Mark Alesia, USA Today Network, Author at Ñî¹óåú´«Ã½Ò•îl Health News Fri, 10 Aug 2018 16:46:04 +0000 en-US hourly 1 https://wordpress.org/?v=6.8.5 /wp-content/uploads/sites/2/2023/04/kffhealthnews-icon.png?w=32 Mark Alesia, USA Today Network, Author at Ñî¹óåú´«Ã½Ò•îl Health News 32 32 161476233 Lax Oversight Leaves Surgery Center Regulators And Patients In The Dark /news/lax-oversight-leaves-surgery-center-regulators-and-patients-in-the-dark/ Thu, 09 Aug 2018 14:15:40 +0000 https://khn.org/?p=861338 The first man died in April 2014. Another died later that month. Then on July 18 of that year, a woman was rushed to a hospital where she was told she was lucky to be alive.

They all went to the same Little Rock, Ark., surgery center for a colonoscopy, among the safest procedures a patient can have. And each stopped breathing soon afterward, court records say, sustaining the same type of brain damage seen in a drowning victim.

What happened at Kanis Endoscopy Center prompted no review by officials in Arkansas, which, like 16 other states, has no mandate to report patient deaths after surgery center care. So no facility oversight authority has examined whether the deaths were a statistical anomaly or cause for alarm.

A Kaiser Health News and USA Today Network investigation found that surgery centers operate under such an uneven mix of rules across U.S. states that fatalities or serious injuries can result in no warning to government officials, much less to potential patients. The gaps in oversight enable centers hit with federal regulators’ toughest sanctions to keep operating, according to interviews, a review of hundreds of pages of court filings and government records obtained under open records laws. No rule stops a doctor exiled by a hospital for misconduct from opening a surgery center down the street.

Even the high-profile death of comedian Joan Rivers — who passed away in 2014 following a routine procedure at a Manhattan surgery center — failed to appear in Medicare’s public tally of patients rushed to a hospital.

When Faye Watkins, 63, walked into Kanis Endoscopy in Arkansas, she was unaware that there had been two deaths after care there within the previous three months, she said. She was in the fog of anesthesia when it struck her that something was amiss. She said she heard men say her blood pressure was falling.

“I said [to myself], ‘Lord, if it’s time for me to go, take me. But I’m not ready,’” Watkins recalled. Her next memory was waking up in a hospital with her chest sore from CPR.

The KHN/USA Today examination raises questions about the need for more robust oversight of surgery centers, where public access to important information, such as surgical outcome data, tends to be more limited than what’s available about hospitals. The gap persists even as the nation’s 5,600 surgery centers have surpassed hospitals in number and taken on increasingly complex procedures.

“It’s disgraceful that there’s so little information” about what happens in surgery centers, said Leah Binder, chief executive of the Leapfrog Group, an employer consortium that surveys more than 2,000 hospitals a year.

Scrutinizing unexpected deaths is the norm for U.S. hospitals. The Joint Commission, their leading accreditation body, recommends that members send the accreditor reports of unexpected deaths so that lessons from one tragedy might prevent another. The top surgery center accreditation body has no similar guideline.

Bill Prentice, executive director of the Ambulatory Surgery Center Association, an organization that represents the centers in policymaking discussions, said the centers safely perform millions of procedures, from tonsillectomies to knee replacements, each year.

Prentice said he supports giving patients access to data that could compare surgery centers with hospital outpatient departments.

“We shouldn’t have a patchwork system where one state asks for one thing and others ask for others,” Prentice said. “What consumers want is consistency.”

Colorado requires surgery centers to report deaths and some major injuries to the state health department, and the agency posts summaries of incidents online for consumers. Several other states — including Pennsylvania, Florida and New Jersey — require incident reports but don’t reveal to the public where they happened.

In at least 17 states, health facility officials confirmed they have no way to know that a patient died because surgery centers have no duty to report. So just as in Arkansas, surgery centers had no mandate to notify an official over cases outlined in lawsuits, including a 33-year-old Missouri man who died after finger surgery, a 66-year-old Georgia woman who died after an eye procedure or a 60-year-old in Oklahoma who died soon after a total hip replacement.

Even in Colorado, a leader in transparency, the outcome of a 2017 jury trial raised questions about the depth of the oversight. Robbin Smith was paralyzed from the waist down after an epidural pain injection at the Surgery Center at Lone Tree in 2013, according to her lawsuit against the center.

Smith’s attorneys cited Medicare rules that say the center’s own governing body has a duty to keep patients safe. Each center must appoint a body that is legally responsible for the center’s operations.

Smith’s legal team argued that the center should have upheld its duty by ensuring that its doctors did not use the drug Kenalog — an injectable steroid — for epidural injections. The drugmaker had changed the label in 2011 to warn against using it that way due to the risk of paralysis.

The center’s governing body never discussed proper usage of the drug prior to Smith’s care, trial testimony shows, and there’s no sign that state or private facility overseers examined the board’s actions before Smith’s injury.

The surgery center’s lawyer argued that the doctor — not the facility — was responsible for choosing Kenalog for Smith’s treatment. The doctor denied wrongdoing and reached a confidential settlement with Smith before her case against the center went to trial.

Jurors ultimately ruled against the center, awarding Smith $14.9 million. The center has filed a motion for a new trial.

Public Reports Flawed

The federal government posts on its “” website far more data about hospitals than surgery centers, and available hospital data cover several types of surgical complications and mortality rates for certain conditions. Some hospitals’ quality measures, like infection rates or patient satisfaction scores, reflect the experience of every patient in the hospital.

The same Medicare website displays different data for surgery centers — and for some key measures, the reported results cover only a fraction of patients. Medicare allows surgery centers to report data for as few as half of just their Medicare patients, ignoring most patients under age 65 who do not yet qualify for Medicare.

In practice, that has allowed surgery centers to report as many hospital transfers as they choose — unless more than half of their patients leave by ambulance.

Yet a person examining the data on the Medicare website would see no explanation about the limits of the information. They would see a national transfer rate that’s less than half the rate reported in .

State records, ambulance records and Medicare’s own inspection reports highlight the apparent disconnect. They show that dozens of centers reporting zero transfers in Medicare’s public data do, in fact, send patients to hospitals.

For example, Memphis-based Urocenter, which specializes in urological procedures, reported to state officials 45 transfers combined in 2014 and 2015. Its public report on the Medicare website for those years showed zero transfers.

When a reporter noted the discrepancy, Urocenter’s administrator responded in an email that the facility “put in place corrective measures … and have provided [Medicare] with the corrected information.”

The Medicare data also show zero transfers in 2014 from Yorkville Endoscopy. The Manhattan surgery center transferred Joan Rivers, 81, to a hospital after complications from a vocal cords procedure that year. Rivers died a week later.

An attorney for Yorkville Endoscopy said all transfers meeting the government’s standards were reported.

After reviewing the reporting rules, Cheryl Damberg, a Rand Corp. researcher who has worked on hospital quality-reporting tools for the federal government, said the 50 percent rule leaves the public with little useful information.

“It seems like this can totally be gamed,” Damberg said. “From a consumer standing, the data [for surgery centers] doesn’t have a lot of utility at this point.”

Medicare officials said in an interview that the agency allows limited reporting so the requirements do not overburden surgery centers.

Yet industry leaders have told Medicare they want to report more data. In letters to Medicare during 2016 and 2017 rule-making periods, the ASC Quality Collaboration, a group of surgery center leaders, urged Medicare to collect reports on every patient transfer to expand transparency and accountability.

Medicare made a very different move in July, proposing to stop collecting surgery center-to-hospital transfer data and seven other measures of quality. The agency said it still plans to report on incidents gleaned from its own records, like visits to the hospital seven days after certain surgery center procedures.

Medicare said in the proposed rule that the transfer measure appears to be “topped out,” meaning there is a tiny difference in transfer rates reported by the centers.

Dr. Ashish Jha, a senior associate dean at Harvard’s School of Public Health, said calling the data “topped out” is puzzling since Medicare is not sampling all of the patients.

“Getting rid of [the transfer measure] doesn’t make a lot of sense to me,” he said.

Prentice, of the surgery center association, lauded the proposal in a press release as recognizing the “outstanding” work of surgery centers in preventing harm. In an interview, he conceded that he was “parroting” Medicare’s sentiment and said he hopes the industry will find a way to report meaningful quality data.

“I want us to fill that gap,” Prentice said. “We need to be robustly reporting data to [Medicare] and the world on quality of care.”

Cluster Of Cases In Arkansas

Medicare’s rules for surgery centers require them to track unusual events, analyze them internally and try to learn from them. But after two deaths and a close call after procedures at Kanis Endoscopy Center, no outside official went in to see if patients remained at risk.

Medicare spokesman Tony Salters confirmed that, lacking a consumer complaint, no state or federal official was notified of the events and no special review occurred.

Yet what happened in a stretch of three months was far from routine. In April 2014, Rev. Ronald Smith, 63, died at a hospital after visiting Kanis for a colonoscopy. His family later alleged in a lawsuit that Smith’s sleep apnea and heart disease made him “extremely high risk” for undergoing anesthesia at the center, rather than at a hospital.

