Natalie MacLachlan
with her son Trevor
and her husband Mac
I am writing to express my concern and dismay over the fatal illness that affected my sister, Natalie Knauth MacLachlan, following surgery for spinal stenosis at UWMC. Natalie was an otherwise healthy woman when she underwent this elective surgery on May 18, 2014 to relieve back pain and associated symptoms. Due to continuing symptoms the surgical team recommended an additional surgery on June 4th. Approximately 2 months following the first surgery Natalie began having worrisome neurological symptoms, and after several ED visits and repeat hospitalizations at UWMC and Harborview, she was diagnosed with advanced fungal meningitis on October 10, 2014. Due to the extent of the infection, treatment was ineffective and on February 20, 2016, Natalie died at Lakeview Family Home in Kenmore WA. Natalie was unable to walk after her admission to UWMC on August 13, 2014, progressively lost mobility, and was placed on a feeding tube on September 23, 2014, and a tracheotomy placement and respirator at Kindred Hospital on November 24, 2014. At the time of her death she was a quadriplegic, unable to eat or speak or even blink her eyes due to facial paralysis. As you can imagine, Natalie’s nearly 2-year decline was devastating to her family, both due to the loss of her precious life and the suffering she endured throughout. During her ordeal Natalie displayed extraordinary strength of character, never complaining about her predicament in spite of all the frightening implications and unknowns of her illness and the numerous operations and painful procedures she had to undergo. Instead she became everyone’s favorite patient, smiling and thanking all her caretakers no matter what they had to do to her. When it was finally revealed to her on November 13, 2015 that further treatment was futile and she would not survive, she spelled out the word S.O.R.R.Y on her word chart.
Out of respect for Natalie’s memory and her ordeal, and to help her family come to terms with what happened, we are writing this letter to seek answers, and if possible, to prevent this sort of catastrophic result from happening in the future. Toward this end, we are asking for a response to the following concerns
- The cause/origin of the fungal infection,
- The length of time it took to diagnose the infection.
- Co-ordination/continuity of her care
But these concerns must first be prefaced by a synopsis/ timeline of events chronicling Natalie’s case from the first operation on May 18, 2014 until her death on February 20, 2016.
Synopsis
Prior to the surgery Natalie had just turned 70 years old on April 17, 2014. She was a healthy, energetic woman with no chronic or acute health conditions other than spinal stenosis. She began exhibiting symptoms of cognitive disability about one month following the second operation. After several falls requiring visits to emergency care at UW, she finally had such a severe fall that she was re-admitted to UW Medical Center on August 1, 2014 for the long term Her cognitive symptoms worsened to the extent that she became verbally non-responsive, though she was able to eat, use the bathroom with assistance, and be helped into a wheel chair.
From August 15, 2014, through September 26, Natalie had 5 lumbar punctures and 5 MRIs in attempts to diagnose her condition. The third MRI (September 3, 2014) revealed “masses in her spine and lower skull”. On the following day she was prescribed high doses of steroids to reduce inflammation. Her condition did not improve, and, it was finally decided, on September 26, 2014, that Natalie should undergo a brain biopsy to include the placement of shunts after the fluid was drained from her brain. The biopsy finally identified the culprit as a rare fungal infection called Pseudallescheria Boydii. The antifungal, Vericonazole, was immediately prescribed, and our family was exuberant that we finally had a specific diagnosis, which could be treated.
Following the placement of the shunts, Natalie’s cognitive abilities immediately returned. However an MRI (on October 8, 2014) of her head and neck revealed that the infection, undetected for 4 months, had worked its way throughout her central nervous system and done irreparable damage. On October 11, 2014 we were told that she was dying. We were advised that the feeding tube and other treatments be discontinued in favor of palliative care. The family, of course, devolved from exuberance to despair. However, as a last ditch effort, the medical team decided to increase her dose of Vericonazole to the maximum safe range and add another anti-fungal medication. This seemed to be having a positive effect. So the treatment was continued with the hope that her life might be spared as long as she could still enjoy some quality of life. At that time we were concerned that she might end up in a wheel chair for the rest of her life. We didn’t realize what a high bar we were setting.
