The FDA and CDC yesterday announced that the latest romaine lettuce E. coli outbreak was over.  Industry groups crowed that romaine is now safe to eat and they attested to doing more in the future to prevent another outbreak while at the same time discounting the cause of the last one. 

For some these outbreaks are never really over.

Carolyn Graham is a 74-year-old woman residing in Loomis, California with her husband Kenneth. Carolyn was food poisoned after eating contaminated romaine lettuce in a meal she purchased with cash and consumed from a local restaurant in April 2018.

Carolyn began to experience symptoms consistent with E. coli infection on April 14, 2018. An exposure on April 11 is consistent with an incubation period that can averages 3 to 4 days for Shiga toxin-producing E. coli (STEC). A stool specimen collected on April 15, 2018 tested positive for STEC at Kaiser Regional Laboratory in Berkley, California. This specimen was further tested at the California Department of Public Health Laboratory, where it was found to genetically match the Yuma, Arizona romaine outbreak strain (PFGE pattern: EXHX01.0047/ EXHA26.0626).

Given Carolyn’s confirmed infection with STEC O157, her exposure to romaine lettuce within the STEC incubation period, and the genetic evidence connecting her infection to the outbreak, Carolyn was identified as a confirmed case in the Yuma, Arizona romaine E. coli outbreak (Outbreak ID: 1804MLEXH-1) by the California Department of Public Health.

Symptom Onset

Carolyn first noticed that something was amiss with her health when, on April 14, 2018, she began to suffer from severe diarrhea early in the day. By 11:30 PM that night, there was blood in her diarrhea: “… I begin bleeding and the bleeding continued throughout the night.” She did not wait for the night to end before making the decision to seek medical attention. At around 3:30-4 AM, Carolyn called the Kaiser Hospital advice nurse, because she found herself unable to move without feeling blood escape from her rectum. Carolyn was instructed to go immediately to the hospital.

Kaiser Hospital – Roseville, California

It was just past 6 AM on Sunday, April 15, 2018 by the time Carolyn arrived at the Kaiser Hospital located in Roseville, California, where Jessica Holley Derkacs, MD evaluated her in the emergency department. In triage, Carolyn described the onset of lower abdominal pain and diarrhea a little over 24 hours earlier. She noticed her stools looked brownish at first and later turned frankly bloody. She told the nurse that she had tried taking Imodium without relief. Carolyn answered questions about possible exposures, explaining that she had not taken any antibiotics recently, but she had been on Aleve since January for a pinched nerve, taking it a few times a week. She was not on blood thinners and had never had these kinds of symptoms before.

Carolyn was horrified when she experienced an episode of incontinent stool in the bed while she was waiting to see the doctor. The nurse helped Carolyn clean herself up and gave her “pull-ups” to put on, replacing the linens on her bed and providing a clean gown.

On exam, Dr. Derkacs found Carolyn afebrile, but her abdomen was tender in the right upper to mid quadrant, and her bowel sounds were hyperactive. The doctor did identify external hemorrhoids, but these were not bleeding, and she did not identify any anal fissures. Carolyn’s stool was guaiac positive for occult blood. She told the doctor that her last colonoscopy was in 2013, and she was noted to have hemorrhoids and diverticulosis at that time.

Dr. Derkacs started Carolyn on intravenous fluids and sent blood, urine, and stool samples to the lab for analysis. She kept under Carolyn observation in the ER for several hours on IV fluids, as well as clear liquids by mouth. Carolyn required supplemental oxygen to keep her blood oxygen saturation above 92%. She continued to pass “odiferous bloody diarrhea stool (no formed stool at all)” while in the ER.

When Carolyn’s lab results began filtering in, they were significant for an elevated white blood cell count of 17.2; however, she was not anemic (hemoglobin 12.4, hematocrit 38.0) and her renal function was normal (BUN and creatinine 18 and 0.76).[1] Her stool was negative for toxigenic C. difficile. Dr. Derkacs discussed Carolyn’s case with the on-call gastroenterologist, who suspected she had infectious colitis and advised culturing her stool. He recommended avoiding antibiotics until the culture results were back. He saw no indication for colonoscopy at that time.

Dr. Derkacs initially planned to let Carolyn go home after a period of observation; however, when she passed another stool that consisted mostly of bright red, nonclotting blood, she called the hospitalist service to admit her.

Admitted for rectal bleeding – Hospital Day 0

It was just past noon on April 15, 2018 when Pamela Mercado, DO formally admitted Carolyn to the observation unit for a principal diagnosis of “rectal bleeding.” She was kept under contact isolation out of concern for an infectious process. Dr. Mercado planned to trend Carolyn’s blood counts and discharge her from the hospital later that day if her hemoglobin remained stable. If Carolyn exhibited worsening bleeding, Dr. Mercado wanted to bring gastroenterology in for consultation and possible endoscopy.

Later that afternoon, Carolyn was admitted to the medical/surgical unit when her bloody diarrhea increased in frequency to every 20-30 minutes, and her abdominal cramping worsened. In addition, her white count was increased to 20K. Dr. Mercado requested a CT scan.

CT Imaging consistent with pancolitis

Radiologist James Smith, MD took Carolyn for a contrast-enhanced CT of her abdomen and pelvis at 4 PM, during which he observed diffuse wall thickening throughout the entire length of her colon, which appeared edematous. Dr. Smith identified scattered diverticuli without diverticulitis. Her small bowel appeared to be unaffected. He diagnosed Carolyn with inflammatory versus infectious colitis, but he did not think this looked like mesenteric ischemia. He saw no free fluid or gas to suggest perforation.

Initiation of IV antibiotics (Rocephin and Flagyl)

At 6:31 PM, Nidhi Shukla, MD was the hospitalist overseeing Carolyn’s care and received the results of the CT scan. She discussed the CT differential diagnoses of inflammatory vs. infectious colitis with the on-call gastroenterologist, who recommended starting antibiotics if Carolyn spiked a fever or had worsening pain. When the nursing staff alerted her at 7:26 PM of an increase in Carolyn’s abdominal pain, Dr. Shukla conferred with infectious disease, who advised that Carolyn be started on IV ceftriaxone and metronidazole (Rocephin 1 gram IV daily, Flagyl 500 mg IV three times daily). Dr. Shukla implemented the antibiotic infusion and gave Carolyn oral narcotics (Norco) for pain.

Hospital Day 1

On Monday, April 16, 2018 at 4:39 PM, hospitalist Shanin Zanganeh, MD came in to see Carolyn in the afternoon and observed that there had been no change in her symptoms. Her white count was higher at 25.7K, but she was not running a fever. She had little urinary output, but she was losing a great deal of fluid through her diarrhea. Dr. Zanganeh consulted with gastroenterology, who planned to consult in the morning and assess the need for endoscopy.