Smith was close to death at the Little Rock hospital when, coincidentally, an Arkansas health official began a routine inspection of the center on behalf of Medicare, records show. The lack of public information makes it impossible to determine precisely what happened in Smith’s case.

Medicare spokesman Bob Moos said state recertification inspectors come in every four to seven years and review all cases in the previous year in which a surgery center patient was transferred to a hospital. When the state inspector visited Kanis, “nothing on the hospital transfer log raised a red flag for her to investigate,” the spokesman said.

Officials would not describe what was on the transfer log or which cases were on it or confirm that Smith’s name had been included on it.

A Kanis spokesperson said it would violate patient confidentiality to comment on what the staff showed the inspector. Arkansas Department of Health spokeswoman Meg Mirivel provided no details, saying state law prohibits releasing information about hospital or surgery center investigations.

The state official’s inspection report does not mention any patient transfers. It does say the center was operating outside of industry norms by performing colonoscopies without an additional nurse in the room. The center pledged to health officials that it would add a nurse to the endoscopy suites.

The extra set of hands can be critical in case of an airway failure, said Dr. John Dombrowski, an anesthesiologist and a board officer with the American Society of Anesthesiologists.

“When you have an airway problem, you’ve got minutes,” he said. “When you have more hands on deck, you’re better able to save somebody.”

About three hours after the inspector left Kanis, another ambulance was speeding to the center.

It remains unclear if having another medical professional present would have helped save Clarence Creggett, 83, who also stopped breathing at the center after his colonoscopy, according to his family’s lawsuit. He died in a hospital nine days later, the family alleged.

Creggett’s family also filed a lawsuit, alleging that he was at “extremely high risk” as a surgery center patient, given his age and history of respiratory problems, including asthma.

Watkins, who survived after she stopped breathing, according to her lawsuit, said she only learned about the deaths of Smith and Creggett through gossip at her bank and hair salon. “My eyes got big then,” Watkins said. “That’s how I actually found out.”

Attorney Lamar Porter filed lawsuits in Pulaski County, Ark., on behalf of Watkins and the families of Smith and Creggett. The suit alleged that Dr. Alonzo Williams, who performed all three procedures, failed to properly screen the patients. The suits also claim that the nurse anesthetists did not administer the anesthesia appropriately.

The endoscopy center denied wrongdoing in court filings, and the suits ultimately ended with confidential settlements. Suzette Siegler, director of Kanis, stated in a letter that the center “strives to provide the very best care possible.”

The anesthetists also denied fault or negligence in legal filings. Dustin Wixson, the nurse anesthetist on the Creggett case, said the death was the only one in his 14-year career.

Williams denied wrongdoing in court filings for each case. He did not respond to requests for comment. Siegler’s letter stated that he was dismissed from the lawsuits before they settled and has “practiced for over 35 years with an unassailable reputation nationally. He was appointed by three separate Arkansas Governors to [the] Arkansas State Medical Board.”

Crackdowns That Don’t Stick

Medicare inspectors have a harsh sanction they mete out sparingly after serious safety lapses: involuntary decertification. It means the federal government won’t pay for seniors’ care at a health facility.

Such actions cut off a major source of patients and payments to hospitals and tend to make headlines. Hospitals that were involuntarily decertified in recent years closed for good, had to reopen as a clinic or reorganized before seeing another patient.

But surgery centers hit by such penalties have hardly skipped a beat.

Medicare pulled its certification from Cascade Cosmetic Surgery Center in Orem, Utah, on Dec. 28, 2014, after state inspectors said the center failed to meet basic standards mandated by federal regulations.

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

The inspection also said the center did not meet Medicare’s infection-control rules, such as putting a licensed professional in charge, determining what kind of bacteria infected patients or logging antibiotic use.

In some states, licensing officials would follow Medicare’s lead and revoke their approval. But in Utah, any licensed surgeon can operate in a one-operating-room surgery center without state approval, said Tom Hudachko, spokesman for the Utah Department of Health.

That meant Cascade was open for business — five days after Medicare pulled its approval — when Sandy Lee Walters, a 37-year-old real estate agent and mother of three, flew to Utah from Hawaii for breast reduction, tummy tuck and liposuction surgeries. The procedures took nearly nine hours, from 2:30 p.m. to 11:20 p.m., court records show.

Five days later, Walters died after a blood clot lodged in her lung. Her autopsy report notes “recent surgery” as a “significant contributing condition” in her death.

A lawsuit filed by her family alleged that Walters was at high risk for a blood clot because of her recent air travel and the extent of the surgery, yet she was not prescribed a “sequential” compression device or clot-busting medication. The suit is ongoing.

Walters’ eldest daughter testified in a deposition that her brother treasures a blanket his grandmother made from his mother’s blue jeans. “We all have a little piece of us missing,” the teen testified.

Three months after Walters’ death, a 55-year-old woman went to the same surgery center to have her breast implants removed. Within a week, the woman was found to have infections so severe that her nipples had to be removed in subsequent surgeries. In 2017, the woman filed a lawsuit alleging malpractice by Jones and the center. The suit is ongoing.

Cascade, Jones and his attorneys did not return calls or emails seeking comment. In both lawsuits, Cascade and Jones denied the allegations, according to court documents.

In California, eight centers that Medicare decertified over health violations have continued to operate on patients, with the blessing of private accreditation agencies hired by the centers to perform inspections. They include a center that was operating without a lifesaving drug in the crash cart and a facility where managers pressed an unqualified receptionist into duty disinfecting scopes used inside the body.

A Medicare official said accreditation bodies are notified when the agency pulls an approval, but officials do not control the private body’s decisions.

Owners In Charge

Hospitals have committees and administrators focused on making sure doctors’ skills are sharp and their insurance is in place. Surgery centers have similar rules, but the oversight is lacking when a controversial doctor is also the facility owner.

Dr. Paul Mackoul, a Maryland gynecological surgeon, lost his hospital privileges in 2001 after a medical staff committee at Washington Hospital Center reviewed his “competence or conduct,” according to Washington, D.C., Board of Medicine records. Mackoul criticized the decision, saying he never had a chance to defend himself.

Mackoul has faced 14 lawsuits since 1991 alleging substandard obstetrics and gynecological care, according to court records. Women have accused him of leaving them infertile, incontinent or with perforated bowels. Mackoul said in an email that settlements were paid on his behalf in four cases, two were decided in his favor at trial, one case is pending and the others were dismissed or resulted in no payment on his behalf.

Despite losing privileges at Washington Hospital Center, Mackoul and his wife, who is also a gynecologist, co-own and operate Innovations Surgery Center in Rockville, Md. The facility is Medicare-approved, based on the recommendation of an accreditation body.

An insurer’s lawsuit shows that in early 2015, Mackoul’s malpractice policy did not cover him to perform cancer surgery. Most hospital executives would not allow a physician to perform procedures that aren’t covered, according to interviews with hospital administration experts.

Mackoul, his wife and the facility administrator served as the governing board at Innovations, according to court records and Mackoul. He also said he has privileges at one Maryland hospital.

In February 2015, Jeanette Nelson, 73, a soprano gospel singer, turned to Mackoul for care after she had been diagnosed with uterine cancer.

He performed her hysterectomy without incident. Mackoul saw her again a month later to install a catheter in her chest that would better deliver chemotherapy drugs to her bloodstream. Nelson died in a hospital later that same day, her autopsy report says.

The autopsy report states that blood built up in Nelson’s chest wall and caused her lung to collapse, but the source of the blood was “not definitively identified.” However, the report concluded that her death was the result of “a complication of attempted treatment for her” cancer.

Nelson’s family alleged in a lawsuit that Mackoul punctured a vein as he installed the catheter, and his mistake caused internal bleeding that proved fatal.

George Nelson said he was devastated by the loss of his wife of 48 years, who was both devoutly religious and fascinated with murder-mystery detective shows. Before her death, the couple was looking forward to her graduation from a master’s program in cybersecurity policy.

After his wife’s passing, he said: “I didn’t care if I would have died.”

In an email, Mackoul said Jeanette Nelson’s death was related to a “major cardiac episode” and that experts he retained found no shortcomings with his care. He denied wrongdoing in the lawsuit, which reached a confidential settlement.

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

Mackoul’s malpractice insurer sued him over the wrongful death case, revealing in court records that he had not been covered to perform cancer surgeries. Mackoul said in an email that the port procedure is not specifically a cancer surgery, though he was not aware of the clause at the time and was self-insured. He denied negligence in court filings, and the case reached a confidential settlement.

The question remains whether the center’s governing board was independent enough to perform the typical doctor-oversight practices, said Dr. Jonathan Burroughs, a faculty member of the American College of Healthcare Executives. And it’s a question that applies to an untold number of surgery centers.

“When push comes to shove,” he said, “the board has to make decisions in the best interest of the community and good patient care.”

KHN senior correspondent Jay Hancock contributed to this report.

