Deficiencies characterized as “serious” and “critical” by a federal official range from management oversight, to contracted staff competency, to medical staff responsibilities to problems with a dialysis provider are detailed in a 16-page report conducted three months ago during an in-person complaint investigation launched by the Federal Department of Health and Human Services, Centers for Medicare and Medicaid Services, known as CMS.

The Gilroy hospital responded to the report that called attention to 12 items characterized as “not meeting the standard” for conditions of participation as a Medicare provider.

“Each hospital, when they sign that provider agreement, agrees to meet all applicable conditions and regulations at all times,” said Steven Chickering, associate regional administrator with CMS. “From our point of view, it is serious.”

Hospital CEO Joanne Allen wrote and signed a “plan of correction” letter that addresses each of each of the 12 items.

One of Allen’s responses to the finding that Saint Louise did not provide any oversight to water testing procedures of its dialysis provider states, “since 2010, the Infection Control Officer has reviewed water testing reports on a monthly and quarterly basis, and verifies all testing requirements are met.”

The Dispatch inquired with Allen as to the discrepancy, but did not hear back as of press time.

Rufus Arther, CMS manager for the division of survey and certification, non-long term care branch for the region that includes Saint Louise, said he could not speak specifically to Allen’s plan of correction. CMS still has to review the document, he said.

Allen declined to elaborate on the report or its contents despite numerous requests via phone and email, at one point writing “I’m sure you have all the information you need for your story from Jasmine;” instead deferring all inquires to hospital spokeswoman Jasmine Nguyen.

Nguyen described the survey process as a proactive “partnership” with CMS that helps the hospital improve and “be better.”

“A lot of this helps us to see things that we miss,” she said. “(CMS) helps us see things that we didn't see as well.”

Nguyen said “these surveys are not a big deal at all.”

When asked to comment on that characterization, Chickering said, “They may have characterized it a certain way, but really – this is very important,” he said. “They have a point of view, but obviously we take this very seriously. From our point of view, each requirement is important.”

The bottom line is that any hospital receiving Medicare/Medicaid funding should be in compliance with the Conditions of Participation 24/7, he said.

The 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 at 9400 No Name Uno to be “out of compliance” with a dozen Medicare regulations.

Because of this, the hospital’s status as a “provider deemed to meet Medicare Conditions of Participation” has been removed.

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 “deemed” status back until (1) Allen’s plan of correction is accepted, and (2) a full re-survey of the hospital is conducted by CMS to ensure that all Medicare Conditions of Participation are being met.

“Whenever there’s a non-compliance to our conditions, we take that very seriously. We’re very interested in this case and the follow-up will hopefully reveal that those (deficiencies) identified have been resolved,” said Arther.

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 Nguyen.

As no two scenarios are alike, Chickering said it is difficult to compare Saint Louise’s situation against other hospitals. Sometimes, CMS will find “one egregious, deficient practice” that warrants major concern; other times, CMS will uncover multiple deficient practices that “fortunately” have not yet merited serious consequences, said Chickering.

Signing Medicare and Medicaid agreements is a voluntary process wherein a hospital or healthcare provider agrees to be in compliance with Conditions of Participation at all time, Chickering reiterated. Hence, “when a survey occurs, all that should be in place,” he said. “Not just from our point of view – it's not just a paper exercise. It's ensuring overall patient safety.”

A complaint survey is not infrequent, he added – “but it's not common, either.” On average, Chickering processes about 40 to 50 complaint validation surveys annually for the region that he oversees, which includes California, Arizona, Nevada and Hawaii.

The resurvey is usually conducted unannounced within a 90- to 120-day period following the acceptance of the plan of correction, according to Chickering.

Survey results

“Deficiencies” discovered during the CMS investigation conducted nearly a month-long are chronicled in a 16-page report, which the Dispatch obtained through a Freedom of Information Act Request.

Some specific examples of “deficiencies” include:

- Failing to ensure that a contracted dialysis provider “performed services in a manner that was safe and effective for patient care.”

- 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.

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

- Deficiencies in the practice for appraising and assessing the competency of three staff nephrologists (kidney specialists).

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

If a patient is going to receive anesthesia, Chickering said the anesthesiologist must have a patient’s latest information (Allergies? Pre-existing conditions? Current prescriptions?). Such factors can impact a patient’s reaction to certain types and dosage amounts of anesthesia, he said.

“We don’t want any surprises,” said Chickering. “It’s very critical.”

Among the dozen or so findings, Chickering underlined each item as uniformly crucial.

Several of the issues stem from the hospital's former contracted dialysis provider, which had been working with Saint Louise since 2006. Saint Louise terminated the provider’s contract one day after the cell phone incident.

The hospital, which regularly assists about 22 dialysis patients per month, should have a new dialysis provider by the end of April, Nguyen said.

When asked to name the former dialysis provider, and to provide a copy of the contract, Nguyen said those details are confidential.

CMS uncovered other problems with the former dialysis provider, such as the fact Saint Louise did not provide “any oversight” to the group’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. 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, Chickering explained.

“We hold the hospital responsible to make sure that they know the water is in place,” he continued. “They can’t just say, 'we rely on the contractor to tell us that it is.’ How do you know for sure? That's very serious.”

For several of the contracted dialysis staff, CMS also found that competencies and performance evaluations – which should be conducted on an annual basis – were almost four years old. There also “lacked evidence of current nurse competencies in providing dialysis care,” according to the report.

Saint Louise has not informed any of its past dialysis in-patients as to the situation with its former dialysis provider, because “no other patients were impacted” Nguyen replied.

The Dispatch requested additional clarification regarding this topic, but did not hear back from Nguyen or Allen as of press time.

In her plan of correction, Allen addresses each issue individually. She explains how Saint Louise has, or plans to, remedy the problem.

Nguyen said the survey has been an educational and “great opportunity” for hospital staff to focus on improving its facilities and practices.

“Honestly, this has not affected our patients’ care,” she said. “It’s a great opportunity to see all of our staff and nurses come together and team up in all departments, because we never know what the surveyor will request.”

About Saint Louise

Saint Louise originally opened in 1989 just south of Cochrane Road in Morgan Hill. It competed with South Valley Hospital in Gilroy; now the current location of Saint Louise.

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,” according to the organization's website. It is sponsored by the Daughters of Charity of St. Vincent de Paul, who have been serving the sick and impoverished for 375 years through healing ministries worldwide. The Daughters of Charity recently announced a memorandum of understanding to merge with Ascension Health Alliance, self-described as “the nation’s largest Catholic and nonprofit health system.”

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