form and 4.0B was a document titled Blood and Blood Product Administration Consent Form. The hospital was not using the informed consent document attached to the informed consent policy. The hospital was using a document titled Informed Consent for Transfusion with a Created Date of 7/24.


An interview was conducted with CCO/COO Staff #3 and DQM Staff #6 on 1/28/2025 after 2:00 PM. Staff #3 and Staff #6 were asked if the physician had to sign the informed consent for blood transfusions. Staff #6 stated, "Yes they are required to sign the consents". Staff #3 and Staff #6 were asked why was there information about the state of California requirements above the physician signature line on the informed consent. Staff #3 stated, "Our physicians do not acknowledge that statement. This is a corporate consent form used at all facilities, not just for Texas".

An interview was conducted with RN Staff #12 at 10:45 AM on 1/28/2025. RN Staff #12 was asked who gets the consent signed for the blood transfusions. RN Staff #12 stated, "Usually the nurse that is giving the blood gets the consent signed". RN Staff #12 was asked how she confirmed the physician explained all the risks and benefits of a blood/blood product transfusion to the patient. RN Staff #12 stated, "The risks and benefits are on the consent form and the physician is supposed to sign the consent".

An interview was conducted on 1/28/2025 after 2:00 PM with CCO/COO Staff #3 and DQM Staff #6. DQM Staff #6 confirmed the physician failed to sign the informed consent for the transfusion of blood/blood products for 2 (Patient #7 and Patient #9) of 2 patients' medical records reviewed. Also, it was confirmed that the staff failed to follow the facility policy by not ensuring there was a date and time of the signatures documented on the consent and not use abbreviations.

Based on document review and interviews the facility failed to:

A. ensure that chemical restraints administered were identified as chemical restraint/ emergency behavioral medications (EBM) in 1 of 1(pt #13) charts reviewed.

B. ensure psychotropic medications ordered IV or IM were not written as PRN orders for behavioral emergencies in 2 of 2 (pt #10 and 13) charts reviewed.

C. ensure a process was in place for monitoring after administering a chemical restraint/emergency behavioral medication for side effects, respiratory or cardiac distress, and assessment of medication effectiveness, safety after administration, and for how long in 1 of 1 (pt #13) charts reviewed.

D. follow their own policy and procedures to ensure the restraint packet was filled out appropriately and completely, a face-to-face was conducted by a trained individual, and patient/ staff debriefing was completed and appropriate in 1 of 1 (pt #13) charts reviewed.

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

Findings:

Patient #10

A review of patient # 10's medical chart revealed patient #10 was admitted to the facility on 7/8/24. She was a 64-year-old female admitted to the facility to receive IV antibiotics due to sepsis from a post-surgical laminectomy. A review of the physician's history and physical revealed she had a history of major depressive disorder. The physician stated under Neurological: "There were no focal deficits ... The patient has a past history of hypertension, diabetes mellitus, hypothyroidism, and underlying depression with psychosis..." Patient was documented as being alert and oriented x3. There was no documentation that patient #10 had any current mental health diagnosis or current behaviors that would describe the need for psychotropic medications to be given therapeutically.

A review of the physician orders dated 7/8/24 stated Zyprexa 2.5mg = 0.5 ml IM q6hr prn for aggression, violence, paranoia. Seroquel (antipsychotic) 25mg by mouth twice a day as needed for anxiety. There was no documentation of current mental health diagnosis or inappropriate behaviors by the physician that would constitute the use of IV or IM psychoactive medications for therapeutic mental health disorders.

A review of the facility's policy and procedure Restraint Reduction Plan stated, "The use of PRN or standing-order drugs or medications is only prohibited if the drug or medication meets the definition of a drug or medication used as a restraint ... Pg 4 of 10 PRN ordering of a restraint: Orders for the use of restraint must never be written as a standing order or on an as needed basis (PRN)."

There was no agitation scale or physician order found that defined agitation or aggression and the multilevel of agitation that would require a chemical restraint. A registered nurse must follow physician orders that provide an objective (not requiring the nurse to use medical judgment to interpret symptoms) scale or scoring system for PRN medications to stay within their scope of practice. Nurses had to use medical judgment to determine if a patient should be medicated based on a symptom and not objective parameters identified by the physician within the order.
According to the "TEXAS BOARD OF NURSING CHAPTER 217
LICENSURE, PEER ASSISTANCE AND PRACTICE RULE §217.11
Standards of Nursing Practice
The RN does not perform medical diagnosis or prescription of therapeutic or corrective measures unless licensed as an advanced practice registered nurse."

