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Based on review of records and interview, the facility failed to ensure that patients were provided with all of the information and disclosures on the required consent form to ensure that patients were making a fully informed decision when consenting to receive blood or blood products in 7 (Patient #31, #32, #33, #34, #35, #36, and #37) of 8 patient charts reviewed.

Findings included:

A review of blood transfusion records was conducted. During the review, it was noted that seven charts for Patients #31, #32, #33, #34, #35, #36, and #37) did not have the correct consent for the medical procedure identified as transfusion of blood and/or blood products. The charts contained only a patient verification that the Physician had informed the patient of the following:

"My physician has informed me that I need or may need a transfusion of Packed Red Blood Cells

My physician has described to me the risks and benefits of receiving transfusion(s). These risks exist despite the fact that the blood has been carefully tested.

The alternatives to transfusion, including the risks and consequences of not receiving therapy, have been explained to me.

I have had the opportunity to ask questions, and I consent to the transfusion(s)."

This form had a line for a witness to sign and the provider to sign.

The treating physician, patient condition that required treatment, and the specific risks associated with the procedure were not found to be listed on the consent. Leaving this information off of the consent creates a condition where necessary information may not have been provided by the physician or misunderstood by the patient. The patient could believe that all necessary information was verbally explained when it wasn't. The requirement to have this information on the consent form ensures that the patient has an opportunity to read all of the necessary information and verify that nothing was missed or left out prior to consenting to a blood transfusion, ensuring a fully informed consent.

A review was made of the Emergency Hospital Systems Blood Administration Policy, Reference #1025, Revised 03/10/20 as follows:

"Informed Consent:

Purpose of the Informed Consent:
To ensure the treating provider has obtained an informed consent from the patient.
To provide the patient with the opportunity to exercise his/her right to give an informed consent or refusal for the transfusion recommended by the provider.
To provide the patient with the opportunity to acknowledge that the provider adequately explained the benefits, risks, complications, and alternatives to blood transfusion and discuss all the information concerning the transfusion to the patient's satisfaction.

Consent:
Emergency Hospital Systems verifies by means of the Blood Transfusion Consent Form that the patient's informed consent has been obtained by the treating provider, before the patient receives a transfusion."

Without listing the treating physician, patient condition that required treatment, and the specific risks associated with the procedure, Emergency Hospital Systems witnessing staff would not be able to verify that the patient had been fully informed.

On the afternoon of 5/6/2021, Staff #2 was interviewed. Staff #2 confirmed that the only time the complete information required on an informed consent for treatment/procedure was present would be if the patient was also going to have a surgical procedure and had signed a full informed consent form for Surgical Procedures and Medical Treatments that included blood products.

Based on review of records and interview, the facility failed to ensure that the form titled "Blood Transfusion Record" was filled out completely and accurately by nursing staff for 6 out of 7 medical records reviewed for completeness (Patients #31, #33, #34, #35, #36, and #38).

Findings included:

Medical records were reviewed for proper blood administration on the morning of 5-6-2020. Review of the Blood Transfusion Record were as follows:

Patient #31

The review showed that the medical records contained 2 forms for the transfusion of 2 units. The forms were incomplete or inaccurate in the following fields:
First unit of blood transfused
Expiration Date of the blood product was not filled in.
Volume Transfused was not filled in.

Second unit of blood transfused
Expiration Date of the blood product was not filled in.
Volume Transfused was not filled in.

An interview was conducted with Staff #2 on the afternoon of 5/6/2021. Staff #2 confirmed that the information on the above forms was incomplete and/or inaccurate.


Patient #33

The review showed that the medical records contained 2 forms for the transfusion of 2 units. The forms were incomplete or inaccurate in the following fields:
First unit of blood transfused
Testing Interpretation box not completed for Antibody Screen and Compatibility Testing
Volume Transfused was not filled in.
Date/Time Transfusion Completed not filled in.
Administering Nurse Printed Name, Date/Time, and Signature not filled in.

