Monday, October 20, 2014

TN State University Cited for Research Missteps

By Walter F. Roche Jr.

Eastern Tennessee State University is notifying some student athletes that they were involved in four research studies that did not go through federally mandated reviews.
The notifications stem from an investigation by the U.S. Department of Health and Human Services into charges that some students involved in ETSU athletic programs may have been coerced or under undue influence to participate in research studies being conducted by graduate students.
In a Sept. 25 letter to William N. Duncan, vice provost for research at the Johnson City institution, HHS bureau director Kristina Borror wrote that some ETSU athletes "might believe that if they do not agree to have the test results used for research purposes, they will not be able to play and will lose their scholarships."
Duncan, in an email response to questions about the investigation wrote, "The investigation is complete and the Office of Human Research Protection has accepted our corrective action plan, including notifying individuals that we were able to contact who had participated in the four studies listed in the letter."
The studies, according to the report, included blood draws and tissue sampling in tests of "various physical performance characteristics."
Duncan added that new procedures have been implemented to ensure continued compliance.
The university official did not respond to questions concerning the number of students involved in the studies or in which athletic programs those students participated.
According to the letter from Borror,  the doctoral students involved in conducting the research are often team coaches,
"If they are taking a course taught by the doctoral student, they might also be concerned that they might receive a lower grade if they don't participate in the research," Borror wrote, adding that OHRP was concerned that enrollment procedures for the studies "perhaps do not minimize possibility of coercion or undue influence."
OHRP faulted the university for proceeding with the four studies without submitting them in advance for approval by the ETSU Investigative Review Board.
The university also was cited for failing to get informed consent from the parents of two student participants who were under the age of 18.
Among the steps promised by ETSU were ensuring that team coaches were not present when students are asked to give their consent to participation in the research and doing random interviews of research subjects in the future to query whether there was any undue pressure.

Friday, October 17, 2014

Four CHOP Patients Hit in Spring Norovirus Outbreak

By Walter F. Roche Jr.

 Four patients in addition to 19 nursing staffers were sickened in an outbreak of norovirus earlier this year at the Childrens Hospital of Philadelphia.
A hospital spokesman disclosed the number of patients affected in response to questions Friday.
As previously reported, state inspection records disclosed the number of staffers who were sickened but provided no information on patients.
The outbreak prompted a visit to the facility in May by state regulators and the subsequent issue of a citation for failing to follow state and federal regulations.
CHOP officials say that all the deficiencies have been corrected and new procedures and retraining programs put in place to ensure there are no future incidents.
Disclosure of the state citation comes as CHOP has been designated by the U.S. Centers For Disease Control and Prevention as one of the pediatric hospitals across the country that will be called upon to handle ebola cases involving children, if and when any occur.
According to the six-page state inspection report, the outbreak occurred when CHOP staffers failed to properly sanitize a room previously occupied by a norovirus patient. Inspectors also faulted the facility for failing to require that any sickened workers not report to work until 48 hours after they displayed no symptoms of the virus.
The outbreak occurred in late March and early April of this year.
Norovirus, which has become increasingly common on ship cruises, is marked by severe vomiting and diarrhea.
According to CHOP officials all the patients and staffers recovered from the outbreak.

Thursday, October 16, 2014

Childrens Hospital of Philadelphia Cited in Norovirus Outbreak

By Walter F. Roche Jr.

Nineteen nursing staffers at Childrens Hospital of Philadelphia were stricken with norovirus earlier this year after workers failed to properly sanitize a contaminated patient's room.
The outbreak, which has not previously been made public, triggered an inspection by the state Health Department and  a six-page citation by the agency for violations of state regulations.
According to the health agency report, workers at CHOP "failed to implement appropriate cleaning protocols in accordance with facility policy to ensure care was provided in a safe setting for one nursing unit affected by the Norovirus."
The outbreak, which occurred in late March and early April of this year, struck staffers in 4E/4S, a post surgical unit.
A CHOP spokeswoman said all the staffers recovered. She said some patients also were sickened but did not provide further details.
The state report, which was issued in May, concluded that hospital workers failed to properly sanitize the room with a hospital approved bleach.
In addition state inspectors found that the hospital failed to require that affected workers remain out of work for 48 hours after any symptoms disappeared.
It was not until March 27 that the staffers were directed not to return to work until 48 hours had passed without norovirus symptoms, the report states.
The state found that between March 11 and April 10, 19 CHOP nursing staffers were identified with norovirus symptoms.
Norovirus is highly contagious and results in acute gastroenteritis. Symptoms include diarrhea and vomiting. It can be fatal especially for the young, elderly and those with a compromised immune system.
Disclosure of the outbreak comes amid growing concern about an international outbreak of deadly ebola virus and more contained outbreaks of enterovirus D68. CHOP, in fact, has treated four confirmed enterovirus victims. That number may grow pending test results from the U.S. Centers for Disease Control and Prevention.
Two Texas health care workers, who were involved in the treatment of a now deceased ebola victim, have been diagnosed with ebola.
A CHOP spokeswoman, Rachel Salis-Silverman, said that the Spring outbreak helped the facility in dealing with the current issues.
"This norovirus outbreak among staff taught CHOP that a process needed to be put into place for earlier identification of an outbreak, and additional training on sanitizing patient areas was required. These new processes help support CHOP’s broader preparations underway, which are designed to address the most recent outbreaks," she wrote in an email response to questions.    
CHOP, state records show,  filed a plan of correction following the May inspection in which they stated that staffers had been retrained on proper cleaning methods. That plan was implemented by early July.
More recently CHOP was again cited by state inspectors for giving a patient 10 times the proper dose of morphine.
The seven-page report dated Aug. 8 concluded that staffers failed to follow a series of safety checks before administering by intravenous solution 1.5 milligrams of morphine instead of the 0.15 dose prescribed by a physician.
While the unnamed patient subsequently had decreased respirations, "Naxalone was given with immediate improvement in his respirations."
According to the state records, both inspections were triggered by unidentified complaints.
CHOP also filed a corrective action plan following the overdose incident which included retraining of staff in proper safety checks before administering "high-alert medications."