Natalie was discharged from UWMC on October 17 to “recover” at home in Kenmore with assistance from Providence home care helpers. On October 28 she vomited and aspirated, and was rushed again to the emergency ward at UWMC with pneumonia. After this crisis was averted she was discharged to Kindred acute care hospital in Northgate on November 4, 2014. On November 19, she contracted another, more severe case of pneumonia resulting in a permanent tracheotomy. She was never able to speak again.
She stayed at Kindred from November 4 until she was transferred to Everett Care Center on January 23, 2015. Finally she was transferred to Lakeview Adult Family Home in Kenmore on May 29, 2015. During all this time, she continued to receive the fungicidal medication through the feeding tube. She was cognitively alert and responsive. Although she received physical and occupational therapy at the Evergreen Care facility, she made little progress. The shunts failed on at least three occasions causing her to lapse into a coma requiring immediate transfer to emergency care at the nearest hospital where she would spend considerable time in the ICU. Natalie’s husband worried that she would lose her place at her current care facility, but she was always welcomed back. However he continued to pay full price for the facility even during the lengthy periods when she had to be re-admitted back into the hospital.
The final crisis came on October 15, 2015, less than a month after she underwent emergency surgery to re-insert the shunts. This time she was found unconscious again and rushed to UWMC emergency from Lakeview Adult Family Home. The ventricles in her brain were greatly distended. It had previously become clear that Natalie’s specific fungus was attracted to the plastic shunts creating a “catch 22” type of dilemma. The shunts were drained and Nat regained consciousness, but her family noticed that her eyes were crossed and that her face was partially paralyzed. Her family informed the attending doctor of these symptoms, and he ordered an immediate MRI to help determine the cause of this new development. It was inconclusive. At this point we were at our wit’s end and begged for a consultation with all the doctors who had been involved in her case for the last 18 months. On November 3, 2015, eleven doctors assembled around her bed, with her family present and Natalie, restored to awareness and full consciousness. The conclusion was that the fungal infection was progressing and that further treatment was futile.
On November 4, 2015 the shunts were replaced near her heart so that she could be released to return to Lakeview Adult Family Home under the care of Evergreen Hospice and provided with palliative care for pain, anxiety, and other needs. The feeding tube and the antifungal medication continued to be administered. Eventually the antifungal medication was discontinued. The amount of nutrition was cut back and finally terminated on Feb 10, 2016. She died on February 20, 2016 at 4:00 PM with her husband, son, and sister in attendance. Her family members, and friends are heart broken and worn out from stress and grief.
The cause/origin of the infection:
To this day, the family has not been presented with a considered explanation of the cause/origin of Natalie’s infection or the results of an investigation, assuming one took place. How did such a rare and lethal fungal infection make its way into her body? The research indicates, “Fungal meningitis is a very rare cause of meningitis, typically limited to people who have had surgical procedures, or have impaired immune systems due to cancer or other diseases affecting immune function.” http://www.emedicinehealth.com/meningitis_in_adults/page2_em.htm#adult_meningitis_causes
Only two other causes of Pseudallescheria Boydii infection were cited in the research: 1. Near drowning in contaminated water. 2. Working in the farming industry in certain regions of the country (the Pacific Northwest was not mentioned) where frequent contact with manure is part of the job. Neither of these conditions applies to Natalie in any way. She was neither a swimmer nor a gardener. Thus it is logical to conclude that Psuedallesheria Boydii was introduced into her body during surgery, either the first or the second, through contaminated instruments or in some other insidious way. This conclusion is re-enforced by the fact that her symptoms began to manifest within about a month after her second surgery.