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A medida que crecen los centros de cirugía, los pacientes están pagando con sus vidas /news/a-medida-que-crecen-los-centros-de-cirugia-los-pacientes-estan-pagando-con-sus-vidas/ Fri, 02 Mar 2018 19:41:24 +0000 https://khn.org/?p=818787 La cirugía fue bien. Los doctores que la atendían se fueron. Cuatro horas después, Paulina Tam comenzó a jadear por falta de aire.

Una hemorragia interna le estaba bloqueando la tráquea: era de las posibles complicaciones tras la cirugía de columna vertebral a la que había sido sometida.

Pero un informe de Medicare en el que se evalúa la situación indica que ninguno de los que estaban de guardia esa noche en el centro de cirugía del norte de California sabía qué hacer.

En medio de la desesperación, una enfermera hizo algo impensable en un centro de salud.

Llamó al 911.

Según el informe, una ambulancia llevó a Tam a la sala de emergencias; pero la mujer, de 58 años y madre de tres hijos, llegó sin vida.

Si a Tam la hubieran operado en un hospital, un procedimiento relativamente simple podría haberle salvado la vida.

Pero al igual que cientos de miles de pacientes cada año, Tam acudió a uno de los más de 5,600 centros de cirugía que hay en el país.

Estos centros comenzaron a funcionar hace casi 50 años como alternativas de bajo costo para cirugías menores. Ahora superan en número a los hospitales, ya que los reguladores federales han aprobado una gama cada vez mayor de procedimientos ambulatorios en un esfuerzo por reducir los costos federales de atención médica.

Miles de veces al año, estos centros llaman al 911 cuando los pacientes experimentan complicaciones que pueden ser desde menores hasta fatales. Pero se desconoce el número de personas que muere como consecuencia de estas complicaciones porque no existe un reporte oficial a nivel nacional. Una investigación realizada por Kaiser Health News y USA TODAY Network ha descubierto que más de 260 pacientes han muerto desde 2013 en el país después de ser sometidos a una cirugía ambulatoria. Decenas de personas, incluyendo niños de tan solo 2 años, fallecieron luego de operaciones de rutina, como colonoscopías y extracción de amígdalas.

Los periodistas examinaron informes de autopsias, presentaciones legales y más de 12,000 documentos de inspecciones estatales y de Medicare, y entrevistaron a docenas de médicos, expertos en políticas de salud y pacientes, en toda la industria, para llevar a cabo la investigación más exhaustiva que se ha hecho de estos archivos hasta la fecha.

Esto es lo que la investigación reveló:

  • Los centros de cirugía han ido ampliando sistemáticamente sus servicios ofreciendo cirugías cada vez más riesgosas. Al menos 14 pacientes murieron después de complejas cirugías de columna como las que los reguladores federales de Medicare aprobaron recientemente para estos centros. Pero si es cierto que el riesgo de efectuar tales cirugías fuera de un hospital puede ser enorme, también lo es la recompensa. Los médicos que son dueños de una parte del centro pueden ganar sus propios honorarios y una porción del costo, una suma significativa para operaciones que pueden alcanzar los $100,000 o más.
  • Para proteger a los pacientes, Medicare requiere que estos centros de cirugías establezcan un acuerdo con un hospital local adonde llevar a los pacientes cuando surjan emergencias. Pero en las zonas rurales, los centros pueden estar a 15 millas o más de un hospital. Incluso cuando el hospital está cerca, pueden pasar de 20 a 30 minutos entre la llamada al 911 y el arribo a una sala de emergencias.
  • Se acusa a algunos centros de pasar por alto problemas de salud de alto riesgo para tratar a pacientes que, según los expertos, deberían ser operados solo en hospitales. Al menos 25 personas con afecciones médicas subyacentes murieron minutos o días después de salir de uno de estos centros. Los casos incluyen a una mujer de Ohio con la presión arterial fuera de control, un hombre de West Virginia de 49 años que estaba en lista de espera para un trasplante de corazón, y varios niños con apnea del sueño.
  • Algunos centros quirúrgicos arriesgan la vida de los pacientes escatimando en capacitación o equipos que salvan vidas. Otros envían a los pacientes a casa antes que se recuperen por completo. En camino a sus hogares, familiares en Arkansas, Oklahoma y Georgia descubrieron que sus seres queridos no estaban dormidos, sino al borde de la muerte. Los centros de cirugía han sido criticados en casos en los que el personal no tenía las herramientas para abrir la vía aérea de un paciente o carecían del conocimiento necesario para salvar a un paciente de una hemorragia letal.

La mayoría de las operaciones realizadas en centros quirúrgicos se efectúan sin problemas. Está claro que la cirugía conlleva riesgos, sin importar en dónde se haga. Algunos centros cuentan con equipos de última generación y personal altamente capacitado que está bien preparado para manejar emergencias.

Pero Kaiser Health News (KHN) y USA TODAY Network encontraron más de una docena de casos en los cuales la ausencia de personal capacitado o la falta de equipo de emergencia adecuado parece haber puesto a los pacientes en peligro.

Y en casos similares a los de Tam, a los pacientes de cirugía de la columna vertebral superior se les ha enviado a casa demasiado pronto, con el riesgo de asfixia inminente.

En 2008, un padre de tres hijos de Oregon, de 35 años, comenzó a asfixiarse, golpeando el techo del automóvil con frustración mientras su esposa lo llevaba a un hospital. En 2011, un hombre de Dallas se desplomó en brazos de su padre mientras esperaban una ambulancia. Otro hombre de Oregon sintió que se quedaba sin aire en la sala de estar de su hogar la noche después de su cirugía de columna vertebral, en 2014. Un hombre de San Diego comenzó a jadear “como un pez”, en palabras de su esposa, mientras esperaban una ambulancia el 28 de abril de 2016.

Ninguno de ellos sobrevivió.

El paciente de cirugía espinal, McArthur Roberson, de 60 años, perdió más de un litro de sangre durante la operación y luchó por respirar después de la cirugía, afirmó su familia en la demanda legal. Murió camino a casa.

El doctor Daniel Silcox, cirujano de columna vertebral de Atlanta y testimonio experto de la familia en la demanda, dijo que si “se le hubiera mantenido en observación en un hospital durante la noche, su muerte no habría ocurrido”.

El centro quirúrgico se eximió de culpa en el caso que se cerró con un acuerdo confidencial en 2017.

Muchos en el campo de la salud, desde médicos hasta compañías de seguros privadas y Medicare, han descartado que la enorme cantidad de muertes se deba a errores que escapan al control de los médicos.

Los periodistas de USA TODAY Network y KHN contactaron a 24 médicos y administradores de centros quirúrgicos para preguntarles sobre la muerte de pacientes, pero ninguno respondió a la pregunta sobre qué fue lo que salió mal, citando leyes de privacidad de los pacientes o derivando a los reporteros a los abogados. En respuesta a demandas en todo el país, los centros de cirugía han argumentado que las complicaciones fatales se encuentran entre los resultados conocidos de dichas cirugías. Dos centros culparon a los pacientes fallecidos por negligencia.

Bill Prentice, director ejecutivo de la Asociación de Centros de Cirugía Ambulatoria, se negó a hablar sobre casos individuales, pero dijo que no ha visto datos que demuestren que los centros sean menos seguros que los hospitales.

“No hay nada peculiar o diferente en el modelo de un centro de cirugía que haga que la atención médica pueda ser más peligrosa que en cualquier otro lugar”, dijo Prentice. “El cuerpo humano es algo misterioso, y un paciente que ha cumplido con todos los protocolos posibles puede venir un día y le puede ocurrir algo inimaginable que no tiene nada que ver con la atención que se le ha brindado”.

Sin embargo, el doctor Kenneth Rothfield, miembro de la junta de directores de la Physician-Patient Alliance for Health & Safety, afirmó que muchos centros de cirugía y sus médicos se extralimitan sobre cuánto se puede hacer en los centros para pacientes ambulatorios.

“Es importante entender que los centros de cirugía no son hospitales”, dijo. “Tienen diferentes recursos, diferentes equipos”.

El crecimiento explosivo de los centros de cirugía, que reciben $4.1 mil millones al año de Medicare, se ha dado bajo circunstancias que algunos expertos médicos consideran indecorosas.

La ley federal permite que los médicos de un centro de cirugía, a diferencia de otros, envíen a sus pacientes a instituciones de las que ellos lucran, en lugar de a un hospital de servicio completo que esté más cerca. Esta práctica puede, en algunos casos, aumentar el riesgo para un paciente, pero duplica las ganancias del médico.

Prentice indicó que es bueno que los médicos sean dueños de los centros de cirugía.

“Los médicos que ejercen allí son responsables de todo lo que sucede en ese centro desde el momento en que el paciente sale de su automóvil en el estacionamiento hasta el momento en que se va”, dijo.

Pero varios estudios han demostrado que los médicos de los centros de cirugía que son propietarios realizan operaciones con más frecuencia. Y en pleitos en todo el país, han sido acusados ​​de tomar riesgos con sus pacientes.

