Bill To Strengthen Regulations For Kidney Dialysis Centers Moves Forward - NBC 7 San Diego
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Bill To Strengthen Regulations For Kidney Dialysis Centers Moves Forward

According to state lawmakers, in California kidney dialysis centers are inspected every six years despite federal guidelines requiring recertification every three years.

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    Bill To Strengthen Regulations For Kidney Dialysis Centers Moves Forward
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    A dialysis machine cycles the blood of a patient who needs help to remove toxins.

    Ed Note: This story has been updated from a previous version to reflect that it is the Center for Medicare and Medicaid Services and not the Center for Disease Control that set requirements for when kidney dialysis centers are recertified.

    In California 63,000 patients rely on kidney dialysis, a life sustaining medical procedure but critics say there is a gap in this live-saving care in San Diego and across the state.

    A major problem in California, according to health professionals, is that the dialysis centers aren’t inspected as often as facilities like nursing homes and hospitals.

    Wednesday, in Sacramento, the Dialysis Patient Safety Act (SB349), an attempt by lawmakers to address the problems, passed its first hurdle. The bill, sponsored by State Senator Ricardo Lara (D-Bell) would require annual inspections of the clinics and according to California Senator Lara would “set safe staffing levels.”

    The bill would also mandate a ratio of one technician for every three patients, one nurse to every eight patients and one social worker for every seventy five patients.

    San Diegan Roberta Mikles supports the bill.

    “I am an RN and I researched thoroughly the CMS (Centers for Medicare and Medicaid Services) requirements” for kidney dialysis patient care, she said. Her father Mickey was in dialysis for five years before he died.

    “Three days a week I sat with him through the entire treatment,” Mikles said. She said she would sit with him three and half, sometimes four hours depending on how much blood needed to be cleaned. Over time, she said, she began to form a critical opinion on how her father was treated.

    “There were a lot of things that were very, very disturbing” she said.

    In California kidney dialysis clinics are only inspected on average once every six years, California Senator Lara said. In comparison, hospitals are required to be inspected every two years, nursing homes once a year.

    Kidney dialysis clinics must adhere to federal guidelines but without consistent annual inspections there is no way to know if the clinics are performing up to standards.

    According to the CMS, recertification surveys based on inspection reports, are supposed to be completed every three years but state records show that’s not happening in California. In 2015, according to the California Department of Public Health, state inspectors visited 148 centers across California. There are 372 dialysis centers in Southern California alone.

    Mikles said she believes this lack of oversight created a culture in the clinics that included ignoring complaints of patients or their family and sloppy and improper infection control practices. She told NBC 7 Investigates that throughout the years there were several instances where she caught staff “inserting the needle the wrong way.”

    NBC 7 Investigates obtained inspection records of several San Diego area dialysis clinics. The inspections support Mikels claims of “infection control” issues, indications of an overworked staff demonstrated by required tests not being done or care plans for patients not followed.

    “As far as I am concerned, they do a cookie cutter treatment,” she said.

    Mikles spoke before lawmakers Wednesday in support of the latest bill. She told the Senate Health committee, “we need to stand up for our family members who depend on dialysis, these are the brothers, sisters, mothers and in my case, my father. This is a life sustaining treatment and we need reform now.”

    This is isn’t the first time she took her concerns to Sacramento though. Before her father died, Mikles said she was so disturbed by what she had witnessed, she worked to help create legislation intended to increase state oversight of dialysis centers. That bill never made it out of committee.

    “I went up against the dialysis companies and the lobbyists,” she said.

    According to the New England Journal of Medicine, the dialysis business is “enormously profitable.” The two leading dialysis companies, according to the Journal, are Fresenius Medical Care and DaVita Healthcare Partners, which combined control 70% of the kidney dialysis market in the United States.

    Wednesday at the hearing in Sacramento, Dr. Brian Wong, a medical director at both a DaVita and Fresenius clinic, opposed the bill. He said he thinks the concerns laid out by the bill’s proponents are not as dire as stated. He added the industry is already heavily regulated by the Centers for Medicare and Medicaid.

    California State Senator Toni Atkins (D-San Diego) is on the committee and during the hearing said she’d spoken to a number of dialysis clinic employees about staffing levels.

    “I heard story after story of someone who called in sick and there seemed to be no back up plan,” she said. “I heard too many stories of not having adequate staff” and concluded that it affects the employee's morale and the quality of care for patients.

    Next the bill will be in front of the Senate Labor Committee which will focus on the proposed staffing levels the bill suggests.

    In preparing for the hearing, NBC 7 Investigates reviewed donations to all members on the Senate Health Committee from Fresenius Medical Care and DaVita Healthcare Partners. The analysis showed, only Senator Atkins received any significant amount of funds.

    According to the California Secretary of State, Atkins received a total of $7,000 from Davita for the period between August 2013 and April 2015. During the hearing Wednesday Atkins voted in support of the bill.

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