Patient #13

A review of patient # 13's medical chart revealed he was admitted to the facility on 10/2/24 for an acute ischemic stroke.

A review of patient #13's physician orders revealed a telephone order on 10/2/24 at 1829 for Geodon (psychotropic) 10mg IM q 8 hrs. prn agitation."

A review of patient #13's Medication Administration Record (MAR) revealed patient #13 received the Geodon IM 10mg on 10/2/24 at 2130 and 0530.

A review of patient #13's physician orders revealed a telephone order on 10/22/24 at 2140 for "Geodon 10mg IM 1 dose now." There was no indication on the physician's order why this medication was to be given "now". As of 1/28/25, there was no physician signature for this order. There was no documentation in the physician progress notes for 10/23/25 on why the patient received a "now" order for an IM psychotropic medication.

A review of the nurse's note for 10/22/24 at 2138 stated, "Agitated, vulgar, biting mittens, pulling tubes/lines. MD informed new orders received. See chart."

A review of patient #13's chart revealed the patient had hand mittens on. There was no de-escalation documented before the administration of a chemical restraint. There was no documented evidence that a PO medication was attempted to alleviate symptoms. There was no restraint packet completed in the chart. There was no face-to-face performed. There was no nursing assessment, vital signs, or documentation of the medication effect.

A review of the policy and procedure Restraint Reduction Plan stated, "Patients placed in restraint for violent or self-destructive behavior should be monitored every two hours (when in physical restraints). There was no direction in the policy on when the nurse should reassess the patient after receiving a chemical restraint, how often to reassess, and for how long.

An interview was conducted with Staff #3 and Staff #6 on 1/28/25. Staff #3 confirmed the chemical restraints were written PRN. Staff #3 and #6 confirmed the policy did not address the chemical restraint for nursing assessment. Staff #6 confirmed the facility had restraint care plan packets but there were no packets used for the chemical restraints. The staff were only using nonviolent packets for physical restraints. The restraint care plan packets came in two different forms. Violent /self-destructive and non-violent/ non-self-destructive. Both packets were designed for physical restraints.

The facility was unable to provide a restraint log. An interview with Staff # 6 on 1/28/25 revealed that the facility did not have a restraint roster. Staff #6 confirmed that the information she kept about physical restraints was general information on quality reports; however, the facility did not monitor chemical restraints. There were no findings of restraint and seclusion reporting in the Quality meeting minutes for the last two quarters of 2024.

Geodon (Ziprasidone) belongs to a class of drugs called atypical antipsychotics used to treat schizophrenia. It is also known as a second-generation antipsychotic (SGA) or atypical antipsychotic. Ziprasidone rebalances dopamine and serotonin to improve thinking, mood, and behavior. All antipsychotics have been associated with the risk of sudden cardiac death due to an arrhythmia (irregular heartbeat). To minimize this risk, antipsychotic medications should be used in the smallest effective dose when the benefits outweigh the risks. All antipsychotics can cause sedation, dizziness, or orthostatic hypotension (a drop in blood pressure when standing up from sitting or lying down). These side effects may lead to falls which could cause bone fractures or other injuries. This risk is higher for people with conditions or other medications that could worsen these effects. Summary Of FDA Black Box Warnings Increased Mortality in elderly patients with dementia-related psychosis. Both first-generation (typical) and second-generation (atypical) antipsychotics are associated with an increased risk of mortality in elderly patients when used for dementia-related psychosis.

Although there were multiple causes of death in studies, most deaths appeared to be due to cardiovascular causes (e.g., sudden cardiac death) or infection (e.g., pneumonia).

Antipsychotics are not indicated for the treatment of dementia-related psychosis.
https://www.nami.org/About-Mental-Illness/Treatments/Mental-Health-Medications/Types-of-Medication/Ziprasidone-(Geodon).


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Findings:

An interview was conducted with RN Staff #12 on 1/28/2025 after 9:30 AM. RN Staff #12 was asked to explain the difference between a medical restraint and a behavioral restraint. RN Staff #12 confirmed she was unable to describe the differences between the two different types of restraints.

Based on document review and interview the facility failed to:

1. ensure 3 (Physician #10, Physician #11, and Nurse Practitioner #9) of 3 provider orders included the rate or duration for the transfusion of blood/blood products in 2 (Patient #7 and #9) of 2 patient medical records reviewed.

