HospitalInspections.org

Based on document review, policy review, record review and interview, the hospital failed to provide adequate laboratory services to meet the needs of its patients. The laboratory failed to make provision for proper receipt and reporting of tissue specimens and failed to ensure the transportation, receipt, and labeling of specimens were correct for 2 of 2 (Patient #1, 2) patients, which resulted in 1 of 2 (Patient #1) patients that suffered harm from a serious surgery which was performed based on incorrect specimen results.

The findings included:

1. Review of the hospital's policy titled, Cytology Slide Preparation, 1084 with a last revised date of 5/25/15 and last reviewed 10/2/21 revealed, "...all slides are labeled on the frosted end with patient name and accession number using a pencil or xylene resistant marking pen...Lay out coverslips individually on a clean, dry, absorbent surface...Place the glass microscope slide on the warmer to dry...Apply a computer-generated slide label to each coverslipped slide, making sure that the handwritten accession number and name on the slide match the accession number and name on the slide label...All stains and reagents must be properly labeled, dated and stored..."

2. Medical Record Review revealed Patient #1 was admitted to the hospital on 3/5/22 with diagnoses to include Biliary Acute Pancreatitis without Necrosis (tissue death) or Infection.
Patient #1 was transferred from another outlying facility with a concern for acute pancreatitis. An Endoscopic Retrograde Cholangiopancreatography (ERCP- a diagnostic procedure to diagnose and treat problems in the liver, gallbladder, bile duct and pancreas) was performed and Patient #1 was subsequently diagnosed with Pancreatic Cancer.

Medical Record Review revealed Patient #1 was again admitted to the hospital on 5/12/22 for a surgical Whipple procedure for pancreatic cancer. (A Whipple procedure is a complex operation to remove the head of the pancreas, the first part of the small intestine, the gallbladder and the bile duct.) A Whipple surgical procedure was performed on Patient #1 on 5/12/22 based on the previous lab results which indicated Pancreatic Cancer. Post surgical laboratory results revealed Patient #1 did not have pancreatic cancer. Patient #1 had received a surgical procedure based on incorrect laboratory results based on pathology slides being labeled incorrectly with another patient's name (Patient #2).
Refer to A-585.

Based on document review, policy review, record review and interview, the hospital failed to provide adequate laboratory services to meet the needs of its patients. The laboratory failed to make provision for proper receipt and reporting of tissue specimens and failed to ensure the transportation, receipt, and labeling of specimens were correct for 2 of 2 (Patient #1 and 2) sampled patients, which resulted in 1 of 2 (Patient #1) patients that suffered harm from a serious surgery which was performed based on incorrect specimen results.

The findings included:

1. Review of the hospital's policy titled, Cytology Slide Preparation, 1084 with a last revised date of 5/25/15 and last reviewed 10/2/2021 revealed, "...all slides are labeled on the frosted end with patient name and accession number using a pencil or xylene resistant marking pen... Lay out coverslips individually on a clean, dry, absorbent surface... Place the glass microscope slide on the warmer to dry... Apply a computer-generated slide label to each coverslipped slide, making sure that the handwritten accession number and name on the slide match the accession number and name on the slide label... All stains and reagents must be properly labeled, dated and stored..."

2. Medical Record Review revealed Patient #1 was admitted to the hospital on 3/5/2022 with diagnoses to include Biliary Acute Pancreatitis without Necrosis (tissue death) or Infection.
Patient #1 was transferred from another outlying facility with a concern for acute pancreatitis. An Endoscopic Retrograde Cholangiopancreatopaghy (ERCP- a diagnostic procedure to diagnose and treat problems in the liver, gallbladder, bile ducts and pancreas) was performed and Patient #1 was subsequently diagnosed with Pancreatic Cancer.

A Non-Gyn Final Pathology Report dated 3/7/2022 revealed, "...Diagnosis COMMON BILE DUCT BRUSHING: ATYPICAL EPITHELIAL CELLS, NOT DIAGNOSTIC OF MALIGNANCY (SEE COMMENT)...Completed by Cytotechnologist 03/09/22...Completed by...MD...05/27/22...COMMENT This is a corrected report issued on 05/27/2022. Due to laboratory technical error, this case was initially inaccurately signed out as adenocarcinoma on 03/09/2022. This case has been reviewed through intradepartmental consultation by four additional pathologists. CYTOLOGIC STUDIES SHOW Atypical epithelial cells present, not diagnostic of malignancy...Specimen source Common Bile Duct Brushing..."