Dr. Eric Chang said that an examination of the operating room revealed no signs of contamination. Was he talking about examinations of the operating arena for the first or second surgery? Were these examinations done before the surgeries and no contamination was detected however illusive it might have been? Or were the examinations done after Nat’s operation (s), and/or after it was discovered that an infectious agent might have been present? If the inspections were done after the operations they would have no relevance since standard hospital protocol requires that the facility and all equipment be cleaned and sterilized following each operation, and therefore no suspicious infection would have shown up. How are such lethal microbes detected and eliminated prior to surgeries? Is standard protocol always successful and/or observed? We would like to know more about this. (Please see addendum attached with this letter)
One of the many doctors involved in Natalie’s case speculated that the fungal infection might have already been present in her brain, lying dormant, prior to the operation, and that the trauma of the surgery simply “triggered” the infection, which then traveled from her brain down into the spine. This scenario seems highly improbable, considering the rare causes of fungal meningitis cited earlier. Is there any known precedent in medical records to support such a scenario?
It seems way more logical that the fungus entered her blood stream during one of the operations and managed to cross the blood brain barrier, causing encephalitis; hence her increasingly severe cognitive impairment as well as physical symptoms. Then it worked its way down into her spine. The MRI on September 3, 2014 revealed masses in her spine as well as the base of her skull. So maybe the direction of travel was the other way around or occurring simultaneously.
- Delayed diagnosis:
Why did it take four months to diagnose the fungal infection? If it had been detected early enough, perhaps the anti-fungal medications would have been effective; maybe not enough to restore Natalie to pre-operation health, but at least so that she could have enjoyed some quality of life for another decade or longer, even if she had been bound to a wheel chair.
Following her second surgery Natalie was admitted to the emergency room at UWMC twice due to falling down and displaying some worrisome signs of weakness and cognitive symptoms. Both times she was discharged within a day or so without further tests or observation. The third fall was serious enough to cause a concussion and finally UWMC decided to keep her for further observation and tests (on August 1, 2014 … 2 months and 13 days following her first surgery.) Maybe her symptoms should have been investigated more thoroughly at her first admission to emergency care rather than waiting for the third incident?
As Natalie’s symptoms continued to worsen, numerous lumbar punctures failed to reveal any substantive cause for her condition. I wonder if the fungus went undetected because the doctors were looking for a viral or bacterial cause since fungal infections are so rare? When the results are cultured do they include all possible sources, or is there a separate culture required to detect fungal infections because of their rarity? If so, were these cultures performed?
On September 3, 2014 an MRI detected “masses” in her spine and lower skull. On Sept 17, drain tubes were inserted in the top of her skull. On Sept 26, more than four months after Natalie’s admission to the emergency room at UW and 3 weeks after the MRI discovered the “masses” in her spine and skull, it was decided to perform the brain biopsy in an attempt investigate these findings. Thus the diagnosis was finally made…but too late for effective treatment. Why was the biopsy postponed for more than 3 weeks from the time these masses in her spine and skull were first detected?
I am also mystified by the fact that the numerous brain scans, prior to the biopsy, did not reveal the distended ventricles in her brain characteristic of encephalitis? It was obvious from the very beginning, that something was wrong with Natalie’s brain. At the time of the biopsy the first shunts were installed resulting in the full restoration of Natalie’s cognitive function. But the infection had had 4 months to spread throughout her nervous system, spelling imminent doom for Natalie.
- 4. Concerns about co-ordination of care:
Our family has been concerned about the continuity of care Natalie received throughout this 2-year ordeal. She had been in three major hospitals for extended periods of time: UWMC, Harborview, and Providence in Everett. In addition she resided at Kindred Acute Care in Northgate from November 4, 2014 until she was transferred to Everett Care on January 23, 2015, and finally Lake View Adult Family Home in Kenmore on May 29, 2015. During all these lengthy residential stays she was frequently transferred to the nearest hospital due to emergency situations followed by periods of time in ICU.
