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Based on document review and interview, the facility failed to ensure a properly executed informed consent was signed and dated prior to the administration of blood and/or blood products in 4 (Patient #20, #21, #22, and #24) of 4 medical records reviewed.

Refer to Tag A0131

Based on record review and interview, the facility failed to ensure a properly executed informed consent was signed and dated prior to the administration of blood and/or blood products in 4 (Patient #20, #21, #22, and #24) of 4 patient medical records reviewed. Also, the facility failed to follow their own Informed Consent policy.

Findings:

Patient # 20

Patient # 20 was admitted to the facility on 09/09/2023 with a diagnosis of coronary artery stenosis (a disease where the arteries to the heart are smaller and struggle to supply blood and oxygen to the heart) and scheduled for a Coronary Artery Bypass Graft (CABG) Procedure on 09/11/2023.

A review of Patient # 20's medical records revealed an informed consent for blood/blood products was signed by the patient and witnessed by the nurse on 09/10/2023 at 12:35 PM.

Physician #36 signed the informed consent on 9/11/2023 at 12:50 PM.

Staff #5 and #11 confirmed the nurse had Patient #20 sign the informed consent before the risks and benefits of a blood transfusion were explained by Physician #36.


Patient # 21

Patient # 21 was an 84-year-old male who presented to the ER (Emergency Room) on 09/06/2023 with a diagnosis of chronic anemia, blood in his stool, and low hemoglobin.

Patient #21 was examined in the ER and treated by Physician #39. A review of the physician's order dated 9/06/2023 at 6:07 PM read, "Transfuse Blood, RBC 2 units Stat."

A review of the blood transfusion record revealed the ER nursing staff documented the verification of a blood consent was completed on 9/06/2023 at 9:16 PM and on 9/07/2023 at 12:57 AM. Further review of the blood transfusion records revealed RBC (Red Blood Cell) Unit #1 was started on 9/06/2023 at 9:18 PM and completed at 11:43 PM. RBC Unit #2 was started on 9/07/2023 at 1:00 AM and completed at 3:14 AM.

Staff #31 confirmed Patient #21 did not sign an informed consent to receive blood/blood products before the transfusion of 2 units of RBCs.


Patient # 22

A review of Patient # 22's medical record revealed Patient # 22 was admitted to the facility on 04/27/2023.
A review of the informed consent for blood/blood products revealed Patient #22 signed the informed consent but failed to date or time the document. The witness's signature was illegible but was dated and timed on 4/28/2023 at 04:30.

The physician failed to sign the consent. No documentation was found in the medical record that the physician discussed the risks and benefits of a blood transfusion with the patient before the nurse had the informed consent signed.

In an interview with Staff # 11 on 09/12/2023 at 3:00 PM, Staff # 11 confirmed Patient #22 received 2 Units of RBCs on 4/28/2023 before the physician explained all risks and benefits to the patient and a properly executed informed consent was signed.


Patient #24

Patient #24 was an 84-year-old male admitted to the facility on 3/7/2023. He was brought to the ER by ambulance with a breathing tube already in place.

A review of Patient #24's medical record was conducted on 9/13/2023 at 10:30 with Staff #6 and revealed the informed consent for blood/blood products was signed by the patients brother on 3/09/2023 at 0844 and witnessed by the nurse. Physician #44 failed to sign the informed consent until 5/31/2023 at 8:02 PM.

Staff #6 confirmed Physician #44 failed to sign the informed consent for 83 days attesting that he discussed all risks and benefits of a blood transfusion with the family prior to transfusing the patient with blood or blood products.

Staff #6 confirmed there was no documentation in the medical record confirming the physician had discussed the risks and benefits of a blood transfusion prior to the nurse having the consent signed.



A review of the facility policy titled, "INFORMED CONSENT" with a reviewed date of 7/18 was as follows:

" ...POLICY: A medical and Surgical Procedures Disclosure and Consent must be signed and dated by the patient or surrogate decision maker before certain medical or surgical procedures may commence on any patient. However, in cases of emergency or unusual circumstance, surgery or procedures may occur without consent, Informed consent is the responsibility of the physician ...

