By Walter F. Roche Jr.
December sentencing dates have been set for the final two defendants in the criminal case stemming from the 2012 fungal meningitis outbreak.
U.S. District Judge Richard G. Stearns, sitting in Boston, Mass., set a Dec. 1 hearing for Gregory Conigliaro and a Dec. 13 date for Sharon Carter.*
Conigliaro was vice president and part owner of the now defunct New England Compounding Center. Carter was a supervisor for the drug compounding firm.
Both were convicted of conspiring to defraud the U.S. Food and Drug Administration by making it appear that NECC was a small family owned drug compounding firm not subject to federal regulation. In fact the firm was shipping thousands of vials of compounded pharmaceuticals all over the country.
The two were convicted by a jury in late 2018, but were then acquitted by Stearns in June of 2019. A federal appeals court overturned Stearn's decision and restored the guilty verdicts.
Conigliaro and Carter were among 14 people connected to NECC following a two year probe of the fungal meningitis outbreak caused by contaminated drugs shipped by NECC. Ultimately over 800 patients died after being injected with fungus riddled steroids.
*In fact Stearns issued two Conigliaro orders, the second appaarently overiding the first which had called for a Dec. 8 hearing
.
Contact: wfrochejr999@gmail.com
Wednesday, August 31, 2022
Tuesday, August 30, 2022
Penn State Statement On Berini's Departure
Deborah Addo, executive vice president and chief operating officer for Penn State Health, assumed leadership responsibilities for Penn State Health Milton S. Hershey Medical Center on Thursday, August 25. Deborah Berini, former Hershey Medical Center president, has left the organization. Penn State Health plans to conduct a national search for a new Hershey Medical Center president.
Patients are at the heart of everything we do, and Penn State Health is dedicated to recruiting and retaining leaders with a passion for providing patients with world-class, locally accessible care that a highly coordinated system should deliver.
Addo joined Penn State Health in August 2021 with more than 30 years of leadership experience in health care operations and management. She has a proven track record of leading hospitals and physician groups through times of transition and will provide strong, seasoned leadership for Hershey Medical Center during this time. Addo also will continue serving in her role of health system executive vice president and chief operating officer, which provides oversight for the system’s medical centers and their presidents.
Patients are at the heart of everything we do, and Penn State Health is dedicated to recruiting and retaining leaders with a passion for providing patients with world-class, locally accessible care that a highly coordinated system should deliver.
Addo joined Penn State Health in August 2021 with more than 30 years of leadership experience in health care operations and management. She has a proven track record of leading hospitals and physician groups through times of transition and will provide strong, seasoned leadership for Hershey Medical Center during this time. Addo also will continue serving in her role of health system executive vice president and chief operating officer, which provides oversight for the system’s medical centers and their presidents.
Monday, August 29, 2022
Hershey President Abruptly Resigns
By Walter F. Roche Jr.
The president of the Milton S. Hershey Medical Center has abruptly resigned in the wake of the disclosure of serious problems in the facility's liver and kidney transplant programs, both of which have been shutdown for four months.
Deborah Berini's departure was disclosed in a terse press release issued Monday. Hershey and Penn State officials declined to give any reasons. Berini had served in the post since 2018.
The announcement comes following the disclosure on this blog of two critical state Health Department reports on Hershey's abdominal transplant program.
One report cited Hershey for failing to disclose to transplant receipients that the organs they were about to receive had been classified as high risk for failure. The report also cited several cases in which transplant recipients had to be returned to the operating room for problems with the original procedure.
In a second report, also from the state Health Department, the facility was faulted when a live transplant had to be halted after the donor had already been placed under general anesthesia.
The suspension of the abdominal transplant program was not publicly disclosed until facility officials were questioned about one of the critical health reports last week.
Contact: wfrochejr999@gmail.com al
The president of the Milton S. Hershey Medical Center has abruptly resigned in the wake of the disclosure of serious problems in the facility's liver and kidney transplant programs, both of which have been shutdown for four months.
Deborah Berini's departure was disclosed in a terse press release issued Monday. Hershey and Penn State officials declined to give any reasons. Berini had served in the post since 2018.
The announcement comes following the disclosure on this blog of two critical state Health Department reports on Hershey's abdominal transplant program.
One report cited Hershey for failing to disclose to transplant receipients that the organs they were about to receive had been classified as high risk for failure. The report also cited several cases in which transplant recipients had to be returned to the operating room for problems with the original procedure.
In a second report, also from the state Health Department, the facility was faulted when a live transplant had to be halted after the donor had already been placed under general anesthesia.
The suspension of the abdominal transplant program was not publicly disclosed until facility officials were questioned about one of the critical health reports last week.
Contact: wfrochejr999@gmail.com al
Harrisburg Patient in ER, Dead For an Hour
By Walter F. Roche Jr.
A patient in the Emergency Department at a Harrisburg hospital lay dead in a wheelchair for about an hour before a nurse noticed the patient looked distressed and searched for a pulse. There was none.