Incluso algunos que se han ganado la vida en esta industria de los centros de cirugía han expresado su preocupación. El doctor Larry Teuber, neurocirujano de Dakota del Sur que trabajó como ejecutivo en la industria de centros quirúrgicos durante 22 años, dijo que ha visto a los dueños de estos centros realizar cirugías ortopédicas y espinales cada vez más complejas y lucrativas, socavando las ganancias de un hospital cercano en incremento de la suya propia.

“Cuando estás ganando dinero haciendo [cirugías complejas] te encuentras en una pendiente ética resbaladiza”, dijo Teuber. “El dinero eclipsa todo”.

La historia

El primer centro de cirugía en los Estados Unidos se abrió en Phoenix, Arizona, en 1970, un lugar “metido entre las tiendas del vecindario y una iglesia Bautista”, donde por $90 se le podía practicar a un niño una incisión para aliviar la presión en el oído interno, según informó The Arizona Republic en aquella época.

Los doctores John Ford y Wallace Reed fueron los pioneros, quienes cuestionaron por qué los pacientes debían ser hospitalizados para someterse a cirugías menores.

Sacar estos procedimientos de los hospitales reduce el costo para los pacientes y para las aseguradoras porque los centros de cirugía no requieren el mismo nivel de personal ni de equipo para salvar vidas.

Medicare ayudó a impulsar la expansión de los centros cuando comenzó a pagar por las cirugías en 1982.

Luego, en 1993, el Congreso alentó a los médicos a abrir centros de cirugía al eximirles de la segunda Ley Stark, que impide a los médicos referir a sus pacientes a instituciones de las que son dueños.

Al principio, los médicos-empresarios impulsaron el crecimiento al recomendar a sus pacientes que probaran los centros. Luego, al ver que perdían lucrativas cirugías, los hospitales comenzaron a comprar sus propios centros. El año pasado, el gigante de seguros UnitedHealth Group gastó $2,3 mil millones en la compra de una cadena nacional de centros quirúrgicos.

Los centros han sido bien aceptados entre los pacientes, que disfrutan de la comodidad y de una atención personalizada. Los médicos dicen que les gusta la facilidad para planear operaciones sin la posibilidad que cirugías de emergencia, inesperadas, modifiquen el calendario. Y los centros de cirugía han prosperado incluso cuando los hospitales luchaban para contener la propagación de infecciones.

En estos momentos existen 5,616 centros certificados por Medicare. La expansión se ha producido a pesar de las persistentes preocupaciones sobre la seguridad. En 2007, Medicare puntualizó que los centros quirúrgicos “no cuentan con los estándares de seguridad del paciente establecidos para los hospitales, ni se les exige tener el personal capacitado ni el equipo necesario para brindar una amplia atención médica… “Algunos procedimientos son “inseguros” para ser realizados en los centros de cirugía, concluyó el informe.

Medicare recomendó a los centros transferir pacientes a hospitales cuando surjan emergencias. Pero solo un tercio de los centros quirúrgicos participan voluntariamente en esta iniciativa de reportar la frecuencia con que esto ocurre. En el año que finalizó en septiembre de 2017, los centros enviaron al menos 7,000 pacientes al hospital, según muestra un análisis de KHN de los datos de la industria de centros quirúrgicos. No todos sobreviven el viaje.

Ese fue el caso de James Long, de 56 años, quien no tenía pulso cuando llegó una ambulancia al centro de cirugía de Colorado donde se había sometido a más de cinco horas de cirugía de columna inferior en 2014, según se establece en los registros médicos del centro proporcionados al abogado de la familia.

El estado revisó el caso y no citó deficiencias. Jen Kenitzer, la administradora del Minimally Invasive Spine Institute, aseguró que el centro cuenta con “amplios procedimientos para responder rápida y apropiadamente” en caso de emergencia.

Sin embargo, los familiares de Long siguen preocupados por el caso.

“En el siglo 21 en los Estados Unidos, ¿un médico que opera a un paciente tiene que llamar al 911?”, exclamó Robin Long, su ex esposa, quien no demandó al centro. “Por favor… Es absurdo”.

Experiencia en emergencias

Los pacientes ingresan a hospitales con ataques cardíacos, heridas de bala y lesiones traumáticas. Allí, los médicos y las enfermeras se vuelven expertos en salvar vidas en casos de emergencia.

Los médicos de los centros de cirugía pueden llegar a ser expertos en los procedimientos que realizan con más frecuencia. Pero no siempre están preparados para afrontar una situación de crisis, de acuerdo con una revisión de los registros de Medicare y más de 70 demandas.

Los inspectores de salud que representan a Medicare han descubierto 230 fallos en equipos de rescate o en regulaciones de entrenamiento en centros quirúrgicos desde 2015.

Un centro en California tenía tanques de oxígeno vacíos. Otro que operaba a niños en Arkansas no tenía un set de traqueotomía pediátrica para restaurar la respiración; a otro le faltaban las almohadillas desfibriladoras pediátricas para recuperar el ritmo cardíaco.

En una demanda en curso contra ella y el centro en donde ejerce, la anestesióloga Yoori Yim testificó que, el 23 de diciembre de 2015, no pudo encontrar el tubo de ventilación adecuado para salvar la vida de un paciente que había dejado de respirar.

Rekhaben Shah, de 67 años, había ingresado al Oak Tree Surgery Center en Edison, Nueva Jersey, para una simple colonoscopía.

Yim intentó ayudar a Shah a respirar, sin mucho éxito. Desde el momento en que Shah dejó de respirar en la mesa de operaciones, pasaron 33 minutos hasta que un paramédico le insertó un tubo de respiración, de acuerdo con los registros médicos y de EMS.

Los paramédicos que respondieron a la llamada al 911 del centro tuvieron que usar un video GlideScope para ver dentro de la garganta de la paciente, un equipo que el centro de cirugía no tenía, según el testimonio de la corte.

Para entonces ya era demasiado tarde. A Shah se le retiró el soporte vital en un hospital cercano el día de Navidad.

Ni Yim ni el centro respondieron a las llamadas solicitando su comentario. En registros judiciales, un experto del centro quirúrgico dijo que las vías respiratorias de Shah estaban obstruidas y que se despejaron cuando llegaron los paramédicos. También indicó que el GlideScope no es obligatorio en Nueva Jersey, y que probablemente no habría hecho una diferencia. Sin embargo, un experto hablando en defensa de la doctora Yim dijo que sus acciones habían sido las apropiadas y que si se hubiera encontrado un GlideScope en el centro, “tal vez no estaríamos discutiendo este caso”.

Cuando llegan los equipos de emergencia, los centros de cirugía no siempre están preparados para recibirlos.

En el caso de Yim, los paramédicos testificaron que ella se negó a alejarse de Shah y que les permitió intentar revivir al paciente.

En Florida, los paramédicos que acudieron a un centro de cirugía fuera del horario habitual de atención se encontraron con la puerta cerrada con llave mientras, adentro, un paciente respiraba con dificultad. El hombre de 55 años permanece en estado vegetativo.

En 2016, los paramédicos llegaron al West Lakes Surgery Center en Iowa cuando el personal intentaba revivir a Reuben Van Veldhuizen, de 12 años, después que experimentara complicaciones durante una amigdalectomía, según un informe de inspección de Medicare.

Un paramédico le dijo a los inspectores estatales que tuvo que preguntar quién estaba a cargo de la resucitación del paciente. Nadie respondió, dice el informe.

El niño llegó al hospital 37 minutos después que el personal del centro de cirugía llamó al 911. Allí fue declarado muerto.

La familia presentó una demanda, alegando que el centro y el anestesiólogo se equivocaron al darle al niño un anestésico que conlleva una advertencia sobre el riesgo de paro cardíaco en niños pequeños. En las presentaciones judiciales que siguieron a la demanda, el centro quirúrgico y el anestesiólogo dijeron que la muerte de Reuben fue el resultado de “condiciones preexistentes, actos de terceros o condiciones sobre las cuales (los demandados) no tenían control ni responsabilidad”.

Sin embargo, los abogados que demandan a los centros e investigan sus registros internos dicen que a menudo se observan demoras mortales en la atención.

Pedro Maldonado, de 59 años, fue al Ambulatory Care Center en Nueva Jersey para que le hicieran un examen de diagnóstico del tracto gastrointestinal superior. El procedimiento duró siete minutos. Unos 10 minutos después, el paciente no daba señales de vida, según la demanda de su viuda.

Le tomó al personal del centro de cirugía 25 minutos más para comenzar la Reanimación Cardiopulmonar (CPR, en inglés), según la demanda que el abogado de Philadelphia, Glenn Ellis, presentó en nombre de la viuda de Maldonado. Pasaron otros 27 minutos antes que Maldonado ingresara en el servicio de emergencias, alega la demanda. Maldonado nunca recuperó la consciencia.

Durante una llamada telefónica, un administrador del centro se negó a comentar. En documentos legales, el centro negó las acusaciones de irregularidades.

“En un hospital, los médicos y las enfermeras… saben cómo van a responder”, dijo Ellis. “El personal en los centros quirúrgicos caminan sobre una cuerda floja sin red de seguridad”.