THERAPEUTIC AND DIAGNOSTIC PROCEDURES REQUIRING CONSENT

Therapeutic and diagnostic procedures that require informed consent include, but are not limited to: ...

*Administration of blood and/or blood products; and HIV antibody or antigen tests...

No procedure on the preceding list may be performed, except in an emergency when the patient's well-being would otherwise be seriously endangered. Otherwise, the patient's written consent must be obtained, or the patient has waived their right to be informed (See 'Patient Waiver' section of this policy) with the exception of minimally invasive imaging procedures ...

ELEMENTS OF DISCLOSURE REQUIRED FOR INFORMED CONSENT

The physician must provide specific information to constitute informed consent. The physician must provide an attestation with a signature that this information was discussed with the patient. This will vary according to the patient's intelligence, experience, age, and other similar factors. Information the physician reasonably believes is already known to the person giving consent need not be specifically disclosed. The physician must disclose to the person giving the consent the following:

*The nature of the proposed care, treatment, services, medications, interventions, or procedures.
*Potential benefits, risks, or side effects, including potential problems related to recuperation.
*The likelihood of achieving care, treatment, and service goals.
*Reasonable alternatives to the proposed care, treatment, and service.
*The relevant risks, benefits, and side effects related to alternatives, including the possible results of not receiving care, treatment, and services ..."


An interview was conducted with Staff #10 on 9/12/2023 after 1:30 PM. Staff #10 was asked who has the responsibility to ensure there is a signed consent on the medical record for the transfusion of blood and/or blood products. Staff #10 replied, "It is the ultimate decision for the physician to make sure that he has explained all the risks and the benefits of a blood transfusion to the patient and have them sign the consent. The nurse can have the consent signed as long as the patient understands everything, and the physician has documented somewhere in the medical record that he discussed all the risks and benefits with the patient."

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

A.
1. ensure the physician's order for the administration of blood/blood products included a transfusion rate and duration in 5 (# 3, # 20, # 21, # 22, # 24) of 5 patient medical records reviewed.

2. ensure a physician order to transfuse blood/blood products was in the medical record prior to a blood product transfusion in 1 (patient #24) of 1 patient medical record reviewed.

3. ensure a policy and procedure approved by the Governing Body, gave clear guidelines for the administration of blood/blood products.

It was determined that these deficient practices posed an Immediate Jeopardy to patient health and safety and placed all patients in the facility at risk for the likelihood of harm, serious injury, and possibly subsequently death due to the unsafe administration of blood products.

(Cross Refer to Tag A410)


B. follow the nurse staffing plan for staffing measures, acuity levels and grid/matrix in 2 of 2 (unit 2 and 5) patient care units reviewed.

(Cross Refer to Tag A392)

Based on review and interview, the facility failed to follow the nurse staffing plan for staffing measures, acuity levels and grid/matrix in 2 of 2 (unit 2 and 5) patient care units reviewed.

A review of the staffing matrix/grid revealed a guideline for minimal staffing required to safely care for the patients on the nursing unit. A review of the nursing daily assignment sheets revealed Registered Nurse (RN's), Licensed Vocational Nurse (LVN's), Patient Care Technician (PCT's), Unit Clerks (UC) and Sitters were listed. The grid revealed that the RN and LVN were listed as the same discipline. An LVN must have supervision by an RN and cannot be scheduled as a Registered Nurse (RN).

A review of the daily assignment sheets revealed RN's, LVN's, PCT's, Unit Clerks and Sitters were scheduled. There was no defined schedule for the LVN per patient census nor an acuity tool. The acuity tool allows the scheduler to determine when staffing should be increased or decreased for safe patient care. The acuity tool determines the level of care required for the patients' needs.