After being discharged from UWMC on October 14, 2014, as Natalie progressed (regressed?) from her short period of “home care” through many different hospitals, acute care, and nursing facilities, there didn’t seem to be any primary care doctor or team who kept track of her case and coordinated the care she was receiving from a wide variety of different specialists including surgical, infectious disease, neurology, respiratory, speech, social and occupational therapists.
Frequently, doctors and medical staff in the various facilities where Natalie was treated had little information about her case, and there didn’t seem to be primary care physician/co-coordinator to indoctrinate new providers about her long and complex medical history. Fortunately, Natalie’s husband, Douglas “Mac” MacLachlan, kept a meticulous daily spreadsheet from the day of her first operation up until her death. It includes all operations, medical procedures and other pivotal events, visits by all medical personnel, prognosis’, consultations, infections, treatments and outcomes, and personal notes on Natalie’s daily routines, her moods etc. There were numerous occasions, after Natalie was originally discharged from UWMC, that doctors and other medical professionals from other facilities used Mac’s spreadsheet to fill themselves in on Nat’s history. Even UW personnel used the spreadsheet to get them up to speed on what had happened to her during her time in other medical facilities. I’m curious why this crucial information would not have been readily accessible, in the form of existing medical records, to all personnel working on Natalie’s case; or perhaps a number of Natalie’s caretakers were just not referring to these records?
Generally, it seemed to us that UWMC, had washed its hands of Natalie once she was discharged to Kindred Hospital on November 4, 2014, rather than diligently following the case of a patient who was seriously jeopardized by a possible medical error, however unintended. This may not be the case and I hope to be reassured of this in a response to this inquiry.
I think it is also relevant that 11 doctors attended the consultation in Natalie’s room to finally tell us that the fungus was progressing and there was no hope of Natalie’s survival…Too many cooks in the kitchen and no one in charge?
Please see “Note” on page 7.
Requests from UWMC by the family of Natalie Knauth MacLachlan :
- A legal consultant informed me that it is highly unlikely/ practically impossible to imagine, that a reputable teaching hospital like UW Medical Center would not have done a thorough investigation of a case as catastrophic as Natalie’s. If an investigation was, in fact done, the family requests a copy of that investigation so that we can rest assured that the hospital is taking all the precautions possible to insure that this does not happen again to another patient. We deserve a clear understanding of exactly what happened and what was learned from her case. This could provide us with some peace of mind to know that Natalie’s suffering and death might have some positive effect for future treatment of this deadly disease.
- In addition we request that the hospital establish an enhanced quality control program for surgeries that would include additional training for hospital staff, specifically in the area of detection and prevention of hospital acquired infections (HAIs), in the name and memory of Natalie Knauth MacLachlan.
I expect that you will respond to this letter and give these requests your deepest consideration. It would help her family find some closure for our loss, and restore confidence in your hospital.
In the meantime I cannot, in good conscience recommend to any relatives, friends or acquaintances that they seek medical treatment at UW Medical Center. I will not hesitate to express my concerns and opinions to anyone who may be interested.
Sincerely,
Beryl Knauth (sister of Natalie Knauth MacLachlan)
Addendum:
In the wake of the recent investigation reported by KOMO news, I am making an allegation of probable patient harm by the University of Washington Medical Center for repeatedly and willfully failing to meet the minimum standards of patient safety. I have included a copy of the news report.
This is an amendment to a letter I wrote earlier regarding the death of my sister Natalie MacLachlan from complications of fungal meningitis, which her family believes was acquired following an elective surgery for spinal stenosis. I began writing the original letter in December 2015 – about 2 months before her death on February 20, 2016 – and continued working on it until after Natalie’s “celebration of life” on April 17th (her birthday). I waited so long to complete and send the letters because we needed to focus our depleted energies on honoring her life in an atmosphere of hope and optimism. The original letter, which I mailed to 6 recipients on Wednesday and Thursday May 11 and 12, chronicles Natalie’s ordeal, which began following her first operation on May 18, 2014 and ended with her death on February 20, 2016. For those recipients who have not already received a copy of the original letter, I have included the letter in this mailing.
