HospitalInspections.org

Based on interview and record review the facility failed to meet the Condition of Participation (CoP) for Nursing Services by failing to ensure that nursing personnel adhere to the policies and procedures set forth and by failing to comply with the requirements for patient monitoring and to promptly identify a blood transfusion reaction.

Refer to 0410.

Based on record review and interview the facility failed to ensure that nursing personnel adhered to the policies and procedures regarding monitoring the patient for transfusion reactions (adverse events associated with the transfusion of whole blood or one of its components) during blood product administration (giving blood through a catheter inserted into a vein) for 2 patients (P)1 and P21 of 25 (P1-P25) patients in the Emergency Department (ED) by:
1. Failing to ensure that a transfusion reaction was identified for P1.
2. Failing to ensure that a Transfusion (a procedure in which whole blood or parts of blood are put into a patient's bloodstream through a vein) Reaction Investigation form was completed in its entirety for P21.
These deficient practices are likely to affect all patients receiving blood products in the Emergency Department and delay identification and treatment of transfusion reactions potentially causing serious injury or death.
The findings are:

A. Record review of the document policy title:" Blood and Blood Product Administration, Current Effective Date: 08/12/2021, Procedure:"
1. "8.1. Monitor for signs and symptoms of transfusion reactions both acute and delayed and treat accordingly (see Addendum C: Blood Transfusion Reactions). 8.2. If reaction is suspected: 8.2.1. Stop transfusion immediately."

B. Record review of the document policy title: "Blood and Blood Product Administration, Current Effective Date: 08/12/2023, Addendum C: Blood Transfusion Reactions:"
1. "Cause: Hemolytic Reactions (a serious complication that can occur after a blood transfusion where the transfused red blood cells that were given during the transfusion are destroyed by the person's immune system).
Caused by incompatibility between donor and recipient; Can be either immediate (acute) or delayed; acute hemolysis (destruction of red blood cells) can occur when recipient plasma antibodies (proteins in the blood that fight diseases) that react with the donor RBC (red blood cells) antigens (a foreign substance which causes an immune response in the body) or less often, vice versa (the other way around); most likely to occur with administration of WB (white blood cells-fight infection) or RBCs (red blood cells-a type of blood cell that is made in the bone marrow and found in the blood)
Signs & Symptoms: Apprehension; chills, headache, fever; pain in back, abdomen or chest, or at infusion site; ...hypotension (blood pressure under 90/60 millimeters of mercury ((a measure of blood pressure)), tachycardia (a fast heart rate >100)."

C. Record review of Patient P1, male, medical chart reveals diagnoses of chronic hepatitis C (an infection of the liver), liver cell carcinoma (liver cancer), and cirrhosis (late-stage liver disease) resulting in gastrointestinal bleeding (bleeding within the stomach-intestinal area) and a resulting hemoglobin (protein contained in red blood cells responsible for delivery of oxygen with a normal range for males of 14-18 grams per deciliter) of 7.0 grams per deciliter and hematocrit (volume of red blood cells compared to total blood volume with a normal range for males of 40-54%) of 22% requiring a blood transfusion; and finds the following entries:
1. Pre-transfusion vital signs on 10/30/2022 at 1:37 am revealed temperature 97.7 Fahrenheit (a scale of temperature) (F) (normal range 97.5 F through 98.8 F), heart rate 99, blood pressure 101/68, respiration rate 17 breaths per minute.
2. 10/30/2022 at 1:46 am transfusion of the first unit (bag) of uncross matched PRBC (packed red blood cells) was initiated.
3. 10/30/2022 at 1:59 am P1's vital signs were temperature increased to 98.2 F, heart rate increased to 118 (tachycardia-a heart rate >100), blood pressure 103/70, respiration rate 17 breaths per minute. The transfusion was not stopped.
4. 10/30/2022 at 3:30 am unit was completed
5. 10/30/2022 at 3:38 am P1's vital signs were temperature 98.2 F, heart rate 115 (tachycardia >100), blood pressure 126/80, respiration rate 18 breaths per minute.
6.10/30/2022 at 3:38 am per Quick Updates (nursing free text note) "After first unit of blood was completed at 0330 and VS obtained within ~5-6 minutes patient started to moan and groan in pain reporting pain/cramping to his lower abdomen. Patient also c/o of "feeling cold". Primary RN notified and will administer pain medications per MAR [medication administration record]."
7. 10/30/2022 at 3:46 am RN (Registered Nurse) S (staff) 17 started the 2nd unit of uncross matched PRBC.
8. 10/30/2022 at 4:00 am P1's vital signs were temperature 98.5 F, heart rate 152 (tachycardia >100), blood pressure 136/92, respirations 28 breaths per minute.
9. 10/30/2022 at 4:04 am S17 stops the transfusion and initiates the Transfusion Reaction Evaluation order set on 10/30/2022 at 4:20 am.
10. 10/30/2022 between 5:02 am and 7:00 am vital signs were not obtained by facility staff.
11. 10/30/2022 at 7:25 am per Medical Doctor (MD) S29, P1 was tachycardic, diaphoretic (excessive sweating) and having nausea, and became unresponsive. P1 was intubated (a tube placed down the throat to help the patient breath) and required medications to increase the blood pressure.

