16 Jun 19
The Denver Post
More than 60 patients[cq comment=”cq”] who suffered post-surgical infections are suing Denver’s Porter Adventist Hospital over a breach in sterilization procedures, which a state investigation found was far more serious than the hospital divulged a year ago.
The lawsuit, filed at 12:02 a.m. Saturday [cq comment=”cq”], alleges the hospital’s failure to adequately clean equipment caused “hundreds of severe infections” in patients as far back as 2015[cq comment=”cq”] — and at least one death.[cq comment=”cq”]
“This is not about money, it’s about Porter not doing this to anybody else,” said Michael Pitcock, a plaintiff who said he developed an infection after a knee replacement four years ago[cq comment=”cq”]. “This should be preventable.”
RELATED: “So many people hurt”: More than 60 patients file lawsuit against Porter Adventist Hospital
When Porter in April 2018[cq comment=”cq”] publicly revealed its problems cleaning equipment used in surgeries, hospital officials said there was only one case in which a contaminated tool came close to a patient. Hospital officials also downplayed the risk patients faced in getting infections.
“We have not seen a bump in our overall totals or infection rates,” Dr. Patty Howell, Porter’s chief medical officer, told The Denver Post as she and other officials offered insights into the trouble with the hospital’s sterilization practices.
But a 2018 [cq comment=”ca”]state investigation of Porter found hospital officials knew more of their patients were developing post-surgical infections by early 2017[cq comment=”cq”] when a hospital committee was told of a jump in infections related to hip and spine surgeries, according to results of the health department’s investigation, which was obtained by The Denver Post.
The investigation documented 76 times[cq comment=”cq”] contaminated surgical instruments and trays — tainted by blood, chunks of bone, cement, hair and even a dead insect — were brought into operating-room suites in 2017 and early 2018.[cq comment=”cq”]
This photo shows Porter surgical instruments after purportedly being sterilized.
The state’s investigative report said Porter failed to track data and change its operations, leading to “ongoing incidents in which contaminated surgical instruments were being delivered to the operating room for surgical cases and potentially contributed to an increase in surgical site infections and adverse patient events.”
However, Dr. Tista Ghosh, chief medical officer at Colorado Department of Health and Environment, said in a statement the state has never conclusively linked infections to the sterilization problems.
Centura Health, which operates Porter, declined to comment for this story.
Sterilization problems revealed in 2018
Porter announced it had trouble with its sterilization process for surgical instruments in April 2018 by sending roughly 5,800[cq comment=”cq”] letters to patients, warning that those who had orthopedic or spine surgeries dating back almost two years were at risk for contracting hepatitis B, hepatitis C or HIV.
Pitcock, who got an infection after a knee replacement, remembers receiving the letter from Porter and getting tested for the viruses.
“It scares you to death,” he said.
The news prompted state health officials to investigate the hospital and Porter briefly suspended surgeries after the department found problems with how instruments were cleaned.
At the time, the state’s Department of Public Health and Environment confirmed “a number of patients” at Porter had infections, but said it could not directly connect them to the hospital’s sterilization problems. Dr. Larry Wolk,[cq comment=”cq”] former executive director of the agency, also said the risk of patients getting HIV, hepatitis B or hepatitis C was “very low.”
On Saturday, Ghosh said in a statement that the agency spoke with the Centers for Disease Control and Prevention at the time of the sterilization breach and determined that while there was a low risk for HIV, hepatitis B or hepatitis C, the risk was higher than what is typical.
“When there is an increased risk of bloodborne pathogens, we take action,” Ghosh said. “In this case, we informed the hospital they needed to notify patients of the possible risks of surgical site infections and bloodborne pathogens and that patients should be tested for bloodborne pathogens.”
Timeline of incidents
State health officials say Porter knew of at least 76 instances of contaminated surgical instruments and trays being sent to operating rooms. Below are a few examples of their findings:
Jan. 24, 2017
Chunks of bone were found inside a surgical pan
Jan. 25, 2017
A surgical instrument was noted as clogged with the previous patient’s blood
Jan. 26, 2017
Blood was found on a surgical drill bit
Feb. 16, 2017
Cement was found on the surgical instrumentation
March 8, 2017
Visible bone and blood were found in the surgical pan
April 21, 2017
Blood was found on top of spinal surgical instruments
June 1, 2017
A surgical instrument was found to have dried blood on it
June 28, 2017
Black residue was found on a surgical instrument
June 29, 2017
Operating room staff documented a dead bug in a surgical tray
Aug. 28, 2017
Crusty blood or tissue was found on a surgical instrument
Nov. 22, 2017
Blood from a previous surgical case was found on a piece of a surgical instrument
Jan. 23, 2018
A piece of bone was found in the bottom of a surgical tray
Feb. 19, 2018
Hair was found on surgical instruments
March 12, 2018
Bone was found in the bottom of a surgical tray and “contaminated” the “entire setup”
March 29, 2018
“Rust/blood” was found on a surgical drill
April 2, 2018
Questionable residue was found on instruments which “lead to cancellation of surgery”
Porter is on a conditional license, which means it requires increased monitoring from the state Department of Public Health and Environment.
