By Walter F. Roche Jr.
In a scathing report that eerily echoed details of a five-year-old deadly national outbreak, a Pennsylvania hospital has been cited with multiple violations of drug compounding standards placing cancer patients in immediate jeopardy.
The findings by the Pennsylvania Health Department forced the Pottstown Hospital to immediately shutdown its cancer center pharmacy where supposedly sterile drugs were being compounded for administration to cancer patients.
The report concluded that hospital management and staffers "failed to ensure established procedures for hand hygiene and donning protective gear were followed for the compounding of hazardous drugs."
State surveyors observed staffers working under hoods without required protective gear. Numerous violations of the industry standard code known as Chapter 797 were observed.
Officials of Tower Health, the holding company for the hospital did not respond to requests for comment. The hospital did file a corrective action plan with the state in response to some but not all of the deficiencies.
State surveyors also cited Pottstown, a 232 bed facility, for an array of violations of the federally mandated Life Safety Code. The report states that the main hospital building "exceeds the maximum story height allowed" and multiple areas were found to lack the required fire rating.
Other violations also were noted in several areas other than the cancer center pharmacy.
Staffers failed to follow proper procedures for blood transfusions and mold was observed in an ice machine.
Still other deficiencies included failure to ensure the privacy of patient records, failure to maintain infection control in multiple areas and improper cleaning of endoscopy equipment.
IV bags were observed without expiration dates and expired gloves and drugs were also observed in the endoscopy area.
In the clean room where critical procedures were performed gaps were observed on counter tops, floors were damaged and even when microbial sample showed contamination, no action was taken. According to the report there were over 30 incidents of microbial growth without documented follow up.
The facility "failed to ensure environmental microbial samples were evaluated," the lengthy report states.
The descriptions in the report were similar to the court testimony in the recent trials of former officials of the New England Compounding Center, the company blamed for the 2012 fungal meningitis outbreak.
In those trials federal investigators described similar deviations from the 797 standards including the failure to take corrective action when environmental tests showed evidence of contamination in the clean rooms. The two NECC official were found guilty of racketeering, mail fraud and related charges and are now serving prison sentences.
Still other citations included failure to have adequate post anesthesia services for pediatric
surgical patients and failure to maintain proper temperatures in an operating room.
Pottstown was one of five hospitals purchased by Tower Health from Community Health Associates last year for $418 million.
Another hospital purchased from CHA was the Brandywine Hospital in Coatsville, which was also the subject of a recent critical health department report.
That facility was cited for failure to comply with the state Child Protective Services Act. According to the surveyors, hospital staffers watching a monitor observed a visitor touching a child in an appropriate manner but subsequently failed to properly report the incident immediately. Instead, a report was filed three days late, the report states. The incident occurred on Aug. 27, 2017, two months before the purchase.
Brandywine also was cited for failure to properly follow up on patients who had discharged themselves against medical advice.
The surveyors found that Brandywine failed to contact the patients' outpatient therapists.
Wednesday, July 11, 2018
Friday, June 29, 2018
By Walter F. Roche Jr.
A Reading hospital has been cited for violations of state and federal law in the treatment of a 59-year-old woman who was critically injured in a two-car April accident and died later the same day.
In a 10-page report the Pennsylvania Health Department found that Saint Joseph Medical Center, part of Penn State Health, failed to stabilize the woman before having her airlifted to the Penn State Milton S. Hershey Medical Center.
The state surveyors found that the handling of Debra A. Becker's case violated the federal Emergency Medical Treatment and Labor Act (EMTALA), better known as the Anti-Dumping law.
In addition the report states that the hospital failed to comply with a state law requiring the reporting of serious or sentinel events to the department and a related state authority.
In a statement issued today officials of Penn State Health acknowledged that the Reading facility had been cited by state and federal officials.
"The hospital immediately began to implement measures to address these citations, as noted in a plan of correction the hospital submitted June 28. The plan is due July 2. We expect the plan to be posted publicly upon acceptance." the statement read.
According to the report, which does not name the victim, she was brought to the St. Joseph's emergency department at 9:54 a.m.following an accident in which her car was T-Boned.
The patient's daughter, Karin Vasquez of Lancaster, said the patient was her mother who died on April 28, the same day as the accident. Her mother died after being transferred to the Hershey Medical Center, also part of Penn State Health.
Vasquez said she was rebuffed in her attempts to get information from the Reading hospital.