D. Record review of ED (emergency department) Provider note by Medical Doctor (MD) S18 dated 10/29/2022 at 5:48 pm revealed: "Vital signs: Notify provider for SBP <100 [systolic blood pressure (a measure of the pressure in the arteries when the heart beats) less than 100] or HR >100 [heart rate greater than 100]."

E. Record review of "HFL&C (Health Facility Licensing and Certification) Incident Report SFY (State Fiscal Year) 2011)" dated 11/01/2022 at 4:09 pm completed by Clinical Risk Manager RN (S32) concluded that per "post-transfusion reaction investigation by the blood bank revealed that the patient's first emergent non-crossmatched transfusion was positive for JK antigens (a protein in the blood that allows the kidney to concentrate urine), which resulted in the patient having an acute hemolytic transfusion reaction (destruction of red blood cells during a transfusion)." The patient lacked JK antibodies.

F. Interview with Registered Nurse Manager of Clinical Excellence (S7) on 04/17/2023 at 2:57 pm, S7 stated her role in the investigation involving P1, was to talk to the staff involved as soon as an issue was identified, and in the investigations the issue identified was that the first unit was not cross matched with P1 and within the first 7 minutes into the transfusion the patient became tachycardic. When asked, if the transfusion should have been stopped within the first 7 minutes, S7 stated. "I think so."

G. Interview with Registered Nurse (S22) on 04/19/2023 at 9:30 am, S22 was asked how they knew if a patient was having a transfusion reaction. S22 stated. "If the patient gets a rash, short of breath, tachycardia, a temperature." S22 was further asked, what the procedure was if a patient was having a reaction to the blood. S22 stated. "If the temp (temperature) goes up a point, I would be bringing it up to the doctor. A lot of times if a patient become tachycardic it is 90 or above." When asked when the transfusion would be stopped. S22 stated. "Anytime there is a reaction of some sort. I would, stop the blood, disconnect, and flush the line."

H. Interview with Emergency Department Charge RN (S21) on 04/19/2023 at 11:28 am. S21 was asked how they know if a patient was having a transfusion reaction. S21 stated. "Abdominal pain, chills, pain, rash at insertion site, chest pain, pressure, difficulty breathing. First thing you do is turn off the blood."

I. Record review of facility policy titled "Transfusion Reaction Investigation Procedure - [Name of Healthcare Provider] dated 06/03/22 states, "V. Procedure Instructions: A. The Transfusionist [Nurse] will call the Blood Bank regarding a suspected transfusion reaction. If a phone call is not received from the Transfusionist within 15 minutes of a "Transfusion Reaction Evaluation" order printing in the blood bank, please call the Patient Unit. Lab personnel receiving the call can state the following to the transfusionist: [bolded in policy] 3. "What is your tube station number? We will tube up the Transfusion Reaction Investigation Form. Follow the instructions on the form." D. Laboratory Investigation for all reactions excluding mild allergic reactions: [bolded in policy] 1. A member of the clinical team will provide the blood bank with the implicated blood product with attached tubing and tag along with the completed sections of I and II of the Transfusion Reaction Investigation Form. The post-reaction specimen may come from either the clinical team or Phlebotomy Services.

J. Record review of P21 medical chart finds "Transfusion reaction evaluation" "Path interp of Rxn" (pathologist interpretation of reaction) is "Transfusion Associated Circulatory Overload" (TACO-a reaction to a blood transfusion that commonly causes pulmonary edema [fluid build up in the lungs] and difficulty breathing). Vital signs are key to identifying and treating this syndrome.

K. Record review of P21 medical chart finds form titled "[Name of Facility] Transfusion Reaction Investigation Form" under "Section II-Clinical Findings-To be completed by the RN or Provider" under "Reaction Onset Vials [sic]" for P21 finds no vital signs recorded:
1. Blood pressure field is not completed and left blank
2. Pulse field is not completed and left blank
3. Temperature field is not completed and left blank
4. Respiratory Rate is not completed and left blank
5. O2 Saturation field is not completed and left blank
6. Final Interpretation from Pathologist - TACO (Transfusion Associated Circulatory Overload)

Based on record review and interview the facility failed to obtain consent with the minimum elements (patient name and identifier, providers name, name of procedure and all blanks on consent) for 9 (P (patients) 1, P2, P4, P5, P6, P7, P8, P9 & P10) of 11 (P1 - P10 & P19). This failed practice is likely to cause harm, death or diminish the quality of patient care for all patients receiving surgery or procedures in the facility.

