Investigation Underway At Saint Francis Hospital

Federal authorities have authorized a top-to-bottom investigation of Saint Francis Hospital and Medical Care Center.

The failure of an oxygenator — medical equipment often used in cardiac surgery in conjunction with a heart-lung machine — triggered a complaint by the state of Connecticut to the Centers for Medicare & Medicaid (CMS), said Roseanne Pawelec, an agency spokeswoman.

All hospitals that receive Medicare and Medicaid reimbursements must meet minimum health and safety standards in about 23 major areas of hospital operations, she explained. A top-to-bottom probe is not unusual, authorities said. Since Oct. 1, there have been nine such investigations in Connecticut.

“On July 1, the state [of Connecticut] asked the federal government for the green light to conduct a survey to determine if any federal laws, conditions of participation with Medicare and Medicaid had been violated,” Pawelec said. CMS authorized the state to conduct a survey, or investigation, on its behalf to examine four areas at the hospital that pertained to the complaint. The four areas were: governing body; quality assessment and performance improvement; physical environment; and surgical services.

The investigation, which concluded on Aug. 3, determined that the minimum health and safety standards or conditions for participation in the federal Medicare and Medicaid programs were not met. That finding triggered the current, full-scale investigation that is now underway, Pawelec said.

State investigators were conducting on-site reviews of Saint Francis’ operations last week.

The state public health department is conducting a separate investigation focusing on Connecticut regulations, said agency spokesman William Gerrish.

Serious Deficiencies

CMS characterized the complaint as a “substantial allegation of serious deficiency or deficiencies which would, if found to be present, adversely affect the health and safety of patients” in an Aug. 5 letter to Christopher Dadlez, Saint Francis Hospital president and CEO.

In a written statement, Saint Francis said that the CMS letter to Dadlez was “related to our early-July, five-day voluntary suspension of cardiac surgeries.”

Details about the incident that triggered the voluntary suspension and ongoing state and federal investigations will not be disclosed until a plan of correction is submitted by Saint Francis, Pawelec said.

Saint Francis’ cardiac unit is a nationally recognized program, rated among the top in the nation for treating all heart patients on average within 55 minutes upon arrival; the national goal is within 90 minutes. It has been the recipient of national awards, and, according to the hospital, operates the largest open-heart surgery center in the state and conducts the largest number of cardiac catheterizations in central and northern Connecticut.

Not Unusual

Despite CMS’ current probe of Saint Francis, it rates the hospital’s surgical care as meeting treatment standards at a higher rate than U.S. and state averages. The data is posted on CMS’ Web site at www.hospitalcompare.hhs.gov.

The authorization of similar, “condition-level noncompliance surveys” or full-scale investigations is not uncommon in Connecticut, said Gerrish of DPH. According to the state DPH, there were nine conducted since Oct. 1 of last year. In fiscal year 2008 there were seven investigations, and in fiscal year 2007, there were nine.

“In the vast majority of cases, the hospital will make changes to its operations, to list procedures to address the deficiencies and to demonstrate to the federal government that they have set the proper procedures in place so that these types of incidents can not reoccur,” Pawelec said. “The goal is to ensure patient safety and that a hospital has corrected whatever led to the core nature of these deficiencies.”

Pawelec agreed that CMS surveys of hospital operations are “not an unusual occurrence.”

[A CMS-ordered investigation] doesn’t happen frequently, but it does happen in regular intervals in any hospital in Connecticut,” she said. “Complaints and incidents occur at hospitals every day. It is not unusual for a condition to be out of compliance.”

Hospitals that do not correct the areas of noncompliance jeopardize their agreement with Medicare, Pawelec explained.

Gerrish said that a CMS finding of “condition-level noncompliance” is similar to the serious nature of the state’s consent orders where medical institutions are not meeting state health codes and regulations.

Although such investigations are not uncommon, they “represent a serious action against the hospital,” he said.