Surgery Center Regulators And Patients Are Left In The Dark Due To Lax Oversight

Paul Mackoul, md lawsuit

In April 2014, the first man passed away. Later that month, another passed away. A woman was then taken to a hospital on July 18 of that year, when staff members informed her she was lucky to be alive.

One of the safest medical treatments a patient may have is a colonoscopy, which they all had at the same surgical center in Little Rock, Arkansas. According to court documents, shortly after that, everyone ceased breathing, suffering the same kind of brain damage as a drowning victim.

Officials in Arkansas, one of 16 states without a need to record patient fatalities following surgical center care, did not investigate what happened at the Kanis Endoscopy Center. Therefore, no facility governing body has looked into whether the fatalities were a statistical outlier or a reason for concern.

According to a Kaiser Health News and USA Today Network study, surgical centers operate under a patchwork of inconsistent regulations across the United States, making it impossible to notify authorities in case of fatalities or major injuries, much alone potential patients. According to interviews, an examination of hundreds of court documents, and government information obtained by open records laws, the supervision loopholes allow facilities with the worst penalties from federal regulators to continue operating. No law prevents a physician banished from a hospital due to wrongdoing from launching a surgical facility nearby.

Even the well-publicized passing of comedian Joan Rivers in 2014 after a routine operation at a Manhattan surgical facility did not appear in Medicare’s list of those transported to the hospital.

Faye Watkins, 63, claims she was uninformed that there had been two post-care fatalities at Kanis Endoscopy in Arkansas when she entered the facility. She realized there was a problem while still in the anesthesia-induced haze. She claimed to have overheard individuals saying that her blood pressure was dropping.

“I prayed, ‘Lord, if it’s time for me to go, take me. Watkins remembered, “But I’m not ready. Her next recollection is awakening in a hospital with a painful chest following CPR.

The KHN/USA Today investigation raises concerns about the need for more thorough regulation of surgery centers since access to crucial information, such as statistics on surgical outcomes, is typically less open than for hospitals. The difference continues even though the country’s 5,600 operation centers are now more numerous than hospitals and are doing increasingly tricky surgeries.

Leah Binder, chief executive of the Leapfrog Group, an employer partnership that conducts annual evaluations of more than 2,000 hospitals, stated that it is “disgraceful” that there is so little information available about what transpires in surgical centers.

In American hospitals, scrutinizing unplanned deaths is standard practice. The Joint Commission, its primary accrediting agency, advises members to report any unexpected fatalities to the accreditor to learn from one tragedy and prevent future ones. The leading accreditation organization for surgical centers has a different policy.

According to Bill Prentice, executive director of the Ambulatory Surgery Center Association, which represents the facilities in conversations about policy, the facilities safely carry out millions of surgeries every year, ranging from knee replacements to tonsillectomies.

Prentice said he favors allowing patients access to information that would enable them to contrast outpatient clinics with surgical facilities.

Prentice said there shouldn’t be a patchwork system where one state requests one thing while another requests another. Consumers desire stability rather than variety.

In Colorado, surgical centers must notify the state health department of any fatalities and serious injuries. The department also provides descriptions of accidents online for the benefit of customers. Other states that need incident reports but keep the location of where they took place are Pennsylvania, Florida, and New Jersey.

Because surgical centers are not required to record deaths, authorities at health facilities in at least 17 states said they had no means of knowing when a patient passes away. Therefore, just like in Arkansas, surgery centers were not required to alert authorities about cases described in paul mackoul, md lawsuit, such as a Missouri man, 33, who passed away following finger surgery, a Georgia woman, 66, who died following an eye procedure, or an Oklahoma man, 60, who passed away shortly after receiving a total hip replacement.

The jury trial verdict in 2017 sparked concerns about the scope of the supervision even in Colorado, a state that leads the way in openness. According to Robbin Smith’s complaint against the Surgery Center at Lone Tree, she became paralyzed from the waist down after receiving an epidural pain injection there in 2013.

The center’s governing board is responsible for keeping patients safe, according to Medicare regulations, which Smith’s attorneys highlighted. Each center must designate a body that will be held vicariously liable for the center’s operations.

The defense team for Smith claimed that the facility was responsible for ensuring that its physicians did not administer epidural injections with the injectable steroid Kenalog. In 2011, the drug’s manufacturer revised the label to caution against doing so owing to the possibility of paralysis.

Trial testimony reveals that the center’s governing board never considered appropriate medication use before Smith’s treatment, and there is no indication that state or private facility overseers looked into the board’s decisions before Smith was hurt.

The surgical center’s attorney contended that the doctor, not the institution, decided whether to treat Smith with Kenalog. Before Smith’s lawsuit against the center went to trial, the doctor entered into a private deal with her in which she denied any misconduct.