The findings are as follows:

A. Record review of facility policy title "Informed Consent" dated 06/14/2021, states:
POLICY:
"Informed consent process requires:
2. Documentation evidencing that the informed consent took place.
Nursing & Staff role in the informed consent process: Only a provider can obtain informed consent but and/or other staff play a vital role in helping to ensure that appropriately documented informed consent has been obtained before a procedure or treatment occurs and in helping to ensure a patient has had an opportunity to have their questions asked and answered.
Requirements for Documentation: The completed and signed consent form must be sent to PDS [Presbyterian Delivery System] and be scanned into in the patient's electronic medical record prior to any procedure or treatment requiring informed consent being performed or undertaken.
Procedure:
1. Completing and Documenting the Informed Consent Process
1.3 Licensed, Certified, or Clinical Staff Responsibilities:
1.3.3. Ensure all blanks have been filled in before each section of the consent form is signed.
2. Special Consents:
2.6 Blood Product Administration:
2.6.2. If a blood product has been ordered, the patient, or the patient's personal representative, shall be informed of his/her right to refuse blood product administration. The patient, or the patient's representative, must indicate whether he/she authorizes blood product administration, or if he/she does NOT authorize blood product administration and understand doing so is against medical advice. The form shall be completed and placed in the patient's medical record when blood or blood products are indicated. The witness signature is optional."

B. Record review of facility policy "Patient Identification" dated 06/07/2021 states "Policy: 1. Two patient identifiers that shall be used by all healthcare personnel to identify the patient or verify the correct patient's identity when communicating or providing patient care, treatment, or services. The two patient identifiers that all healthcare personnel shall use are:
1.1. The patient's name, which may include the patient's preferred name.
1.2. The patient's date of birth."

C. Record review of consent form "Consent for Procedure or Surgery and Acknowledgement for receipt of Information" for P1 dated 10/30/22 showed Section 1 - Operation or Procedure Consent: missing the name of the practitioner who will perform the operation or procedure.

D. Record review of consent form "Disclosure and Consent to Receive or Refuse Blood Transfusion" for P2 dated 04/01/2023 showed patient's name who has the blood transfusion order and the practitioner's name who ordered the blood transfusion and obtained consent have not been filled out. Page 2, Printed name and relationship to patient has been signed by RN (Registered Nurse) (witness) and not filled out by the patient.

E. Record review of consent form "Blood Product Transfusion Consent Form" for P4 dated 11/29/2022 and P6 dated 03/08/2023 showed on page 2 printed name and relationship to patient section of form have not been filled out.

F. Record review of consent form "Blood Product Transfusion Consent Form" for P5 dated 01/07/2023 showed page 1 missing from chart and no patient name, and no ordering provider name filled out.

G. Record review of consent form "Blood Product Transfusion Consent Form" for P7 dated 02/12/2023 showed ordering provider name is incomplete. Page 2 showed relationship to patient section had not been filled out and under patient identification did not have a patient sticker and P7's first name and last initial has been handwritten in with no additional patient information.

H. Record review of P8 consent form "Consent for Procedure or Surgery and Acknowledgement for Receipt of Information" dated 02/21/2023 showed Section 1 - Operation or Procedure Consent missing name of practitioner who will perform the operation or procedure. Name of the operation or procedure does not show a procedure and states "back page is signed."

I. Record review of P9 consent form "Consent for Procedure or Surgery and Acknowledgement for Receipt of Information" dated 12/31/2022 showed Section 1 - Operation or Procedure Consent: physician/provider name is incomplete and page 2 under patient identifier was missing patient sticker and has P9 last name and MRN (medical record number) handwritten in with no additional patient information.

J. Record review of P10 consent form "Blood Product Transfusion Consent Form" dated 10/29/22 showed on page 2, "Check one of the boxes below: I authorize you to administer the ordered blood products / I do NOT authorize you to administer blood products, OR I accept only specific [bolded in policy] blood products" was left blank. Section patient name and relationship to patient was not filled out.

K. Interview with S8, Chief Nursing Executive on 04/27/2023 at 4 pm when asked about blanks on the consent forms shared with him, S8 answered, "From what you forwarded me we have a few lapses on all the blanks being filled out." When asked about patient identifiers being on all pages of document, S8 confirmed according to facility policy two identifiers are needed, patient name and date of birth at minimum. S8 stated "We should have name and date of birth on that, and we only have name and it's a 2-page document and if they were separated that would be a problem ..."

L. During interview with S21, Charge RN on 04/18/2023 at 2:15 pm, when asked who obtains consents for the patient, S21 answered "The doctor gets consent then the nurse has the patient sign the form."

M. During interview with S22, RN on 04/16/2023 at 12:20 pm when asked who obtains consent, S22 answered "Usually the doctor will go in and talk to them and then we [the nurses] witness the signature on the consent."