HospitalInspections.org

Based on document review and interview, it was determined that the Hospital failed to maintain adequate laboratory services to meet the needs of its patients. As a result, the Condition of Participation, 42 CFR 482.27 Laboratory Services was not in compliance.

Findings include:

1. The Hospital failed to provide laboratory services in accordance with hospital policy, including appropriate labeling of specimens. Subsequently, resulting in Pt #1's death. (A-582)

Based on document review and interview, it was determined for 1 of 1 (Pt # 1) laboratory sentinel event patient records and 4 of 20 (Pt # 11 -Pt #14) adverse events which could cause significant harm, the Hospital failed to provide laboratory services in accordance with hospital policy, including appropriate labeling of specimens. Subsequently, resulting in Pt #1's death.

Findings include:

1. The policy titled, "Specimen Collection Guidelines for Urine, Blood (Line Draw), and Blood Cultures" (revised August 2024) was reviewed. The policy noted, "Objective: To obtain specimen(s) using proper identification, collection, and labeling process that will ensure that patient care requirements are met. Policy: ... 2. Specimen labels are to be generated at the time a specimen is collected and labeling is to occur at the bedside .... 8. All specimens being submitted to the laboratory via the pneumatic tube system must be labeled properly, packaged in a clear biohazard bag, and protected by foam padding placed inside the pneumatic tube system carrier ...."

2. The Laboratory Adverse Event and the Laboratory Sentinel Event Logs were reviewed 3/1/2024 through 12/11/24. The logs included an event for Pt #1 on 3/21/2024 which stated, "Labeling issue." The Sentinel Event Log indicated, "Final Harm: Unexpected Clinical Outcome."

3. Pt #1's record was reviewed throughout the survey Pt #1 arrived to the Emergency Department (ED) on 3/19/24 at 10:10 PM with a chief complaint of "sent here by oncologist for neutropenic fever temp at home 104." The ED Physician noted, "History of Present Illness: 49-year-old with history of AML (Acute Myeloid Leukemia - cancer) on chemotherapy, PE (Pulmonary Embolism - blood clot in the lung) not on chemotherapy secondary to pancytopenia (low counts of all blood cells) and thrombocytopenia (low platelet count), diabetes 2, severe morbid obesity, here with fever, malaise and shortness of breath. Patient was discharged yesterday from the hospital after being admitted for neutropenic (low white blood cell count - white blood cells help to fight off infection) ... (Pt #1) came in today because (Pt #1) had a fever at home of 100.5, (Pt #1) felt very chilled and malaise. (Pt #1) is on antibiotics currently. (Pt #1) has not been able to take anticoagulation (blood thinners to reduce the risk of blood clot) due to severe thrombocytopenia but has a known pulmonary embolism which had initially improved on Eliquis (blood thinner) ...Lab results: ... Hemoglobin - 8.6 (normal count is 10-12), Hematocrit - 23% (36% -48%), Platelets - 27 (flagged as Critical - normal range 150-450) ...

Reexamination/Reevaluation: Time: 3/20/24 2:12 AM - Assessment: Patient resting, still tachycardic (fast heart rate - greater than 100 beats per minute) after a Liter of fluids, CTA (Computed Tomography Angiography - test that checks for blood clot, bleeding, and tumors) showing evidence of possible pneumonia on the right side. Given (Pt #1) tachycardia, symptoms of dyspnea (difficulty breathing), current antibiotic regimen, will broaden coverage with cefepime (antibiotic) and vancomycin (antibiotic). Will admit the patient for clinical observation ... Plan: Condition: Stable ...."

- The CTA completed on 3/20/24 at 12:56 AM indicated, " ... Impression: 1. No evidence of pulmonary embolism... 3. Nodular structure in the right middle lobe. This could be infectious or inflammatory at this is new since 2/24/24. A follow-up exam in 3 months is recommended.

- Pt #1 was admitted to the Hospital on 3/20/24 at 11:04 AM.
-Pt #1's History and Physical on 3/20/24 at 4:49 AM indicated, "Impression: SIRS (Systemic Inflammatory Response Syndrome), HAP (Hospital Acquired Pneumonia), Pancytopenia secondary to AML, AML on chemo ..."

- Hospitalist MD progress note dated 3/20/24 at 6:07 AM noted, " ... Plan: ... Platelet count has improved and is in the 20s now (referencing previous admission lab results). Transfuse as needed for platelet count less than 20 or symptoms. She was last transfused on 3/18/2024 ...