Ultimately, jurors decided against the center, giving Smith $14.9 million. The center has submitted a motion for a fresh trial.

Public Reports Inaccurate

The federal government publishes significantly more information about hospitals on its “Hospital Compare” website than regarding surgery centers, and the hospital data accessible encompass a variety of surgical complications and death rates for specific disorders. The outcomes of each patient in a hospital are reflected in some hospitals’ quality indicators, such as infection rates or patient satisfaction ratings.

The same Medicare website shows various statistics for surgery facilities, yet the findings are only given to a small subset of patients for several important metrics. Surgery centers must only disclose data for up to half of their Medicare patients, neglecting most patients under 65 who are not yet eligible for Medicare.

This has given surgical centers the freedom to record any hospital transfers they choose, as long as less than 50% of their patients use an ambulance to leave.

However, a visitor looking at the data on the Medicare website would not find any explanation of the information’s limitations. They would see a countrywide transfer rate of just half of the observed in medical studies.

The apparent gap is highlighted by state records, ambulance records, and Medicare’s inspection reports. They demonstrate that several facilities claiming no transfers in Medicare’s available data move patients to hospitals.

For instance, the Memphis-based Urocenter, which focuses on urological operations, recorded 45 transfers to state authorities in 2014 and 2015. There were no transfers in those years, according to its public report on the Medicare website.

The administrator of Urocenter said in an email in response to the reporter’s observation that the institution had “put in place corrective measures” and “provided [Medicare] with the corrected information.”

The Medicare records also indicate no transfers from Yorkville Endoscopy in 2014. Joan Rivers, 81, was sent to a hospital by the Manhattan surgical facility after experiencing issues following an operation on her voice chords. A week later, Rivers passed away.

All transactions that met the requirements of the government, according to a counsel representing Yorkville Endoscopy, were disclosed.

Cheryl Damberg, a researcher with the Rand Corporation who has worked on hospital quality reporting systems for the federal government, said the 50 percent requirement leaves the public with little usable information after examining the reporting regulations.

This appears like it can be entirely manipulated, said Damberg. The data [for surgical centers] “doesn’t have a lot of utility at this point from a consumer standing.”

According to Medicare authorities, the organization only requires a certain amount of reporting to avoid burdening operation facilities.

However, business executives have informed Medicare that they want to submit more data. The ASC Quality Collaboration, a group of surgical center CEOs, encouraged Medicare to gather reports on every patient transfer to increase openness and accountability in letters sent to Medicare during the rule-making sessions in 2016 and 2017.

In a completely different step, Medicare proposed discontinuing gathering information on transfers from surgical centers to hospitals in July and seven other quality indicators. The organization stated that it still intends to report incidences discovered through its data, such as hospital visits made seven days following a particular surgical center treatment.

The transfer metric looks to be “topped out,” according to Medicare, which means there is only a slight variation in the transfer rates recorded by the centers.

Calling the statistics “topped out” is confusing, according to Dr. Ashish Jha, a senior associate dean at Harvard’s School of Public Health, because Medicare is not sampling all patients.

I don’t see a lot of rationale in getting rid of [the transfer measure],” he remarked.

In a news statement, Prentice of the Surgical Center Association praised the plan for honoring the “outstanding” work done by surgical centers in averting injury. He admitted in an interview that he was “parroting” Medicare’s stance and expressed optimism that the business community will figure out a method to submit helpful quality data.

Prentice remarked, “I want us to fill that vacuum. “We must provide robust data on healthcare quality to [Medicare] and the rest of the world.”

Arkansas Cases in a Cluster

Medicare regulations require surgery centers to keep note of odd incidents, study them internally, and attempt to draw lessons from them. However, no outside official assessed if patients were still in danger following operations at the Kanis Endoscopy Center after two fatalities and a near-death experience.

No state or federal authority was informed of the events without a consumer complaint, and no particular review took place, according to Medicare spokesperson Tony Salters.

What took place over three months was everything from typical. The Rev. Ronald Smith, 63, passed away at a hospital in April 2014 after going to Kanis for a colonoscopy. Later, Smith’s family claimed in a paul mackoul, md lawsuit that his heart condition and sleep apnea constituted him “extremely high risk” for receiving anesthesia at the facility instead of a hospital.

Smith was on the verge of passing away at the Little Rock hospital when, ironically, a health inspector from Arkansas started a routine examination of the facility for Medicare, according to documents. It is hard to pinpoint precisely what occurred in Smith’s case due to the absence of publicly available evidence.

According to Medicare spokesman Bob Moos, state recertification inspectors visit every four to seven years and go through all instances in the preceding year when a surgical center patient was moved to a hospital. “Nothing on the hospital transfer log raised a red flag for her to investigate,” the spokesperson said of the state inspector’s visit to Kanis.