Several days following the first mailing, a friend of mine sent me a link to an article regarding a KOMO investigation of dangerous practices at UWMC putting patients at risk for infection. The article sheds a new light on my inquiry and answers some of the questions in my original letter, which are arranged in 3 categories. The first category asks questions regarding “The origin/cause of the fungal infection.”
I had written, “How are such lethal microbes detected and eliminated prior to surgeries? Is standard protocol always successful and/or observed? We would like to know more about this.”
After reading the article it has become clear that, in fact, standard protocol for patient safety is not only not always observed but has, on a number of occasions, been willfully disregarded. I had been hoping that the anticipated responses to my letter would restore our family’s confidence in UWMC. But after the allegations in the KOMO investigation, along with our own horrific personal experience, we have basically lost almost all confidence. We will be compelled to warn others that they use the services of UWMC at their peril.
Here are some critical portions of the article, which apply specifically to Natalie’s case.
“For 17 months, patients of the University of Washington Medical Center were put at risk because the hospital repeatedly failed to keep critical drug mixing areas clean and sterile.”
“Because from May 2014 through October 2015, the critical drugs going into surgical IVs, cancer care, chemotherapy and even simple injectable steroids for joint pain, were produced in University pharmacies that were so dirty, they failed inspections.
This is significant to Natalie’s case because she underwent her first surgery on May 18, 2014 and experienced a steady decline, following her second surgery, until her death on February 20, 2016…the exact time period when patients were considered to be most at risk for infection due to contamination.
This statement appears in the last paragraph of the article:
“The University of Washington……adds that there were no allegations of patient harm.”
Well, let it be known that an allegation of probable patient harm has now been made. I hope that this allegation will prompt further investigation and other patients may be identified. But I understand that, as stated in the final sentence of the article: “As former Commissioner Harris put it, in general it’s possible for patients to be harmed if drugs are contaminated but he doesn’t know how you would ever prove it.”
Natalie’s family hasn’t the energy, will, or the financial means to take legal action and have decided firmly against pursuing a lawsuit. But, I suggest that if UWMC wants to do the right and moral thing, it will acknowledge the loss suffered by our family, apologize for putting Natalie’s life at risk, and offer some form of compensation.
I suggest using the link below to access the article because it contains additional links leading to important related information.
SEATTLE — Patient safety advocates tell us they are “horrified” by what a KOMO investigation has uncovered. For 17 months, patients of the University of Washington Medical Center were put at risk because the hospital repeatedly failed to keep critical drug mixing areas clean and sterile. The state Department of Health oversees all pharmacies but despite inspections showing the UW Pharmacy wasn’t meeting minimum safety requirements, it continued to operation. Raising the question: is the UW getting special treatment?
Inside a UW surgical suite, patients might feel pretty safe. The teaching hospital is rated number one in the state in U.S. News and World Report’s annual rankings and 5th in the nation for its cancer treatments.
But that’s not the entire story. Because from May 2014 through October 2015, the critical drugs going into surgical IVs, cancer care chemotherapy and even simple injectable steroids for joint pain, were produced in University pharmacies that were so dirty, they failed inspections.
“I’m horrified,” says patient advocate Karie Fugate. We asked Karie and her husband Wayne Fugate to take a look at inspection records the KOMO Investigators discovered.
In May of 2014 pharmacy investigators from the Department of Health examined the rooms where critical drugs are mixed into IVs. It’s called sterile compounding and the rooms where they’re prepared are, by law, also supposed to be sterile. In the records we obtained, the investigators note finding ventilation hoods with, “rust and other discoloration,” and grates with, “layers of dust and growth of some sort inside.”