Review of the discharge summary dated 3/8/2022 revealed, "...[Named Patient 31]...presented to hospital as a transfer from an outlying facility with concern for acute pancreatitis. Initially this was felt to possibly represent a gallstone pancreatitis as he had dilated ducts on imaging. However, there was no common bile duct seen...An ERCP was performed...There was no stone seen and no specific mass seen though he did have what appeared to be a common bile duct stricture. This was stented...he has pathology/cytology pending...If this is positive, he will need further evaluation and potential surgical evaluation...Patient preferred to discharge home...Patient aware...of the pending pathology report..."

During an interview on 6/2/2022 beginning at 10:16 AM in the Conference Room, Cytotechnologist (Cyto Tech) #1 revealed he was the Cyto Tech that had picked up the tissue samples for Patient #1. Cyto Tech #1 stated there were approximately 40 specimens that day and they were behind. Cyto Tech #1 stated whatever happens on Friday affects Monday and so on. There was a lot of work. Cyto Tech #1 stated his shift is 8 hours but then he stated he was working 10 to 12 hours each day. Cyto Tech #1 stated his primary job was to screen slides under a microscope and go and assist Proceduralists, Pulmonary Doctors, Gastrointestinal Doctors, and Radiologists to ensure they get adequate samples from the patients. Cyto Tech stated they weren't fully staffed at the time of this incident. He confirmed an additional Laboratory Technician was hired 7 weeks ago. Cyto Tech #1 stated he was unclear how this error occurred. He stated he either put the labels on at the beginning or he got distracted and switched the labels. He stated he was way behind. He stated he hand-labeled the slides. He stated he is usually very careful and it was a mistake. He stated he hand-labeled the slides and put them on the warmer. He stated when he pulled them off the warmer was when it (the error) occurred. He stated he put the label over the written name and once that was done, it was matched to the paperwork, so it wasn't seen. He confirmed he had put Patient #1's label on Patient #2's slide and Patient #2's label on Patient #1's slide. Both patients had the same procedure and their Session numbers were 248 and 249. Patient #1 had an ERCP done on 3/7/2022 and Patient #2 had an ERCP done on 3/8/2022. Once the slides were verified with the stickers and the paperwork, it appeared they were matched when verified. Cyto Tech #1 stated he tries to get specimens to the Pathologist by 10:00 AM so they can get additional work done.

Patient #1 was advised after discharge he was diagnosed with Pancreatic Cancer and would need additional surgery. The surgery was scheduled for 5/12/2022.
Patient #1 was admitted to the hospital on 5/12/2022 with diagnosis of Pancreatic Cancer and was scheduled to undergo a Whipple surgical procedure (A Whipple procedure is a complex operation to remove the head of the pancreas, the first part of the small intestine, the gallbladder and the bile duct.) Patient #1 was prepped and taken into surgery on 5/12/2022. Patient #1 tolerated the procedure well and additional tissue specimens were taken during the surgery to be sent to pathology.

Review of the Surgical Pathology Final Report dated 5/17/2022 revealed, "...DIAGNOSIS A. GALLBLADDER...NEGATIVE FOR MALIGNANCY...B. LYMPH NODE, COMMON HEPATIC ARTERY...TWO LYMPH NODES NEGATIVE FOR MALIGNANCY...C. LYMPH NODE, RIGHT PEROPORTAL...ONE LYMPH NODE NEGATIVE FOR MALIGNANCY...D. PANCREAS, DUODENUM, AND GASTRIC ANTRUM...COMMON BILE DUCT ULCERATION, FIBROSIS...NEGATIVE FOR MALIGNANCY (SEE COMMENT)...26 LYMPH NODES NEGATIVE FOR MALIGNANCY...COMMENT The entire common bile duct was submitted for histologic examination. It shows ulceration and reactive change but no malignancy. This case was reviewed in intradepartmental consultation.