2. ensure 3 (Physician #10, Physician #11, and Nurse Practitioner #9) of 3 providers gave orders to increase the rate of transfusion from the initial rate of the blood/blood product transfusion in 2 (Patient #7 and #9) of 2 patient medical records reviewed.

3. ensure the nursing staff followed the facility policy titled, "Blood and Blood Components-Administration" and documented the vital signs (blood pressure, pulse, respirations, temperature, and oxygen level) during and after a blood/blood product transfusion in 2 (Patient #7 and #9) of 2 medical records reviewed.

4. ensure the nursing staff had a properly executed informed consent before initiating a blood/blood product transfusion in 2 (Patient #7 and #9) of 2 patient medical records reviewed.


Findings:

Patient #7
A review of the medical record for Patient #7 was conducted on 1/28/2025 after 9:00 AM with Chief Clinical Officer (CCO)/Chief Operating Officer (COO) Staff #3 and Director of Quality Manager (DQM) Staff #6. The review revealed the following.

Patient #7 was a 92-year-old female admitted to the facility on 11/01/2024 with a diagnosis of Sepsis secondary to bilateral pneumonia, acute hypoxic respiratory failure, metabolic encephalopathy, and chronic multiple ulcers.

Review of a Telephone Order Read Back (TORB) dated 11/19/2024 at 2122 (10:22 PM) from Nurse Practitioner (NP) #9 was as follows:

" ...11/19/24 2122 - Type/Crossmatch & transfuse 1-unit (Packed Red Blood Cells) PRBC ...TORB NP #9/Physician #10" ... The Registered Nurse's (RN) signature that obtained the telephone order was illegible. There was no rate or duration ordered for the blood transfusion and no order to increase or decrease the rate after the first 15 minutes.

Review of the blood transfusion flow sheet dated 11/19/24 revealed the blood transfusion was started at 2350 (11:50 PM). The first set of vital signs was taken at 12:05 AM (15 minutes after the initiation of the transfusion) and again at 1:05 AM, 2:05 AM, and 3:05 AM. The transfusion was completed at 3:05 AM and vital signs were taken again at 3:35 AM, 30 minutes after the transfusion was completed.

Further review revealed there was no documentation of the rate of infusion for the entire time of the transfusion. The surveyor was unable to determine the rate of the infusion or if the rate was increased or decreased over the total time of the transfusion.

An interview was conducted with DQM Staff #6 on 1/28/2025 after 9:00 AM. Staff #6 confirmed there was no rate or duration of the blood transfusion ordered by the provider. Also, Staff #6 confirmed the nursing staff failed to document the vital signs according to the facility policy. There were no vital signs documented 5 minutes after the initiation of the blood transfusion and there were no vital signs documented 1 hour after the completion of the blood transfusion as required by the facility policy. Staff #6 confirmed the informed consent had not been signed by the provider before the start of the blood transfusion.


Patient #9
A review of the medical record for Patient #9 was conducted on 1/28/2025 after 9:00 AM with Chief Clinical Officer (CCO)/Chief Operating Officer (COO) Staff #3 and Director of Quality Manager (DQM) Staff #6. The review revealed the following.

Patient #9 was admitted to the facility on 12/27/2024 to the care of Physician #11.

A review of the order revealed a telephone order was given by Physician #11. A review of the telephone order was as follows:

"The date was illegible. At 1730 (5:30 PM) Type and crossmatch for PRBC and transfuse 1-unit PRBC. TORB Physician #11/signature of staff that obtained the telephone order was illegible". There was no rate or duration ordered for the transfusion.

Review of the blood transfusion flow sheet dated 12/29/2024 revealed the blood transfusion was started at 2:45 AM. The first set of vital signs was taken at 3:00 AM (15 minutes after the initiation of the transfusion) and again at 4:00 AM, 5:00 AM, and 5:30 AM. The transfusion was complete at 5:30 AM and vital signs were taken again at 6:00 AM. There was no signature of the nurse discontinuing the blood transfusion.

Further review revealed there was no documentation of the rate of infusion for the entire time of the transfusion. The surveyor was unable to determine the rate of the infusion or if the rate was increased or decreased over the total time of the transfusion.