Hospital Day 2 – GI consultation – IV antibiotics changed to azithromycin

At 11:32 AM on April 17, 2018, gastroenterologist Christopher Romberg, MD came in for a consultation. He assigned Carolyn the diagnosis of acute colitis, “most likely community acquired.” He called the bacteriology lab (“bacti”) and was told the GI Pathogen PCR results should be ready later that afternoon. Dr. Romberg stopped Carolyn’s ceftriaxone and metronidazole and changed her to IV azithromycin. He planned to perform a sigmoidoscopy later that day if she had not improved. He called “bacti” again later in the day and the stool results were still not available. He deferred the sigmoidoscopy but continued the IV azithromycin.

Hospital Day 3 – Altered mental status, anemia, anuria, thrombocytopenia

On April 18, 2018, the nursing staff alerted the hospitalist service at 11:17 AM, when Carolyn became hypotensive and tachycardic. Her blood pressure was 92/42 and she was noted to have only 1 mL of urine output in the prior 24 hours. Her white cell count increased to 28, and she was anemic with a hemoglobin of 10.6 and hematocrit 32.3%. Her platelet count fell to 112K. Carolyn was feeling so weak, she had to ask her husband to move her covers when she felt cold. She was able to move all her extremities but exhibited weak grip strength. She was noted to be confused, “… as she was asking her husband to remove the bathroom door.” Carolyn also reported visual disturbances with “narrow” vision. The nursing staff alerted the rapid response team (RRT) so they would be aware of Carolyn’s potentially unstable status.

Hospitalist Dr. Driscoll thought Carolyn’s leukocytosis fit with C. difficile, but her stool sample tested negative.

Flexible sigmoidoscopy

Dr. Romberg went forward with a flexible sigmoidoscopy that afternoon, citing Carolyn’s failure to respond to the IV antibiotics. During the exam, he observed patchy colitis from the rectum “… to the extent examined.” These areas exhibited patchy submucosal hemorrhages but no visible ulcerations. Dr. Romberg did not think Carolyn had inflammatory bowel disease; he thought the visual appearance of her colon was most consistent with moderate ischemic colitis. He suggested a viral etiology and continued her IV azithromycin. Because Carolyn’s abdomen was extremely tender to examination, he recommended a surgical consultation if her she began to exhibit peritoneal signs.

Confirmation of E. coli O157 DNA by PCR, Shiga toxin 2 positive

Just before 4 PM, the hospital laboratory called a critical value to the floor, reporting that Carolyn’s stool had tested positive for E. coli O157 DNA by PCR testing, as well as positive for Shiga toxin 2 gene. The lab report carried a cautionary warning:

Patients with E. coli O157:H7 infection are at risk of developing hemolytic-uremic syndrome (HUS). Antibiotic treatment and/ or loperamide in the setting of shiga toxin positivity is contraindicated in most cases. E. coli O157:H7 is a reportable disease.

Hospital Day 4 – continued anuria, leukocytosis, thrombocytopenia, acute renal failure

On April 19, 2018, Carolyn’s morning labs had worsened significantly, with a white blood cell count up to 32.5K, and a hemoglobin and hematocrit down to 10.9 and 33.5. Her platelets were down to of 111K. Her urinalysis was significant for moderate hemoglobin, proteinuria, and leukocyte esterase. Carolyn’s renal function was also markedly abnormal, with a BUN and creatinine of 50 and 4.53. In addition, her LDH was elevated at 1548. Carolyn had produced no urine overnight, and nephrology was asked to consult. A Foley catheter was inserted to more accurately measure her output.

Nephrology consultation – possible HUS, altered mental status

At 11 AM,  Tuan Anh Nguyen, MD came in for nephrology at the request of Dr. Driscoll. He reviewed the onset and progression of Carolyn’s diarrhea illness, including her serial lab results and imaging. He noted the negative stool test for toxigenic C. difficile, but positive PCR testing for E. coli O157 and Shiga toxin 2. He observed the WBC spikes, thrombocytopenia, elevated LDH, and abnormal renal function. He saw that Carolyn had been anuric for two days and exhibited signs of fluid overload. She had puffy hands, and her husband reported she was having hallucinations and exhibiting mild delirium. On the plus side, her diarrhea was improving.

Dr. Nguyen assessed Carolyn with “acute kidney injury secondary to ‘multifactorial,’” possibly from acute tubular necrosis (ATN) related to colitis, “… in the setting of lisinopril and contrast-induced injury vs. HUS due to E. coli.” He did not think Carolyn needed hemodialysis at this point, but he discussed with her husband and family that they would need to monitor her closely and he could not rule that out. He wanted to get a hematology consultation for HUS and an assessment of whether apheresis[2] would be recommended. “If apheresis is recommended, she will need an apheresis catheter by IR, and nephrology would be the one to coordinate and perform apheresis.” Particularly in light of Carolyn’s altered mental status, Dr. Nguyen advised avoiding morphine given her acute kidney injury, “due to buildup of metabolites.” He also wanted to avoid the use of nephrotoxins, such as IV contrast, aminoglycoside antibiotics, Fleets enemas, and NSAIDs, and requested that her care team renally adjust all medications for her current eGFR. He requested the insertion of a Foley catheter so Carolyn’s fluid intake and output could be carefully monitored.

Hospital Day 5 – negative head CT

Shortly after midnight on April 20, 2018, the nursing staff placed an urgent call to the rapid response team (RRT) when Carolyn was found moaning loudly, exhibiting increasing confusion, expressive aphasia, and the inability to respond about where she was hurting. Dr. Driscoll responded as well and ordered brain imaging, Tylenol IV, and Dilaudid for pain. Nakiye Yegul, MD performed an urgent head CT urgently, no evidence of an acute intracranial process.

Hematology consultation – diagnosis HUS – CNS involvement

Dinesh Kotak, MD came in for a hematology consultation later than morning and reviewed Carolyn’s clinical presentation, including her abnormal lab results so far. He noted that she had exhibited gradually worsening CNS symptoms over the prior couple of days. “These started with hallucinations; patient has had periods where she is lucid and remembers her family.” Dr. Kotak reviewed a peripheral blood smear that showed 3-4 schistocytes per high power field, with normal appearing platelets but occasionally nucleated red blood cells. Her thrombocytopenia had worsened slightly, with a current platelet count of 91K. Dr. Kotak explained to the family that Carolyn now met the criteria for a diagnosis of hemolytic uremic syndrome (HUS), and the primary treatment for that condition was supportive care only. However, given the severity of Carolyn’s CNS symptoms, Dr. Kotak consulted with a regional expert (“Dr. Bradley”) about her case, who recommended treating Carolyn with one dose of eculizumab[3] (Soliris). Dr. Kotak discussed the need for pre-medication with vaccination, as well as antibiotic coverage for meningococcus per infectious disease.[4] Dr. Kotak deferred to infectious disease for how to treat that.