"I didn't get any information,"she said.
All she was told, Vasquez said, was,"We did everything we could."
The state report however, found fault with what the hospital did while Becker was at the facility and even after she was airlifted by helicopter to Hershey.
Though an IV was inserted immediately after she arrived at the hospital shortly before 10 a.m., no fluid was started until an hour later. After a CAT scan and other tests were completed, the report states, her blood pressure had plummeted to 64/44.
Finally at 11:07 a.m. two liters of saline solution were started.
Meanwhile tests showed multiple rib fractures and likely complex lacerations of the spleen, according to the state report.
A half hour later, the report continues, the patient complained of difficulty breathing. She was also reported to be sweating profusely.
"Decision made for transfer to trauma facility," the report states citing hospital records.
Citing those hospital's record, the report states,"it was determined the facility failed to provide an appropriate transfer within the capability of the hospital."
A Hershey Medical Center staffer told state surveyors that they told their colleagues at St. Joseph that if the patient was unstable she "needs to go to the OR (operating room) and then be transferred."
However, the report states,"The patient did not go to the operating room" and "the surgeon (at St. Joseph) did not evaluate the patient."
At Hershey surgeons attempted to stop the bleeding but the patient's heart stopped and she could not be revived. Death was declared at 1:46 p.m., according to the report.
The state surveyors concluded that the hospital also failed to comply with the state Medical Care Availability and Reduction of Error Act (MCARE) by not notifying the Health Department and the Patient Safety Authority within 24 hours of the incident.
The report also faults the hospital for failure to notify the patient's family of a "serious event" within seven days.
Vasquez said the family has yet to receive any notification from the hospital. Nor were they informed of the state Health Department findings.
"I am more than sure this was my mother. I wish it wasn't," Vasquez said after reading a copy of the report provided by a reporter.
Tuesday, June 26, 2018
By Walter F. Roche Jr.
Two additional state run mental hospitals have been cited by Pennsylvania health regulators in recent inspections for violations of state and federal standards, including failure to properly sterilize meters used on diabetes patients.
The citations were issued in April and May to the Danville and Warren State Hospitals.
The state Health Department surveyors inspected the facilities to certify their continued inclusion in the federally funded Medicare and Medicaid programs.
The two reports are in addition to a 67-page report recently issued on the Norristown State Hospital. That highly critical report cited the Montgomery County facility for failing to eliminate ligature and other risks for patients known to be at risk for suicide.
The same failure was cited in the report on the Danville State Hospital, located in Montour County.
The hospital failed to ensure ligature risks were eliminated, the report states. Cited were electrical cords, door handles and television wires found by inspectors in patient care areas.
In another finding the health department said hospital administrators had failed to set specific performance standards for a variety of services provided by outside contractors.Those included dental, laundry and respiratory services.
Inspectors found the same deficiency in Norristown.
Other findings in Danville include failure to ensure a sanitary environment in food preparation areas where a pail of soapy water was observed on the same cart as food. Light fixtures in that same area "had a heavy accumulation" of grease and dust.
The hospital responded with a corrective action plan promising improvements in the cited areas including the dietary department.
At the Warren State Hospital in the northwest corner of the state, surveyors found the same deficiency regarding the establishment of performance standards for outside contractors.
They also found staffers were not following the recommended sterilization standards for glucometers used to check blood sugar levels. Instead of sterilizing after every use, a staffer told surveyors they only sterilized the meters at the end of the day.
Documentation for the sterilization was missing for 16 of 30 days reviewed, according to the report.
Like their Danville counterparts, officials from Warren filed a plan of correction in which they promised to correct all the deficiencies.
Officials of the Office of Human Services, which oversees the hospitals, did not respond to requests for comment.
The three remaining state mental hospitals have not been inspected in over a year.
Friday, June 22, 2018
By Walter F. Roche Jr.
A state run Pennsylvania mental health facility has been cited for multiple deficiencies including placing patients deemed at risk for suicide in "immediate jeopardy."
In a 67-page report made public this week, the Pennsylvania Health Department also cited the Norristown State Hospital for multiple other deficiencies ranging from poor sanitation practices to improper overuse of restraints to serious pharmaceutical lapses.
The critical report comes amid recent controversy over the future of the facility which now occupies but a small part of a more than 220 acre site. The hospital is also operating under a consent decree stemming from a suit filed by the state chapter of the American Civil Liberties Union.