A review of the TORB taken on 12/30/2024 at 10:20 AM by the RN was as follows:

"Transfuse 1 unit of single dose platelet donor. Give Tylenol 650mg oral once prior to transfusion". There was no rate or duration ordered for the transfusion of the platelets by Physician #11.

A review of the transfusion flow sheet dated 12/30/2024 revealed the platelet transfusion was started at 1403 (2:03 PM). The first set of vital signs were taken at 1418 (2:18 PM) (15 minutes after the initiation of the transfusion) and again at 1503. (3:03 PM). The transfusion was completed at 1530 (3:30 PM) and vital signs were taken at 1600 (4:00 PM).

Further review revealed there was no documentation of the rate of infusion for the entire time of the transfusion. The surveyor was unable to determine the rate of the infusion or if the rate was increased or decreased over the total time of the transfusion.


A review of the TORB dated 1/03/2025 was as follows:

"1/03/2025 11:00 AM Transfuse 1 single dose donor platelet. Pre-medicate with PRN Tylenol. TORB Physician #11/staff receiving telephone order was illegible". There was no rate or duration ordered by Physician #11 for the transfusion of the 1 unit of donor platelets.

A review of the transfusion flow sheet dated 1/03/2025 revealed the platelet transfusion started at 1632 (4:32 PM). The first set of vital signs after the initiation were taken at 1647 (4:47 PM) 15 minutes after the initiation of the transfusion and again at 1745 (5:45 PM). The transfusion was completed at 1745 (5:45 PM). There were no other vital signs documented after the completion of the transfusion.

Further review revealed there was no documentation of the rate of infusion for the entire time of the transfusion. The surveyor was unable to determine the rate of the infusion or if the rate was increased or decreased over the total time of the transfusion.

A review of the document titled, "Informed Consent for Transfusion" was as follows:

" ...1. Proposed Treatments(s)/Physician:
For: Patient #9
Transfusion(s) proposed: The proposed transfusion was blank
Transfusion(s) ordered by: Physician #11 (last name only) ..."

The patient and the RN signed the bottom of page 1 (1 of 2 pages). There was no date or time when the patient or the nurse signed the document. Page 2 was the signature page for the patient, witness, and the physician. The page was blank.

An interview was conducted with DQM Staff #6 on 1/28/2025 after 9:00 AM. Staff #6 was asked if Patient #9 was consented for the transfusions she was administered on 12/29/2024, 12/30/2024, and 1/03/2025. Staff #6 confirmed there was no way to confirm that the consent that was signed was before the transfusions were administered on 12/29/2024, 12/30/2024, and 1/03/2024. Staff #6 stated, "I cannot prove to you that Patient #9 had a signed informed consent before the blood and platelet transfusions were administered.


A review of the order dated 1/05/2025 was as follows:

"Transfuse 1-unit PRBC today. Transfuse 1-unit single dose platelets. Premedicate with Tylenol 650mg po (oral) and Benadryl 25 mg po". There was no rate or duration ordered by the provider for the blood or platelet transfusion.
The ordering prescriber's signature was illegible and there was no date or time when the order was written.

A review of the transfusion flow sheet for the platelets dated 1/05/2025 revealed the transfusion was started at 2125 (9:25 PM). The first set of vital signs were taken at 2140 (9:40 PM) 15 minutes after the initiation of the transfusion and again at 2225 (10:25 PM). The transfusion was completed at 2240 (10:40 PM). Vital signs were taken at the completion of the transfusion at 10:40 PM and again at 11:10 PM 30 minutes after the completion of the platelet transfusion. There was no signature of the nurse discontinuing the blood transfusion.

Further review revealed there was no documentation of the rate of infusion for the entire time of the transfusion. The surveyor was unable to determine the rate of the infusion or if the rate was increased or decreased over the total time of the transfusion.

A review of the transfusion flow sheet dated 1/05/2025 for the transfusion of the PRBCs revealed the transfusion started at 2245 (10:45 PM). The first set of vital signs were taken at 2300 (11:00 PM) 15 minutes after the start of the transfusion and again at 2345 (11:45 PM), 0045 (12:45 AM), 1:45 AM, and at 2:20 AM. The transfusion was completed at 2:20 AM. Vital signs were taken again 30 minutes after the completion of the transfusion at 2:50 AM. There was no signature of the nurse discontinuing the blood transfusion.

Further review revealed there was no documentation of the rate of infusion for the entire time of the transfusion. The surveyor was unable to determine the rate of the infusion or if the rate was increased or decreased over the total time of the transfusion.