Nephrologist Dr. Nguyen conferred with Dr. Kotak after his consultation regarding apheresis therapy, and Dr. Kotak advised against it. He cited his discussion with the regional expert and medical literature review, who had recommended the single dose of Soliris based on limited case studies with patients who had exhibited a rapid CNS decline. They would have to request the drug from another medical center and planned to do one hemodialysis treatment before giving Carolyn the Soliris, “… so that the drug is not cleared off.” He advised discontinuing Carolyn’s bicarbonate drip, and Dr. Nguyen did so. After conferring with Dr. Kotak, Dr. Nguyen discussed with Carolyn’s husband and daughter the indication to proceed with renal replacement therapy (hemodialysis versus other methods), which he hoped would be a temporary measure.

Hemodialysis No. 1

At 2 PM, Benedict Hsu, MD performed the insertion of a dual lumen 19 cm right internal jugular tunneled dialysis catheter under fluoroscopic guidance. Both lumens were functioning normally at the conclusion of the procedure. The catheter was then flushed with heparin as recommended by the manufacturer, secured in place, and a sterile dressing was applied. Carolyn tolerated the procedure without difficulty or immediate complications. Dr. Nguyen put a request in to Davita to implement the inpatient hemodialysis procedure. Gary Miller, RN started Carolyn’s hemodialysis at 7:26 PM, ending at 10:26 PM, with a net fluid removal of 1900 mL

Only later, Carolyn talked with her family to piece together what was happening to her during this period of time:

A dialysis port was inserted and my first dialysis started that evening. I had a CT Head/Brain scan to make sure I hadn’t had a stroke. I started a new, rare and expensive, cancer medication to block the E coli. Kaiser Hospital had to find medication. I had no urine output. I did not recognize my family.

Hospital Day 6 – Soliris administered – continued altered mental status

At 1:30 AM on April 21, 2018, Carolyn received a second peripheral IV line to accommodate the administration of eculizumab, which was administered at 1:50 AM. She tolerated the medication without complications. Hospitalist Lifang Zhang, MD implemented a renal dose (500 mg) of intravenous azithromycin for coverage of meningococcus at 2:40 AM. She had originally intended to use oral Penicillin VK, but Carolyn was too sleepy and so she chose the IV azithromycin instead. When she was more alert, Dr. Zhang wrote orders to go back to giving her Pen VK orally twice a day.

Carolyn continued to exhibit a great deal of confusion that morning, so much so that the rapid response team was again called when she began moaning loudly around 5 AM. Dr. Zhang responded to the call as well and ordered the administration of IV Tylenol, as she did not want to give Carolyn and more Dilaudid because of her altered state of consciousness.

Lisa Law, MD came in for hematology around 10 AM and saw Carolyn along with hospitalist Dr. Driscoll. Her husband and granddaughter were at the bedside, and the doctors discussed how Carolyn was doing. Her morning labs showed a slight decrease in her white count to 29.0, with significant hemolytic anemia (hemoglobin 8.2, hematocrit 24.8) and thrombocytopenia (platelets 80K), and abnormal renal function (creatinine 4.46). She did not have a fever and her blood pressure was stable, although she was tachycardic with a pulse of 105. According to her husband and the nursing staff, Carolyn’s mental status was improved, and she was able to answer questions appropriately that morning. She stated her diarrhea had decreased, as had her abdominal pain. Dr. Law did not think her anemia warranted a blood transfusion at that point and they could follow her blood counts for now, as well as a daily LDH.[5] If Carolyn showed no clinical improvement over the next few days, she wanted her to have another dose of eculizumab in one week after the first dose.

Hospital Day 7 – Hemodialysis No. 2 – anuric, continued hemolysis

On April 22, 2018, Dr. Law returned to see Carolyn, finding her mental status worse than it was the day before. Her husband stated that she was not talking and appeared to be more confused, although her eyes were open and she was moving her arms and legs. Her LDH had increased slightly to 1520, her anemia was worse (hemoglobin 8.5, hematocrit 26.3), although her platelets were stable (82K). Her serum creatinine was higher at 6.26. Carolyn had not produced any urine whatsoever in the prior 24 hours. Dr. Nguyen came in for nephrology and made the same observations as Dr. Law, and initiated Carolyn’s second hemodialysis treatment at 12:30 PM. She also received a dose of EPO[6] to stimulate red blood cell production. Carolyn’s doctors continued her diagnoses of “colitis,” “severe sepsis,” and “hemolytic uremic syndrome.” Dr. Driscoll noted that she was much calmer later that afternoon, but she was not in peaceful sleep, “startling” whenever anyone touched her.

Hospital Day 8 – Hemodialysis No. 3 – continued encephalopathy

The following morning, Jignesh Kantibhai Patel, MD was in for nephrology and noted that Carolyn was still anuric with “negligible” urine production. Her mental status remained altered and she was still non-verbal, although her husband thought she was more alert. Dr. Patel looked at her morning labs and observed improvement in her renal function, with a BUN and creatinine of 41 and 4.91, so he did not think her poor mental status was consistent with “uremic confusion.” She was still very anemic but not at a level that required a blood transfusion. Carolyn underwent her third hemodialysis treatment beginning at 2:41 PM, along with another dose of EPO.

Carolyn later recalled what a difficult time this was for her:

It was a rough night. I started a new pain medication that I received every 3 hours. I was still unconscious and I couldn’t seem to move anything, except for my arms, which caused me to scream in pain.

Hospital Day 9 – still anuric, but no hemodialysis today

On April 24, 2018, Dr. Kotak came in for hematology and was happy to see Carolyn speaking with her husband and responding appropriately to questions, albeit in monosyllables. Her granddaughter was at her bedside when the doctors came to see her, and she told them that she had noticed her grandma had difficulty speaking about three days earlier.

Carolyn’s morning labs exhibited slight improvement in her renal function (BUN 34, creatinine 4.27), but she was still not producing any urine; however, Dr. Patel did not think she needed hemodialysis that day.

Hospital Day 10 – Hemodialysis No. 4

On April 25, 2018, hospitalist Irina Badalyan visited Carolyn in the morning. She still carried the diagnosis of severe sepsis with “acute organ dysfunction,” accompanied by leukocytosis with a white count of 21.8; she remained afebrile and was hemodynamically stable, however. Infectious disease specialist Dr. Fontanilla weighed in on her care plan and recommended that she be given meningococcal prophylaxis as long as she still required monoclonal antibody treatment (eculizumab). When she discovered that Carolyn had been given only a Meningococcal B vaccine on the 24th and not the Meningococcal A, C, Y, W vaccine (“apparently there is a shortage”), she recommended they get the vaccine from an outside pharmacy and give it immediately. Dr. Fontanilla approved the use of oral amoxicillin for antibiotic prophylaxis at this point. Carolyn’s blood count had dipped almost down to transfusion levels, with a hemoglobin of 7.2 and hematocrit 21.9, and the plan was to transfuse her with packed red blood cells (PRBCs) if her hemoglobin went below 7.0.

