It's a 333 page federal report on the Marymount hospital blood lab, obtained exclusively by newsnet5.com, which reveals technicians at the lab committed a wide variety of procedural errors on thousands a patient blood tests.
Officials with the Centers for Medicare and Medicaid Service, or CMS, report the blood lab at Marymount Hospital in Garfield Heights was closed on Sept. 3 due to a series of testing violations.
newsnet5.com learned exclusively the sweeping CMS survey, which started in March, uncovered six violations in the handling of blood samples at the facility including enrollment and testing of samples, Hematology and Immunohematology procedures.
The federal report reveals the lab director and lab team leader were removed from their jobs, lab employees are facing vigorous re-training and competency assessments, and new equipment maintenance and calibration procedures are now required.
CMS officials said Cleveland Clinic is already facing more than $600,000 in fines, and must have all issues at the lab taken care of by Oct. 5, or face losing its federal certificate.
Cleveland Clinic told newsnet5.com its clinical staff conducted an extensive review of more than 11,000 patient records. Based on the results of the in-depth audit, it was determined patient care was not compromised and no additional testing is needed.
Still, the CMS told newsnet5.com an average of 1.4 million tests are conducted at the Marymount blood lab every year, and it's not feasible to be able to re-test or review all patients.
The Cleveland Clinic issued the following statement in response to our story:
"We take this seriously and are very committed the quality of our lab services at Marymount Hospital and across our health system. Please know that our clinical staff has conducted an extensive review of more than 11,000 patient records. Based on the results of the in-depth audit, it was determined that patient care was not compromised. No additional testing for patients was needed.
We have been working closely with CMS to begin to resolve their concerns and voluntarily stopped the services affected at Marymount. As of a letter dated September 3, please know that CMS has removed the immediate jeopardy status.
Since then, we are in the process of hiring a CMS-approved outside consultant to help us with improving our policies and procedures. We have also formed a full team working with CMS to ensure we’re doing all that needs to be done. We have conducted extensive re-training of our employees over the last three months, improving our policies, re-validating tests, and increasing oversight.
At this time, we understand that there are pending fines accruing, but we will not know CMS’s final decision until the matter has been resolved."
CMS explained the on-going survey by telling newsnet5.com that surveyors found the lab was out of compliance with six condition level deficiencies, which rose to the level of immediate jeopardy.
As of Aug. 28, the lab was out of compliance with three condition level deficiencies and the immediate jeopardy was not removed.
CMS imposed a civil money penalty that began on June 30 with an associated amount of $10,000 per day through Sept. 3. Beginning Sept. 4, the amount changed to $2,500 per day.
Cleveland Clinic told newnet5.com it hopes to have all issues at the Marymount Hospital lab solved by Oct. 3.
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