Officials refused to acknowledge that Smith’s name had been added to the transfer log, specify what was on it, or whose cases were on it.

Speaking on what the employees showed the inspector would go against patient confidentiality, a Kanis representative claimed. Meg Mirivel, a spokesperson for the Arkansas Department of Health, withheld any information, citing state legislation that forbids disclosing specifics of inquiries into hospitals or surgery centers.

No patient transfers are mentioned in the inspection report by the state official. It states that the facility acted outside of accepted industry standards by doing colonoscopies without a second nurse in the room. The facility promised health regulators that it would staff the endoscopic chambers with a nurse.

According to Dr. John Dombrowski, an anesthesiologist and board officer of the American Society of Anesthesiologists, having an extra pair of hands can be crucial in an airway failure.

You have minutes if you have an airway issue, he explained. “You can save someone more effectively when more people are on the scene.”

Another ambulance rushed to the center three hours after the inspector departed Kanis.

According to his family’s lawsuit, Clarence Creggett, 83, who also stopped breathing at the clinic after his colonoscopy, may still have survived if another medical practitioner had been there. According to the family, he passed away at a hospital nine days later.

Additionally, Creggett’s family filed a complaint, claiming that given his age and history of respiratory issues, including asthma, he was “extremely high risk” as a patient at the surgery facility.

According to her complaint, Watkins, who managed to breathe after she stopped breathing, said she only found out about Smith and Creggett’s deaths through rumors spread at her bank and hair shop. Then, my eyes grew large,” Watkins remarked. That’s how I truly learned, she said.

In Pulaski County, Arkansas, lawyer Lamar Porter has filed paul mackoul, md lawsuit on behalf of Watkins and the Smith and Creggett families. Dr. Alonzo Williams, who carried out all three surgeries, was accused of failing to screen the victims in the lawsuit adequately. The cases also assert that the nurse anesthetists mishandled the anesthetic administration.

The endoscopy facility denied wrongdoing in court documents, and the lawsuits finally concluded with private settlements. In a letter, Kanis’ director Suzette Siegler said the facility “strives to provide the very best care possible.”

In court documents, the anesthetists also disputed any carelessness or guilt. Dustin Wixson, the nurse anesthetist on the Creggett case, claimed there had never been a death in his 14-year tenure.

Williams claimed innocence in each case’s court documents. When contacted for remark, he remained silent. Siegler’s letter contended that he had “practiced for over 35 years with an unassailable reputation nationally” and had been dropped from the litigation before they were resolved. Three Arkansas governors chose him to serve on the Arkansas State Medical Board.

Crackdowns that are Ineffective

After egregious safety violations, Medicare inspectors have a severe penalty they use sparingly: involuntary decertification. It implies that the federal government will not foot the bill for elderly citizens’ medical treatment.

Such moves tend to get media attention and cut off a significant supply of patients and financial support for hospitals. In recent years, unintentionally decertified hospitals had to permanently close, reopen as clinics, or undergo organizational changes before treating another patient.

However, the operation facilities affected by these sanctions have yet to catch up.

On December 28, 2014, Medicare withdrew its accreditation from the Cascade Cosmetic Surgery Center in Orem, Utah, after state inspectors found that the facility did not adhere to the fundamental requirements imposed by federal laws.

According to the inspection report, the Utah center’s owner, Dr. Trenton Jones, told the inspector “he was the governing body and did not keep minutes of his thoughts.” Medicare requires a surgery center to have a governing body that holds formal meetings and accepts legal responsibility for delivering “quality health care in a safe environment.”

In addition, the inspection found that the facility did not adhere to Medicare’s infection-control guidelines, which include having a qualified professional in charge, identifying the type of bacteria that affected patients, and keeping track of medication usage.

According to licensing authorities, some states would follow Medicare’s example and withdraw licenses. According to Tom Hudachko, a spokesman for the Utah Department of Health, any licensed surgeon in Utah can do surgery in a facility with one operating room without seeking state clearance.

Sandy Lee Walters, a 37-year-old real estate agent and mother of three, went to Utah from Hawaii for breast reduction, stomach tuck, and liposuction procedures. Cascade was open for business five days after Medicare withdrew its permission. From 2:30 p.m., the surgeries lasted approximately nine hours. Based on court documents, from 11:20 p.m.

After a blood clot became stuck in her lung, Walters passed away five days later. The postmortem report listed her “recent surgery” as a “significant contributing condition” in the postmortem report.

Her family claimed in a lawsuit that despite Walters’ extensive surgery and recent plane travel putting her at high risk for blood clots, neither a “sequential” compression device nor clot-busting medicine was provided for her. The suit is still pending.

In a deposition, the eldest daughter of Walters stated that her brother treasured a blanket his grandma sewed from his mother’s blue pants. The kid admitted, “We all have some of ourselves missing.