Carolyn’s renal function panel continued to exhibit markedly abnormal values on the 25th, with a BUN and creatinine of 31 and 4.58, and she was still anuric. She underwent her fourth hemodialysis treatment, along with another dose of EPO. Carolyn also received the appropriate meningococcal vaccine that afternoon.

Carolyn recalls:

Today was my fourth day of dialysis. I started to remember some things, and I am trying to talk, but I have difficulty forming words. I worked with the speech therapist. I received a phone call from Lynnette at Placer County Health Department and she spoke with my husband, explaining that that the E. coli strain I had contracted had been traced to a restaurant in Rocklin, California that served Yuma romaine lettuce.

Hospital Day 11 – transfusion PRBCs

On April 26, 2018, Carolyn was noted to have an increase in her rectal bleeding. Her anemia worsened to a hemoglobin of 6.9, and she required a transfusion of PRBCs. Dr. Patel visited her during rounds that morning with her sister and daughter at the bedside. Carolyn was more alert and talkative. Dr. Patel noted that she was tolerating hemodialysis with ultrafiltration.[7] He discussed her minimal urine output and the likelihood of plans for outpatient hemodialysis. Dr. Patel also spoke with Carolyn’s husband in the hallway and explained that, as part of discharge planning, they needed to start looking for an outpatient dialysis spot. He was hoping she might be ready to go outpatient dialysis as early as the following week. Meanwhile, her next dialysis was planned for the 27th.

Hospital Day 12 – Hemodialysis No. 5 – continued anuria

On April 27, 2018, Carolyn’s blood count was improved, reflecting the blood transfusion the day before, with a hemoglobin and hematocrit of 8.3 and 25.4, and her white count had also improved at 17.9. Her platelets were in normal range. Her BUN and creatinine remained markedly abnormal at 42 and 5.80.

Carolyn was more alert and began working with physical therapy to get her ambulatory and increase her stamina, in anticipation of a safe transition to either her home or a skilled nursing facility. Per Dr. Fontanilla, Carolyn was also going to be on antibiotic prophylaxis against meningococcus for a total of three months of amoxicillin treatment. She underwent her fifth hemodialysis that evening, and nephrologist was working on arranging outpatient hemodialysis, as she was still anuric.

Carolyn recalls coming out of the fog of her altered mental status:

After being admitted to my hospital room, I don’t have any recall of the events that took place while in the hospital until April 26 or 27.

Hospital Day 13-14 – Hemodialysis No. 6 – discharged to SNF

On April 28, 2018, Dr. Patel came in for nephrology and noted that Carolyn was alert and conversant. She was beginning to make a little urine, so he approved the removal of her Foley catheter. He had arranged outpatient dialysis for her (“FMC Secret Ravine”), and so he hoped to discharge her the following day after her treatment.

Carolyn’s morning labs on the 29th showed improvement of her anemia and her white count was coming down towards normal range; however, her renal function remained markedly abnormal (BUN 37, creatinine 5.38). She underwent her sixth hemodialysis treatment that morning. Afterwards, Irina Badalyan, MD discharged Carolyn from the hospital, transferring her to the care of a skilled nursing facility. The nursing facility was instructed to continue her antibiotic therapy with oral amoxicillin and three times weekly hemodialysis.

Kindred Siena Skilled Nursing & Rehabilitation – Generations Healthcare

On April 29, 2018, Sreehar Javagal, MD admitted Carolyn to Siena Skilled Nursing and Rehabilitation, where she was slated to receive both occupational and physical therapy, as well as continued hemodialysis. Carolyn remained at Siena until May 11, 2018. Her first dialysis treatment after her arrival at Siena (Hemodialysis No. 7) was administered at the Davita Auburn Dialysis Clinic on Wednesday, May 2, 2018, and she returned there for repeat HD once more that week on Friday, and again on Monday and Wednesday the following week (Hemodialysis Nos. 8, 9 and 10).

On Friday, May 11, 2018, Dr. Javagal reviewed Carolyn’s progress over the prior ten days. She had progress in PT to where she was ambulating over 200 feet with minimal assistance. Despite receiving dialysis treatments three times a week, her serum creatinine had not fallen below 5.0. Her anemia was stable above 7.0 g/dL, but that was just above transfusion threshold and Dr. Javagal thought she would need to continue on EPO with her dialysis. Her platelets were stable in normal range. Carolyn had not exhibited any confusion or other signs of altered mental status during her stay, and Dr. Javagal thought she was ready to go home. She had another dialysis treatment at Davita that day and was discharged from the skilled nursing facility later that afternoon.

Carolyn recalls her stay at the SNF:

I spent 12 days at Sienna Skilled Nursing facility in Auburn, CA. I worked with occupational and physical therapists for a couple of hours every day to learn how to use a walker, dress myself, get in and out of bed, use the bathroom with help, at first, and then, without help near the end of my stay. They also worked on trying to get my mental facilities back. At that time, I was having a hard time figuring out how to use my cell phone, the controls on the bed, and adding and subtracting numbers. I had dialysis three times a week, at Davita Dialysis Center, Auburn, CA while I stayed at the skilled nursing facility.

Fairwood Medical Clinic – Secret Ravine Dialysis Clinic

On Monday, May 14, 2018, Carolyn presented to FMC Secret Ravine outpatient dialysis clinic to resume hemodialysis.

Over the next few weeks, Carolyn continued with regular outpatient hemodialysis, EPO therapy, and serial lab tests to watch her renal function.

Carolyn recalls resuming dialysis in Roseville:

I started dialysis at Secret Ravine Parkway, Roseville, CA- 3 times a week for 3 hours of treatment. Blood tests were done every Monday. They also gave me protein shots and iron supplements to help build up my hemoglobin, which was very low. My labs slowing started improving every week.

Kaiser Riverside Outpatient Clinic – recurrent diarrhea

On May 17, 2018, Carolyn presented to Kaiser Riverside Clinic, where Cindy Loh, MD evaluated her in follow-up of her hospitalization for STEC HUS. Carolyn was still on three days of hemodialysis every week. Since she left the Kaiser SNF, Carolyn reported that she had experienced recurrent diarrhea. It did not contain blood, but she had abdominal cramping and fecal urgency when it occurred. She did not have any fevers, chills, nausea or vomiting. She was taking Lasix for lower extremity swelling and wondered if it was causing her diarrhea. Dr. Loh did not think that the Lasix was the cause and wanted Carolyn to start taking probiotics.

Carolyn told Dr. Loh that she was still taking the amoxicillin prescribed when she was discharged from the hospital. Dr. Loh reviewed her labs and saw that Carolyn still exhibited abnormal renal function, with a serum creatinine of 4.5 the day before this visit. She sent blood work to the lab, as well as a urinalysis with culture if indicated.