A review of the informed consent was as follows:

" ...Proposed Treatment(s)/Physician:
For: Patient #9
Transfusion(s) proposed: PRBC, platelets
Transfusion(s) ordered by: Physician #11 (last name only) ..."

An interview was conducted with DQM Staff #6 on 1/28/2025 after 9:00 AM. Staff #6 confirmed there was no rate or duration of the blood transfusion ordered by the provider. Also, Staff #6 confirmed the nursing staff failed to document the vital signs according to the facility policy. There were no vital signs documented 5 minutes after the initiation of the blood/blood product transfusion and there were no vital signs documented 1 hour after the completion of the blood/blood product transfusion as required by the facility policy. Staff #6 confirmed there should be no abbreviations on the informed consent and that PRBC should be spelled out.


A review of the facility policy titled, "Blood and Blood Components-Administration", Policy # CL-3.2, with a last review date of 1/2023 was as follows:
"PURPOSE:
* To restore blood constituents depleted or destroyed by disease, injury or surgery.
* To provide guidelines for the verification process with replacement of blood and blood
components.
* To provide·nursing services with guidelines for the safe administration of blood and
blood components and proper documentation of blood and blood components.

POLICY:
Registered Nurses may initiate the administration of and monitor blood and blood components. Licensed Vocational nursing staff may monitor the administration of blood and blood components ...

III. At the time of infusion
The registered nurse who administers the blood is the last point at which positive
identification occurs before the patient is transfused. Evidence of informed consent
should be checked prior to the administration of the blood ...

5. Order: The blood or component should be checked against the physician's
written order ...

ADMINSTRATION PROCEDURE:
I. Administration of Blood/Blood Components
a. Verify physician's order.
b. Identify the patient insuring the correct identification procedures (see Patient
Identification policy).
c. Verify blood transfusion consent ...
u. Vital signs should be performed and documented per Blood and Blood Components
Flow sheet ...

V. Documentation
a. Document all vital signs:
1. Baseline vital signs may be taken within 30 prior to start time. Vital signs
should then be taken at 5 minutes and 15 minutes, then end and 1 hour posttransfusion
2. All vital signs must be documented on the Blood/Blood Components form.
b. Document the starting and ending time of the transfusion on the Blood and Blood
Components form ..."


An interview was conducted with RN Staff #12 on 1/28/2025 at 10:45 AM. RN Staff #12 was asked who determined the rate of infusion or the duration of the blood/blood products transfusion. RN Staff stated, "I usually start it at a slow rate of about 80ml an hour and then I will increase it". RN Staff #12 was asked what was the duration of the blood/blood product transfusion. RN Staff #12 stated, "It goes on a pump and the pump calculates it. We consider each unit of blood is about 325 ml and we start it slow then increase it so that it gets in within 4 hours". RN Staff #12 was asked about the rate of transfusion for platelets. RN Staff #12 stated, "Platelets can go in pretty fast". RN Staff #12 was asked if the providers ordered the rates or duration for any of the blood products. RN Staff #12 confirmed the providers did not order rates for blood/blood product transfusions.


An interview was conducted with RN Staff #13 on 1/28/2025 at 11:15 AM. RN Staff #13 was asked who gets the informed consent for the blood transfusion. RN Staff #13 confirmed the nurses get the consent from the patient before they start the transfusions. RN Staff #13 was asked who discussed the risks and benefits of receiving blood/blood products with the patient. RN Staff #13 stated, "The nurses do". RN staff #13 was asked how did she determine the rate and duration of the transfusion for the blood/blood products. RN Staff #13 stated, "It depends on the patient's overall health. I usually start it at 75ml an hour and then I will increase it to 100ml an hour if they are not having any problems". RN Staff #13 was asked if the physician ordered the rate or duration for the transfusions. RN Staff #13 confirmed the physicians do not put that in their transfusion orders.

An interview was conducted with CCO/COO Staff #3 and DQM Staff #6 on 1/28/2025 after 11:00 Am. Staff #3 and Staff #6 were asked if the providers documented the rate or duration for the transfusion of blood/blood products in their orders. Staff #6 confirmed the providers were not documenting a rate or duration for the transfusion in their orders. Also, Staff #6 confirmed the nursing staff failed to follow the facility policy titled, "Blood and Blood Components Administration".