Un círculo de atención

Mientras que el devenir de un hospital continúa durante toda la noche, algunos médicos de centros quirúrgicos trabajan en horarios de oficina. Eso significa que los pacientes cuyas cirugías terminan a última hora del día, a veces, se quedan al cuidado de una o dos enfermeras para estadías de hasta 23 horas. En algunos casos, los pacientes son enviados a casa y deben lidiar con las complicaciones por sí mismos.

Sondra Wallace fue al Surgery Center of Oklahoma a principios de 2017 para un procedimiento sinusal.

Después del procedimiento, los médicos vieron cómo bajaba su nivel de oxígeno en la sangre. Se dieron cuenta que había tenido una reacción a la anestesia y a las 2 pm le administraron un medicamento para revertir los efectos, según una demanda en curso presentada por su esposo.

Una hora después, la enviaron a casa con su esposo, Larry, dice la demanda.

Eran las 3 pm del viernes antes del fin de semana del Día de los Presidentes.

“Simplemente creo que tenían prisa por comenzar su fin de semana de tres días”, dijo su hija Casey Podoll.

Larry Wallace alega en la demanda que el centro no le advirtió que Sondra había tenido una reacción a la anestesia.

Wallace pensó que su esposa dormía en el asiento trasero mientras condujo por más de dos horas a través de los pastizales de Oklahoma, camino a casa. Cuando llegó, descubrió a su esposa fría en el asiento trasero. Fue declarada muerta en el Jackson County Memorial Hospital a las 6:30 pm de ese mismo día.

“No me dieron ninguna indicación… no me advirtieron de nada”, se quejó Podoll.

Craig Buchan, abogado del Surgery Center of Oklahoma, dijo que Wallace cumplía con los criterios de alta y que no se había determinado la causa de su muerte. Dijo que el centro no cerró antes “de lo que suele hacerlo después que el último paciente es dado de alta”.

Cecilia Aldridge dijo que también había sentido que el personal de un centro quirúrgico la estaba apurando para que se marchara después de la cirugía de amígdalas de su hija de 2 años en Arkansas en 2015.

Una demanda presentada por los padres dijo que el centro “dio de alta a Abbygail demasiado pronto porque se acercaba una tormenta de nieve en el área”.

Abbygail se puso azul en el auto, camino a casa. Su madre dijo que corrió a la sala de emergencias y gritó pidiendo ayuda, con su pequeña en brazos.

“Nunca se despertó”, dijo Aldridge entre lágrimas.

Los padres de Abbygail se preguntan ahora si el centro de cirugía debió haber aceptado tratar a su hija.

Debido a que los centros de cirugía tienen menos equipo de seguridad y personal que los hospitales, los líderes de la industria enfatizan la importancia de seleccionar pacientes lo suficientemente saludables como para que les vaya bien. Sus predicciones, sin embargo, no siempre son correctas.

Abbygail, quien adoraba su cobijita y la película “Frozen”, tenía apnea del sueño, latidos cardíacos irregulares y era muy pesada para su edad, según la demanda.

La apnea del sueño aumenta el riesgo de complicaciones graves en la cirugía y la noche posterior, según investigaciones médicas. Dada su condición, Abbygail “debería haber sido ingresada (en un hospital) y monitoreada después del procedimiento”, dijo el doctor Charles Cote, profesor retirado de anestesiología pediátrica de la Universidad de Harvard que no participó en la demanda de la familia.

La demanda dice que los factores de riesgo de Abbygail “fueron documentados y eran conocidos por los demandados”, incluido el médico. Y añade que la pequeña debería haber sido operada “en un hospital para pacientes internados bajo cuidado hospitalario y monitoreada durante la noche”.

El doctor Michael Marsh realizó la amigdalectomía de Abbygail en el Executive Park Surgery Center en Fort Smith, Arkansas.

El abogado del centro de cirugía no quiso hacer ningún comentario. El abogado del médico no devolvió el correo electrónico ni los mensajes de voz. En los documentos judiciales que respondieron a la demanda, Marsh y el centro negaron haber actuado mal.

En corte, Marsh dijo que las lesiones de la niña eran “la progresión natural” de su enfermedad. El Centro de Cirugía de Executive Park dijo en corte que “ninguna acción de parte de la institución… fue causa inmediata de daños o lesiones”. Se logró un acuerdo en el caso.

En al menos 25 casos, los centros quirúrgicos atendieron a pacientes enfermos y frágiles que murieron luego de procedimientos simples, como amigdalectomías, desprendimiento de retina o colonoscopías, según la investigación de KHN y USA TODAY Network.

Medicare le pide a los centros de cirugía que evalúen el riesgo de cada paciente, pero, solo en 2015 y 2016, los inspectores identificaron 122 centros de cirugía por errores en las evaluaciones de riesgo. Algunos centros no pudieron medir el riesgo en absoluto. Otros pasaron por alto sus propios protocolos.

Los médicos pueden usar una evaluación del riesgo de anestesia para descartar pacientes frágiles: los pacientes sanos obtienen una puntuación de 1, y una puntuación de 5 significa que una persona está casi muerta.

Algunos estados, como Pennsylvania y Rhode Island, impiden que ciertos centros quirúrgicos operen con pacientes con un puntaje de riesgo 4 de anestesia. Pero la mayoría de los estados no son tan estrictos y dejan estas decisiones a los doctores.

Y algunas de esas decisiones han tenido trágicas consecuencias. Sabino Sifuentes, de 74 años, había sobrevivido a la cirugía de triple bypass. Sin embargo, el 23 de marzo de 2015, nueve minutos después del comienzo de la anestesia para un procedimiento ocular, dejó de responder y ya no pudo ser revivido, según un informe de inspección de Medicare. Una enfermera anestesista que revisó el caso en el centro de cirugía Eye-Q Vision Care en Fresno, California, dijo a los inspectores estatales de salud que a Sifuentes se le debería haber asignado un puntaje de riesgo 4 y que su atención fue “completamente mal manejada”, dice el informe de la inspección.

En respuesta a la demanda de la familia, el centro de cirugía dijo que el caso de Sifuentes fue resultado de su propia negligencia y la de otros.

Otros cinco pacientes con el mismo puntaje de riesgo murieron después de procedimientos de rutina en centros de cirugía de los Estados Unidos.

Pero tales tragedias rara vez son parte de la discusión cuando Medicare decide si aprueba nuevos procedimientos en los centros de cirugía.

Un ejemplo es la cirugía de columna vertebral.

Hasta 2015, Medicare no pagaba por esta operación en los centros de cirugía. Luego, la asociación de la industria instó a la agencia a realizar el cambio y alentó una campaña de redacción de cartas de los centros de cirugía de todo el país.

Entre los que escribieron esas cartas estuvo el doctor Alan Villavicencio, cirujano de Colorado quien dijo que había estado haciendo estas cirugías durante 12 años y descubrió que sus pacientes “aprecian la conveniencia y el ahorro de costos”. No mencionó que James Long, de 56 años, había muerto tres semanas antes en un centro quirúrgico de Lafayette, Colorado, del que es co-propietario, según un informe del departamento de salud de Colorado y de registros en el colegio de médicos.

United Surgical Partners International, una cadena de centros quirúrgicos, también pidió la aprobación de más procedimientos, sin mencionar el fallecimiento de un paciente horas después de una cirugía de columna vertebral en uno de sus centros afiliados varios meses antes, según documentos judiciales y registros de valores. La cadena dijo en un comunicado que respalda sus comentarios en apoyo de la propuesta.

Estas cartas tienen influencia sobre Medicare, que aprueba los procedimientos que se deben realizar en los centros quirúrgicos en función de si la cirugía es invasiva o compleja, y de los aportes de los interesados.

Robert Beatty-Walters, abogado de Portland, Oregon, quien ha representado a las familias de tres personas que murieron después de los procedimientos de columna vertebral en un centro de cirugía, dijo que el proceso de toma de decisiones de Medicare no es imparcial.

“Las partes interesadas, como se les llama, son los que se benefician durante estos procedimientos regulatorios, no las personas a las que se les proporciona el servicio”, expresó. “Los centros de cirugía espinal solo quieren que vengan más personas. Así ganan más dinero. Odio ser tan cínico al respecto, pero eso es lo que he visto”.

Medicare aprobó 10 códigos de cirugía espinal para que puedan ser facturados en los centros de cirugía a partir de 2015 y agregó más procedimientos espinales para 2017. Una vocera de Medicare declinó una solicitud de entrevista telefónica. En un correo electrónico, una vocera dijo que Medicare solicitó el comentario público y no recibió respuestas que sugirieran que los procedimientos representaban una amenaza para los pacientes de Medicare. Ella dijo que la decisión final acerca de dónde se operará a un paciente depende de un médico y de un paciente.

Para 2017, al menos 14 personas habían muerto apenas después de cirugías espinales realizadas en centros quirúrgicos, según la investigación de KHN/USA TODAY Network.