The inspection was made as part of a periodic review to determine eligibility for the federally funded Medicare and Medicaid programs.
The state health surveyors declared a state of "immediate jeopardy" shortly after their arrival at the hospital on May 7 at 1:15 p.m.
Cited in the report were multiple available means of suicide including door hinges, bathroom grab bars and air vents. The inspectors also were critical of the frequency at-risk patients were being observed.
In twelve of twelve patient areas with ligature and safety risks,"the facility failed to ensure adequate observation rounding was conducted."
According to the report the facility management put together an action plan that was accepted at 6:41 p.m. and the "immediate jeopardy" was abated hours after it was imposed. The action plan calls for increased screening for suicide risks, furniture replacement, replacing doors knobs and hinges and eliminating beds with wooden slats for at-risk patients.
"The safety and well-being of the individuals we serve is the top priority of the Wolf Administration. In response to the recent inspection, Norristown State Hospital immediately addressed the issues identified as posing an immediate risk to the patients," said department spokeswoman Rachel Kostelac.
The report was critical of management at the facility for failing to review service contracts to ensure those services were being provided in "a safe and effective manner" and failure "to ensure patients' rights" were protected in the use of restraints and seclusion.
The hospital management filed corrective action plans for some but not all of the deficiencies cited. For instance an acceptable plan of correction was filed in response to the charge that the facility "failed to ensure patient rights for restraint or seclusion were met."
The accepted plans of correction included staff re-education, new forms for restraint use to clarify the need for the least restrictive measures and audits to ensure that the corrective action plans were being followed.
Reviewing the use of restraints, the inspectors cited three of four individual patient records which failed to include proper justification for the restraints and failure to ensure that the least restrictive measures were considered first.
One patient record "revealed no documented evidence that restraint alternatives and/or de-escalation techniques were implemented and determined to be ineffective, prior to the application of a physical hold/restraint to protect a patient or others from harm."
The inspectors found that in some records, the staff didn't even disclose what restraint was used.
Still other deficiencies include the failure to develop and implement quality improvement plans or to even collect data needed to identify areas needing improvement.
In the review of pharmaceutical services, surveyors found that state and federal rules were not followed. In some cases they found "no documented evidence" that patients received the prescribed medications.
Staffers told state surveyors that discrepancies between the drugs dispensed and the drugs actually administered "has been going on since 2000."
In radiological services the inspectors found a failure to monitor staffers for excess exposure. Dental X-Ray equipment was operated even though its certification had expired almost a year earlier. In addition the department had a single lead apron for staff protection.
Laboratory services also were faulted and an inspection of a laboratory services area "revealed a dirty unkempt in appearance, disorganized cluttered environment with direct-patient care supplies." Leftover food was commingled with lab specimens in a refrigerator.
Hospital officials responded by shutting down the lab storage area and promising further corrective actions.
"The Department of Human Services and the Department of Health are working together to respond to the violations cited in the report to ensure the health and safety of individuals in care, and to ensure a comprehensive plan of correction is submitted and executed by Norristown State Hospital," Kostelac stated.
Friday, June 8, 2018
By Walter F. Roche Jr.
Reaching back nearly two years, Pennsylvania health officials have cited Abington Hospital for a "mishap" in which a patient was given a dose of a medication four times the strength prescribed by her doctor.
In a six-page report recently made public, the health department surveyors found that a resident physician and his supervisor failed to properly perform a medication reconciliation process when the woman appeared at the hospital's emergency room on July 10, 2016.
Instead, the report states, they relied on the incorrect information provided by the patient's husband. Apparently overlooked was a fax from the woman's primary care physician, sent about 10 minutes before the wrong dosage was administered, listing the correct dosage of the cardiac medication, 5 milligrams three times per day.
A few hours after the patient was administered 20 milligrams of Midodrine on July 11, her blood pressure shot to 207/100 and she reported dizziness and other symptoms requiring rapid response team intervention.
In addition to failing to note the fax from the PCP, the surveyors cited the staffers for failing to ask the patient herself about the correct dosage.
Hospital records reviewed by the state showed the patient's own hospital record stated,"of note a mishap was made on the patient's medication reconciliation during admission."
Abington, a 665-bed facility, is part of Abington-Jefferson Health.
