CMS fines Cleveland Clinic hospital for lab deficiencies

A CMS inspection of Cleveland Clinic's Marymount Hospital in Garfield Heights, Ohio, found six serious violations of procedures that rose to the level of immediate jeopardy for a period of time, according to a newsnet5 report.

According to an emailed statement from Cleveland Clinic, CMS selected Marymount Hospital for a Clinical Laboratory Improvement Amendments validation survey and visited the hospital in March.

CMS found six issues that needed to be addressed, and put the hospital in immediate jeopardy status. The deficiencies were in the areas of handling and testing blood samples and staff competency assessment requirements, according to newsnet5. Since that time, three of the violations have been fully addressed and, as of Sept. 3, CMS took the hospital out of immediate jeopardy.

However, the hospital is still out of compliance with three conditions.

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Earlier this month, the hospital announced it would stop offering some lab services voluntarily for an unspecified period of time because of the deficiencies found by CMS. Cleveland Clinic officials are working with CMS to get all of the issues resolved.

Some of the deficiencies cited by CMS include failure to evaluate staff competency, failure to follow blood sample testing procedures, not maintaining and checking the temperature of blood products, failure to calibrate machinery and using expired materials to perform tests, according to The Plain Dealer.

Cleveland Clinic removed the director of laboratory services at Marymount from her position and has hired a new director, as well as a team leader and lab manager, The Plain Dealer reported. While lab services are suspended, employees are completing required training.

Marymount Hospital's clinical staff has performed a review of more than 11,000 patient records and determined that patient care quality was not compromised in the lab, according to the statement from Cleveland Clinic.

Additionally, Marymount Hospital is facing more than $600,000 in fines from CMS, which imposed a civil money penalty on the hospital at the end of June, according to newsnet5. The fines were $10,000 per day through Sept. 3 and are now at $2,500 per day.

"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," the Cleveland Clinic statement reads.

Additionally, a Cleveland Clinic spokeswoman reports the hospital is working with CMS and will be able to respond with a plan for the Marymount lab by Oct. 3.

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