Las 14 muertes por cirugía de columna han tenido escasa repercusión en la industria o en otros ámbitos. Solo uno de esos fallecimientos fue noticia en los periódicos locales. El resto está documentado en lugares como la corte de Macon, Georgia. O en oscuros informes regulatorios. Y puede haber muchos más porque algunos estados, incluidos Nueva York, Illinois y Florida, no revelan ningún detalle sobre las muertes en centros quirúrgicos.

La muerte de Paulina Tam en Fremont Surgery Center fue un trágico ejemplo. A los 58 años, esta madre de tres hijos había terminado su carrera como enfermera y educadora. Pronto planeaba viajar por el mundo con quien fue su esposo por 32 años.

“Ella era la fuerza impulsora de la familia, el espíritu”, contó su hijo, Eric Tam, médico en la ciudad de Nueva York. “No esperábamos que sucediera lo peor”.

La atención que recibió en el centro está registrada en documentos de corte, informes de los paramédicos (EMS) y un informe de inspección de Medicare que concluyó que el centro “no proporcionó un entorno seguro para la cirugía”.

El doctor de Tam le programó un procedimiento para reemplazar dos discos en su columna vertebral superior el 7 de abril de 2014. El dolor a raíz de un accidente automovilístico la había molestado por años. Cualquier cirugía de este tipo (que implica invadir la parte delantera del cuello para tratar el dolor en la columna) conlleva el riesgo de asfixia, según el informe de inspección de Medicare.

Pero ni su cirujano ni su anestesiólogo se encontraban en el centro, y el único médico disponible era un especialista en salud digestiva, según el informe de inspección. Aproximadamente cuatro horas después de su procedimiento, Tam le dijo a una enfermera que su collar quirúrgico estaba demasiado apretado. Y luego que no podía respirar.

La enfermera estableció un “código azul” justo después de las 6:30 pm, según los registros del centro.

Los expertos médicos dicen que el primer paso para ayudar a esos pacientes es eliminar las grapas quirúrgicas para que la sangre acumulada se pueda dispersar, permitiendo así que el paciente respire.

En el caso de Tam, el personal intentó sin éxito insertarle un tubo de respiración a través de la boca y en sus vías respiratorias, según muestra el informe de inspección. Un remedio de última hora habría sido hacerle un agujero en la garganta para restaurar la respiración, pero el gastroenterólogo le dijo a un inspector que “no estaba preparado” para hacerlo.

La incapacidad para realizar la técnica de rescate de asfixia, según el informe de inspección, equivalía a “no garantizar la seguridad del paciente” del centro.

Desde el momento en que una enfermera llamó al 911, tomó 24 minutos llevar a Tam al hospital más cercano, según muestran los registros del EMS. La paciente llegó sin pulso y permaneció con soporte vital durante la noche, mientras sus hijos se acercaban a su lado para despedirse.

El centro no devolvió las llamadas y negó cualquier irregularidad o infracción en el caso judicial. El cirujano de Tam se negó a hablar sobre el caso, pero presentó alegatos ante la corte que decían que el “descuido y negligencia” de Tam le causó la muerte. No está claro a qué se refería la defensa al hablar de “negligencia”. El caso llegó a un acuerdo confidencial.

Después de la muerte de Tam, el centro les dijo a los inspectores de Medicare que un médico especialista permanecería siempre en su puesto después de los casos de cirugía de columna vertebral alta.

La doctora Nancy Epstein, jefa de atención neuroquirúrgica y de la columna vertebral del Hospital Winthrop de la Universidad de Nueva York, dijo que los centros quirúrgicos que realizan trabajos delicados cerca de la médula espinal, la tráquea y el esófago en un procedimiento en el mismo día le causaban “repugnancia”. Pero ella dijo que los centros están ganando tanto dinero, “a manos llenas”, que los posibles peligros están siendo ignorados.

“Desde un punto de vista médico no se debería tolerar”, dijo, “pero se tolera”.

Ìý³å³å³å³å³å

Un equipo de periodistas con base en California, Indiana, Nueva Jersey, Florida, Washington D.C. y Virginia trabajaron para contar esta historia como parte de una asociación entre USA TODAY Network y Kaiser Health News, un servicio de noticias sin fines de lucro que cubre temas de salud. Los reporteros examinaron miles de páginas de registros judiciales y viajaron por los Estados Unidos para hablar con pacientes afectados o familias de fallecidos. Durante más de un año, usando leyes federales y estatales de acceso a registros, los reporteros reunieron más de 12,000 registros de inspección y 1,500 informes de quejas, así como autopsias, documentos de EMS y registros médicos que se convirtieron en la base de este informe.

Lindy Washburn de The (Bergen County, N.J.) Record y NorthJersey.com contribuyeron con este informe.

La cobertura de KHN de temas de envejecimiento y la mejora de la atención de adultos mayores es apoyada en parte por la .

Ñî¹óåú´«Ã½Ò•îl Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about .

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As Surgery Centers Boom, Patients Are Paying With Their Lives /news/medicare-certified-surgery-centers-are-expanding-but-deaths-question-safety/ Fri, 02 Mar 2018 11:00:40 +0000 https://khn.org/?p=816126 The surgery went fine. Her doctors left for the day. Four hours later, Paulina Tam started gasping for air.

Internal bleeding was cutting off her windpipe, a well-known complication of the spine surgery she had undergone.

But a Medicare inspection report describing the event says that nobody who remained on duty that evening at the Northern California surgery center knew what to do.

In desperation, a nurse did something that would not happen in a hospital.

She dialed 911.

By the time an ambulance delivered Tam to the emergency room, the 58-year-old mother of three was lifeless, according to the report.

If Tam had been operated on at a hospital, a few simple steps could have saved her life.

But like hundreds of thousands of other patients each year, Tam went to one of the nation’s 5,600-plus surgery centers.

Such centers started nearly 50 years ago as low-cost alternatives for minor surgeries. They now outnumber hospitals as federal regulators have signed off on an ever-widening array of outpatient procedures in an effort to cut federal health care costs.

Thousands of times each year, these centers call 911 as patients experience complications ranging from minor to fatal. Yet no one knows how many people die as a result, because no national authority tracks the tragic outcomes. An investigation by Kaiser Health News and the USA TODAY Network has discovered that more than 260 patients have died since 2013 after in-and-out procedures at surgery centers across the country. Dozens — some as young as 2 — have perished after routine operations, such as colonoscopies and tonsillectomies.

Reporters examined autopsy records, legal filings and more than 12,000 state and Medicare inspection records, and interviewed dozens of doctors, health policy experts and patients throughout the industry, in the most extensive examination of these records to date.

The investigation revealed:

  • Surgery centers have steadily expanded their business by taking on increasingly risky surgeries. At least 14 patients have died after complex spinal surgeries like those that federal regulators at Medicare recently approved for surgery centers. Even as the risks of doing such surgeries off a hospital campus can be great, so is the reward. Doctors who own a share of the center can earn their own fee and a cut of the facility’s fee, a meaningful sum for operations that can cost $100,000 or more.
  • To protect patients, Medicare requires surgery centers to line up a local hospital to take their patients when emergencies arise. In rural areas, centers can be 15 or more miles away. Even when the hospital is close, 20 to 30 minutes can pass between a 911 call and arrival at an ER.
  • Some surgery centers are accused of overlooking high-risk health problems and treat patients who experts say should be operated on only in hospitals, if at all. At least 25 people with underlying medical conditions have left surgery centers and died within minutes or days. They include an Ohio woman with out-of-control blood pressure, a 49-year-old West Virginia man awaiting a heart transplant and several children with sleep apnea.
  • Some surgery centers risk patient lives by skimping on training or lifesaving equipment. Others have sent patients home before they were fully recovered. On their drives home, shocked family members in Arkansas, Oklahoma and Georgia discovered their loved ones were not asleep but on the verge of death. Surgery centers have been criticized in cases where staff didn’t have the tools to open a difficult airway or skills to save a patient from bleeding to death.

Most operations done in surgery centers go off without a hitch. And surgery carries risk, no matter where it’s done. Some centers have state-of-the-art equipment and highly trained staff that are better prepared to handle emergencies.

But Kaiser Health News and the USA TODAY Network found more than a dozen cases where the absence of trained staff or emergency equipment appears to have put patients in peril.

And in cases similar to Tam’s, upper-spine surgery patients have been sent home too soon, with the risk of suffocation looming.

In 2008, a 35-year-old Oregon father of three struggled for air, pounding the car roof in frustration while his wife sped him to a hospital. A Dallas man collapsed in his father’s arms waiting for an ambulance in 2011. Another Oregon man began to suffocate in his living room the night of his upper-spine surgery in 2014. A San Diego man gasped “like a fish,” his wife recalled, as they waited for an ambulance on April 28, 2016.

None of them survived.

Spinal surgery patient McArthur Roberson, 60, lost more than a quart of blood during the operation and struggled to breathe after surgery, his family claimed in a lawsuit. He died on the way home.

If he “had been observed in a hospital overnight,” said Dr. Daniel Silcox, an Atlanta spine surgeon and expert for the family in their lawsuit, “his death would not have occurred.”