Based on review and interviews the facility failed to ensure the physicians and providers had dated, timed, and authenticated all physician orders within 96 hours as required by the Texas Administrative Code133.41(j)(7) in 4 of 4 (Patients #12, #13, #7, and #9) charts reviewed. The facility failed to follow the policy and procedure on verbal orders to ensure verbal restraint orders were being signed within 24 hours in 1(pt. #13) of 4 of 4 (Patients #12, #13, #7, and #9) charts reviewed.

A review of patient medical records revealed the following orders did not have a date, time, or signature from the provider for authentication as of 1/28/25.

Patient # 13

1. Telephone order dated 10/2/24 at 1829 stated, "RE: pulled out NG tube, attempting OOB
-ok to place bilateral hand mittens ( failed to follow policy and procedure to ensure the order was signed within 24 hours.)
- Resume Geodon 10mg IM Q8hrs PRN agitation."

2. 10/2/24 at 1830 RE: Pulled out NGT
-Reinsert NGT
-CXR post placement to verify placement.

Patient # 12

1. Restraint Assessment Physician Order dated 11/1/24. Telephone order for bilateral mittens.

2. 11/3/24 1205 pm verbal order, "Seroquel 25 mg po BID."

3. 11/3/24 0930 verbal order, "VA to set up Hospice services at an SNF due to life expectancy of less than 6 months."

An interview was conducted with Staff # 8 on 1/28/25. Staff #8 was shown multiple orders without a date, time, or signature from the provider for authentication. Staff #8 was asked how she monitored the charts that did not have the physician's signature over 96 hours. Staff #8 stated that she sends the physicians text messages to remind them. Staff #8 stated she was unaware of any time frames. Staff #8 stated that she did not have a current list of expired charts but maybe the corporate office had them. Staff #8 stated there had been no physician privileges suspended. Staff #8 was unable to provide the surveyor with a delinquent list.

A review of the policy and procedure Verbal and Telephone orders stated, "5. Verbal/telephone orders shall be countersigned as soon as possible by the ordering practitioner with the following exception: verbal /telephone orders for restraints, Scheduled class II drugs, and DNRs must be signed and dated by the ordering physician within 24 hours."


40989

Findings:

Patient #7
A review of Patient #7s medical record revealed unsigned telephone orders greater than 96 hours.

A review of the Telephone Orders dated 11/19/2024 were as follows:

"11/19/24 (no time documented) Chem 8 today to verify Hgb & Hct.
TORB Physician #10/Registered Nurse (RN) signature illegible".

"11/19/24 2122 Re: Chem 8 recheck H/H 6.1/18
Type/Crossmatch & transfuse 1-unit PRBC
Repeat CBC in AM
TORB Nurse Practitioner #9/Physician #10/RN signature was illegible".


Patient #9
A review of Patient #9's medical record revealed unsigned telephone orders greater than 96 hours.

A review of the telephone dated 12/30/2024 at 10:20 AM was as follows:

"Transfuse 1 unit of single platelet donor. Give Tylenol 650mg oral once prior to transfusion".
The physician's signature was illegible and there was no date or time when the physician authenticated the telephone order.

The physician's signature was illegible and there was no date or time when the physician authenticated the telephone order


A review of the telephone order dated 1/3/25 at 1110 AM was as follows:

"Transfuse 1-unit single dose platelets. Pre-medicate with PRN Tylenol. TORB Physician #11/staff signature was illegible."

The physician's signature was illegible and there was no date or time when the physician authenticated the telephone order.


An interview was conducted with Staff #3 on 1/28/2025 after 10:00 AM. Staff #3 confirmed the physicians were not authenticating their telephone orders within 96 hours.

Based on observation and interview, the facility failed to maintain a clean and sanitary environment to ensure patient safety in 8 (Main Hallway, Patient Hallway, Emergency Treatment Room in the Radiology Department, Central Supply, Patient Room #114 in the ICU, Medication Room, Patient Nourishment Room, and Shower Room) of 8 areas observed.


Findings:


An observation tour was conducted with Chief Executive Officer (CEO) Staff #1 on 1/27/2025 at 11:49 AM. The following was observed:

Main Hallway to Patient Care Units

Stored in a cubby in the main hallway were 8 wheelchairs and 1 patient lift. There was no way to identify if the patient equipment was clean or dirty. 6 pieces of tape were left on the arm of a wheelchair making it incapable of cleaning the surface. The vinyl covering on the armrest of two of the wheelchairs was torn and exposed the cushion beneath. The cloth cushion could not be cleaned and would absorb bodily fluids that could be unseen. The patient lift was visibly soiled with dirt and dust. Staff #1 confirmed the equipment was available for patient use.

