After suffering a severe reaction while undergoing dialysis treatment at the Northwest Detroit Dialysis Center on Sept. 26, 1997, Mable Tubbs Johnson was rushed to Sinai Hospital's emergency room. She died less than three months later from an infection, according to hospital discharge papers.
This February, members of her family began holding weekly protests at both the dialysis treatment center and the hospital to warn patients about what they claimed were serious problems with the dialysis program jointly owned by the Henry Ford Health System and Detroit Medical Center, which runs Sinai Hospital.
As patients entered the facility, family members routinely handed them fliers claiming Johnson was exposed to the chemical formaldehyde -- used to sterilize dialysis machines -- during her treatment on that day in September. The same allegations were later made in formal complaints filed with state investigators.
Henry Ford officials deny the allegation and say lab reports prove the allegation is false.
In July 1998, a three-person team of investigators from the Michigan Department of Consumer and Industry Services and the federal Health Care Finance Administration conducted a "survey" of the facility. According to a report issued in August, investigators "did not substantiate" that Johnson was exposed to formaldehyde on the date claimed.
The family continues to insist that the event occurred, and in follow-up complaints allege a cover-up is under way.
However, the clinic was cited for 13 violations, including a number of problems with procedures designed to prevent patients from being accidentally exposed to formaldehyde.
As a result of the state investigation, Ford agreed to discontinue reusing "dialyzers," as the artificial kidney bags are called. Because a new bag is now used every time, there is no need to disinfect them with formaldehyde.
The Metro Times asked both Henry Ford and the Detroit Medical Center how clinic operators could allow an atmosphere where so many serious violations were found, especially with protesters standing outside the facility for months alleging substandard care?
Neither health care corporation would respond to the question.
Among the violations identified in an August report:
* There was no record showing that the two primary staff members providing treatment involving the "reuse" of dialyzers had been trained and certified to perform the task. This violation, stated the report, "represents a serious and immediate threat to patients receiving dialysis." One of the two technicians began work the day before Mable Tubbs Johnson was rushed to the hospital.
* No evidence was available to indicate the dialysis machines were being properly disinfected. This is critical because dialysis patients are particularly susceptible to infections, which can be fatal.
* When questioned, technicians did not know "what method to use or how to verify the germicide (formaldehyde) concentration."
* When a selected dialyzer was tested for germicide concentration by staff called from another unit, the concentration level was found to be below the minimum acceptable limit. It was later reported that the unit was malfunctioning and in need of maintenance.
* Before a patient begins treatment, a check is supposed to be conducted to ensure no formaldehyde remains in the machine; an indication this test has been conducted is to be entered into the patient's chart prior to each treatment. A random survey of seven patients being treated the morning of July 1 found that, in all seven cases, the box indicating the required test had been conducted was not checked.
"Interviews with different staff members indicated that they were unsure of the reason for this not being completed," stated the report.
* The facility's quality assurance process failed to identify "critical indicators." For instance, there was a lack of water-quality monitoring results. This is a crucial issue because patients are exposed to as much as 150 times the amount of water the average person consumes during the day. If bacteria, chemicals such as chlorine or various minerals are present in high concentrations, the patient is threatened with severe illness or death.
* An outdated reagent used to test for residual formaldehyde was apparently being used, calling into question the validity of any formaldehyde testing that was being done.