Fairwood Medical Clinic – Secret Ravine – continued HD

On June 12, 2018, Christopher McConnell, RN, the Kaiser Renal Care Coordinator, documented a phone call with Dr. Yuan discussing Carolyn’s dialysis clinic lab work and progress. Dr. Yuan was satisfied that Carolyn was showing signs of renal recovery and probably no longer required hemodialysis. He wrote orders for her to return to the FMC Secret Ravine Clinic on Saturday, June 16, 2018 for HD catheter care and another blood draw to check her renal function and complete blood count, and he would base his final HD orders on those results.

Kaiser General Surgery – HD catheter removal

On June 24, 2018, Carolyn presented to Kaiser General Surgery outpatient clinic for removal of her hemodialysis catheter. Matthew Kurowski, PA-C performed the procedure under local anesthesia in the clinic, under the supervision of Joshua Kehoe, MD. There were no complications of the procedure. Carolyn’s blood was drawn that day, and the Kaiser lab returned results showing an improvement in her serum creatinine to 1.89, and she was no longer anemic, with a hemoglobin and hematocrit of 11.4 and 37.5.

Kaiser Roseville Nephrology Clinic

On July 10, 2018, Carolyn presented to Kaiser’s outpatient nephrology clinic in Roseville, where Tuan Anh Nguyen, MD saw her in follow-up of her STEC HUS acute renal failure status post dialysis. Dr. Nguyen reviewed the onset and progression of Carolyn’s diarrhea illness, which had been diagnosed as Shiga toxin related E. coli O157 HUS, complicated by acute renal failure that required renal replacement therapy until June. He noted that she had received one dose of Soliris in the hospital and was still taking amoxicillin for meningococcal prophylaxis. Carolyn reported that she was feeling much better and was even playing golf. Her appetite was back to normal. She was having some ankle swelling, but she had no shortness of breath, cough, or other pulmonary symptoms. She no longer had diarrhea or loose stools.

Dr. Nguyen diagnosed Carolyn with “AKI due to HUS, was on HD, now off, still improving.” He advised her to avoid NSAIDs, herbal supplements and other nephrotoxins. He wanted to repeat her renal function labs in a month, then every two months.

On August 5, 2018, Carolyn had her blood drawn, which returned lab results showing a serum creatinine of 1.71, eGFR 29, parathyroid hormone 85 (RR 10-65 pg/mL), and hemoglobin and hematocrit of 13.1 and 40.8. A recheck on October 4th showed further improvement in her renal function to a BUN and creatinine of 22 and 1.22, the latter of which was still slightly elevated.

Dr. Nguyen telephoned Carolyn on October 31, 2018 to discuss her lab results, explaining that her renal function panel placed her in the category of CKD-3. [8] He reassured her that she was gradually improving and he expected that to continue. He advised her to avoid medications such as NSAIDs, herbal supplements, aminoglycoside antibiotics, and any other medications or substances that were nephrotoxic. He also advised her to stay well hydrated. She had improved sufficiently to where he did not think she needed lab testing as frequently, and they could go to every six months for retesting.

Aftermath

Carolyn reflects on her recovery from her E. coli HUS infection:

In conclusion, I am grateful that my kidneys are functioning better, and that I no longer have to be on dialysis. I know I still have a ways to go, as I continue to have problems with my memory, with confusion, and some difficulty with walking up and down the stairs/steps. I will forever be grateful to my family for their love and support throughout this terrible ordeal. They were at the hospital day and night, working with the nurses and doctors. I am positive that without my family’s care and participation in my recovery, my ordeal and continuing recovery would have been more difficult and the results more dire.

The Future

Providing a prognosis for a patient’s renal outcome who has suffered HUS due to E. coli O157:H7 is often imprecise, but Carolyn’s 4-week history of anuria and 2 months of dialysis dependence suggest she is likely to undergo progressive chronic kidney disease. Her 5-month follow-up with an eGFR of 51 ml/min/1.73m2 with proteinuria make it highly likely she will require kidney replacement therapy in the next 8-13 years. The duration of her initial kidney failure and associated significant renal impairment (eGFR 51 ml/ min/1.73 m with proteinuria) following recovery suggests she will likely require renal replacement therapy and in view of her age it will be some form of dialysis since her age will preclude transplantation.

Carolyn’s proteinuria and renal impairment make it highly likely that she will undergo rapid renal decline (losing 3-5ml/ min/year ). Over the next 5-8 years she will develop symptoms of fatigue and will require erythropoietin therapy and judicious use of phosphate binders and dietary salt restriction plus or minus antihypertensive therapy. Her quality of life will be gradually reduced as her CKD advances and if she requires hemodialysis her quality of life will be about 50% of normal and her life expectancy will be shortened due to her underlying CKD. The only other concern is her prior CNS involvement due to HUS means she requires sensitive psychometric testing re cognitive dysfunction which can potentially have a significant impact on her quality of life.

__________________

[1]           Reference ranges for this lab: WBC 3.7-11.1K, hemoglobin 11.5-15.0 g/dL, hematocrit 34.0-46.0%, BUN 7-27 mg/dL, creatinine <1.11 mg/dL, LDH <270 U/L

[2]           Plasmapheresis is performed by two fundamentally different techniques: centrifugation or filtration. With centrifugation apheresis, whole blood is spun so that the four major blood components are separated out into layers by their different densities. With filtration plasmapheresis, whole blood passes through a filter to separate the plasma components from the larger cellular components of red blood cells, white blood cells, and platelets. Nguyen, Trung C et al. “The role of plasmapheresis in critical illness” Critical care clinics vol. 28,3 (2012): 453-68, vii.

[3]           Severe complications due to Shigatoxin-associated hemolytic uremic syndrome (STEC-HUS) currently present a serious challenge since no specific treatment for this condition is available. Eculizumab, a terminal complement inhibitor, has been used especially in STEC-HUS patients with severe neurological involvement, but the efficacy remains undetermined. Keenswijk, Werner, et al. “Is Eculizumab Efficacious in Shigatoxin-Associated Hemolytic Uremic Syndrome? A Narrative Review of Current Evidence.” European Journal of Pediatrics, vol. 177, no. 3, 2017, pp. 311–318., doi:10.1007/s00431-017-3077-7.

[4]           Eculizumab recipients are at 1,000 to 2000 times greater risk for getting meningococcal disease compared to otherwise healthy individuals in the United States. https://www.cdc.gov/meningococcal/clinical/eculizumab.html

[5]           In HUS, lactate dehydrogenase (LDH) level is commonly elevated. Serial measurements of LDH help track the approximate level of hemolytic activity. Gillespie, Robert, MD. “Pediatric Hemolytic Uremic Syndrome Workup.” Pediatric Hemolytic Uremic Syndrome Workup: Laboratory Studies, Imaging Studies, Other Tests. Medscape, 13 June 2016. Web. 31 Jan. 2017.