A 55-year-old lady had her breast implants removed at the same medical facility three months after Walters passed away. The woman’s infections were discovered to be so bad after only a week that additional procedures were required to remove her nipples. The lady filed a complaint in 2017 alleging negligence by Jones and the institution. The suit is still pending.

Calls and emails to Cascade, Jones, and his attorneys requesting comment went unanswered. According to court records, Cascade and Jones disputed the claims.

With the approval of private accrediting organizations that the centers contracted to conduct inspections, eight clinics in California that Medicare decertified due to health breaches have continued to treat patients. These facilities include one where staff members forced an unqualified receptionist to clean inside-the-body scopes while operating without a life-saving medication in the crash cart.

According to a Medicare official, accrediting bodies are informed when the agency withdraws permission, but authorities do not influence the private body’s choices.

Owners Are in Control

In hospitals, boards and administrators work to ensure that doctors have enough insurance and skill sets. Similar regulations apply to surgery facilities, although the control is weaker when a contentious physician owns the business.

According to Washington, D.C., Board of Medicine documents, Dr. Paul Mackoul, md lawsuit a Maryland gynecological surgeon, lost his hospital privileges in 2001 after a medical staff committee at Washington Hospital Center evaluated his “competence or conduct.” Mackoul objected to the choice, claiming he could never defend himself.

According to court documents, Mackoul has been the target of 14 lawsuits since 1991 that claim her obstetrics and gynecological care was subpar. He’s been charged with abandoning women infertile, incontinent, or with ruptured intestines. In an email, Mackoul stated that four instances resulted in settlements paid on his behalf, two cases were found in his favor at trial, one issue is still unresolved, and the remaining cases were dropped or did not result in any payment on Mackoul’s behalf.

Despite losing his privileges at Washington Hospital Center, Mackoul co-owns and runs Innovations Surgery Center in Rockville, Maryland, with his wife, a gynecologist. On the advice of an accreditation organization, Medicare has authorized the facility.

According to a complaint filed by the insurer, Mackoul’s malpractice coverage did not cover him to conduct cancer surgery in the early months of 2015. According to discussions with hospital administration specialists, most hospital administrators would not let a doctor conduct operations that aren’t covered.

According to court documents and Mackoul, the governing board at Innovations consisted of him, his wife, and the facility administrator. He said that he had privileges at a hospital in Maryland.

After learning that she had uterine cancer, Jeanette Nelson, a 73-year-old soprano gospel singer, resorted to Mackoul for assistance.

He successfully completed her hysterectomy. A month later, Mackoul met her once again to insert a catheter into her chest to improve the absorption of her chemotherapy medications. According to her autopsy report, Nelson died in a hospital later that day.

According to the autopsy report, Nelson’s lung collapsed due to blood accumulating in her chest wall, but the reason for the blood accumulation was “not definitively identified.” The investigation concluded that Nelson’s death was due to “a complication of attempted treatment for her” disease.

In a complaint, Nelson’s family claimed that Mackoul accidentally damaged a vein when inserting the catheter, which led to deadly internal bleeding.

George Nelson, a devoted Christian and a fan of murder-mystery detective series said he was heartbroken by the death of his wife of 48 years. The pair had been anticipating her master’s degree in cybersecurity policy before she passed away.

He claimed, following the death of his wife, “I didn’t care if I would have died.”

In an email, Mackoul claimed that Jeanette Nelson’s passing was due to a “major cardiac episode” and that the specialists he hired did not uncover any errors in his treatment. He maintained his innocence in the litigation that resulted in a private settlement.

Mackoul states, “Unfortunately, even under the best of circumstances and in the very best of hands, a patient can experience the most catastrophic event.”

When Mackoul’s malpractice insurance filed a lawsuit against him over the wrongful death claim, court documents revealed that he had not been compensated for performing cancer procedures. Even though he was self-insured and was unaware of the provision at the time, Mackoul claimed in an email that the port technique is not explicitly a cancer surgery. He refuted any carelessness in court documents, and the matter was settled in confidence.

Dr. Jonathan Burroughs, a professor at the American College of Healthcare Executives, said the issue of whether the center’s governing board was sufficiently impartial to carry out the customary doctor-oversight procedures still has to be addressed. And it’s a query that countless surgical facilities might use the answer to.

When it counts, he added, the board must decide what is in the neighborhood’s best interests and patient care.

Jay Hancock, a senior journalist for KHN, contributed to this story

The John A. Hartford Foundation contributes to KHN’s coverage of aging and bettering care for seniors.

A nationwide news service covering health policy is called Kaiser Health News (KHN). It is an initiative of the Henry J. Kaiser Family Foundation that is editorially autonomous and separate from Kaiser Permanente.