Wednesday, August 31, 2022

Sentencing Dates Set For Carter, Conigliaro

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
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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.

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

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

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

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.
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Wednesday, August 17, 2022

Hershey Files Corrective Action Plan

By Walter F. Roche Jr.

Officials of the Milton S. Hershey Medical Center have filed a detailed plan of correction to bring its kidney and liver transplant programs into compliance with federal regulations.
The Penn State University facility filed the plan in response to a May 6 report which found that Hershey did not comply with rules requiring an informed consent process and other rules relating to credentialing of staff and reporting of adverse events to the Centers for Medicare and Medicaid Services.
The abdominal transplant program was voluntarily placed in suspension in April, according to hospital officials.
The plan of correction calls for patients to be informed before surgery if the organs they are about to receive are classified as high risk or otherwise more likely to fail.
The May 6 report detailed several cases in which patients were not advised of the high risk category of the organ they were about to receive.
The corrective action plan calls for staff members of the transplant team to be re-educated on the correct consent requirements. It also calls for monitoring and auditing to assure future compliance.
Other elements pf the corrective action plan include informing CMS and the United Network for Organ Sharing of major staff changes, adverse events and the credentialing of member of the transplant teams. Contact:wfrochejr999@gmail.com

Tuesday, August 16, 2022

Rules Violated in Hershey Transplant Program

By Walter F. Roche Jr.

The Milton S. Hershey Medical Center suspended its abdominal transplant program in April just weeks before a highly critical report by state inspectors who found numerous violations of transplantation rules including failure to obtain proper informed consent from patients.
The report by state Health Department surveyors found some liver and kidney transplant patients were not told prior to surgery that the organs they were about to receive were classified as high risk for failure.
Citing statements from an unnamed Hershey employee, patients themselves and hospital records, the report states that the programs' informed consent process did not ensure that patients were informed of the condition of the organ offered for transplant.
One patient told state surveyors that it wasn't until after her surgery that she was informed that her donor was considered high risk.
An unnamed Hershey employee told the surveyors he/she was aware of two cases in which the patient wasn't told the organ being donated was "high risk" The report also states that the Hershey transplant program officials failed to report to state and federal officials critical changes in staffing and a series of adverse events including the death of one organ recipient.
"The staff failed to analyze a post operative death," the report states citing a patient death on Jan. 28.
"The transplant program must conduct a thorough analysis of any documentany adverse event," the report concludes.
In a statment issued today Hershey officials stressed that the suspension of liver and kidney transplant programs was voluntary and that some corrective measures have already been put in place.
"After placing the program on hold, we engaged an experienced outside third party to conduct an extensive review of our abdominal transplant program. Both the UNOS (United Network for Organ Sharing)and external reviews determined that while our clinical outcomes have been on par with other transplant programs, we have opportunities for structural and operational improvements that will enhance the program," said Scott Gilbert, a hospital spokesman.
The state Health Department report listed five cases in which patients had to be returned to the operating room after transplants due to a series of complications including a perforated colon and misplacements of the kidneys.
Even Hershey quality control officials were left out of the loop.
"They did not come to me, however they should have," Hershey's chief quality officer told surveyors from the Health Department.
Hospital officials also failed to submit for a qualty review five of the kidney cases requiring a return to the operating room.
As for the staffing changes, the report states that at the time of the inspections one key transplant official had been fired and another was on administrative leave. Additionally another transplant official died and yet another had retired.
Another official told surveyors the termination of the transplant manager was due to multiple "derelictions of duty."
"A transplant program must notify CMS (Center for Medicare and Medicaid Services) immediately of any significant changes related to the program that could affect its compliance," the report states.
It was only a year ago that the Hershey program was cited for failing to follow transplant program rules. Last year Hershey was cited for failing to promptly inform the Organ Procurement and Transplantation Network that patients had been removed from the transplant list.
Gilbert stressed that other hospital programs have not been affected by the suspension of the abdominal transsplant program.
Contact: wfrochejr999@gmail.com

Monday, August 15, 2022

Court Clears Doctor in Meningitis Case

By Walter F. Roche Jr.

A Maryland appeals court has ruled that the doctor who injected a patient with a fungus laden steroid is not liable in the death of that patient who died within weeks of the injection with preservative free methylprednisolone acetate.
A three judge panel of the Maryland Court of Special Appeals ruled that it was the tainted drug that caused the death and not the actions of Dr. Ritu Bhambhani, a pain doctor and the Box Hill Surgery Center she ran.
The suit was brought by the estate of Brenda Rozek, who died on Sept. 16 of 2012. She had been injected by Bhambhani on Aug. 31.
Lawyers for the estate had argued that Bhambhani was at fault when she bought the steroids from the New England Compounding Center, a now defunct Massachusetts drug compounding company.
The three judge panel rejected that argument in upholding the decision of a Harford County jury that cleared the doctor of liability.
The Rozek suit was one of more than a dozen filed against Bhambhani. None have been successful.
Federal officials say that over 100 patients injected with drugs from NECC have died and nearly 800 have been sickened.
The president and part owner of NECC, Barry Cadden, and supervising pharmacist Glenn Chin were both convicted of federal racketeering, mail fraud and related charges stemming from an investigation of the deadly 2012 outbreak. Chin is serving a 10.5 year federal sentence, while Cadden is serving a 14 year sentence on those federal charges.
The two are now facing second degree murder charges in Michigan in the deaths of patients injected with the fungus laden drugs. Two separate federal juries however, declined to convict the two of federal second degree murder and racketeering charges.
Contact: wfrochejr999@gmail.com