The lawsuit, which was filed in Denver District Court, alleges the issues with Porter’s surgical instruments were not just limited to orthopedic or spine surgery patients as previously stated. In total, the lawsuit was filed by 67 patients and 20 of their spouses.[cq comment=”cq”]
Among them is a woman who developed infections after a mastectomy. Another patient ended up with an infection following an eye procedure, the lawsuit states.
As Porter patients sought treatment for the illnesses, they amassed massive medical bills — as much as $2 million for one patient — for emergency room and hospital visits, additional surgeries and antibiotics, according to the attorneys representing them.
“From the information, we have obtained, it appears that the sterilization problems at Porter caused extensive infections in surgical patients,” David Woodruff[cq comment=”cq”], a partner with Denver Trial Lawyers, said in an email. “It also appears that Porter may not have accurately reported these infections to the Department of Health as required by law.”
The 93-page lawsuit alleges Porter didn’t use “reasonable care” to make sure equipment was properly sterilized as required by state and federal law, industry practices and hospital protocols. As a result, the patients in the lawsuit had surgeries performed on them with instruments that were “improperly” sterilized, causing infections in their surgical sites or other bloodborne infections, according to the document.
Patients developed hepatitis B, meningitis, and urinary tract, e. coli and staph infections, the court document claims.
Two patients were under general anesthesia and ready for surgery when their procedures were canceled because of contaminated instruments. In one case, a doctor had started the surgery, cutting the patient’s skin, when he discovered a brown-yellowish, pasty material on an instrument. After other equipment showed residue, the doctor decided to cancel the operation, the lawsuit alleges.
The lawsuit also alleges a patient died three months after his surgery at Porter in 2017 [cq comment=”cq”]for a fractured femur. Thomas Wriston, 78, [cq comment=”cq”]died after he was diagnosed with sepsis, respiratory failure, pneumonia, anemia, and subacute kidney injury, according to the court document.
Betty Wriston holds a photo of her and her late husband Tom and their dog at her home in Fairplay, Colorado on June 12. The quilt covering her bed is made from Tom’s shirts, of 21 matching shirts and dresses she made for them over the years.
One of the patients in the lawsuit is Rebecca Brown, a 33-year-old [cq comment=”cq”]who was diagnosed with sepsis, a life-threatening infection, following her lumbar fusion surgery at Porter in 2017[cq comment=”cq”].
She was also diagnosed with clostridium difficile [cq comment=”cq”]– also known as C.diff — infection, which causes inflammation in the colon. The diagnosis meant additional trips to the hospital and antibiotics, according to the lawsuit.
“It wasn’t just my life they affected, they affected my kids, they affected my husband, they affected my job, they affected every single part of me that was me and I’ll never get any of that back,” Brown said.
Rebecca Brown struggles to rise from the couch at home with her children after a trip to the emergency room in Castle Rock on June 7.
In their investigation, state health officials noted that not only did Porter know there was an increase in surgical-related infections in 2017, but the hospital also didn’t report a number of them to a national infection tracking system in 2018.[cq comment=”cq”] The state report did not say how large the increase was.
In one case, a patient had two procedures — a spinal fusion and laminectomy — in late 2017[cq comment=”cq”] and visited the emergency department in January 2018 [cq comment=”cq”]because of back pain.
At the emergency department, a physician noted the patient — who is not named in the state’s investigation — had white, milky fluid with pus at the spot of the surgery. Tests later determined there were bacteria that cause infections, the documents show.
A month later[cq comment=”cq”], the patient was back in the emergency department — this time complaining of paralysis of the lower body. Test results showed an infection at the spot of the surgery, according to the state investigation.
Staffing issues at Porter
The breakdown in Porter’s sterilization process coincided with staffing issues in the department responsible for cleaning surgical instruments, state records show.
[related_articles location=”right” show_article_date=”false” article_type=”curated” curated_ids=”3008850,3008272,3124540″]
And when employees reported problems with how the equipment was cleaned, hospital leaders failed to provide them with additional training or change how the department operated, the state report said.
The state records show that in one year, at least 17 of 22[cq comment=”cq”] employees in the department experienced one or more incidents involving contaminated surgical tools.
One employee, who is not named in the report, was involved in at least 63 incidents [cq comment=”cq”]where there were concerns with surgical trays he or she processed, such as when chunks of bone were found in a pan, according to the health department.
The technician received a written warning for dirty instruments, but contaminated tools still appeared. In one case, staff in the operating room found a dead insect in a surgical tray, the records show.
When state officials spoke with a manager, he said he was aware contaminated trays were making their way into the operating room but he didn’t have time to check the equipment after they were sterilized.
At one time, the department processed instruments for up to 50 [cq comment=”cq”]cases a day, which was “not safe,” he said.
“I don’t have enough staff,” he told officials in the investigation.