An interview was conducted with staff #9 and #38 on 9/13/2023 in the afternoon. Staff #38 confirmed there was no clear delegation on the staffing grid for LVN's. Staff #38 stated "I'm not really sure how to schedule the LVN per the grid". Staff #38 was asked how the LVN is scheduled if they are not listed on the nursing grid. Staff #38 stated "I schedule to what I think is needed". Staff #38 confirmed there was no clear guidelines on how to staff the nursing unit. Staff #38 also confirmed there was no acuity tool to assist in making nurse staffing assignments for an increase or decrease in patient care needs.

A review of the policy and procedure "Nurse Staffing Plan" stated " To provide procedures for the on-going assessment and implementation of appropriate staffing for the provision of safe nursing care including a plan for assigning and allocating nursing staff on a shift-to-shift basis in order to ensure safe, quality patient care ... POLICY: 1. Guidelines for safe and appropriate staffing patterns are created in collaboration with the Safe Staffing Committee and recommended to the governing board for adoption, implementation, and enforcement.

Upon review of the Safe Staffing Committee minutes for 01/13/2023, 3/10/2023, 5/12/2023, 09/08/2023 revealed there was no documentation concerning a safe staffing matrix/grid, plans, or performance improvement processes to ensure safe staffing.

A review of the policy and procedure "Nurse Staffing Plan" stated "2. The Safe Staffing Committee is a standing committee of the hospital that shall meet at least quarterly and includes as voting members: a. Chief Nursing Officer of the Hospital b. Registered Nurses representing the types of nursing services provided in the hospital I. 60% of the committee must be RN's who provide direct patient care at least 50% of their work time and are selected by their peers who provide direct care at least 50% of their work time. 11. Meetings are considered part of an associate's work time. Committee Members are relieved of work duties during meetings."

An interview was conducted with staff #9 on 9/13/2023 in the afternoon. Staff #9 confirmed the Safe Staffing Committee failed to discuss and implement a safe nursing matrix/grid. Staff #9 confirmed the LVN position was not scheduled as its own discipline on the nursing matrix/grid. An LVN must have supervision by an RN and cannot be scheduled as a Registered Nurse (RN). The nursing staff matrix/grid should show what was the minimum nursing staff used compared to the patient census and patient needs.

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

1. the physician's order for the administration of blood/blood products included a transfusion rate and duration in 5 (# 3, # 20, # 21, # 22, # 24) of 5 patient medical records reviewed.

2. a physician order to transfuse blood/blood products was in the medical record prior to a blood product transfusion in 1 (patient #24) of 1 patient medical record reviewed.

3. a policy and procedure that had been approved by the Governing Body, gave clear guidelines for the administration of blood/blood products.


It was determined that these deficient practices posed an Immediate Jeopardy to patient health and safety and placed all patients in the facility at risk for the likelihood of harm, serious injury, and possibly subsequently death due to the unsafe administration of blood products.



Findings:

Patient # 3

Patient #3 was admitted to the hospital on 7/22/2022 with acute blood loss. At 1:20 PM, Patient #3 was transferred to the ICU (Intensive Care Unit) for hemorrhagic shock (a systemic shock caused to the body due to heavy blood loss) and received a total of 4 units of RBCs (red blood cells), 2 units of FFP (fresh frozen plasma), and 1 unit of platelets.

A review of the medical record with Staff # 11 revealed the physician's orders dated 7/22/2022 for RBCs, FFP, and platelets did not include a transfusion rate or transfusion duration for the blood and/or blood products.


Patient # 20

Patient # 20 was admitted to the facility on 09/09/2023 with a diagnosis of coronary artery stenosis (a disease where the arteries to the heart are smaller and struggle to supply blood and oxygen to the heart) and scheduled for a Coronary Artery Bypass Graft (CABG) Procedure on 09/11/2023.