Second unit of blood transfused
Testing Interpretation box not completed for Antibody Screen and Compatibility Testing
Volume Transfused was not filled in.
Date/Time Transfusion Completed not filled in.
Administering Nurse Printed Name, Date/Time, and Signature not filled in.
Time of the 1-hour post-transfusion vital signs taken was not filled in.

Patient #34

The review showed that the medical records contained 3 forms for the transfusion of 3 units. The forms were incomplete or inaccurate in the following fields:
First unit of blood transfused
Administering Nurse Printed Name, Date/Time, and Signature not filled in.

Second unit of blood transfused
Administering Nurse Printed Name, Date/Time, and Signature not filled in.

Third unit of blood transfused
Administering Nurse Printed Name, Date/Time, and Signature not filled in.

Patient #35
The review showed that the medical records contained 2 forms for the transfusion of 2 units. The forms were incomplete or inaccurate in the following fields:
First unit of blood transfused
Testing Interpretation box not completed for Antibody Screen and Compatibility Testing.
Volume transfused did not list the number of units.

Second unit of blood transfused
Observation for Transfusion Reaction not filled in.
Date and Time the transfusion was completed not filled in.

Patient #36

The review showed that the medical records contained 2 forms for the transfusion of 2 units. The forms were incomplete or inaccurate in the following fields:
First unit of blood transfused
Testing Interpretation box not completed for Antibody Screen and Compatibility Testing.
Volume transfused was not filled in.
Date and Time the transfusion was completed not filled in.
Nurse placed time in the column intended for the initials of the nurse who was monitoring the patient's vital signs. Initials of the nurse monitoring the patient's vital signs were missing for each set of vital signs taken. There were 7 entries in the Initials column that were obliterated and unreadable.

Second unit of blood transfused
Testing Interpretation box not completed for Antibody Screen and Compatibility Testing.
Volume transfused was not filled in.
Date and Time the transfusion was completed not filled in.
1-hour post-transfusion vital signs taken was not filled in.

Patient #38

The review showed that the medical records contained 2 forms for the transfusion of 2 units. The forms were incomplete or inaccurate in the following fields:
First unit of blood transfused
Observation for Transfusion Reaction not filled in.
Volume transfused was not filled in.
Date and Time the transfusion was completed not filled in.
1-hour post-transfusion vital signs taken was not filled in.

Second unit of blood transfused
Volume transfused was not filled in.
Date and Time the transfusion was completed not filled in.
1-hour post-transfusion vital signs taken was not filled in.

An interview was conducted with Staff #2 on the afternoon of 5/6/2021. Staff #2 confirmed that the information on the above forms was incomplete and/or inaccurate.

Based on review of records and interview, the facility failed to appoint a Director of Rehabilitation Services.

On the morning of 05/04/2021, during the entrance conference, Staff #1 confirmed that the hospital provided limited Physical Therapy services at the Cleveland Emergency Hospital (CEH) and Texas Emergency Hospital (TEH) locations. Staff #1 explained that these services were provided under contract. The contract for services and policies were requested for review.

On 05/05/2021, the contract for Physical Therapy (PT) was reviewed. No approved policies were provided for review. On the afternoon of 05/05/2021, and interview was conducted with Staff #1. Staff #1 stated that because the need for PT services was minimal, the hospital did not employ their own staff and had not appointed a Rehabilitation Services Director. Review of the contract confirmed that the contracted services did not identify a contracted Rehabilitation Services Director.

Based on review of records and interview, the facility failed to establish hospital approved policies for the delivery of Physical Therapy (PT) services.

On the morning of 05/04/2021, during the entrance conference, Staff #1 confirmed that the hospital provided limited Physical Therapy services at the Cleveland Emergency Hospital (CEH) and Texas Emergency Hospital (TEH) locations. Staff #1 explained that these services were provided under contract. The contract for services and policies were requested for review.

On 05/05/2021, the contract for Physical Therapy (PT) was reviewed. No approved policies were provided for review. On the afternoon of 05/05/2021, an interview was conducted with Staff #1. Staff #1 stated that because the need for PT services was minimal, the hospital had not developed any policies or procedures for Physical Therapy to follow. Review of the contract confirmed that the contracted services did not identify that the contractor would provide policies for the delivery of PT services to patients