The report states that there was no record that the patient herself "was given the opportunity to confirm what the spouse may have discussed with the medical resident/attending physician in regards to their Midodrine dosage."
Stating that "there was no documented evidence that the patient was determined to be disoriented, incompetent and/or unable to answer questions," the report states that there was "no documented evidence that the admitting medical resident and/or their supervising attending physician made a good faith effort to involve the patient in the medication reconciliation process."
The report cites a notation in the patient's record stating "Minimizing midodrine dose may help prevent future hemorrhages."
A subsequent hospital record from the Rapid Response Team questioned the 20 milligram dosage.
"Need to clarify the dose of Midordine as 20 mg three times a day, seems a very high dose which is usually not recommended,"the record states, adding that no further doses should be administered.
"Hold Midodrine for now," the note states.
Abington filed a plan of correction which included the implementation in the pharmacy system to alert pharmacists when dosage of Midordine exceeds the usual range."
Hospital officials did not respond to a series of questions about the incident.
Tuesday, June 5, 2018
By Walter F. Roche Jr.
A Philadelphia behavioral hospital videotaped patients without their consent and captured one of those patient being assaulted twice within a matter of minutes.
In a lengthy report, inspectors from the Pennsylvania Health Department found the violations during a four day visit to Friends Hospital, a facility that has been the subject of prior critical reports from the state agency. Though it was founded as a Quaker institution, the hospital is now owned by a for-profit chain, Universal Health Services.
The report was made public last week even though the hospital had not yet filed an approved plan of correction. Friends officials did not respond to requests for comment.
"The facility failed to protect and promote the rights of each patient by failing to ensure that informed consent was obtained prior to the video recording of direct patient care," the report states.
Despite the widespread use of cameras, inspectors learned that there were no viewing monitors for staff to monitor patient safety.
All patients and staff, the report states, were under constant camera surveillance. The surveyors found "multiple ceiling mounted cameras dispersed through out patient care areas."
A subsequent review of patient records showed a patient who was admitted to the facility on March 24 had not signed a consent to video surveillance.
Video showed the same patient being kicked by two of his peers on March 31. The patient was "taken down to the floor and the other two punched his face with hands and feet."
A second assault on the same patient occurred minutes later, according to the report.
Records showed the patient had swelling over his right eye and had substantial nose bleeding.
As for the cameras, the report states, patients who don't sign the consent form are "still recorded through out their hospital stay without their explicit consent or knowledge."
The surveyors also found that records of the incident were inaccurate.
The facility "failed to ensure patient care was provided in a safe setting," the report concludes.
Other findings involving a second patient who was so heavily sedated she could barely sit up.
"Patient was asleep and barely rousable in the day room," according to the report.
Still other findings included the improper use of physical and chemical restraints. Staffers also failed to recheck the blood pressure of a patient who had a seriously low pressure in a routine check and those same staffers failed to notify the patient's physician of the reading.
Friday, May 25, 2018
By Walter F. Roche Jr.
Philadelphia's Wills Eye Hospital has been cited for a series of rules violations including failure to provide appropriate and required radiology services for more than a half dozen patients.
In an 18-page report, state Health Department inspectors found that between November of last year and January of 2018 the hospital was shuttling patients to an outpatient radiology center located in the same building but run by the adjacent Thomas Jefferson University Hospital.
Cathy Moss, the Wills spokeswoman, said that after the April inspection the hospital sought and obtained a waiver from the requirement to provide the radiology services in-house.
Moss said that while Wills "has a very large sophisticated imaging center that is fully utilized for our patients," the hospital has an agreement with Jefferson for "neurological imaging needs."
She said Wills own imaging department is for vision/eye-only imaging.
Moss said that the state had also approved Wills' corrective action plan for other violations cited in the April report.
Those other citations included the failure to verify the performance of pre-surgical patient anesthesia evaluations within 48 hours before surgery, failure for surgeons to verify a patient's identity after placement on the operating table and failure to document that a follow up anesthesia evaluation was performed within 24 hours following surgery.
"It was determined that the facility failed to ensure that patients had been identified by the surgeons after placement on the operating table prior to the procedure for 13 of 13 surgical records reviewed," the report states.
Moss characterized the citations as paperwork issues that did not impact the quality of patient care. The inspection, which began in February, was performed as part of the annual state license renewal process.
Still other deficiencies included the failure to include the names of participating fellows on consent forms and in one case there was no signed consent form.