During an observation tour of the facility on 09/12/2023 at 11:00 AM with Staff # 5 and Staff # 11, the surveyor observed Patient # 20 receiving a unit of RBCs. The unit of RBCs contained 350ml (milliliters) of blood.
An interview was conducted with Staff # 30 on 9/11/2023 at 11:00 AM. Staff #30 was asked about the rate of the blood transfusion for Patient #20. Staff #30 stated, "The patient is receiving 1 unit of RBCs. I just started it about an hour ago. It is running to gravity so 14 gtts/min (drops per minute). I was told we can transfuse RBCs to gravity on post-operative CABG patients. The blood must be completed within 4 hours of the start because the tubing is only good for 4 hours. If there is still half of the blood left in the bag with only 30 minutes left in the transfusion, I have to make sure the patient gets the blood before the 4 hours is up."

Staff #5 and #11 confirmed the unit of blood was transfusing at 42 ml/hr (42 milliliters per hour) or 14 gtts/min and would not be completed within 4 hours at the rate of 42 ml/hr (14 gtts/min).



Patient # 21

Patient # 21 was an 84-year-old male who presented to the ER (Emergency Room) on 09/06/2023 with a diagnosis of chronic anemia, blood in his stool, and low hemoglobin.

Patient #21 was seen in the ER and treated by Physician #39. A review of the physician's order dated 9/06/2023 at 6:07 PM read, "Transfuse Blood, RBC 2 units Stat."

Physician #39 failed to document a transfusion rate or duration on the blood transfusion order.

The patient received 1 unit of RBCs on 09/12/2023. The physician's orders for RBCs on 09/12/2023 did not include a duration or rate in the order.

During an interview with Patient # 21 on 09/12/2023 at 11:49 AM, Patient # 21 stated, "I was not aware I was receiving blood until I woke up and looked up at the bag hanging. The nurse did not tell me she was going to give me blood."

An interview was conducted with Staff #31 on 09/12/2023 at 11:55 AM. Staff # 31 was asked what rate the blood was transfusing and how long would it take to complete. Staff # 31 stated, "The order does not say what rate to run the blood or for how long. I know that the blood must be completed within 4 hours. I typically run the blood slow at 75ml/hour for the first 15 minutes and then I will increase it to 125ml/hour once I know the patient can tolerate it."
During the observation of Patient #21, Staff #5 and #11 confirmed the blood was transfusing at a rate of 125 ml/hr.



Patient # 22

A review of Patient # 22's medical record with Staff # 11 revealed Patient # 22 was admitted to the facility on 04/27/2023 with a diagnosis of iron deficiency anemia.

Patient #22 received 2 units of RBCs on 4/28/2023. The physician's orders for RBCs did not include a transfusion rate or transfusion duration.



A review of the facility policy titled, "Blood Product Administration" Number 3.120 with a created date of 07/2023 was as follows:

" ...OBJECTIVE: To provide guidelines for the administration of blood and blood products in CHRISTUS Health ministries in non-emergent situations that do not require rapid infusion or massive transfusion guidelines.

GUIDELINE STATEMENT: Blood product transfusion is one of the most common invasive procedures performed in the health care setting. Transfusion involves the introduction of active biological products (cells and proteins) from a living donor to a patient, and thus, complex biological reactions may occur. Completing key safety elements can help ensure that the risk of an adverse event involving blood administration is minimized. Additionally, understanding the possible complications of transfusion and recognizing reactions at the bedside contribute to the best patient outcomes. This document establishes the guidelines for the key elements of safe blood administration.

IV. Procedure:

A. Pre-Transfusion:
1. Informed consent will be obtained prior to the transfusion of blood/blood products ...

B. Initiating and continuing the transfusion:
...
4. The RN shall remain with the patient during the first 15 minutes of the transfusion to observe for any signs and symptoms of adverse reactions. Continue to observe periodically at least every 60 minutes for any adverse reactions...

b. Non-emergent transfusions should be initiated slowly, as major reactions usually appear before the first 50ml have been infused. If there are no signs of a reaction within 15 minutes, the rate may be increased (see Table 2)...