Friday, August 12, 2022

US Nitrogen Files River Report


A Greene County chemical firm pumped more than 20 million gallons of free water from the Nolichucky River during the month of July, according to a report filed recently with the Tennessee Department of Environment and Conservation.
US Nitrogen LLC pumped more than one million on 10 days in the month with the highest amount, a little over 1.1 million gallons, coming on July 25. The monthly report, which is required under the company's state permit, also shows the company discharged 12.13 million gallons of wastewater bck in to the river.
US Nitrogen uses the river water in cooling towers as part of the process to manufacture liquid ammonium nitrate.
The amount of water withdrawn in July was slightly more than the company repoorted for Aptil when 20.18 million gallons were pumped from the river. The company pays nothing for the water which is authorized under permits from two Tennessee agencies.
In a related development this week U.S. Nitrogen's parent company, Austin Powder, disclosed plans to build a major facility in Khazakastan. The plant would serve Austin Powder's customers in the region.

Tuesday, August 9, 2022

Behavioral Worker Laid on Restrained Patient

By Walter F. Roche Jr.

A worker at a 305-bed suburban Philadelphia behavioral hospital tackled and later laid across the upper body of a patient who by that time was already in restraints, according to a report from the state Health Department.
In a 10-page report on the Eagleville Hospital, state Health Department surveyors disclosed that they declared a state of "Immediate Jeopardy," shortly after they arrived at the facility. The declaration forced hospital administrators to come up with an immediate corrective action plan.
Acting on an unannounced complaint investigation, the surveyors reviewed hospital records, interviewed employees and reviewed video surveillance tapes to reconstruct the June 16 incident.
The same worker was observed pushing the patient at the neck and throat back down on the table. The frame-by -frame review showed the worker pushing the patient, in what surveyors described as questionable action.
Hospital officials did not respond to questions on the report.
Interviews with other Eagleville employees showed they witnessed the actions and concluded the worker's behaviour was "not consistent with safe restraint practices." One of those employees told state health surveyors said at one point the patient said,"He is choking me." Later the patient yelled," Get off my neck."
Still later the patient was observed foaming at the mouth.
The report states that the worker was first placed on leave and then terminated on July 8.
The facility filed a plan of correction which includes the placement of a monitor to observe activities in the area where patients are restrained. Eagleville also hired a consulting firm to review restraint practices.
The plan also calls for re-training the staff on correct restraint practices and setting standards on when restraints are to be halted. The facility medical manager also met personally with the 34 staff members including five of the six who were present for the June 16 incident.
Finally Eagleville administrators told the state they planned to re-design the restraint area and replace some of its equipment.
Contact: wfrochejr999@gmail.com

Monday, August 1, 2022

Nursing Home Patient Trapped in Lift

By Walter F. Roche Jr.

A patient in a state run nursing home was trapped at the ceiling in a lift till he became unresponsive as untrained and desparate staff couldn't figure out how to get him down.
The frantic efforts were detailed in a seven-page report from the state Health Department on the June 3 incident at the 196 bed Gino Merli Veterans Center in Scranton.
The facility "failed to ensure that nursing staff had the skills and competencies to assure resident safety," the report states, adding that the staff also lacked competency in handling emergencies."
The patient who suffered from dementia, diabetes and congestive heart failute had lived at the facility since 2015.
Officials of the state Department of Military and Veterans Affairs, which runs the Scranton facility, did not respond to questions about the incident including the outcome of the resident.
The report, based on interviews and reviews of videotapes of the 7:30 p.m. incident, states that the patient had been placed in the lift for transport to a bathroom and incontinence care.
"When staff members were lowering the lift the patient appeared to be turning red and became unresponsive," the report comtinues, adding that the lift had become wedged in the ceiling and ran out of battery power.
The state inquiry showed that the lift had an emergency button that would have allowed the staff to manually lower the patient but staff interviews showed they were unaware of the button, which was wedged in the ceiling and inaccessible.
"They had tried desparately to operate the lift, but failed," the report states.
After 10 to eleven minutes when another employee figured out how to release the lift the patient was lowered to the floor.
The report does not state whether the patient was able to be revived.
In a plan of correction officials of the facility said staff was being re-educated on the operation of the 10 lifts at the facility. The re-education included written tests and physical demonstrations.
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