Video tapes of the June 26 incident at the UPMC Pinnacle Hospital showed no less than five employees, nurses and a security officer, walked past the woman whose head was hyperextended over the back of the wheelchair.
About an hour earlier the unidentified woman had gone to the registration desk and reported she couldn't breathe.
The videotapes showed she returned to her wheelchair and didn't move again until her lifeless body was found by the nurse at 5:24 a.m. The official time of death was set at 5:46 a.m.
A hospital spokeswoman, Amber Depew, said the faciliity worked with the state to prepare a corrective action plan and that the plan had been implemented and accepted by the state.
According to the report state inspectors, acting on a complaint went to the hospital in late June to examine records and question employees. They declared a state of imediate jeopardy, which forced hospital officials to immediately come up with a corrective action plan.
A plan was submitted about 90 minutes later which called for mandatory reassessment of patients awaiting care in the emergency department including an assessment of whether the patient's condition was worsening.
"The hospital must meet the emergency needs of the patients in accordance woth acceptable standards of practice," the 14-page report states. "The hospital failed to provide emergency care in a timely manner."
According to the report the unidentified woman arrived at the hospital at 3:08 a.m. with chest pains and vomiting.
At 4:07 a.m. she went to the intake desk reporting that she couldn't breathe.
"Patient able to speak in whole sentences," the registration employee wrote in the patient's record.
The next entry at 5:24 a.m.reported the patient's lifeless body had been found and the nurse who discovered it yelling out for help. But that only happened after five other staffers walked past the woman with her head hyperextended over the back of the wheelchair and her left arm outstretched over the armrest of the wheelchair.
The report states that actions or inactions by staff "may have delayed interventions which could have possibly prevented the patient's death."
The hospital's plan of correction includes re-educating all staffers on the need to periodically re-assess patients awaiting care.
"Staff to be vigilant for signs of anything unusual when completing rounds," the plan states. It also calls for periodic audits to assure compliance.
Contact: wfrochejr999@gmail.com
A patient in the Emergency Department at a Harrisburg hospital lay dead in a wheelchair for about an hour before a nurse noticed the patient looked distressed and searched for a pulse. There was none.
Video tapes of the June 26 incident at the UPMC Pinnacle Hospital showed no less than five employees, nurses and a security officer, walked past the woman whose head was hyperextended over the back of the wheelchair.
About an hour earlier the unidentified woman had gone to the registration desk and reported she couldn't breathe.
The videotapes showed she returned to her wheelchair and didn't move again until her lifeless body was found by the nurse at 5:24 a.m. The official time of death was set at 5:46 a.m.
A hospital spokeswoman, Amber Depew, said the faciliity worked with the state to prepare a corrective action plan and that the plan had been implemented and accepted by the state.
According to the report state inspectors, acting on a complaint went to the hospital in late June to examine records and question employees. They declared a state of imediate jeopardy, which forced hospital officials to immediately come up with a corrective action plan.
A plan was submitted about 90 minutes later which called for mandatory reassessment of patients awaiting care in the emergency department including an assessment of whether the patient's condition was worsening.
"The hospital must meet the emergency needs of the patients in accordance woth acceptable standards of practice," the 14-page report states. "The hospital failed to provide emergency care in a timely manner."
According to the report the unidentified woman arrived at the hospital at 3:08 a.m. with chest pains and vomiting.
At 4:07 a.m. she went to the intake desk reporting that she couldn't breathe.
"Patient able to speak in whole sentences," the registration employee wrote in the patient's record.
The next entry at 5:24 a.m.reported the patient's lifeless body had been found and the nurse who discovered it yelling out for help. But that only happened after five other staffers walked past the woman with her head hyperextended over the back of the wheelchair and her left arm outstretched over the armrest of the wheelchair.
The report states that actions or inactions by staff "may have delayed interventions which could have possibly prevented the patient's death."
The hospital's plan of correction includes re-educating all staffers on the need to periodically re-assess patients awaiting care.
"Staff to be vigilant for signs of anything unusual when completing rounds," the plan states. It also calls for periodic audits to assure compliance.
Contact: wfrochejr999@gmail.com
Saturday, August 27, 2022
Suit vs Compounder Goes On
https://www.reuters.com/legal/government/azurity-lawsuit-over-compounding-pharmacys-rival-drug-revived-court-2022-08-15/
Tuesday, August 23, 2022
More Problems at Hershey Transplant Program
By Walter F. Roche Jr.
A living donor kidney transplant procedure at the Milton Hershey Medical Center had to be halted after the donor had already been anesthesized, according to a a six-page report from the state Health Department.
The new report was made public just days after another state report detailed errors that led to the shutdown of the abdominal transplant program.
In a report made public last week, state inspectors found multiple cases in which the recipients of the transplanted organ were not told before surgery that the organ they were about to receive had been classified as high risk for failure.
In the newly released report state surveyors found that the living donor had already been put under general ansthesia when it was discovered that test results on the recipient showed that it might be "inadvisable" to go forward with the procedure.