- Infectious Disease Consult Note on 3/20/24 at 2:50 PM noted, "Reason for consult: Antimicrobial management ... Assessment: fever in an immunosuppressed host, this patient has hematological malignancy in the form of AML, and (Pt #1) is on chemotherapy. (Pt #1) was previously pancytopenic and on G-CSF (granulocyte-colony stimulating factor - growth factor that increases WBCs), is not currently neutropenic, thrombocytopenic, diabetes with hyperglycemia, new pulmonary nodule, not present on CT (computed tomography) imaging from 2/24... Plan: ... In light of new lung nodule seen on CT chest, would recommend biopsy for diagnostic purposes ... however (Pt #1) also has refractory thrombocytopenia which complicates any possible diagnostic biopsy ..."

-Complete Blood Count (includes hemoglobin, hematocrit, and platelet counts) was drawn on 3/21/24 at 5:49 AM. The platelet count results indicated Pt #1's count was 173 (within normal ranges - no treatment had been provided to increase the platelets from the critical level of 27).

- MD progress note 3/21/24 6:13 AM noted, " ... Plan: ... ID (Infectious Disease) consulted. Discussed (ID MD) yesterday and again today ... Will get a biopsy / aspirate of (Pt #1's) new right middle lobe lung nodule as (Pt #1's) platelet counts have now normalized .... Platelet count has improved and is now 170s. (Pt #1) was last transfused on 3/18/24 .... Addendum: Saw (Pt #1's) for recurrent episodes of hypotension (low blood pressure) after lung bx (biopsy). CT showed new hemothorax (blood in lung cavity) but no active extravasation (leaking of blood from vessels) per my discussion with IR (Interventional Radiology). Consulted ICU (Intensive Care Unit). Patient evaluated with (IR), (ICU intensivist), and RR (Rapid Response) team ..."

- A CT guided lung biopsy was completed in IR on 3/21/24 at 1:12 PM. The procedure noted included, "The patient complained of chest discomfort immediately after the procedure. The patient also experienced a brief change in mental status with lightheadedness and diaphoresis (sweating). Immediate postprocedural imaging demonstrates no intracranial (inside the head/brain) findings. CT chest demonstrates a new moderate right hemothorax without evidence for active bleeding .... Patient's vital signs remained stable with a return to baseline at the status. The patient is an inpatient and has been returned to the floor. ... Impression: CT guided right middle lobe lung nodule complicated by moderate right hemothorax ..."

- Rapid Response Team was called at 3:26 PM to the CT Scanner due to an "acute change in LOC (Level of consciousness)." Pt #1 was then transferred to IMC (Immediate Care Unit).

-Rapid Response Team was again called at 3:39 PM due to "Patient exhibiting another unresponsive episode when transferring from bed to bed. BP (blood pressure) dropped to 83/55 with HR (heart rate) 85 ... ICU consulted and accepted... Disposition: Transfer to ICU ..."

- "SIU ICU Code Note" at 9:41 PM noted, "(Pt #1) was recently diagnosed with AML s/p (status post) induction chemotherapy. (Pt #1) was admitted on 3/20/24 due to concerns for sepsis, after recently being discharged on the 18th for neutropenic fever of unknown etiology. A new lung nodule was noted, therefore underwent CT guided Bx (biopsy) today. This was followed by symptoms of chest pain, hypotension, in addition to a 3 g (gram) Hb (hemoglobin) drop. Repeat CT showed right sided hemothorax, upgraded to the ICU for closer monitoring. At 7:42 PM, Code was called due to PEA (pulseless electrical activity) arrest. It seems that the patient developed bradycardia, apneic episodes prior to the code ... After a few rounds of CPR(cardiopulmanary resuscitation), eventually achieving ROSC (return of spontaneous circulation) at 7:58 PM, sinus tach (tachycardia) on the monitor. At 8:01 PM another code was called for asystole (no heart activity)/PEA following multiple rounds of CPR with similar rhythms without achieving ROSC, eventually expiring at around 8:55 PM after discussing poor prognosis with family. Labs showed declining Hb despite multiple PRBC (packed red blood cells) .... Potential etiologies of the PEA arrest including hemorrhagic shock ...."

- "Report of Postmortem Examination" dated 3/26/24 noted, " ... Opinion: the proximal cause of death is attributed to the right hemothorax with resulting mass effect on the right lung and mediastinum, originating from the recent biopsy site of the lung. Contributing to (Pt #1's) death is acute myeloid leukemia."