Patient Hallways

It was noted in 2 separate patient care hallways that portable vital sign machines were being stored and plugged into an electric outlet and ready for patient use. The compartments under the tabletop were noted with dirt, dust, debris, and hair. The base of the portable machines was soiled with heavy dirt and dust.

Emergency Treatment Room in the Radiology Department

The emergency treatment room in the radiology department had an emergency cart that stored emergency medications and supplies. Inside the cart the following supplies were noted:
12-10ml normal saline syringes expired 11/30/2020
3-24 gauge (g) intravenous (IV) catheters expired 5/31/2022
5-25g IV catheters expired 4/30/2024
2-21g IV catheters expired 11/30/2024
4-16g IV catheters expired 1/31/2022
1 bottle of 500ml normal saline expired 4/06/2022
Inside a gray rolling cart was a 100 ml single-dose vial of Sterile Water. The vial was open and had been used with no opened or beyond-use date noted on the bottle.
6 large sterile gowns were stored on a shelf in the room. 1 expired on 4/2019, 1 expired on 7/2020, and 4 expired on 7/2017.


Central Supply

The supply room was used to store patient supplies. There was no separation between clean and dirty. External shipping boxes were stored next to sterile supplies. Supplies were delivered to this room and not to a dirty area outside the central supply. Corrugated boxes with webbed edges were stored can harbor insects and contaminate all supplies in the room. Storage bins used to store supplies were heavily soiled with dirt and dust on the lids. The lids were cracked and broken. Inside the bins there was dirt, dust, and dead insects stored with patient supplies.
An interview was conducted with Staff #7 on 1/28/2025 at 1:30 PM. Staff #7 was asked to show the separation of the clean and dirty area in the supply room. Staff #7 replied, "I try and keep it separated the best I can". Staff #7 confirmed when the supplies come in they come to his department directly and there is no other storage for them. Staff #7 confirmed he was not aware that external shipping boxes could not be stored with other supplies. Staff #7 was asked if he monitored the temperature and the humidity in the supply room due to sterile supplies and sterile solutions being stored in the room. Staff #7 confirmed he was not aware that the temperature and humidity had to be controlled or documented in the supply room.


Patient Room #114/Intensive Care Unit

Patient Room #114 was ready to receive a new admission. Beneath the mattress on the bed frame, it was noted to be heavily soiled with dirt, dust, and a black sticky substance.

An interview was conducted with CEO Staff #1 on 1/28/2025 after 1:30 PM. Staff #1 was asked if the facility had an Infection Control Nurse. Staff #1 replied, "We do not have a full-time Infection Control Nurse. We are looking to hire an Infection Control Nurse now. Staff #6 is the interim Infection Control Nurse but she also has 2 other roles that she has responsibility over". Staff #1 confirmed the facility did not have a policy on monitoring temperature and humidity on patient sterile supplies.


32143

Findings:
Medication Room- in the nurse's station for the medical unit.

The medication room had a refrigerator for medication storage. The fridge was soiled with dirt, dust, and hair. The refrigerator was freezing along the back wall creating ice.
The medication preparation area was soiled with dust and hair. The plastic containers holding patient medication and supplies were soiled with dust, hair, paper particles, and dried spilled substances.
The metal trash can was rusted and dirty.
The mechanical pill crusher was heavily soiled with dust, medication residue, and dried spilled liquids.
The stainless worktable had rusted legs. The rust was unable to be cleaned.

Patient Nourishment Room

The refrigerator and freezer were soiled with hair and dust. The freezer was frozen inhibiting cleaning of the freezer surface.
Patient Isolation Room on the medical unit.
The patient isolation room had a wooden bedside table and chair not sealed in some areas exposing wood. The wooden furniture Wood pieces had a porous surface and were not cleaned properly.
The sink area was missing laminate from the bottom of the base leaving exposed wood.
The bottom of the pyxis was soiled with dust and hair. IV fluids were placed in containers that were soiled within the pyxis.

Shower Room

A large shower room was found on the medical floor. The room had equipment stored within the bathroom area. A large reclining Geri Chair and a bedside commode were found. Staff # 3 was unable to identify if this equipment was clean or dirty.