C. General considerations for transfusion: ...

3. Ensure the transfusion is infused in the prescribed amount of time. Electronic infusion pumps can be used to deliver blood/blood products without significant risk of hemolysis.
a. RBCs should be completed within 4 hours.
b. Platelets should be administered over 1-2 hours ....

4. Suggested rates of transfusion

Table 2

All Components, first 15 minutes: Duration/Rate: 100ml/hr
RBC: Estimated Volume: 350ml; Duration/Rate: 1.5-4 hours
Plasma: Estimated Volume: 200-250ml; Duration/Rate: 15-60 minutes
Platelets: Estimated Volume: 250-350ml; Duration/Rate: 1-2 hours
Cryoprecipitate: Estimated Volume: 90-120ml; Duration/Rate: 15-30 minutes..."


An interview with Staff # 2 on 09/12/2023 at 1:20 PM confirmed the facility nursing staff were referring to and using a policy that had not been approved by the facility's Governing Body. Staff # 2 also confirmed that the policy stated a suggested rate of transfusion as opposed to giving clear and precise guidelines.

The facility's failure to ensure the nursing staff had an approved policy and procedure for the safe administration of blood products could result in unsafe administration of blood products.



40989


Findings:

Patient #24
Patient #24 was an 84-year-old male admitted to the facility on 3/7/2023. He was brought into the ER by ambulance and intubated (had a breathing tube) with a diagnosis of Severe Sepsis.

A review of the Patient #24's medical record was conducted on 9/13/2023 at 10:30 with Staff #6.

Findings included:

Patient #24 received 2 units of FFP (Fresh Frozen Plasma-a blood product) in the ER on 3/09/2023. The first unit was started by Staff #40 on 3/09/2023 at 9:20 AM and completed at 10:40 AM and the second unit was started by Staff #40 on 9/09/2023 at 12:07 PM and completed at 12:47 PM.

Staff #6 confirmed there was no physician order for the transfusion of the FFP.

Physician #41 gave a verbal order on 3/10/2023 at 1:27 PM for 1 unit of RBCs to be transfused. There was no transfusion rate or duration documented on the order. Staff #42 started the transfusion on 3/10/2023 at 3:10 PM and it was complete at 6:00 PM.

Physician #43 wrote the following orders:

" ...3/11/2023 10:49 AM Transfuse Blood 1 Unit ...
3/11/2023 10:51 AM Transfuse Blood (Platelets) 1 Unit ...
3/12/2023 10:53 AM Transfuse Blood 1 Unit ...
3/13/2023 8:43 AM Transfuse Blood (Platelets) 1 Unit ..."

Staff #42 confirmed there was no transfusion rate or duration of transfusion for the blood/blood products ordered by the physician on 5 of 5 orders reviewed. Also, Staff #42 confirmed the 2 units of RBCs ordered on 3/11/203 and 3/12/2023 were administered and the 2 units of platelets ordered on 3/11/2023 and 3/13/2023 were administered to Patient #24.

An interview was conducted with Staff #19 on 9/12/2023 at 1:46 PM. Staff #19 was asked if the physician puts a transfusion rate on the order for blood or blood products. Staff #19 replied, "No we just have a rate we normally use. We have 4 hours to make sure it's all in starting from the time we pick the blood up from the lab." She was then asked to show this surveyor the policy that is currently in use for the administration of blood/blood products.
Staff #19 printed the policy titled, "Blood Product Administration" Number 3.120, with a created date of 7/2023 and no revised or reviewed date documented. Staff #19 was asked if the policy is the most current and she stated, "Yes, it is."

An interview was conducted with Staff #2 on 9/12/2023. Staff #2 confirmed the policy titled, Blood Product Administration," Number 3.120 had not been approved by the Governing Body. She stated this policy was being reviewed and would be used throughout the system in the future.

An interview with Staff #2, #5, and #10 on 09/13/2023 at 2:00 PM confirmed Policy Number 3.120 had not been approved by the Governing Body and was the current policy being used at the facility.