The surgery center denied wrongdoing in the case, which reached a confidential settlement in 2017.

Many in the health care field — from doctors to private insurance companies to Medicare — have dismissed the mounting deaths as medical anomalies beyond the control of physicians.

USA TODAY Network and KHN reporters contacted 24 doctors and surgery center administrators about patient deaths and none would answer questions about what went wrong, citing patient privacy laws, or referring reporters to attorneys. Responding to lawsuits around the nation, surgery centers have argued that fatal complications were among the known outcomes of such surgeries. Two centers blamed patients for negligence in their own demise.

Bill Prentice, chief executive of the Ambulatory Surgery Center Association, declined to speak about individual cases but said he has seen no data proving surgery centers are less safe than hospitals.

“There is nothing distinct or different about the surgery center model that makes the provision of health care any more dangerous than anywhere else,” Prentice said. “The human body is a mysterious thing, and a patient that has met every possible protocol can walk in that day and still have something unimaginable happen to them that has nothing to do with the care that’s being provided.”

However, Dr. Kenneth Rothfield, board member of the Physician-Patient Alliance for Health & Safety, said many surgery centers and physicians push the envelope on how much can be done in outpatient centers.

“It’s important to realize that surgery centers are not hospitals,” he said. “They have different resources, different equipment.”

The explosive growth of surgery centers — which receive $4.1 billion a year from Medicare — has taken place under circumstances some medical experts consider unseemly.

Federal law allows surgery center doctors — unlike others — to steer patients to facilities they own, rather than the full-service hospital down the street. In some cases, doing so could increase the risk to a patient, but double a physician’s profits.

Prentice said physician ownership of surgery centers is a good thing.

“The physicians who practice there are responsible for everything that happens in that surgery center from the moment the patient walks out of their car in the parking lot to the moment they leave,” he said.

But several studies have shown that surgery center doctors who are owners perform operations more frequently. And in lawsuits across the country, surgery center doctors have been accused of taking risks with patients.

Even some who’ve made their living in the surgery center industry have expressed concerns. Dr. Larry Teuber, a South Dakota neurosurgeon who worked as an executive in the surgery center industry for 22 years, said he has watched surgery center owners take on increasingly complex — and lucrative — orthopedic and spinal surgeries, undercutting a nearby hospital’s profits for their own gain.

“When you’re making money doing [complex surgeries] you get on a slippery ethical slope,” Teuber said. “The money overshadows everything.”

The History

The first surgery center in the U.S. opened in Phoenix in 1970, a place “squeezed between neighborhood shops and a Baptist church,” where, for $90, a child could receive an incision to relieve pressure on the inner ear, The Arizona Republic reported at the time.

The pioneering doctors, John Ford and Wallace Reed, didn’t see why patients needed to be hospitalized for such minor surgeries.

Taking the procedures out of hospitals reduced the cost for patients and insurers because surgery centers don’t require the same level of staffing or lifesaving equipment.

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Medicare helped drive the expansion of surgery centers when it began paying for procedures in 1982.

Then in 1993, Congress encouraged doctors to open surgery centers by exempting them from the second Stark Law, which prevents doctors from steering patients to other businesses they own.

Doctors-turned-entrepreneurs drove early growth, urging their patients to give the centers a chance. Seeing lucrative elective surgeries moving away, hospitals increasingly bought centers of their own. Last year, insurance giant UnitedHealth Group spent $2.3 billion buying a national surgery center chain.

The centers have been popular with patients, who enjoy the convenience and personalized care. Doctors say they like the ease of planning operations without unexpected trauma surgeries upending the schedule. And surgery centers have thrived even as hospitals have battled to contain the spread of infections.

Today, there are 5,616 Medicare-certified centers. The expansion has come despite lingering safety concerns. In 2007, Medicare noted that surgery centers “have neither patient safety standards consistent with those in place for hospitals, nor are they required to have the trained staff and equipment needed to provide the breadth of intensity of care. …” Some procedures are “unsafe” to be handled at surgery centers, the report concluded.

Medicare advised the centers to transfer patients to hospitals when emergencies arise. Only a third of surgery centers participate in a voluntary effort to report how often that happens. They sent at least 7,000 patients to the hospital in the year that ended in September 2017, a KHN analysis of surgery center industry data shows. Not all survive the trip.

They include James Long, 56, who had no pulse when an ambulance came to the Colorado surgery center where he’d undergone more than five hours of lower-spine surgery in 2014, according to the center’s medical records provided to the family’s attorney.

The state reviewed the case and cited no deficiencies. Jen Kenitzer, the Minimally Invasive Spine Institute administrator, said the center has “extensive procedures in place to respond quickly and appropriately” in emergencies.

Yet Long’s loved ones remain troubled by the case.

“In the 21st century in the USA, a doctor doing a surgery on a patient has to call 911?” said Robin Long, his ex-wife, who did not sue the center. “Give me a break. … It’s just absolutely ignorant.”

Preparation Under Par

Patients enter hospitals with heart attacks, gunshot wounds and traumatic injuries. There, doctors and nurses become skilled at saving lives in emergencies.

Doctors in surgery centers may excel at the procedures they perform most often. But the centers aren’t always prepared and sometimes struggle in a crisis, according to a  review of Medicare records and more than 70 lawsuits.

Health inspectors working on behalf of Medicare have discovered 230 lapses in rescue equipment or training regulations at surgery centers since 2015.

A center in California had empty oxygen tanks. One operating on children in Arkansas didn’t have a pediatric tracheotomy set to restore breathing; another lacked pediatric defibrillator pads to shock hearts back into rhythm.

In an ongoing lawsuit against her and the center, anesthesiologist Dr. Yoori Yim testified that she came up empty-handed on Dec. 23, 2015, when grappling to find the right-sized airway tube to save a patient who had stopped breathing.

Rekhaben Shah, 67, had come to Oak Tree Surgery Center in Edison, N.J., for a simple colonoscopy.

Yim tried a variety of methods to help Shah breathe, with limited success. From the moment Shah stopped breathing on the operating table, 33 minutes passed before a paramedic effectively inserted a breathing tube, according to medical and EMS records.

Paramedics responding to the center’s 911 call had to use a video GlideScope to see inside the patient’s throat, equipment the surgery center didn’t have, court testimony says.

By then it was too late. Shah was removed from life support at a nearby hospital on Christmas Day.

Neither Yim nor the center returned calls for comment. In court records, an expert for the surgery center said Shah’s airway was obstructed and it was cleared around the time the paramedics arrived. He said the GlideScope is not required in New Jersey, nor would it likely have made a difference. An expert for Yim, however, said her actions were appropriate and if a GlideScope had been at the center, “we would probably not be discussing this case at all.”

When emergency crews arrive, surgery centers are not always prepared to receive them.

In Yim’s case, paramedics testified that she refused to move away from Shah and allow them to attempt lifesaving measures.

In Florida, paramedics who rushed to a surgery center after its usual operating hours hit a locked door while a patient inside gasped for breath. The 55-year-old remains in a vegetative state.

In 2016, paramedics arrived at West Lakes Surgery Center in Iowa as staff tried to revive 12-year-old Reuben Van Veldhuizen after he experienced complications during a tonsillectomy, according to a Medicare inspection report.

One paramedic told state inspectors she had to ask who was in charge of the resuscitation efforts. No one replied, the inspection report says.

The boy made it to the hospital 37 minutes after the surgery center staff called 911. There, he was pronounced dead.

The family filed suit, alleging that the center and anesthesiologist erred in giving the boy an anesthetic that carries a warning about cardiac arrest risk in young boys.

In court records responding to the lawsuit, the surgery center and anesthesiologist said Reuben’s death was a result of “pre-existing conditions, acts of others, or conditions over which (Defendants) had no control or responsibility.”

Yet lawyers who sue the centers and scrutinize their internal records say they often see deadly delays in care.

Pedro Maldonado, 59, went to Ambulatory Care Center in New Jersey to have his upper digestive tract scoped. He was discovered unresponsive 10 minutes after the seven-minute procedure, according to his widow’s lawsuit.

It took surgery center staff 25 more minutes to start CPR, according to a lawsuit that Philadelphia attorney Glenn Ellis filed on behalf of Maldonado’s widow. Twenty-seven more minutes passed before Maldonado was wheeled into an ER, the widow’s ongoing suit alleges. Maldonado never regained consciousness.

Reached by phone, a center administrator declined to comment. In a legal filing, the center denied claims of wrongdoing.

“At a hospital, doctors and nurses … know how they are going to respond,” Ellis said. “These guys at the surgery centers are walking on a tightrope with no safety net.”

Conveyor Belt Of Care

While the thrum of a hospital continues through the night, some surgery center doctors keep banker’s hours. That means patients whose surgeries end later in the day are sometimes left in the care of one or two nurses for up to 23-hour stays. Some patients have been sent home to grapple with complications on their own.

Sondra Wallace went to the Surgery Center of Oklahoma in early 2017 for a sinus procedure.

