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Based on interview with staff and review of medical records, and other pertinent documentation, it was determined that hospital staff failed to ensure that medical records accurately documented the rate of occlusion present for patients receiving interventional cardiology procedures by physician #1 as evidenced by:

During an interview with hospital staff, it was determined that physician #1 did not accurately document the degree of occlusion in coronary arteries of 585 patients' interventional cardiology reports where physician #1 placed stents. These stent placements were predicated on a determination of the percent of arterial occlusion that was overstated in the reports of the procedures for 585 patients. Subsequent review of the records by an outside peer review organization hired by the hospital led to the hospital's conclusion that stents were placed in these patients when it may not have been medically necessary.

For example, it was determined by the peer review organization experts that patient #1 received a cardiac stent that was not medically necessary. The medical record for patient #1 showed that on 11/07/2008 the patient had a cardiac catheterization procedure performed by physician #1. Physician #1 documented on the the medical records that patient #1 had " a 90% obstruction just past the diagonal branch" in her left anterior descending coronary artery. An external peer review process conducted after there were allegations of medically unnecessary stent placements by another patient, revealed that patient #1 actually had less than a 20% occlusion and that the stent placement may have been "inappropriate."

The external peer review included a review of the interventional radiology reports and the review of the corresponding films made during the cardiac catheterization procedures performed by physician #1. The interventional cardiology reports for patients did not accurately reflect the degree of occlusion present on the films for 585 of approximately 2000 patients reviewed by the external peer review experts.

Based on review of the medical record and other pertinent documentation, the hospital failed to send necessary medical information, in the form of the transfer summary, along with patient #3 when he was transferred to the rehabilitation on 3/28/09.

Patient #3 is a 60 year old male admitted to St. Joseph Medical Center on 3/20/09 with severe peripheral vascular disease with rest pain and ulceration distally on the foot. The patient other diagnoses include Coronary Artery Disease with CABG 12/2/2002, Congestive Heart Failure compensated, ESRD, with HD, Hyperlipidemia, Hypertension, Diabetes, Chronic Atrial Fibrillation, and ejection fraction = 43%. The patient also has history of Hodgkin's disease and a pacemaker. The patient was cleared in 2008 for a kidney transplant. Per the patient he was to have a kidney transplant at the University of Maryland, however, they were unable to perform the transplant.

The patient underwent a femoral-to-peroneal bypass using Gore-Tex on 3/20/09. After the procedure the patient had an extensive amount of oozing and pressure dressings were used to close the wound. However, the pressure dressing caused the skin to slough off in one area. The patient had good Doppler pulses distally. He started physical therapy and could bear some weight. Five days after surgery the left upper arm fistula thrombosed and a dialysis catheter was inserted to get the patient dialysis. During his inpatient stay the patient had persistent hypotension with blood pressures ranging from systolic 71 to 127 over diastolic 46 to 72 mmgh. The patient had a blood pressure of 71/51 on 3/28/09. The vascular and renal physicians coordinated the care and monitored the hypotension. The patient was placed on Vancomycin and transferred to rehabilitation on 3/28/09.

Upon assessing of patient #3 at the rehabilitation center, the nurse documented his blood pressure was 64/35 and oxygen saturation of 84% and that there was extremely foul odor coming from yellow drainage that saturated a chux pad under the patients legs. The physician was notified and the patient was returned to Saint Joseph Medical Center.

The medical transfer summary dictated by the physicain which was sent to the rehabilitation center did not include pertinent clinical information regarding the patient's persistent problems with hypotension, occasional need for oxygen, specific treatment for the drainage from the leg wounds, specific information regarding the patient hemodialysis, how often the patient receives treatment, location of his dialysis center, and his renal physicians name and contact information. Although the case manager discussed the patient's needs with the admission coordinator at the nursing home, to ensure continuity of care of a patient transferred on the weekend, the patient care needs should have been provided to the nursing staff at the rehabilitation center. The patient's hypotension and drop in his oxygen saturation possibly could have been managed by the rehabilitation center if enough information was provided by the hospital .

Based on interview and review of policies, procedures, medical records, and other pertinent documentation, the hospital's quality assurance/ performance improvement department failed to have a process to provide oversight of the quality of care provided by physician #1, an interventional cardiologist, as evidenced by:

Physician #1 was an interventional cardiologist employed by the hospital since January 2008 who also had privileges and practiced at the hospital nearly exclusively for many years. Physician #1 functioned as the Department Chairperson of Interventional Cardiology and performed the greatest volume of interventional cardiology procedures done at the hospital.

On April 27, 2009, the hospital received a complaint from a patient who also was employed by the hospital which prompted the hospital to initiate a review of the placement of cardiac stents in the patients of physician #1. Further review of the procedures performed by physician #1 was conducted by an external peer review organization hired by the hospital from May 2009 and into 2010. According to the determination of the external peer reviewers, physician #1 had placed stents when the stents may not have been medically required in 585 patients. The results of the external review led to the physician #1 being removed from patient care responsibilities on May 12, 2009 and his loss of privileges at the hospital on July 08, 2009. Review of a sample of cases for all other interventional cardiologists was also performed however, no similar irregularities were found.

Based on review of the hospital's peer review process and interview of staff, it was determined that peer review process prior to the hospital's investigation, was coordinated by the chairperson of the department and the minutes were kept in the department. The indicators identified for review included mortalities and complications. The hospital had two committees designated to do the reviews: Interdisciplinary Mortality Review Committee and Mortality and Morbidity Review. There was no standardized scoring for cases reviewed.

The hospital's quality assurance/ performance improvement program would also review cases of mortality and complications. Physician #1 had not had any specific cases of mortality or complications that would have triggered a review of his cases.

Further, the hospital monitored a series of quality indicators identified for tracking the care provided by the interventional cardiologists. These indicators were consistent with other hospitals performing interventional cardiology procedures. Since physician #1 also performed well on these indicators the quality assurance process did not recognize any problems or concerns related to the practice of physician #1. The surveyors were informed by hospital staff that even though the physician #1 had not had any cases requiring a quality or mortality review, the hospital's peer review process included a review of cases performed by physician #1. However, in his role as the department chairperson, physician #1 selected those cases.

The hospital's data and staff interviews indicated that physician #1 was the hospital's most productive interventional cardiologist. The hospital's quality oversight did not identify concerns with the number of cases completed or the rates of cardiac stents placed by physician #1 that may have prompted a review specific to a patient's clinical presentation or medical necessity until the complaint was received on April 27, 2009.

Although the hospital had a process for the review of complications and mortality for physician #1 and the other interventional cardiology which included specific case reviews, the practice of only reviewing physician #1's hand picked cases failed to identify any cases that fell outside of the standards of practice for quality.

After learning of the placements of cardiac stents that may not have been medically necessary by physician #1, the hospital did conduct an extensive external peer review of nearly 2000 procedures, did notify the cardiologists and 585 patients who may have been affected by unnecessary cardiac stent placements, and immediately revised its quality oversight of physicians to include hospital wide independent review of cases selected by the Quality Assurance Department.