"At that time I learned that there could be issues with the recipient, and we might not be able to proceed," an unidentified member of the transplant team told the surveyors.
"The living donor was put under anesthesia due to miscommunication regarding labs of the recipient," the report states.
The procedure was then halted and the patient was taken to the recovery room, according to the report. The incident occurred in March just weeks before the program was suspended.
When the health inspectors asked if there was a written policy in place to ensure coordination, they were told there was no written policy.
The facility filed a plan of correction calling for better communication between members of the transplant team including audits to ensure 100 per cent compliance.
The new process, the report states, will ensure "that the living donor is not subject to unnecessary procedures, medication or risks."
The report does not indicate whether the transplant was performed at a later date.
Hershey officials told the state that the confusion over the test results came after a change was made in the scheduling procedure. Under the old procedure tests were performed the day before the transplant. The new procedure called for the tests to be performed the same day as the transplant.
The report also cited the failure to fill out required forms.
Also contributing to the confusion was the fact that some members of the team were new.
In the report issued last week state inspectors found that the consent process was not being properly executed.
They also cited the fact that many Hershey tranplant patients had to be returned to the operating room due to the misplacement of the donated organ and, in one case, a perforated colon.
Contact: wfrochejr999@gmail.com
A living donor kidney transplant procedure at the Milton Hershey Medical Center had to be halted after the donor had already been anesthesized, according to a a six-page report from the state Health Department.
The new report was made public just days after another state report detailed errors that led to the shutdown of the abdominal transplant program.
In a report made public last week, state inspectors found multiple cases in which the recipients of the transplanted organ were not told before surgery that the organ they were about to receive had been classified as high risk for failure.
In the newly released report state surveyors found that the living donor had already been put under general ansthesia when it was discovered that test results on the recipient showed that it might be "inadvisable" to go forward with the procedure.
"At that time I learned that there could be issues with the recipient, and we might not be able to proceed," an unidentified member of the transplant team told the surveyors.
"The living donor was put under anesthesia due to miscommunication regarding labs of the recipient," the report states.
The procedure was then halted and the patient was taken to the recovery room, according to the report. The incident occurred in March just weeks before the program was suspended.
When the health inspectors asked if there was a written policy in place to ensure coordination, they were told there was no written policy.
The facility filed a plan of correction calling for better communication between members of the transplant team including audits to ensure 100 per cent compliance.
The new process, the report states, will ensure "that the living donor is not subject to unnecessary procedures, medication or risks."
The report does not indicate whether the transplant was performed at a later date.
Hershey officials told the state that the confusion over the test results came after a change was made in the scheduling procedure. Under the old procedure tests were performed the day before the transplant. The new procedure called for the tests to be performed the same day as the transplant.
The report also cited the failure to fill out required forms.
Also contributing to the confusion was the fact that some members of the team were new.
In the report issued last week state inspectors found that the consent process was not being properly executed.
They also cited the fact that many Hershey tranplant patients had to be returned to the operating room due to the misplacement of the donated organ and, in one case, a perforated colon.
Contact: wfrochejr999@gmail.com
Friday, August 19, 2022
Two Midway Firms Get TDEC approval
By Walter F. Roche
Two Midway firms underwent recent inspections by the Tennessee Department of Environment and Conservation and were found in compliance with the provisions of their permits.
The inspections in late July took place at Linde, Inc, which produces liquefied carbon dioxide, and at Yara, which will produce calcium nitrate once its plant is constructed. Those two firms share the site with US Nitrogen LLC.
Linde was notified that no violations were found during the inspection. Its permit was first issued on Jan. 30, 2000 and it was amended several times due to typographical errors.
TDEC told the company that its records were "adequate."
Records reviewed were for the period from July 30, 2021 to July 28 of this year.
"There were no malfunctions of monitoring systems during this period," the report states.
Under the permit Linde can produce up to 90,789 per year but the total produced was 65,358 pounds, the records showed.
Yara, which is not yet in production, was also found in compliance with its permit. TDEC said its records were also adequate.
"No performance tests performed," the inspection report states.
Contact: wfrochejr999@gmail.com
Two Midway firms underwent recent inspections by the Tennessee Department of Environment and Conservation and were found in compliance with the provisions of their permits.
The inspections in late July took place at Linde, Inc, which produces liquefied carbon dioxide, and at Yara, which will produce calcium nitrate once its plant is constructed. Those two firms share the site with US Nitrogen LLC.
Linde was notified that no violations were found during the inspection. Its permit was first issued on Jan. 30, 2000 and it was amended several times due to typographical errors.
TDEC told the company that its records were "adequate."
Records reviewed were for the period from July 30, 2021 to July 28 of this year.
"There were no malfunctions of monitoring systems during this period," the report states.
Under the permit Linde can produce up to 90,789 per year but the total produced was 65,358 pounds, the records showed.
Yara, which is not yet in production, was also found in compliance with its permit. TDEC said its records were also adequate.
"No performance tests performed," the inspection report states.
Contact: wfrochejr999@gmail.com
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