Patient #1 had his gallbladder, multiple lymph nodes, a portion of his pancreas, the common bile duct, a portion of his stomach, and a portion of his small intestine removed during this surgical procedure.

During an interview on 6/2/2022 beginning at 11:50 AM, the Risk Manager was asked how this labeling error was discovered. The Risk Manager stated the Surgeon who performed the Whipple surgery called her around or before 1:00 PM on 5/19/2022. The Surgeon stated to the Risk Manager that (Named Lab Pathologist #1) had contacted him around 11:00 AM that morning and told the Surgeon the biopsies from (Named Patient #1) Whipple (procedure) did not have any cancer cells. The Risk Manager stated that the 2 physicians were deducing at that point that something had been mis-labeled, but they were not sure where the issue was. The Risk Manager stated she asked the Surgeon to let her speak to the Director of the Endoscopy Lab and the Assistant Manager of the Endoscopy Lab. The Risk Manager let them know Patient #1's name and to look at other patients that day. The Risk Manager stated she then called the Chief Physician of Pathology and had been made aware. The Risk Manager stated Lab Pathologist #1 had read the original slide for adenocarcinoma, and another Lab Pathologist (#2) had received the slides from the Whipple procedure and there was no cancer in the bile duct as previously seen on the other slide. The Risk Manager stated Lab Pathologist #1 examined the original slide an turned it over and he could see (Named Patient #2's) name on it and it was the handwritten assession name and number. The Risk Manager stated she called the Surgeon back and explained to him what had happened and let him know it happened in the Pathology Lab.

During an interview on 6/2/2022 beginning at 2:04 PM in Lab Pathologist #1's office in the Anatomic Pathology Lab, Lab Pathologist #1 was asked to explain the steps that led to the mistake and the finding of the mistake. Lab Pathologist #1 stated there were 2 common bile duct brushings. The Lab Pathologist showed this surveyor the actual slides and stated the slides are handwritten with the assession number and patient's name upon arrival to the lab. The fail safe is to have the stickers and the paperwork together with the slide and looking at the sticker and comparing it with the paperwork. In this case there were 2 common bile duct brushings, within a short period of time, and the stickers were placed on the wrong slides. This surveyor turned over the slide and visualized Patient #2's name written under the sticker. It could only be seen when the slide was turned over. Lab Pathologist #1 was asked what long term effects could come from the Whipple procedure. Lab Pathologist #1 stated Patient #1 has a lot of pancreas left, he is not a diabetic. He stated his hopes are he will eat ok and not get diabetes. This procedure may affect his eating. Lab Pathologist was asked about Patient #2's results showing no malignancy. Lab Pathologist #1 stated Patient #2 had other pathology that clearly showed cancer, so his course of treatment was based on that. Our first concern was - is there someone walking around with cancer that doesn't know it, once we found out that wasn't the case, our focus turned to (Named Patient #1).

During an interview on 6/3/2022 beginning at 10:22 AM, Patient #1 was asked how he was feeling and what happened regarding his surgery. Patient #1 stated he was hanging in there but he is having a hard time recovering. Patient #1 stated he was upset about it but (Named Lab Pathologist #1) explained that someone else's sticker was on his report, but he didn't really understand it. Patient #1 stated he had a small blockage in my bile duct and they put a stent in and he stated he was getting better. Patient #1 stated he met with the Surgeon and was told he needed a Whipple surgery. He stated he had a feeling and he asked for another test but they told him when you have pancreatic cancer this procedure has to be done. Patient #1 stated 4 days after the surgery, they came to his room and told me what happened. He stated he was in shock that he had cancer to begin with. He stated, "I guess my body is totally redesigned now..." Patient #1 stated the hospital didn't try to hide anything and they were very upfront. Patient #1 stated Lab Pathologist #1 gave him his personal phone number. Patient #1 stated he and Lab Pathologist #1 talked and he tried to explain things. Patient #1 stated, "...As a patient and that happens, you go to the professionals, you just go with what they say. I trusted them. I didn't know to get a second opinion, but I know now. They have been very good about being honest and upfront..."