After the procedure, doctors saw her blood-oxygen level sinking. They realized she had had a reaction to the anesthesia and at 2 p.m. gave her a drug to reverse the effects, an ongoing lawsuit filed by her husband says.

Then, an hour later, they sent her home with her husband, Larry, the lawsuit says.

It was 3 p.m. on the Friday before Presidents Day weekend.

“I just think they wanted to start their three-day weekend,” said daughter Casey Podoll.

Larry Wallace alleges in the suit that the center gave him no hint that Sondra had a reaction to the anesthesia.

So, Wallace thought nothing of her napping in the back seat as he drove for more than two hours through Oklahoma pastures on his way home. When he arrived, he discovered his wife cold in the back seat. She was pronounced dead at Jackson County Memorial Hospital at 6:30 p.m. that day.

“They didn’t give any indication … that there were any red flags whatsoever,” Podoll said.

Craig Buchan, attorney for the Surgery Center of Oklahoma, said Wallace met discharge criteria and her cause of death has not been determined. He said the center did not close any earlier “than often occurs after the last patient is discharged.”

Cecilia Aldridge said she also felt as if the staff at a surgery center was rushing her out the door, after her 2-year-old daughter’s tonsil surgery in Arkansas in 2015.

A lawsuit filed by the parents said the surgery center “discharged Abbygail too early because a snow storm was moving into the area.”

Abbygail turned blue in the car on the way home. Her mother said she raced into an emergency room, shouting for help, her toddler in her arms.

“She never woke up,” Aldridge said tearfully in an interview.

Abbygail’s parents now question whether the surgery center ever should have been willing to treat their daughter.

Risky Patients

Because surgery centers have less safety equipment and staffing than hospitals, industry leaders stress the importance of selecting patients healthy enough to fare well. Their predictions, though, are not always correct.

Abbygail, who loved her hand-me-down blanket and the film “Frozen,” had sleep apnea, an irregular heartbeat and was very heavy for her age, according to the lawsuit.

Sleep apnea increases the risk of serious complications in surgery and the night after, medical research shows. Given her condition, Abbygail “should have been admitted [to a hospital] and monitored post-procedure,” said Dr. Charles Cote, a retired Harvard pediatric anesthesiology professor who was not involved in the family’s lawsuit.

The lawsuit says Abbygail’s risk factors “were documented and known by the Defendants,” including the doctor. It said the toddler should have been operated on “in an inpatient setting under hospital care and monitored overnight.”

Dr. Michael Marsh performed Abbygail’s tonsillectomy at Executive Park Surgery Center in Fort Smith, Ark.

The surgery center’s lawyer declined to comment. The doctor’s lawyer did not return email and voice messages. In court documents responding to the lawsuit, Marsh and the center denied wrongdoing.

In the court filing, Marsh said the toddler’s injuries were “the natural progression” of her illness. Executive Park Surgery Center said in a court filing that “no action on their part … was a proximate cause of any damages or injury.” The case was settled.

In at least 25 cases, surgery centers opened their doors to ailing and fragile patients who died after simple procedures, such as tonsillectomies, retinal repairs or colonoscopies, KHN and USA TODAY Network found.

Medicare asks surgery centers to assess each patient’s risk, but inspectors flagged 122 surgery centers in 2015 and 2016 alone for lapses in risk assessments. Some centers failed to gauge risk at all. Others overlooked their own policies.

Doctors can use an anesthesia risk assessment to screen out fragile patients — healthy patients get a score of 1, and a score of 5 means a person is nearly dead.

A few states, including Pennsylvania and Rhode Island, bar certain surgery centers from operating on patients with an anesthesia risk score of 4. But most states don’t go that far. They leave such decisions up to doctors.

And some of those decisions have been cited in tragic outcomes. Sabino Sifuentes, 74, had survived triple-bypass surgery. But on March 23, 2015, nine minutes after the start of anesthesia for an eye procedure, he became unresponsive, never to be revived, according to a Medicare inspection report. A nurse anesthetist who reviewed the case at Eye-Q Vision Care’s surgery center in Fresno, Calif., told state health inspectors that Sifuentes should have been given a risk score of 4 and his care was “completely mismanaged,” the inspection report says.

In response to the family’s lawsuit, the surgery center said Sifuentes’ injury was caused by his own negligence and others’.

Five other patients with the same risk score died after routine procedures at surgery centers across the U.S.

A Widening Niche

Such tragedies rarely find their way into the discussion when Medicare decides whether to approve new procedures at surgery centers.

Take spinal surgery.

Until 2015, Medicare wouldn’t pay for it at surgery centers. Then, the industry’s trade association urged the agency to make the change, and encouraged a letter-writing campaign from surgery centers across the nation.

Letter writers included Dr. Alan Villavicencio, a Colorado surgeon who said he’d been doing such surgeries for 12 years and found that his patients “appreciate the convenience and cost savings.” He did not mention that James Long, 56, had died three weeks earlier at a Lafayette, Colo., surgery center where he is an owner, a review of Colorado health department and medical board records shows.

United Surgical Partners International, a surgery center chain, also weighed in urging even more procedures to be approved, not mentioning a patient death hours after a spine surgery at one of its affiliate centers several months before, according to court records and securities filings. The chain said in a statement that it stands behind its comments in support of the proposal.

Such letters carry weight with Medicare, which approves procedures to be done in surgery centers based on the invasiveness and complexity of the surgery and on input from stakeholders.

Robert Beatty-Walters, a Portland, Ore., attorney who has represented the families of three people who died after surgery center spine procedures, said Medicare’s decision-making process is not even-handed.

“The stakeholders — they call them — during these regulatory proceedings are the profit-makers, not the people who are being provided the service,” he said. “The spine centers just want to have more people come. They make more money. I hate to be that cynical about it, but that’s just what I’ve seen.”

Medicare approved 10 spine-surgery codes to be billed at surgery centers starting in 2015 and added more spinal procedures for 2017. A Medicare spokesman denied a request for a telephone interview. In an email, a spokeswoman said Medicare opened the spine proposal to the public and received no comments suggesting the procedures would pose a threat to Medicare patients. She said the final decision about where a patient will have surgery is up to a doctor and patient.

By 2017, at least 14 patients had died soon after spine operations at surgery centers, according to the KHN/USA TODAY Network investigation.

The 14 spine-surgery deaths have gleaned little recognition in the industry or beyond. Only one made headlines in local newspapers. The rest are documented in places like the Macon, Ga., courthouse or in obscure regulatory reports. And there may be far more because some states, including New York, Illinois and Florida, disclose no details about surgery center deaths.

Paulina Tam’s death at Fremont Surgery Center was a tragic example. At 58, the mother of three had finished careers as a nurse and an educator. Next, she planned to travel the world with her husband of 32 years.

“She was the driving force of the family, the spirit I guess,” said her son, Eric Tam, a doctor in New York City, said. “We didn’t expect the worst to happen.”

The care she received at the center is documented in court records, EMS reports and a Medicare inspection report that concluded that the center “failed to provide a safe environment for surgery.”

Tam’s doctor scheduled her for a procedure to replace two discs in her upper spine on April 7, 2014. Pain from a car crash had bothered her for years. Any such surgery — entering the front of the neck to address pain in the spine — comes with a risk of suffocation, according to the Medicare inspection report.

Yet, with her surgeon and anesthesiologist already gone, the only doctor on-site was a digestive health specialist, the inspection report shows. About four hours after her procedure, Tam told a nurse that her surgical collar felt too tight. Then, that she couldn’t breathe.

The nurse called a “code blue” just after 6:30 p.m., records say.

Medical experts say the first step in helping such patients is removing the surgical staples so the pooled blood can disperse, allowing the patient to breathe.

In Tam’s case, staff repeatedly tried and failed to insert a breathing tube through her mouth and into her airway, the inspection report shows. A last-ditch remedy would have been to punch a hole through the front of her throat to restore breathing, but the gastroenterologist later told an inspector that he was “not prepared” to do so.

The inability to perform the suffocation-rescue maneuver, the inspection report says, amounted to the center’s “failure to ensure patient safety.”

From the time a nurse called 911, it took 24 minutes to get Tam to the nearest hospital, EMS records show. She arrived without a pulse and remained on life support overnight, as her children raced to her bedside to say goodbye.

The center did not return calls and denied wrongdoing in the court case. Tam’s surgeon declined to discuss the case but filed pleadings in court saying Tam’s “carelessness and negligence” caused her death. It’s unclear what the defense meant by negligence. The case reached a confidential settlement.

After Tam’s death, the center told Medicare inspectors that a qualified doctor would stay on-site after all upper-spine cases.

Dr. Nancy Epstein, chief of neurosurgical and spine care at New York University Winthrop Hospital, said surgery centers doing delicate work near the spinal cord, windpipe and esophagus in a same-day procedure is “pretty revolting.” But she said the centers are making so much money — “reeling it in hand over fist” that the potential dangers are being ignored.

“Medically, it should not be tolerated,” she said, “but it is.”

Lindy Washburn of The (Bergen County, N.J.) Record and NorthJersey.com contributed to this report.

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