[6]           Erythropoietin (also known as EPO) is a growth factor that stimulates the production of red blood cells. Most of the cells in the blood are red blood cells, whose main function is to carry oxygen throughout the body. https://www.themmrf.org/multiple-myeloma-knowledge-center/myeloma-treatments-guide/growth-factors/erythropeietin/

[7]           Ultrafiltration refers to filtration of a colloidal substance in which the dispersed particles, but not the liquid, are held back. During hemodialysis treatments, water and sodium are not ordinarily removed by diffusion but rather through the process of ultrafiltration. Venes, Donald. Taber’s Cyclopedic Medical Dictionary (Taber’s Cyclopedic Medical Dictionary (Thumb Index Version)) (Page 2407). F.A. Davis Company. Kindle Edition.

[8]           A person with stage 3 chronic kidney disease (CKD) has moderate kidney damage. This stage is broken up into two: a decrease in glomerular filtration rate (GFR) for Stage 3A is 45-59 mL/min and a decrease in GFR for Stage 3B is 30-44 mL/min. As kidney function declines waste products can build up in the blood causing a condition known as “uremia.” In stage 3 a person is more likely to develop complications of kidney disease such as high blood pressure, anemia (a shortage of red blood cells) and/or early bone disease. Reference: https://www.davita.com/kidney-disease/overview/stages-of-kidney-disease/stage-3-of-chronic-kidney-disease/e/4749

The Yolo County District Attorney’s Office reached a settlement with Xin Jiang, the owner of “Anna’s Kitchen,” a popular Chinese food delivery business that operated through WeChat and primarily marketed itself to Chinese foreign exchange students at UC Davis in a civil enforcement action. The Yolo County Environmental Health Division began investigating Mr. Jiang after receiving multiple complaints from UC Davis students who reported becoming ill after ordering and consuming food prepared and delivered by Anna’s Kitchen. The investigation revealed that Mr. Jiang did not have a permit to operate a food facility in Yolo County, and had repeatedly delivered hundreds of meals that had not been kept properly hot or cold for extended periods of time, increasing the likelihood of food-borne illness.

The settlement was approved by Yolo County Superior Court Judge Peter M. Williams on December 18, 2019. Mr. Jiang admitted wrongdoing and is no longer operating Anna’s Kitchen. Mr. Jiang will pay $106,997 in costs and penalties, and will forfeit an additional $90,000 in penalties if he is discovered operating Anna’s Kitchen or offering any type of food for retail purchase without a valid permit going forward. Anyone with an outstanding “VIP Card” balance may obtain a cash refund or restaurant credit at Hunan Bar & Restaurant, located at 207 D Street in Davis.

Yolo County District Attorney Jeff Reisig stated, “Consumers who purchase food have the right to expect that their meals are being prepared, handled, and delivered safely and correctly by businesses. We thank the Yolo County Environmental Health Division for bringing these student complaints to our attention, and for thoroughly investigating this matter with assistance from our District Attorney Investigators and UC Davis Environmental Health and Safety staff. We remain dedicated to prosecuting individuals and businesses who knowingly jeopardize public health and safety for their own personal profit.”

This fellowship was created in Dave’s honor after his sudden passing in 2017. It is a special opportunity for a young food scientist to work closely with Stop Foodborne Illness and learn from members who have experienced the consequences of failures in food safety firsthand. The Dave Theno Food Safety Fellowship is a partnership between Stop Foodborne Illness and Michigan State University Online Food Safety Program. The Fellow will work full-time for Stop Foodborne Illness and complete a 12-credit Online Food Safety Certificate with Michigan State University.

Salary for the Fellowship is $25,000. Start Date: August 24, 2020 | End Date: August 13, 2021

This is what I wrote about Dave before his untimely death:

In 2013, I wrote a piece on my blog about “Why I Love my Job.”  Its ironic how much of my job and my life over they last 25 years has been intertwined with Dave Theno.  I will miss the occasions we shared a good meal – Dave with a rare steak and mine well-done – with always a very good bottle of wine.  We will all miss his humanity and leadership.

Here is the piece I wrote:

A few months ago I was asked to write something by WSBA about my practice and life as a lawyer.  The ask was something like this:

Mr. Marler, I noted that you are a (“the” – I must admit I added that) preeminent litigator in food poisoning cases in our state (well, actually the “world” – I must admit I added that too). Our members would love an article from you describing a significant case or client that resonated with you, or a description of what it is like to practice in your area of law.

I thought a lot about the ask and my 20 plus years of practice, and the fact that I may well be at the downslope of a job that I truly love.  In a not so often-quite moment, I thought about the beginning of what became both my passion and my job.  Honestly, it has had very little to do with being a lawyer.

I had just turned 35-years-old and was only five years out of Law School, I was a young lawyer in a job that seemed quite dead-end, and then my world changed.

Lauren Beth Rudolph died on December 28, 1992 in her mother’s arms due to complications of an E. coli O157:H7 infection – Hemolytic Uremic Syndrome – also know as acute kidney failure.  She was only 6 years, 10 months, and 10 days old when she died. The autopsy described her perforated bowel as being the consistency of “jelly.”  Her death, the deaths of three other children, and the sicknesses of 600 others, were eventually linked to E. coli O157:H7 tainted hamburger produced by Von’s and served undercooked at Jack in the Box restaurants on the West Coast during late 1992 and January 1993.  I pushed myself to the front of the pack of lawyers.  Roni Rudolph, Lauren’s mom, I have known for nearly 20 years.

Dave Theno became head of Jack in the Box’s food safety shortly after the 1992-1993 outbreak. I too have known Dave for 20 years, mostly because I spent several days deposing (he would say – grilling/torturing) him over the course of the multi-year, multi-state litigation.  However, a decade after spending such quality time (for me anyway) with him, I only recently learned a significant fact about Dave – one that made me admire him even more – one that I think, that all leaders in corporate food safety, or any position of authority, should emulate.

Last year Dave and I shared the stage at the Nation Meat Association (NMA) annual “Meating” in Tampa as an odd pair of keynote speakers. The NMA is an association representing meat processors, suppliers, and exporters.  Dave, spoke just before I did and was rightly lauded as someone who takes food safety to heart.  However, it was his story about Lauren Rudolph and his relationship with Roni that struck me in a physical way.

Dave told the quiet audience about Lauren’s death. He too knew the same autopsy report.  Dave told the audience that the death of Lauren and his friendship with Roni had changed him also in a physical way. He told us all that he had carried a picture of Lauren in his briefcase everyday since he had taken the job at Jack in the Box. He told us that every time he needed to make a food safety decision – who to pick as a supplier, what certain specifications should be – he took out Lauren’s picture and asked, “What would Lauren want me to do?”

I thought how powerful that image was. The thought of a senior executive of any corporation holding the picture of a dead child seeking guidance to avoid the next possible illness or death is stunning, but completely appropriate.

I hugged Dave and we promised to get together again – sometime, someday.

Shortly after leaving Tampa, I spent time with a family in South Carolina whose 4 year old ate cookie dough tainted with E. coli O157:H7 and suffered months of hospitalizations, weeks of dialysis and seizures. She faces a lifetime of complications despite oversight by the Food and Drug Administration of the food she consumed.

