HospitalInspections.org

This CONDITION is not met as evidenced by:

Based on clinical record review, laboratory's standard operating procedures, patient test reports, and laboratory personnel interviews, for 1 of 6 patients reviewed for abnormal fibrinogen levels (Patient #80) the Laboratory failed to ensure timely processing, reporting, and notification of STAT (urgent) patient specimens and failed to monitor the corrective actions taken to prevent recurrence of delayed STAT specimens that adversely affected patient care in accordance with the Clinical Laboratory Improvement Amendments (CLIA) requirements. The patient was transferred to the ICU with hemorrhagic shock. The findings include:


1. Patient #80 was admitted to the hospital at 41 weeks gestation for an induction of labor.

A physician's order dated 06/19/24 at 4:14 AM directed to obtain a STAT (immediately) fibrinogen level. (fibrinogen is a protein that helps with blood clotting).

Review of the clinical record identifed a registered nurse (RN) obtained the ordered fibrinogen sample on 06/19/2024 at 04:18 AM which was sent to the laboratory at 4:21 AM


The operative note dated 6/19/24 at 12:48 PM indentfied that Patient #80 had exhibited symptoms consistent with placental abruption (separation of the placental from the wall of the uterus which can cause heavy bleeding in the mother) which led to the patient being taken to the OR for a cesarean section. The note further documents that upon closing of the incision, staff observed blood in the patient's urinary catheter, and the final uterine expression resulted in a blood loss of 500 cubic centimeters (cms). Consequently, additional assistance was requested, and the patient was reopened. The note also identified that although 300cc of hemoperitoneum (presence of blood in the peritoneal cavity) was observed, exploration revealed no obvious signs of bleeding, and the patient was transferred to interventional radiology for a uterine artery embolization. Further review of the clinical record identified Patient #80 was subsequently transferred to the ICU with hemorrhagic shock. The clinical record identified a total estimated blood loss of 2000 milliliters (mls).


Review of the fibrinogen result, obtained on 06/19/24 at 4:18 AM, identified a fibrinogen level of less than 50 mg/dL (normal range 187- 446) at 8:16 AM (nearly four (4) hours after the sample was obtained).

Review of patient #80's final test reports on 08/13/2024 identified the following:

a. Fibrinogen sample (Specimen #1):
Collection date/time: 06/19/2024 at 04:18 AM
Sample receipt date/time: 06/19/2024 at 04:21 AM
Sample report date/time: 06/19/2024 at 06:17 AM
Sample turnaround time of 1 hour and 56 minutes.


b. Fibrinogen sample (Specimen #3):
Collection date/time: 06/19/2024 at 07:11 AM
Sample receipt date/time: 06/19/2024 at 07:14 AM
Sample report date/time: 06/19/2024 at 08:16 AM
Sample turnaround time of 1 hour and 2 minutes.

Record review of the laboratory information system (LIS) on 08/13/2024 revealed a lack of documentation that the ordering practitioner was notified of the delay for the fibrinogen results.

Interview with Laboratory Director (LD) #80 and Testing Personnel #1 (TP#1) on 08/16/2024 at 9:00 AM confirmed the turnaround time of 45 minutes for STAT specimens was not met. TP#1 stated that he/she took a long time to report specimen #1 due to all the repeated attempts and troubleshooting of the instrument errors. The Lab Director further identified that he/she is unaware of the reason that specimen #3 exceeded the acceptable turnaround time and why the practitioner was not notified of the delay.

Review of the laboratory's 'GH GL-22 Specimen Processing' standard operating procedure on 08/13/2024 directed the following:

a. 'When there is an unusual delay in testing and the turnaround time (TAT) is prolonged, or expected to be prolonged, the laboratory staff must notify the ordering practitioner'.

b. 'This notification should be documented in the communication log pertaining to the order, or as a printed document maintained by the manager of each section in instances that multiple test/samples are affected'.

c. 'The expected TAT standard for STAT testing is within 45 minutes'.


An interview with RN #88 on 8/16/24 at 10:30 AM identifed that during Patient #80's cesarean section, she noticed that other bloodwork results were available, but the fibrinogen result was still pending. The RN stated she contacted the laboratory to inquire about the fibrinogen result and was informed that it was not yet available and the message was relayed to the team. The RN identified that when patient #80 began hemorrhaging, the RN again called the laboratory to obtain the fibrinogen result, emphasizing the urgency of the situation due to the patient's bleeding in the OR. However, the laboratory staff person reported that the fibrinogen result was still unavailable.

Record review and interview with MD #80 on 8/19/24 at 1:00 PM identified that she placed an order for a fibrinogen level at 4:14 AM and the nurse immediately obtained the sample and sent it to the lab. MD #80 explained that the patient began exhibiting symptoms consistent with placental abruption and was brought to the operating room for an emergency cesarean section at 4:42 AM. The MD stated that once the patient was closed, the team noted blood in the urinary catheter and during the final uterine expression, the patient began to hemorrhage. MD #80 identifed she recalled that the RN called the laboratory to inquire about the delayed fibrinogen results, but the results continued to be unavailable. Subsequently, the Massive Transfusion Protocol was activated and the team decided to send another blood sample to the laboratory to obtain the fibrinogen level. MD #80 indicated that if the fibrinogen result had been available, she would have ordered cryoprecipitate (blood product containing clotting factor that help control bleeding) which could have prevented Patient #80's significant blood loss and subsequent transfer to the ICU.


2. Record review of the 'Laboratory's Performance Improvement Plan' on 08/13/2024 revealed a lack of documentation that tests sent for redraw for any STAT laboraotry testing was communicated to the collector via text message using Mobile Heartbeat' to meet the updated standard operating procedures for the current acceptable STAT turnaround time of 45 minutes.

Interview with Laboratory Director #80 and General Lab Supervisor #1 on 08/16/2024 at 9:00 AM confirmed the lack of documentation of monitoring for compliance pertaining to the updated standard operating procedures.

Review of the laboratory's 'GH GL-31 Cancellation and Notification of Tests Not Resulted' standard operating procedure (Document # 160974.367, version # 4.0) identified 'Communication: On ED and inpatient tests that are sent for redraw must be communicated to the collector via text message using Mobile Heartbeat'.