A plan of correction addressing “serious” and “critical” deficiencies at Saint Louise Regional Hospital received the stamp of approval from the Federal Department of Health and Human Services, Centers for Medicare and Medicaid Services, which will conduct an unannounced follow-up survey within the year to ensure the hospital is meeting all the conditions of participation as a Medicare provider.

While the logistics of the survey are “an open book” in terms of when it will take place and what will come under the magnifying glass, “it's not an open book test,” said CEO Joanne Allen Tuesday.

CMS spokesman Jack Cheevers confirmed the hospital's plan of correction has been approved.

“We'll conduct an unannounced survey of the hospital to ensure that the changes and improvements outlined in the plan of correction are in fact put in place,” he said.

The month-long survey was launched by CMS – a federally funded agency that provides oversight to hospitals and ensures health care providers comply with rules – from Dec. 22, 2011 to Jan. 18, 2012 – following complaints that a contracted dialysis nurse was talking on a cell phone while caring for a patient. During the investigation, CMS officials found the hospital to be “out of compliance” with a dozen Medicare regulations.

One of these problems is well on its way to being remedied, said Allen.

Saint Louise initiated a complete overhaul of its dialysis services, terminating the contract with its former provider one day after the cell phone incident. The hospital is now in the homestretch of smoothing out the final details of a new agreement with DaVita, “a leading provider of kidney care in the United States, delivering dialysis services to patients with chronic kidney failure and end stage renal disease,” according to the group's website.

As of Dec. 31, 2011, DaVita operated or provided administrative services at 1,809 dialysis facilities in the U.S., serving approximately 142,000 patients, according to its website.

DaVita will have three to four South County personnel assigned to Saint Louise, said Allen. She expects by late May the new provider to be set up and operating out of Saint Louise.

Dialysis is provided to in-patients only at Saint Louise. In the interim, those patients requiring dialysis care (a monthly average of 22) are currently being transferred to other hospitals.

Problems with Saint Louise’s former dialysis provider – which had been working with the hospital since 2006 – were a standout finding by CMS investigators. Hospital management failed to ensure the contracted employees “performed services in a manner that was safe and effective for patient care,” according to CMS.

Investigators uncovered other dialysis-related issues. One involved the lack of “any oversight” to the contractor’s water testing procedures.

During hemodialysis, which performs the function of the kidneys, water is a “vital” part of the solution that removes impurities from a patient's blood. Thus, it is absolutely critical to ensure that the water is properly purified before use, according to CMS. A hospital should have strict standards in place to check for certain contaminates or minerals that could react to other solutions used in the dialysis process, said Steven Chickering, associate regional administrator with CMS.

As outlined in the plan of correction, the new contract with DaVita outlines “definitive expectations” for safety, quality, effectiveness, annual check-ups on staff competency as well as water testing procedures and standards.

There will be zero difference between the competencies expected of Saint Louise personnel and its contracted employees, Allen said.

Now that the plan of correction has been approved, a “full-fledged,” follow-up accreditation review will be conducted at an unknown time by three CMS officials. They will post their intent to survey on Saint Louise's website the morning the survey is scheduled to take place, Allen explained.

After 10 years in hospital administration in which she has experienced a handful of CMS surveys, Allen says the process has evolved into a “more positive and educational” experience for hospitals who utilize the valuable feedback.

“Their job is to find something, and you hope they don't find too many things,” she said, touching on the thoroughness of CMS officials.

Constructive criticism come what may, “their purpose is to be educational and to make sure we're providing safe patient care,” Allen said.

Review methods will sometimes entail “patient tracers,” Allen explained, wherein a CMS official shadows a patient from the emergency room all the way to being discharged. Investigators often focus on “anything that touches patients along the way,” as well as efficiency of communication that takes place between nurses, physicians, pharmacists, floor staff, labs, etc., Allen said.

While Saint Louise can still receive Medicare patients and is currently not at risk of losing its Medicare funding, the hospital won't get its status back as a provider “deemed” to meet Medicare Conditions of Participation until CMS conducts its full re-survey.

Saint Louise is a member of the Daughters of Charity Health System; “a regional health care system of six hospitals spanning the California coast from the San Francisco Bay Area to Los Angeles. Per the DOCHS policy, no one is turned away because of inability to pay. After a patient is cared for, a financial adviser will work with that patient if he/she is uninsured.

So far this year, Medicare patients account for approximately 35 percent of the patient population at Saint Louise, which has 96 licensed beds and saw 26,000 patients walk through its emergency room doors last year, according to hospital spokeswoman Jasmine Nguyen.

As for the other 11 specific problems characterized as “not meeting the standard” for conditions of participation as a Medicare provider, several of the issues entailed:

• Failure to implement policies regarding the control of infections, by allowing certain contracted patient care personnel to work without having evidence of several vaccinations required by hospital policy.

• Failing to maintain updates to a patient's medical history, along with a physical examination, prior to a surgery.

• Failure to monitor and evaluate annual tuberculosis testing compliance for a handful of hospital nurses and practitioners.

Allen has addressed all 12 of the “deficiencies” individually in her plan of correction to CMS.

“Saint Louise Regional Hospital is committed to patient quality and safety at the highest levels,” said Nguyen. “Saint Louise is standing by and prepared for our unannounced CMS survey.”

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