After leaving South Carolina I headed to Cleveland, Ohio where I sat across the kitchen table with a family who lost their only daughter, Abby, because she died from an E. coli O157:H7 infection from meat inspected by the United States Department of Agriculture Food Safety Inspection Services.

Neither head of either agency, nor the president of either corporation, whose product took the life of one and nearly the life of the other, ever visited either family, and, that is a shame.

In 20 years of litigation, in 20 years of spending time with Lauren’s or Abby’s family, I am changed.  I see the world far differently than most do now.

If I had any advice to offer to corporate or governmental leaders – run your departments like Dave ran food safety at Jack in the Box. Go meet the families that Dave and I have met.  Sit across their kitchen tables. Go to their child’s hospital room and see more tubes and wires than you can count. Understand what these people have lived though. Take their stories into your heart.

It is hard, very hard, but it will give you a real reason to do your jobs and to love it.

This is what I wrote on the day I spoke at his memorial:

I’m not sure I will get through what I plan on saying today at Dave’s Memorial, so I thought I would put it here:

Funerals are painful, and our hearts go out to Jill and the entire Theno clan. We all share just a small part of your grief.

Funerals are also uncomfortable, because they remind us all of life’s fragile nature and of all the things we should have said too so many.  Especially as we grow older, we think of all the deeds that we have not done, and the ever – decreasing time to do them.

However, we are here today to honor our friend Dave, who unlike most of us, left nothing undone and leaves this life a hero.  Dave was honored by so many.  Here are just a few:

  • NSF Lifetime achievement award
  • American Association of Food Hygiene Veterinarians
  • American Meat Science Association
  • International Association of Food Protection
  • International Meat & Poultry HACCP Alliance
  • Institute of Food Technologists
  • National Advisory Committee on Meat & Poultry Inspection
  • National Advisory Committee for Microbiological Criteria for Foods
  • National Cattlemen’s Beef Association’s Beef Industry Food Safety Council
  • National Meat Association
  • Black Pearl Award by the International Association of Food Protection
  • Innovator of the Year Award from Nation’s Restaurant News
  • California Environmental Health Association’s Mark Nottingham Award
  • Nation’s Restaurant News “Top 50 Players”
  • STOP’s Hero Award and Scholarship

And, this coming year Dave was due for even more deserved recognitions.

Of course, many in the food safety community’s most poignant visual, and most vivid memory, is of Dave asking a picture of Lauren what was the right thing to do.  However, Dave always knew what the right thing to do was, and Lauren was always beside him to confirm it.

In the end, Dave’s profile will not be etched into Mount Rushmore or on the Washington D.C. Mall – but it should be.  Why?  Because Dave’s life’s work saved countless lives and will continue to do so long after all of us have attended our own funerals.

Dave is and will be missed, but he will always be a hero remembered.

Here is Dave and I speaking together in 2012:

Ninety-six people infected with the outbreak strain of Salmonella Javiana have been reported from 11 states – California 1, Colorado 1, Connecticut 1, Delaware 39, Illinois 1, Minnesota 1, New Jersey 12, New York, 4, Pennsylvania 34, Virginia 1 and Washington 1.

Illnesses were reported from states where Tailor Cut Produce distributes, including Pennsylvania, New York City, New Jersey, and Delaware. Ill people from other states reported traveling to these states in the week before their illness started.

Twenty-seven hospitalizations have been reported. No deaths have been reported.

Since the last update on December 11, 85 additional ill people have been reported from 11 states.

These illnesses started during the same time period as the illnesses reported on December 11, but were not confirmed as part of the outbreak at that time.

Epidemiologic and traceback evidence indicate that cut fruit, including honeydew melon, cantaloupe, pineapple, and grapes, produced by Tailor Cut Produce of North Brunswick, New Jersey, is a likely source of this outbreak.

According to the FDA, Sprouts Unlimited of Marion Iowa is recalling clover spouts in 4 oz packages because it may be contaminated with Escherichia coli O103 bacteria (E. coli O103).

The affected batches of clover sprouts were distributed to Hy Vee Food stores, Fareway Food Stores and Jimmy John’s restaurants in Iowa.

The sprouts available at retail were packaged in in pint containers from Sprouts Unlimited Inc. with a blue label on the lid. The UPC code 7 32684 00013 6 is stamped on the bottom right side of the label.

Sprouts Unlimited Inc. became aware of the potential contamination after receiving information from the Iowa Department of Inspections and Appeals, Des Moines, IA that a cluster of E. coli O103 illnesses epidemiologically linked to clover sprouts from Sprouts Unlimited Inc. An investigation and further tests are being conducted to determine the source.

Sprouts have long been a problem as my friend Doug has repeatedly warned on Barfblog:

Kate Bernot of The Take Out wrote, “If you ask anyone in food safety, ‘What is the one food you will not eat?’ Raw sprouts tops the list, always.”

That’s one of the first sentences out of the mouth of Doug Powell, a former professor of food safety and the publisher of barfblog, a frequently updated site that publishes evidence-based opinions on food safety.

I’ve asked him whether food-safety fears about sprouts—those tiny, crunchy squiggles in your salad or sandwich—are well-founded. He tells me the public isn’t concerned enough about them.

“Risk is inherent in the nature of the product which is why Walmart and Costco got rid of them,” he says. (Kroger also stopped selling sprouts in 2012.) “This is not a new problem. It’s been going on for decades.”

According to a paper he and three colleagues published in the journal Food Control in 2012, sprouts have been responsible for at least 55 documented foodborne outbreaks affecting more than 15,000 people globally in the past two decades. The Food And Drug Administration tallies 46 reported outbreaks of foodborne illness in the United States linked to sprouts between 1996 and 2016, accounting for for 2,474 illnesses, 187 hospitalizations, and three deaths. In an effort to reduce these outbreaks, the FDA in 2017 collected 825 samples of sprouts from across the U.S.; 14 of those tested positive for E. coli, listeria, or Salmonella.

Here’s a table of over 75 sprout-related outbreaks going back to 1973.

A Farm is under investigation: 

The FDA continues to actively investigate the cause of this outbreak. An investigation team consisting of staff from FDA, CDC, the California Department of Public Health and the California Department of Food and Agriculture are attempting to identify any factors that could have led to contamination at a common farm identified by traceback. This investigation involves assessing and sampling soil, animal droppings, compost, water, and other potential environmental sources at the ranches of this grower. The samples and information collected during the farm investigations will be analyzed.