4. The "Summary of Root Causes and Recommended Improvement Plan" for Pt #1's event was reviewed. It included, "Root Cause: Mislabeled Specimen. Corrective Actions: Remediation with individual and huddles with all phlebotomy staff to review process. QI (Quarter 1) review of Bridge Specimen Collection Process (identification of additional process gaps) and create check list for phlebotomy. Root Cause - Platelet Delta Flag (computerized alert for abnormal labs - whether high, low, or a significant change from the last results) - Not acknowledged/addressed by lab technologist. Corrective Action: Remediation with individual technologist involved. Reviewed procedure with all lab technicians.

5. An interview was conducted with the Director of Clinical Laboratory (E #2) on 12/11/24 at 10:45 AM. While reviewing Pt #1's adverse event, E #2 stated, "This patient I remember very well. This labeling issue was a mislabel. This actually was mislabeled by one of our phlebotomists (E #6). An investigation of this event was done, and it was found that basically the phlebotomist went into this patient's room and went through the process of scanning the patient's arm band, printing out the labels, went to go attempt to draw. It was an oncology patient, so patient ended up being a line draw and the phlebotomist didn't end up drawing the patient. (E #6) finished out and left that room, left the two labels that she printed on the zebra printer (portable lab label printer that phlebotomist carry to each room). The two labels were sticking up on the printer, (E #6) went to the next patient's room which was next door and basically scanned that patient's arm band and printed those labels, did draw that person's blood but utilized those two labels that were first on the printer to label those specimens and basically then (Pt #1)'s labels were then put on that other patient's blood. Those tubes were sent down for testing. The specimens came down went through processing and results then were filed. There was a platelet count issue on this patient where it was an oncology patient whose platelet count was very low. I don't remember the exact number, but it was very low, and the platelet counts that got reported off that blood the phlebotomist drew was 174, so it was total opposite extreme of what that initial platelet was in the hematology department. Approximately about an hour later the nurse went in and drew samples and so then we got those."

While discussing the process of data entry related to the Pt #1, E #2 stated, "So there were two issues, there was the mislabel and then in the hematology department. We have deltas (computerized alert for abnormal labs) set up in our computer system on some of our analytes to detect things like abnormal platelets. A delta will flag if there's a percent difference in the results. The machine does look at previous results. If there's a difference in those previous results then based on our criteria that we have preset, then it will flag that delta. It did in this scenario because that patient's platelet count was really low, I want to say in the critical range. It did delta the technologist and it reported out those results. The technologist missed that delta and reported out that result. When the Provider saw the result, they ended up determining the Pt's labs had improved and ended up taking the patient to do a lung biopsy. The patient didn't do well and had some issues going on and then ultimately ended up dying."

While discussing the investigation regarding Pt # 1, E #2 stated, "We did a root cause analysis on this. I started investigating. Once I got the information then I went back and saw that there were extra tubes that had been drawn by the nurse and went and reran those tubes the next day to see if those results matched that of (Pt #1) and to make sure they were truly (Pt #1's) and they matched exactly of what the patient's previous results were originally. Those results then got error corrected. An error correction process is where we go in and basically take out those results and put "see footnote" and then there's an option for us to put a blurb in about what the situation was. I think I did those corrections."

6. A review of Laboratory Labeling Issue adverse event report was reviewed. The log included 20 events from 3/25/24 through 11/1/24. The log included 5 "Near Miss," 11 "No Harm" and 4 "Unsafe Condition." The "Unsafe Condition" events included:
-7/17/24 - Blood specimen from 7B (Maternity) that was mislabeled.
-8/17/24 - Urine specimen labeled with the wrong patient label
-10/4/24 - Blood was sent from room C205 (Surgical ICU) with the wrong label 3 times. The label that was used was a label left over from the previous patient that was in the same room.
-10/13/24 - a bag of urine and a swab that were not labeled.

7. An interview with the Manager of Patient Safety and Accreditation (E #4) on 12/12/24 at 11:30 AM. E #4 reviewed the Laboratory Adverse Event log for "Labeling Issues." E #4 stated, "The Harm level indicated 'Unsafe Condition' means that the harm didn't reach the patient but has the potential for serious harm." E #4 reviewed four events (7/17/24, 8/17/24, 104/24 and 10/13/24) that were noted as "Unsafe Conditions." E #4 stated Manager of patient safety and accreditation states, "The unit manager is responsible for the investigation and determines what level of discipline is required. We do not investigate too deeply once it's determined PSO (Patient Safety Organization)."