Investigators found the main sterile room which is supposed to be entirely enclosed, had an open window into the active pharmacy area. There were several surfaces, including ceilings and countertops, with porous and cracked surfaces that could collect dust. They found 56 drugs that were too old to use and some drugs, cleaning compounds and anesthesia liquids incorrectly stored. And they found pharmacy techs were mixing the critical IV drugs without adequate supervision by pharmacists. The hospital failed the inspection and was under orders to fix it within 14 days.
A month later the hospital had improved its score by such things as fixing patient record-keeping and removing all out-dated drugs but still failed with a rating of “conditional” because it wasn’t keeping critical areas sterile. UW Spokeswoman Tina Mankowski says the hospital contacted DOH in August of 2014 for a re-inspection but that DOH never responded. But she agrees that the UW Pharmacies again failed a federal inspection in October of 2015.
Karie Fugate: “So it’s like no one’s doing anything; so this will continue over and over again.”
And it remained at that level for 16 months.
“They have a systemic issue,” says Wayne Fugate, “I would think it would be time to start holding people accountable.”
The Fugates became patient advocates after what happened to Karie’s son, Mark Turnage. Mark had been admitted into a different hospital, not the UW, for pancreatitis and gallstones. State investigators cleared the hospital of violating any standards, but Mark developed several drug resistant infections – and died after 68 days in the hospital.
Karie: “It never goes away.”
Wayne: “You’re a member of a club that nobody wants to be a member of.”
The Fugate’s turned their grief into action by joining Washington Advocates for Patient Safety. And they are outraged that the UW pharmacy left patients at risk for so long.
Karie says, “I think they need to fine them.”
So how did the university get away with ignoring the state for so long?
Gary Harris just retired after serving 11 years on the State Pharmacy Quality Assurance Commisson – PQAC. “I don’t want to see people injured and if somehow that’s going on I want it to stop.”
In 2012, 64 people died after a Massachusetts compounding pharmacy sent out hundreds of contaminated injectables. Harris says that was a wake-up call, proving how critical it is that injectable drugs are sterile, particularly for cancer patients and other people with compromised immune systems. “If you have a 50% chance of being around for even one more year and we kill you today – that’s unacceptable.”
The next year, Washington’s state legislature adopted the stricter federal standards here. For the first time, many hospital pharmacies started failing inspections. Most made changes and quickly passed their follow-up inspections. But some hospitals, like the UW, continued to fail. And Harris and other KOMO sources say investigators were pressured to back off. That angers Harris, ” Well it’s illegal. It’s patient safety, which is why we’re coming after you.”
In September of 2015, PQAC filed a Statement of Charges against the UW Pharmacy saying the alleged violations put patients’ health or safety at risk. But instead of prompting the UW to change, the KOMO Investigators found what followed was a flurry of emails, memos and meetings between Secretary of Health John Weisman, the Governor’s office and the Washington State Hospital Association – WSHA – a professional and lobbying organization.
Harris told us, “the pressure is from these organizations.”
Only when the UW failed a third inspection by the Centers for Medicare and Medicaid and the federal government threatened to pull its funding did the hospital pharmacy clean up its act — 17 months after that initial failed inspection.
Harris wasn’t involved directly in the UW case, but says it’s symptomatic of what he believes is happening with some other hospital pharmacies. “I spent 11 years, a whole ton of hours, doing this and I don’t want to see that go to hell because someone says, ‘Oh, you’re being too hard on us.’ ”
KOMO asked DOH Secretary Weisman for an interview specifically to address the allegations of undue influence and he declined, his office saying that such meetings are common for feedback and do not change the Department’s commitment to patient safety. WSHA President and CEO Scott Bond agrees there was no undue influence and goes on to say as a trade organization advocacy is part of their job.
In a written statement, the University of Washington said they have fully responded to the PQAC’s allegations and continues to work with them and adds that there were no allegations of patient harm. As former Commissioner Harris put it, in general it’s possible for patients to be harmed if drugs are contaminated but he doesn’t know how you would ever prove it.
Beryl Knauth (sister of Natalie Knauth MacLachlan)