Positive Products and Recalls:

  • The Wisconsin Department of Health Services recently reported that they identified the outbreak strain of E. coli O157:H7 in an unopened bag of Fresh Express brand Leafy Green Romaine collected from an ill person’s home. The source of the romaine identified in the bag was Salinas, California. It was determined that one of the growers of this product also supplied romaine linked to other E. coli outbreaks that FDA is investigating.
  • On Nov. 21, 2019, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced a recall by Missa Bay, LLC, a Swedesboro, N.J. establishment, of approximately 75,233 pounds of salad products that contain meat or poultry because the lettuce ingredient may be contaminated with E. coli 0157:H7. Products in this recall were produced with the same lot of lettuce that was used to produce the packaged salad that the Maryland Department of Health found to contain E. coli 0157:H7.
  • The Maryland Department of Health identified E. coli O157:H7 in an unopened package of Ready Pac Bistro® Chicken Caesar Salad collected from an ill person’s home in Maryland. Analysis of this salad, through Whole Genome Sequencing (WGS), has linked strain E. coli O157:H7 to three Maryland cases and the multi-state outbreak.

All current outbreaks linked:

These outbreaks are each caused by strains that are different from each other and different from the larger outbreak. One of the outbreaks is in Washington state, is potentially linked to romaine lettuce served at Evergreens restaurants (13 sick). Another outbreak, with cases in the U.S. and Canada, is linked to Fresh Express Sunflower Crisp Chopped Salad Kits (26 sick in US and Canada).  And, the third outbreak:

Total Illnesses: 138

Hospitalizations: 72

Acute Kidney Failure: 13

First illness onset: September 20, 2019

Last illness onset: December 1, 2019

States with Cases:

AZ (3)

CA (4)

CO (6)

FL (2)

IA (1)

ID (3)

IL (10)

MD (5)

MI (1)

MN (5)

MT (1)

NE (2)

NJ (9)

NC (2)

NM (2)

OH (12)

OR (1)

PA (17)

SC (1)

SD (1)

TN (1)

TX (6)

VA (6)

WA (4)

WI (33)

And, let’s not forget this outbreak that was announced October 30, 2019 – long after it ended:

CDC notified the FDA of this illness cluster in mid-September 2019 and the agency promptly initiated a traceback investigation. The FDA, CDC, along with state and local partners, investigated the illnesses associated with the outbreak. A total of 23 people infected with the outbreak strain of E. coli O157:H7 were reported from 12 states: Arizona (3), California (8), Florida (1), Georgia (1), Illinois (2), Maryland (1), North Carolina (1), Nevada (1), New York (1), Oregon (1), Pennsylvania (2) and South Carolina (1). Eleven people were hospitalized and no deaths were reported. Illnesses started on dates ranging from July 12, 2019 to Sept. 8, 2019. No illnesses were reported after CDC began investigating the outbreak on Sept. 17, 2019.

Investigators were sent to visit farms located in California’s central coast region which were identified through the traceback investigation. They collected and tested many environmental samples, and the outbreak strain was not identified. While romaine lettuce is the likely cause of the outbreak, the investigation did not identify a common source or point where contamination occurred.

Almark Foods  and the FDA need to explain why positive product tests and illnesses in 2017 did not stop positive product tests and illnesses in 2019.

As of December 17, 2019, a total of seven people infected with the outbreak strain of Listeria monocytogenes have been reported from five states – Texas, Florida, South Carolina, Pennsylvania and Maine.

Listeria specimens from ill people were collected from April 10, 2017, to November 12, 2019. Ill people range in age from less than 1 to 82 years, with a median age of 75. Seventy-one percent of ill people are male. Of six ill people with information available, four hospitalizations have been reported. One death has been reported from Texas. One illness was reported in a newborn who was infected with Listeria while the mother was pregnant, but the newborn survived.

Epidemiologic and laboratory evidence indicates that bulk hard-boiled eggs produced by Almark Foods of Gainesville, Georgia, are a likely source of this outbreak.

Additionally, based on whole-genome sequencing, the Listeria monocytogenes found in environmental samples collected at the firm’s processing facility during an FDA inspection conducted in February 2019 is a genetic match to the outbreak strain.  FDA laboratory analysis of the environmental sample collected February 6, 2019, confirmed that two (2) environmental swabs were positive for L. monocytogenes.  The two swabs were collected from the peeling room in the following locations:

  • One (1) environmental swab was collected from the peeling room floor drain near (b)(4).
  • One (1) environmental swab was collected from the egg counter entrance and stainless-steel area at the end of the conveyor belt. This location is a food contact surface.

Whole Genome Sequencing (WGS) analysis was conducted on the two (2) L. monocytogenes isolates obtained from the FDA environmental sample collected on February 6, 2019.  WGS analysis of food-borne pathogens provides high-resolution data, which can be used to infer the evolutionary relationship (or phylogeny) within a given set of isolates as it measures each DNA position in a bacterial genome, enabling direct links to be established between clinical isolates and food or environmental sources of bacterial contamination and illness.  The WGS phylogenetic analysis established that there is at least one (1) strain of L. monocytogenes present in your facility and that strain contains both of the referenced isolates.  Specifically, WGS analysis of the strain revealed that the two (2) isolates, collected from two (2) different zone locations, are genetically identical to each other, which suggests possible cross-contamination between the locations.  Further, the WGS analysis of the strain also showed that the isolates are genetically identical to 2 cases of human illness dating back to 2017.

According to the FDA, this outbreak strain was found during environmental sampling in 2017 of one other Almark food facility. That facility is not currently handling food and ceased operation in 2018.

On December 20, 2019, Almark Foods recalled and suspended production of hard-boiled and peeled eggs in pails due to the potential for contamination with Listeria monocytogenes. These hard-boiled and peeled eggs were sold in pails under the following names: Rainbow Select Hard-cooked Eggs, Rainbow Select Hard-cooked Eggs in Vinegar, Nic’s Salad Hard-boiled Eggs, Almark Hard-cooked Eggs, and Sutherland Select Hard-cooked Eggs.

Note:  According to the FDA – “The FDA, CDC and our state partners have identified a common grower between each of the outbreaks, which is a notable development.”

According to the FDA, there are presently three outbreaks under investigation.  These outbreaks are each caused by strains that are different from each other and different. One of the outbreaks in Washington state (13 sick), is potentially linked to lettuce. Another outbreak, with cases in the U.S. and Canada, is linked to Fresh Express Sunflower Crisp Chopped Salad Kits (8 sick in US and 25 sick in Canada). And, the largest outbreak according to the CDC, has a total of 138 people infected with the outbreak strain of E. coli O157:H7 have been reported from 25 states.  States with Cases: AZ (3), CA (4), CO (6), FL (2), IA (1), ID (3), IL (10), MD (5), MI (1), MN (5), MT (1), NE (2), NJ (9), NC (2), NM (2), OH (12), OR (1), PA (17), SC (1), SD (1), TN (1), TX (6), VA (6), WA (4), WI (33).  Two illnesses have been reported in Canada.

I have filed lawsuits in each of the three cases above, and eventually, likely within 90 days, the Court process will out that “common grower.”  However, certainly federal, state and county officials know, as do others in private industry.

If someone either announces the name or calls me with it in the next 24 hours, I will donate $25,000 – half to the Arizona Leafy Green Marketing Agreement and half to the California Leafy Green Marketing Agreement.